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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outlined in the severely outdated Compulsory Medical Program, which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.
