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EXECUTIVE
SPECIAL ONCOLOGY ISSUE
CANCER MOONSHOT
Better quality, lower costs by 2020
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November 2016
VOL. 26 NO. 11
Your members with retinal diseases* may be facing the serious risk of vision loss without screening
and doctor-recommended treatment.1-3 Vision loss may require ongoing resources.1-3
THERE’S EYLEA—a treatment option that can fit
your plans for proven visual acuity outcomes
EYLEA has proven outcomes as demonstrated in phase 3 clinical trials in patients with
Wet AMD, Macular Edema following RVO, DME, and DR in patients with DME
With monthly and every-other-month dosing,† EYLEA offers flexible dosing options to meet
the needs of your providers and your members
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
• EYLEA® (aflibercept) Injection is indicated for the treatment
of patients with Neovascular (Wet) Age-related Macular
Degeneration (AMD), Macular Edema following Retinal Vein
Occlusion (RVO), Diabetic Macular Edema (DME), and
Diabetic Retinopathy (DR) in Patients with DME.
CONTRAINDICATIONS
• EYLEA® (aflibercept) Injection is contraindicated in patients
with ocular or periocular infections, active intraocular
inflammation, or known hypersensitivity to aflibercept or to
any of the excipients in EYLEA.
WARNINGS AND PRECAUTIONS
• Intravitreal injections, including those with EYLEA, have
been associated with endophthalmitis and retinal
detachments. Proper aseptic injection technique must
always be used when administering EYLEA. Patients
should be instructed to report any symptoms suggestive of
endophthalmitis or retinal detachment without delay and
should be managed appropriately. Intraocular inflammation
has been reported with the use of EYLEA.
• Acute increases in intraocular pressure have been seen
within 60 minutes of intravitreal injection, including with
EYLEA. Sustained increases in intraocular pressure have
also been reported after repeated intravitreal dosing with
VEGF inhibitors. Intraocular pressure and the perfusion
of the optic nerve head should be monitored and
managed appropriately.
• There is a potential risk of arterial thromboembolic events
(ATEs) following intravitreal use of VEGF inhibitors, including
EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial
infarction, or vascular death (including deaths of unknown
cause). The incidence of reported thromboembolic events in
wet AMD studies during the first year was 1.8% (32 out of 1824)
in the combined group of patients treated with EYLEA. The
incidence in the DME studies from baseline to week 52 was
3.3% (19 out of 578) in the combined group of patients treated
with EYLEA compared with 2.8% (8 out of 287) in the control
group; from baseline to week 100, the incidence was 6.4%
(37 out of 578) in the combined group of patients treated with
EYLEA compared with 4.2% (12 out of 287) in the control group.
There were no reported thromboembolic events in the patients
treated with EYLEA in the first six months of the RVO studies.
ADVERSE REACTIONS
• Serious adverse reactions related to the injection procedure
have occurred in <0.1% of intravitreal injections with EYLEA
including endophthalmitis and retinal detachment.
• The most common adverse reactions (≥5%) reported in
patients receiving EYLEA were conjunctival hemorrhage,
eye pain, cataract, vitreous floaters, intraocular pressure
increased, and vitreous detachment.
*The FDA-approved indications for EYLEA are Wet AMD, Macular Edema following RVO, DME,
and DR in Patients with DME.
†
After an initial monthly dosing period for certain indications.
References: 1. American Academy of Ophthalmology. Preferred Practice Pattern®: Age-Related
Macular Degeneration. http://www.aao.org/preferred-practice-pattern/age-related-maculardegeneration-ppp-2015. 2. American Academy of Ophthalmology. Preferred Practice Pattern®: Retinal
Vein Occlusions. http://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp-2015.
3. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy.
http://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp-updated-2016.
Please see brief summary of full Prescribing Information on the following page.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
©2016, Regeneron Pharmaceuticals, Inc.,
777 Old Saw Mill River Road, Tarrytown, NY 10591
All rights reserved
08/2016
US-PMA-12565
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
FOR COMPLETE DETAILS, SEE FULL PRESCRIBING INFORMATION.
1 INDICATIONS AND USAGE
EYLEA® (aflibercept) Injection is indicated for the treatment of patients
with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular
Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema
(DME), and Diabetic Retinopathy (DR) in Patients with DME.
2 DOSAGE AND ADMINISTRATION
2.1 Important Injection Instructions. For ophthalmic intravitreal injection.
EYLEA must only be administered by a qualified physician.
2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD).
The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters)
administered by intravitreal injection every 4 weeks (monthly) for the first
12 weeks (3 months), followed by 2 mg (0.05 mL) via intravitreal injection
once every 8 weeks (2 months). Although EYLEA may be dosed as frequently
as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated
in most patients when EYLEA was dosed every 4 weeks compared to every
8 weeks. Some patients may need every 4 week (monthly) dosing after the
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2.3 Macular Edema Following Retinal Vein Occlusion (RVO). The
recommended dose for EYLEA is (0.05 mL or 50 microliters) administered
by intravitreal injection once every 4 weeks (monthly).
2.4 Diabetic Macular Edema (DME). The recommended dose for EYLEA
is (0.05 mL or 50 microliters) administered by intravitreal injection every
4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL)
via intravitreal injection once every 8 weeks (2 months). Although EYLEA
may be dosed as frequently as 2 mg every 4 weeks (monthly), additional
efficacy was not demonstrated in most patients when EYLEA was dosed
every 4 weeks compared to every 8 weeks. Some patients may need every
4 week (monthly) dosing after the first 20 weeks (5 months).
2.5 Diabetic Retinopathy (DR) in Patients with DME. The recommended
dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by
intravitreal injection every 4 weeks (monthly) for the first 5 injections,
followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks
(2 months). Although EYLEA may be dosed as frequently as 2 mg every
4 weeks (monthly), additional efficacy was not demonstrated in most
patients when EYLEA was dosed every 4 weeks compared to every 8 weeks.
Some patients may need every 4 week (monthly) dosing after the first
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2.6 Preparation for Administration. EYLEA should be inspected
visually prior to administration. If particulates, cloudiness, or discoloration
are visible, the vial must not be used. Using aseptic technique, the intravitreal
injection should be performed with a 30-gauge x ½-inch injection needle.
For complete preparation for administration instructions, see full prescribing
information.
2.7 Injection Procedure. The intravitreal injection procedure should be
carried out under controlled aseptic conditions, which include surgical
hand disinfection and the use of sterile gloves, a sterile drape, and a sterile
eyelid speculum (or equivalent). Adequate anesthesia and a topical broad–
spectrum microbicide should be given prior to the injection.
Immediately following the intravitreal injection, patients should be monitored
for elevation in intraocular pressure. Appropriate monitoring may consist of a
check for perfusion of the optic nerve head or tonometry. If required, a sterile
paracentesis needle should be available.
Following intravitreal injection, patients should be instructed to report any
symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye
pain, redness of the eye, photophobia, blurring of vision) without delay (see
Patient Counseling Information).
Each vial should only be used for the treatment of a single eye. If the
contralateral eye requires treatment, a new vial should be used and the sterile
field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles
should be changed before EYLEA is administered to the other eye.
After injection, any unused product must be discarded.
3 DOSAGE FORMS AND STRENGTHS
Single-use, glass vial designed to provide 0.05 mL of 40 mg/mL solution
(2 mg) for intravitreal injection.
4 CONTRAINDICATIONS
EYLEA is contraindicated in patients with
• Ocular or periocular infections
• Active intraocular inflammation
• Known hypersensitivity to aflibercept or any of the excipients in EYLEA.
Hypersensitivity reactions may manifest as severe intraocular inflammation.
5 WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis and Retinal Detachments. Intravitreal injections,
including those with EYLEA, have been associated with endophthalmitis
and retinal detachments (see Adverse Reactions). Proper aseptic injection
technique must always be used when administering EYLEA. Patients should
be instructed to report any symptoms suggestive of endophthalmitis or
retinal detachment without delay and should be managed appropriately (see
Dosage and Administration and Patient Counseling Information).
5.2 Increase in Intraocular Pressure. Acute increases in intraocular pressure
have been seen within 60 minutes of intravitreal injection, including with
EYLEA (see Adverse Reactions). Sustained increases in intraocular pressure
have also been reported after repeated intravitreal dosing with vascular
edothelial growth factor (VEGF) inhibitors. Intraocular pressure and the
perfusion of the optic nerve head should be monitored and managed
appropriately (see Dosage and Administration).
5.3 Thromboembolic Events. There is a potential risk of arterial
thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors,
including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial
infarction, or vascular death (including deaths of unknown cause). The
incidence of reported thromboembolic events in wet AMD studies during the
first year was 1.8% (32 out of 1824) in the combined group of patients treated
with EYLEA. The incidence in the DME studies from baseline to week 52 was
3.3% (19 out of 578) in the combined group of patients treated with EYLEA
compared with 2.8% (8 out of 287) in the control group; from baseline to
week 100, the incidence was 6.4% (37 out of 578) in the combined group
of patients treated with EYLEA compared with 4.2% (12 out of 287) in the
control group. There were no reported thromboembolic events in the patients
treated with EYLEA in the first six months of the RVO studies.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the
Warnings and Precautions section of the labeling:
• Endophthalmitis and retinal detachments
• Increased intraocular pressure
• Thromboembolic events
6.1 Clinical Trials Experience. Because clinical trials are conducted under
widely varying conditions, adverse reaction rates observed in the clinical
trials of a drug cannot be directly compared to rates in other clinical trials of
the same or another drug and may not reflect the rates observed in practice.
A total of 2711 patients treated with EYLEA constituted the safety population
in seven phase 3 studies. Among those, 2110 patients were treated with
the recommended dose of 2 mg. Serious adverse reactions related to
the injection procedure have occurred in <0.1% of intravitreal injections
with EYLEA including endophthalmitis and retinal detachment. The most
common adverse reactions (*5%) reported in patients receiving EYLEA were
conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular
pressure increased, and vitreous detachment.
Neovascular (Wet) Age-Related Macular Degeneration (AMD). The data
described below reflect exposure to EYLEA in 1824 patients with wet AMD,
including 1223 patients treated with the 2-mg dose, in 2 double-masked,
active-controlled clinical studies (VIEW1 and VIEW2) for 12 months.
Table 1: Most Common Adverse Reactions (*1%) in Wet AMD Studies
Active Control
EYLEA
(ranibizumab)
(N=1824)
(N=595)
Conjunctival hemorrhage
25%
28%
Eye pain
9%
9%
Cataract
7%
7%
Vitreous detachment
6%
6%
Vitreous floaters
6%
7%
Intraocular pressure increased
5%
7%
Ocular hyperemia
4%
8%
Corneal epithelium defect
4%
5%
Detachment of the retinal pigment
3%
3%
epithelium
Injection site pain
3%
3%
Foreign body sensation in eyes
3%
4%
Lacrimation increased
3%
1%
Vision blurred
2%
2%
Intraocular inflammation
2%
3%
Retinal pigment epithelium tear
2%
1%
Injection site hemorrhage
1%
2%
Eyelid edema
1%
2%
Corneal edema
1%
1%
Less common serious adverse reactions reported in <1% of the patients
treated with EYLEA were hypersensitivity, retinal detachment, retinal tear,
and endophthalmitis.
Macular Edema Following Retinal Vein Occlusion (RVO). The data described
below reflect 6 months exposure to EYLEA with a monthly 2 mg dose in 218
patients following CRVO in 2 clinical studies (COPERNICUS and GALILEO) and
91 patients following BRVO in one clinical study (VIBRANT).
Adverse Reactions
Table 2: Most Common Adverse Reactions (*1%) in RVO Studies
Adverse Reactions
CRVO
BRVO
EYLEA Control EYLEA Control
(N=218) (N=142) (N=91) (N=92)
Eye pain
13%
5%
4%
5%
Conjunctival hemorrhage
12%
11%
20%
4%
Intraocular pressure increased
8%
6%
2%
0%
Corneal epithelium defect
5%
4%
2%
0%
Vitreous floaters
5%
1%
1%
0%
Ocular hyperemia
5%
3%
2%
2%
Foreign body sensation in eyes
3%
5%
3%
0%
Vitreous detachment
3%
4%
2%
0%
Lacrimation increased
3%
4%
3%
0%
Injection site pain
3%
1%
1%
0%
Vision blurred
1%
<1%
1%
1%
Intraocular inflammation
1%
1%
0%
0%
0%
Cataract
<1%
1%
5%
Eyelid edema
<1%
1%
1%
0%
Less common adverse reactions reported in <1% of the patients treated with
EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity,
and endophthalmitis.
Diabetic Macular Edema (DME). The data described below reflect
exposure to EYLEA in 578 patients with DME treated with the 2-mg dose in 2
double-masked, controlled clinical studies (VIVID and VISTA) from baseline
to week 52 and from baseline to week 100.
