HCV POLICY

The AAHIVM Institute for Hepatitis C focuses on policy issues that affect the care and treatment of HCV-infected individuals, and providers in the field.

This section contains a roundup of information about state and federal policy efforts, regulations, legislation, decisions, and debates that affect HCV care and treatment, and its coverage and delivery.

In addition, this section provides a summary of the work being done on these issues by AAHIVM and other stakeholder policy organizations, groups, and partners who are influencing the HCV issues.

POLICY ISSUES AND HCV

HIV & HCV Facts

Currently the CDC estimates that there are 56,000 new cases of HIV transmission in the United States each year. Although there is no cure available for HIV disease currently, new available drug treatment options have the ability to effectively manage HIV patients disease to a state that is virtually undetectable with side effects like those of many common chronic conditions.

Meanwhile, while the CDC estimates 12,000 deaths annually in the US from liver disease caused by hepatitis C. An estimated one-third of people with HIV in the U.S. are co-infected with HCV and liver disease is one of the leading causes of death in people with HIV.

If untreated, HCV can lead to cirrhosis, liver failure, carcinomas as well as autoimmune, and other conditions outside of the liver. End-stage liver disease from HCV co-infection is a leading cause of death among HIV-positive people in the U.S.

HCV Medical Care Providers

Medical providers from a diversity of specialties, including internal medicine, family medicine, oncology, and obstetrics-gynecology have played a key role in the medical response to HIV. In recognition of this, AAHIVM developed the first ever credentialing program to identify expert HIV clinicians. States such as California, have adopted the AAHIVM recommendations for identifying HIV experts.

HIV providers have been managing the care and treatment of HCV for both their co-infected patients and also mono-infected patients in many cases.

HIV providers have extensive experience managing complex antiretroviral drug regimens in a highly vulnerable patient population and delivering care as part of a team to support the high adherence rates critical to achieving viral suppression. A similar care model and clinical knowledge base is necessary to achieve success with the new HCV antiviral regimens.

In some areas and regions of the country, especially rural areas, the only accessible qualified provider available to treat an HCV-infected patient may be a HIV provider.

Access to HIV providers to treat HCV infection, and to serve as the overall coordinator of care or medical home, is a critical issue for HCV-infected patients.

HCV Treatment

Prior to 2014, former treatment protocols of HCV infection included 24 to 48 weekly injections of pegylated interferon and twice-daily ribavirin pills. This treatment often carries significant side effects and offer only about 55% cure rates to patients.

In 2014, a newly approved drug offered hope of a total cure for HCV patients. The introduction of sofosbuvir (Solvaldi) represents a breakthrough treatment opportunity to cure hepatitis C without the use of interferon-based regimens. In clinical trials, cure rates for those using sofosbuvir were as high as 95 percent with 12 weeks of oral medication. However, the introductory market price for sofosbuvir has created significant challenges for access to the medication.

Insurance companies, and government payers (Medicaid, Medicare, and Ryan White) are facing challenges in determining coverage and availability of the drug.

Additionally, some coverage programs have established restrictions to the prescription or coverage of the drug in response to this challenge.

Below is a list of some of the treatment restrictions on sofosbuvir that have been put into place by private insurers and government payers:

  • Required drug testing to determine abstinence from alcohol or substance abuse.
  • Prescription availability for only patients at a certain (advanced) stage of liver disease.
  • Restriction of prescription ability to only certain types of medical providers.

LATEST AAHIVM POLICY WORK ON HCV

AAHIVM Letter to New York Drug Utilization Review Board
In response to a report that the New York Medicaid Drug Utilization Review Board had proposed new restrictions to prescription and coverage of sofosbuvir, AAHIVM submitted the following comments.


AAHIVM & HIVMA Speak out on Prescriber Restrictions Issue

In response to a growing trend by some private insurance companies in several states to restrict the prescription of new HCV  treatments to only certain types of providers, AAHIVM & HIVMA issued the following press statement.


AAHIVM & HIVMA Joint Letter to Gateway Health (Pennsylvania)

In response to a report that a private insurance company had issued restrictions to prescriptions by certain types of providers, AAHIVM & HIVMA wrote the following letter, addressing the issue.


AAHIVM & HIVMA Joint Letter to United Health Care (New Jersey) 

In response to a report that a private insurance company had issued restrictions to prescriptions by certain types of providers, AAHIVM & HIVMA wrote the following letter, addressing the issue.


AAHIVM & HIVMA Joint Letter to Horizon Health (New Jersey)

In response to a report that a private insurance company had issued restrictions to prescriptions by certain types of providers, AAHIVM & HIVMA wrote the following letter, addressing the issue.