Analyzing Accelerated Approval, employers and PBMs, IRA and the Premium Stabilization Demonstration, 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

Analyzing the FDA’s Accelerated Approval Program: Today in the American Journal of Managed Care, NPC’s Julie Patterson, John M. O’Brien, and Jon D. Campbell author a new analysis supporting the FDA’s conclusion that the Accelerated Approval (AA) Program is successfully working to address unmet medical needs.?

• From the Commentary: “Because of AA, patients and their clinicians have treatment options earlier than they otherwise would and this has likely led to more than 250,000 life-years gained in patients with cancer… The evidence suggests that the benefits of the AA Program — namely, expedited access to new drugs for patients with serious conditions and high unmet medical need — outweigh its risks.”

Continuing the Conversation on Employer PBM Choices: In the second part of a video interview series with the American Journal of Managed Care, NPC President and CEO John O'Brien discusses recent NPC research on the critical role of rebates in employer benefit choices. In the interview, Dr. O’Brien calls for further research into employer choices and the influence of benefit consultants in the pharmacy benefit manager (PBM) landscape.

Value Viewpoint: In her latest? “Value Viewpoint,” NPC Chief Strategy Officer Kimberly Westrich reviews several ICER-related items, including concerns about the transparency and accessibility of ICER Analytics’ updated obesity management model.

Industry News

Payer Changes Anticipated Due to IRA Costs: The promise of lower costs through the IRA's price setting provisions may lead to higher costs for seniors in other Medicare plan provisions, according to a recent survey from Magnolia Market Access . Provisions include the increased use of prior authorizations for Part B products, favoring more generics and biosimilars, and scaling back enhanced benefits.

Unclear Impact of CMS’s Premium Stabilization Demonstration: In late July, CMS announced the Premium Stabilization Demonstration, a voluntary demonstration to improve stability for rising Medicare Part D premiums in part to the IRA (a notable projected 21.5% increase in 2024). Lawmakers recently submitted a letter to the Government Accountability Office questioning the legality of the demonstration as more plans leave the Medicare Advantage market.

• IRA’s Unintended Consequences: NPC’s review of Medicare Part D coverage for 10 drugs in the Medicare Drug Price Negotiation Program, published in February in JAMA Health Forum, raised concerns about how the implementation of the IRA may impact patient access. The research found that current Medicare beneficiary access to the drugs studied was often high without prior authorization or step therapy in 2019 and 2023. The increased utilization management requirements that are likely in response to Part D redesign could actually reduce patient access – exactly the opposite of what the program intends to do.

Trends on Outside Pharma R&D Spending: Charles River Laboratories, a provider of drug-discovery services to biopharmaceutical companies, previewed “profound cuts” in outsourced pharmaceutical research and development, with manufacturers citing the impact of the IRA.

Primer on Copay Adjustment Programs: A new primer published in the Journal of Managed Care + Specialty Pharmacy describes the structure and impact of copay accumulators and maximizers on patients , including insights from pharmacists on how care teams can assist patients in navigating these programs.

• Impact on OOP Costs and Medication Persistence: NPC research presented at #AMCP2024 found that when compared to patients with standard benefit designs, patients whose employers use copay accumulators and maximizers face at least 4x higher out-of-pocket costs — leading them to abandon treatments.

State-Level Health Spending Targets: New research from Bailit Health published in Health Affairs Forefront examines the performance of five states (CT, DE, MA, OR, and RI) that established a statewide target for healthcare spending growth in 2022. Though growth did indeed moderate, spending still exceeded targets in four of the five states — with retail prescription drug expenditures increasing across all five states.

ICYMI

NPC Adds to Executive Leadership Team: NPC is excited to announce the appointment of Tanya Bailey, MS, to the executive leadership team in the role of Chief of Staff. Ms. Bailey previously held the role of NC Head of Membership and Meetings.

Pricing Across Multiple Indications: InsideHealthPolicy reports that a Senate health committee hearing scheduled for September could put a spotlight on indication-specific pricing, in which drugmakers brand and price a molecular entity distinctly for different approved indications.

Insurers See Profits From PBMs, Pharmacies: As legislators consider how insurer-PBM relationships may affect costs and access for patients, Axios’ Tina Reed describes how health insurers are seeing greater profits from non-core products like owned pharmacies, physician networks, and PBMs compared to the core business of providing health insurance.

Canada Expands Expedited Reimbursement: Canadian health administrators have expanded the use of rolling reimbursement reviews , an approach piloted in September 2023 to accelerate patient access to COVID-19 products. The process can now be initiated for any drug application, signaling more progress towards Canada’s “Target Zero” campaign which aims to achieve zero days between the regulatory approval of a drug and the HTA body’s reimbursement recommendation to participating public drug plans.

Congress Needs Subject Matter Experts: In light of the recent overrule of the Chevron deference allowing the power of federal agencies to rely on their own interpretation of the law, Professors David Blumenthal and Sara Rosenbaum, writing for STAT News , describe the crucial role subject matter experts will hold in helping Congress craft health policy in the wake of recent Supreme Court rulings.

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 at Astellas Pharma, and Andrew Kaplan, Senior Vice President of U.S. Public Affairs at Takeda, 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.

October 16-18: Save the date for the 14th Annual Association for Value-Based Cancer Care (AVBCC) Summit and Educational Program! This year’s conference will take place in New York City (and virtually) and provides exclusive networking and educational opportunities with 300+ diverse experts representing every stakeholder of the cancer care ecosystem. Learn more and register for the AVBCC Summit here .