AmerisourceBergen is releasing documents on Medicare Part B’s ASP methodology.

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Feb. 28, 2020

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Editor’s Note: This week, the focus from most stakeholders was (rightfully) on the coronavirus, which is okay because—with less policy news out there—we’re watching the evolution of the global story and how different countries handle the public health crisis. In the meantime, keep washing your hands, staying home if you’re sick, and rest assured that we’ve got you covered on your health policy news.

 
CASE STUDY
 

If Part B Ain’t Broke, Maybe Leave It Alone

 
 

Despite its demonstrated savings to the federal government and taxpayers, the Medicare Part B’s average sales price (ASP) payment methodology for drugs has come under criticism for not adjusting to market incentives. In the last 4 years, the federal government has proposed potential “demonstrations” to modify the ASP methodology. (See “Part B Drug Payment Model” and “International Pricing Index Model for Medicare Part B Drugs.”)

However, AmerisourceBergen believes the assertions that the ASP payment methodology is not market-based have been steered by critics of drug pricing in general or those seeking to advance their own alternative, preferred “solution.”

To counter those critics, and to demonstrate how Part B’s ASP payment methodology for physician-administered drugs promotes market competition, AmerisourceBergen is releasing 2 documents: a 2-page ASP issue brief that is available now, and a longer manuscript that will be published shortly. Health Policy Weekly will announce the manuscript’s availability upon publication.

 

 

 

Gene Therapies Pave the Way to a Potential Cure for Sickle Cell Disease

 
 

Cell and gene therapies (CGT) present unparalleled opportunities to cure diseases with high unmet need. One such underserved patient population showing great promise from these medical advancements is sickle cell disease. While new advancements appear very promising, innovators in the overall gene therapy space also face unprecedented challenges across their commercialization journey—from market access, coverage and reimbursement issues, to contracting and real-world evidence requirements that do not follow the norm.
 
In our most recent CGT white paper, we examine considerations manufacturers need to make for successful launch of these therapies. Learn more >

HPW Rebuild

 
THE VALUE CORNER
 

Can’t Stop, Won’t Stop: ICER’s Hits Just Keep on Coming

 
 

On Tuesday, the Institute for Clinical and Economic Review (ICER) announced the publication of its Final Evidence Report and Report-at-a-Glance assessing 3 acute treatments for migraine: lasmiditan (REYVOW), ubrogepant (UBRELVY), and rimegepant. Members of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) unanimously voted that the evidence was adequate to demonstrate a superior net health benefit for all 3 therapies compared to no treatment, but there was insufficient evidence for any treatment relative to triptans. The council also found insufficient evidence to distinguish the net health benefit for the gepants compared to each other and to lasmiditan. Compared to announced annual list prices, ICER’s health-benefit price benchmark ranges are higher for both lasmiditan ($4,610 vs $2,770–$3,150) and ubrogepant ($4,896 vs $4,150−$4,630); the estimated annual list price of $4,896 for rimegepant is also higher than ICER’s health-benefit price benchmark range of $4,160–$4,640.

On Monday, ICER announced that Aetion was selected as its preferred vendor for generating real-world evidence (RWE), which aligns with ICER’s commitment in its 2020 Value Assessment Framework update to expand the use of RWE in its evaluations. Aetion states its Evidence Platform® analyzes real-world data to produce transparent, rapid, and scientifically validated information on treatments, costs, and outcomes and will be used in select upcoming assessments and 24-month re-evaluations. ICER plans to release the protocols used for RWE generation to the public so that studies can be replicated.

Last Friday, ICER announced it will review 2 non-drug topics related to opioid use disorder: digital apps and supervised injection facilities (SIFs); comments from all interested stakeholders will be accepted on each topic until March 10 and May 14, respectively. The Midwest CEPAC will discuss and vote on the use of digital apps during a September 2020 public meeting, and the New England CEPAC will review SIFs in December 2020.

