Barriers to HIV generics in the US Posted 16/03/2018

Combination antiretroviral therapy (ART) has dramatically improved survival rates among people with HIV and is a mainstay of HIV prevention. Generic ART medications offer the potential for treating and preventing HIV at a lower cost [1].

ART treatment is not cheap. It accounts for 60% of the projected US$326,500 discounted lifetime medical cost of HIV treatment in the US. A 2013 study estimated that the US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients [2].

Researchers from the US analysed four HIV treatment regimens currently recommended by the Department of Health and Human Services (HHS) [1]. Their analyses found that, for example, switching from a brand-name to a generic formulation of the three-drug combination of dolutegravir, abacavir and lamivudine would yield a 25% reduction in both the wholesale acquisition cost (generating savings of US$667) and the federal supply schedule cost (generating savings of US$553) for a 30-day supply.

However, despite the savings to be made the authors noted that there are many barriers to uptake of generic ARTs. In fact, a recent study found that a third of French HIV physicians and their patients were unwilling to prescribe or use generics – and that the majority were unwilling if switching to generics resulted in an increased pill burden [3]. Just some of the barriers to uptake of generic ARTs identified by the authors included:

  • Modification of brand-name products coupled with aggressive marketing of modified products
  • Developing co-formulations with medications that have longer patent lives, e.g. co-formulating tenofovir disoproxil fumarate with emtricitabine
  • Changing inactive drug components, e.g. adding a new binding agent to the combination of efavirenz, emtricitabine and tenofovir to resist degradation
  • Filing for approval for additional indications that introduce new patent claims and extend market exclusivity, e.g. obtaining US Food and Drug Administration approval to market lamivudine to treat hepatitis B virus
  • Obtaining patents on paediatric formulations, e.g. patenting the combination of lopinavir and ritonavir
  • Emphasizing the side effects of older products compared to newer brand-name alternatives, thereby increasing the general mistrust of generics, e.g. efavirenz has been linked to increased suicidality
  • First-line ART regimens contain 3 or 4 medications and due to the staggered availability of generics of each component this could require replacing co-formulated tablets with multiple individual pills, thereby affecting adherence
  • Financial incentives for switching to generics vary among payers and in some cases disincentives to muse generics exist

The authors concluded that ‘many factors will delay widespread adoption’. They added that ‘although information and education about generics can improve health professionals’ and patients’ confidence in generics substitution, there is limited evidence on which interventions are most effective at improving perceptions of generic drugs’.

Conflict of interest
Disclosure forms provided by the authors [1] are available at NEJM.org.

Related article
Generic substitution of antiretroviral drugs in Ireland: healthcare provider views 

References
1.  Martin EG, Schackman BR. Treating and preventing HIV with generic drugs - barriers in the United States. N Engl J Med. 2018;378(4):316-9.
2.  GaBI Online - Generics and Biosimilars Initiative. HIV generics could significantly cut treatment costs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Generics/Research/HIV-generics-could-significantly-cut-treatment-costs
3.  GaBI Online - Generics and Biosimilars Initiative. Physicians’ perceptions of HIV generics in France [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Generics/Research/Physicians-perceptions-of-HIV-generics-in-France

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