The Quiet Reconstruction of HCV Treatment Restrictions

The most recent iteration of the HIV/HCV Co-Infection Watch, Quarter 3, July 2026, has just been published. This publication remains a core tenet of CANN’s communications as it is a direct translation of the mission to define, promote, and improve access to healthcare services and support for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking. Analysis of the many subjects the Watch covers is not only pertinent to specific HIV and Hepatitis concerns but also informs a multifocal picture of healthcare access concerns with regard to systemic financial and legal characteristics.

This quarter, there have been formulary changes that not only present access challenges but also showcase the outcomes of state-level budgetary constraints and repercussions that are beginning to be seen as a result of HR1. The Georgia and Missouri ADAP formularies, for example, have undergone significant cuts. Georgia previously covered several HCV treatments; however, the entirety of Hepatitis C treatment coverage is on hold until further notice due to funding constraints. Missouri ADAP previously covered a few select HCV medications, but has now removed all non-HIV medications from its formulary. This eliminates all HCV treatments as well as other non-HIV medications whose access is essential for people living with HIV/HCV co-infection as well as other co-morbidities. Several other states have implemented omissions of some brand-name direct-acting antivirals (DAA) in favor of generics, whereas some have removed coverage of previously covered generics.

The trends in observed Medicaid formulary HCV coverage changes are also concerning. Fibrosis staging testing is making a return to some states as a requirement. Historically, some states restricted coverage to individuals with advanced liver disease, such as those with a score of F3 or F4. Requirements evolved to the point where all state Medicaid programs phased out advanced damage as a clinical requirement for coverage and the requirement for a fibrosis score.

This quarter’s research revealed that Missouri and Maryland have reintroduced fibrosis-scoring requirements. Presently, that equates to seven state Medicaid programs that now have fibrosis staging as a requirement for HCV treatment approval: Maryland, Massachusetts, Missouri, Montana, South Carolina, Washington, and West Virginia. There are no specific fibrosis stage requirements; only evidence of testing and a recorded score are required. Thus, early levels of disease still qualify individuals for treatment. In the same manner ADAP formularies have omitted previously covered HCV medications, Medicaid formularies are following suit. However, the changes are increasingly utilization management related. For example, Indiana and New Hampshire moved previously covered preferred drugs to non-preferred status. On their formularies, non-preferred status means drugs require step-therapy with a preferred medication before use is allowed. This is a barrier to accessing effective treatment when patients are subjected to the potential harms of medications that are not suited to their medical needs.

Federal funding for the Ryan White HIV/AIDS Program, from which ADAPs receive funds, has remained flat for a long time and has not been adjusted for inflation. Yet ADAP budgets have been strained by increasing enrollments, increasing drug prices, higher insurance premiums, and more. Many states have been dealing with Medicaid-related budget deficits for multiple fiscal years. The drastic Medicaid cuts, yet to be implemented as part of HR1, will only compound fiscal strain. The current trends in drug omissions and utilization management implementation will likely increase among ADAPs and Medicaid programs, which means patient access will continue to erode. When patients fall out of care, adverse health outcomes are the result, in addition to degraded public health and increased health expenditures.

Another notable revelation in this quarter’s research is that most of the charitable non-profit organizations with patient assistance programs to help patients obtain Hepatitis C treatments that the Watch had been following longitudinally are closed or waitlisted due to lack of funding. These are programs that were able to provide some relief for patients who did not qualify for other manufacturer assistance programs as recipients of Medicare and Medicaid. Moreover, the remaining open programs highlighted in the recent Watch iteration do not cover the costs associated with HCV monitoring and diagnostic tests. Uninsured people need financial support for things such as HCV RNA viral load and antibody tests. Even when assistance exists for obtaining medication, when there is no safety-net for monitoring support, treatment access still suffers.

The aforementioned discussion highlighted significant formulary and funding changes identified during the preparation of this quarter's Watch. However, we encourage you to review the entire publication for up-to-date information in all other sections, including Harm Reduction, Veterans Administration, and Latest News.