Download Improvement of Cold-Chain Management Helps Ensure

Volume 10, Number 2
February 2013
News and Strategies for Managing High-Cost Specialty Products
Contents
Specialty Spend
3 Study:
Will Exceed Nonspecialty
Spend by 2018
Proposed in Some
4 Bills
States Could Limit
Biosimilars’ Uptake
for
5 Expectations
Biosimilars’ Price Impact
May Be Wavering
Pricing
6 Charts:
Implications of Biosimilar
Entry
Will Shore Up
8 Centene
Pharmacy Focus With
AcariaHealth Deal
FDA Specialty
8 New
Approvals
D. Smith Reorganizes
10 H.
Its Units With Specialty
New SBS Drug Is Costly, but It May Reduce
Other Care Costs, Improve Quality of Life
A recently approved drug to treat a deadly condition is offering a major advancement over a pair of therapies that have been on the market for about a decade. And
while its annual price tag of nearly $300,000 may warrant a double take, NPS Pharmaceuticals, Inc.’s Gattex (teduglutide [rDNA origin]), which is indicated for the treatment
of short bowel syndrome, could eliminate potentially hundreds of thousands of dollars
spent on care for someone suffering from SBS.
SBS occurs when portions of the small intestine — usually half of it or more — are
removed through surgery or are missing due to a congenital defect. When a lot of
the small intestine is missing, people can have problems with absorbing fluids and
nutrients from food that are “needed to sustain life,” notes the FDA. These people are
dependent upon parenteral nutrition, and Gattex is indicted for use in this patient population. It’s injected once daily to help improve the absorption of fluids and nutrients
and in turn reduce the need for parenteral support. Data show that some people may
be able to stop receiving parenteral nutrition entirely.
SBS prevalence estimates for the U.S. patient population vary from as many as
15,000 people to as few as 3,000. “Based on our patient population and 30 years of experience in the industry, we think likely that SBS occurrence is two to three patients per
million lives,” says Karen Hamilton, strategic manager for nutrition at Coram LLC.
continued on p. 10
Drug Focus
12 News Briefs
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Managing Editor
Angela Maas
[email protected]
Executive Editor
Jill Brown
Director, Databases
and Directories
Susan Namovicz-Peat
Improvement of Cold-Chain Management
Helps Ensure Integrity of Specialty Drugs
Although there is not a standard definition of “specialty pharmacy,” one characteristic of these drugs that most within the industry can agree on is a medication that
requires special handling. Most times that means a product needs to remain refrigerated or frozen, which is especially critical while the drug is being transported to patients
and physicians.
But even though companies utilize an array of tactics in cold-chain management,
a recent study suggests that some of these containers may be lacking in their ability to
actually maintain an appropriate temperature.
Bill Bailey, chief operating officer (COO) of PBM Citizens Rx, LLC who also is a
licensed pharmacist in eight states, says that as a pharmacist, “my concern is around
the proper storage and handling of biologics. A lot of times not much attention is paid”
to this. “There isn’t a good process” to make sure the drug remains the temperature it
needs to be during transit, he contends.
Bailey estimates that “about 60% of specialty drugs fall within temperature-sensitive opportunities.”
And “that number is growing rather significantly year over year,” adds Gary M.
Hutchinson, president of Modality Solutions LLC, which helps companies across highvalue and high-risk industries improve their controlled-environment logistics.
continued Published by Atlantic Information Services, Inc., Washington, DC • 800-521-4323 • www.AISHealth.com
An independent publication not affiliated with insurers, vendors, manufacturers or associations
10 Specialty Pharmacy News H. D. Smith Reorganizes Its
Units With Specialty Drug Focus
Last month wholesaler H. D. Smith reorganized
some of its units under an umbrella organization focused
on specialty drugs. H. D. Smith Specialty Solutions will
include such subsidiaries as specialty distribution unit
Smith Medical Partners and the recently acquired Triplefin, which offers reimbursement, patient assistance and
pharmaceutical brand support.
H. D. Smith Specialty Solutions was launched with
a focus on “develop[ing] a business unit that’s able to
coordinate all those service offerings we can supply for
manufacturers, payers and patients across a product’s life
cycle,” says Tom Doyle, executive vice president of commercial solutions for H. D. Smith.
