Argentina announces innovative reimbursement deal for Spinraza

On 8 May, Argentina's Ministry of Health and Social Development (MoHSD) announced the signing of an "innovative" agreement with US drug manufacturer Biogen for the reimbursement of the latter's spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). According to the ministry's statement, the agreement was reached upon negotiations with the manufacturer over the drug's price and conditions of administration, involving representatives of both national and provincial health authorities as well as the pre-paid health insurance sector (prepagas). The deal covers the reimbursement of the drug for patients with types I, II and III of the disorder and will "permit an important reduction in cost", the MoHSD revealed.

The ministry hailed the development as a "novel system of access to high-cost innovative drugs", which also comprises the creation of a National Care Program for SMA Patients, the approval of a clinical practice guide and the accreditation of sites for treatment administration and follow-up. SMA is a rare genetic disorder and there are currently approximately 260 diagnosed patients in Argentina, with an estimated 31 new cases every year. Thanks to the deal with Biogen, the ministry said, the number of patients being treated with Spinraza in Argentina is expected to double.

First authorized in Europe in October 2016 and in the United States the following December, Spinraza gained fame and notoriety as the first-ever approved SMA treatment to reach the market. However, it is also one of the most expensive drugs around, with a published US price of USD750,000 in the first year and USD375,000 annually after that. Unsurprisingly, its reimbursement by public payors has been the subject of protracted and sometimes stalled negotiations in countries around the world.

In this context, the reimbursement agreement for Spinraza serves as welcome news for Argentine SMA patients and their families, although uncertainties remain around eligibility and actual access guarantees. But the development is interesting for other reasons, too. Although few details were revealed — certainly not the reimbursement price, which will remain confidential — the very announcement of this type of deal is something of a novelty in Argentina. Minimum pharmaceutical coverage in the country is outlined in the severely outdated Compulsory Medical Program, which applies to the nearly 300 distinct national level social security plans (obras sociales) and private insurers (prepagas), but not the 24 provincial obras sociales and an additional group of unregulated insurance funds. Beyond that, significant discrepancies exist in coverage across the highly fragmented health system. While consolidation of demand between payors can increasingly be seen on the procurement side, Spinraza may well be the first publicly announced system-spanning, MoHSD-brokered pricing and reimbursement deal concerning a specific high-cost drug.

For Biogen, this type of deal maximizes the market potential of its product — in this case one with an already small target audience — and removes the need for separate negotiations with multiple payors, likely in exchange for a generous discount. Let us not forget that Spinraza is soon to face competition from rival Zolgensma (onasemnogene abeparvovec), a potential one-off SMA cure developed by Novartis subsidiary AveXis and greenlighted by the US FDA in May.

Here are the interesting questions: is this a one-off development, or does it herald a new approach to the reimbursement of expensive therapies in Argentina? Is it going to work, and could it be replicated with other high-cost and/or rare-disease drugs? At the very least, it shows that there is willingness on the part of national health authorities in Argentina to engage in direct negotiations with manufacturers over access to high-cost treatments, and among public and among public and private payors to tag along. At a time when the economic recession and high inflation rates continue to heap pressure on public as well as private health budgets in Argentina, it is something for other pharmaceutical companies to note.

Posted 30 May 2019 by Ewa Oliveira da Silva, Senior Analyst, Life Sciences, IHS Markit