Following a request by SMA Europe, Biogen held a conference call on Friday 9th June regarding the company’s pricing policy for Spinraza™. In response to a subsequent request to share a summary of the discussion, Biogen has provided the following update.
Please see below for a community update on the call.
Dear members of the SMA community,
In response to a request from SMA Europe, Biogen representatives and the board members of SMA Europe participated in a joint conference call on Friday 9th June, 2017. In response to a subsequent request to share a summary of the discussion, Biogen is providing the following update.
The call was opened with an acknowledgment of the recent significant milestone reached for SPINRAZA® (nusinersen): marketing authorisation for the treatment of 5q spinal muscular atrophy (SMA). Much of the discussion was then spent on the price of nusinersen in Europe; In early launch countries, nusinersen’s list ex-factory price (i.e., price at the factory) for the three-dose maintenance therapy is expected to be up to €270,000 per individual per year – generally in line with the annual cost of other rare disease therapies in Europe. Nusinersen’s first year cost in most cases will be higher due to the initial loading dose regimen that includes four loading doses and two maintenance doses. The price of nusinersen is expected to vary country by country, and takes into account differences at the local level such as the distribution model, tax policies, rebates and discounts, and other aspects of the healthcare systems. While there will be no single identical number across Europe there will be a focused range. Due to local process, none of the European country level prices have been published yet.
The price of treatment was determined through a rigorous and thoughtful process that evaluated a range of information and strived to achieve an appropriate balance using our Biogen pricing principles – principally focused on the nusinersen clinical value and impact to the healthcare system. The approach to pricing reflects, nusinsersen’s robust evidence package including data from the recent clinical trial readouts. Biogen recognizes that cost and access to treatments are key considerations for patients, providers, payers, and policy makers. We are working with policy makers, healthcare systems and governments in Brussels and across Europe to find solutions to secure broad and sustainable access to nusinersen including exploring innovative pricing models or strategies. Additionally, we will continue to advance the ongoing collection of evidence generating data and the development of a robust registry strategy.
In countries where Biogen does not have an affiliate, we are working diligently to find the right partner to represent us in local discussions with appropriate agencies to ensure long-term sustainable access through regulatory approval and reimbursement. We remain committed to transparent and timely communications and will continue to be available to provide any requested updates.
Following the granting of a marketing authorization for nusinersen, the EAP in Europe will remain open for new and existing patients for a period of time. This will vary on a country-by-country basis and be determined predominantly by the commercial availability of nusinersen in the respective country. In the Nordics, the EAP has closed as required by local regulation. In countries, where nusinersen will be commercialized soon after the granting of the marketing authorization,for example in Germany and Austria, the EAP will close for new and existing patients immediately prior to the commercialization of the medicinal product. Biogen is already working to ensure that the transition from EAP to the commercial setting is seamless. For the remaining countries, to minimize the gap between marketing authorization and access to nusinersen, the EAP will remain open for new patients for a period of time, if allowed per local regulations. The actual date of closure for new patients will be defined by Biogen on a country by country basis and we will work on a country specific basis to manage the transition from EAP to a commercial setting.
We appreciated the opportunity to have this important discussion with the board members of SMA Europe. We will continue to work closely with patient advocacy organizations to ensure that the perspectives of patients and families are taken into account in Biogen’s decision making process.