Immunocore’s advanced uveal melanoma drug, Kimmtrak, and Hansa’s Idefirix for increasing the chances of a successful kidney transplant are among the latest treatments that NICE has appraised regarding their cost-effectiveness.
UK Health technology assessment institute, NICE, has issued draft guidance saying that the National Health Service in England should not fund Immunocore’s Kimmtrak (tebentafusp), which this month became the first treatment approved by the UK medicines regulator to treat advanced uveal melanoma.
Meanwhile, NICE said that Idefirix (imlifidase) should be made available via the NHS, making the drug from Hansa Biopharma the first product that the institute has recommended for the
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.
The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.
In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.
A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.
