HIV PrEP insurance/drug co shenanigans

 One does not have to dig too far to find examples of drug company or insurance company shenanigans. A recent article documented a lack of access to HIV preexposure prophylaxis (PrEP) for large numbers of people, a significant public health issue (see HIV PrEP shenanigans JAMA2023 in dropbox or doi:10.1001/jamanetworkopen.2023.42781). Thanks to Jen Brody for bringing this to my attention  

  

Details:  

-- the goal of this study was to assess qualified health plan (QHP) coverage of PrEP formulations 

    -- QHPs are health insurance plans that are certified by the Affordable Care Act (ACA, also referred to as Obamacare) 

    -- there are two PrEP formulations on the market, an older one TDF/FTC, and a newer one TAF/FTC (see the commentary below for more information on these two products) 

-- this was a cross-sectional study analyzing QHPs in the US from 2018 to 2020, prior authorization (PA) requirements for the medications, insurance company tiering of these two PrEP medications, as well as whether the jurisdictions adopted the CDC initiative of Ending the HIV Epidemic (EHE) initiative (see commentary below for more information on EHE) 

  

-- Main outcome and measures: annual variation in QHP coverage and PA requirements for TDF/FTC and TAF/FTC  

-- secondary outcome: whether the PrEP formulation was determined by the QHP to be placed on a specialty drug tier 

  

Results:  

-- 58,087 QHPs were analyzed (roughly 20,000 for each year) 

-- TDF/FTC was covered as follows: 

    -- 2018: 98.1% of QHPs 

    -- 2019: 99.8% of QHPs 

    -- 2020: 98.1% of QHPs 

-- TAF/FTC was covered as follows: 

    -- 2018: 91.8% of QHPs 

    -- 2019: 92.7% of QHPs 

    -- 2020: 87.4% of QHPs 

-- ie, TDF/FTC had more coverage, though both were largely covered 

  

-- QHPs requiring exclusive Prior Authorizations for PrEP formulations, by regions of the country:  

    -- Northeast:  

        -- TDF/FTC: 0.8% in 2018 to 8.1% in 2020 

        -- TAF/FTC: none 

    -- Midwest:  

        -- TDF/FTC: 12.3% in 2018 to 39.6% in 2020 

        -- TAF/FTC: 0.6% in 2018 to 0.1% in 2020 

    -- South: 

        -- TDF/FTC: 10.0% in 2018 to 46.8% in 2020 

        -- TAF/FTC: none 

    -- West:  

        -- TDF/FTC: 7.6% in 2018 to 8.8% in 2020 

        -- TAF/FTC: 0% in 2018 to 0.2% in 2020 

    -- ie,  TDF/FTC required much more Prior Authorizations, and this increased over time 

-- Specialty tiering by region of the US from 2018 to 2020, as well as whether jurisdictions adopted the CDC's Ending the HIV Epidemic (EHE) initiative: 

    -- Northeast: 

        -- TDF/FTC: 6.1% in 2018 to 18.4% in 2020 

        -- TAF/FTC: 7.1%  in 2018 to 11.0% in 2020 

    -- Midwest: 

        -- TDF/FTC: 33.7% in 2018 to 36.8% in 2020 

         -- TAF/FTC: 29.7% in 2018 to 33.4% in 2020 

    -- South: 

        -- TDF/FTC: 9.3% in 2018 to 10.2% in 2020 

        -- TAF/FTC: 5.7% in 2018 to 6.2% in 2020 

    -- West: 

        -- TDF/FTC: 20.5% in 2018 to 25.5% in 2020 

        -- TAF/FTC: 22.6% in 2018 to 22.5% in 2020 

    -- National EHE jurisdiction vs not: 

            -- TDF/FTC: EHE vs non-EHE jurisdiction: 6.4% versus 20% in 2018, 9.3% versus 25.5% in 2020 

            -- TAF/FTC: EHE vs non-EHE: 5.5% versus 18% in 2018, 6.2% versus 21.2% in 2020 

    -- ie, increased tiering of both over time, most dramatically for TDF/FTC in the Northeast; jurisdictions that were part of the CDC initiative to End the HIV Epidemic had  1/3 of the specialty drug tiering 

