Predictions, new year outlook(s) and last year “lookbacks,” the reality of drug prices and patent issues.

January 9, 2024

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NPC Highlights

Outlook for 2024: NPC President and CEO Dr. John M. O’Brien wrote in Chain Drug Review about how this election year could see even more restrictions in access to future innovations, though he’ll also be on the lookout for “moves toward paying for medicine based on the value it provides rather than on the amount of margin some other part of the value chain can extract.”

• Speaking of 2024 outlooks, IQVIA’s Murray Aitken outlined “7 potential key indicators of progress” in 2024 for the life sciences industry. (A longer version of his post is on IQVIA’s blog.)

Value and Access: Writing in The Evidence Base, NPC Chief Strategy Officer Kimberly Westrich covered some of the more interesting recent value-and-access developments, including the lack of clarity from Centers for Medicare & Medicaid Services on the process for drug price controls.

We Don't Make the Rules: But research-driven comment letters are an important part of the process. As such, NPC submitted two comment letters to CMS in response to proposed rules, one focused on regulations governing health plans and programs offered under the Affordable Care Act and the other focused on CMS' proposed technical and policy changes to Medicare Advantage and other Medicare programs.?

Industry News

Drug Prices Falling: In his annual “reality check” on drug prices, Adam Fein wrote that net drug prices, when adjusted for inflation, dropped for the sixth consecutive year, and he predicted they will fall even further this year.?

• The Commonwealth Fund compared the prices of the first 10 drugs set for U.S. drug price controls with prices for those drugs in the rest of the world. While the Commonwealth Fund attempted to measure list and net US prices, it did not consider the patient voice, unmet need, comparative effectiveness, or broader medicine access issues that patients in many other countries face.

• Former Congressional Budget Office Director Doug Holtz-Eakin says an HHS division was “cherry-picking” pricing data in a recent report, ignoring instances when pricing of certain drugs was flat or falling.

Reimportation: The Food and Drug Administration approved Florida's plan to import medicines from Canada, a move that was widely criticized within the pharmaceutical industry. The law allowing such a move passed two decades ago, but no one ever thought the FDA would approve such a plan, health policy expert Deborah Williams noted.?

Patent Rights: Waiving international intellectual property rights for treatments and diagnostic innovations, as some advocate, would “do immense damage to America’s high-tech industries,” BIO’s Chief Policy Officer John Murphy wrote in The Hill.

• Also: Jack Kalvritinos wrote in The Washington Examiner that using the Bayh-Dole Act to cancel drug patents because of price would set a dangerous precedent.

Inhalers: Sen. Bernie Sanders, I-Vt., wants an investigation into the pricing of inhalers, The Washington Post reported. (The Wall Street Journal covered this topic in a slightly different way in late December; last week’s issue covered that story.)

#JPM2024: Ahead of this week’s J.P. Morgan Healthcare Conference in San Francisco, an advocacy group for biopharma venture capitalists predicted that CMS would impose “draconian" price controls, BioSpace reported.

ICYMI

Biosimilars: The commercial formularies for CVS Health are going to prefer Humira?biosimilars over the branded drug.

Prior Auth Scrutiny: The Washington Post explores the administration's efforts to rein in the use of prior authorization and the frustration and delayed care inflicted on patients.

IRA Fix for Rare Disease: In RealClearHealth, Dr. Ted Love of BIO's Board of Directors outlines how Congress can fix barriers to rare disease research created by the IRA.

Mark Your Calendar

NPC Joins Fierce Panel on the Future of PBMs?

John O’Brien joins a panel of prominent leaders to discuss the evolving landscape of pharmacy benefit managers, exploring the issues, changes, and challenges reshaping the role and influence of PBMs. Other participants include Mostafa Kamal (President and CEO, Prime Therapeutics), Adam Kautzner, PharmD (President, Express Scripts), Anthony J. Loiacono (Chief Executive Officer, Capital Rx), and Paige Minemyer (Senior Editor, Fierce Healthcare). This panel discussion will air on January 18 from 10:40 am – 11:30 am ET as part of Fierce JPM Week Virtual 2024.?