CurrentAlaska MedicaidPolicy N/A

Clinical Criteria for Use - Hepatitis C Direct-Acting Antiviral Agents

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Clinical criteria governing Alaska Medicaid coverage and preferred-product selection for hepatitis C direct-acting antiviral agents; affects prescribers, pharmacists, and Alaska Medicaid members.

Policy Summary

PayerAlaska Medicaid

PolicyClinical Criteria for Use - Hepatitis C Direct-Acting Antiviral Agents

Policy CodePolicy N/A

Change TypePreferred-product designation and criteria update

Effective DateOct 1, 2017

Last ReviewSep 15, 2017

Next Review DateN/A

Key ActionObtain prior authorization and include a patient readiness assessment with signed attestation when requesting the preferred agent.

SourceLink

POLICY UPDATE CHANGES

Selection of a preferred product (Mavyret™ glecaprevir/pibrentasvir) and associated clinical criteria effective October 1, 2017.

Patients with Metavir F0-F1 may be approved for treatment with the preferred agent if other approval criteria are met.

Treatment durations specified for common subpopulations (e.g., 8 weeks for many non-cirrhotic treatment-naïve patients; 12 weeks for most cirrhotic treatment-naïve; 16 weeks for genotype 3 previously treated with peg-interferon + ribavirin).

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CurrentAlaska MedicaidPolicy N/A

Clinical Criteria for Use - Hepatitis C Direct-Acting Antiviral Agents

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Sign up for all Alaska Medicaid policy alerts

Know when Alaska Medicaid releases new policies or updates existing guidance.

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Clinical criteria governing Alaska Medicaid coverage and preferred-product selection for hepatitis C direct-acting antiviral agents; affects prescribers, pharmacists, and Alaska Medicaid members.

Policy Summary

PayerAlaska Medicaid

PolicyClinical Criteria for Use - Hepatitis C Direct-Acting Antiviral Agents

Policy CodePolicy N/A

Change TypePreferred-product designation and criteria update

Effective DateOct 1, 2017

Last ReviewSep 15, 2017

Next Review DateN/A

Key ActionObtain prior authorization and include a patient readiness assessment with signed attestation when requesting the preferred agent.

SourceLink

POLICY UPDATE CHANGES

Selection of a preferred product (Mavyret™ glecaprevir/pibrentasvir) and associated clinical criteria effective October 1, 2017.

Patients with Metavir F0-F1 may be approved for treatment with the preferred agent if other approval criteria are met.

Mavyret™Preferred DAA

8 weeksCommon non-cirrhotic duration

7,500-10,000Alaska HCV carriers

$40-50M6‑month cost (preferred)

$100M+6‑month cost (other DAA)

Coverage Criteria for Hepatitis C DAA Agents

Initial therapy

Covered when ALL of the following are met (new criteria effective Oct 1, 2017):

Core approval requirements

Fibrosis staging allowance: Patients with Metavir fibrosis score F0-F1 are eligible for approval with the preferred agent provided all other approval criteria are met.
During the Oct 1–Oct 31, 2017 transition overlap, prescribers may use either the prior (July 1, 2016) or new (Oct 1, 2017) criteria for patients with Metavir F2–F4; on Nov 1, 2017 the new criteria apply to all fibrosis stages.

Age-specific coverage: For patients aged 12–17, Alaska Medicaid will authorize a direct-acting antiviral that is FDA-approved for that age range if Mavyret™ is not FDA‑approved for the patient’s age at the time of request.

Prescribers should use the DAA product with the FDA-approved indication for the patient’s age.

Alternate agent authorization: If there is an absolute contraindication to the preferred agent (Mavyret™), prescribers may request authorization for an alternate FDA‑approved DAA with the labeled indication for that patient.

Refer to the criteria and FDA-approved package insert for specifics about alternate agents and labeled indications; prescribers may request alternates per the criteria.

Patients with a Metavir fibrosis score of F0–F1 are eligible for approval with the preferred agent when all other approval criteria are met. Those other criteria include completion of a documented patient readiness assessment and a signed patient attestation in which the patient agrees to complete the prescribed treatment course and acknowledges the risks of reinfection and contributors to liver damage. Prescribers should refer to the full criteria for genotype- and history-specific treatment durations and are encouraged to refer patients with substance‑use or other readiness concerns to the Alaska Medicaid Coordinated Care Initiative (AMCCI) for assistance.

