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Value Vs. Values: ICER’s Review Of Opioid Abuse-Deterrent Formulations

 
• By Michael McCaughan

The Institute for Clinical & Economic Review is setting an appropriately broad scope in its review of the abuse-deterrent opioid class. But the project opens up a much larger question of how broadly to define value – and how to weigh non-economic values – in cost-effectiveness reviews.

The Institute for Clinical & Economic Review is making waves in the biopharma sector by taking on a very difficult task: attempting to define a “fair” price for innovative new medicines, using a rigorous and transparent (if not universally accepted) methodology.

ICER’s formal “value and effectiveness” reviews started with a bang almost exactly one year ago, making national headlines by asserting...

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China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.

Medicaid Changes Could Have Major Impact on Recent Coverage Improvements

 
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Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 
• By Eliza Slawther

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Here At Last: Canada’s Long-Contested Guidelines For Curbing Excessive Drug Prices

 
• By Neena Brizmohun

Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.

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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.