Advice - re-extend the conditional inclusion procedure for ataluren (Translarna®)
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to re-extend the conditional inclusion of ataluren (Translarna®). We recommend an extension of 1 year until 1 October 2025. The Minister has adopted this advice. Ataluren has been conditionally admitted to the basic health care package since 1 November 2021. The medicinal product can be used in the treatment of Duchenne's muscular dystrophy. This is a rare and progressive muscular disease. Up to now, 15 Dutch patients have been given access to ataluren through conditional inclusion.
Update September 2024: Conditional inclusion extended until 1 October 2025
The Minister has adopted this advice. This means that the conditional inclusion (CI) has been extended. The end date of the CI procedure has therefore been definitively changed from 1 October 2024 to 1 October 2025.
Ataluren is intended for certain people with Duchenne's muscular disease
Ataluren can be used in the treatment of Duchenne's muscular dystrophy due to a so-called nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Duchenne's muscular dystrophy is a rare and progressive muscular disease. Up to now, 15 Dutch patients have been given access to ataluren through conditional inclusion.
Read more about conditional inclusion.
Advice from the National Health Care Institute on the second extension of the conditional inclusion of ataluren
The National Health Care Institute advises the Minister of VWS to change the end date of the CI procedure for ataluren from 1 October 2024 to 1 October 2025. This is an extension of one year. The marketing authorisation holder must, no later than 6 months after the (deferred) decision of the European Commission, submit a reimbursement dossier to the National Health Care Institute, consisting of a pharmacotherapeutic dossier, a budget impact analysis and a pharmacoeconomic evaluation. The National Health Care Institute will then have sufficient time to issue a package advice.