A conversation on PBM rebate guarantees, the IRA waiting game, Cancer Moonshot, 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 and Devon Bortz

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NPC Highlights

A Conversation on PBM Rebate Guarantees: In a video interview with the American Journal of Managed Care, NPC President and CEO John O'Brien discussed recent NPC research that provides key insights into rebate arrangements for specialty drugs, the role of benefits brokers and consultants, and the importance of rebate guarantees in selecting a pharmacy benefits manager (PBM).

NPC Comments on the 21st Century Cures Initiative: On Friday, NPC submitted comments in response to a Congressional Request for Information regarding opportunities to build on the 21st Century Cures Act. NPC shared support for strategies that promote biopharmaceutical innovation, monitor the impacts of the IRA, promote better use of real-world evidence, and continue to build towards a patient-centered healthcare system.

Industry News

IRA Announcement Nears: Last Thursday marked the official end of the first cycle of the Medicare Drug Price Negotiation Program (DPNP). Administrators are set to announce “maximum fair prices” for 10 prescription drugs no later than September 1. STAT’s John Wilkerson previewed four key questions to assess the impact of the government’s price setting efforts.

• Looking Back on NPC Research: NPC has conducted research that can help stakeholders understand the unintended consequences of price negotiation, including the potential for insurers to restrict access to selected drugs.

340B Contract Pharmacies and PBMs: New research from Avalere found that 69% of 340B contract pharmacies were associated with a PBM through vertical integration or contractual arrangements — deepening the policy debate around 340B contract pharmacy relationships with vertically integrated PBMs.?

• Discount Duplication… the Next 340B Issue? Once the first batch of IRA-negotiated prices go into effect in 2026, there remains uncertainty around which price manufacturers will pay covered entities in the 340B discount program. “Manufacturers will have to discern whether a drug should get a 340B price or the negotiated price because CMS declined to do so in recent guidance on the negotiation program,” writes Pink Sheet’s Cathy Kelly.

Cancer Moonshot Faces Uncertain Future: President Biden has championed a bold "Cancer Moonshot" for almost a decade, but his upcoming White House exit leaves uncertainty over the future of the initiative, according to advocates interviewed by STAT.

• IRA Threats to Oncology: NPC research shows that the IRA’s Medicare DPNP could have unintended consequences on the development of small-molecule drugs to treat cancer — which could threaten the Cancer Moonshot’s goals.

ICYMI

Drivers of Increased ACA Premiums: On average, ACA Marketplace insurers are raising premiums by a median proposed 7% in 2025, similar to the increase seen last year. The Peterson-KFF Health System Tracker analyzed annual filings to uncover the drivers behind these increases, finding hospital market consolidation and inflation to be some of the catalysts.

Unmet Medical Need Under the IRA: Authors of a recent Health Affairs Forefront article argue that CMS’s definition of “unmet medical need” is too narrow and creates a ripple effect on pricing, coverage, and access to prescription drugs for Americans — and may lead to consequences for future investments in medicines. The article calls for CMS to develop a “workable and person-centered definition” that accounts for clinical and non-clinical benefits and includes patient and caregiver input.

Biopharmaceutical Investment in R&D:? A new study published in Nature Reviews Drug Discovery estimates that R&D investment in 2021 was $276B across 4,191 biopharmaceutical companies. The authors found a 30% R&D intensity (R&D investment as a share of revenue) for public U.S. companies, larger than a previous estimate from the CBO.

• From the Report: “To the extent that our finding of greater R&D intensity indicates costlier drug development overall, we believe it provides a critical input for scholarly investigations and regulatory policy aimed at discerning levers to optimize R&D productivity across the ecosystem.”

CMS Launches “Premium Stabilization” Demo: Last Friday, CMS released guidance for Part D 2025 Medicare Part D bid information released by CMS shows average plan bids have more than doubled from 2024. In turn, CMS is offering to buy down premiums in a voluntary demonstration for standalone prescription drug plans intended to stabilize the market.

Opinions on PBMs: PBMs were a frequent topic of op-eds and editorials last week, with pieces published on anti-competitive practices , market consolidation , and restricted access to biosimilars .

Mark Your Calendar

September 30: On the first day of the 2024 Fierce Biotech Summit in Boston, NPC President and CEO John O’Brien will join Christie Bloomquist, Vice President of Government Affairs and Policy for Astellas, for a panel discussion on “Political Pathways: Navigating the 2024 Election Cycle in Biotech.” The session aims to empower biotech industry leaders with actionable insights and strategic approaches to thrive amidst the complexities of the 2024 election cycles and its implications on the industry landscape. Learn more and register for the 2024 Fierce Biotech Summit here.

October 15: At AMCP Nexus 2024 in Las Vegas, NPC Chief Strategy Officer Kimberly Westrich will participate in a panel on “What You Need to Know About Copay Accumulators, Maximizers, and Alternative Funding Programs.” The session will take place from 8:30 – 9:45 AM PT and will include a deep dive into the regulation and potential employer implementation of accumulators, maximizers, and AFPs. Learn more and register for AMCP Nexus 2024 here.