Triplefin Fills Gap
The company acquired Triplefin in January. That
deal came about because “we continue to respond to
market needs and the needs of the manufacturers we service,” says Doyle. Offering reimbursement and patientassistance services “fills a gap in our portfolio,” he says.
“The other piece of Triplefin that’s important is its
part ownership of SPNN,” or Specialty Pharmacy Nursing Network, which the company acquired in November,
he says. SPNN provides clinical and nonclinical services
to specialty pharmacies and manufacturers.
Triplefin is “dealing mostly with patients and prescribers now,” says Patty Benjamin, vice president of
managed care for H. D. Smith Specialty Solutions. For
now “the model will continue as is” but later likely “will
expand and grow.”
CompleteCare Pharmacy, an H. D. Smith company,
also has three locations in Illinois. Those retail pharmacies are able to “negotiate with health plans for their
covered lives, allowing the stores to dispense” medications, notes H.D. Smith spokesperson Carolyn Webb.
And “Triplefin does have a pharmacy with the potential
to have a presence” in specialty pharmacy that is licensed
in all 50 states. The company has “not executed on that
capability, but it’s being explored,” she tells SPN.
H. D. Smith has “four or five limited-distribution
agreements” for specialty products, says Doyle. He declines to give specifics but says that “in some cases they
are in our core space of blood plasma” products.
H. D. Smith Specialty Solutions will be “another
competitor to the integrated segment including McKesson, AmerisourceBergen and Cardinal,” maintains F.
Randy Vogenberg, Ph.D., principal at the Institute for
Integrated Healthcare.
Doyle says that this is “a space with a lot of fabulous
companies providing services,” but he maintains that
February 2013
there is “a niche in the market” that H. D. Smith Specialty
Solutions can fill.
The launch of the new unit reflects the “recognition
that biologics and specialty is the future for a wholesaler
if they want to stay competitive or survive through this
decade,” says Vogenberg.
Contact Vogenberg at [email protected] and
Benjamin and Doyle through Webb at carolyn.webb@
hdsmith.com. G
FDA Approves SBS Drug Gattex
continued from p. 1
NPS has a limited-distribution agreement for Gattex
with five specialty pharmacies: Accredo Health Group,
Inc.; BioScrip, Inc.; Coram; ThriveRx; and Walgreens
Infusion Services.
“Short bowel syndrome is a highly complex disorder
that requires a high degree of coordination of care at the
local level,” explains Eric Pauwels, senior vice president
and chief commercial officer of NPS. “When we designed
our distribution strategy, it made the most sense to be
very selective in the design of our network and utilize
leading specialty infusion pharmacies that are already
providing home infusion services to SBS patients. We
believe this approach will offer optimal care for patients
and may ultimately improve patient outcomes.”
And it’s not only SBS that can cause problems for
people. Additional complications, particularly when
people are dependent upon parenteral nutrition, often
affect this patient population.
SBS may have been caused by conditions such as
Crohn’s disease, scleroderma or radiation enteritis that
come with their own challenges, says Deborah Pfister,
director of nutrition at ThriveRx. SBS, explains Pauwels,
is “really a ‘condition of a condition.’”
Those conditions, in turn, can make some SBS symptoms more severe, says Steve Kennedy, Pharm.D., national director of infusion pharmacy services for Walgreens
Infusion Services. SBS can vary in severity depending on
how much small intestine the person still has. But when
people with SBS “suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia and weight loss
due to the intestine’s reduced ability to absorb nutrients,
water and electrolytes,” they must receive parenteral
nutrition, he points out.
Long-term parenteral nutrition, notes Hamilton,
“may predispose a patient to potential therapy-related
complications. Chronic dehydration from unchecked
diarrhea can result in kidney dysfunction. Long-term
complications can include: metabolic bone disease, cho-
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February 2013
lestasis, liver dysfunction and of course, due to the need
for a central venous catheter, catheter infection.”
Pauwels tells SPN that “parenteral support…does
not improve intestinal absorption, and its use is associated with numerous potentially life-threatening
complications.…Parenteral support also results in hospitalizations. On average, patients on parenteral support
experience two hospital stays per year directly related to
complications of parenteral support.”