Table 3: Most Common Adverse Reactions (*1%) in DME Studies
Adverse Reactions
Baseline to Week 52 Baseline to Week 100
EYLEA
Control
EYLEA
Control
(N=578) (N=287) (N=578) (N=287)
Conjunctival hemorrhage
28%
17%
31%
21%
Eye pain
9%
6%
11%
9%
Cataract
8%
9%
19%
17%
Vitreous floaters
6%
3%
8%
6%
Corneal epithelium defect
5%
3%
7%
5%
Intraocular pressure increased
5%
3%
9%
5%
Ocular hyperemia
5%
6%
5%
6%
Vitreous detachment
3%
3%
8%
6%
Foreign body sensation in eyes
3%
3%
3%
3%
Lacrimation increased
3%
2%
4%
2%
Vision blurred
2%
2%
3%
4%
Intraocular inflammation
2%
<1%
3%
1%
Injection site pain
2%
<1%
2%
<1%
Eyelid edema
<1%
1%
2%
1%
Less common adverse reactions reported in <1% of the patients treated with
EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema,
and injection site hemorrhage.
6.2 Immunogenicity. As with all therapeutic proteins, there is a potential for
an immune response in patients treated with EYLEA. The immunogenicity
of EYLEA was evaluated in serum samples. The immunogenicity data reflect
the percentage of patients whose test results were considered positive for
antibodies to EYLEA in immunoassays. The detection of an immune response
is highly dependent on the sensitivity and specificity of the assays used,
sample handling, timing of sample collection, concomitant medications,
and underlying disease. For these reasons, comparison of the incidence of
antibodies to EYLEA with the incidence of antibodies to other products may
be misleading.
In the wet AMD, RVO, and DME studies, the pre-treatment incidence of
immunoreactivity to EYLEA was approximately 1% to 3% across treatment
groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were
detected in a similar percentage range of patients. There were no differences
in efficacy or safety between patients with or without immunoreactivity.
6.3 Postmarketing Experience. The following adverse reactions have been
identified during postapproval use of EYLEA. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship
to drug exposure.
• Hypersensitivity including rash, pruritus, and urticaria as well as isolated
cases of severe anaphylactic/anaphylactoid reactions.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy. Pregnancy Category C. Aflibercept produced embryo-fetal
toxicity when administered every three days during organogenesis to
pregnant rabbits at intravenous doses *3 mg per kg, or every six days at
subcutaneous doses *0.1 mg per kg. Adverse embryo-fetal effects included
increased incidences of postimplantation loss and fetal malformations,
including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft
palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele,
heart and major vessel defects, and skeletal malformations (fused vertebrae,
sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete
ossification). The maternal No Observed Adverse Effect Level (NOAEL) in
these studies was 3 mg per kg. Aflibercept produced fetal malformations at
all doses assessed in rabbits and the fetal NOAEL was less than 0.1 mg per kg.
Administration of the lowest dose assessed in rabbits (0.1 mg per kg) resulted
in systemic exposure (AUC) that was approximately 10 times the systemic
exposure observed in humans after an intravitreal dose of 2 mg.
There are no adequate and well-controlled studies in pregnant women.
EYLEA should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus. Females of reproductive potential should use
effective contraception prior to the initial dose, during treatment, and for at
least 3 months after the last intravitreal injection of EYLEA.
8.3 Nursing Mothers. It is unknown whether aflibercept is excreted in human
milk. Because many drugs are excreted in human milk, a risk to the breastfed
child cannot be excluded. EYLEA is not recommended during breastfeeding.
A decision must be made whether to discontinue nursing or to discontinue
treatment with EYLEA, taking into account the importance of the drug to
the mother.
8.4 Pediatric Use. The safety and effectiveness of EYLEA in pediatric patients
have not been established.
8.5 Geriatric Use. In the clinical studies, approximately 76% (2049/2701)
of patients randomized to treatment with EYLEA were *65 years of age
and approximately 46% (1250/2701) were *75 years of age. No significant
differences in efficacy or safety were seen with increasing age in these
studies.
17 PATIENT COUNSELING INFORMATION
In the days following EYLEA administration, patients are at risk of developing
endophthalmitis or retinal detachment. If the eye becomes red, sensitive
to light, painful, or develops a change in vision, advise patients to seek
immediate care from an ophthalmologist (see Warnings and Precautions).
Patients may experience temporary visual disturbances after an intravitreal
injection with EYLEA and the associated eye examinations (see Adverse
Reactions). Advise patients not to drive or use machinery until visual function
has recovered sufficiently.
Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
EYLEA is a registered trademark of
Regeneron Pharmaceuticals, Inc.
© 2016, Regeneron Pharmaceuticals, Inc.
All rights reserved.
Issue Date: June 2016
Initial U.S. Approval: 2011
June 2016
Opinion
from DANIEL J. HILFERTY
Why we cover whole genome sequencing
Independence’s president
and CEO explains
groundbreaking decision
W
hen it comes to covering emerging medical
technologies,
insurers
must responsibly steward
the resources of those who
ultimately pay for healthcare—employers, governments, and individuals who buy
health insurance. At the same time, we must embrace
our role in giving patients access to lifesaving innovations as quickly as possible.
Nowhere is that balance more important
than cancer care.
Personalized medicine is revolutionizing clinical care, including oncology,
and the next great leap forward in cancer
treatment may be just around the corner.
New genetic tests can show which treatment regimen will be most effective in
an individual, and what therapies are unlikely to work and may even cause more
suffering. Among the most promising
advances is whole genome sequencing,
which fully sequences thousands of genes
in a single test. Whole genome sequencing detects specific DNA mutations that may guide oncologists to the optimal treatment for each of their patients.
cancers for which the test is most likely to help determine
effective therapies: certain rare cancers, tumors in children, metastatic cancer of unknown primary, triple negative breast cancer, primary brain cancer, virally infected
tumors, and metastatic cancer where conventional therapies have been exhausted and patients remain candidates
for further therapy.
Whole genome sequencing for cancer is an evolving area of medicine that requires ongoing research and
evaluation. Our decision to make this test available for
the patients who might benefit the most reflects our commitment to our members to balance innovation and cost
management.
Collective effort needed
Doing what’s best for patients
The success of personalized medicine also depends on
vastly expanding the evidence base across all types of cancer and all clinical circumstances. To that
end, Independence supports the Cancer
MoonShot 2020 Program, which you’ll
read about in this issue’s cover story. The
program is a series of phase 2 trials in
20,000 patients and 20 tumor types seeking quantum advances in individualized
cancer treatment by 2020. I believe insurers have a responsibility to engage with efforts like this that are bringing stakeholders together to find new solutions.
Independence is proud to promote
both of these objectives—testing a patient’s entire genome to find out how
best to treat her or his individual cancer,
and accelerating the large-scale research
that will lead to new therapies. We know these are ambitious undertakings, but given the toll that cancer takes
on our community, ambitious thinking is exactly what is
needed.
After carefully considering its promise and consulting
with experts, Independence Blue Cross this year became
the first major insurer to provide coverage for certain
members who are seeking access to whole genome sequencing. We are beginning with patients with specific
Daniel J. Hilferty is president and CEO of Independence
Blue Cross.
“The next great
leap forward in
cancer treatment
may be just around
the corner.”
2
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
ABOUT THE AUTHOR ❚
ManagedHealthcareExecutive. com
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Mission Managed Healthcare Executive provides healthcare executives at health plans and provider organizations
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Roy Beveridge, MD, is senior vice president and chief
medical officer for Humana, where he’s responsible for developing
and implementing Humana’s clinical strategy with an emphasis on
advancing the company’s integrated care delivery model.
Don Hall, MPH, is principal of DeltaSigma LLC, a consulting
practice specializing in strategic problem solving for managed
care organizations. He most recently served as president and chief
executive officer of a nonprofit, provider-sponsored health plan.
Mark Boxer, PhD, is executive vice president and global
Daniel J. Hilferty, MPA, is president and chief
chief information officer for CIGNA, where he is responsible for
driving the company’s worldwide technology strategy.
executive officer of Independence Blue Cross, a leading health
insurer in southeastern Pennsylvania with nearly 10 million
members in 25 states.
Joel V. Brill, MD, is the chief medical officer for Predictive
Health, LLC, which partners with stakeholders to improve coverage
of value-driven care that optimizes health for people.
Margaret A. Murray, MPA, is the founding chief
executive officer of the Association for Community Affiliated Plans,
which represents 54 nonprofit safety net health plans in 26 states.
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chief pharmacy officer of OptumRx, a pharmacy benefits firm that
manages more than 200 million prescriptions each year on behalf
of 25 million members.
Kevin Ronneberg, MD, is vice president and associate
medical director for health initiatives at HealthPartners, an
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Delivery Systems and a managed care thought leader.
U.S. Health & Life Sciences division of Microsoft Corp., where he
is responsible for setting the company’s strategy and overseeing
solutions for the managed care industry.
Perry Cohen, PharmD, is chief executive officer of The
Paul J. Setlak, PharmD, MBA, is associate director,
Outcomes Solutions, at Astellas Pharma, where he focuses on
strategic market access, pricing and reimbursement.
Pharmacy Group and the TPG family of companies, which provides
services to associations, healthcare and information technology
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3
Volume 26 Issue 11
EXECUTIVE
NOVEMBER 2016
COVE R STORY
CBetter
ANCER MOONSHOT
quality, lower costs by 2020
10 PROGRAM OVERVIEW
12 INSURER INVOLVEMENT
11 NEW CANCER TEST
14 BROADER EFFORTS
6 BUSINESS STRATEGY
Cater to consumers
by Judy Packer-Tursman
8 THE LIST
Effective ways to partner with your board
by Aubrey Westgate
16 TECHNOLOGY
Cancer initiative harnesses big data’s full
potential
by Donna Marbury
18 PHARMACY BEST PRACTICES
Drug pricing tools that influence
consumers
by Mari Edlin
20 HOSPITALS AND PROVIDERS
Fall prevention programs gain traction
by Mari Edlin
23 DRUGS IN THE PIPELINE
Four things to know about the oncology
pipeline
by Erin Bastick, PharmD, RPh
25 POLICY OUTLOOK
Precision medicine initiative has staying
power
by Judy Packer-Tursman
27 HEALTH MANAGEMENT Highmark’s cancer collaborative
by Rachael Zimlich, RN
31 CONFERENCE INSIDER
Highlights from ASCO 2016
by Bryant Furlow
COMMEN TARY
2 OPINION
Why we cover whole genome sequencing
by Daniel J. Hilferty
33 INDUSTRY ANALYSIS
Oncology medical home model pays off
by Tracey Walker
DEPARTMEN TS
3 EDITORIAL ADVISORS
33 AD INDEX
29 Q&A
Fertility benefit services: pros and cons
by Tracey Walker
4
MANAGED HEALTHCARE EXECUTIVE ] NOVEMBER 2016
Managed Healthcare Executive. com
Cover: Lightspring / Shutterstock.com (cancer); Joe Belanger / Shutterstock.com (pencil)
ESSEN TIALS
WHAT ARE
BIOSIMILARS?
Let’s Clarify Biosimilars
Biosimilars are a new step in biologic medicines and are
highly similar to originator (or “reference”) biological products.1
Merck can help.
There is a great deal of complexity surrounding biosimilars. At Merck, we believe in
providing clarity among the confusion. We want to deliver clear, concise answers and
information that will help you understand biosimilars.
Get answers at
merckclarifiesbiosimilars.com
Reference:
1. US FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. www.fda.gov/downloads/
drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Published April 2015. Accessed June 3, 2016.
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
BIOS-1193204-0000
08/16
Business Strategy
TO P-LI N E O P E R ATI O NAL TR E N D S
CATER TO CONSUMERS
Your customers want more, and it’s time
to deliver by J U DY PACKE R-TU R S MAN
B
6
y the time federal open
enrollment begins November 1, Horizon Blue
Cross Blue Shield of New
Jersey intends to have what
one executive describes as
a “much simpler” consumer
website so individuals know immediately where to find information.
The insurer also is providing more
bill payment options, and conducting major outreach to individual
members. That outreach focuses
on its plans’ broad value—including wellness products, telemedicine, prenatal care, and free basic
preventive services.
Spurred on by the Affordable
Care Act’s emphasis on the individual market, Horizon is also pursuing targeted initiatives, such as
the launch of a dedicated Hispanic
enrollment and service center, and
mall kiosks with bilingual agents
and Spanish-language materials.
This is part of an ongoing marketing
partnership with HolaDoctor. The
upshot? Nearly 400% membership
growth since 2013 to 30,000-plus
Hispanic members—about 15% of
the previously uninsured people
who joined Horizon for 2016.
“We’ve had a customer-experience team since 2012 trying to
understand the most important
things our customers look for. …
We’re looking for ‘pain points’ and
where to fix them for all members,”
“We’re looking for ‘pain
points’ and where to fix
them for all
members.”
- ED LARA, HORIZON
BLUE CROSS BLUE
SHIELD OF NEW JERSEY
explains Ed Lara, Horizon’s vice
president of marketing and product development.
The health plan’s efforts are part
of a national trend in which managed care plans are using an array
of tools to improve members’ experiences, build trust, and become
more accessible.
Long way to go
The trend isn’t surprising to consultant Ingrid Lindberg, chief experience officer at Chief Customer,
a customer-experience consulting
firm. Her clients include national
carriers and Blues plans.
Yet Lindberg, who served as
chief experience officer for Cigna in
2007, says the healthcare industry
still has a lot to learn. “Plans have
been doing consumerism ... for
years and it’s not changing consumer experience with health plans,”
she says. “Some plans have lots of
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
[consumer] engagement tools and
very low engagement scores.”
Larry Bridge, senior vice president of strategy and corporate development for TriZetto, a business
unit within Cognizant’s healthcare
practice, says finding ways to better
engage with consumers is critical.
