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The Post Office vs. FedEx?

 
• By Michael McCaughan

One idea the Democrats have for reforming Part D is launching a Medicare-run prescription drug plan. The proposal underscores how much ground Big Pharma has gained since the Medicare debate began.

The starting point for legislative work on making price negotiation a reality is expected to be a bill introduced in February 2005 calling for the Medicare program to launch a government run national prescription drug plan (PDP) to compete against the dozens of private plans in the Medicare market. (See "Interference Pattern," in this issue Also see "Negotiating Price Negotiation: Why the Democrats Will Struggle to Pressure Part D Prices" - Pink Sheet, 1 December, 2006..)

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Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
• By Cathy Kelly

Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

 
• By Cathy Kelly

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

UK MHRA Tackles Staff Burnout As It Eliminates Filings Backlog

 
• By Vibha Sharma

Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.