G-BA and healthcare community call for tighter regulations of unlicensed high-cost medicines

The G-BA – The Gemeinsamer Bundesausschuss (Federal Joint Committee) and the wider healthcare community have called for stricter regulations of high cost medicines after Novartis’ gene therapy drug Zolgensma was funded by the insurance group fund, the GKV-Spitzenverband.

The one-shot therapy has been used to treat Spinal Muscular Atrophy (SMA) under the Härtefallprogramme (compassionate use programme), despite not receiving market authorisation.

From a patient access perspective this is positive, as under the scheme patients that face an imminent threat in their health condition are provided access to the therapy. In Germany this is estimated to be some 50 SMA patients.

However there is concern that these moves have been primarily driven by media pressure rather than appropriate assessment. The healthcare community have voiced concerns over the precedent this appears to create, noting the strong pipeline of high-cost cell and gene therapies likely to enter the market soon, and questioning the financial sustainability of this approach.

The GKV-SV and G-BA together with alliance fund groups and the VUD – Verband der Universitätsklinika Deutschlands (Association of University Clinics) have appealed to Health Minister of the Bundestag (Federal Government) Jens Spahn, to implement tighter controls over insurance funding for unlicensed medicines.

MAP will be closely following further developments. For more information on market access in Germany, see here.

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Published 28. November 2019 in News, News Germany