The Centers for Medicare and Medicaid Services (CMS) is proposing a rule change that will take us back 15 years or more in the struggle to end the HIV epidemic.
If a proposed rule change currently under consideration ends up taking effect, drug companies will be disincentivized from developing new combination therapies that improve medication adherence, viral suppression, and quality of life for people with chronic conditions. In plain English, CMS is going to make me take more pills.
This proposed rule change would adopt a definition of “line extension” as almost any new formulation of a drug. Policy states that drug companies must pay a higher Medicaid rebate for “line extensions” of drugs. Here, the devil is in the details. What types of new formulations constitute real advances and have real benefits for consumers, and what types of new formulations are just about profit?
In the proposed CMS rule, “new formulations” include:
“Extended release formulations; changes in dosage form, strength, route of administration, ingredients, pharmacodynamics, or pharmacokinetic properties; changes in indication accompanied by marketing as a separately identifiable drug (for example, a different NDC); and combination drugs, such as a drug that is a combination of two or more drugs or a drug that is a combination of a drug and a device.”
It’s great that CMS is trying to close loopholes and avoid abuse, but to disincentivize the development of new drug formulations — particularly combination drugs — would harm efforts to end the HIV epidemic in the U.S. Ultimately, this rule change would disproportionately harm Black communities — already overrepresented with respect to HIV, diabetes, asthma, cancer, high blood pressure and COVID-19 — by limiting available treatment options. CMS should limit the definition of “line extension” to those formulations that are not legitimately distinct products.
A combination drug saved my life. The once-daily pill I was prescribed after testing positive for HIV 15 years ago didn’t agree with me, so I was switched to a three-tablet regimen. That was a lot for someone who wasn’t used to taking a daily pill. Eventually, one of those three prescription antiretroviral medications became available in generic form. But that one pill was replaced with three new pills — bringing my total ARV burden to five pills each day. And since I’m aging with HIV, my provider has added a statin, a muscle relaxer, an anti-inflammatory, an allergy medicine and a vitamin D supplement. That’s a lot of pills.
And consistently having to get prescription refills is another form of pill burden. Because most of my prescriptions were started at different times, my refills were never coordinated. Sometimes I would get a one-month supply. Sometimes three. I advocated (pushed, pressed, begged) to get back to a single-tablet regimen for months. My final argument was the winner: “I’m tired of taking pills. I haven’t taken mine for months because there are too many of them, and I’m tired.”
Search the web for “antiretroviral adherence and treatment fatigue.” You’ll see that they’re linked. The drugs are great, but they only work when you take them. It sounds a little wimpy when you think about all of the people who spent the early years of the epidemic taking handfuls of pills multiple times daily. Toxic stuff. Everybody didn’t make it.
But it’s 2020. Combination drugs are just one example of the future of improved efficacy and adherence for those living with HIV. But CMS wants to stop them from being developed — they want to make me take more pills.
It’s unfortunate that we are living in a world where the government is now creating roadblocks for patients, rather than removing them. I know that there are millions of people who are living with HIV in this country, just like me, who would be hurt by the implementation of this proposed change. We all need to speak up and tell CMS that now — especially in the middle of a pandemic — is not the time to enact a policy that would put at risk or make more difficult individuals’ ability to access and stick to their treatment regimen. It’s bad policy, and it’s bad for patients.
Newells is the director of national programs for the Black AIDS Institute, a national nonprofit organization is dedicated to ending HIV in Black America.