The explosion of 340B spending, insights on PBMs, the IRA’s impact on independent pharmacies, and more.

October 22, 2024

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 and Devon Bortz

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NPC Highlights

Assessing Copay Offset Programs: If you missed NPC Chief Strategy Officer Kimberly Westrich 's AMCP Nexus session last week on "What You Need to Know About Copay Accumulators, Maximizers, and Alternative Funding Plans," you can check out the recaps in Managed Healthcare Executive (MHE) and AJMC .

• NPC’s Kimberly Westrich in MHE: "All [benefit design] programs have ethical tradeoffs and considerations. They have been shown to lead to disruptions in access, exposing patients to unexpected [OOP] costs and reducing medication adherence."

Value Viewpoint: In her latest "Value Viewpoint," Ms. Westrich reviews a report from the Center for Innovation & Value Research on patient journey mapping and new study from researchers at the Washington University in St. Louis on the impact of direct and indirect costs on Black prostate cancer survivors and their caregivers.

Industry News

340B Spending Hits New High: Drug purchases under the 340B Drug Pricing Program reached $66.3 billion in 2023, according to new data from the Health Resources and Services Administration . This marks a 23.4% increase over the $54 billion in 340B purchases during 2022, with Disproportionate Share Hospitals responsible for more than three-quarters of purchases.

• Go Deeper: Read NPC's research exploring why the complex financial flow and hidden costs of the 340B program can cause hidden revenue loss for employers.

NYT's PBM Investigation — Part II: Reed Abelson and Rebecca Robbins of 纽约时报 released the second story in their series on pharmacy benefit managers, detailing how the three major PBMs "are profiting by systematically underpaying independent drugstores."

• More on PBMs: A new investigation by Barron's sheds light on PBMs' role in the opioid crisis and how the intermediaries impact prescription drug access.

IRA Concerns Independent Pharmacies: Independent pharmacies are increasingly concerned about potential unfair reimbursements under Medicare's Drug Price Negotiation Program. Half of independent pharmacies surveyed by the National Community Pharmacists Association (NCPA) are "strongly considering" not stocking Medicare-negotiated drugs because their anticipated refund payments — worth at least $27,000 by NCPA's estimates — will take more than 30 days to be processed.

Part D Protected Classes Lower Drug Rebates: New research published by Health Affairs estimates the association between Medicare Part D protected-class status, U.S.-level rebates, and formulary coverage from 2011–19, finding that average rebates in protected classes were lower than non-protected classes among drugs with high Medicare market share.???

ICYMI

Industry Talks 2024 Election With STAT: As Election Day nears, STAT 's First Opinion asked leaders at biopharmaceutical companies to "reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration." Read more from leading voices including:

• Sebastian Guth , COO at 拜耳医药保健 and President of 拜耳 U.S., on bad policy ideas.
• Daniel Skovronsky , Executive Vice President, Chief Scientific Officer, and President of Lilly Research Laboratories and President of Immunology at 礼来 , on fallacies surrounding patents, drug discovery, and affordability.
• Fritz Bittenbender , Senior Vice President of Public Affairs and Access at Genentech , on the danger of political soundbites.

Delayed Access to New Essential Medicines in Low- and Middle-Income Countries: In a new Health Affairs article, 英国伦敦政治经济学院 researchers Olivier Wouters and Jouni Kuha analyze 艾昆纬 data to explore how long it takes from drug launch for medicines to reach patients in 75 low-, middle-, and high-income markets from 1982 to 2024. The report found that the median time to availability ranged from 2.7 years for high-income countries to 8.0 years for low-income countries. ?

New Price Transparency Rules Take Effect in New Jersey: As Gov. Phil Murphy appointed the final two members of New Jersey’s Drug Affordability Council, new state rules went into effect that require major entities in the prescription drug supply chain to provide information on prescription drug list prices and “significant price increases,” writes Gabrielle Wanneh of Inside Health Policy .

The "False Promise" of PDABs: Dr. Mark Fendrick of the University of Michigan Center for Value-Based Insurance Design writes that Maryland's first-in-the-nation prescription drug advisory board (PDAB) has a "narrow focus on drug prices" that will not encourage high-value care for patients and clinicians.

• Go Deeper: In June, NPC published a primer in Health Affairs Forefront detailing the uncertainties, challenges, and unintended consequences for patients as state PDABs take varying approaches to implementing upper payment limits.

Challenges for HTAs and Ocular Gene Therapies: A new paper published by Value in Health , which identifies the relevant value elements for gene therapies targeting a rare inherited eye disease, found that several key elements, like productivity impacts, are often overlooked in current health technology assessment (HTA) frameworks — affecting payer coverage decisions and ultimately patient access.

Price Controls Harm Post-Approval Research: Medicare price negotiation will "disincentivize companies from finding new clinical applications for already approved drugs," writes Dr. Peter Rheinstein, M.D., J.D. , President of Severn Health Solutions. Dr. Rheinstein’s concerns echo recent NPC research on the program’s unintended consequences.

• Go Deeper: Earlier this month at the Washington Health Economics Symposium, NPC Chief Science Officer Jon Campbell presented preliminary research findings on the slowing of post-approval clinical trial initiation post-IRA.

Mark Your Calendar

October 22-24: Industry thought leaders and visionaries will convene in D.C. on October 22 and 23 for the 2024 Patient-Centered Outcomes Research Institute (PCORI) Annual Meeting. Then, on October 24, PCORI’s Annual Congressional Science Fair will highlight PCORI-funded research projects on various topics such as telehealth, rural health, intellectual and developmental disabilities, and more. While registration for the Annual Meeting has closed, you can still invite your colleagues to attend the Science Fair here.

October 23-24: NPC Vice President of Policy and External Affairs Jackie McRae, PharmD, MS and Senior Director of Alliance Development Katherine Lovro will join industry and alliance partners at the BIO 2024 Patient and Health Advocacy Summit in Washington, D.C. Learn more about the BIO PHAS here.?

November 7: At the Galien Forum, NPC President and CEO John O’Brien will join a panel discussion on “BioPharma Pressure Points: PBMs, Pricing, Access, and the Global Supply Chain.” Joining Dr. O’Brien for the conversation: Ariel Katz , Co-Founder and CEO of H1, Dan Mendelson , CEO of Morgan Health, JPMorgan Chase & Co., janet woodcock , Former Principal Deputy Commissioner of the U.S. FDA, and Ezekiel Emanuel, Vice Provost for Global Initiatives at the University of Pennsylvania. Learn more and register to attend the Galien Forum here.

November 18-20: Will you be at the National Alliance Annual Forum in Arlington, VA? If so, be sure to connect with the NPC team! First up, on November 18 from 2:15 – 3:45 PM, NPC Chief Strategy Officer Kimberly Westrich will be leading a PBM Misalignment Initiative workshop. The next day, November 19, from 11:30 AM – 12:25 PM, NPC President and CEO John O’Brien will join a panel discussion on “Unlocking Value: Building Trusted Tools to Assess High-Value Care.” Dr. O’Brien will speak alongside Sarah Emond , EVP & COO of the Institute for Clinical and Economic Review (ICER) , Shawn Gremminger , President and CEO of the National Alliance of Healthcare Purchaser Coalitions and Caroline Pearson , Executive Director of the Peterson Center on Healthcare . Learn more and register to attend the National Alliance Annual Forum here.