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Watching the Dominoes of Restriction Begin to Fall

In recent years, the revolution in hepatitis C therapy engendered by interferon-free DAAs brought intense gratification, relief and hope for millions of patients and their health care providers. However, for a large class of patients, an initially unexpected byproduct of this revolution emerged in the form of restricted access to these therapies therapy on the basis of cost.

It is a deep rooted belief among HCV caregivers that every patient with hepatitis C deserves a chance for cure. The need to incorporate these existing restrictions, put into place by a number of governmental and commercial carriers and payers, into our discussions with patients has been an unwelcome component of care in this otherwise very exciting time.

This challenge was exacerbated by a very well-intended addition of AASLD Guidance documents in August 2015. In this iteration, the experts stated it was “most appropriate to treat those at greatest risk of disease complications before treating those with less advanced disease,” introducing the concept of prioritization by degree of hepatic fibrosis.

The basis for this was entirely understandable given the concerns about resources. Unfortunately, it served to further fuel the imposition of restrictions by carriers who could now quote clinical experts as supporting the concept of restriction of therapy to conserve resources and mitigate the challenges to existing budgets.

In 2016, the Guidance panel changed the language to remove the concept of prioritization, but it has remained difficult under some circumstances to access care for patients considered to need treatment.

In this context, patients and providers have been greatly cheered by recent developments, which have lifted the fibrosis-based restrictions in several states.

In New York State, for example, the state attorney general announced in late April 2016 an agreement with seven insurers to expand coverage for chronic hepatitis C treatment with the removal of restrictions based on disease severity.

Shortly thereafter, the New York State Medicaid Drug Utilization Review Board (DURB) recommended changes to the Medicaid Fee-For-Service (FFS) pharmacy prior authorization programs that were approved by the Commissioner of Health. Disease prognosis and severity were eliminated as clinical criteria for availability of DAA therapy.

In the same timeframe, announcements came in rapid succession from Washington Apple Health, approving coverage for all patients with chronic HCV infection regardless of fibrosis scoring; Delaware Medicaid, removing restrictions to curative therapy for hepatitis C, under threat of a federal class action lawsuit; and Florida Medicaid, announcing the removal of restrictions on coverage of DAAs. Most recently, Massachusetts announced its Medicaid system will follow suit and remove restrictions for HCV medications. In the Centers for Medicare & Medicaid Services announcement of the Massachusetts change, the organization expressed optimism that more states will follow this path and also called for manufacturers and pharmacy benefit managers to make treatment more affordable.

One can only hope that these actions will, like a cascade of falling dominoes, result in widespread or even universal removal of restrictions based on hepatic fibrosis across the country in short order.

The arguments in favor of removing degree of hepatic fibrosis as a criterion for treatment are familiar to all providers. These arguments include the risk forprogressive fibrosis in every patient with HCV, making it ultimately unpredictable to gauge precisely when a patient crosses the threshold of vulnerability to the risk for complications, especially hepatocellular carcinoma.

Additionally, we have increasingly come to understand HCV as an extrahepatic disease with impending morbidities, including a greater risk for diabetes, atherosclerosis and lymphoproliferative disorders. The public health advantages of viral eradication in terms of reduced risks for transmission are self-evident.

In sum, we now have increasingly enlightened changes in policy that are in tune with the extraordinary scientific and clinical advances made in this field.

With the approval of yet another important regimen, sofosbuvir/valpatasvir, on the day that this editorial is being written, and other regimens still to come, we can all rejoice at the increasing opportunities for clinicians to choose what they consider to be the optimal treatments for their patients. These recent developments in regards to access will continue to have ever more important practical ramifications.

– Ira M. Jacobson, MD
Co-Chief Medical Editor
HCV Next