Download Management Strategies for Hepatitis C and Gaucher Disease

Case Study:
Management Strategies for
Hepatitis C and Gaucher Disease
Mark Godwin, PharmD, AAHIVP
Manager – Clinical Pharmacy
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Agenda
As payers continue to be challenged with the increasing costs of specialty
medications, various management tools are implemented to maintain an
affordable benefit offering for employers and individuals. This session builds
on the previous discussion and provides a deep dive into one payer’s
management strategies for Hepatitis C and Gaucher Disease.
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•
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Highlight the different challenges associated with managing specialty medications
covered under the pharmacy versus the medical benefit
Explain the current prior authorization program in place for Hepatitis C
Discuss specialty pharmacy engagement/management programs for Hepatitis C
Outline the product preferencing strategy implemented for enzyme replacement
therapy indicated for the treatment of Gaucher Disease
Discuss pull-through efforts as well as program results
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Hepatitis C
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Hepatitis C in the Headlines
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Condition Overview
Hepatitis C Virus (HCV) is a chronic infection that causes severe liver disease and is the
leading cause for liver transplants.
HEPATITIS C OVERVIEW
As a contagious liver disease, it is spread primarily through contact with blood
infected with the Hepatitis C Virus.
• Top 6 class by spend under pharmacy benefit
• Estimated 3.2 million have Hepatitis C, most are unaware
• Each year 17,000 Americans become infected
POPULATION
• Most common in those born 1945-1965
• 31% of UHC’s membership is at risk
GENOTYPES
Are identified by lab tests. They help determine therapy, length of treatment, and
predicting therapy response.
• Genotype 1 is most common in U.S. accounting for 75%
• Genotypes 2-3 are less common (10-15%)
• Other genotypes are rare in the U.S.
1. Hepatitis C Fact Sheet. Centers for Disease Control and Prevention Department of Health and Human Services. June 2010.
2. Hepatitis C Genotypes and Quasispecies. U.S. Department of Veterans Affairs. Referenced Feb. 2014.
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The scope of Hepatitis C
3.2 million persons are infected with Hepatitis C (HCV) in the U.S. and
many don’t know they have the disease.1
Left undetected, HCV can result in costly, long-term health problems:
Chart source: Centers for Disease Control and Prevention. Hepatitis C Information for Health Professionals. Updated May 7, 2013.
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Who has Hepatitis C?
Each year 17,000 Americans become infected. Currently, 31% of UnitedHealthcare’s population
are baby boomers.
• Adults born between 1945 and
1965 are 5 times more likely to
be infected
• 3 out of every 4 people with HCV
were born between these years
• Screening is now recommended
for all adults born during this time
Chart source: Centers for Disease Control and Prevention. Hepatitis C Information for Health Professionals. Updated May 7, 2013.
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Impact of New Therapies
After much anticipation for these new more effective therapies, drug use has sharply
increased since their launch.
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Progression of Treatment Options
LAUNCH
MEDICATION NAME
TOTAL COST
OF THERAPY1
CURE RATE
$20-40k
44%
$50-70k
72%
$108-168k
80-100%
$63-189k
>95%
NA
>95%
Dual therapy
2001-2011
2011-2013
2013
• Peg-interferon (injection)
• ribavirin (oral)
Incivek2 or Victrelis
Added to dual therapy
Sovaldi or Olysio
Replaces Victrelis
Added to dual therapy
2014
Harvoni & Viekira Pak
2015+
Daclatasvir,
BMS-791325, GS-9669,
MK-8742, MK-5172
1.
2.
Replaces Sovaldi / Olysio
Total cost per therapy depends on length of therapy and regimen. Current totals based on one-time treatment and not recurring annual costs.
Incivek was withdrawn from the market Oct. 2014.
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Hepatitis C Drug Pipeline Timeline
Nov. 28, 2013:
Olysio (Janssen)
launched
2013
Dec. 10, 2013:
Sovaldi (Gilead)
launched
December 2014
Viekira Pak (AbbVie)
launched
2014
October 2014
Harvoni (Gilead) launched
Mid-2016:
grazoprevir / elbasvir
(Merck)*
2015
2016+
Q3 2015:
daclatasvir / asunaprevir /
BMS-791325 (BMS)
* Merck announced 1/12/2015 that it plans to file an FDA application in the first half of 2015 for a single
tablet combining the NS3/4A protease inhibitor grazoprevir (MK5172) and the NS5A inhibitor elbasvir (MK8742) which will expedite the approval timeline.
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2017:
alisporivir
(Novartis)
Current Management Strategies
Managing the class as a whole helps identify program and cost savings opportunities
Benefit Design
Utilization Management
Therapy Assessment
First Fill Consults
Clinical Management Program
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Hepatitis C Management
Prior Authorization with Medical Necessity
Staying current with rapidly changing treatments is key to controlling costs.
With industry-leading coverage criteria, we’ve been at the forefront of managing Hepatitis C.
2014
2014
APR
AUG
Medical necessity criteria
implemented to prioritize
coverage based on clinical
interpretation.
Revisions published to Guidance
Document supports how we
prioritized coverage in our criteria
implemented in April 2014.
When and whom
to treat highest
priority:
•
Advanced fibrosis and compensated cirrhosis (F3/F4)
•
Liver transplant recipients
•
Severe extra hepatic hepatitis C
Guidance document from American Association for the Study of Liver Diseases and Infectious
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OptumRx Specialty Pharmacy
Therapy Assessment
Hepatitis C Members
One Month
Supply
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•
•
•
Genotype
Capture
Receive a therapy assessment
during their first fill with OptumRx
Treatment Based on
Clinical Evidence
Combination Therapy Review
Duration of Treatment
Claims Database Check
Tailor Refills and Notify Prescriber
The processes outlined above are specific to OptumRx. Processes may vary, depending on specialty pharmacy.
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Prior
Authorization
Initiation
OptumRx Specialty Pharmacy
Dedicated Support for Hep C Members
Hepatitis C members receive a clinical consultation during their first fill with OptumRx and can
continue to have one-on-one conversations through our Clinical Management Program.