“I think the key shift that healthcare hasn’t made is moving from
functional communication to real
[member] engagement,” he says.
Apart from investing in tools
and technology, plans must think
broadly about how to address
members’ preferences (such as
not focusing on mobile apps for
seniors), Bridge says. It’s important
to have “24-7 multi-channel engagement,” ensuring that members
trust you to follow up and respect
their time by not making them
repeat information, he says.
Here are six other strategies
plans should consider:
STRATEGY #1
SIMPLIFY LANGUAGE
“We know understandability is one
of three major drivers of the customer experience, so the first thing
I tell plans to do is simplify their
language,” Lindberg says. People
don’t understand terms such as
“coinsurance” and “provider,” and
acronyms are overused.
Robin Gelburd, president of
FAIR Health, an independent notfor-profit organization providing
access to healthcare cost and
insurance information, says plans
must also clearly communicate
basics, such as the difference
between emergency care and
urgent care, and the availability of
telehealth. They also must explain
how consumers may face larger
out-of-pocket costs depending on
their choices, she says.
“We see movement from trans-
Managed Healthcare Executive. com
Business Strategy
parency—making information and
data available—to clarity,” Gelburd
says.
Horizon’s initiatives provide a
good example of how this guidance can be applied. It streamlined
its welcome letter, and instead
of sending the member ID card
and welcome letter separately,
now affixes the card to the letter,
Lara says. ID cards also have a
sticker with information on how
to sign up for online services, and
consumers can phone-scan part of
the letter to reach an educational
video on how products work.
STRATEGY #2
SHORE UP BASIC CHANNELS
Consumers want to easily access
information on the plan’s website, and be able to email and call
easily, Lindberg says. Ensure basic
channels are functioning well so
responses are timely whether they
are given by phone representatives
or by online chat. “If you can’t nail
the basics, then you can’t open
new channels,” she says.
“In healthcare the costs keep going up,
yet health plans aren’t showing customers
the value for their dollar.”
INGRID LINDBERG, CHIEF CUSTOMER
right, language and access are
important,” she says.
“I’ve found, time and again,
plans tend to push information
out [to members on clinical issues,
claims, benefits, etc.] ... and it’s not
orchestrated,” says Lindberg. “So
I say, ‘Print and put all the pieces
in a room and look at what the
company is distributing and pare
it back.’”
Also, ensure members are receiving correct information, she says.
For example, a new member doesn’t
want inaccurate data about which
physicians are in-network or accepting new patients.
procedures based on their plan
design and deductible. Since its
2010 launch, the tool has gotten
6.6 million-plus hits, according to
Aetna, and members using it are
saving on out-of-pocket costs.
Fresh, clearly presented information creates a win-win situation extending beyond members’
informed decisions and administrative savings, Gelburd says. “It’s
creating a level of comfort and
goodwill between the member
and the plan that information is
being provided in a way that brings
[clinical and financial] value to
consumers.”
STRATEGY #5
Judy Packer-Tursman is a writer in Washington, D.C.
STREAMLINE PROCESSES
STRATEGY #3
OPEN NEW CHANNELS
Lindberg often discusses access
with clients. It’s “about being available through lots of different channels and being available on your
customers’ time, not your own,”
she says. Most plans don’t offer online chats or rapid responses, even
though phoning a plan Monday
through Friday, 8 a.m. to 5 p.m. is
not convenient for many patients,
she says. Find ways to be available
to members 24/7. STRATEGY #4
ORCHESTRATE
COMMUNICATIONS
Typically, plans only have 1.4 oneon-one interactions per member
per year—whether through a
conversation with a case manager,
an email correspondence, or an
interaction at an enrollment fair,
Lindberg says. “Because you only
have that one moment to get it
Managed Healthcare Executive.com
Be proactive with new members by
getting information on drugs that
need prior authorization and making the process easier upfront, says
Lindberg. For example, if members
are transferring between plans
due to the employer changing the
insurer, make medication continuity a part of the transition and do
outreach to members based on
their claims data.
Horizon BCBSNJ individual
membership growth
173,933
127,940
116,407
STRATEGY #6
SHOW VALUE
“In healthcare the costs keep going
up, yet health plans aren’t showing customers the value for their
dollar,” Lindberg says. Plans must
compare and communicate—
telling members, for example,
whether they’re paying $100 for
a medical service instead of $300
that non-members pay.
Aetna, Inc.’s online “Member
Payment Estimator” shows what
members will pay for common
2013
2014
2015
Source: Horizon Blue Cross Blue Shield of New Jersey
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
7
The List
EFFECTIVE WAYS
TO PARTNER WITH YOUR BOARD
INDUSTRY LEADERS SHARE THEIR GO-TO STRATEGIES
BALANCE PERFORMANCE ANALYSIS AND FUTURE GOALS
“On the IHI Board, we’ve
been talking recently about
the need to balance looking
back at our performance
to generate learning, and
looking forward to create
strategy. An effective board
partnership needs that type
of discourse. In many ways,
it comes down to finding
the right balance between
assurance and strategy,
between ‘holding to
account’ and empowerment,
and between governance
of operations and tolerance
of risk. As with much of
what we do in healthcare,
relationships are vitally
important, as are finding
ways to connect the board
to the impact our work is
having at the point of care.
So the board meeting can’t
just be about looking at the
numbers; the board needs
to hear the stories and
engage with the staff who
are making a difference for
patients.”
—Derek Feeley, president and CEO, Institute for Healthcare Improvement
UNDERSTAND BOARD
MEMBERS’ PRIORITIES
“We clearly and regularly
communicate with our
board, but we don’t send
trivial information they
can easily get from a
news source. We also
regularly hold one-on-one
meetings to probe where
the board member is on
an issue and whether
their organization’s
priorities have changed.”
—Joel White, president, the
Council for Affordable Health
Coverage
“Be upfront, honest, present
the facts, and ask for their
guidance. Your board is
there to assist you. They
bring expertise and have
often dealt with the problems
you are facing. Most
importantly—if you report
to the board, and you aren’t
meeting the objectives of the
board (which represents the
shareholders), and you lose
the trust of the board, well,
you can figure out how that
story ends.”
MAKE TIME FOR ONE-ON-ONES
“It’s important to meet with board members
individually and build a relationship based on one-toone interaction and trust. This can help defuse many
situations where board members need to support their
CEO on the basis of that trust.”
—Don Hall, principal, DeltaSigma LLC, Managed Healthcare
Executive editorial advisor
BE TRANSPARENT
“I think the CEO and
board partnership comes
from building and maintaining trust. Trust comes
from open communication
and transparency—you
never want your board to
be surprised. It’s essential
in board effectiveness.
This fosters support of
innovative ideas and
helps to keep pace with
change.”
FOCUS ON
THE INDIVIDUAL
—AND THE GROUP
“An engaged board is
an effective board. I try
to ensure each member
has a defined role and
feels an ownership for
our shared vision.”
—Chad Johnson, senior vice
president, Phoenix Children’s
Care Network
—Pamela Morris, president
and CEO, CareSource
—Joel Brill, MD, chief medical
officer, Predictive Health, LLC,
Managed Healthcare Executive
editorial advisor
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
dotshock / Shutterstock.com
8
ASK FOR HELP
by AU B R EY WE STGATE
Managed Healthcare Executive. com
CANCER MOONSHOT
Better quality, lower costs by 2020
By K AR E N APP OLD
EXECUTIVE VIEW
Efforts include:
❚ Collaborations
to advance
combination
immunotherapy
❚ Trials to develop
a vaccine-based
immunotherapy
10
with a sense of uncertainty. Our goal is to develop personalized immunotherapeutic treatment
options and arm oncologists with the necessary
tools to combat cancer with certainty.”
The Cancer MoonShot 2020 Program brings
together stakeholders from pharma, community and academic oncology, as well as government and scientific communities to accelerate
the potential of combination immunotherapy
as the next-generation standard of care in cancer patients.
The program’s goal is to initiate randomized phase 2 trials in 20,000 patients at
all stages of disease in 20 tumor types
before 2020, called the Quantum Integrative Lifelong Trial (QUILT).
These findings will be used to
develop an effective vaccinebased immunotherapy to
combat cancer by 2020.
Lightspring / Shutterstock.com (cancer); Joe Belanger / Shutterstock.com (pencil).
❚ A new test
to identify
personalized
treatment
IN 2016, MORE THAN 1.6 MILLION new cases of
cancer will be diagnosed and cancer will kill
an estimated 600,000 Americans. The Agency
for Healthcare Research and Quality estimates
that the total cost for cancer care in the United
States in 2011 was $88.7 billion. Fifty percent
of this cost was for hospital outpatient or doctor office visits, 35% was for inpatient hospital
stays, and 11% was for prescription drugs.
“The truth is, cancer is still a mystery; no two
cancers are alike, making it nearly impossible to
choose the best treatment path for each patient,”
says Patrick Soon-Shiong, MD, founder and chief
executive officer of NantWorks and founder of
the Chan Soon-Shiong Institute of Molecular
Medicine, located in Culver City, California.
In January 2016, the billionaire launched the
Cancer MoonShot 2020 Program in an effort to
win the war on cancer. “When a patient is first
diagnosed with cancer, they are overwhelmed
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
Managed Healthcare Executive. com
Cancer MoonShot
The approach provides researchers with
necessary testing materials and patients with
more opportunities to participate through local
facilities and wider insurance coverage. Oncologists receive real-time clinical trial results, and
patients have hope for more positive outcomes.
BREAKING NEW GROUND
According to Leonard Sender, MD, medical director, Hyundai Cancer Institute at Children’s
Hospital Orange County, Orange, California, and
codirector of the Chan Soon-Shiong Institute of
Molecular Medicine, “Cancer MoonShot 2020 is
the first program to test the hypothesis that the
immune system has the ability to defeat cancer.”
Up until recently, he says, major advances
in cancer medicine involved targeted therapy,
in which a particular drug targeted a change in
DNA (the whole genome), and immunotherapy.
These treatments were often separated in different silos. “This program will bring both concepts together; multiple partners will conduct
testing in real patients, not animals, to see if
the combination results in greater cures,” says
Sender. “This will be done as quickly as possible
by bringing in infrastructure that will allow for
rapid adoption of clinical trials in light of governmental regulations.”
Immunotherapy, a form of biologic therapy, is
a type of cancer treatment designed to boost the
body’s natural defenses to fight cancer. “We are
using lower-dose chemotherapies in a way that
the immune response is maintained,” says John
Lee, MD, cancer center director, Chan SoonShiong Institute of Molecular Medicine, and
surgical oncologist at Sanford Health in Sioux
Falls, South Dakota, which is one of the first
national and regional self-insured employers to
cover next-generation whole genome sequencing and proteomics for various cancers. “Treatments also include immune modulators—both
antibodies and small molecule therapy—as well
as a natural killer cell therapy.”
HOW THE PROGRAM WORKS
Soon-Shiong is using NantHealth, his foundation, to help fund oncology patients on clinical
trials with a new molecular cancer test called
GPS Cancer. The test sequences the whole DNA
of 3 billion base pairs with more than 20,000
genes, as well as RNA, to identify mutated genes
which express the proteins from a patient’s cancer. Testing is performed in NantOmics’ CLIAcertified laboratories that are accredited by the
College of American Pathologists.
Only through this test can physicians more
ManagedHealthcareExecutive. com
Ultimately, the aim of the program
is to win the war on cancer—to get to
a point in the very near future when cancer is
managed the same way as other
chronic disease, such as diabetes
or asthma.”
—PATRICK SOON-SHIONG, MD, NANTWORKS
accurately identify which molecular alterations
are present in cancer cells that will translate to
abnormal proteins being produced—which are
the key targets for many therapeutic interventions, Soon-Shiong says. This helps oncologists
develop personalized treatment strategies.
The opportunity to identify through GPS assay
which patients have “hot” (inflamed) or “cold”
(immunosuppressed) tumors will play a critical
role in treatment decisions and trial design in
the MoonShot Program.
“The GPS Cancer test allows clinicians to
better predict whether a cancer drug will or
won’t work,” says Lee, noting that it’s very similar to how physicians perform laboratory testing to determine if an antibiotic for a bacterial
infection will be effective.
“For the first time, we can measure proteins
that denote resistance to taxanes and cisplatin ... standard chemotherapy that has been administered in an empiric fashion,” Soon-Shiong
says. “Now with GPS, information regarding
chemo resistance or chemo sensitivity can be
identified from the patient’s tissue by GPS and
a better informed decision can be made before
treatment begins. The patient and doctor can
now address the question: What information
could be gleaned from my tissue sample that
would better inform the treating physician of
the probability that the treatment about to be
prescribed would be effective?”
The GPS test is unique in that it measures
RNA transcription and affected protein pathways downstream and has the capability of profiling the inflamed status of the tumor. “In this
era of immunotherapy, knowing whether the
tumor is ‘hot’ or ‘cold’ has huge outcome implications,” Soon-Shiong says.
EXPERTISE FROM MULTIPLE AREAS
As part of the initiative, Soon-Shiong formed clin-
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
11
Cancer MoonShot
ical working groups in specific cancer specialties,
including the Melanoma and Sarcoma Working
Group, Head and Neck Cancer Working Group,
Breast Cancer Working Group, and Radiation
and Immuno-Oncology Working Group. “We will
collect data from scientists and clinicians in both
academic and community settings,” says Sender,
a founding member of Cancer MoonShot 2020’s
National Pediatrics Consortium. “We want to
learn about experts’ ideas for treating specific
cancers and evaluate all of the science that is
known about these cancers so we can start creating our first clinical protocols.”
