How to make one line in the FDA Commissioner's new drug review program into a force for affordable access for patients

Health Affairs Scholar

The FDA Commissioner's new National Priority Voucher program seeks to accelerate drug approvals for products meeting certain criteria. Interestingly, the program intends to increase affordability of new drugs.

With few specifics available as to how the program will achieve that goal, this paper, co-authored by ICER President and CEO Sarah K. Emond and Chief Scientific Officer Dan Ollendorf, proposes a framework for leveraging independent value assessments to achieve affordable access while incentivizing evidence development and innovation.

 MUST READS

Colorado board makes first-in-the-nation move by setting a payment limit on an Amgen drug

STAT

In a first-in-the-nation move, a Colorado panel has voted to limit what health plans in the state will pay for a costly arthritis treatment, a step that may encourage other states to pursue similar strategies to contain spending on prescription medicines.

The landmark vote by the Colorado Prescription Drug Affordability Board creates an upper payment limit for the widely prescribed Enbrel medication, which is a blockbuster treatment sold by Amgen. As a practical matter, the decision establishes a payment ceiling for government agencies and commercial plans that provide health insurance for state residents.

 Trump excludes generics from big pharma tariff plan

The Wall Street Journal

The Trump administration said it isn’t planning to impose tariffs on generic drugs from foreign countries, after months of wrangling over whether to impose levies on the vast majority of drugs that are dispensed in the U.S.

The move, which isn’t final and could change in the coming weeks, comes after months of debate within the administration over how to bring manufacturing of generic drugs back to the U.S. and what role tariffs should play in that effort.

Amgen unveils DTC platform with 60% discount on Repatha, giving US lowest price of G7 nations

Fierce Pharma

Amgen has joined the wave of major drugmakers setting up direct-to-consumer programs amid President Donald Trump’s call for more DTC options to lower U.S. drug prices.

The "AmgenNow" program is anchored by an offer of significantly discounted Repatha on the site. The cholesterol drug will be available for $239 per month, nearly 60% below its list price of $572.70 per month, which Amgen said in this week’s announcement represents the lowest direct-to-patient price for Repatha among the G7 advanced economies.

Pharma companies scramble to make deals with Trump after Pfizer scored White House praise

STAT

The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.

Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.

OTHER HEADLINES

• Pharmaphorum: FDA pilots fast-track scheme for US-made generics
• The Hill: Costco to sell Ozempic, Wegovy for $499 a month
• The New York Times: How private equity oversees the ethics of drug research
• STAT: CDC approves updated Covid-19, chickenpox vaccine recommendations
• Politico: CDC, its advisers quietly expand access to Covid-19 shot for pregnant women
• CBS News: Amazon to start offering prescription drugs through vending machines

Join ICER!

Want to work for a fast-paced, mission-driven organization? Look no further! ICER is looking to expand our team, which includes a diverse set of clinicians, researchers, and policy experts.

Health Technology Assessment

• Research Assistant

Key Upcoming Dates

• 10/20: Smoking Cessation -- Draft Evidence Report
• 10/23: Launch Price and Access -- Final Report
• 10/29: Obesity -- Evidence Report

Learn more about ICER’s ongoing and recently completed reports:

• COVID-19
• Special Assessment to Inform CMS Drug Price Negotiation
• IgA Nephropathy
• Non-Cystic Fibrosis Bronchiectasis
• Obesity Management
• Smoking Cessation
• Spinal Muscular Atrophy

Email info@icer.org for more information.

When you make a gift to ICER, you help keep ICER independent.