CurrentHawaii Department of Human ServicesPolicy QI-1614

Direct acting antiviral (DAA) medications for treatment of chronic hepatitis C infection

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Policy guidance on coverage criteria, limitations, and prescribing requirements for FDA‑approved direct acting antiviral medications used to treat chronic hepatitis C for Hawaii Medicaid (FFS and QUEST Integration) members.

Policy Summary

PayerHawaii Department of Human Services

PolicyDirect acting antiviral (DAA) medications for treatment of chronic hepatitis C infection

Policy CodePolicy QI-1614

Change TypeEligibility threshold lowered (fibrosis requirement reduced to Metavir F1+)

Effective DateJan 1, 2017

Next Review Date

Key ActionObtain prior authorization with documentation of age ≥18, baseline quantitative HCV RNA within 3 months, fibrosis assessment, and specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Effective January 1, 2017, inclusion criteria will include patients with a Metavir fibrosis score F1 or greater.

≥18Minimum patient age for treatment

F1+Minimum fibrosis score eligible

Child-Pugh >6Decompensated liver disease excluded

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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 TypeEligibility threshold lowered (fibrosis requirement reduced to Metavir F1+)

Effective DateJan 1, 2017

Next Review Date

Key ActionObtain prior authorization with documentation of age ≥18, baseline quantitative HCV RNA within 3 months, fibrosis assessment, and specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Effective January 1, 2017, inclusion criteria will include patients with a Metavir fibrosis score F1 or greater.

≥18Minimum patient age for treatment

F1+Minimum fibrosis score eligible

Child-Pugh >6Decompensated liver disease excluded

Coverage Criteria for DAA Therapy

Initial Therapy

Covered when ALL of the following are met:

Initial inclusion criteria: 1) Patient is at least 18 years of age; 2) Treatment is in accordance with FDA‑approved treatment regimens; 3) Patient has chronic HCV infection with a baseline quantitative HCV RNA result within the previous 3 months of the request for treatment; 4) Patient meets at least one of the disease-specific criteria (see children); 5) Medication is prescribed by, or in consultation with, a hepatologist, gastroenterologist, infectious disease specialist, or HIV specialist; 6) Patient has no alcohol or other substance abuse within the 3 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 monitoring (e.g., HCV RNA levels) when ordered; c) no active alcohol or substance abuse; d) compliance with drug screening when ordered; 9) Medical conditions that may impact adherence, including mental health conditions and substance abuse, must be well controlled prior to starting treatment.

See disease-specific inclusion for item 4

Disease-specific inclusion

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

Disease criteria: a) Metavir fibrosis score F1 or greater (effective January 1, 2017); 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) Chronic HCV‑induced renal disease; f) History of chronic HCV with 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 single item (a–h) satisfies the disease-specific inclusion criterion

The policy excludes members with chronic decompensated liver disease and those with hepatocellular carcinoma from coverage for direct‑acting antiviral therapy unless an exception applies. Specifically, chronic decompensated liver disease is defined as a Child‑Pugh score > 6, and both that condition and hepatocellular carcinoma are exclusions unless the patient is an active candidate for liver transplantation.

Treatment is not covered for patients who have decompensated liver disease (Child‑Pugh > 6) or hepatocellular carcinoma, unless the member is an active candidate for liver transplantation. Providers should confirm transplant candidacy documentation when requesting authorization for individuals with these diagnoses.

Coding and Clinical Thresholds

FDA‑approved DAA medications listed (Appendix A)NDC | mixed

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	Combination referenced 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

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inv-06: Child-Pugh score — > 6 (decompensated disease excluded unless transplant candidate)

Coverage restrictionDecompensated liver disease defined as Child-Pugh score > 6 is excluded from coverage unless the patient is an active candidate for liver transplantation.

Threshold value> 6 (Child-Pugh class B or C constitutes decompensated disease).

Action for transplant candidatesException to exclusion: coverage may be considered if the patient is an active liver transplant candidate.

Provider Required Actions and Authorization

Prior Authorization

Prior authorization required documenting FDA‑approved regimen and baseline HCV RNA

Prior authorization is required. The request must document that treatment follows FDA‑approved treatment regimens and that the patient meets inclusion criteria including age ≥18 and a baseline quantitative HCV RNA result within the previous three months. The prescriber must be or consult with a designated specialist (hepatologist, gastroenterologist, infectious disease specialist, or HIV specialist).

Patient is at least 18 years of age (current FDA approvals limited to adults).
Treatment is in accordance with FDA approved treatment regimens.
Baseline quantitative HCV RNA within the previous three months of request for treatment.
Medication prescribed by, or in consultation with, a hepatologist, gastroenterologist, infectious disease specialist, or HIV specialist.

Step Therapy

No explicit step therapy — specialist oversight and FDA regimens required

Background

Chronic hepatitis C management has evolved with multiple FDA‑approved direct acting antivirals; this policy directs prescribers to follow FDA‑approved regimens and the coverage criteria. Note that certain advanced liver conditions preclude coverage: decompensated liver disease (Child‑Pugh > 6) and hepatocellular carcinoma are exclusions unless the patient is an active liver transplant candidate, consistent with the policy limitations below.

Definitions

inv-12: Child-Pugh score — scoring system to classify severity of liver disease (encephalopathy, ascites, albumin, INR/PT, bilirubin)

PurposeScoring system to classify severity of liver disease and likelihood of survival (Child-Turcotte-Pugh).

ComponentsFive clinical/laboratory parameters: encephalopathy, ascites, serum albumin, prothrombin time/INR (or PT prolongation), and bilirubin.

Score categoriesChilds A (5–6 points, compensated), Childs B (7–9 points), Childs C (10–15 points).

Clinical interpretationCompensated liver disease: score ≤ 6 (Class A); decompensated liver disease: score > 6 (Class B or C).

inv-13: Metavir fibrosis score F1 — Metavir stage indicating at least mild fibrosis; effective 1/1/2017 policy covers patients with Metavir F1 or greater

Definition

Documentation Required

Required documentation to support authorization

Authorization requests must include documentation that the patient is ≥18 years old, a baseline quantitative HCV RNA within the previous three months, and disease staging such as Metavir fibrosis score (Fl or greater effective 1/1/2017) or other listed clinical criteria. Also document absence of recent substance abuse, specialist prescribing/consultation, clinician attestation of low risk for non‑compliance, and patient agreement to 100% medication compliance and required monitoring. Medical conditions affecting adherence must be well controlled prior to treatment.

Patient age documented as ≥18 years.
Baseline quantitative HCV RNA result within previous three months.
Metavir fibrosis score F1 or greater (effective 1/1/2017) or other disease criteria (cirrhosis, extrahepatic manifestations, transplant candidate, HCV‑induced renal disease, HIV coinfection, healthcare worker with direct patient contact, women of childbearing age).
Prescribing physician attestation that patient is low risk for non‑compliance.
Documentation of no alcohol or other substance abuse within prior three months (history and urine toxicology).
Patient agreement to 100% medication compliance, regular follow up and lab monitoring, and compliance with drug screening.
Medical conditions that may impact adherence must be well controlled prior to starting treatment.