“In addition, the use of parenteral support is also
time-consuming for many patients,” says Pauwels.
“Those dependent on parenteral support typically infuse
it up to seven nights per week, and in extreme cases
some patients could receive parenteral support for 24
hours a day.”
With that in mind, Hamilton contends that quality of
life “is paramount in this population.”
“There is a significant quality of life aspect to SBS,
and this should be underscored,” agrees Accredo spokesperson Ann Smith. “A number of factors associated with
parenteral nutrition can affect patient quality of life;
these include inconvenience, expense, and loss of independence. Physical problems resulting from parenteral
nutrition include fatigue and diarrhea. Depression may
develop.”
According to Pauwels, “there is research showing
that the disorder can be restrictive socially for many.
Patients must combat the stigma of dealing with the constant threat of an accident, and they are often consumed
with knowing where the bathroom is located. Further,
many SBS patients are unable to work.”
The FDA notes that it approved EMD Serono, Inc.’s
Zorbtive (somatropin) in 2003 and Emmaus Medical,
Inc.’s NutreStore (glutamine) in 2004 to treat SBS in
adults receiving parenteral nutrition.
“The goal of these therapies is to enhance the absorption of the remaining intestine, while Gattex is the first
long-term treatment that increases absorptive capacity,”
says Pfister. Zorbtive is approved for treatment of up
to four weeks, and NutreStore is approved for up to 16
weeks of treatment.
Gattex, says Kennedy, reduces patients’ “dependence on parenteral nutrition — so much so that some
patients may be able to wean off the therapy completely.”
SBS Care, Complications May Be Costly
When NPS disclosed that the annual per-person
price for Gattex was $295,000, that made news.
“Given the expense of this orphan drug and the fact
that only a few thousand patients will be on treatment
nationwide, it is extremely important to have experienced specialty clinicians and a specialty pharmacy sup-
Specialty Pharmacy News
11
port team working with these patients to help ensure
proper use of the medication, adherence, managing side
effects and potential comorbidities,” asserts Smith.
Pauwels tells SPN that the company took many factors into account when it established the drug’s price:
u “SBS is a serious life-threatening disorder associated
with reduced mortality. The current standard — parenteral support — is supportive care. It does not address
the malabsorption of SBS, and it is associated with significant comorbidities and complications.”
u “Gattex is the first and only product of its kind that
has been clinically proven to improve intestinal absorption and significantly reduce or even eliminate parenteral
support,” he says.
u NPS has made a “substantial multimillion-dollar
investment…in this product during the 17 years of its
discovery, formulation and clinical testing.”
u Long-term parenteral support “places a substantial
economic burden on patients and the health care system,” Pauwels explains. “A substantial portion of the
costs of SBS are likely due to the need for parenteral support.” He cites a National Institute of Health publication
that “reported that the annual mean costs of lifelong,
complex home health care associated with PN/IV [i.e.,
parenteral nutrition/intravenous fluids] support ranged
from $185,000 to $568,000. This does not include the indirect costs associated with disability. We also have to associate a value to giving these patients the freedom to be
independent from parenteral support for a day or more
a week or possibly forever — Gattex has been clinically
proven to deliver this to patients.”
If Gattex produces a 20% reduction in parental support, says Pauwels, that’s one fewer day a week someone
would need parenteral support. “Over one year, this
translates to almost two additional months of freedom
from parenteral support. Gattex may reduce IV catheter
access in patients with SBS, thereby reducing the risk of
catheter-related infections and other complications.”
According to Pfister, “The cost burden of an SBS
patient is between $383 and $630 per day.” She tells SPN
that “approximately 50% of SBS patients get end-stage
liver disease if they are on parenteral nutrition for more
than five years. Septicemia accounts for approximately
50% of PN/IV hospitalizations. Various surgeries may be
attempted to elongate or otherwise increase the absorptive surface of the bowel.”
In addition, she says, if intestinal failure occurs, “SBS
patients may undergo a transplant. SBS accounts for
approximately 64% of transplant diagnoses. Transplants
can cost between $150,000 and $500,000. Post-transplant
complications (e.g., rejection, infection) can further increase costs.”
