A study led by Massachusetts General Hospital (MGH) and Weill Cornell Medical College investigators examines the potential impact of such a change.
"The switch from branded to generic antiretrovirals would place us in the uncomfortable position of trading some losses of both quality and quantity of life for a large potential dollar savings," says Doctor Rochelle Walensky, lead author of the study. "By estimating the likely magnitude of these offsetting effects now – before generic antiretrovirals actually hit the shelves – we can confront our willingness as clinicians, patients and as a society to make these difficult choices."
In 2011 the cost of antiretroviral drugs in the U.S. was around 9 billion Dollars, most of which was paid for by government sources. The currently recommended treatment for newly diagnosed patients is a single pill (Atripla) taken daily that combines three brand-name antiretrovirals: tenofovir (Viread), emtricitabine (Emtriva) and efavirenz (Sustiva). A generic form of the antiretroviral drug lamivudine, which has a similar mechanism of action to emtricitabine, became available in January 2012, and a generic version of efavirenz is expected in the relatively near future.
Replacing two of the three branded drugs with generics could significantly reduce costs, the authors note, but such a strategy would also have disadvantages. A more complicated treatment regimen, requiring three daily pills instead of one, increases the risk that some patients will miss doses, leading to the loss of antiretroviral effectiveness called treatment failure. Laboratory studies have also found that lamivudine may be slightly less effective and more vulnerable to the development of drug-resistant viral strains than emtricitabine.
To evaluate the impact of a switch to a generic-based antiretroviral regimen, the research team used a widely used mathematical model of HIV progression to simulate the effects of a daily three-pill regimen of generic efavirenz and lamivudine plus brand-name tenofovir, compared with the current one-pill combination drug.
They adopted a worst-case scenario to project the efficacy of the generic drugs and their impact on viral resistance
Their results indicated that switching all HIV-infected patients in the U.S. to the three-drug generic strategy would produce lifetime savings of 42,500 Dollars per eligible patient. In the first year alone, the nationwide savings would reach nearly 1 billion Dollars. However, the quality-adjusted loss of life expectancy could be as much as 4.5 months.
MEDICA.de; Source: Weill Cornell Medical College