Last Thursday, ICER announced plans to evaluate nadofaragene firadenovec (INSTILADRIN) for the treatment of bladder cancer. INSTILADRIN has received a fast-track and breakthrough therapy designation from the Food and Drug Administration (FDA), with an anticipated decision expected in mid-2020. Comments will be accepted from all interested stakeholders until March 10, and the topic will be reviewed during a public meeting of the Midwest CEPAC in September 2020.

Last Thursday, ICER also announced the release of its Draft Evidence Report evaluating elexacaftor/tezacaftor/ivacaftor (TRIKAFTA) for the treatment of cystic fibrosis. Additionally, ICER examined new data that have become available since its May 2018 review of 3 other cystic fibrosis treatments already approved by the FDA: tezacaftor/ivacaftor (SYMDEKO), lumacaftor/ivacaftor (ORKAMBI), and ivacaftor (KALYDECO). The Draft Evidence Report considers all 4 drugs in conjunction with best supportive care to be very effective compared to best supportive care alone in all populations studied; however, all therapies exceed commonly used cost-effectiveness thresholds due to high costs. ICER is accepting public comments on this document until March 18, and the revised report will be reviewed by the California Technology Assessment Forum (CTAF) on April 30.

If you need assistance with all things ICER or value-related, please contact Linnea Tennant.

HPW Rebuild

 
REGULATORY UPDATES
 

Purple Reign: FDA Updates Its Database of Biological Products

 
 

Earlier this week, the FDA announced it would be upgrading the Purple Book, its database of FDA-licensed biological products. The anticipated updates, which will be rolled out in phases, include:

  • Addition of the product’s proprietary and proper names, type of Biologics License Application (BLA) submitted, dosage form and strength, product presentation, license status, BLA number, and approval date
  • Full search functionality for both approved biosimilars and their reference products
  • Information about exclusivity and demonstrated interchangeability with reference products
  • Data on transition biological products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)

According to FDA Commissioner Stephen M. Hahn, MD:

“This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users, and other stakeholders…. Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”

This update aligns with the FDA’s commitment to transparency and improved patient access around biosimilars, as stated in its biosimilars action plan from July 2018.

To gather stakeholder feedback and improve the update process, the FDA indicated it will open a public docket and review comments at a later date.

 

Information Buffet (AKA, Other Stuff That Caught Our Attention)

 
 

We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:



 

Xcenda’s MCN Forum in Houston: Your Path to Payer Market Insights

 
 

MCN Forum | Tuesday, April 21 | Houston, TX

Looking for payer input to refine your clinical, market access, and/or health economic and outcomes research plans?

Xcenda is hosting a 1-day event in Houston, TX on April 21. Learn more about the Managed Care Network (MCN) Forum.

Learn more >

 
HEARD ON THE STREET

“It’s becoming a situation where privacy is for the privileged. People use GoodRx when they’ve been prescribed something to improve their health, which in some cases can be a life-changing drug. But people shouldn’t be in a position where they have to choose which is more important, their health or their privacy.”

 – Dena Mendelsohn, Senior Policy Counsel for Consumer Reports, commenting on how GoodRx’s digital products are sending personal details about users of its app to more than 20 other internet-based companies. After the article was published, GoodRx posted a statement saying it planned to stop sharing personal medical information with Facebook, had appointed a new VP of data privacy, and was providing a way for GoodRx users to delete their data.

Source: “GoodRx Saves Money on Meds—It Also Shares Data With Google, Facebook, and Others,” Consumer Reports, February 27

 
POLICY BY NUMBERS
 

From 78.6 to 78.7

 

The Centers for Disease Control and Prevention’s National Center for Health Statistics reported that life expectancy for the US population in 2018 was 78.7 years, an increase of 0.1 year from 2017.

Source: “Mortality in the United States, 2018,” CDC, January 2020

 
 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
 
FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Isabell Kang | Scott Shields | Robin Tan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Feb. 28, 2020

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