A Democratic task force, led by Sen. Bernie Sanders, set forth a number of policy proposals, including healthcare, for the party’s platform ahead of the national convention.

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July 10, 2020

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FEATURED STORY

Waiting in the Weeds for You: Democratic Task Force Agrees on Drug-Pricing Platform

On Wednesday, a task force of Democratic policymakers and influencers led by Sen. Bernie Sanders (S-VT) released a set of policy proposals intended to unify support around the Democratic Party’s presumptive nominee for President, former Vice President Joe Biden. The task force addressed various domestic issues including healthcare, the economy, immigration, criminal justice reform, education, and climate change. 

The healthcare section offers guiding principles for responding to the COVID-19 pandemic, lowering prescription drug prices, and achieving universal healthcare coverage. Specifically, the task force recommends:

  • Empowering Medicare to negotiate prescription drug prices for all public and private purchasers
  • Capping price increases for brand-name and outlier generic drugs to the inflation rate
  • Allowing consumers to import drugs
  • Supporting policies to promote approval and distribution of generics
  • Eliminating tax breaks for prescription drug advertisements
  • Scaling up US manufacturing for essential medicines
  • Setting an out-of-pocket maximum on prescription drug costs for seniors
  • Increasing federal funding to allow states to enroll more adults in Medicaid
  • Increasing access to health insurance coverage through a public option
  • Expanding COVID-19 testing and contact tracing, free to everyone
  • Subsidizing insurance for individuals who lose their job as a result of the COVID-19 public emergency

Ideologically, the recommendations fall somewhere between Vice President Biden’s and Sen. Sanders’ stances. The policies are expected to be reviewed by Biden and incorporated into the Democratic Party’s platform ahead of the national convention in August. While some of these proposals could be done through regulation (including demonstrations), many would require legislation. History has its eyes on the November elections, which will determine what comes next for drug pricing. 

Navigating COVID-19: Responding to the Needs of the Uninsured (Virtual Event)

The COVID-19 pandemic continues to leave its mark on American life. With the US unemployment rate still at one of the highest we’ve seen in years, many Americans have been without work for months, making it difficult for some to access and afford the therapies they need.

Watch a panel of experts, from Lash Group and Xcenda and led by Tommy Bramley, during the PAP 2020: 21st Annual Patient Assistance and Access Programs Virtual Event on Monday, August 3, from 1:30–2:15 PM ET. The panel will offer insights on how the pandemic will impact insurance coverage, new policies that affect access and affordability, and considerations for manufacturers regarding program design.

Learn more >

LEGISLATIVE UPDATE

Congress is on recess until July 20.

COVID-19 UPDATE

The World Turned Upside Down: GAO Report on Herd Immunity for COVID-19


On Tuesday, the Government Accountability Office (GAO) released a report on herd immunity for COVID-19. For diseases like COVID-19 with no vaccination available, the GAO scientists believe achieving natural herd immunity by allowing the virus to run its natural course could result in significant complications and risk post-infection as well as high mortality and morbidity rates. 

The authors suggest researchers do not have enough data to determine important factors related to achieving herd immunity against COVID-19, including the herd immunity threshold, the number of secondary cases typically generated by an infected individual, the viral mutation rate, and the length of time immunity lasts. 

The brief lists several opportunities from achieving herd immunity, including halting the spread of the disease, supporting economic recovery, and restoring medical capacity by reducing the number of patients seeking treatment. 

The brief also covers several challenges we face in achieving herd immunity: 

  • Limited data on immunity—multiple unknown factors related to immunity and determining the herd immunity threshold
  • Implications of natural herd immunity—risk involved in exposing the population to a “debilitating and potentially fatal disease” in order to achieve natural immunity without a vaccine
  • Lack of vaccine—time, cost, and process of developing a vaccine
  • Inconsistent immunity—nonuniform immunity across the population may lead to outbreaks occurring after herd immunity is achieved 

The report poses a series of questions for consideration including: 

  • How are resource priorities reflecting the data needed to achieve herd immunity?
  • What factors will need to be considered if a COVID-19 vaccine is approved but with a limited number of doses available?
  • What steps are needed to balance public health and a functioning economy while we’re on an uncertain path to achieving herd immunity? 

These questions and others will be vital for shaping research focuses as we attempt to move closer to achieving herd immunity, developing a vaccine, and continuing to enable economic recovery from government actions in response to COVID-19.

