1. Pink Sheet
  3. >>Pricing Debate

FDA Drug Development Meetings May Be Better Model For Future CMS Patient-Listening Sessions

 
• By Ramsey Baghdadi

The ability for Medicare officials to follow-up on patient testimony could make the sessions more informative. They also don’t all have to be the same.

drugs_coming_out_of_ear
CMS got an earful on drug pricing. Can they make it meaningful next time? • Source: Shutterstock

The inaugural set of 10 CMS-hosted patient-listening sessions for the drugs selected for Medicare price negotiation fell short of delivering anything like a diverse and comprehensive view of patient experiences with the selected drugs and their therapeutic alternatives. 

The decision by CMS to style the sessions like an FDA advisory committee open public hearing, where patients present in succession under strict time limits without any follow-up questions, may have been a misstep if the goal was to get useful, real-world patient insight to help inform price negotiations

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Pricing Debate

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

More from Market Access

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.