France Implements New Early Access Pathway For Innovative Medicines

Current Procedures Have Become Too Complex, Says Health Ministry

Reforms to the French early access processes will make reimbursement decisions more predictable and bring greater consistency into the medicinal product pathway says the French pharmaceutical industry body Leem. Others, though, say the system is too complicated and lacks clarity in a number of areas.

The concept of France-the hand gives a thumbs up with the flag of France.
France will have a new scheme for OKing early access to medicines • Source: Alamy

A new simplified system for giving patients early or exceptional access to medicines for serious or rare disorders is to be put in place in France following the publication of a decree outlining the procedures to be followed when access applications are submitted.

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France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.

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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

 

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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.