Another goal is to find treatments for solid
tumor cancers that don’t fall into the top 10
types of cancers and pediatric cancers that
haven’t been successfully treated before. These
include uncommon cancers that don’t typically
have clinical trials such as head and neck cancer
along with melanoma and sarcoma, says Lee, a
leader of the Head and Neck Working Group
and a member of the Radiation and ImmunoOncology Working Group.
Test results for certain patients will be obtainable within 21 days, and oftentimes within
seven days. By using a HIPAA-compliant app,
called the GPS genome browser, physicians and
study investigators can access report summaries. “No one on the market today has that level
of sophistication,” Sender says.
14.5
MIL L ION
69%
The number of Americans with a
cancer or a history of cancer who
were alive January 1, 2014.
The 5-year relative survival rate for all
cancers diagnosed between 2005
and 2011.
Death rates are declining for all four of
the most common cancer types: lung,
colorectal, breast, and prostate.
23%
The drop in rate of cancer deaths
per 100,000 persons between
1991 and 2012.
Source: American Cancer Society, “Cancer Facts and Figures 2016”
12
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
The Cancer MoonShot 2020 program can
work with both academic and communitybased cancer centers, which is important given
that 85% of cancer patients are treated at community cancer hospitals.
BIGGEST ACCOMPLISHMENTS SO FAR
To date, more than 300 individuals with cancer have had their testing completed. Fifteen
QUILT clinical trials have opened as of September 2016. “Hopefully, we will have sequenced
5,000 patients by the end of this year,” Lee says.
“I think we can make it if we ramp things up
a bit. We’ve had more enrollment as the year
progresses. Oncology patients are seeking out
newer testing methods and are looking for newer therapies that use their body’s own immune
responses to fight off cancer. By using less toxic
treatments, patients experience less sickness
and may not lose their hair.”
Another achievement is the formation of The
National Pediatric Consortium, formed in February 2016. The consortium is focused on offering
combined immunotherapy as the next-generation standard of cancer care to children. Ten
founding members spanning major cities nationwide are participating in a national data sharing
infrastructure to accelerate clinical development
of next-generation immunotherapy. For example, as a physician and scientist whose practice
and laboratory specializes in cancer caused by
human papillomavirus, Lee will facilitate a collaboration between Sanford Health and the Chan
Soon-Shiong Institute of Molecular Medicine to
advance cancer care and increase immunotherapy clinical trials available at Sanford.
Also, the first clinical trial milestone was
achieved in January when an immunotherapy
trial demonstrated encouraging survival rates
in patients with end-stage metastatic colorectal cancer who were not responsive to standard
therapy. More than 30% of patients who failed
all standard chemotherapy and antibody therapy are still alive after neo-epitope immunotherapy ensituximab. The longest current survivor
was treated more than two years ago.
INSURER INVOLVEMENT
Health insurers can play a significant role in the
MoonShot Program. “Managed care companies
may find the cancer space scary because pharma prices are rising quickly and it’s difficult to
determine which drugs will actually work,” says
Sender. “But now, by using NantHealth’s novel
GPS Cancer test, which provides a more rational, science-based approach, we will start to
Managed Healthcare Executive. com
Cancer MoonShot
provide the types of tools that allow managed
care providers to better understand what drugs
should be used to treat cancer patients. This will
result in less-expensive care in the long-term.”
Treating cancer patients with medicines that
won’t work is occurring much too frequently.
For example, data has emerged showing that
HER2, a new test to detect breast cancer, often
has incorrect results. Consequently, patients
with a false positive result have been given extremely expensive drugs and patients that were
falsely negative were not given life-saving drugs,
Sender says.
“Although a physician wouldn’t prescribe an
antibiotic to a patient with a bacterial infection
if they knew it wouldn’t work, this has been done
with cancer medicine,” he says. “But with the
GPS Cancer test, which employs next-generation whole genome sequencing and proteomic
testing, physicians can now know that a particular drug will not work, although they still may
not know which drugs will work for sure. This
becomes more important as expensive checkpoint inhibitors become commonplace, but is
found effective in only 10% of patients. With the
GPS Cancer test we may be able to predict which
patient would benefit and which would not.”
“We think it’s a win-win program for patients, providers, and health insurers,” Sender
says. “Our goal is to cure many patients with
treatments that are less toxic at reduced costs.
The fact is, if we don’t proceed in this manner, the healthcare industry may become
unsustainable.”
INSURER PARTNERSHIPS
When health insurers partner with Cancer
MoonShot 2020, drugs will be provided to their
members on clinical trials free of charge. “Insurers will still be responsible to pay for GPS testing, delivering the cost of care, and part of the
cost of clinical trials [which are also funded by
pharma companies],” Sender explains. “In the
long-run, it is in a managed care company’s best
interest for patients to be treated with appropriate imaging, therapies, and drugs.”
Lee says his institution chose to offer GPS
testing because, “We felt that the informatics
and depth of coverage of DNA sequencing offered the best testing option available. In addition, our health insurer decided to cover this
testing because by gleaning knowledge from
the GPS test, we will be able to save a significant
amount of money because some drugs cost
hundreds of thousands of dollars.”
“This is a value-added test from the perspec-
ManagedHealthcareExecutive. com
tive of cost savings,” Lee continues. “What is exciting is that more insurance companies are getting on board since the launch of this test just a
few months ago.”
FIRST INSURER ON DECK
The National Immunotherapy Coalition—a collaboration with Independence Blue Cross, one of
the nation’s largest payers, and Bank of America,
one of the country’s largest self-insured companies, formed around the same time the Cancer
MoonShot 2020 began. The collaboration’s singular focus is to accelerate the potential of combination immunotherapies as the next-generation
standard of care in oncology patients.
Independence Blue Cross became the first
major insurer to offer access to GPS Cancer testing in March 2016, after entering into an agree-
With this initiative
we are hoping to
complete what normally takes
10 years in five years.”
- LEONARD SENDER, MD, HYUNDAI CANCER INSTITUTE
MoonShot 2020 vs. Cancer Moonshot program
Cancer MoonShot 2020 is led privately and is focused on
investigating the potential of combination immunotherapy as the
next standard of care by leveraging the power of genomics and
proteomics.
VS
The National Cancer Moonshot program, which was tasked
to Vice President Joe Biden by President Obama in January
2016, is aimed at pooling resources from multiple federal agencies and is focused on multiple initiatives (e.g., cancer prevention,
early cancer detection, building an FDA Oncology Center of Excellence, cancer immunotherapy and combination immunotherapy,
investing in high-risk/high-reward projects).
In April, the National Cancer Institute appointed Soon-Shiong
to the Blue Ribbon Panel, a group of scientific experts, cancer
leaders, and patient advocates that will inform the scientific direction and goals of the National Cancer Moonshot program.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
13
Cancer MoonShot
SURVIVORS IN MILLIONS
20
18.9
THERE ARE
14.5 MILLION CANCER SURVIVORS
IN THE U.S. BY 2024 THERE WILL BE
ALMOST 19 MILLION
15
14.5
10
5
1970
3.3
1975
1980
1985
1990
1995
2000
2005
2010
2015
2020
2025
Source: American Cancer Society, 2014
ment with NantHealth in January 2016.
“Whole genome sequencing fully sequences
thousands of genes in a single test, detecting
DNA mutations that may serve as markers that
inform decisions about optimal cancer therapy,”
says Anthony V. Coletta, MD, MBA, executive
vice president and president, Facilitated Health
Networks, Independence Blue Cross. “The science around genomics and immunotherapy and
their potential to advance cancer care is evolving. Making the GPS Cancer test available is one
way that Independence is responsibly contributing to the development of the evidence base
and potentially helping to advance cancer care.”
The test will be covered for insured members
with specific conditions including rare cancers, tumors in children, metastatic cancer of
unknown primary brain cancer, triple negative
breast cancer, and metastatic cancer when conventional therapies have been exhausted and
patients remain candidates for further therapy,
including immunotherapy.
“Insurers have an obligation to engage in
responsible efforts to advance cancer care and
to encourage innovative approaches,” Coletta
says. “Our goal is to support our members and
their oncologists in accessing the best care and
helping our customers continue to be able to afford coverage. By offering access to GPS Cancer,
we are giving our members one more option
to help inform a personalized, effective cancer
treatment plan. Rapid advances in molecular
biology and genetics may require healthcare
executives to fundamentally rethink the way we
determine whether a given service is considered effective—so we are responsibly promoting
the adoption of more effective therapies.”
clinical report that provides actionable patientspecific clinical information for physicians and
patients at the point of care. Earlier this year
NantHealth, which already offers the eviti oncology decision support software, added NaviNet
Open, a payer-provider collaboration platform.
The eviti clinical decision support platform
facilitates determination of evidence-based
protocols based on the molecular and clinical
stage of a patient’s cancer. The NaviNet Open
payer-provider collaboration platform enables
doctors and payers to review information in real
time. Together, the NantHealth operating system
serves as a scalable, real-time access point and
portal for providers and patients to receive scientific, clinical, and other information about novel
therapies and relevant clinical trials, all based on
the results from a patient’s GPS Cancer test.
Support from leading insurance companies
and self-insured employers is crucial in order to
provide coverage for whole genome sequencing
and proteomic testing, says Soon-Shiong. These
payers will ensure medical policy is in place to
support patients having access to leading edge
science. “The launch of GPS Cancer, together
with coverage by a major payer serving with
their affiliates 10 million people in 34 states,
combined with the introduction of a collaboration and clinical decision support portal providing access to more than 450,000 healthcare
professionals for real-time communications
and access to ground-breaking clinical trials,
and a multi-payer portal for more than 100 million covered lives, collectively creates a healthcare collaboration network at a national scale,”
he says. “We believe this platform will provide
more personalized and cost-effective treatment
options for patients with cancer.”
BROADER EFFORTS
The GPS Cancer test includes a web-based
14
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.
Managed Healthcare Executive. com
Isn’t it time to move beyond
software? Learn about how
the athenahealth® network is
helping to unbreak hospitals.
athenahealth.com
Technology
TR AN S FO R M I N G CAR E TH R O U G H H EALTH IT
Cancer initiative harnesses
big data’s full potential
New database makes research more
accessible by DON NA MAR B U RY
C
ancer research is becoming
more accessible due to a
new initiative that gives
researchers access to big
data from thousands of
patient cases. In June 2016,
the Genomic Data Commons
(GDC), a web portal that features information on cancer tumors
from more than 30,000 patients,
was revealed to the public during
the American Society of Clinical
Oncology’s (ASCO) annual meeting.
The database is managed by the
National Cancer Institute (NCI) at
the University of Chicago, and it is
funded by the National Cancer Institute through President Obama’s
Precision Medicine Initiative for
Oncology. A portion of the GDC
data is open to the public, while
qualified researchers can access
more detailed data, says Louis M.
Staudt, MD, PhD, senior investigator at NCI.
“The database includes all common cancer types. There are 50 to
500 or more tumors in each type,”
Staudt says. The pediatric database
features 29 cancer types and more
than 3,000 patient cases.
What makes it unique
The GDC is the first open-access
cancer database that combines
genetic information on cancer
16
“The Genomic Data
Commons has the
potential to transform
the study of cancer at
all scales.”
—ROBERT GROSSMAN,
UNIVERSITY OF CHICAGO
tumors and treatment information.
In total, the database features 4.1
petabytes—or about 4 million gigabytes—of information. Staudt says
that depending on the type of cancer included in the database, some
behavioral or environmental data is
collected, such as whether patients
with lung cancers are smokers.
“Data sets include genomic
data from tumors from patients
with cancer, clinical data, treatment, and the results from treatment,” says Staudt. “There’s also
genomic data mutations in DNA,
RNA expressions data, which is the
activity of genes in a cancer cell.
It’s a multiple platform approach
to looking at data.”
Nearly 14,000 patient cases in
the GDC came from the NCI. Foundation Medicine, a cancer genome
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
analysis company, donated 18,000
cases, Staudt says
“We can easily add many more
thousands of patients from other
public databases,” he says. “We are
measuring the success of the Genomic Data Commons attracting
other public data sets.”
Inspired by Facebook
and Google
GDC creation began in 2014 at the
University of Chicago Center for
Data Intensive Science. Working
with the NCI, researchers from
the University of Chicago created information frameworks
and standards that make raw and
processed data from cancer treatment more accessible and easier to
understand.
The architects of the GDC used
Facebook and Google as inspiration—both platforms house large
amounts of diverse data, but also
focus on the user experience,
which can vary from computer
novice to expert. Though the full
data is only open to qualified
researchers, it is open to research
teams regardless of size or budget.
In 2014, Robert Grossman,
GDC co-principal investigator and
professor of medicine and director
of the Center for Data Intensive
Science at the University of Chicago, stated, “The Genomic Data
Commons has the potential to
transform the study of cancer at all
scales. It supplies the data so that
any researcher can test their ideas,
from comprehensive ‘big-data’
studies to genetic comparisons of
individual tumors to identify the
best potential therapies for a single
patient.”