COVID-19 RESOURCES AND BULLETIN

COVID-19 Resources


Coronavirus Task Force Resources and Updates

Centers for Disease Control and Prevention (CDC) Information for Healthcare Professionals

Centers for Medicare & Medicaid Services (CMS) Current Emergencies (Coronavirus)

Food and Drug Administration (FDA) COVID-19 Information

Medicaid and Children’s Health Insurance Program (CHIP) Resources

American Medical Association (AMA) Physician’s Guide to COVID-19

Health Affairs COVID-19 Resource Center

National Foundation for Cancer Research (NFCR) Coronavirus Resource Center for Cancer Patients and Caregivers

COVID-19 Bulletin


  • Bicameral Democratic Health Committee leaders sent a letter to the Department of Health and Human Services (HHS) expressing concerns with allowing insurance plans to deny coverage claims for COVID-19 tests.
  • The Senate Appropriations Committee held a hearing on researching, manufacturing, and distributing a safe and effective coronavirus vaccine.
  • House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) requested information from companies on potential “unconscionable and clearly excessive” COVID-19 test pricing.
  • The Association of American Medical Colleges submitted comments on lessons learned from COVID-19 and recommendations for future preparedness in response to a white paper released by Sen. Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee.
VALUE CORNER

Scrappy and Hungry, ICER Is Busier Than Ever


On Wednesday, the Institute for Clinical and Economic Review (ICER) announced the public meeting on cystic fibrosis was rescheduled to August 27 and will now be held virtually. ICER previously postponed the original meeting scheduled for April 30 due to the COVID-19 pandemic. To register for the virtual meeting, visit ICER’s website.

On Monday, ICER announced the release of a Draft Scoping Document describing its plan for a review of high-cholesterol treatments, including inclisiran, bempedoic acid (NEXLETOL), and bempedoic acid/ezetimibe (NEXLIZET), in the setting of heterozygous familial hypercholesterolemia or secondary prevention of atherosclerotic cardiovascular disease (ASCVD). Public comments on the Draft Scoping Document will be accepted through July 24, and the Revised Scoping Document will be posted on or about August 3. 

Last week, ICER posted a blog in response to Gilead’s recent pricing announcement for remdesivir as a treatment for COVID-19. ICER’s President, Dr. Steven Pearson, stated that the decision to charge $3,120 for a 5-day course of remdesivir was “reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care.” Pearson said that, although the announcement demonstrates restraint and sets a promising precedent for future pricing of pandemic treatments, the US should explore other approaches to drug pricing. 

But then, only 2 days later, ICER published a white paper titled, “Alternative Policies for Pricing Novel Vaccines and Drug Therapies for COVID-19,” which is meant to guide decision-maker discussions around the pricing of treatments and preventive therapies for the coronavirus pandemic. Specifically, the paper evaluates the pros and cons of 6 possible pricing approaches: 

  • Status quo (unrestricted pricing): Private companies decide how to price vaccines and treatments
  • Cost-recovery pricing: Insurers conduct a cost analysis to set a ceiling price
  • Value-based pricing: Insurers use a cost-benefit analysis to set a price based on a measure of added benefit
  • Monetary prizes: The government awards a prize to the first private company that successfully develops a vaccine, but the government owns the intellectual property and manufactures and distributes the vaccine at cost through separate contracts
  • Compulsory licensing: The government pays royalties to the innovator but allows others to make, sell, use, or import products without requiring permission from the patent holder
  • Advanced market commitments (AMCs) and subscription models: AMCs are designed to subsidize research and development costs through a commitment by a funder or pool of funders to a future purchase price; under subscription models, innovators and funders decide on a set price that would provide a guaranteed minimum return on investment and set a cost cap, regardless of the number of patients needing treatment

ICER is also hosting a 3-part webinar series to accompany the white paper. Links to register for each session are available through the press release

On June 26, ICER announced it will assess the comparative clinical effectiveness and value of roxadustat, a treatment for anemia in patients with chronic kidney disease. Roxadustat is currently undergoing FDA review, with an anticipated decision expected at the end of 2020. The topic will be reviewed by the California Technology Assessment Forum (CTAF) during a public meeting scheduled for February 2021. Interested stakeholders can submit public comments during the Open Input Period, which closes July 15.

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

The Future of Payer Engagement: How Pharma Can Break Through

Payers and integrated delivery networks (IDNs) representing over 275 million covered lives count on FormularyDecisions for pertinent product information pre-, peri-, and post-approval.

In a new article, Xcenda’s Matt Sarnes and FormularyDecisions’ Allen Lising share insight on the product information that payers and other healthcare decision makers find most valuable.

Learn how to meet them where they are.

Read article >

REGULATORY UPDATES

Non-Stop: NASHP Unveils New Anti-Price-Gouging Model


On Monday, the National Academy for State Health Policy (NASHP) unveiled new anti-price-gouging model legislation. To date, 11 states have enacted drug transparency laws, none of which have empowered state action to force prices lower. The model bill proposed by NASHP is intended to grant states the authority to penalize manufacturers found in violation of “excessive pricing” of generic drugs.

