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The Sovaldi anti-diversion debate: Placing Gilead's access initiatives under the spotlight
While a great deal of the media attention showered on Gilead's blockbuster hepatitis C treatment, Sovaldi, has focused on the product's pricing and fate in the hands of developed market payers, only recently has attention shifted back toward the developing world. This time, it focuses on what Médecins Sans Frontières (MSF) has labeled as "barriers to access," from Gilead's so-called anti-diversion programme that forms part of its voluntary licensing agreements with a number of Indian generics firms.
The company first announced these agreements back in September as part of its global access programme for Sovaldi. Under this arrangement, the generics firms are able to register versions of the medicine in a large number of developing markets identified by Gilead, where they will be sold at greatly reduced prices relative to those observed in developed markets.
At issue are the obligations and restrictions imposed on licensees by these agreements with regards to prescription and dispensation of the products. In particular, by requiring licensees and/or their partners to obtain patient information and limit dispensation to one bottle at a time, MSF alleges that patient confidentiality, access and treatment have the potential to be compromised.
A track record in access
For all the debate that the latest headlines are now generating, Gilead is a company which, following the historical controversy surrounding pharmaceutical pricing in HIV/AIDS, has actually emerged with something of an enviable track record in the access landscape. One need look no further than the most recent Access to Medicine Index, where the company secured a sturdy fifth-place ranking among its peers and was lauded for its leadership position in IP management and equitable pricing in particular.
In the field of HIV/AIDS, Gilead has maintained voluntary licensing agreements as part of its global access programme (including a commitment to reinvest royalties in support of licensee product registration, medical training and other initiatives) for some time, and was the first company to enter into a licensing agreement with the Medicines Patent Pool.
There remains the reality that pricing is one of a number of factors driving access to medicines. A critical prerequisite for sustainable access in many cases is the existence of infrastructure supporting diagnosis and ongoing patient management. Here too, Gilead, like a number of its peers, has collaborated with government and other stakeholders to help build capacity and scale up treatment.
The future access landscape
In addition to voluntary licensing, public-private partnerships and patient support programmes, the access landscape also encompasses relatively novel approaches such as inter- and intra-country tiered pricing models. In our recent studies exploring these latter two topics, we identified a strong curiosity among payers and industry alike in extending these models from infectious diseases to other therapeutic areas, including chronic diseases and fields such as oncology.
Where Gilead is concerned, it is interesting to note the organization's ongoing pivot into the oncology space. Having secured FDA approval for its new blood cancer drug Zydelig last year, the company has steadily been extending its foray into oncology and related fields such as inflammation via a combination of acquisitions and strategic collaborations.
Given the strides Gilead has made in the access landscape as part of its historical legacy in antivirals, one might expect that any access initiatives it chooses to implement for these new franchises will be all-the-more high profile, particularly as stakeholders look to gauge how these decisions square with the access philosophy that Gilead has developed to date. For that reason, the organization may well have the opportunity to set a new standard for how models such as inter- and intra-country tiered pricing are applied to non-traditional therapeutic areas in the years to come.
Cameron Lockwood is a life sciences analyst for IHS
Posted 29 April 2015
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