Staudt says that increasing the
usability is a short-term goal of the
project. The GDC also provides an
application programming interface
ManagedHealthcareExecutive. com
Technology
that allows developers to access
specific data files. “In the near
future, we hope that researchers
will be able to ask questions on the
site, and visualize the data,” Staudt
says. “Also, the massive size of the
data precludes many researchers.”
Use and potential
Here are four ways the GDC could
advance cancer care and other
treatments:
Make it easier for researchers
to advance care. The diversity
of data available is important,
because often researchers in different groups are analyzing different
aspects of cancer and its treatment. The GDC uses algorithms to
harmonize and standardize data
to ensure that researchers across
platforms can utilize it.
Improve the understanding of
cancer tumors. One of the goals
of the GDC is to create a more diverse pool of candidates for clinical
trials to get a better understanding
of the differences in cancer tumors.
Vice President Joe Biden, who
leads President Obama’s National
Cancer Moonshot initiative, announced the GDC to researchers,
clinicians and patient advocates
at ASCO. “Increasing the pool of
researchers who can access data
and decreasing the time it takes
for them to review and find new
patterns in that data is critical
to speeding up development of
lifesaving treatments for patients,”
Biden said at the event.
(From left to right) Grossman, Biden, Staudt touring the Genomic Data Commons
Advance precision medicine. In
the future, the GDC will support
single-person clinical trials, which
is a first step in enhancing precision medicine for cancers. Also,
GDC architects are working with
cloud-based technologies that
will allow researchers to perform
on-site experiments and remote
analyses of large amounts of data.
“Long term, we want to create
a knowledge base for cancer and
increase clinical data on drugs,”
Staudt says. “This is called precision medicine in oncology. We
hope to collect data from clinical
trials and move forward with some
more useful clinical knowledge.”
Donna Marbury is a writer in Columbus, Ohio.
Top 10 GDC data downloads as of September 2016
Source: University of Chicago
# of requests
File Size
56,713,391
114.90 TB
1,210,351
34.10 TB
Lung Adenocarcinoma
383,309
43.57 TB
Glioblastoma Multiforme
354,541
22.70 TB
Skin Cutaneous Melanoma
344,659
17.15 TB
Brain Lower Grade Glioma
285,509
21.54 TB
Colon Adenocarcinoma
284,960
22.53 TB
Serve as a model for future databases. The GDC could be used
Bladder Urothelial Carcinoma
263,929
20.48 TB
to create open-source databases
for other illnesses, including diabetes, heart disease and Alzheimer’s,
says Grossman.
Ovarian Serous Cystadenocarcinoma
262,898
39.68 TB
Kidney Renal Clear Cell Carcinoma
239,632
12.47 TB
ManagedHealthcareExecutive.com
Project Name
Thyroid Carcinoma
Breast Invasive Carcinoma
Source: NCI GDC Portal https://gdc-portal.nci.nih.gov/reports/data-download-statistics
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
17
Pharmacy Best Practices
I N N OVATIVE I D EAS FO R D R U G UTI LI ZATI O N AN D MANAG E M E NT
Drug pricing tools that
influence consumers
Three tools that meet patients’ demands
by MAR I E D LI N
M
ore companies are turning
to price transparency tools
to help members make the
smartest decisions about
their medications.
“Drug pricing tools have
the potential to help employees
and their organizations significantly reduce their prescription
drug costs, while helping those
without insurance find the lowest
costs between different pharmacies and to take advantage of
coupons and discounts,” says
Marcia Otto, vice president, pricing
and transparency applications at
Health Advocate, a national health
advocacy, patient advocacy and
assistance company.
Here’s an in-depth look at three
popular online price transparency
tools, sponsored by pharmacy benefits managers (PBMs) and other
organizations:
1
SingleCare
Rick Bates, CEO/cofounder of
SingleCare, an online retail marketplace that helps users compare
prices for a wide range of healthcare services, including medications, says consumer-driven
healthcare is the impetus behind
online pricing marketplaces like
his. Consumers are concerned
18
about coverage limits, costs, and
access, he says.
Launched in early 2016, the tool
is available in Arizona, Maryland,
Virginia, Washington, D.C., and
Pennsylvania, totaling 750,000
users.
Users can view prices for prescription offerings at major pharmacies including Walmart, CVS,
Walgreens, Rite Aid and Kroger, by
specific location.
Bates says the site includes
all drugs that can be dispensed
at a regular pharmacy, excluding
specialty medications. If a request
is for a branded drug, the site will
provide information on an equivalent generic and its price.
“It’s important to publish
drug prices because they might
be lower outside of insurance
coverage if a member has not hit a
deductible yet,” he says. “This is the
only way consumers can truly understand the competitive market
price for a specific drug; otherwise
plan members become a captive
audience.”
Prices found on the SingleCare site vary depending on the
pharmacy and whether a transaction is cash-based or through
insurance with copayments or
deductibles.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
2
Castlight Health
Castlight Health introduced its
prescription drug comparison tool
to employer groups in 2013—not
unlike SingleCare but with some
bells and whistles. “Our core objective is to help employees make
better decisions using information
on our site or through their mobile
devices,” says Will Bondurant,
director of product marketing for
Castlight.
In addition to comparing prices,
users can:
❚ Compare generics to branded
counterparts;
❚ Base prices on the amount and
dosage of a prescription; and
❚ Tailor prices to their pharmacy
benefits packages—formularies
and tiers.
The tool also compares prices
based on whether consumers
have copayments or coinsurance,
purchase at retail or through home
delivery, use a discount card, or
have pharmacy services that overlap with a medical benefit.
Bondurant says the site also
provides contextual information
about each drug from Consumer
Reports; and educational content
from physicians and insurers
including information on side effects, medication alternatives and
appropriate use.
Fifty-one percent of eligible
members have used information from Castlight over the year,
including all offerings—pharmacy,
medical and dental services.
Bondurant identifies two primary groups of users:
❚ Those with serious health conditions
relying on long-term medication management and whose pharmacy and
medical benefits might overlap; and
Managed Healthcare Executive. com
Pharmacy Best Practices
❚ Those with high-deductible health
plans or covered by PPOs with a
$300 to $500 deductible topped by
coinsurance.
3
Our core objective is to help employees
make better decisions using information
on our site or through their mobile devices.”
Express Scripts
The country’s largest PBM has
an online price transparency tool
on its website and via mobile devices. The product provides drug
prices along with retail and home
delivery alternatives based on a
member’s location.
Unlike the other tools,
members can refill prescriptions
through the app. For new drugs,
they only can price the medication. Then, a physician needs to
submit a prescription via e-prescribing or by phone, or a member
can mail the script request to a
pharmacy.
The PBM also offers My Rx
Choices, which provides lessexpensive generic alternatives and
branded drugs when a member
inputs a brand name.
The tool provides clinical information on each drug based on
a member’s profile—side effects;
drug-drug, drug-OTC and drugallergy interactions; information
based on age, gender and medical
conditions; administration; and
dosing.
Brian Cavanagh, senior director,
home delivery product management for Express Scripts, says that
when the PBM surveyed members
about information they most desired, it was potential side effects.
Users can also input how they
take their medications—whether it
be once a day for 90 days, a rather
straightforward prescription, or two
inhalers a month rather than one—
so that they can see exactly how
much they should expect to pay.
“We believe our patients absolutely must have full transparency as
to what a drug will cost them and if
there are opportunities to decrease
that cost,” says David Whitrap,
Express Scripts spokesperson.
The website and mobile app
prompt members with additional
Managed Healthcare Executive.com
— WILL BONDURANT, CASTLIGHT HEALTH
An ideal price comparison tool
According to the California Health Care Foundation’s California
Health Care Almanac survey, released in March 2015, 26%
of consumers look for information about the cost of a test,
treatment or other type of healthcare service before receiving
the care. The majority of them seek information using the
Internet.
If you are considering a drug price comparison tool for
your members, Maribeth Shannon, program director for the
foundation, says to offer these key assets:
❚
❚
❚
❚
SHANNON
Information on drug interactions and side effects;
Pricing based on formularies;
Comparisons of retailers to online pricing; and
Information on generic alternatives to branded drugs.
Legislating drug price transparency
Many states are considering legislation that would require drug manufacturers
to be transparent about the high cost of their drugs by sharing research and
development costs.
Most of the measures have stalled this year, except in California, New Jersey
and Pennsylvania, according to the National Council of State Legislatures.
Although California Sen. Ed Hernandez (D-West Covina) recently pulled his
sponsored legislation that required drug manufacturers to notify state agencies
and health insurers when an FDA-approved new drug costs $10,000 or more
per year or per course of treatment, California Proposition 61 is on the November
ballot. It prohibits state agencies from paying more for any prescription drug than
the lowest price paid by Veterans Affairs.
savings opportunities based on
their specific benefit designs, such
as using a less expensive, clinically
equivalent alternative or dispensing a medication at a more affordable retail pharmacy.
Express Scripts’ members can
take advantage of a lower cost if a
pharmacy offers patients a “usual
and customary” cost of a drug that
might be less than the price available with a plan’s copayment and
still achieve the benefit of Express
Script’s clinical safety review of the
medication.
Mari Edlin, a frequent contributor to Managed Healthcare Executive, is based in Sonoma, California.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
19
Hospitals & Providers
C LI N I CAL C O N S I D E R ATI O N S WITH SYSTE MWI D E I M PACT
Fall prevention
programs gain traction
Effective strategies cut costs,
improve quality by MAR I E D LI N
O
ne out of three older adults
falls each year, making
falls the leading cause of
injuries for adults ages 65
years and older, according
to the CDC. Combine those
statistics with the aging of
America—the number of adults 65
and older is projected to jump to
83.7 million by 2050, almost double
the estimated 43.1 million in
2012, according to the U.S. Census
Bureau—and a disaster is ready to
happen. As many as 2.5 million older
adults end up in hospital emergency departments for treatment
every year, creating a financial
burden of $34 million annually in
direct medical costs, with hospitals
assuming two-thirds of the total,
according to the CDC. In response to the frequency
and potentially dangerous repercussions in older adults, hospitals
and other organizations have
developed a variety of programs to
address fall prevention.
Patient engagement
makes big differences
In 2011, Sharp Memorial Hospital
in San Diego started its STOP
program targeting falls. As Verna
Sitzer, manager, nursing innova-
20
tion and performance excellence
says, the hospital has been improving upon it ever since.
In 2010, the hospital experienced 95 falls with injuries, dropping to 36 in 2015. As reported by
the CDC, the average hospital cost
for a fall injury is $35,000 (2012 dollars), translating to cost avoidance
for Sharp of $2.07 million.
What made the difference?
Sharp formed a special team that
developed patient assessments
and recommendations to prevent
falls, and staff training. “Outcomes related to falls are nursingsensitive indicators (depend on
the quantity or quality of nursing
care),” says Sitzer, “but falling is
also an interdisciplinary problem
so everyone needs to be trained.”
Sitzer says being in a new environment such as a hospital where
so much is happening at once, and
taking new medications, opens the
door for more risk for falls. When
patients are admitted to Sharp
Memorial, they have to “unlock”
televisions in their rooms. Once
registered, they watch a video that
introduces them to the hospital
and also covers safety issues,
including fall prevention.
Six hours after being admitted,
patients take a fall risk survey and
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
if any of the questions prompt a
“yes” response, staff members urge
patients to watch a more comprehensive video pointing out areas
for potential falls during their stay.
Specific areas to watch
Since toileting is one of the major
activities generating falls, nurses at
Sharp pay attention to what mode
of toileting—bedpans, bedside
commode or a bathroom—should
be used based on mobility, says
Sitzer. “We make it easy to do the
right thing.”
The hospital also conducts
monthly debriefings on falls and
has developed a variety of fall
prevention protocols, such as
lowering beds before patients try
to get out of them.
Sharp uses special signage
outside patient rooms to indicate
certain conditions to staff members
(red maple leafs signify patients
who are at risk for falling). Patients
at risk also wear yellow armbands
and red, non-skid socks. Nurses also
include risk information on whiteboards in patient rooms. Further,
stop signs in patient rooms remind
patients to ask for help if needed,
while alarms notify nurses if patients are trying to get out of bed.
Sitzer says the hospital is
exceeding benchmarks based on
voluntary reports to organizations,
such as the National Database of
Nursing Quality Indicators. These
organizations measure nursing
quality and satisfaction, monitor relationships between quality
indicators and outcomes, assess
staffing levels and improve reimbursement.
Adopting a broader focus
While older adults tend to have
higher fall risks, patients of all ages
Continued on page 22
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Hospitals & Providers
Continued from page 20
are susceptible. That’s why Holy
Cross Hospital in Silver Spring,
Maryland, implemented a fall
prevention program that targets
patients of all ages and starts with
a fall assessment upon admission
and upon transfer of each patient
every shift.
2.8
$31
MILLION
The number of elderly
patients treated in
emergency departments
for falls each year.
The direct medical costs
for fall injuries, adjusted
for inflation. Hospital
costs account for twoBILLION ANNUALLY thirds of the total.
Source: CDC
“We believe that every patient
that comes through our doors is at
risk for falling regardless of their
age,” says Kimberly Elliott, senior
director, medical/surgical senior
services for the hospital.
Holy Cross uses signage in every
patient room that states, “Call
Don’t Fall,” along with a telesitter
(someone who monitors patient
activity remotely) to oversee
patients who are at risk for falls.
