January 15, 2013
Switching to Generic HIV Treatments Could Save Billions
Lee Rannals for redOrbit.com — Your Universe Online
Replacing brand-name, antiretroviral drugs recommended for control of HIV infection with generic medications could save nearly $1 billion a year on health care costs in the US.
"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," Rochelle Walensky, MD, MPH, of the Massachusetts General Hospital Medical Practice Evaluation Center, lead author of the study, said in a statement. "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."
The cost of antiretroviral drugs in the U.S. in 2011 was around $9 billion, most of which was paid for by the government. The recommended treatment for newly diagnosed patients is a single pill taken daily that combines three brand-name antiretrovirals, including tenofovir, emtricitabine and efavirenz.
A generic form of emtricitabine became available in January 2012, and a generic variation of efavirenz is expected to be released in the near future.
The authors said replacing two of the three branded drugs with generics could significantly reduce costs, but such a strategy would also have disadvantages.
A more complicated treatment regimen requires three daily pills instead of one, increasing the risk of some patients missing doses, which could lead to the loss of antiretroviral effectiveness called treatment failure.
Studies have found lamivudine may be slightly less effective and more vulnerable to the development of drug-resistant viral strains than emtricitabine.
The team employed 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.
Their results indicated that switching all HIV-infected patients in the US to the three-drug generic strategy would produce lifetime savings of $42,500 per patient.
"Diverting patients from the most effective, branded treatment alternative could be made more acceptable if the savings were directed to other HIV-related needs," Bruce Schackman, PhD, associate professor of Public Health at Weill Cornell Medical College, said in a statement. "For example, fewer than half the state-funded AIDS Drug Assistance Programs include the effective protease-inhibitor-based treatment for hepatitis C virus (HCV), which infects up to 25 percent of HIV-infected individuals."
He said they calculated that for every 15 patients switched to the generic-based regimen, one who is also infected with HCV could be treated and potentially cured of that infection.
"For patients who take their medications well and adhere to the medical regimen, the generic option will be a bit more complex but could be as effective as the standard regimen," adds Walensky, a professor of Medicine at Harvard Medical School, explained. "But a patient who relies heavily on the simplicity of taking a single pill is more likely to suffer detrimental effects, since missing doses will increase the risk of treatment failure."
She said there is no getting around the fact savings from generics will only be realized if we route patients away from the most effective, branded treatment alternative.
"This is a trade-off that many of us will find emotionally difficult, and perhaps even ethically impossible, to recommend. All of us — consumers, providers and advocates — would be far likelier to embrace such a policy change if we knew the savings would be redirected towards other aspects of HIV medicine," Walensky said.