Authors

Rahul Nayak was a fourth-year medical student at Harvard Medical School during his fellowship year. As part of the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham & Women's Hospital, his research interests are in pharmaceutical policy, physician prescribing habits, and access to health care. He attended Duke University, where he studied biomedical engineering and economics. He then completed a two-year fellowship at the NIH Department of Bioethics. His research has led to first-author publications in JAMA, Annals of Internal Medicine, Health Affairs, and Bioethics. He is currently a resident in the internal medicine residency program at Massachusetts General Hospital. Rahul was a Student Fellow during the 2018-2019 academic year, and completed a project entitled “Public Support for Late-Stage New Drug Discovery,” which examines the role of public-sector research on new drug discovery.
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New HarvardX Course on the FDA and Prescription Drugs

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Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!

Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course). Read More

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Healthcare Already Taking Center Stage in 2020 Democratic Primary Race

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With Massachusetts senator Elizabeth Warren (D-MA) announcing that she was forming a Presidential exploratory committee, I suppose that means the 2020 Democratic Primary is off to the races. Joining her are some lower profile candidates, including John Delaney (former MD congressman), Richard Ojeda (WV state senator and former congressional candidate), Tulsi Gabbard (HI congresswoman), Julian Castro (former secretary of HUD). And within the last week, senators Kirsten Gillibrand (D-NY) and Kamala Harris (D-CA) put their hats in the ring.

While many issues are likely to play prominent roles in this campaign — immigration, taxes, inequality, housing, universal pre-k, college affordability, environment/climate change — healthcare is likely to play an outsized role after Democrats found it to be a winning issue in 2018.  Read More

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Election Round Up: Medicaid Expansion is an Electoral Winner

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With the midterm elections now behind us, I thought it was time to revisit a prior blog post where I discussed the prospects of state Medicaid expansion ballot propositions in Idaho, Utah, and Nebraska. I had predicted that despite the conservative nature of these states, Medicaid expansion would have a good chance of passing due to the program’s popularity.

Indeed, voters in all three states endorsed Medicaid expansion. It received 60 percent support in Idaho and 53 percent in both Utah and Nebraska.

The latter two results were closer than what I was expecting.

In the case of Utah this may because a funding mechanism was explicitly included as part of the ballot proposal. Regardless, this means that roughly 300,000 people will be newly eligible for Medicaid. Not only do may patients stand to benefit, but this could be a huge boon for struggle rural and safety-net hospitals. Read More

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The Rotten U.S. Antiparasitic Drug Market

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Recently, there has been a lot of media attention on galling price hikes of generic drugs.

Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.

Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.

Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.

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Medicaid Expansion Goes to the Polls

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With the 2018 midterm elections fast approaching, there are key some voter propositions with important health implications.

Most notably, this November, voters in three conservative states — Idaho (Proposition 2), Utah (Proposition 3), and Nebraska (Initiative 427) — will be deciding on whether to expand Medicaid. In addition, voters in Montana will decide whether to permanently extend their state’s Medicaid expansion. This is coming at the heels of the closely watched November 2017 referendum where Mainers decisively supported Medicaid expansion 59 percent  to 41 percent.

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Step therapy explained: An increasingly popular tool for cost control

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News that the Centers for Medicare and Medicaid Services will allow Medicare Advantage programs to enact “step therapy” programs for drugs under Part B as part of an effort to combat rising drug prices has been making rounds in the health policy world recently.

Step therapy is used by all major private insurers and is aimed at curbing expenditures on expensive drugs. It requires that a patient to try a less expensive alternative treatment. Those who fail treatment with the less expensive drug would then be eligible for coverage of the more expensive treatment. Note that it is very similar to prior authorization, a ubiquitous policy tool in which a drug is approved for coverage only after ensuring certain clinical criteria are met.

What was once a relatively rare tool is now commonly used. I examined UnitedHealthcare’s list of step therapy drugs and there are now over 100 listings. This is an order of magnitude increase from the number of drugs listed just four years ago, when I first got interested in this issue.

Drugs listed for step therapy tend to be either new, extremely expensive therapies (e.g., 3rd-line biologics for rheumatoid arthritis, sofosbuvir for hepatitis C) or more expensive formulations of common drugs (e.g., extended release formulation of quetiapine).

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