HIV care is threatened by proposed changes to Medicare Part D

Successfully treating HIV, and the even greater goal of ending the HIV pandemic, are based on a fundamental science-backed premise: that all people living with HIV should have early and uninterrupted access to effective antiretroviral medications that suppress the virus and keep it at undetectable levels for the rest of their lives. That premise for optimal HIV care, along with the great progress that has been made against HIV, is now threatened by proposed changes to Medicare aimed at lowering drug prices. That’s a terrible trade-off.

Effective treatment of HIV that begins as early as possible after infection and continues without interruption has well-established benefits to individual health, and prevents life-threatening opportunistic infections that result from untreated HIV. The benefits to public health are equally large: Individuals with undetectable amounts of HIV in their bodies, the result of effective treatment, cannot transmit HIV to others. That is a powerful tool for ending the HIV epidemic.

As a physician who has cared for individuals with HIV for more than three decades, and who has investigated treatment and prevention interventions for just as long, I’m worried about a recent proposed rule from the Centers for Medicare and Medicaid Services. Although the stated intention of the proposal is laudable, it will impose new obstacles to uninterrupted therapy by restricting access to HIV medications.

The proposed rule, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses,” has the important aim of lowering drug expenditures for higher-cost conditions by increasing negotiating power. An estimated 25 percent of people living with HIV have access to care and medicine through Medicare. Lifelong treatment should be affordable for them and everyone who needs it.

CMS has long demonstrated its understanding of the importance of unimpeded access to effective treatment for conditions that include HIV by requiring Part D drug insurance plans to cover all or nearly all drugs in six protected drug classes, including antiretroviral treatments for HIV. In recognition of the importance of an individualized approach to HIV treatment, HIV medications have had the added protection of being covered without restrictions.

The proposed rule would change that. While still requiring that Part D plans cover the drugs, it would allow them to impose obstacles to some drugs based on cost. Those obstacles would include requiring prior authorization, a time-intensive process that forces doctors to justify the prescriptions they write to insurance company staff who often have no expertise in treating HIV. Prior authorization is not a good idea for treating HIV, due to the potential consequences of delaying the start of treatment and possibly causing dangerous lapses in treatment.

This proposal runs counter to the goals in federal HIV treatment guidelines and the National HIV/AIDS Strategy to start antiretroviral treatment as soon as possible following diagnosis, to avoid lapses in treatment, and to help individuals take their medications as prescribed.

Another big concern is that the rule would also allow a Part D plan to impose what’s known as step therapy. This practice requires patients to first try a cheaper drug and then move on to often more expensive treatment options only after the initial treatment fails. Step therapy is never an appropriate practice or approach for treating HIV because the use of an ineffective or toxic drug can lead to viral resistance or nonadherence. It can also render other drugs in a patient’s treatment regimen ineffective.

Established medical consensus, strongly supported by published clinical trial data, recommends that people living with HIV start taking the most effective, best-tolerated regimen as the best initial approach to staying healthy and reducing the risk of transmitting the infection to someone else.

People who qualify for Medicare coverage are either medically disabled or age 65 or older. These individuals are likely to have been living with HIV for many years and have limited treatment options due to their previous treatment histories. If they are starting antiretroviral therapies for the first time or switching to new regimens, they need timely access to treatment that is expected to be the most effective and well-tolerated with minimal side effects. If a regimen has proven to be effective for them, it makes little sense to make them switch to lower-priced — and often older — treatments and run the risk of inducing viral resistance. Lower drug prices should never come at the cost of optimal patient care.

Fortunately, one component of the proposed rule would lower costs without compromising access to HIV treatment. It would allow Part D plans to exclude coverage of more expensive drugs that are simply newer formulations of old drugs and offer no meaningful added benefit. That component of the rule would discourage pharmaceutical companies from exercising a patent-extending practice known as evergreening that keeps cheaper generic drugs from entering the market, and would also encourage the development of more effective new drugs. Here also, quality should be the first concern.

CMS has proposed that Part D plans could exclude new formulations of old drugs unless they offer a unique route of administration. This proposal would be even more meaningful, and better encourage the development of more effective medicines, if Part D plans could exclude new formulations of older drugs unless they offer a unique route of administration or demonstrate improved safety, effectiveness, or treatment adherence.

The comment period on the proposed rule ends Friday, so CMS still has time to revisit the rule to ensure that it achieves its stated goal of lowering drug prices as well as what should be the intent behind that goal — expanding access to critically needed medications.

W. David Hardy, M.D., is chair of the HIV Medicine Association and an adjunct professor of medicine in the division of infectious diseases at Johns Hopkins University School of Medicine. He has cared for individuals with HIV infection since 1982 and conducted research on the disease since 1984. He reports having received salary funding from research grants given to his institution by the NIH, CDC, ViiV Healthcare, and Gilead, and has been on advisory boards to ViiV Healthcare, Merck, and Gilead.