PrEP4ALL Applauds The Updated USPSTF Grading Adding Long-Acting PrEP, But Demands Gov’t Action to Ensure Access
The U.S. Preventive Services Task Force (USPSTF) released its updated draft PrEP grading today adding long-acting Cabotegravir (CAB-LA), the every-other-month injectable PrEP medication to the A rating already given to daily oral PrEP in 2019, making it possible to get a new HIV prevention option to people who would rather take a shot 6 times a year than a daily pill. According to the rating, CAB-LA must be made available without cost-sharing to people with employer-based health coverage and ACA approved health plans. The draft recommendation will be open to public comment until January 17th.
The more options we have for people to prevent HIV, the better. Due to persisting stigma and misinformation around PrEP use, studies are showing the injectable may be a preferred method among cisgender women, Black and Brown gay and bisexual men.
But good medicine doesn’t work by itself. Like daily oral PrEP, it has to be administered through a healthcare system. And at present, we have several challenges ahead if CAB-LA can really be used by most people who would see it as a viable, preferred, or even as the only option they’re willing to accept.
The biggest issue with making CAB-LA more widely available has everything to do with how much it costs. At approximately $22,500USD for 6 shots annually, public health departments with PrEP access programs for the un- and under-insured will not be able to add it as an option for most people who want to use it. Furthermore with generic TDF/FTC now less than $30 for a 30-day supply, we are certain to see insurance companies continue to put up barriers to access, like prior authorization without a medical reason for needing CAB-LA over TDF/FTC. These FDA-approved generic TDF/FTC medications are excellent options for many potential PrEP users, but we do not want to repeat the same unnecessary delays in scale up for CAB-LA that we have seen for daily oral formulations. We have yet to even fulfill the promise of daily oral PrEP; in 2020 only 25% of the 1.2 million Americans most in need of PrEP had received a prescription. Among potential Black and Latinx PrEP users, only 9% and 16% had a prescription, respectively.
But there are other issues with the insurance market to cover PrEP meds and services. Despite the 2019 USPSTF ruling that gave an A grade to daily oral PrEP and the 2021 FAQ issued by Center for Medicare and Medicaid Services clarifying for payers that covering PrEP meant medications, visits and labs, PrEP4All to date has documented over 100 cases of people still being charged for labs, and other organizations nationwide have identified more individuals. This year the Senate got involved, led by Senator Merkley (D-OR) and called on AHIP to answer for its member insurers who continue to charge PrEP users, effectively breaking the law. With an injectable that is so much more expensive than generic daily oral PrEP, we are likely to see this continue.
So while PrEP4ALL welcomes this ruling, there is still no law or institution by which insurance companies can be held accountable to ensure those who want to take PrEP, in whatever form, will have access to it. The high price will also continue to make CAB-LA too expensive for public programs for un- and under-insured individuals. We have been working with many allies to hopefully have Congress fund a National PrEP Program, which would greatly expand access to even more people who want PrEP but are presently un- and/or under- insured, but until ViiV– the sole manufacturer of CAB-LA– and the US government negotiate a reasonable public health price, the intervention will likely remain out of reach through such an initiative.
While we celebrate this necessary step toward expanding PrEP options for all, we unfortunately have far to go for equitable access. In addition to a national PrEP Program and this USPSTF rating, we also need drug pricing reform on expensive medications, CMS should quickly update their guidance to include CAB-LA, and we desperately need mechanisms to hold insurance companies accountable for paying for those preventative services.