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Amylyx ALS Drug: ICER Revised Evidence Report Casts Doubt On Firm’s New Data Analyses

 
• By Cathy Kelly

ICER’s take on the Amylyx analyses raises questions about whether FDA will take a similar view and suggests payers may restrict coverage upon approval, at least initially, should it carry a very high price tag.

ICER Analysis And AMX0035 Payment Policy: New Ice Bucket Challenge? • Source: Shutterstock

The Institute for Clinical and Economic Review (ICER) opted not to include new data analyses by Amylyx Pharmaceuticals, Inc. in its revised evidence report on the company’s AMX0035 (sodium phenylbutyrate/taurursodiol) candidate for amyotrophic lateral sclerosis due to concerns with missing data and other aspects of the post hoc studies.

As a result, ICER’s latest report reiterates the conclusion from its draft report that the clinical evidence “suggests AMX0035 provides...

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Respiratory Treatments Hit Hardest By HTA Terminations In England

 
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Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

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New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

Saving Part D: US Medicare Advisors Sound The Alarm

 
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US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 
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