The availability of highly efficacious and tolerable all-oral direct acting antiviral (DAA) regimens for the treatment of chronic hepatitis C virus (HCV) infection in 2014 was met with a mix of joy and relief among both HCV providers and chronically infected patients. Finally we could do away with the low cure rates and toxicities associated with interferon-based therapy. The clinical benefits and cost-effectiveness of achieving a cure for chronic HCV with these agents provided a strong rationale for treating all chronically infected patients with DAA therapy.1 Consequently, the American Association for the Study of Liver Diseases and Infectious Diseases Society of America jointly developed national HCV treatment guidelines that recommended DAA treatment for all chronic HCV-infected patients. The ability to cure chronic HCV in nearly all infected people made the prospect of eliminating HCV in the US possible.2
However the high costs of DAAs led public and private insurers to restrict access to these medications.3 Soon after their release, DAAs were classified as “specialty” drugs and placed on the highest costsharing tier. Insurers established criteria for prescription approval, such as evidence of advanced liver fibrosis and consultation with a specialist. Many insurers required a specified period of abstinence from use of alcohol and illicit drugs, and some requested drug screening to confirm sobriety. State Medicaid programs were especially aggressive at rationing DAA therapies. Two reports in 2015 highlighted the restrictions on reimbursement of DAAs across these programs.4,5 One of these reviews found that 74 percent of Medicaid programs require evidence of advanced hepatic fibrosis or cirrhosis, 69 percent requested prescription by or consultation with a specialist and 50 percent required a period of abstinence from drugs and alcohol. No reviews have reported restrictions to DAA therapies among U.S. Medicare and commercial insurance beneficiariesAs a result of the varying restrictions imposed by insurers, obtaining approval for DAA prescriptions became labor-intensive. Insurers required that DAA prescriptions undergo prior authorization, a pre-approval process to determine if the patient meets insurer-specific criteria for HCV treatment. Providers now spend considerable time and effort to complete these prior authorization requests and face the possibility of insurer denials and the need for subsequent appeals. This onerous process has dissuaded many health-care providers from trying to obtain DAA treatment for chronic HCV-infected patients.6
Two recent studies have highlighted the current limitations in access to DAA therapy. One prospective cohort study determined the incidence of absolute denial of DAA prescription (defined as lack of approval of prescription fill by the insurer) by type of insurance (Medicaid, Medicare, commercial insurance) among chronic HCV-infected patients who had a DAA prescription submitted to a specialty pharmacy covering Delaware, Maryland, New Jersey and Pennsylvania between November 1, 2014 and April 30, 2015.7 Among 2,321 patients prescribed a DAA regimen, 16.2 percent were absolutely denied. The most common reasons for absolute denial were insufficient information to assess medical need (35.5 percent) and lack of medical necessity (35.0 percent). Notably, absolute denial was significantly more common among patients covered by Medicaid (46.3 percent) than by Medicare (5.0 percent) or commercial insurance (10.2 percent).
A separate cohort study evaluated the incidence and reasons for not starting Sofosbuvir-based treatment among chronic HCV-infected patients prescribed these regimens between December 2013 and September 2014 within Trio Health.8 Among 3,841 patients, 8 percent did not start the prescribed Sofosbuvir-containing regimen. Insurance-related processes and financial reasons accounted for 81 percent of the nonstarts. Consistent with the prior report, the incidence of non-start was higher among Medicaid beneficiaries (35 percent) compared to patients covered with Medicare (2 percent) or commercial insurance (6 percent). Although denials of DAA treatment hit Medicaid beneficiaries particularly hard, restrictions in access to these regimens also affected patients covered by Medicare and commercial health insurance. Through the first three quarters of 2015, 25 percent of Medicare beneficiaries and 39 percent of patients with commercial insurance sought DAA treatment access assistance through the Patient Advocate Foundation’s Hepatitis C Care Line.6 Further, after approval of the prescription, the copay may be too high to permit proceeding with treatment.9 Thus access to DAA treatment has also been challenging for patients covered by Medicare and commercial health insurance.
Denial of DAA treatment allows ongoing HCV-associated inflammation, which might increase the risk of extra-hepatic complications.
These limitations in access to DAA therapy have been frustrating for HCV providers. Patients denied access to new DAA therapies can have continued progression of hepatic fibrosis and remain at risk for the development of cirrhosis, end-stage liver disease and hepatocellular carcinoma. Denial of DAA treatment allows ongoing HCV-associated inflammation, which might increase the risk of extra-hepatic complications. Further, failure to treat and cure chronic HCV can lead to continued risk of HCV transmission. Finally, denial of DAA therapy can promote anxiety and stress about HCV disease progression and may provoke distrust among patients of the healthcare system and their HCV providers.
However the groundswell against the restrictions in DAA reimbursement and the lack of access to HCV treatment has been growing, and stakeholders have used the above evidence to galvanize support for increasing access to these regimens. Given the disparity in access to DAA therapies among Medicaid beneficiaries, the Centers for Medicare and Medicaid Services notified state Medicaid directors on November 5, 2015, that restricting access to DAAs based on cost containment violates federal law. This notification prompted class action lawsuits and threats of legal action against some state Medicaid programs. In February 2016, chronic HCV-infected patients in the state of Washington initiated a class-action lawsuit against the state’s Medicaid agency to expand access to DAA therapies after the agency rationed these therapies to only those with advanced hepatic fibrosis or cirrhosis. On May 27, 2016, the federal district court ordered that access to DAA treatment be provided without regard to the extent of liver fibrosis. In addition, in March 2016, attorneys notified Delaware Division of Medicaid and Medical Assistanceofficials that unless it immediately agreed to remove existing restrictions to DAA therapies from its Medicaid policy, Delaware would face a federal class action lawsuit. On, June 3, 2016, Delaware Medicaid issued a formal policy change stating that as of January 2018, DAAs will be approved for all chronic HCVinfected patients regardless of fibrosis stage. On September 19, 2016, the American Civil Liberties Union initiated a class-action lawsuit against Colorado’s Medicaid program, seeking a permanent injunction barring the state from denying access to DAAs.
Recently voluntary improvements in access to DAA therapy have occurred within a variety of settings. This February, the Department of Veterans Affairs, the nation’s largest integrated health-care system, agreed to cover DAA treatment without restrictions. In April New York State Drug Utilization Review Board voted to allow Medicaid recipients in fee-forservice plans to receive coverage for all DAAs regardless of hepatic fibrosis stage, and a few other states have followed suit.
Thus over the past several months, progress has been made in improving access to DAA therapies for chronic HCV. However major restrictions in access to these agents remain in place within many public and private health plans across the U.S. Researchers must provide additional data on the limitations in access to DAAs, confirm the cost effectiveness of HCV treatment for all patients and evaluate the outcomes of rationing policies on patient outcomes. Additionally, stakeholders must use this evidence to advocate for improved access to DAAs and solutions need to continue to be negotiated between insurers and pharmaceutical companies. These actions are necessary to achieve the goal of elimination of chronic HCV.
Lo Re has received grant support through UPenn from Astra Zeneca for a post-marketing study,
and serves on the board of directors of the International Society for Pharmacoepidemiology.
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