UK Buyers Club To Get Lower Cost Versions Of Vertex’s CF Drugs

A buyers club in the UK is planning to import generic versions of Vertex’s cystic fibrosis drugs that are not available on the NHS.  Some commentators think such clubs may become more common.

CysticFibrosis
UK Buyers Club Aims To Access Generic Versions Of Orkambi For CF

The Cystic Fibrosis Buyers Club, set up in the UK by parents of children with the condition, is hoping to help some patients import generic versions of Vertex’s cystic fibrosis drug Orkambi (ivacaftor/lumacaftor) from Latin America. Health advocates hope the move could lead to a compulsory license for Orkambi and believe that buyers clubs could be used more frequently in response to medicine prices that prohibit access to medicines.

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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

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CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

One CDRH employee said the cuts already are having a major effect on morale.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.