Belgium - Medicine Pricing | Avastin-Lucentis and Related Matters
The prices of medicines took again centre stage during the plenary session of Tuesday 8 October 2019 of the federal Parliament (see attached). At issue were specifically the prices and reimbursement status of Lucentis (Novartis) and Avastin (Roche). Five members of parliament wanted to learn why the Minister of Social Affairs and Public Health (the “Minister”) had failed to rely on a possibility which the Court of Justice of the European Union (“CJEU”) expressly created in November 2018 to reimburse the off-label use of a medicine for budgetary reasons (see, Van Bael & Bellis Life Sciences Newsflash of 21 November 2018).
Under the approach proposed by the members of parliament at issue and endorsed by the CJEU, Avastin would be reimbursed for the treatment of the eye-condition wet age-related macular degeneration (“AMD”) while it has no therapeutic indication for the treatment of that condition. Avastin would thus function as a replacement for Novartis’ significantly more expensive Lucentis which does benefit from a therapeutic indication covering AMD. For its part, Avastin only has a marketing authorisation for a range of unrelated oncology indications.
In her response, the Minister explained that she had managed to secure beneficial reimbursement conditions for Lucentis by concluding a Managed Entry Agreement (“MEA”) whose financial conditions are confidential. Additionally, the Minister defended her medicines policy of the last few years which was based on budgetary prudence, rewards for innovation and international cooperation among payers.
However, this response did not satisfy the members of parliament who had raised the Avastin/Lucentis matter. They engaged in broadsides against Novartis, the wider pharmaceutical industry, the Belgian Competition Authority (which allegedly failed to investigate a competition complaint against Novartis and Roche) and the Minister. They promised further fireworks in a fresh debate on Avastin/Lucentis in the parliamentary committee for health and equal opportunities scheduled on Wednesday 9 October 2019 as well as during hearings on innovative expensive medicines which will take place in November 2019.