By: Ranier Simons, ADAP Blog Guest Contributor
Healthcare insurance policy and finance are not abstract entities relegated to the arenas of political debate and Wall Street discourse. The convoluted machinations of how money flows in healthcare insurance finance affect the bank account of anyone who has ever been prescribed a prescription drug. People living with HIV are very aware of the importance of understanding how insurance operates regarding paying for expensive antiretroviral medications that cost thousands of dollars per month.
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When choosing insurance plans, one of the most important aspects people living with HIV/AIDS (PLWHA) consider is how or if a particular plan covers their anti-retroviral (ARV) therapy. AIDS Drug Assistance Programs (ADAP) also pay close attention to drug coverage and drug pricing, given that they help provide medications to those who are uninsured as well as those who are underinsured. The Affordable Care Act (ACA) has enabled many PLWHA to access lifesaving medicines. However, the drug benefit design of many qualified health plans (QHP) participating in the ACA Marketplaces can hinder expeditious access to efficacious drugs.
A recent study examined how insurance benefit design affects antiretroviral access. The study focused on the changes in insurance coverage of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (dolutegravir/abacavir/lamivudine). These two drugs are first-line single-tablet regimens that have proven to be very effective. The U.S. Food & Drug Administration (FDA) approved Triumeq in 2014 and Biktarvy in 2018. Current treatment guidelines suggest that PLWHA start ART as soon as possible upon diagnosis, same day if possible. However, the study showed that access to novel treatments, such as Triumeq and Biktarvy, is slowed by delayed QHP coverage and benefit design.
|Photo Source: Rohan Khazanchi, MD, MPH | Twitter|
The study assessed individual and small-group QHPs’ responses to the two new regimens. For the years 2018-2020, researchers examined coverage, cost sharing, specialty tiering, prior authorization (PA), and out-of-pocket (OOP) costs for Triumeq and Biktarvy nationally under QHP’s. Coverage refers to if a plan does or does not offer a drug in its formulary. Cost sharing refers to copays and coinsurance for drugs. A copay is a set fee patients pay for a prescription, whereas coinsurance is a percentage of a drug’s wholesale cost. Specialty tiering is the designation insurance drug formularies give to medications based on their costs. The higher the tier, the more of the costs are passed onto the consumer. More expensive drugs, such as ART, are in the higher tiers. Prior authorization is the bureaucratic process requiring healthcare providers to get pre-approval from a health plan before a drug is prescribed for the patient to qualify for payment coverage.
For 2018, 2019, and 2020, respectively, the study identified 19,533, 17,007, and 21,547 QHPs. Overall, in 2018, 93% of the QHPs covered Triumeq, but only 60% covered Biktarvy. Triumeq coverage increased to 97% in 2019 and decreased to 91% in 2020. Biktarvy coverage decreased to 59% in 2019 but sharply increased to 86% in 2020. Concerning coinsurance, over the entire study period, a higher percentage of QHP’s required coinsurance for Biktarvy than Triumeq. The study also explicitly assessed coverage comparisons in EHE (Ending the HIV Epidemic Initiative) Phase I priority jurisdictions. Overall, across all three years studied, in both EHE and non-EHE jurisdictions, more QHPs covered Triumeq than Biktarvy. Interestingly, Biktarvy QHP coverage in 2020 was higher in EHE jurisdictions (90%) compared to non-EHE jurisdictions (85%). Biktarvy coverage in EHE jurisdictions increased from 74% in 2018 to 90% in 2020 due to increased coverage with coinsurance and copays. The study also found differences in prior authorization requirements. The prevalence of PA requirements for Triumeq was very low (2%, 2%, and 1% for 2018, 2019, and 2020, respectively). PA prevalence was higher for Biktarvy, with 5% in 2018 and 8% in 2019. In 2020 all QHP had eliminated Biktarvy PAs except for 18 plans in Washington State.
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A multi-center, phase 3, double-blind, randomized control clinical trial of treatment naïve PLWHA showed that Biktarvy had the efficacy of viral suppression equal to Triumeq.[2,3] Additionally, it showed that Biktarvy had no evidence of treatment-emergent resistance and was better tolerated gastrointestinal due to its formulation and smaller pill size. Moreover, Biktarvy does not contain abacavir and thus does not require HLA-B*5701 testing making it a good candidate for same-day ARV initiation.
Evidence-based data showed Biktarvy to be a better candidate for first-line drug treatment for many than Triumeq. Yet, as stated previously, QHPs lagged in coverage of Biktarvy compared to Triumeq, even in EHE priority-1 jurisdictions. There were higher OOP costs given that more QHP’s required coinsurance for Biktarvy, and PA requirements were also initially more frequent for Biktarvy.
The critical takeaway from the study is that QHPs can slow the adoption of new HIV single-pill regimens by non-coverage decisions and other hurdles that limit access. This does not stop at single-pill regimens. Ongoing HIV research continues to produce novel and innovative treatments such as Cabenuva and Sunlenca. Insurance companies base their coverage decisions mainly on the costs of the medications. Strident efforts are needed to create regulations to lower drug pricing. Additionally, cost-sharing measures need to evolve, such as basing patient coinsurance on post-PBM discounted drug prices instead of pre-discounted prices.
Increasing the pricing of novel and effective medication challenges ADAP’s ability to continue to help people. Additionally, prohibitive OOP costs for patients discourage medication adherence and treatment initiation. Many structural barriers to HIV treatment equality exist. Runaway pharmaceutical pricing and insurance drug coverage that is not scientifically evidence-based should not be amidst those barriers.
 Khazanchi, R., Powers, S., Killelea, A. et al. Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018–2020. J of Pharm Policy and Pract 16, 57 (2023). https://doi.org/10.1186/s40545-023-00559-8
 Acosta RK, Willkom M, Martin R, et al. Resistance analysis of Bictegravir–Emtricitabine–Tenofovir Alafenamide in HIV-1 treatment-naive patients through 48 weeks. Antimicrob Agents Chemother. 2019;63(5):e02533-18. https://doi.org/10.1128/AAC.02533-18
 Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825–32. https://doi.org/10.1097/QAD.0000000000002124
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.
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