The hospital also uses bed and
chair alarms for those at higher
risk; hourly rounding; floor mats;
non-skid socks; and a self-release
roll belt for impulse patients.
Modifying known
risk factors
The John A. Hartford Foundation develops models of care to
improve health outcomes for
older adults. One if its initiatives is
funding research on fall preven-
Death rate Per 100,000 U.S. individuals ages 65 and older
Unintentional Fall Death Rates, Adults 65+
58
56
54
52
50
48
46
44
42
40
2004
2005
2006
2007
2008
2009
Year
Source: www.cdc.gov/injury/wisqars
22
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
2010
2011
2012
2013
tion that supports a program
developed by Mary Tinetti, MD,
professor of medicine and chief
of geriatrics at Yale School of
Medicine.
Tinetti’s research studied 301
men and women who were at least
70 years old, lived in the same
community, and who had at least
one of the following risk factors
for falling: postural hypotension
(a rapid drop in blood pressure
when standing); taking four or
more medications or psychoactive
medications causing dizziness; or
impairment in range of motion,
balance or gait.
The control group of 148 had
usual healthcare services and
social visits, while the intervention group of 153 subjects received
a combination of medication adjustment, behavioral instructions
and exercise programs.
After a year of observation,
35% of the intervention group fell,
while 47% of the control group
did. Of the research participants
who had a particular risk factor
at baseline, a smaller percentage
of those in the intervention group
than in the control group still had
the risk at reassessment.
More recent outcomes indicate
a risk reduction in falls of 25% to
35% when older adults receive a
combination of similar interventions as described above.
Amy Berman, a registered
nurse and senior program manager with the John A. Hartford
Foundation, says falls are preventable, which is why the program
addresses the modification of
known risk factors. She says the
number one risk of falling is a previous fall. “When it happens, older
adults stop becoming as active,
lose their mobility and stay in bed
more,” she says.
Mari Edlin is a frequent contributor to Managed
Healthcare Executive. She is based in Sonoma,
California.
Managed Healthcare Executive. com
Drugs In The Pipeline
Four things to know about
the oncology pipeline
How to recognize changes, maximize value
by E R I N BASTICK, PHAR M D, R PH
utilization and cost.
The IMS Health Report predicts
that future growth in the oncology drug market will be driven by
wider utilization of new products,
especially immunotherapies, and
will be offset by decreased use of
existing treatments. More than 70
new cancer treatments approved
to treat more than 20 tumor types
have been developed in the past
five years.
pipeline
2 The
is expanding
O
ncology therapeutic and
supportive care agents in
the development pipeline
promise to be more effective, more therapeutically
targeted, more personalized—and far more costly,
according to industry experts.
“At the same time, more effective management of cancer
care is increasingly facilitated by
increasing penetration of electronic health records [EHRs],
EHR-embedded clinical pathways,
increasing share of patients treated
in integrated delivery systems and
larger oncology practices, transition from fee-for-service payment
to risk-share payment, and the use
of ‘big data’ to discover how resources can be optimally applied,”
says Elan Rubinstein, PharmD,
MPH, principal of EB Rubinstein
Associates, a pharmaceutical man-
“Medicines are personalized via
use of biomarkers for
whom therapy is likely
to be effective.”
—ELAN RUBINSTEIN,
EB RUBINSTEIN ASSOCIATES
Managed Healthcare Executive.com
agement consulting firm. “Understanding the many changes under
way in the healthcare marketplace,
including oncology drugs in the
pipeline, healthcare executives
can coordinate the reaction of
their organization to those market
changes and thereby maximize
value for money related to the care
of cancer patients.” Here are the top four trends you
should keep on your radar.
trend
1 Drug
is increasing
The global oncology market
reached $107 billion in 2015, according to the “Global Oncology
Trend Report: A Review of 2015
and Outlook to 2020” released
by IMS Health in June 2016. This
amount represents an 11.5%
increase in spend from 2014. The
annual global cancer drug market
is expected to grow another 7.5%
to 10.5% in the next few years, to a
total of approximately $150 billion
in 2020, according to the report. Nadina Rosier, health and
group benefits practice leader
at Willis Towers Watson, says
oncology drug trend will increase
exponentially over the next few
years because of the rich pipeline
of innovative new drugs and their
According to IMS Health, the pipeline for oncology drugs in clinical
development has grown by more
than 60% in the past decade. One
possible explanation is the fact
that the median time from patent
filing to approval for cancer drugs
The average cost
of branded oncology
treatments is $10,000
a month, up from
$5,000 a decade ago.
Source: IMS Health “Global Oncology Trend
Report: A Review of 2015 and Outlook to
2020,” June 2016
in 2015 was 9.5 years, down from
10.3 years in 2013. Contributing to
the reduction in approval time may
be the FDA’s breakthrough therapy
designation introduced in 2012.
More than 500 companies are
currently pursuing oncology drug
development, accounting for approximately 600 new molecules
through late-stage clinical development, according to IMS Health.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
23
Drugs In The Pipeline
Of these 600 new agents, most are
seeking approval for non-small cell
lung, breast, prostate, ovarian and
colorectal cancers.
Several oncology drugs are
expected to be approved sometime
in 2017. One is abemaciclib, an oral
CDK4 and CDK6 inhibitor being
developed by Eli Lilly for breast
cancer treatment. Other examples
include brigatinib, from Ariad
Pharmaceuticals for lung cancer,
and rucaparib (Clovis Oncology),
for ovarian cancer.
Cynthia Ambres, MD, principal
at KPMG Strategy and a member of
the firm’s Global Healthcare Center
for Excellence, adds that biosimilar
drugs could also reach the market
for some of the targeted therapies
that were introduced in the 2000s.
According to Ambres, some of
the adjuvant treatments, such as
filgrastim to help restore white
blood cell counts, already face
competition and these could act as
a constraint against rising prices.
3 Personalized
medicine is growing
According to PHRMA’s “Medicines
in Development for Cancer” 2015
report, 73% of cancer medicines in
the pipeline have the potential to
be personalized medicines.
“Medicines are personalized
via use of biomarkers to identify
patients for whom therapy is likely
to be effective,” says Rubinstein. “So
while healthcare executives can
expect new cancer therapies to be
increasingly expensive, biomarkers
[i.e., personalized medicine] can
support that their use is channeled
in such a way to minimize waste
of drugs and unnecessary risk to
patients, due both to toxicity and to
delay in alternative therapy that has
a better chance of being effective.”
Ambres agrees. “The medicines
will target the cancers more effectively and have fewer side effects
than the older, toxic chemotherapies and the treatments will gradually become the standard of care
as treatments gain more exposure
24
Cancer drugs now
make up 11.5% of the
total drug costs in the
United States, a value
that is up from 10.5%
in 2011.
The U.S. now accounts
for about 45% of the
global market for
oncology therapeutics,
up from 39% in 2011.
Source: IMS Health “Global Oncology
Trend Report: A Review of 2015 and
Outlook to 2020,” June 2016
in the market,” she says. “The treatments reaching the marketplace
are targeting much more specific
biomarkers, so oncology care will
become more personalized.”
One growing area of targeted
cancer treatments is adoptive cell
transfer (ACT), an approach to
immunotherapy that involves engineering a patient’s immune cells to
recognize and attack their tumors,
according to the National Cancer
Institute. In ACT, a patient’s T cells
(immune cells collected from the
patient’s blood), are genetically
engineered to produce special
receptors called chimeric antigen
receptors (CARs). CARs allow the T
cells to recognize a specific antigen
on tumor cells.
“From a medical coverage perspective, the CAR T cell therapies
are of high interest as these therapies have shown very effective
results, but have also been noted
to be very expensive at $500,000 to
$1,000,000 per course of therapy,”
says April Kunze, PharmD, senior
director, formulary development
and trend management strategy at
Prime Therapeutics. “Additionally,
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
they are used with other expensive
treatment options and therefore
will have a significant impact on
medical drug trend. This will push
payers to evaluate the best patient
population to receive these therapies, with the potential for some
difficult coverage decisions.”
change
4 Payment
is coming
As more cancer therapies are
developed, payers are expected to
tighten their negotiation stance
with manufacturers and adopt
new payment models to drive
greater value from their expenditures, according to IMS Health.
There has also been a swing in
the mix of new therapies toward
oral medications, which make up
nearly 40% of the targeted therapies
in the U.S. and shifts drug payment
to pharmacy benefits and demands
greater delivery via retail channels.
As for drug management strategies, Rosier says most pharmacy
benefit managers (PBMs) use traditional utilization management like
prior authorization, quantity limits, and step therapy for oncology
drugs. Rosier has also seen some
PBMs use preferred oncology “formularies” or contracting efforts to
“prefer” one drug over another for
specific cancer indications.
“In 2017, we will see oncology
exclusions for the first time in the
marketplace,” says Kunze, “With
more ‘me-too’ therapies, payers will be looking for additional
management opportunities and
preferred product designations as
a way to manage trend in a class
that has historically been managed
by the FDA-labeled indication(s).”
The IMS Health report notes
that the average total treatment
costs for patients in commercial
insurance plans with a cancer
diagnosis who are receiving active
treatment reached $58,000 in 2014,
up 19% from 2013.
Erin Bastick, PharmD, is a graduate intern at University
Hospitals Elyria Medical Center in Elyria, Ohio.
Managed Healthcare Executive. com
Policy Outlook
LEG I S LATIVE / PO LI CY D EVE LO P M E NTS, TR E N D S AN D I M PACTS
Precision Medicine Initiative
has staying power
Effort could better target patient care
by J U DY PACKE R-TU R S MAN
D
espite significant challenges, President Obama’s
ambitious initiative to lay
the scientific foundation
for precision medicine
remains on track, say federal
officials and outside experts.
Yet, the long-term effort to accelerate research aimed at helping
clinicians tailor medical treatments to individual patients must
have funding to continue. Obama
asked Congress for $309 million
to fund the Precision Medicine
Initiative (PMI) in fiscal year 2017,
up about $100 million from the
previous year.
Some experts assert that PMI’s
bipartisan support and enrollment of the first volunteers into
its 1-million-person research
cohort (the PMI Cohort Program)
will also put pressure on Capitol
Hill to keep the initiative going.
PMI is “a strong effort, a great
commitment from the [Obama]
administration, and I believe it will
continue on ... regardless of the
outcome of the elections,” Daryl
Pritchard, PhD, vice president of
science policy for the Personalized
Medicine Coalition in Washington, D.C. told Managed Healthcare
Executive earlier this fall. “... It’s
not a controversial program.”
The coalition’s 225-plus members
Managed Healthcare Executive.com
include Aetna and numerous academic health centers, community
hospital systems and information
management firms.
A complex initiative
The PMI, first announced by
Obama during his 2015 State of
the Union Address, has many
moving parts. Funding for fiscal
year 2016 provided $130 million to
the National Institutes of Health
What is the PMI?
A collaborative public and private
effort that will leverage advances
in genomics, emerging methods
for managing and analyzing large
data sets, and health information
technology to accelerate biomedical
discoveries. The Initiative will engage
a million or more Americans to
volunteer to contribute their health
data to:
❚ Improve health outcomes;
❚ Fuel the development of new
treatments, and
❚ Catalyze a new era of data-based
and more precise medical
treatment.
Source: A 2015 statement from The White House
Office of the Press Secretary
(NIH) to create a 1-million-person
research cohort (the PMI Cohort
Program); $70 million to the
National Cancer Institute (NCI)
to ramp up efforts to identify
genomic drivers in cancer; $10
million to the FDA to acquire more
expertise and develop databases to
support the regulatory framework
for precision-medicine advances;
and $5 million to the Office of
the National Coordinator for
Health Information Technology to
develop interoperability standards
and ensure privacy.
Anyone in the U.S. who is
willing to share their medical
information, take a health survey,
get a baseline medical exam, and
provide a blood sample can volunteer to serve as part of the PMI
Cohort Program.
In February 2016, during a
summit to discuss next steps, John
Holdren, director of the White
House Office of Science and Technology Policy, described PMI as “an
all-hands-on-deck operation.”
“Precision medicine holds
incredible promise for the future
of healthcare,” Holdren says. The
initiative has brought the “relevant
federal agencies to a new level
of activity and collaboration in
pursuit of that promise, and it’s
drawing as well on the essential
contributions of groups outside of
government—providers, technologists, researchers, privacy and
security experts, physicians, and,
of course, patients.”
Progress to date
Infrastructure. NIH has made
“significant headway” in establishing the infrastructure for the
PMI Cohort Program, including a
data and research support center,
biobank, participant technologies
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
25
Policy Outlook
Could PMI disappoint?
PMI’s potential upside? “This effort, through the
patient-consent policies they develop, can truly be a
shared information resource,” says Pritchard. “...What
you really have here is an opportunity to create this
‘learning health system’ at a scale that can make a
difference...[and] you can really utilize information
from the Human Genome Project in a way you
couldn’t previously.” The genome project finished
sequencing and mapping all human genes in 2003.
The possible downside? “The main concern is
[PMI] will be a lot of investment and time and won’t
have as much impact as we hoped,” Pritchard says.
