Though several new generics for HIV/AIDS are on deck for the U.S., they likely won’t create significant disruptions to the market due to the complexity of HIV/AIDS treatment and the current use of combination therapies.
Two generic products have been introduced: Mylan N.V. launched a generic version of Bristol-Myers Squibb’s Sustiva (efavirenz), and Teva Pharmaceutical Industries Ltd. launched a generic version of Gilead Sciences’ Viread (tenofovir disoproxil fumarate). These two products are mainly used in combination therapies with other drugs that still have patent protection.
“While the prospects of more generics becoming available for HIV drugs is exciting, significant uptake of generics will likely be challenging due to HIV treatment regimens that require triple and quad medication therapy cocktails, says Lynn Nishida at Solid Benefit Guidance. “The need to combine individual generic components — while certainly possible — will add an element of complexity and bring challenges in competing in a market that has been largely dominated for years as one pill once daily/all-in-one combination pills.”
Teva also gained FDA approval for a generic version of Truvada (emtricitabine and tenofovir disoproxil fumarate), which might have the most potential for uptake in the near future, says PerformRx President Mesfin Tegenu.
Nishida agrees, but adds “[t]he degree to which plans will place prior authorization on the brand to divert prescriptions to the generic will likely depend on how fast the price of the generic falls relative to the brand as multiple manufacturers bring their generic versions to market.”
As Teva has not announced the date to launch genetic Truvada and its future price remains unknown, it is unclear when these potential savings might materialize.
In addition, switching a patient to take two individual HIV/AIDS drugs instead of a two-drug combination has never been successful, according to Tegenu.
Increasing the number of tablets a patient must take also increases copays and adds difficulties to patient compliance. Nishida suggests that plans follow the best practice of tracking markers of medication adherence.