Prior Authorization : Preferred Drug List

Hepatitis C Agents

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Preferred drugs in the hepatitis C agents drug class do not require PA.

PA requests for non-preferred hepatitis C agents must be completed, signed, and dated by the prescriber. PA requests for hepatitis C agents should be submitted using the Prior Authorization Drug Attachment for Hepatitis C Agents form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescriber should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Hepatitis C Agents form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred hepatitis C agents may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Pharmacy Provider-Specific PA Requests for Hepatitis C Agents

PA requests for non-preferred hepatitis C agents are approved as pharmacy provider-specific. This approach is used to ensure continuity of care for members approved for treatment with these complex drug therapies. When a PA request is approved for drugs in this class, the pharmacy provider will be notified of the pharmacy provider-specific PA status via the decision notice letter. ForwardHealth recommends that the pharmacy provider inform the member of the pharmacy provider-specific PA requirement. The pharmacy provider should explain to the member that the drug therapy authorized must be dispensed by the pharmacy provider approved under the PA request.

Pharmacy providers should not submit PA requests for non-preferred hepatitis C agents if they do not intend to also dispense the entire drug therapy approved under the PA request to the member. If the member needs to discontinue receiving the drug from the approved pharmacy provider once the approved treatment has begun, the pharmacy provider is required to contact Provider Services. Provider Services will work with the pharmacy provider on the approved PA request to ensure the member does not experience a disruption of therapy, and if necessary, will facilitate the transfer of the PA to a new pharmacy provider.

Clinical Information That Must Be Documented on PA Requests for Hepatitis C Agents

A copy of the member's medical records that document the following must be submitted with the PA request:

• HCV assessment and treatment plan
• Current history and physical, including complete problem and medication list
• Lab tests (performed within the last six months) for:
  • Albumin
  • CBC
  • INR
  • Liver function panel
  • Serum creatinine
  • HCV-RNA level
• HCV genotype and subtype
• HCV clinical data and medication treatment history, including the following:
  • Likely source of the HCV infection and date diagnosed
  • Liver biopsy, imaging studies, or blood assay tests to determine hepatic fibrosis
  • History of previous hepatitis C drug therapy including medication name(s), dates taken, and treatment results (for example, null response, partial response, or relapse)
• If the member has cirrhosis, documentation of the following clinical assessments:
  • CTP class and score
  • HCC status based on an imaging study performed within the last six months
  • Presence or treatment of any of the following:
    • Ascites
    • Hepatic encephalopathy
    • Portal hypertension
    • HCC

If the required documentation is not submitted with the PA request, the PA request will be considered incomplete and will be returned to the provider, or it may be denied.

Clinical Criteria for Hepatitis C Agents

The requested non-preferred hepatitis C agent is being prescribed in a manner consistent with the FDA-approved product labeling.

Note: Only eight weeks of Harvoni treatment will be approved for treatment-naive members who have HCV genotype 1 infection without cirrhosis, have an HCV-RNA level less than 6 million IU/mL, and are HIV uninfected.

The clinical criteria for approval of a PA request for non-preferred hepatitis C drugs are all of the following:

• The member is unable to take the preferred hepatitis C agent drugs due to one of the following:
  • There is a clinically significant drug interaction with another drug the member is taking and the preferred drugs.
  • The member has a medical condition(s) that prevents the use of the preferred drugs.
• The member does not have a significant or uncontrolled concurrent disease that would significantly reduce their life expectancy or limit adherence (for example, cardiovascular disease, cancer, pulmonary disease).
• For PA requests for Sovaldi, Vosevi, or Zepatier, the member does not have cirrhosis with moderate liver functional compromise (that is, CTP class B).
• The member does not have cirrhosis with severe liver functional compromise (that is, CTP class C). Currently, there is no evidence to support that HCV treatment of members with end-stage liver disease impacts morbidity or mortality. The severity of liver damage present in decompensated liver disease makes it unlikely that treating the underlying infection would lead to meaningful liver function improvement. The only definitive treatment for end-stage liver disease is a liver transplant.

In addition to meeting all of the above clinical criteria and HCV treatment program requirements, Zepatier requests for members with HCV genotype 1a infection must be tested for the presence of NS5A resistance-associated polymorphisms.

For members who have received a liver transplant, ForwardHealth will consider the requested HCV treatment regimen based on the member's entire medical record. The level of clinical evidence for the requested HCV treatment regimen will be considered. If there is low clinical evidence of the treatment's effectiveness, the PA request will be denied.

For members who have received prior HCV treatment, ForwardHealth will consider the requested HCV treatment regimen based on the member's entire medical record in addition to the HCV treatment history and response (for example, null response, partial response, or relapse). The level of clinical evidence for the requested HCV treatment regimen will be considered. If there is low clinical evidence of the treatment's effectiveness, the PA request will be denied.