The US Department of Health and Human Services (HHS) has announced a plan to lower drug costs by importing prescription drugs intended for sale in foreign markets. They have outlined two potential pathways to accomplish this feat.
The first is their commitment to authorize pilot programs developed by states, wholesalers or pharmacists. These would need to be submitted for HHS review and outline how they would import certain drugs from Canada that are versions of existing FDA-approved drugs. In this scenario, the federal government is only providing permission in certain instances to import drugs from Canada, but they are not taking an active role in doing so.
In the second proposed pathway, the FDA will provide guidance to drug manufacturers who seek to import the drugs they sell in foreign countries. The drug manufacturers would essentially just create a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. The drug manufacturers already do something similar with US drugs and call it either an authorized generic or authorized product. The glaring question, however, is why would a manufacturer want to do this? It’s not clear if there will be any penalty or tax incentive or anything really that would encourage a drug manufacturer to compete with themselves in order to create a lower priced NDC of a drug it has been selling in the US for a high price.
HHS has said they are aware of the many operational challenges associated with each of these pathways, and they are actively working through them. They plan to formally announce these policies, with opportunity for public comment, in the coming months.
New HIV PrEP Drug Trial Shows Gender Bias
The FDA has raised concerns regarding the efficacy of Gilead’s Descovy for HIV pre-exposure prophylaxis (PrEP) in women. In a recent study called DISCOVER, Descovy was shown to be non-inferior to Truvada in patients at high risk of contracting HIV.
This study, however, only included transgender women and cisgender men who have sex with men. No cisgender women or adolescents were able to participate but Gilead argues that data from this study and prior clinical trials of Descovy and Truvada can be extrapolated to support its use in these groups.
In this day and age, it is hard to understand how a clinical trial intended to gain FDA approval for a drug can be designed to exclude all women. And then when questioned about this, a drug manufacturer suggests that the data should be extrapolated from other studies.
The FDA is not convinced it can extrapolate these assumptions for cisgender women and would like to see evidence that women could achieve high enough concentrations of the drug to actually prevent disease transmission.
Descovy is already approved for HIV treatment and Gilead has agreed to conduct post-marketing studies of Desovy for PrEP but this would occur after the drug was already on the market and being used for HIV pre-exposure prophylaxis.
SGLT2 Inhibitors Used for Diabetes May Treat Heart Failure
Farxiga and Jardiance have been associated with cardiovascular benefits for patients taking these drugs to treat type 2 diabetes. Now, AstraZeneca and Lilly/Boehringer Ingelheim, respectively, are seeking FDA approval for these drugs to treat heart failure in patients both with and without diabetes.
AstraZeneca has already reported positive results in their Farxiga heart failure clinical trial and Jardiance results are expected soon. If the FDA approves the new indication, these SGLT2 Inhibitors may gain market share in both the diabetes and cardiovascular markets. That means plan sponsors may see an increase in spend for these drugs in the near future, possibly even before the official FDA label changes.
This class of drugs, however, has had some challenges and it is not clear if cardiologists will actually start prescribing these drugs in full force. The concerns arise from the FDA’s 2017 black box warning that Invokana may increase the risk of leg and foot amputations. In 2018, the FDA added another warning that Invokana may be associated with Fournier’s Gangrene, a rare infection that occurs around the genitals of males and females that may become fatal. There are concerns that these side effects may be a class effect and it is possible that even with new FDA approved uses, physicians may be hesitant to start prescribing Farxiga or Jardiance.