Advice - Early discontinuation of conditional inclusion of medicinal products rhPTH 1-84 (Natpar®) and ataluren (Translarna®)
The National Health Care Institute advises the Minister for Medical Care to discontinue the conditional inclusion of the medicinal product rhPTH 1-84 (Natpar®) earlier than planned. The National Health Care Institute also advises that the conditional inclusion of ataluren (Translarna®) be discontinued early as soon as the European Commission adopts the advisory report of the Committee for Medicinal Products for Human Use (CHMP).
Early discontinuation conditional inclusion of rhPTH 1-84
On 4 October 2022, marketing authorisation holder Takeda announced that the production of rhPTH 1-84 at all doses will be discontinued worldwide by the end of 2024. Due to this termination of production, the National Health Care Institute will not carry out a package assessment. The National Health Care Institute assumes that physicians and patients have already been given sufficient additional time to discontinue treatment with rhPTh 1-84 and switch to an alternative. We therefore recommend that the conditional inclusion of rhPTH 1-84 be discontinued early.
Early discontinuation conditional inclusion of ataluren
On 26 January 2024, the Committee for Medicinal Products for Human Use (CHMP) decided definitively not to renew the market authorisation of ataluren. This was because studies failed to show that the medicinal product is effective. If the European Commission adopts the CHMP advice, ataluren will be withdrawn from the European market. The National Health Care Institute will therefore not carry out a package assessment of ataluren. Consequently, we recommend that the conditional inclusion of ataluren be discontinued early, as soon as the European Commission adopts the CHMP advice.