Hepatitis C Treatment Restrictions In Spotlight After HHS Report
Executive Summary
Study finds one-third of insured adults have access to hepatitis C treatment within 360 days of the first positive test. CDC suggests treating all eligible patients without restrictions and eliminating preauthorization requirements. For state Medicaid programs, 38 states require prior authorization and 12 states have substance use restrictions.
The US Centers for Disease Control and Prevention called for unrestricted access to hepatitis C treatment in releasing a report that found approximately one-third of adults with private insurance and one quarter of Medicaid and Medicare recipients initiated treatment with a direct-acting antiviral (DAA) within 360 days of diagnosis.
The data on the low rates of treatment may help compel states to remove restrictions in Medicaid programs that limit access to hepatitis C drugs, including prior authorization, and restrictions based on disease severity and substance use.
The agency revealed the low treatment rates in a Morbidity and Mortality Weekly Report released 9 August. Using data from HealthVerity, an administrative claims and encounters database, CDC researchers constructed a cohort of 47,687 adults aged 18-69 years with HCV infection who were diagnosed from 30 January 2019 to 31 October 2020 and were continuously enrolled in insurance for at least 60 days before and at least 360 days after diagnosis.
They found that DAA treatment is lowest among young adults aged 18 to 29 and Medicaid recipients, and within Medicaid, among persons reporting as Black or another race and persons in states with treatment restrictions.
The CDC reported that the prevalence of DAA treatment initiation within 360 days of the first positive hepatitis C virus RNA test result among Medicaid, Medicare, and private insurance recipients was 23%, 28%, and 35% respectively. Among those who were treated, 75%, 77%, and 84%, respectively, initiated treatment within 180 days of diagnosis.
“Medicaid and Medicare recipients with hepatitis C were 46% and 38% less likely, respectively, to receive timely treatment compared with those with private insurance. Further, Medicaid recipients with diagnosed hepatitis C in states with Medicaid treatment restrictions were 23% less likely to receive timely treatment than were those living in states without restrictions,” the authors, led by William Thompson, state.
“Unrestricted access to timely DAA treatment is critical to reducing viral hepatitis-related mortality, disparities, and transmission,” they assert.
Asked for a response to the CDC's findings and recommendations, a Centers for Medicare & Medicaid Services spokesperson said, "With this new data on access to these medications in CMS programs, we will continue to review options to expand access to these treatments. CMS remains committed to continuing to improve access to necessary medications and to increase screening and treatment of hepatitis C."
The CDC study is one of two recent reports on use of hepatitis C treatment. The US Department of Health and Human Services' Office of Inspector General issued a report noting that the majority of Medicare Part D beneficiaries are receiving branded drugs rather than lower-cost authorized generics. (Also see "Hepatitis C Treatment: Most Medicare Beneficiaries Are Not Getting Authorized Generics" - Pink Sheet, 15 Aug, 2022.)
Gilead Is ‘Committed To Expanding Access’
The authors note that oral hepatitis treatment results in a cure in ≥95% of cases. They report that approximately 2.2 million civilian, noninstitutionalized adults had hepatitis virus infection in the US from January 2017 to March 2020. However, only an estimated 1.2 million persons initiated hepatitis C treatment with direct-acting antivirals in the US during 2014-2020.
They report that the number of persons treated was highest in 2015 and declined to its lowest level in 2020. Approximately 14,200 hepatitis C-related deaths were reported in the US in 2019.
The authors note that the initial cost for a course of oral treatment in 2014 exceeded $90,000, which resulted in many insurers establishing access restrictions. Since Gilead Sciences, Inc.’s Sovaldi (sofosbuvir) was approved by the US Food and Drug Administration in December 2013, several other DAAs have come on the market, including Gilead’s Harvoni (sofosbuvir/ledipasvir), Epclusa (sofosbuvir/velpatasvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and AbbVie Inc.’s Mavyret (glecaprevir/pibrentasvir). Drug costs have decreased with competition.
In response to a query about the report, Gilead said it remains “committed to expanding access to its medicines through efforts to address access gaps in the healthcare system.”
“Gilead continues to pursue solutions to address many challenges cited in the CDC report, including eligibility restrictions, prior authorization requirements, screening and linkage to care, and stigma surrounding HCV.”
