CurrentHawaii Department of Human ServicesPolicy QI-1614

Direct Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection

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Policy governing coverage criteria and limitations for FDA‑approved direct acting antiviral medications to treat chronic hepatitis C among Medicaid Fee‑For‑Service and QUEST Integration members in Hawaii.

Policy Summary

PayerHawaii Department of Human Services

PolicyDirect Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection

Policy CodePolicy QI-1614

Change TypeRevised inclusion criteria (Metavir F1+ effective 2017-01-01)

Effective DateJan 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating patient meets inclusion criteria, including age ≥18, baseline HCV RNA within 3 months, and Metavir F1+ (effective 1/1/2017).

SourceLink

POLICY UPDATE CHANGES

Effective January 1, 2017, inclusion criteria expanded to patients with a Metavir fibrosis score of F1 or greater (previously F3 or greater).

18+minimum patient age (yrs)

F1+Metavir fibrosis required

Child‑Pugh ≤6compensated liver disease allowed

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CurrentHawaii Department of Human ServicesPolicy QI-1614

Direct Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection

Customize your policy alerts

Sign up for Hawaii Department of Human Services Policy QI-1614 alerts

Get alerted when Policy QI-1614 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerHawaii Department of Human Services

PolicyDirect Acting Antiviral (DAA) Medications for Treatment of Chronic Hepatitis C Infection

Policy CodePolicy QI-1614

Change TypeRevised inclusion criteria (Metavir F1+ effective 2017-01-01)

Effective DateJan 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating patient meets inclusion criteria, including age ≥18, baseline HCV RNA within 3 months, and Metavir F1+ (effective 1/1/2017).

SourceLink

POLICY UPDATE CHANGES

Effective January 1, 2017, inclusion criteria expanded to patients with a Metavir fibrosis score of F1 or greater (previously F3 or greater).

18+minimum patient age (yrs)

F1+Metavir fibrosis required

Child‑Pugh ≤6compensated liver disease allowed

Coverage Criteria for Direct Acting Antivirals

Initial treatment eligibility

Covered when ALL of the following are met:

Inclusion criteria: 1) Patient is at least 18 years of age (adults only).; 2) Treatment is in accordance with FDA‑approved treatment regimens.; 3) Patient has chronic HCV infection and a baseline quantitative HCV RNA result within the previous three months of the request for treatment.; 4) Patient meets at least one of the disease stage or special indication criteria (see child nodes).; 5) Medication is prescribed by, or in consultation with, a hepatologist, gastroenterologist, infectious disease specialist, or HIV specialist.; 6) No alcohol or other substance abuse within the three months prior to treatment as evidenced by history and urine toxicology screen.; 7) Prescribing physician attests that the patient is at low risk for non‑compliance.; 8) Patient demonstrates good compliance and agrees to: (a) 100% medication compliance; (b) regular follow up with specialty pharmacy, treating providers, and laboratory blood draws (e.g., HCV RNA levels) when ordered; (c) no active alcohol or substance abuse; (d) compliance with drug screening such as urine toxicology when ordered.; 9) Medical conditions that could impact adherence must be well controlled prior to initiating therapy.

See child nodes for item 4 specifics and exceptions.

Disease severity / special indications

For item 4, patient must have at least ONE of the following:

Disease stage or special indications: a) Metavir fibrosis score of F1 or greater (effective January 1, 2017). Prior to 1/1/2017 the requirement was F3+ or based on medical necessity.; b) Radiologic or clinical evidence of cirrhosis (e.g., portal hypertension, ascites, esophageal varices).; c) Extrahepatic manifestations of chronic HCV such as cryoglobulinemia.; d) Patient is a candidate for liver transplantation.; e) Patient has chronic HCV‑induced renal disease.; f) Patient with history of chronic HCV and HIV may be treated at any stage.; g) Healthcare worker with direct patient contact may be treated at any stage.; h) Women of childbearing age may be treated at any stage.

Any one of these permits treatment.

Coverage exclusions: DAA medications are not covered if the member has chronic decompensated liver disease (Child‑Pugh > 6) or hepatocellular carcinoma, unless the member is an active candidate for liver transplantation. These exclusions operate as absolute limitations — a request that meets any of these exclusion criteria should be denied unless documentation shows the patient is actively listed for or being evaluated as a transplant candidate.