“Going forward, I think we’ll need measurable
progress,” he explains. “With the Human Genome
Project there were a lot of naysayers up front, but
sequencing technology accelerated well beyond
what was expected. ...So, the same sort of thing can
happen [with PMI] if we see incremental progress,
and it catches fire and you can see its effectiveness.”
center, and a network of healthcare
provider organizations to help enroll and retain volunteers, collect
samples and handle bio-banking,
says Gwynne Jenkins, PhD, the program’s chief of staff at NIH. NIH’s
network of healthcare provider
organizations includes regional
medical centers such as Columbia
University Medical Center and the
University of Chicago.
Enrollment. NIH is not on track to
recruit 79,000 individuals into the
cohort by the end of 2016, federal
officials say, but Jenkins describes
that figure as an initial estimate.
“We anticipate launching in
phases, when systems are secure
and ready to go and we can ensure
a high-quality experience for our
users,” says Jenkins. “When we are
ready to enroll participants, we
will spread the word.”
Cancer research. As part of NCI’s
contribution to the initiative, Jeff
Abrams, MD, acting director for
clinical research in NCI’s Division
26
of Cancer Treatment and Diagnosis, says his division applied
funding toward expanding its
portfolio of genomic-based trials,
improving the understanding of
resistance to targeted agents and
drug combinations, and developing a mechanistic understanding
of immunotherapy. The Precision
Medicine Initiative in Oncology
(PMI-O), which is part of the larger
initiative, has also committed
resources to improving pre-clinical
models for evaluating targeted
therapeutics, says Abrams.
Finally, a major component of this
overall effort was the launch of
NCI’s Genomic Data Commons
(GDC) in 2016. Abrams’ NCI division intends to deposit molecular
data from clinical trials into the
GDC to foster secondary analyses
and permit data mining by a broad
range of investigators. For more
on the GDC, read “Cancer initiative
harnesses big data’s full potential”
on pg. 16.
Concept to reality
Pritchard says the Personalized
Medicine Coalition is exploring
strategies to rapidly integrate precision medicine into the delivery
system, examining issues ranging
from scientific discovery to regulation, reimbursement and clinical
application. “I am seeing a rapid
increase in the work we’re making
in the clinical adoption area now,”
he says.
According to Pritchard, the
federal PMI effort still faces
“considerable challenges, and they
[i.e., federal officials] are aware
of them.” He cites three primary
hurdles:
Patient empowerment. This
includes data protection, consent,
and ensuring volunteers for PMI’s
cohort are appropriately informed,
he says.
PMI than has likely been collected
in any other research project,
Pritchard says. “You need to collect and manage that to create
a learning health system.” This
means building a system that collects and stores outcomes data in
a standardized way and informs
participants in a timely manner,
he says.
Significance determination. A third
challenge is how to draw results
and determine clinical significance, Pritchard says. Many of the
genetic alterations studied will be
relatively rare, he says, “but because you have 1 million patients,
you can analyze rare occurrences
statistically ... and assess whether
this truly makes a difference.”
As for front-line challenges,
Florence Comite, MD, an endocrinologist who runs a precisionmedicine clinic in New York City
and writes on the topic, describes
“a rift between academic institutions and the practice of medicine.” Clinicians see the promise
of precision medicine, she says,
but the concept “doesn’t yet
have traction” as it does among
academics.
Comite supports PMI, but
views it as “a starting point.” Collecting a wealth of genomic data
is exciting, she says, but it must be
translated into actionable information for clinicians who often
don’t know how to make sense of
Fitbit data, much less genomic information. “We’re actually taught
in medical school you don’t want
to go on any fishing expeditions,”
she notes. “Is one going to be able
to take the scale of 1 million [participants in PMI’s research cohort]
and extract it down to one human
being? It’s a complex universe
we’ve entered into [that is] going
to leave perhaps more questions
than answers because of what we
face in medicine.”
Information management. More
information is being gathered for
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
Judy Packer-Tursman is a writer in Washington, D.C.
Managed Healthcare Executive. com
Health Management
B EST P R ACTI C ES FO R O PTI MAL O UTC O M ES
Highmark’s cancer collaborative
Payers, providers come together in new ways
C
ollaborative, coordinated
care is the catchphrase of
the decade in healthcare,
but for cancer patients
in one area of Western
Pennsylvania, it has become
much more.
With the launch of the new
Highmark Cancer Collaborative,
payers and providers are working
together in a new way, removing
barriers that for too long have prevented true progress in affordable
and accessible cancer care.
David S. Parda, MD, FACP,
professor and system chair of the
Department of Oncology and
the Cancer Institute at Allegheny
Health Network (AHN), which is
part of the collaborative, says he
hopes the partnership will help
overcome what the Institute of
Medicine calls a “cancer care crisis” in the United States.
In a September 2013 report,
the institute noted that despite
remarkable advances in cancer
care over the last 50 years—leading
to a nearly 70% cure rate—cancer
care is still inadequate and being
delivered at unsustainable costs.
“We agree with this assessment
and the tough solutions that are
required,” says Parda. “We need to
improve patient-centered, accessible, coordinated, and evidencebased treatment and care. We need
to increase the focus on prevention
and psychosocial wellness as some
estimates indicate that 50% of
cancers may be preventable.”
Managed Healthcare Executive.com
Program specifics
The collaborative is made up of a
partnership between AHN (which
is based in the Pittsburgh area),
Highmark Blue Cross Blue Shield,
and the Johns Hopkins Sidney
Kimmel Cancer Center.
The premise is that Highmark
is providing AHN physicians with
a system for identifying evidencebased cancer care pathways based
on patients’ individual information. Incentives for ineffective, or
unproven treatments are removed
and instead, value-based care is
pursued. Highmark is also removing pre-authorizations for cancer
patients, and it is streamlining the
claims and payment process to
help providers get paid faster.
by RACHAE L Z I M LICH, R N
Johns Hopkins is also collaborating on patient cases—particularly
in rare or complex cases—through
direct physician peer-to-peer
review and other virtual methods.
It also offers joint educational
programs, and participation in
collaborative research projects and
clinical trials.
Terry Langbaum, MHS, chief
administrative office at Johns
Hopkins Kimmel Cancer Center,
says Johns Hopkins has had a
partnership with AHN for the past
two years, but the new collaboration expands the possibilities.
“We are bringing together a lot of
assets and all working together
toward better outcomes for cancer
patients,” Langbaum says.
“Some estimates indicate that 50%
of cancers may be preventable.”
—DAVID S. PARDA, MD, ALLEGHENY HEALTH NETWORK
AHN and Highmark will focus
on bringing experts together to
advance cancer care on all levels—
quality of care, access, experience
and value for all stakeholders, says
Parda.
Cancer patients can be sure
that they get the most appropriate, earliest treatment by getting a
second opinion or confirmation of
their cancer diagnosis and staging
by specialists at Johns Hopkins.
Patients will not necessarily
receive treatment at Johns Hopkins—which sees 8,000 new cancer
patients each year—with the exception of rare or complex cancers,
or patients who are eligible and
elect to participate in a clinical trial. The majority of cancer care can
and should be delivered at facilities
within a patient’s community, like
at AHN, she says.
“Really the whole point of it is
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
27
Health Management
to make sure each patient has the
right diagnosis and right stage to
drive the correct treatment plan,
and that they are getting their
treatment in the right place,” Langbaum says.
“It’s not just about pathways ...
it’s models and incentives to get
people the care they need.”
—VIRGINIA CALEGA, MD, HIGHMARK BLUE CROSS BLUE SHIELD
Streamlining information
AHN and Johns Hopkins are
integrating their electronic health
record (EHR)/IT platforms to help
providers communicate more
rapidly and efficiently.
The collaborative will utilize a
Web-based tool that connects to
an EHR network and the physician,
accessing patient information, physician, demographic, and genetic
input to match it to an appropriate
pathway. Physicians can even use
the technology for patients not in
the Highmark system.
and the patient, it takes that worry
away from them.”
Calega says the collaboration
brings providers and payers together in a new way to really focus
on improving access, affordability,
and appropriateness of care.
For example, she points to the
use of therapeutic radiation. For
years, providers have used sixweek courses of radiation to treat
Pharma Implications
Stakeholders say the collaborative will have implications for pharmaceutical
cancer care costs. These costs increase 17% each year, and the median cost of
new cancer drugs coming to market is nearly $10,000 per month, according to
Highmark. The partnership will allow patients and providers to review evidencedbased care paths that deliver targeted treatments, reducing the likelihood that a
patient will receive a medication that is unlikely to result in improved outcomes.
The system will also provide
physicians with access cost information, so that they can discuss it
with concerned patients. “Those
kind of discussions are critically
important, and patients want to
have those discussions with their
clinical team,” says Virginia Calega,
MD, MBA, FACP, vice president
of strategic clinical solutions at
Highmark Blue Cross Blue Shield.
“What are the options, and what
are the side effects, and what is
going to be their quality of life? If
you can make the payment more
predictable both for the doctor
28
breast cancer, but now research
shows that a three-week course
can be just as effective with less
negative effects, says Calega.
“Outcomes are equivalent with
less toxicity,” she says, adding the
shorter course is just as effective,
easier for the patient, and more
affordable.
Under the collaborative, providers get paid the same for a six-week
course of treatment or a threeweek course. Prior authorizations
are removed, and providers get half
of the payment up front and half at
the end of treatment.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
Criticisms and concerns
While care pathways have
received some criticisms for
impinging on physicians’ autonomy, Calega says that is not
the case in this collaboration.
“It’s not just about pathways, but
it’s models and incentives to get
people the care they need,” she
says. “You don’t use pathways as
a prior authorization, you use
them to help people get better.”
Physicians are usually pleasantly
surprised once they understand
how the collaboration works; that
they no longer need to deal with
prior authorizations, and that they
will be rewarded for caring for patients in accordance with National
Comprehensive Cancer Network
pathways, she says.
Highmark also plans to sit
down with physicians and look
at historic data to come up with
a payment rate for patients in
various cancer groups. “We’re
going to pull prior authorization
and we’re going to sit down with
[physicians] and say, ‘How are we
doing?’” Calega says. “We’re really
able to not just look at pathways
but how we reimburse differently
for pathways. That’s the piece
where I think having a partnership with an insurance [company]
changes the conversation in the
marketplace.”
Rachael Zimlich is a writer in Columbia Station, Ohio.
Managed Healthcare Executive. com
Q&A
I N D USTRY E X P E RTS WE I G H I N
Fertility benefit services:
pros and cons
Experts weigh in
I
n an effort to attract
and retain top talent,
employers are offering a
variety of family-friendly
benefits including fertility
services, according to a
new survey.
The Employee Benefits
Survey 2016, conducted by
the International Foundation
of Employee Benefit Plans,
found that 24% of employers
with 500 or more employees
offer fertility services as part
of their healthcare benefits.
Nineteen percent cover in vitro
fertilization (IVF) treatments,
12% cover fertility medications
and 9% cover non-IVF fertility
treatments. Smaller numbers
cover visits with counselors
(geneticists, surrogacy, etc.), at
6%, or egg harvesting/freezing
services, at 4%.
Karin Ajmani, president of
by TRACEY WALKE R
healthcare services at Progyny, a
digital healthcare company that
provides a fertility solution to
employers, and Brian A. Levine,
practice director at the Colorado
Center for Reproductive Medicine
(CCRM), New York location,
recently spoke with Managed
Healthcare Executive (MHE) about
the details of fertility plans.
Q:
MHE: What is a fertility
benefit plan?
Ajmani: About 25% of employers
offer some coverage for infertility
treatments and that percentage is
growing annually due to the recognition that infertility is a medical
condition like any other (in 2009,
the World Health Organization
officially designated infertility as a
disease). Typical infertility benefits
are not comprehensive and only
“There are about 15 states where
fertility and infertility benefits are
‘mandated’ by the state legislature.”
—BRIAN A. LEVINE, COLORADO CENTER FOR REPRODUCTIVE MEDICINE
Managed Healthcare Executive.com
cover fertility medications or a
very limited amount of infertility
treatments.
Most infertility benefits
currently offer a defined dollar
maximum, and do not cover all
of the costs associated with the
consultation, diagnostic testing,
and latest infertility treatment
technologies which drive success
rates. Therefore, patients suffer
longer, with higher rates of
infertility treatment failures,
higher miscarriage rates, and
much higher out-of-pocket costs
(the typical retail rate for one full
IVF cycle, including diagnostic
testing and labs, is as high as
$20,000 per cycle). Since the
average fertility benefit only covers
$10,000, and it takes about three
IVF cycles to obtain a successful
live birth, patients are forced to
make difficult decisions about
what treatments to pursue based
on cost, not best practice.
Levine: A fertility benefit plan is
additional coverage for fertility and
infertility benefits to an existing insurance policy. There are about 15
states where fertility and infertility
benefits are “mandated” by the
state legislature. With that said,
the breadth and depth of coverage
can vary quite a bit.
Q:
MHE: What is happening in
healthcare that makes this
benefit attractive?
Ajmani: Employers are getting hit
hard with medical costs related to
high-risk pregnancies and NICU
expenses as a result of employees
seeking infertility treatments. And
this trend is only going to increase,
as the average age of women having children increases.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
29
Q&A
Currently, one in five couples
now has their first child at 35
years of age or older, let alone
their second or third child.
People struggling to get pregnant
don’t stop if they don’t have a
fertility benefit; they simply pay
out of pocket and begin with
less-expensive, less-effective
technologies, such as fertility
medications or intrauterine
insemination, lending to the high
rate of twins. It is widely known
that pregnancies involving twins
result in much higher prenatal,
maternity and neonatal intensive
care unit (NICU) expenses.
