Prescription drug affordability boards, 340B reform, ICER’s fair access criteria, and more.

Welcome to NPC This Week! We hope you'll join us each week for a look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. The DMs are open if you have suggestions — and please share with your network. - Michael Pratt , NPC Chief Communications Officer

Want this newsletter in your inbox? Subscribe here!

NPC Highlights

PDAB Primer: Four U.S. states have given prescription drug affordability boards (PDABs) the authority to set drug prices. A new NPC publication in Health Affairs Forefront highlights the uncertainties, challenges, and unintended consequences for patients amid the varying approaches to implementing upper payment limits (UPLs).?

• Takeaways: “Our examination of PDABs found incredible variance and ambiguity — in board structure, drug identification and selection for affordability review, factors considered when conducting reviews, and the process for setting UPLs,” said Julie Patterson, co-author and NPC Senior Director of Research. "Good policy requires understanding how the current system works, and the current set-up of these boards reflects a lack of understanding of how the pharmaceutical system works, the pressure points patients are feeling, potential legal hurdles, and unintended long-term impacts on benefit design, patient access, and innovation.”?
• More on PDABs: Late last month, Vermont Gov. Phil Scott signed a bill directing the state’s Green Mountain Care Board to create a framework and accompanying legislative proposals for regulating the cost of prescription drugs.

Value Viewpoint: In her latest “Value Viewpoint,” NPC Chief Strategy Officer Kimberly Westrich discusses both a letter published by JMCP on the potential role of real-world evidence in CMS drug price negotiations and a call for expertise by IVI’s Rare Disease Initiative.

Industry News

House Hearing on 340B Reform: In a hearing of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee, some lawmakers expressed support for the 340B program and discussed how to add transparency requirements and address provider consolidation. Committee Chair Rep. Cathy McMorris Rodgers, R-Wash., led the hearing with concern that 340B “is being co-opted by larger, more profitable health care systems that are using it solely for financial gain at the expense of patients.”

• More on 340B: Minnesota became the seventh U.S. state to enact a law prohibiting restrictions on contract pharmacy relationships in the 340B program. The state also enacted a law to expand reporting by covered entities.

ICER’s “Barriers to Fair Access”: ICER released the protocol for its fourth annual “Barriers to Fair Access” report, which assesses how payer coverage policies align with a subset of self-defined fair access criteria . This year’s report will include a new exploratory analysis — in partnership with IQVIA — focused on cost-sharing and prior authorization using real-world claims data.

IRA Medicare DPNP: CMS likely will not disclose its therapeutic alternative selections that will inform prices for the drugs selected for price controls in Medicare, according to CMS Senior Advisor Kristi Martin. “When it comes to the therapeutic alternatives, we hope that as we continue on this process… it will be a little bit of an easier process because we’re going through it together,” she shared at the 2024 ISPOR Annual Meeting in May.

IRA’s Impact on Small Molecule Drugs: At a PhRMA-sponsored panel taking place during the 2024 ASCO Annual Meeting, CEOs of several large pharma companies shared concerns about the IRA’s nine-year restriction on market exclusivity government price-setting for small molecule drugs.?

• More on the IRA: Earlier this year, NPC published research in AJMC that found the IRA’s Medicare DPNP may lead to fewer subsequent indications and delay launches for small molecule drugs.

ICYMI

• Disparities in Medicare Part D: A new JMCP study found several racial and ethnic disparities in the minimum eligibility thresholds for Medicare Part D Medication Therapy Management programs that are not seen when compared with overall plan enrollment. The research also identified disparities related to comprehensive medication review offer, receipt, and delivery.
• Patient Advocacy Podcast: What does it take to grow a patient advocacy group from the ground up? Julie Block, President and CEO of the National Eczema Association, sat down with the hosts of Sanofi’s “Patient Advocacy Voices” to share the challenges, successes, and strategic planning that goes into leading a patient advocacy group that keeps its values at the forefront.
• Drug Delivery Strategies: The latest episode of Genentech’s “Two Scientists Walk Into a Bar” explores the pivotal role of drug delivery strategies and highlights why they must be incorporated at the outset of drug development for next-generation medications.
• Medicaid Coverage of Weight-Loss Drugs: A new Medicaid Obesity Treatment Coverage review analyzed how states are covering the treatment of obesity in their Medicaid programs (specifically comprehensive obesity care, nutrition counseling, intensive behavioral therapy, obesity medications, and metabolic and bariatric surgery. The study found that just 14 state Medicaid programs cover popular weight-loss drugs, and all of those states apply various access restrictions to curtail widespread use.
• Drug Price Setting: Kirsten Axelsen, a visiting scholar with the American Enterprise Institute (AEI) and a Senior Policy Advisor for DLA Piper, writes that the IRA’s price-setting system could steer investment away from drugs for conditions common in seniors and people with chronic conditions — particularly small molecule drugs.
• Healthcare Price Transparency: AEI’s James C. Capretta and Jack Rowing authored a perspective on how the right rules could help promote transparent pricing for medical services and lower healthcare costs without harming quality. They say that expanding on recent transparency efforts could “help consumers become powerful agents for higher value care.”?

Mark Your Calendar

Thursday, June 27: Join The Hill for a deep dive into Medicare and drug pricing! During this hybrid program sponsored by the Alliance for Aging Research, academic experts, lawmakers, and advocates will discuss lessons learned from the first round of Medicare direct negotiation, how CMS can improve the program in year two, how Washington can address the IRA’s unintended consequences, and more. Register here to attend the live event in D.C. or virtually.?