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Medicare’s Draft Policy For Alzheimer’s Drugs And The Question Of Cost

 
• By Cathy Kelly

Critics of the US Centers for Medicare and Medicaid Services’ proposed decision to restrict Medicare coverage of Aduhelm and similar Alzheimer’s drugs have described the policy as an effort to ration treatments based on cost concerns. Even some supporters are connecting cost to the decision.

Should Cost Concerns Influence Medicare Coverage Policy? • Source: Alamy

US Medicare coverage policy is supposed to be fenced off from considerations about the cost of a prescription drug (or other item or service). But the notion that the cost of Biogen, Inc. and Eisai Co., Ltd.’s Aduhelm was a factor in Medicare’s proposed national coverage policy for Alzheimer’s drugs continues to surface in the debate over the policy.

The Centers for Medicare and Medicaid Services released a draft national coverage determination 11 January proposing that Medicare coverage for amyloid-directed monoclonal antibody drugs including Aduhelm would be restricted to use in randomized clinical trials, an approach known as coverage with evidence development

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Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

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US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

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Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

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• By Leela Barham

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.