CBO updates cost of the IRA, final guidance on round two of the DPNP, private and public sector investment in R&D, and more.

October 8, 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

Patient Access in the Accelerated Approval Program: NPC is grateful to the nearly 50 attendees representing 20 or so patient organizations that joined our webinar this week to discuss patient perspectives on FDA’s Accelerated Approval Program. Special thanks to the patient advocacy leaders from Friends of Cancer Research , the EveryLife Foundation for Rare Diseases , and the Alliance for Aging Research who spoke on the panel and participated in an insightful conversation about research and policy.

• More: The authors of "Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model" published in the Journal of the National Comprehensive Cancer Care Network shared highlights from their research.
• Go Deeper: NPC’s publication in AJMC - The American Journal of Managed Care on "The Accelerated Approval Program for Oncology Drugs: Celebrating More Than 250,000 Life-Years Gained and Counting" examines evidence regarding the clinical benefit of the FDA’s Accelerated Approval Program and finds it is working for patients.

Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich reviews the latest "Eye on ICER" calendar of events and new research.

Industry News

CBO Updates Cost of IRA: The Congressional Budget Office updated its estimate of costs associated with the Inflation Reduction Act's redesign of Medicare Part D, which will cost $10 billion – $20 billion more in 2025 than originally anticipated. The CBO also anticipates another $5 billion in costs for the Biden administration’s recently announced premium stabilization program.

• More: CBO-watchers also have been digesting their release on alternative approaches to reducing prescription drug prices.

Final Guidance on Round Two of the IRA's Medicare DPNP: Last week, CMS released its final guidance on the rules for the second round of the Medicare Drug Price Negotiation Program. Among the changes, CMS will replace the previously public listening sessions with a series of private roundtable discussions with patients, caregivers, and patient advocates.

• Other Changes: The guidance also included an accelerated timeline for CMS meetings with biopharma manufacturers during the negotiation process, a Medicare Transaction Facilitator for data exchange, and refined provisions on biosimilar competition and Part D plan formulary coverage for negotiated medicines.
• More: In July, NPC submitted comments to CMS on the draft guidance regarding the second cycle of the Medicare Drug Price Negotiation Program.

Medicare Part D Premiums: Juliette Cubanski of KFF took a deeper look at premium changes for a few of the more popular plans in Medicare Part D, finding a "mixed picture" of premium changes across plan options. In August, CMS announced a voluntary Part D premium stabilization demonstration and last week announced more information on 2025 premiums for Medicare Advantage and Part D plans.

ICYMI

Substituting Private R&D for Public Funding: New research published in the Journal of Medical Economics investigates the economic implications of substituting private pharmaceutical R&D with public funding while maintaining the recent pace of pharmaceutical innovation (spoiler alert: it would take "substantial increases in taxpayer funding").

• Go Deeper: A JAMA Health Forum study found The National Institutes of Health spending on clinical development focuses on early-stage trials , amounting to less than 5% of what private industry spends in phase 3 trials.

"Essential Benefits Loophole": In a response to the unpublished Proposed Rule of the Notice of Benefit and Payment Parameters for 2026 released last Friday, the HIV+Hepatitis Policy Institute’s Executive Director Carl Schmid writes that the proposed rule fails to "close an essential health benefits loophole" utilized by large group and self-funded plans.

Unintended Increases in Medicare OOP Negotiated Prescription Costs: Dr. Mark Fendrick of the University of Michigan Center for Value-Based Insurance Design writes that the negotiated prices for prescription drugs will lead to unexpected OOP cost increases for about 3.5 million Medicare beneficiaries.

CMS Widens PrEP Access: Last week, CMS issued a national coverage determination mandating Part B plans to cover all forms of pre-exposure prophylaxis (PrEP) without cost-sharing. While advocates welcomed the move, concerns remain about potential gaps in treatment and unresolved access barriers in the private market, writes Carl Schmid of the HIV+Hepatitis Policy Institute.

Trends Shaping the Health Economy: Trilliant Health 's fourth annual analysis of health economy trends details how national health expenditures increased from $2.8 trillion in 2012 to $4.5 trillion a decade later despite little change in healthcare demand, utilization, or outcomes.

• From the Report: "The inputs of the U.S. healthcare system, as measured by cost, exceed the outputs, as measured by the actual value or benefits received by Americans," states Dr. Sanjula Jain Nagpal , Trilliant Health's Chief Research Officer, in an interview with Fierce Healthcare .

Coverage Policies Affect Alzheimer's Treatment Access: Private payers are following Medicare's lead in implementing restrictive coverage policies that deny access to novel treatments for patients with early Alzheimer's disease, writes Sue Peschin , President and CEO of the Alliance for Aging Research , in Medical Economics .

"Most Favored Nation": STAT 's Rachel Cohrs Zhang reports that the Trump campaign says the former president does not plan to pursue a "most favored nation" policy if elected.

Mark Your Calendar

October 14-17: The NPC team is heading to Las Vegas for AMCP Nexus 2024! On October 15, 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. Register for AMCP Nexus 2024 here.

October 15: The Cancer Support Community 's Cancer Policy Institute invites all to join its 2:00 PM ET webinar on "Utilization Management Roundtable on Step Therapy." The roundtable will explore the need for step therapy reform as proposed by the Safe Step Act (H.R. 2630/S. 652). Learn more and register for the CSC webinar here .

October 16-18: The 14th Annual Association for Value-Based Cancer Care (AVBCC) Summit and Educational Program will take place in New York City (and virtually) this year from October 16-18, and NPC President and CEO John O'Brien is taking part in three panel discussions! Dr. O'Brien's talks will focus on both the current status and the potential impact of the 2024 election on cancer care providers, patients, and the biotech industry at large. Learn more and register to attend the AVBCC Summit here.

October 22: NPC President and CEO John O'Brien will join Gregory Daniel of 礼来 and Drs. Inmaculada (Inma) Hernandez and Sean Sullivan in an open ISPOR—The Professional Society for Health Economics and Outcomes Research webinar at 10:00 AM ET. The conversation on "IRA Part III: Medicare's Maximum Fair Prices for the First 10 Negotiated Drugs and Anticipated Cost Savings"?will explore the Medicare MFPs and their impact on the Medicare Part D prescription drug budget. Learn more and register for the ISPOR webinar here .

October 22-24: Industry thought leaders and visionaries will convene in D.C. 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.

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 , 摩根大通 & Co., janet woodcock , Former Principal Deputy Commissioner of the U.S. FDA , and Ezekiel Emanuel, Vice Provost for Global Initiatives at the 美国宾夕法尼亚大学 . 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.