CurrentCignaPolicy N/A

Hepatitis C - Mavyret Drug Quantity Management Policy - Per Days

Defines Cigna's drug quantity limits and exception criteria for Mavyret (tablets and oral pellets) for treatment of hepatitis C across genotypes and transplant status; applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyHepatitis C - Mavyret Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation when quantities exceed the standard limit (168 tablets/365 days) and include genotype, prior-treatment history, cirrhosis and transplant status to support exception criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

168standard maximum (per 365 days)

25212-week course

33616-week course

84dispensing size

28pellet carton

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Coverage Criteria for Quantity Exceptions

Exception Criteria (Quantity approvals by genotype, prior therapy, cirrhosis, transplant)

Exceptions to the standard quantity limit are covered as medically necessary when specified genotype-, prior-treatment-, cirrhosis-, and transplant-specific criteria are met. Each numbered criterion below corresponds to a distinct approval scenario with exact AND/OR logic.

1. Genotype 1, treatment-experienced, NS5A-experienced, NS3/4A-naive: Approve 336 tablets or 672 pellet packets per 365 days (16 weeks) if ALL: (A) patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND (B) prior null response, prior partial response, or relapse after prior treatment with an NS5A-inhibitor containing product (Daklinza [daclatasvir], sofosbuvir/velpatasvir, or ledipasvir/sofosbuvir); AND (C) no prior treatment with listed NS3/4A inhibitors or NS3/4A-containing products (Olysio, Victrelis, Incivek, Technivie, Viekira Pak/XR, Vosevi, Zepatier).336 tablets

quantity sufficient for 16 weeks

2. Genotype 1, treatment-experienced, NS3/4A-experienced, NS5A-naive: Approve 252 tablets or 504 pellet packets per 365 days (12 weeks) if ALL: (A) patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND (B) no prior treatment with listed NS5A-inhibitor products (Daklinza, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, Technivie, Viekira Pak/XR, Vosevi, Zepatier); AND (C) prior null response, prior partial response, or relapse after prior treatment with listed NS3/4A inhibitors or NS3/4A-containing products (Olysio, Victrelis, Incivek).252 tablets

quantity sufficient for 12 weeks

3. Genotypes 1, 2, 4, 5, 6 — treatment-experienced (pegylated interferon/interferon, ribavirin, or Sovaldi-experienced): Approve 252 tablets or 504 pellet packets per 365 days (12 weeks) if BOTH: (A) patient has compensated cirrhosis (Child-Pugh A); AND (B) prior null response, prior partial response, or relapse after prior treatment with interferon ± ribavirin, pegylated interferon ± ribavirin, or sofosbuvir (Sovaldi)–containing regimens (with ribavirin and/or pegylated interferon as specified).252 tablets

quantity sufficient for 12 weeks

4. Genotype 3, treatment-experienced (pegylated interferon/interferon, ribavirin, or Sovaldi-experienced): Approve 336 tablets or 672 pellet packets per 365 days (16 weeks) if BOTH: (A) patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A); AND (B) prior null response, prior partial response, or relapse after prior treatment with interferon ± ribavirin, pegylated interferon ± ribavirin, or Sovaldi (sofosbuvir)–containing regimens.336 tablets

quantity sufficient for 16 weeks

5. Recurrent HCV post-liver transplant (any genotype): Approve 252 tablets or 504 pellet packets per 365 days (12 weeks).252 tablets

quantity sufficient for 12 weeks

6. Kidney or liver transplant recipients, genotypes 2, 4, 5, 6: Approve 252 tablets or 504 pellet packets per 365 days (12 weeks).252 tablets

quantity sufficient for 12 weeks

7. Kidney or liver transplant recipients, genotype 1: Approve per one of the following: (A) If NS5A-experienced and NS3/4A-naive: approve 336 tablets or 672 pellet packets per 365 days (16 weeks) when BOTH (i) prior null response, prior partial response, or relapse after NS5A-inhibitor products (Daklinza, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir) AND (ii) no prior NS3/4A inhibitor exposure (Olysio, Victrelis, Incivek, Technivie, Viekira Pak/XR, Vosevi, Zepatier); OR (B) All other genotype 1 transplant patients: approve 252 tablets or 504 pellet packets per 365 days (12 weeks).252 or 336 tablets

see subcriteria

8. Kidney or liver transplant recipients, genotype 3: Approve per one of the following: (A) If pegylated interferon/interferon, ribavirin, or Sovaldi-experienced with prior null response, partial response, or relapse: approve 336 tablets or 672 pellet packets per 365 days (16 weeks); OR (B) All other genotype 3 transplant patients: approve 252 tablets or 504 pellet packets per 365 days (12 weeks).252 or 336 tablets

see subcriteria

9. Complete a course of therapy: For an indication already approved under the above criteria, approve the quantity described to complete the prescribed course at retail or home delivery (e.g., remaining weeks to finish a 12-week course).proportional quantity

example: if 3 weeks received of a 12-week course, approve remaining 9 weeks (189 tablets)

Exceptions to the standard Drug Quantity Limits for Mavyret are covered as medically necessary only when the detailed clinical criteria specified in this policy are met. Any exception not meeting the listed criteria is considered not medically necessary.

