New drug-level research on the IRA and oncology drug development, is the IRA impacting post-approval clinical trials, Cuban on employer contracts...

October 15, 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

Drug-Level Look at Oncology Subsequent Indications: Changes to drug development due to the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (DPNP) hold potential unintended consequences on the heterogeneous nature of post-approval research and development for oncology drugs, according to a new study from NPC published in Therapeutic Innovation & Regulatory Science .

• Dr. Julie Patterson, NPC Senior Director of Research and lead author: “We wanted to know more about drug-level details – as opposed to indication-level details – for oncology medicines as they move toward subsequent indications. In addition to supporting concerns about the impact of the IRA’s price-setting “clock” on subsequent indications, our research found almost two-thirds of these drugs expanded treatment options for additional cancer types.”
• Learn more about the research here .

Is the IRA Impacting Post-Approval Clinical Trials? Preliminary research presented by NPC Chief Science Officer Jon Campbell at the Washington Health Economics Symposium aimed to understand the impact of the passage of the IRA on the initiation of new Phase I-III clinical trials in previously approved drugs. The unadjusted findings suggested a decline of 35% within the post-IRA period.

#AMCPNexus Preview: In a piece for AJMC , NPC Chief Strategy Officer Kimberly Westrich shared a detailed preview of the sessions and topics to watch at this week’s AMCP Nexus conference in Las Vegas. If you’re at Nexus, please drop us a line and say hello and learn more about our research presence here .

Industry News

Part D Changes to Benefit Patients: “Medicare’s new ‘cap and smoothing’ policies are set to significantly impact patients, particularly those managing chronic conditions or taking specialty medications,” writes Michael Petroutsas of Astellas . “With open enrollment underway next week, it’s vital that patients are informed about these updates to Part D and fully understand their available options.”

KFF Survey on Employer Trends: In its 26th annual Employer Health Benefits survey , KFF conducted 2,142 interviews with public and private firms on topics from increases in premiums to coverage for GLP-1 medicines . One main takeaway from KFF Health News: 37% of company officials were unaware of how much of their rebate arrangements with PBMs are returned to their company as savings.

• Cuban Encourages Employer Engagement in Drug Benefits: At a KFF event, businessman Mark Cuban urged large employers to shop around and take agency in negotiating contracts for employee prescription drug benefits, including options to contract directly with providers.
• Go Deeper: NPC research published in AJMC found that nearly two-thirds of employers with self-funded pharmacy benefits reported current rebate agreements for specialty drugs that include a rebate guarantee, calling into question the financial incentives of individuals recommending PBM contracting strategies.

Copay Accumulators Absent from Proposed NBPP: Despite calls from advocates , CMS did not address copay accumulators in the 2026 Notice of Benefit and Payment Parameters proposed rule – but said it would do so in a future rulemaking.

Patients May Not See OOP Savings from Price Negotiation: A new IQVIA Institute analysis finds that six of the ten drugs subject to Medicare DPNP are already covered with fixed co-pays that either will remain unaffected by price changes or may potentially increase, depending on potential formulary changes.

• Good Access for Selected Drugs: NPC research published in JAMA Health Forum found that the average 2023 coverage of the first ten Medicare DPNP selected drugs was generally high in 2023 (91.3%), supporting concerns that negotiations may decrease patient access through increased utilization management or adverse tiering.

ICYMI

340B and HRSA: Last week, PhRMA submitted a letter to HHS and the Health Resources and Services Administration (HRSA) expressing concern regarding the agency’s public statements about a proposal to use a rebate model to offer statutory 340B ceiling prices to covered entities.

Areas of Postapproval Impact: In the latest “Eye on the IRA” report from Health Affairs, researchers project that the IRA Medicare DPNP will have potential post-approval impacts on research into indications for additional tumor types, rare diseases, and pediatric patients.

Prior Auth Reform? Writing for Pink Sheet , Laura Helbling details how reforms to prior authorization could be considered in 2025 as Medicare administrators assess uptake of GLP-1 medicines and revised Part D benefits.

CBO Evaluates Drug Pricing Proposals: The Congressional Budget Office released a report evaluating drug pricing policies proposed by political candidates and Congressmembers, finding that policies such as the expansion of Medicare DPNP would have negligible effect on prices for consumers.

Best Practices for Evidence Synthesis: Since “it is not clear how comprehensive” the CMS-led evidence reviews were for the first round of Medicare DPNP, health economic experts T. Joseph Mattingly II, Adrian Towse, and Louis P. Garrison, Jr outlined the major stages of evidence synthesis and describing best practices in Health Affairs Forefront .?

IRA and Employers: The National Alliance of Healthcare Purchaser Coalitions hosted a webinar with Dr. John O’Brien on the implications of the IRA Medicare DPNP for employers who provide health benefits to their employees.

An Ethicist’s View of Step Therapy: In a video commentary published by Medscape, ethicist Arthur L. Caplan warns that the practice of step therapy for utilization management is “inimical to good medical practice” and interferes “with what being a doctor and having your patient's best interest should be about.”

Mark Your Calendar

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 Greg Daniel of Eli Lilly and Drs. Inma Hernandez and Sean D. Sullivan in an open ISPOR 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: Join NPC President & CEO John O’Brien and Center for Innovation and Research (formerly the Innovation and Value Initiative) CEO Jason Spangler at the Northern Virginia Health Policy Forum on October 22 from 12:00 PM ET for their webinar “Medicare Drug Negotiations: The Current Status, The Potential Impact.” This session will explore perspectives on the current process for ongoing CMS price negotiations and future developments related to price reductions. Register to attend the Northern Virginia Health Policy Forum here . ?

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.

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, Daniel 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 ICER, Shawn Gremminger, President and CEO of the National Alliance of Healthcare Purchaser Coalitions, and Caroline Peterson, Executive Director of the Peterson Center on Healthcare. Learn more and register to attend the National Alliance Annual Forum here.