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Belgium, Ireland, and The Netherlands Jointly Agree under Aegis of Beneluxa Initiative to Reimburse Zolgensma®

  • 11/10/2021
  • Articles

On 8 October 2021, Belgium, Ireland, and The Netherlands announced that they had reached an agreement with Novartis Gene Therapies (Novartis) regarding the reimbursement of Zolgensma® (onasemnogene abeparvovec), a gene therapy medicinal product that was designated as an orphan medicine and is indicated for the treatment of two specific types of Spinal Muscular Atrophy (SMA) (see, attached press release). SMA is the most common genetic cause of mortality in infants and affects nerve cells that cause general muscle weakness. Infants with SMA typically do not survive more than two years. For its part, Zolgensma® is known as the world’s priciest medicine, but the press release does not address the price reductions which Novartis is understood to have consented to in order to secure reimbursement in the three countries.

The agreement was reached under the aegis of the Beneluxa initiative, a collaborative effort of Austria, Belgium, Ireland, Luxemburg, and The Netherlands designed to expand patient access to high quality and affordable medicines.  Under the Beneluxa initiative member governments pursue joint activities in the areas of (i) horizon scanning; (ii) Health Technology Assessment; (iii) the sharing of information; and (iv) pricing and reimbursement. The arrangement with regard to Zolgensma® is the first agreement governing the price and reimbursement of a medicine involving 3 countries. The previous one only applied to two countries, Belgium and The Netherlands, but, interestingly, related to Biogen’s Spinraza® (nusinersen), a medicine also indicated for the treatment of specific SMA conditions (see, Van Bael & Bellis Life Sciences News & Insights of 12 July 2018).  
 
Zolgensma® will qualify for reimbursement in Ireland with immediate effect. In The Netherlands, the medicine will be reimbursable on 1 November 2021, while Belgium will reportedly follow suit on 1 December 2021.     

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