By: Marcus J. Hopkins, Blogger
In our final HEAL Blog post of 2018, we will be continuing from last week our analysis of Hepatitis C (HCV) coverage in the United States. While this was originally designed to be Part 2 of a three-part series, the decision was made to cut this month short by whittling that down to just two posts for the month of December. As such, this final HEAL Blog will focus on the state of Medicaid coverage for HCV Direct Acting Antivirals (DAAs). Read Part 1, The State of Hepatitis C Coverage in America – Part 1: ADAP.
At the time of our inaugural report in January 2015, only 38 state Medicaid programs offered coverage for HCV DAAs. Even then, access to these treatments was severely limited by numerous onerous Prior Authorization pre-requisites, primarily those which required patients to suffer moderate-to-extreme liver decomposition and scarring – scores of F3 or F4 – before even being considered for treatment approval. Other pre-requisites include(d) sobriety requirements, drug use prohibitions, enrollment in recovery treatment programs, and numerous appeals.
In addition to these pre-requisites, both the states that ostensibly offered coverage and those that did not openly argued that made no bones about restricting or refusing coverage based on cost. So overt was their argument and pervasive the problem that the Centers for Medicare & Medicaid Services (CMS) issued a guidance letter to every state Medicaid program specifically stating that cost considerations “…should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections” (Center for Medicaid and CHIP Services, 2015).
With the CMS guidance was announced in November 2015, by August 2016, every state Medicaid program had expanded their coverage to include HCV DAAs. Since August 2016, every state has continued to offer coverage…again, ostensibly. Over time, several states have either reduced or eliminated the F-score requirements for treatment consideration, as well as removing other pre-requisites, the most recent of which was Oregon (this has not been officially announced, yet, so the citation is forthcoming).
As we have covered numerous times since Mavyret’s (AbbVie) August 2017 debut (including in last week’s HEAL Blog), the introduction of the drug at a remarkably lower Wholesale Acquisition Cost relative to other available DAAs allowed many programs to begin reducing or eliminating restrictions altogether. And, again, looking forward to the January 2019 release of Gilead’s authorized generic versions of their breakthrough drugs, Harvoni and Epclusa, the cost of HCV treatment continues to decline in part because of innovation, but mostly, because of AbbVie’s 2017 salvo with the lowest priced DAA on the market.
There are, however, newer DAAs in the pipeline. 2018 was the first year since 2013 in which a new HCV DAA was not released into the U.S. market. With prices demonstrably lower than the initially unconscionably high prices in 2013, it is unclear whether pharmaceutical companies will stay in the HCV game – Janssen, makers of the now-discontinued Olysio, the once-companion drug to Gilead’s Sovaldi – bowed out of game at the end of 2017, pulling Olysio from the shelves in May of this year. Companies that once assumed that their HCV drugs would enter into a highly competitive, high-priced market are coming up against incredibly popular and effective drugs that cost roughly 1/3 of the original DAAs. That difference in entry price does not bode well for newcomers or new drugs hoping to gain a foothold in the market.
The Community Access National Network will continue to monitor the state of HCV coverage in the U.S. Until next year, we wish you and yours the Happiest of Holidays and an even Happier New Year.
- Center for Medicaid and CHIP Services. (2015, November 05). ASSURING MEDICAID BENEFICIARIES ACCESS TO HEPATITIS C (HCV) DRUGS. Baltimore, MD: United States Department of Health and Human Services: Centers for Medicare and Medicaid Services: Center for Medicaid and CHIP Services: Medicaid Drug Rebate Program Notice. Retrieved from: https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/state-releases/state-rel-172.pdf
Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.