The policy does not offer unrestricted coverage of all therapeutically equivalent direct‑acting antivirals because Alaska Medicaid lacks sufficient spending authority to absorb the high upfront reimbursement costs of alternative agents. Without prioritization, treating broadly with higher‑priced products would jeopardize the program’s ability to reimburse for other medically necessary pharmacy services. For this reason, Alaska Medicaid designates a preferred product (Mavyret™) and prioritizes its use; alternate FDA‑approved DAAs may be authorized only when there is an absolute contraindication to the preferred agent or when criteria otherwise permit.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required per Alaska Medicaid clinical criteria

Alaska Medicaid requires prior authorization for hepatitis C direct-acting antivirals per the published clinical criteria; the prescriber must follow the new criteria effective October 1, 2017 and select the preferred product (Mavyret) unless there is an absolute contraindication, in which case an alternate FDA‑approved DAA may be requested for authorization.

Authorization requests must demonstrate the patient meets Alaska Medicaid clinical criteria in effect for the date of request.
If there is an absolute contraindication to Mavyret, prescribers may request authorization for an alternate FDA‑approved DAA with the labeled indication for the patient (see criteria page 3).

Step Therapy

Preferred-agent prioritization: Mavyret as first-line

Alaska Medicaid designates Mavyret (glecaprevir/pibrentasvir) as the preferred first-line DAA based on efficacy, safety, cost-effectiveness, and program financial considerations; prescribers should select Mavyret unless contraindicated.

Clinical and Policy Background

Chronic hepatitis C infection contributes to long‑term morbidity in a subset of affected individuals and, at the population level, sustained treatment can reduce overall viral prevalence. Alaska Medicaid’s selection of a pangenotypic preferred agent (Mavyret™) was informed by clinical efficacy and safety, cost‑effectiveness, and pharmacy reimbursement projections from a population‑health model. Program financial constraints and concerns about preserving the ability to pay for other medically necessary medications were central to the decision to prioritize a lower‑cost, effective DAA for broad use under the clinical criteria.

Key Definitions

SVR12 — definition entry

Termsustained virologic response at 12 weeks (SVR12)

DefinitionNo detectable virus in the blood 12 weeks after finishing treatment.

PurposeUsed to evaluate treatment success of hepatitis C direct‑acting antiviral therapy.

TimingAssessed at 12 weeks post‑treatment completion; a durable indicator commonly reported in clinical guidelines and trials.

Clinical significanceAchieving SVR12 is associated with cure of HCV infection and reduced long‑term liver morbidity.

Policy Summary

PayerAlaska Medicaid

PolicyClinical Criteria for Use - Hepatitis C Direct-Acting Antiviral Agents

Policy CodePolicy N/A

Change TypePreferred-product designation and criteria update

Effective DateOct 1, 2017

Last ReviewSep 15, 2017

Next Review DateN/A

Key ActionObtain prior authorization and include a patient readiness assessment with signed attestation when requesting the preferred agent.

SourceLink

On This Page

Mavyret chosen after DUR Committee review of efficacy, safety, reimbursement projections, and cost-effectiveness.
If Mavyret is contraindicated, prescribers may request an alternate FDA‑approved DAA for authorization.

Documentation Required

Required documentation: signed attestation and readiness assessment

Prescribers must collect and submit a signed patient attestation and documentation of a patient readiness assessment showing the patient agrees to complete therapy and understands reinfection and liver-damage risks; include referrals to AMCCI when readiness concerns exist.

Signed patient attestation affirming agreement to complete the treatment course and understanding of reinfection and contributors to liver damage.
Documentation of a patient readiness assessment addressing adherence and any substance-use or psychosocial barriers.
If appropriate, documentation of referral to the Alaska Medicaid Coordinated Care Initiative (AMCCI) or evidence the member was given AMCCI contact information.

Documentation Required

Transition-period documentation for Oct 1–Oct 31, 2017

For prescriptions written during the Oct 1–Oct 31, 2017 overlap, document which criteria set was applied for the patient: F0–F1 patients qualify under the new Oct 1 criteria; F2–F4 patients may use either the previous (July 1, 2016) or new (Oct 1, 2017) criteria—record which was used.

If Metavir F0–F1 and treatment occurs Oct 1–Oct 31, 2017, indicate the new criteria (effective Oct 1) was applied.
If Metavir F2–F4 and treatment occurs Oct 1–Oct 31, 2017, indicate whether the prior (July 1, 2016) or the new (Oct 1, 2017) criteria set was used.
After Nov 1, 2017, document use of the new criteria only.

Denial Risk

Readiness attestation required — missing attestation may prevent approval

Failure to provide the required patient readiness assessment and signed attestation may prevent approval of therapy and constitute a coverage risk.

The attestation must affirm the patient agrees to complete the treatment course and understands risks of reinfection and contributors to liver damage.
Prescribers are encouraged to document readiness interventions or AMCCI referrals when concerns exist to support approval.