Amarin’s treatment is to be made available in Sweden for cardiovascular risk reduction at a price of SEK1,640 per month. But England’s health technology assessment body has concerns over the drug’s cost effectiveness.
Sweden has become the first European country to agree to reimburse Amarin’s Vazkepa (icosapent ethyl) capsules at the national level for reducing cardiovascular events in certain statin-treated patients.
In contrast, England’s health technology assessment (HTA) institute, NICE, has published draft guidance rejecting the drug due to concerns over cost effectiveness
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
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.
Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