Patients with a Child‑Pugh score > 6 (decompensated liver disease) who are not active candidates for liver transplantation are explicitly excluded from coverage. For operational review, prior authorization requests must include clear documentation of transplant candidacy to override this exclusion; absence of documentation that the patient is an active transplant candidate should result in noncoverage for DAA therapy.

Codes, Scores and Appendix

FDA-approved DAA therapies listed in Appendix Amixed

teleprevir (Incivek)	FDA Approval Date = May 2011
boceprevir (Victrelis)	FDA Approval Date = May 2011
simeprevir (Olysio)	FDA Approval Date = November 2013
sofosbuvir (Sovaldi)	FDA Approval Date = December 2013
sofosbuvir/ledipasvir (Harvoni)	FDA Approval Date = October 2014
simeprevir/sofosbuvir	FDA Approval Date = November 2014
ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekira Pak)	FDA Approval Date = December 2014
daclatasvir (Daklinza)	FDA Approval Date = July 2015
ombitasvir/paritaprevir (Technivie)	FDA Approval Date = July 2015
elbasvir/grazoprevir (Zepatier)	FDA Approval Date = January 2016

1–10 of 11

1/2

inv-06: Metavir fibrosis score — ≥ F1 (effective January 1, 2017)"

Metavir fibrosis score thresholdEffective January 1, 2017: Metavir fibrosis score of F1 or greater required for routine coverage (prior to 1/1/2017 the requirement was F3+ or medical necessity).

Applicability dateEffective date: January 1, 2017.

Prior policyBefore 1/1/2017, coverage required Metavir F3 or greater or demonstration of medical necessity.

inv-07: Child‑Pugh score — ≤ 6 (Class A) allowed; > 6 considered decompensated"

Operational thresholdChild‑Pugh score ≤ 6 (Class A) — compensated liver disease; patients with this score are eligible for treatment under the policy.

Decompensated definition

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required — demonstrate inclusion criteria are met

Prior authorization is required for DAA medications. The request must demonstrate the patient meets all inclusion criteria: patient is ≥18 years of age; treatment follows an FDA‑approved regimen; baseline quantitative HCV RNA within the previous three months; patient meets at least one disease criterion (e.g., Metavir fibrosis score F1+ effective 1/1/2017, radiologic/clinical cirrhosis, extrahepatic manifestations, transplant candidate, HCV‑related renal disease, HIV co‑infection, healthcare worker with patient contact, or woman of childbearing age); medication is prescribed by or in consultation with an approved specialist; no alcohol/substance abuse within prior 3 months as evidenced by history and urine toxicology; prescriber attestation that patient is low risk for non‑compliance; and patient agreement to comply with medication, follow up, and testing.

Inclusion criteria effective January 1, 2017 include Metavir fibrosis score of F1 or greater (prior to 1/1/2017 requirement was F3+ or medical necessity).
Baseline quantitative HCV RNA must be within the previous three months of the treatment request.
Prescriber must be a hepatologist, gastroenterologist, infectious disease specialist, or HIV specialist (or consult with one).
Treatment regimen must be consistent with FDA‑approved regimens; Appendix A lists FDA‑approved DAAs.

Background

Direct acting antivirals (DAAs) are oral, FDA‑approved agents that have transformed treatment of chronic hepatitis C virus (HCV) infection. Multiple DAAs became available between 2011 and 2016 and are used in regimen-specific combinations. Treatment decisions should consider fibrosis stage, cirrhosis status, co‑infections, transplant candidacy, and potential drug–drug interactions; the policy requires applicants to meet all inclusion criteria and notes specific disease‑stage exceptions and exclusions related to transplant candidacy.

Definitions

inv-13: Child‑Pugh Score — definition and operational thresholding"}]}[href=

What the Child‑Pugh score measuresComposite clinical score using encephalopathy, ascites, albumin, bilirubin, and prothrombin time/INR to classify severity of chronic liver disease.

Scoring interpretationCompensated liver disease: Child‑Pugh score ≤ 6 (Class A). Decompensated liver disease: Child‑Pugh score > 6 (Class B or C).

Operational use in policyUsed to determine eligibility: Class A (≤6) permitted for treatment; Class B/C (>6) considered decompensated and generally excluded unless transplant candidate.

Scoring components (per policy table)Encephalopathy, Ascites, Albumin (g/dL), Bilirubin (mg/dL), Prothrombin time/INR — each component scored 1–3 points and summed to yield total Child‑Pugh class.