When developing the new model, NASHP referenced what it considers to be the legal shortcomings of previous drug price-gouging proposals. Among the new components in NASHP’s model legislation is the express restriction of price-gouging laws within the state where the act is promulgated. In past acts, courts determined the undefined limitations of state ability to regulate drug pricing resulted in a violation of the Commerce Clause.

The NASHP model legislation is designed to detect and penalize what it considers to be “excessive” price increases by setting a price threshold alert and establishing civil penalties. In order to trigger a referral for review, the price of a generic drug must increase 15% within the year, or 40% in the past 3 years. Additionally, the model act requires manufacturers to notify the state 180 days before removing a drug from the market and allowing states to impose penalties, including a civil penalty of up to $10,000 a day for each violation. 

In August, NASHP will hold a virtual conference to examine state health policy through COVID-19, where new laws will be considered for input into the model legislation. The summit will only be available to state officials.

NASHP believes the model act will help ensure lower prices and provide for a return of revenues charged to consumers once the state determines the price to be “excessive.”

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:

  • (Non) Pregnant Pause on the Affordable Care Act: Supreme Court upheld the Trump Administration regulation allowing employers to opt out of birth control coverage
  • The Centers for Medicare & Medicaid Services (CMS) requested comment on the Medicaid Drug Use Review Program.
  • CMS released the 2018 Quality Payment Program Experience Report.
  • The Food and Drug Administration (FDA) approved Mylan’s HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA (adalimumab). HULIO is the sixth biosimilar of HUMIRA to obtain FDA approval and the 28th biosimilar overall approved. No HUMIRA biosimilar is available yet; each biosimilar applicant has entered into a license agreement with AbbVie permitting the applicant to begin US marketing only after a specified date in 2023.
  • The Bureau of Labor Statistics showed the healthcare industry added 15% more jobs in June than in May.
  • PhRMA sued the state of Minnesota for ordering pharmaceutical manufacturers to give insulin to state residents at no charge to the recipients and without compensating the manufacturers. The trade association held that the action violated the Takings Clause of the Fifth Amendment.
  • Pharmaceutical manufacturers launched the AMR Action Fund, backed by a pledge of $1 billion, to produce 2 to 4 new antibiotics to market by 2030. The fund aims to: invest in smaller biotech manufacturers focused on developing new antibiotics; give technical support to these companies; and bring together philanthropic organizations, development banks, and governments “to create market conditions that enable sustainable investment in the antibiotic pipeline.”
  • Hospital groups urged HHS to delay the price transparency rule.
  • A Health Affairs article found that changing Medicaid payments to pharmacies for drugs from a percentage of the drugs’ list prices to models where payments were based on surveys of pharmacy invoices had minimal, if any, effects on overall Medicaid drug spending. 
HEARD ON THE STREET

“We’re going to look at a number of issues as it relates to prescription drug prices.”

– White House Chief of Staff Mark Meadows, hinting that President Trump will announce executive orders, including on prescription drug prices

Source: “Mark Meadows Hints at Executive Orders ‘This Week’ on China, Drug Prices Since Congress Won’t Act,” Fox News, July 6

POLICY BY NUMBERS

From 4.2% to 6.1%

The Congressional Budget Office (CBO) updated its economic outlook for the 2020 to 2030 period. Instead of an annual unemployment rate of 4.2% during that period, it would increase to an average of 6.1%. It also projected that annual real Gross Domestic Product (GDP) will be 3.4% lower, on average, than it projected in January.

Source: “An Update to the Economic Outlook: 2020 to 2030,” CBO, July 2

UPCOMING MEETINGS & CONFERENCES

Virtual Student Shadow Day

Friday, July 31, 2020 | 12:00–2:00 PM ET
Experience a day in the life of an Xcenda expert! Spend a day learning about Xcenda, the healthcare industry, managed care, and more during our Virtual Student Shadow Day.

PharmD, PhD, MPH, and other related fields of study are welcome to join us to explore market access, health economics and outcomes research, clinical software development, and other areas that could be of interest for your future. Please note space is limited.

Read our flyer >

Register here >

Learn more about our student programs >

Navigating COVID-19: Responding to the Needs of the Uninsured (PAP 2020 Virtual Event)

Monday, August 3, 2020 | 1:30–2:15 PM ET
As the larger healthcare system looks for ways to alleviate challenges brought on by the coronavirus, patient support providers are shifting how they work with manufacturers to increase impact and provide ongoing support for patients.

Join Xcenda and Lash Group leaders at Informa’s PAP 2020: 21st Annual Patient Assistance and Access Programs Virtual Event August 3–7. The keynote session titled Navigating COVID-19: Responding to the Needs of the Uninsured will be on Monday, August 3, 1:30–2:15 PM ET.

Learn more >

 

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:

Daniel Fellenbaum | Anne Loos | Reeya Patel | Scott Shields | Ryan Sullivan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

July 10, 2020

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