Changes to the six protected class policy are the wrong prescription for Medicare and HIV patients

Tom Wilbur
Tom Wilbur March 15, 2019


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For over 10 years, one of the cornerstones of the Medicare Part D program has been to ensure the sickest and most vulnerable patients have access to the clinically critical medicines they rely on. For the patients whose treatment is covered under six specific classes of medicines – those with HIV, cancer and epilepsy among others – more commonly known as the six protected classes, there is no “one size fits all” for medicines that will work. The medicines for these patients have complex interactions, side effects, contraindications and other factors that must be considered in their coverage.

Unfortunately, a recently proposed rule from the Centers of Medicare and Medicaid Services (CMS) – the Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses – would be detrimental to Part D beneficiaries and in particular, patients suffering from HIV/AIDS.

The protected classes policy is particularly vital to beneficiaries living with HIV/AIDS, given the public health implications of HIV-positive patients not receiving timely and appropriate treatment. The protected class policy enables HIV patients to access “all or substantially all” HIV medicines, which is crucial given that some strains of the virus may be resistant to certain anti-viral medicines. Additionally, newer single tablet combination regimes are easier for patients to take, leading to improved adherence. If patients do not have access to the full breadth and range of anti-viral treatments, it could be harder to reach the goals of more people with HIV achieving viral suppression.

The proposed rule would weaken the six protected classes by allowing Part D plans to restrict access to medicines by using step therapy or utilization management – a practice that aims to reduce drug costs by requiring patients to initiate on less expensive therapies before the can access more expensive specialty ones. That includes patients who are stable taking HIV medicines. These proposed changes would severely undermine patient access to drugs they need to survive and would be the wrong prescription for Medicare and HIV patients who rely on it.

Precision Health Economics is out with an eye-opening new memo where they note the provision of the proposed rule requiring utilization management could lead to “over 6,750 new HIV infections from increased viral loads among Medicare patients with HIV. Those 6,750 additional infections would be transmitted from the Medicare population but the new cases would be distributed across the general population.”

And, in a recently published op-ed in STAT, author W. David Hardy makes it clear: “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.”

The AIDS Institute also joined the chorus of calls for the Trump administration to reject their “dangerous” Part D rule, stating that “Step therapy and prior authorization should never be used in the treatment of HIV and run counter to the US government sponsored HIV treatment guidelines.”

Patients living with HIV deserve unrestricted access to specific prevention and treatment regimens which are critical to their health and the goal of ending the HIV epidemic. The Medicare Part D protected classes policy has been instrumental in the incredible strides and progress that have been made for HIV treatment in the past decade. As we all work towards the goal of ending the HIV epidemic, reversing this progress is the wrong prescription for Medicare and HIV patients.

Topics: HIV/AIDS, Part D, Prescription for Medicare