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12 Specialty Pharmacy News However, it’s not just a reduction in health care
costs for these patients that the therapy could provide,
but an improvement in aspects like people’s social life.
“They can enjoy eating at restaurants, whereas they
may have been unable to do so previously,” says
Kennedy.
And, says Pauwels. “Reduced dependence on
parenteral support could allow patients to experience
the simple activities that many of us take for granted
— joining family functions, traveling from home for a
February 2013
weekend or just getting a full night of uninterrupted
sleep.”
“Because many SBS patients are on PN for up to
eight to 10 hours per day, Gattex could be a life-changing
treatment advance,” contends Kennedy.
Contact Pfister at [email protected], Hamilton
at [email protected], Kennedy at Steve.
[email protected], Smith at [email protected] and Pauwels through Susan Mesco at
[email protected]. G
NEWS BRIEFS
u California consumer advocacy group Consumer
Watchdog on Jan. 14 said it filed a proposed
class-action lawsuit alleging that WellPoint, Inc.
unit Anthem Blue Cross illegally targeted members with HIV/AIDS and other serious conditions by
instituting a policy that requires mandatory use of
mail-order pharmacy programs. Anthem deferred
the program start date until March 1, 2013, and allows members to opt out of the program, according
to the complaint. But Consumer Watchdog takes
issue with the opt-out process. The suit, filed in San
Diego Superior Court, alleges that members who do
not have one of the targeted conditions can continue
to fill prescriptions at local pharmacies. The lawsuit also alleges that the targeted patients won’t be
able to access drug discounts only available at retail
pharmacies or obtain advice and counseling from
pharmacists. Anthem Blue Cross responded that the
policy, which applies to specialty pharmacies that
provide more specialized clinical care, “is being done
with the knowledge of our regulator and applies to
several hundred different drugs for many medical
ailments. Anthem’s policies do not discriminate on
the basis of disease states, and they are reasonable
and compliant with applicable laws.” View the complaint at http://tinyurl.com/bjepxmo.
u Magellan Health Services Inc. and Performant
Financial Corp. are expanding a payment integrity
recovery initiative to all Magellan Pharmacy Solutions commercial customers. The companies piloted the audit and recovery services program in 2012
with some of Magellan Pharmacy Solution’s customers. Magellan says industry estimates show that
claim overpayments for specialty drugs are about 3%
to 10% annually. Contact Magellan’s Joseph Kean at
[email protected].
u CMS unveiled an initiative aimed at improving
the care of Medicare beneficiaries with end-stage
renal disease (ESRD). Through the Comprehensive
ESRD Care Initiative, CMS will partner with groups
of health care providers and suppliers called ESRD
Seamless Care Organizations that will collaborate
to offer patient-centered, coordinated care. The
organizations must include at minimum a dialysis
facility, a nephrologist and one other Medicare
provider or supplier, and they will take clinical and
financial responsibility for a group of beneficiaries
depending on where they are receiving service.
Applicants must file nonbinding letters of intent by
March 15 and applications to participate by May
1. Visit http://innovation.cms.gov/initiatives/
comprehensive-ESRD-care.
u PEOPLE ON THE MOVE: H. D. Smith named Tim
Booth executive vice president of Smith Medical
Partners. He was previously corporate vice president
of H. D. Smith’s Home Healthcare operations. The
company also promoted several employees: Tom
Doyle was promoted to executive vice president,
commercial solutions; Karen Callaway to executive
vice president, human resources; Bob Appleby to
senior vice president, category management; Tom
Twitty to senior vice president, supply chain management; Scott Wilson to senior vice president, drug
division; and Mark Mehmet to corporate vice president, product development and architecture.…Humana Pharmacy Solutions named Anna Theodorou
director of client solutions and Luke Szymanski
market director of sales. Theodorou was previously
a director with CVS Caremark Corp., and Szymanski was senior vice president of sales and marketing
with US Script.…onPoint Oncology LLC named
Rhoda Dunn principal. She previously edited and
authored a variety of medical reports for Kantar
Health.…Prime Therapeutics LLC named Ann Tobin
chief compliance officer. She was previously senior
privacy counsel with UnitedHealth Group.
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