  

Commentary: 

-- PrEP has been embraced in much of the world for over 2 decades in order to decrease HIV transmission, and was approved by the FDA in 2012 

-- PrEP has been shown in several studies to reduce HIV acquisition by  99% for sexual encounters, as well as 74% for injection drug use 

-- PrEP is considered an important arm in the fight to Ending the HIV Epidemic (EHE) in the US (the goal being no new cases by 2030). EHE had a focus on 50 local areas that account for more than half of new HIV diagnoses and 7 states with a substantial rural burden: https://www.cdc.gov/endhiv/jurisdictions.html 

-- though the use of PrEP has increased from 13% of the 1.2 million people wo could benefit from it to 30% in 2021, these numbers are woefully low for preventing this life-changing infection. and there are pretty huge demographic differences/inequities in its use: https://gmodestmedblogs.blogspot.com/2018/10/prep-mostly-given-to-white-men-and.html 

-- the initial medication used for PrEP was emtricitabine/tenofovir disoproxil fumarate (TDF/FTC, initially marketed as Truvada, but is now generic and called emtricitabine-tenofovir) 

-- emtricitabine/tenofovir alafenamide (TAF/FTC, marketed as Descovy, not available as generic) is a new generation of a better tolerated drug that has fewer adverse effects on bone and kidneys 

    -- TAF/FTC has had only limited testing: only men and transgender women who have sex with men are recommended to get this new medication (ie: no females having vaginal sex, or those who inject drugs; these groups were not studied) 

    -- both of these drugs were developed by Gilead pharmaceuticals, and there were quite remarkable drug company shenanigans (which, as per usual, were deliberately designed to enhance their already remarkably large profit margins): https://gmodestmedblogs.blogspot.com/2023/08/a-couple-more-drug-company-shenanigans.html , as well as a blog written by Jon Pincus which adds more information and his perspective: https://gmodestmedblogs.blogspot.com/2019/10/prep-another-blog-here-is-another-blog.html. in brief, Gilead intentionally delayed releasing TAF/FTC (the safer drug) for more than a decade until their patent on TDF/FTC expired, though vociferously denied this charge, per the investigative reporting in the NY Times 

   -- TAF/FTC is also associated with weight gain (on the order of 1.8-4.5 kg/yr: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8035674/ ), as well as changes in lipids, which on switching from TAF to TDF, was associated with an LDL decrease of 12.4%, but also in HDL decrease of 8.2% , so with not much change in the meaningful total cholesterol to HDL ratio: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8753026/ 

 

-- this study reported that QHPs were more likely to cover FTC/TAF and also more likely to require PAs for FTC/TDF or place it on a specialty tier. This may seem counterintuitive, but a few points: 

    -- the higher PA requirements for FTC/TDF (versus FTC/TAF) will have a disproportionate effect on cisgender women, transgender men and injection drug users, where FTC/TDF is not approved for PrEP 

    -- the pharmaceutical company (Gilead) is offering rebates for FTC/TAF, with both clinician and direct consumer advertising, likely to undercut prescriptions for generic FTC/TDF, which brings up a couple of issues: 

        -- once people are on a certain medication and tolerate it, they are at a higher probability of continuing that medication even if the price increases after the rebate system ends 

        -- and it is likely that actual access to these rebates is different if one lives in rural Mississippi vs Boston 

-- it is also notable that those areas that are involved with the EHE initiative coincided with much less specialty tiering (ie, the public health jurisdictions chosen for EHE got additional funding and systems for PrEP) 

-- PrEP coverage in the South is highly problematic because of its high HIV burden and poorest medication coverage (there tends to be less stringent QHP oversight from state departments over insurance regulators); for example, in 2020 there were no PAs required for TAF/FTC but almost ½ of the prescriptions for TDF/FTC needed PAs 

  

-- in addition, insurance companies/pharmacy benefit managers have their ways of decreasing the use of expensive medications such as these: either by establishing prior authorizations (PAs) from healthcare providers as noted above, or developing special tiering where the medication is placed on a high cost-sharing tier or as specialty drugs which further increases the patients' copay and requires special pharmacies. 

