Will New Generics make the Cost of care Affordable?

The cost of care for HIV patients continues to increase year over year, which combined with a growing patient population, places a substantial burden on the healthcare system and is likely leading to limitations in patient-level access to the latest antiretroviral therapies (ARTs). Among the major markets, the United States stands out as behind in the UNAIDS 90/90/90 initiative – to have 90% of HIV patients diagnosed, 90% drug-treated and 90% virally suppressed by the amount of those on treatment. According to DRG’s epidemiology, in alignment with the CDC’s HIV surveillance, only 60% of diagnosed HIV patients in the United States were on ART in 2017. To make additional progress in controlling the HIV epidemic, the gaps in the linkage to care need to be addressed, one of which is making the cost of HIV care affordable.

At the recent IDWeek conference from October 3-7 2018 in San Francisco, California, it was clear that the majority of infectious disease providers are happy with the standard of care in the HIV space, given there are multiple options available for even difficult-to-treat patients, discussed in ‘challenging HIV patient’ panels. However, the options that are recommended in the United States treatment guidelines are largely composed of branded therapies launched within the past few years, carrying increasing premium prices. The most recent single-tablet regimen (STR) to launch in 2018 in the United States, Gilead’s Biktarvy, launched with a list price of $35,839 per year. This STR is positioned to replace Gilead’s own STR Genvoya that launched in 2016 with a list price of $30,930 per year.

HIV patient advocacy groups have been demanding lower cost brands for years, since the launch of STRs into the major markets. Nevertheless, the cost of HIV drugs has increased year over year, with historical annual price increases of 7-8% on branded therapies. Gilead’s fixed-dose combination Truvada has reached a yearly cost of $20,100 in 2018, a list price that is 2.5-fold over its price at launch.

The continuing rise in the cost of ARTs has driven market growth but places an increased burden on payers that seek to provide patients with affordable HIV care while decreasing spending. Payers are looking for ways to encourage patients to seek out these less expensive branded generics. An example was highlighted in Dr. Rochelle Walensky’s IDWeek lecture on drug prices; UnitedHealthcare’s My ScriptsRewards program will offer patients who switch to recently launched HIV generics, zero out of pocket cost and even an additional $500 to use on other health care expenses. However, the issue is whether payers should be providing patients financial incentives to take HIV therapies that are not clinical equivalents to the recommended standard of care. Mylan’s Symfi and Cimduo are very similar but not equivalent to Gilead’s Atripla and Truvada, respectively, due to the substitution of emtricitabine for in class drug lamivudine. Additionally, Atripla and Truvada are no longer first-line choices for HIV clinicians: Atripla was downgraded in the United States treatment guidelines in 2015 owing to its CNS associated toxicities and Truvada has been largely replaced by successor Descovy, which has been shown to have a lower risk of long-term comorbidities, notably renal toxicity and bone demineralization. It is also unclear whether the 40% discount provided by these branded generics will provide sufficient cost savings to justify the quality of life decrease that comes with the side effect profile of these therapies. Therapies recommended in the standard of care, such as Merck’s Isentress And ViiV’s Tivicay, are not expected to see generic launches until 2023 and 2027, respectively.

One potential approach for reducing HIV drug prices is a new market event occurring in the HCV space. Gilead has announced that in 2019 they are launching authorized generics of Harvoni and Epclusa, two therapies that are widely prescribed, through a subsidiary at a list price of $24,000, a substantial discount to the brands’ list prices of $94,500 and $74,760, respectively, and 10% lower than competing brand AbbVie’s Mavyret1. One advantage of this strategy, according to Gilead, is that patients on Medicare plans could save $2,500 in out-of-pocket costs due to the preference for lower cost generics. This approach, if successful, could be of particular interest for HIV patients as there is an increased focus on Medicare covered HIV patients now that they are living longer. Further, Medicare patients are likely to benefit the most from additional cost savings as these patients generally have a large financial burden associated with the cost of medications. Gilead’s authorized HCV generics will provide patients covered by public payers access to the HCV therapies they previously could not get due to cost constraints.  Using a similar approach with HIV medications could provide HIV patients expanded access, at lower cost, to the most efficacious medications available. However, the HIV market is lacking the fierce competition of the HCV market, fueled by the time-limited opportunity due to the curative nature of numerous HCV therapies that is driving down prices, leaving little motivation for developers in the growing HIV market to decrease the costs of ARTs.

Overall, the cost of HIV ARTs will continue to be a barrier to patient-level access in the United States unless a major shift occurs in the market. In absence of such a change, some financial relief for patients does exist from the Ryan White Act and AIDs Drug Assistance programs as well as manufacturer benefits programs. However, achieving the holy grail of low cost access to the ARTs with the best clinical profiles, will likely take a combined effort by payers and manufacturers driven by patient advocacy to address this outstanding public health issue. For a more in depth analysis of the HIV G7 markets, please see Decision Resources Group’s 2018 Human Immunodeficiency Virus Disease Landscape & Forecast.

  1.   Gilead press release, September 24, 2018

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