This policy is subject to a Drug Quantity Management rule intended to prevent stockpiling, misuse, or overuse. Quantities exceeding the Drug Quantity Management limits without meeting one of the specified exception criteria will be denied as not medically necessary. If the quantity rule is not met at point of service, coverage will be determined by the clinical criteria in this policy and all approvals are provided for the duration noted.

Product Strengths, Forms, and Quantity Limits

Product strengths/formsmixed

100 mg/40 mg	Mavyret tablet strength (glecaprevir 100 mg / pibrentasvir 40 mg)
50 mg/20 mg	Mavyret oral pellet packet strength (glecaprevir 50 mg / pibrentasvir 20 mg)

inv-05: Annual tablet limit

Standard annual tablet limit≤ 168 tablets per 365 days (84 tablets per dispensing)

Dispensing size84 tablets per dispensing (retail/home delivery)

Applies toMavyret (glecaprevir/pibrentasvir) tablets and oral pellets

inv-06: 12-week course (quantity sufficient for common approval amount)

12-week course quantity252 tablets (quantity sufficient for 12 weeks; equals 504 pellet packets) per 365 days

Typical scenariosGenotype 1 NS3/4A-experienced & NS5A-naïve; Genotypes 1,2,4,5,6 treatment-experienced PRS with compensated cirrhosis; post-liver transplant (any genotype); kidney/liver transplant recipients (genotypes 2,4,5,6)

Dispensing noteQuantity provided at retail or home delivery

inv-07: 16-week course (quantity approved in select criteria)

16-week course quantity336 tablets (quantity sufficient for 16 weeks; equals 672 pellet packets) per 365 days

Typical scenariosGenotype 1 treatment-experienced NS5A-experienced and NS3/4A-naïve; Genotype 3 treatment-experienced PRS (without cirrhosis or compensated cirrhosis)

Dispensing noteQuantity provided at retail or home delivery

Provider Requirements and Prior Authorization

Prior Authorization

Quantity limit exceptions require prior authorization

Requests for quantities that exceed the Drug Quantity Management maximum (168 tablets per 365 days) require prior authorization and will only be approved when the request meets one of the detailed clinical exception criteria (genotype-, prior‑treatment‑, cirrhosis‑, or transplant‑specific scenarios); approvals are provided for the duration noted in the applicable criterion (typically 12 or 16 weeks).

Standard maximum: 168 tablets per 365 days (84 tablets per dispensing).
Approvals for exceptions are specified in the Criteria (examples: 252 tablets for 12 weeks, 336 tablets for 16 weeks).

Step Therapy

Prior treatment history required for some exceptions

Some exception pathways require documentation of prior treatment exposure and response (for example, prior null/partial response or relapse after NS5A‑inhibitor regimens, NS3/4A‑inhibitor regimens, or interferon/pegylated interferon/ribavirin/Sovaldi regimens) as a condition of approval.

Genotype‑1 NS5A‑experienced approvals require prior null/partial response or relapse after prior NS5A‑inhibitor products (e.g., Daklinza, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir).
Genotype‑1 NS3/4A‑experienced approvals require prior null/partial response or relapse after listed NS3/4A inhibitors (e.g., Olysio, Victrelis, Incivek).
Treatment‑experienced PRS criteria require prior null/partial response or relapse after interferon ± ribavirin or Sovaldi‑containing regimens.

Documentation Required

Supporting documentation — Providers must submit documentation consistent with the applicable benefit plan

Submit prior authorization requests consistent with the terms of the applicable benefit plan and include documentation that supports the patient meets the specific clinical criteria listed (e.g., genotype, prior treatment history, cirrhosis status, transplant status).

Confirm requests comply with the member's specific benefit plan language; plan documents may supersede the policy.
Provide clinical documentation demonstrating how the patient meets the listed exception criteria referenced in the policy.

Denial Risk

Quantity limit enforcement — Coverage determined by criteria when Drug Quantity Management rule not met at point of service

If the Drug Quantity Management rule is not met at point of service, coverage for the requested quantity will be determined by the listed Criteria; quantities exceeding the limits that do not meet one of the specified exception criteria will be denied as not medically necessary.

Coverage determinations for exceptions follow the numbered Criteria in the policy; all approvals are provided for the duration noted.
Any request that does not meet an exception criterion is considered not medically necessary and may be denied.

OpenPayer

Hepatitis C - Mavyret Drug Quantity Management Policy - Per Days

Coverage Criteria for Quantity Exceptions

Product Strengths, Forms, and Quantity Limits

Provider Requirements and Prior Authorization

Key Definitions

Clinical Background