Filling prior to OptumRx
Adherence
Combination Therapy

Side Effects

High Risk Lifestyle

Financial Impact

Prescriber Engagement
Clinical Management Program
• Personalized, one-on-one support
• Evaluates all aspects of a member’s health
• Member contacted on regular schedule based
on their needs.
The processes outlined above are specific to OptumRx. Processes may vary, depending on specialty pharmacy.
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Moving Forward
We will continue to manage the use and cost of Hepatitis C and encourage your clients to
leverage these strategies.
Benefit Design
Utilization Management
Therapy Assessment
First Fill Consults
Clinical Management Program
Constant Monitoring
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Gaucher Disease
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Enzyme Deficiency
Enzyme deficiency includes a class of diseases where enzymes needed for metabolism are missing.
Examples of enzyme deficiencies include Gaucher Disease and lysosomal storage disorders.
TREND FACTORS
•
97.5% of total drug costs were under the medical benefit in 2013
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Patients of all ages can be affected
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There are only a few drugs available in this category
•
Although it is very rare, the conditions are very costly for members
and clients
Average annual cost
of drug therapy1
$154K
SMARTER SOLUTIONS
 Prior Authorization
Ensures appropriate
diagnosis, drug therapy
and duration
 Medical Necessity
To verify that members are receiving the
necessary treatments with the lowest-cost
medications and care centers
 Preferred Products
Direct use to lower-cost
option when clinically
appropriate
We have already implemented preferred product strategies for Gaucher Disease
and looking to expand to other conditions.
1. Approximate average AWP drug cost per patient per year for Legacy Fully Insured business – calendar year 2013.
Source: Information based on UnitedHealthcare drug report from fully insured and self-funded commercial membership who have UnitedHealthcare medical benefits. Fiscal year 2012.
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Gaucher Disease –
Medical Necessity and Preferred Product
Why were these medications chosen for medical necessity?
The specialty medications used for the treatment of Gaucher disease are high-cost.
Prior authorization with medical necessity allows us to guide use of enzyme
replacement medications before coverage is provided.
Why was VPRIV chosen as the preferred enzyme replacement product?
Although only a small number of UnitedHealthcare and Oxford members currently use
the enzyme replacement medications used to treat Gaucher disease, use of these
medications has a significant impact on pharmacy cost trends with the average cost of
therapy ranging from $250,000 to $350,000 per patient, depending on the dose.
UnitedHealth Group’s National Pharmacy and Therapeutics Committee has reviewed
the medications in this class and deemed them clinically comparable since they
provide similar therapeutic outcomes and responses. As such, UnitedHealthcare was
able to negotiate a competitive rate for VPRIV that will help provide an
affordable option for members while keeping costs down for our clients.
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Gaucher Disease –
Member and Physician Outreach
Specialty Pharmacy Outreach:
• UnitedHealthcare’s network of specialty pharmacies engaged members and
their physicians starting 3 months prior to the preferred product effective date
• Bi-weekly calls between UnitedHealthcare and the specialty pharmacy teams
allowed immediate resolution for any concerns
Physician and Professional Society Outreach:
• UnitedHealthcare met with key opinion leaders within the Gaucher community
6 months prior to the preferred product effective date
• UnitedHealthcare met with the National Gaucher Foundation on numerous
occasions in the months leading up to the preferred product requirement
Outreach and Engagement were key to success:
• 35% of existing Cerezyme users switched to VPRIV
• With pro-active engagement member disruption was essentially eliminated
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