Any employer looking to
support their employees during
the stressful and expensive journey
of infertility will be interested
in this benefit. Employees who
struggle with infertility face
higher rates of depression and
absenteeism in the workplace, as
well as turnover.
The employees who need to
utilize their fertility benefit is
small, less than 1% per year, but
they’re disproportionately more
vocal and proactive in their quest
to obtain coverage through their
employers. In the end, HR and
benefits executives recognize that
providing coverage is the right
thing to do from both a cultural
and cost perspective.
By enrolling in this type of
benefit, HR directors are able to
retain and attract employees,
especially millennials.
Q:
MHE: What are the pros
and cons of adding
a fertility benefit?
Levine: It is important to recognize that both the cost of the
plans and the scope of the plans
can vary widely. Many employees
might be excited at first to learn
that they have fertility coverage
only to later find out that they are
only covered for certain treatments at certain clinics.
30
“One in five couples now has their first
child at 35 years of age or older, let
alone their second or third child.”
—KARIN AJMANI, PROGYNY
To further complicate the
matter, certain insurance
companies can dictate where
patients can fill their fertility
prescriptions since the
medications typically come
from a specialty pharmacy. It’s
important when selecting a plan
to select a plan that is broad
and that also allows for fertility
preservation, which includes egg
freezing, something that many
young female employees might be
interested in doing.
Q:
MHE: What is the ROI
of this benefit?
Ajmani: The most significant ROI is
related to medical cost avoidance.
If someone doesn’t have coverage,
or has very limited fertility coverage, an employee will still seek
treatment and pay out of pocket.
This leads people to choose
less expensive, less effective,
treatment options, such as
fertility medications and artificial
insemination, which have the
highest chance of producing
twins or multiples (the current
rate of multiples through use
of fertility treatments is about
27%, as compared to a natural
multiples rate of about 1.5%). And
if that doesn’t work IVF is often
utilized, and multiple embryos are
transferred per cycle to increase
the chance of pregnancy, because
option B is a second round of
IVF at an average retail rate of
$20,000.
The minute a woman gets
pregnant with multiples,
her employer or plan is now
responsible for the costs related
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
to her high-risk maternity care, as
well as a likely C-section, pre-term
birth and NICU expenses. These
downstream expenses far outweigh
having a comprehensive fertility
benefits plan. But just providing
a fixed dollar amount of coverage
doesn’t solve the problem; Progyny
has been able to decrease the rate
of multiples for people needing
fertility treatment to only 4% by
providing patient care advocates
to help our members through the
opaque maze of fertility options,
and by including coverage for the
latest technologies.
Q:
MHE: What are your top
recommendations for
executives thinking about a
fertility benefit plan?
Levine:
sure that the benefit
1 Make
package is accepted by the
providers in the area.
sure that the benefit
2 Make
package does not require the
patient to maximize all out-ofnetwork benefits before using their
fertility benefits.
a plan that is flexible to
3 Select
patients who may want to
preserve their fertility as opposed
to solely seeking fertility treatment.
a plan that is open to
4 Pick
single parents who desire to
reproduce with donor eggs/
sperm.
Tracey Walker is content manager for Managed
Healthcare Executive.
Managed Healthcare Executive. com
Conference Insider
Highlights from ASCO 2016
Biosimilar uptake may lag for cancer patients
by B RYANT FU R LOW
A
s cancer biologics come
off-patent and non-brand
“biosimilars” hit the marketplace over the next few
years, costs should decline.
Still, oncology practices
and cancer centers will confront more complex prescribing
and purchasing decisions—and
challenging conversations with
patients, experts said at the American Society of Clinical Oncology
(ASCO) Annual Meeting 2016, held
in Chicago in June.
As of January 2016, efforts
were under way to develop and
seek FDA approval for dozens
of biosimilar versions of 18
reference biologics under FDA’s
Biosimilar Product Development program.
The larger numbers of biosimilars will have a “major impact in
cancer treatment
and supportive
care management,
with the potential
to drive cost savings in healthcare,”
said Francisco J.
ESTEVA
Esteva, MD, PhD,
of the New York University Clinical
Cancer Center, during a biosimilars panel at the conference.
The estimated cost of developing a biosimilar is one-fourth to
one-eighth the cost of developing
the originator (the brand-name
reference drug), Esteva noted.
Based on what’s happened in
Europe and Asia, he expects to see
biosimilars costing 20% to 30% of
brand-name biologics.
Managed Healthcare Executive.com
Acceptance a concern
It is not yet entirely clear that patients will widely accept biosimilar
cancer drugs, at least right away.
Biosimilar versions of supportive-care medications like filgrastim
(a bone marrow stimulant that
helps cancer patients avoid infections during treatment) do seem
to be acceptable to clinicians and
patients, so far, Esteva noted. The
FDA’s March 2015 approval of
Zarxio ( filgrastim-sndz, Sandoz, a
Norvartis Company), a biosimilar of
Amgen’s Neupogen ( filgrastim), was
the first such approval under the
Biologics Price Competition and
Innovation Act of 2009.
It is less clear how patients will
feel about the arrival of the FDAapproved biosimilar versions of
brand-name cancer treatments—
that actually attack tumor cells.
“Biosimilar cancer therapeutics,
like [biosimilars for] rituximab
and trastuzumab, are likely to raise
concerns,” Esteva said. “Safety and
efficacy data must be communicated effectively to patients.”
Post-marketing surveillance will
sometimes be needed to ensure
that biosimilars match originatorbiologics’ safety and efficacy, he
said. He predicted that widespread
adoption will take more time in
the U.S. than elsewhere. Explaining
the evidence base for biosimilars
to patients might also prove to be
challenging.
Comparative clinical studies
may be undertaken when there is
“residual uncertainty,” but the goal
of biosimilar development is not
to independently re-establish the
safety or efficacy of the proposed
biosimilar for each potential indication, explained Steven Lemery,
MD, MHS, associate director (acting) of FDA’s Division of Oncology
Products, Office of Hematology
and Oncology Products.
Physician misgivings
A “totality of the evidence” approach is used to determine biosimilarity, including
lab animal and human toxicity, pharmacokinetic and
pharmacodynamic
data, analytical
data, immunogeLEMERY
nicity studies, and
clinical findings, Lemery said.
That may leave some clinicians
with misgivings, at least initially.
“How confident will clinicians be
with limited data on the efficacy
and safety of biosimilars compared
with the original biologics?” Esteva
said.
The FDA’s approval of a biosimilar does not mean the product is
interchangeable at the pharmacy
with the brand-name reference
drug.
“An interchangeable product may be substituted without
the intervention of a healthcare
provider,” explained Lemery. “A
biosimilar product must be prescribed by the healthcare provider
and should not be substituted by
the pharmacist without intervention by the provider.”
Continued on page 32
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
31
Conference Insider
Conference Insider continued from page 31
Patient-reported outcomes poised to improve cancer care
by B RYANT FU R LOW
Patient-reported outcomes (PROs)
are playing a growing role in cancer
research and are poised to become
an important part of regulatory
review in drug development—and
even routine clinical cancer care,
according to experts at ASCO.
During the session “Integrating
Patient-Reported Outcomes into
Cancer Clinical Trials and Regulatory Review,” experts discussed
PROs, which are measures of
patients’ symptoms and physical,
cognitive, social and emotional
functioning, and health-related
quality of life, that are obtained via
self-administered questionnaires or
structured interview questions.
In research settings, there are indications that PROs might improve
early detection of side effects. “Early
data suggest PRO [measures] might
also enhance our ability to discriminate adverse events between study
arms,” said Ethan Basch, MD, MSc,
of the University of North Carolina
at Chapel Hill, a
leading researcher
in PRO assessments of adverse
events among
cancer patients.
In one study, the
BASCH
number of adverse
events found to be statistically
significantly different between treatments was three times larger when
adverse events were measured using
PROs instead of traditional cliniciandriven adverse-events reporting,
Basch noted.
Incorporating PROs
in drug development
Such findings have prompted the
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32
FDA to take a serious look at how
best to incorporate PRO assessments of symptomatic adverse
events in drug development, said
Paul Gustav Kluetz, MD, a medical
oncologist at the FDA’s Office of Hematology and Oncology Products.
“We are now in a different
era of drug development; patient
voices are more important,” Kluetz
said. “Thoughtful incorporation of
patients into clinical trials and drug
development is becoming a priority.”
Improved assessment of
tolerability represents a real “PRO
measurement opportunity,” Kluetz
said. “Symptomatic adverse events
are best assessed
by patients themselves.”
Drug developers and regulators have long
“looked at drug
KLUETZ
safety through the
clinician’s lens,” Kluetz said. The
emphasis is on precisely-measured
lab test results and radiographic or
histological variables.
PROs provide new
insights
Such measures have proven to be
very valuable to researchers and
clinicians alike. But adding PROs
to the mix can afford new insights
into how treatments really affect
patients.
PROs offer “different but complementary data to current clinicianreported safety data,” Kluetz
explained. The US National Cancer
Institute (NCI) has developed a PRO
version of the Common Terminology Criteria for Adverse Events
(PRO-CTCAE™)—a “promising tool
for this purpose,” Kluetz said. PRO-
CTCAE data can be collected using
web portals between visits in just
minutes, noted Basch.
Expanding adverse-events detection to include PROs is increasingly
important as the durations of cancer
treatments grow, and the field of
drug development transitions from
an era of cytotoxic chemotherapies
infused intravenously at cancer centers, to more diverse treatments that
are self-administered orally every
day, he said.
Drug efficacy and PROs
There are currently significant challenges in assessing cancer drug efficacy using PRO measures, Kluetz
cautioned.
“Many patients enrolled on
cancer trials are asymptomatic
with good performance status,” he
explained—making it difficult to
detect potential impacts on patients
in real-world clinical settings.
But enrolling more symptomatic
patients could allow researchers to
use PROs to better measure symptom improvement and palliation.
Incorporating PROs into
research will help develop treatments with an eye toward patients’
expressed needs and priorities.
Bringing PROs into clinical
practice can also help practices and
hospitals to bolster quality of care.
ASCO has a PRO committee that
has begun to test PRO quality-ofcare measures. The development
of so-called “ePRO” apps will allow
patients to routinely self-report
symptoms from home. Efforts are
under way to integrate ePRO approaches with electronic health record portals to allow the addition of
longitudinal PRO data to patients’
medical records.
To see Managed Healthcare Executive’s full conference coverage of the ASCO conference, visit bit.ly/MHE-ASCO-2016.
MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016
Managed Healthcare Executive. com
INDUSTRY
Analysis
Oncology medical home model pays off
New partnership between payers, providers
Tracey Walker
CO NTENT MANAGER
A NEW value-based cancer care model is focusing on better aligning providers with health plans and employers through an independent practice
association (IPA) structure that creates oncology patient-centered medical homes.
The Vantage Cancer Care Network
(VCCN) model, launching in Philadelphia, is already under way with the establishment of an IPA advised by John
Sprandio, Sr, MD, FACP, a practicing
medical oncologist and hematologist
and an innovator for the Oncology
Patient-Centered Medical Home. The
VCCN has formed a single specialty
IPA of oncologists who have contracted with a payer in the market to share
savings.
More than 60 oncologists in seven
locations from the Philadelphia area
are participating in the network, and
more than 30 patients are participating. It’s anticipated that 750 patients
will participate by the end of 2016.
“It is a model that ensures the best
outcome, minimizing side effects at a
lower overall utilization of services,”
says John Iacuone, MD, MBA, president and chief clinical officer, VCCN.
“Typically this results in a lower overall cost to the patient and payer, while
providing shared savings with the physician managing the patient.”
WHY ONCOLOGY?
Making critical, value-based care
management decisions is the purview
of the oncologist,
says Iacuone. “A value-based contract
allows the oncologist to manage the
patient, and with
different incentives
for utilization of
IACUONE
services, the health
plan is protected from potentially
harmful overutilization of services.”
He adds that participating oncologists are monitoring outcomes, quality of life, and access to care as part of
their commitment to the payer that
its patients will be receiving comparable or exceptional care—value—while
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reducing inappropriate utilization of
services.
EARLY RESULTS
While it is too soon to report outcomes, preliminary data from the
model show excellent and timely access to providers, and 100% compliance with utilization of value-based
treatment guidelines based on National Comprehensive Cancer Network
Guidelines, according to Iacuone.
“Providers and patients are now incentivized to avoid unnecessary and
costly utilization to manage their cancer that do not improve outcomes, reduce toxicity or improve quality of life
for the patient,” he says. “Historically,
providers have been paid when they
utilize services, for example, order a
test, prescribe a medicine, or perform
surgery. This is bankrupting Medicare
and patients due to unsustainable inflation of healthcare costs that may
have unproven, or limited improvement or value. This is happening in
cancer care as well, but at twice the
inflation rate of all other healthcare
services.”
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in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content.
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ADVERTISER INDEX
The following is a list of the advertisers in this issue. Although every effort is made to ensure accuracy, this publication
assumes no liability for errors or omissions.
Advertiser name
Brand name
Page No
Athenahealth
Great Call
Hologic
Merck & Co., Inc.
Regeneration
RXCrossroads
Corporate
Corporate
Affirm Prone
BioSimilars
Eylea
Corporate
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