CurrentHawaii Department of Human ServicesPolicy QI-1721 FFS 17-10

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

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Defines coverage criteria, limitations, and clinical considerations for Medicaid Fee-For-Service and QI health plans in Hawaii for use of FDA-approved direct-acting antiviral medications to treat chronic hepatitis C infection.

Policy Summary

PayerHawaii Department of Human Services

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

Policy CodePolicy QI-1721 FFS 17-10

Change TypeMemorandum (no material change)

Effective DateOct 4, 2017

Next Review Date

Key ActionObtain prior authorization demonstrating that all inclusion criteria are met and no exclusion criteria apply before initiating DAA therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13DAA therapies named in Appendix A

Child-Pugh >6Decompensated liver disease threshold

Per FDAPatient age requirement

AASLD

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CurrentHawaii Department of Human ServicesPolicy QI-1721 FFS 17-10

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-1721 FFS 17-10 alerts

Get alerted when Policy QI-1721 FFS 17-10 changes without checking for updates manually.

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Policy Summary

PayerHawaii Department of Human Services

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

Policy CodePolicy QI-1721 FFS 17-10

Change TypeMemorandum (no material change)

Effective DateOct 4, 2017

Next Review Date

Key ActionObtain prior authorization demonstrating that all inclusion criteria are met and no exclusion criteria apply before initiating DAA therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13DAA therapies named in Appendix A

Child-Pugh >6Decompensated liver disease threshold

Per FDAPatient age requirement

AASLD

Coverage Criteria for Direct-Acting Antivirals

Inclusion and exclusion criteria for DAA treatment

Treatment may be covered when ALL of the following inclusion criteria are met (subject to limitations/exclusions):

Inclusion Criteria: 1) Patient is of approved age as indicated by current FDA approvalsage per FDA approvals

Documentation should support patient age per current FDA approvals.

Exclusions (must NOT be present unless exception applies): 1) Chronic decompensated liver disease defined by Child-Pugh score > 6; 2) Hepatocellular carcinoma (except for patients who are active candidates for liver transplantation)Child-Pugh > 6

Requests may be denied if exclusion criteria are present; transplant candidates may be eligible.

The policy excludes patients with chronic decompensated liver disease defined by a Child-Pugh score > 6. Hepatocellular carcinoma is also listed as an exclusion. An exception to these exclusions exists for patients who are active candidates for liver transplantation, who may be eligible for DAA therapy despite a diagnosis of hepatocellular carcinoma.

Treatment with DAAs for patients who have decompensated liver disease (Child-Pugh score > 6) is generally not covered under this policy. Coverage may be considered only in specified exceptions (for example, when the patient is an active liver transplant candidate); documentation must demonstrate that an exception applies before prior authorization will be approved.

Coding and Classification

Child-Pugh classification

ClassificationClass A (compensated): score ≤ 6; Class B or C (decompensated): score > 6

Class A (points and prognosis)Childs A: 5–6 points; 10-year survival 80–90%

Class B (points and prognosis)Childs B: 7–9 points; 5-year survival 60–80%

Class C (points and prognosis)Childs C: 10–15 points; 2-year survival < 50%

Provider Requirements and Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. The request must demonstrate that all inclusion criteria are met and no exclusion criteria apply, and the proposed therapy must be consistent with FDA‑approved indications and the DAA regimens listed in Appendix A.

Step Therapy

No step‑therapy sequence specified

There is no specified step‑therapy sequence. Coverage determination is based on meeting the policy's inclusion and exclusion criteria and FDA‑approved indications.

Documentation Required

Required clinical documentation

Background and Clinical Context

Chronic hepatitis C treatment has evolved rapidly with multiple FDA-approved direct-acting antivirals available in recent years. Coverage decisions under this memorandum are driven by clinical eligibility and disease severity: patients are assessed using the Child-Pugh scoring system, which classifies liver disease severity (Class A: 5–6; Class B: 7–9; Class C: 10–15). The policy distinguishes compensated disease (Child-Pugh A, score ≤6) from decompensated disease (Child-Pugh B/C, score >6) and uses that distinction to determine exclusions and coverage exceptions.

Definitions and Scoring

Child-Pugh score — scoring system

Score componentsUses encephalopathy, ascites, serum albumin, prothrombin time/INR, and total bilirubin to calculate a numeric score

Encephalopathy scoring1 = None; 2 = Moderate; 3 = Severe

Ascites scoring1 = None; 2 = Mild; 3 = Moderate

Laboratory scoringAlbumin: 1 >3.5 g/dL; 2 = 2.8–3.5; 3 <2.8; Prothrombin time/INR prolongation: 1 <4 sec (or INR equivalent); 2 = 4–6; 3 >6; Bilirubin: disease-specific thresholds — generally 1–4, 4–10, >10 mg/dL (or <2, 1–3, >3 mg/dL for other diseases per table)