The US FDA has announced the approval of Gilead Sciences (United States)'s Stribild (elvitegravir + cobicistat + tenofovir + emtricitabine) as a ground-breaking new four-in-one therapy for the treatment of HIV/AIDS.
IHS Global Insight Perspective | |
Significance | The announcement falls in line with expectations, and follows the 13–1 vote in favour of the drug from the FDA's Antiviral Drugs Advisory Committee in May. Pricing has been confirmed at USD2,342.47 per month, which also falls roughly in line with expectations, although it is within the USD26,000–34,000 annual cost range that led the US Congress to take the unusual measure of calling on Gilead to limit the price of the drug earlier this month. |
Implications | Stribild's price represents a 33% premium to Gilead's and Bristol-Myers Squibb (BMS, United States)'s triple combination therapy Atripla (efavirenz + emtricitabine + tenofovir), and 7% higher than Merck & Co (US)'s HIV integrase transfer inhibitor Isentress (raltegravir). Is also slightly lower than protease inhibitor regimens, including BMS's Reyataz (atazanavir) with Gilead's Truvada (tenofovir + emtricitabine). |
Outlook | Stribild will be available with almost immediate effect, and represents a key growth driver for Gilead. The initial focus will be on new patients in the absence of data on the safety of switching therapies. The next step also includes expected approval in Europe by year-end. |
The US FDA yesterday (27 August) announced the approval of Gilead Sciences (United States)'s Stribild (elvitegravir 150mg + cobicistat 150mg + tenofovir 300mg + emtricitabine 200mg) as a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. The approval is based on two Phase III trials which focused on non-inferiority to Bristol-Myers Squibb (BMS, US)/Gilead's Atripla (efavirenz 600mg + emtricitabine 200mg + tenofovir 300mg), which was called Study 102, as well as ritonavir-boosted atazanavir plus Gilead's Truvada (emtricitabine + tenofovir), which was called Study 103. The trials met their primary endpoints.
HIV/AIDS Field | |
Drug/Regimen | Annual Cost |
Stribild (Gilead) | USD28,110 |
Isentress (Merck & Co) + Truvada/Norvir* | USD26,190 |
Complera (J&J) | USD20,455 |
Reyataz (BMS) + Truvada/Norvir* | USD29,200 |
Prezista (J&J) + Truvada/Norvir* | USD29,300 |
Atripla (BMS/Gilead) | USD21,100 |
Source: Gilead, IHS Global Insight (POLI) | |
Following on from official warnings from Congress earlier this month that Stribild's price could bankrupt the governmental AIDS Drug Assistance Programs (ADAPs), there was significant interest in the price that Gilead would ultimately put on the new drug. As it stands, the company has opted for relatively conservative pricing, at the lower end of the expected USD26,000–34,000 annual cost range that the market had anticipated: the wholesale acquisition cost (WAC) stands at USD2,342.47 per month The pricing falls very much in line with its nearest competitors—Merck & Co (US)'s Isentress (raltegravir) and BMS's Reyataz (atazanivr)/Truvada—and still represents a significant 33% premium over triple-therapy Atripla.
Stribild's potential success will very much depend on its ability in the first-line setting where it will come up against the dominant Atripla franchise as well as Isentress and Reyataz. There may also be some patient switching from Truvada-based multi-tablet regimens, given the substantial convenience of the one-tablet regimen. Gilead/Johnson & Johnson (J&J, US)'s Complera (rilpivirine + tenofovir + emtricitabine) has seen some success in securing patient switches, and although this is not expected to be a key driver for Stribild given the treatment-naïve labelling, it should not be discounted from the modelling. Gilead estimated that around 28,000 patients were on Complera by the end of 2011, having also secured an August approval.
Outlook and Implications
Stribild will be available with almost immediate effect, and represents a key growth driver for Gilead. The initial focus will be on new patients in the absence of data on the safety of switching therapies. The actual labelling of Stribild is very much in line with expectations—there is slightly more strenuous kidney monitoring than Atripla, but this is generally a routine part of HIV/AIDS treatment and should not represent a commercial setback. The pricing will not please the politicians who warned Gilead over the impact on ADAP, but IHS Global Insight also expects that the company will adopt a favourable discount policy. The next step also includes expected approval in Europe by year-end; however, we expect that most of 2013 will be spent seeking to secure pricing and reimbursement approvals across the European markets, and therefore the commercial impact will only begin to be fully felt in 2014.
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