Prior Authorization, Substance Use Restrictions
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said CDC’s report calls attention to the problem and the need to lift eligibility restrictions and preauthorization requirements. However, he said in an interview that restrictions are not the only issue. “There is not enough testing and awareness,” he said. “You need money for outreach and testing and linkage to care.”
Schmid questioned why it has been left to patient groups to sue states to get access to a curative drug. He said his group would like the federal government to work with the Centers for Medicare & Medicaid Services and states to remove restrictions.
Litigation has forced some states to change their policies. In one case, a group of Medicaid enrollees with chronic hepatitis C filed a class action suit against the Texas Health and Human Services Commission for restricting coverage of DAA treatment to those with severe liver damage. The parties reached a settlement in November 2021 and as a result of the suit, the Commission expanded access to DAAs to Medicaid enrollees diagnosed with HCV regardless of liver damage.
Disease severity is one of the categories of restrictions in state Medicaid programs. States have restricted access to treatment based on a patient’s fibrosis score, with a score of F3 or F4 indicating severe liver damage.
A recent report by the Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable noted that in 2014, when treatment restrictions were first tracked, at least 34 states (65%) imposed fibrosis requirements, requiring patients to be extremely ill before they could access treatment, and the other 18 states (35%) had unknown restrictions. As of June 2022, all but two states, Arkansas and South Dakota, have completely removed fibrosis restrictions. Arkansas requires a minimum fibrosis score of F3 and South Dakota requires a minimum score of F2.
The report, Hepatitis C: State of Medicaid Access, issued in June, tracks six categories of restrictions in state Medicaid programs. The other categories include prior authorization, substance use restrictions, prescriber restrictions, retreatment restrictions, and access in managed care.
Fourteen states have removed prior authorization for most patients while 38 states require prior authorization. Thirty-three states (64%) do not restrict access based on a patient’s drug or alcohol use. In seven states, the provider must address and/or counsel a patient regarding substance use prior to treatment and 12 states have substance use restriction prior to or during treatment, including abstinence and mandatory enrollment in a substance use treatment program.
As for prescribing, 40 states have no prescriber restrictions, while 12 require prescriptions by or in consultation with a specialist. Twenty-nine states have no restrictions on retreatment and 23 have restrictions. The report also tracked restrictions imposed by managed care organizations that contract with states to help administer benefits. It notes that as of 2019, about 70% of all Medicaid enrollees were enrolled in an MCO. The report says that 19 states have at least one MCO that imposes more severe restrictions than the state fee-for-service program, or at least one MCO that does not make its criteria public.
Private insurers have varying requirements. Blue Cross Blue Shield of Massachusetts covers Harvoni and Epclusa as their preferred treatment. A spokesperson said the insurer requires only confirmed diagnosis with genotyping and that the individual being treated be above the age of 3.
Younger Adults Less Likely To Get Treatment
The CDC report says DAA treatment initiation was lowest among adults aged 18-29 and 30-39 among both Medicaid and private insurance recipients, and that these are also the groups with the highest rates of HCV infection. In the 18-29 years group, 17% of Medicaid recipients and 23% of private insurance recipients initiated treatment within 360 days of receipt of a positive test. By comparison, the figures were 28% and 42%, respectively, among those aged 50-59 years.
Schmid noted that many young people are not going to doctors and getting tested and that they may be dealing with substance use. The Harvard report cited the American Association of the Study of Liver Diseases/Infectious Diseases Society of America guidance for HCV treatment, which says that injection drug use is the most common risk factor for HCV infection in the US and Europe, accounting for approximately 70% of new infections.
The CDC authors say their report has several limitations. First, they note that the HealthVerity Data might not be representative of DAA treatment patterns across the US because of the sample characteristics of the payors and providers for whom they process data.
In addition, they note that information on patients who are uninsured or incarcerated were not included and the data did not include those who received care through the Veterans Health Administration. Also, the analytic cohort only included people continuously enrolled for ≥60 days before and ≥360 days after the date of the positive HCV RNA test result, which likely overestimates treatment initiation among all those with infection.
The authors further note that ethnicity data were missing for 61%, and race data for 13% of the analytic cohort, which prevented examination of other potential treatment disparities. And they say that the data does not allow determination of whether absence of claims for treatment was the result of patient nonadherence, clinicians not prescribing DAAs, insurance providers not authorizing treatment, or prohibitive costs associated with copayments and deductibles.