Generics for HIV: Complex Barriers Impede the Uptake
More generic HIV medications are entering the marketplace creating potential for significant cost savings; however, a series of complex and unique barriers facing these medications could slow their use, adoption, and impact in the United States.
In recent years, generic versions of lamivudine, abacavir and efavirenz have been introduced into the market, along with the approval of a generic version of the preexposure prohylaxis (PrEP) known as emtricitabine and tenofovir disoproxil fumarate.
Later this year, a generic version of tenofovir disoproxil is also expected.
These introductions signal a new era in HIV and represent the first time generic medications have become available for drugs that are still highly utilized in treatment.
“What's different about these drugs is that HIV clinical treatment guidelines are frequently revolving and updating and new drugs are always continuously out on the market,” Erika Martin, PhD, MPH, associate professor in public administration and policy at University of Albany SUNY told First Report Managed Care. “So HIV medications have come out on the market in the past that are generic, but this is the first time that medications that have come out while they are still on the clinical guidelines.”
These recent approvals also come at a time when significant progress has been made in the prevention and treatment of HIV, with some states such as New York embracing ambitious goals and programming to effectively “end AIDS” by increasing the number of individuals using PrEP, reducing the number of new HIV infections, and increasing the viral load suppression of those with HIV.
“This is the first time we are realistically thinking we can achieve the end of AIDs and generics really could be part of the solution but complicating all of this is what is going to happen with the ACA,” Dr Martin said.
In addition to the uncertainty surrounding health care reform, experts said the unique nature of the disease state itself, skepticism and resistance from patients and providers, and a complex financial picture are just some of the obstacles that could slow the acceptance of generic HIV medications
Potential for Savings?
Dr Martin and colleague Bruce R Schackman, PhD, recently penned a perspective for the New England Journal of Medicine, on the obstacles that exist to HIV generic use.
In it, they argue, that generic HIV medications have the potential to deliver significant cost savings. For example, based on their analysis, they found that switching from a brand name regimen to a generic combination of dolutegravir, abacavir and lamivudine would result in a 25% reduction in the wholesale acquisition cost and federal supply schedule cost for a 30-day supply, saving $667 and $553 respectively.
However, these cost savings weren't always as significant across all payers or drug regimens. For instance, they found that while a separate generic regimen of dolutegravir, tenofovir, disoproxil fumarate and emtricitabine would yield savings for private insurers of $364 it would yield a savings of only $5 for public payers for a 30-day supply.
“HIV care is financed through a complex patchwork of public and private payers, including private insurance, Medicaid, Medicare, and state ADAPs,” they wrote. “Payers don’t incur identical costs for (antiretroviral therapy).”
Britten Pund, director of health care access for NASTAD, said the impact generic HIV medications will have on payers will be very complex. Typically private payers find ways to leverage generics to maximize savings and, in turn, brand manufacturers try to offset that leveraging through reimbursement or rebates.
People living with HIV are unique because many are able to gain access to HIV medication through safety-net providers who have access to discounted 340B medication prices.
Generic drug cost savings can't be determined simply by looking at the wholesale acquisition price because of the variety of payers and programs in place to provide treatment for individuals with HIV, said Tim Horn, deputy executive director of HIV and Hepatitis C programs for the Treatment Action Group (TAG).
“It's all contingent on this really opaque system of rebates and discounts and negotiations and so on and so forth, so we don't quite know what happens,” he said.
Payers also typically can drive patient decisions by offering lower copays for generic medications, but according to Horn, that may not be as big of an incentive for patients with HIV as it is for the larger population.
"We've been dealing with innovator, brand name products for a long time and all of those manufacturers have some pretty robust copay assistance programs in place,” he said. “Then you compound that by the fact that we really make sure we have this patchwork of systems that ensures that cost isn't a barrier to HIV treatment and essentially very few people living with HIV are facing out-of-pocket costs.”
Skepticism and Resistance from Patients and Providers
Not only will many patients not have the financial incentives that patients in other disease states may face, but they also could face more complicated treatment regimens under generic options.
Most branded ART regimens are often coformulated and include three or four medications, but switching to a generic version may mean coformulated tablets are replaced with multiple individual pills.
Previous research has established that taking more pills more times a day can negatively impact adherence; however, there is limited research into the impact taking multiple pills once a day would have on adherence compared to a single pill, once daily regimen.
Despite this lack of evidence, experts believe physicians may still resist prescribing a treatment regimen that requires the use of more pills.
“Even though efficacy may not be an issue, the way the drugs have to be delivered may be,” said Lisa O'Connor, RN, a senior managing director in the health solutions practice at FTI Consulting.
Some have also voiced concerns about whether the amount a patient pays in copays would increase if the number of pills they take each day also increases.
Another potential barrier is the perception among patients and providers that generic medications may be less safe or differ in efficacy than their brand name counterparts.
“We perceive that the higher end whatever it is—drug, test, intervention— is going to be more efficacious and what we in fact know, is that it's not true, but general consumers don't always understand that,” Ms O'Connor said.
According to Dr Martin, manufacturers that emphasize the negative side effects of older medications when marketing newer products may also foster mistrust surrounding generics,
Brand name manufacturers may also try to delay competition from generics by creating slightly new formulations, developing different drug delivery systems, or creating coformulations with drugs that have longer patents.
“That's a pretty large barrier,” Dr Martin said.
Who Will Drive Demand?
According to Mr Horn, due to some of these issues, it is unlikely that the demand for generic HIV medications will be driven by providers or patients. He said the demand will likely come from payers and how they structure their benefits and policies.
“If payers really start playing hard ball, then I think that will force the circumstance of can I take a regimen that is two pills once a day, instead of one pill once a day,” he said.
Experts note, however, that the unique nature of HIV will make it more complex as payers make decisions on how to structure their benefits.
Unlike some other disease states, HIV has significant public health implications that make it critical that individuals with the disease receive the treatment they need, at a cost they can afford, and are able to maintain adherence to treatment to ensure viral loads can be suppressed.
“It makes it more complicated when you are trying to think about the greater whole and the impact of a disease on a population versus an individual themselves,” Ms O'Connor said.
Over the last two decades, significant progress has been in the treatment and prevention of HIV; however, there is still work to be done. Mr Horn said just 49% of the 1.1 million who are living with HIV are actually on antiretroviral therapy and have suppressed viral loads.
“We need to do much better than that and so the question is, resources will always be finite, so where are we going to get the financial resources to make sure that all people living with HIV have all the services and the treatments that they need,” he said.
If the savings come from generic HIV medications, Mr Horn believes those savings need to be reinvested into HIV treatment and care.
Payers will also need to consider the full implications of any decision they make on individuals and society as a whole.
“We really have great coverage for HIV care needs for all those who need it, plus in many cases minimal if any out-of-pocket expenditures on prescription drugs,” Horn said. “If we move to generics, particularly where there are no copay assistance programs for bona fide generics in the U.S. , the one thing we don't want to see is some individuals facing copays that could potentially prohibit their accessing HIV treatment.”
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