Gene therapy valuation, IRA price controls, copay accumulators, Medicare Part D, and more.

April 23, 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, NPC Chief Communications Officer

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NPC Highlights

Valuing Gene Therapies: NPC's Dr. Tyler Wagner and colleagues responded to a new white paper?published by the Institute for Clinical and Economic Review (ICER) and NEWDIGS at Tufts Medical Center, summarizing the key takeaways and noting concerns pertaining to the framing, scope, and perspective used in this publication. ??

• Read More: The white paper "Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform" intends to identify market solutions and policy reforms to help mitigate the challenges of paying for gene therapies.?

Industry News

IRA Price Controls: Pink Sheet’s Cathy Kelly analyzes the misaligned incentives that plan sponsors will face when deciding where to list drugs selected for Medicare price controls on formularies. Notably, plans are not prohibited from putting price-capped drugs on non-preferred formulary tiers or imposing prior authorization of step therapy restrictions, "utilization management" mechanisms that limit patient access.?

• Go Deeper: BioCentury’s Steve Usdin wrote on the precedent-setting factors most likely to determine the prices in the first cohort of price controls.?

Copay Accumulators: HHS Secretary Xavier Becerra appeared at several Congressional budgetary hearings last week. One exchange on copay accumulators drew the ire of patient advocacy groups, centered on criticisms that manufacturer discounts are pocketed by pharmacy benefit managers (PBMs).?

ICER’s UPI Protocol: InsideHealthPolicy’s Gabrielle Wanneh reported that The Institute for Clinical and Economic Review released the official protocol for its sixth Unsupported Price Increases (UPI) report. ?

• Go Deeper: Read NPC’s concerns regarding last year’s UPI Report from December 2023: "Unsupported Policy Information."

ICYMI

#AMCP2024: It was wonderful to see so many friendly faces at the Academy of Managed Care Pharmacy’s Annual Meeting last week in New Orleans! Among many NPC activities, Chief Strategy Officer Kimberly Westrich sat down with The American Journal of Managed Care to share key takeaways?from the meeting and her presentation "Innovative Approaches to Integrating the Patient Experience."

• Value Viewpoint: Ms. Westrich shared her video interview in the latest "Value Viewpoint," which included a preview of NPC President and CEO John O'Brien's upcoming talk on the future of value-based contracting at Asembia’s AXS24 Summit. Subscribe to the?weekly newsletter for highlights of important value-focused articles, reports, and events!?

PBMs: Four out of the five states that have enacted substantial PBM reforms preferred granting regulators broad authority rather than specific statutory requirements, with one state asserting it allows regulators to more quickly respond to issues as they arise.?

• More: Employers told Congress at a recent hearing that PBMs should be required to act as fiduciaries in the interest of plan beneficiaries in providing benefits and paying expenses.?

Accelerated Approval: Approximately 911,000 Americans gained additional life years from cancer treatments made available to patients earlier through the FDA’s accelerated approval pathway from 2006 to 2022, according to a study published in the Journal of the National Comprehensive Cancer Network. ?

Prior Authorization: CMS is open to looking into insurers’ prior authorization practices for prescription drugs, Administrator Chiquita Brooks-LaSure told hospitals during a recent conference.?

Biosimilars: Uptake of biosimilars for the leading arthritis treatment adalimumab increased from 5% to a whopping 36% in two weeks after CVS Health made one adjustment to its formularies.?

Lame Duck Session: A top Senate Republican teased an active post-election session of Congress for health care bills, including reforms to PBMs and the 340B program.?

Cell & Gene Therapies: Payment models for cell and gene therapies should honor the immense patient benefits and scientific innovation underpinning their value, writes Rep. Michael Burgess, R-Texas, chair of the House Budget Committee Republican Health Task Force.?

• More: "We need to match our 21st? century science with 21st ?century payment models and offer patients hope without breaking the budget," writes Rep. Burgess.?

Mark Your Calendar

April 25: Dr. O’Brien will speak at the UNC Center for the Business of Health’s second annual Chatham House Rules-style research symposium. This year’s event is focused on "The Price of Innovation."

April 30: Dr. O'Brien will be participating in a panel discussion focused on the future of value-based contracting as part of Asembia's Specialty Pharmacy Summit, April 28–May 2, 2024, in Las Vegas.?

May 5-8: NPC will be participating in the ISPOR 2024 conference in Atlanta.??

May 8-9: Join the National Health Council for its 2024 Science of Patient Engagement Symposium! Taking place at the historic National Press Club in Washington, D.C., the theme this year is "Patient Experiences Through Their Lifespan."

May 16: At the Financial Times U.S. Pharma and Biotech Summit in New York City, Dr. O’Brien will join a panel on "Solving the U.S. Drug Pricing Problem" alongside Sarah Emond, President and CEO, the Institute for Clinical and Economic Review, and Greg Baker, CEO, AffirmedRx. Save 20% off your in-person or digital registration with the code FTNPC. Register here!?