The following text aims to clarify the current situation regarding Zolgensma global Managed Access Program after the changes announced by NGTx on the 9th of January 2023.
From SMA Europe we wish to ensure that all our Member Organisations have the most recent updates regarding treatments and related developments.
Therefore, we want to inform you that, following the last updates sent by Novartis on the gMAP Program, Novartis is changing the geographic scope of the global Managed Access Program to focus the program on countries where it is currently possible to make Zolgensma available as a future long-term sustainable solution. Following the company’s communications, this long-term sustainability requires reimbursement frameworks, sufficient local care infrastructure, and partnerships.
The company declares to be seeking sustainable solutions that recognize the value of Zolgensma and achieve appropriate / shared contributions from governments, society and Novartis. Novartis has had conversations with stakeholders in countries where the program will no longer be available and confirms that it is still open to collaborating on concepts for sustainable partnerships in countries that lack access and that have an interest and willingness to invest in co-creating solutions to broaden access to Zolgensma.
Zolgensma is now approved in over 45 countries and more than 2,500 patients have been treated with the gene therapy globally across clinical trials, managed access programs, and in the commercial setting.
The gMAP program will remain available to patients in 12 countries. Countries that remain in scope for gMAP include Colombia, India, Indonesia, Malaysia, Mexico, New Zealand, Philippines, Serbia, Singapore, Thailand, Uruguay and Vietnam.
The change in the gMAP program has been implemented on January 9, 2023. Since then, no new requests are to be accepted from countries that are no longer eligible. Patients who are currently in the pool for the blinded allocation from impacted countries can remain in the pool after January 9, 2023, as long as they remain medically eligible.
We believe that sharing this information with you is crucial and fulfils our desire to inform you in a timely manner about any updates that are relevant to the SMA Community in Europe. From SMA Europe we strive for achieving our vision of creating a better world for all those living with SMA and ensuring that we do our best, so no patient is left behind.