    -- establishing the need for PAs is a significant obstacle for busy clinicians, since it involves paperwork and perhaps phone calls to make sure the meds are approved (which is really weird: the CDC and international public health agencies clearly define who is at risk, and actually sharing this information to the pharmacies/etc is an unnecessary violation of patient privacy) 

    -- increasing the co-pays by elevating the tier for cost sharing leads to some patients not being able to afford these expensive copays 

        -- the most extreme tiering is “specialty tiering” (Tier 4 or 5), typically for expensive specialty drugs that are usually used to treat serious illness (eg cancer, multiple sclerosis), and, per, Blue Cross, requires a copay of 45-50% if tier 4 and 25-33% if tier 5: https://www.bcbsm.com/medicare/help/using-your-plan/drug-tiers/#:~:text=Tier%205%3A%20Specialty%20drugs,for%20drugs%20in%20this%20tier. 

            -- In general, tiering is supposed to reflect either extremely expensive medications or medications that are used infrequently. Neither of these factors apply to the above medications. In fact tiering for PrEP drugs, as noted above, is used for even the generic formulation TDF/FTC (which is roughly 60 times cheaper than non-generic FTC/TAF!!!) 

-- prior research by this same research group during the time when only TDF/FTC was available found regional disparities in PA requirements, where PAs were required 16 times as often in the South versus the Northeast 

  

Limitations: 

-- this article only addresses what is happening in the qualified health plans, and QHPs only apply to roughly 11 million Americans 

    -- so, these results may not apply to the vast majority of insured Americans having other systems of care 

    -- and, an increasing number of Americans have no health insurance and very limited access to the healthcare system. And many live in areas with very high HIV rates 

So, as has been suggested by others, the issue of PrEP  availability reconfigures the concept of social determinants of health to being commercial determinants of health, with profit being the motive for the pharmaceutical and health insurance companies. A few points: 

-- PrEP is an important component in the goal of eliminating HIV; it is embraced by the public health community as such, here and abroad 

    -- though the numbers of new HIV cases, per the CDC, has decreased 12% from 2017 (36,500 cases) to 2021 (32,100 cases), this is still a huge number for a disease that is largely preventable through PrEP  

-- as we know, though the medications for HIV disease are significantly more potent and tolerable, the goal for HIV is prevention instead of lifelong treatment, which leads to more medicalization of patients, dramatic differences in their quality of life and relationships with others,  and significant decreases in the quantity of their life 

    -- a recent analysis of over 200,000 people with HIV estimated that 40 yo woman with HIV who started HIV therapy after 2015 had a 39 year life expectancy, and a 40-year-old man had 37 years (if therapy was started before 2015, these numbers would be 3 to 5 years lower): https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(23)00028-0/fulltext 

-- and, for the health care system as a whole, treatment of patients with known HIV infection is in fact extraordinarily expensive 

    -- still, many HIV patients are unaware of their disease until it is quite advanced, further impairing their lives and adding to the health care costs 

 

-- these shenanigans leading to decreased access of PrEP, both by the pharmaceutical industry as well as the health insurance industry through their pharmacy benefit managers, run directly counter to the real public health imperative 

    -- their pushing for the TAF/FTC combination is really unconscionable: this further marginalizes cisgender women, transgender men with vaginal intercourse, and those with injecting drug use for whom TAF/FTC is not recommended 

    -- and it dramatically increases the drug company profits, at the expense of a huge sector of the population who might be exposed to HIV infection 

-- unfortunately, as per usual, those who are the poorest and most marginalized have the least access to state-of-the-art care. And, for the >50% of Black individuals who live in the South, there are clear disparities in HIV acquisition (1 in 27 Black men have a lifetime risk of acquiring HIV versus 1 in 171 white men; and even higher disparities for women: 1 in 75 Black women versus 1 in 874 white women) 

-- and, as with many issues in the US, the clear public health imperative here is undercut by the financial and political clout of these major healthcare players. This fundamental structural issue needs to be addressed aggressively for both PrEP as well as many other very important public health issues.  we also know from the EHE initiative that governmental/public health intervention and funding can really decrease these health care inequities!!!  

 

geoff

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