Pharma's Patience Pays Off: Patient Advocates Are Powerful Allies in Part D

The pharmaceutical industry has long counted on patient advocates as allies in the FDA drug approval process. But their relationship on issues related to drug coverage has often been tense. The Medicare drug benefit has opened a new chapter in the relationship. Patient advocates have worked closely with the Centers for Medicare & Medicaid Services in the early months of Part D, and they have had an impact. Industry's long-time effort to establish alliances is paying off.

At the start of 2006, it looked like Pfizer Inc. might have a big headache in positioning pregabalin (Lyrica) under the newly implemented Medicare Part D drug benefit. The epilepsy drug is one of Pfizer’s most important new products, but when formulary information for Part D was first made public, Lyrica was nowhere to be found. In other words, Pfizer faced the prospect of missing out on a lucrative new prescription drug market.

Lyrica’s coverage profile was something the Epilepsy Foundation noticed as well. The organization had been very involved in the planning...

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

More from Market Access

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

More from Pink Sheet

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.