Currentmedical mutual - ohioPolicy N/A

Preferred Specialty Management for Hepatitis C Direct-Acting Antivirals (DAAs)

Defines a Preferred Specialty Management (PSM) program directing use of preferred HCV DAAs by genotype and specific clinical situations, and exception criteria for non-preferred DAAs. Requires meeting the respective standard Hepatitis C Prior Authorization (PA) policy criteria and documentation when requesting non-preferred products.

Policy Summary

Payermedical mutual - ohio

PolicyPreferred Specialty Management for Hepatitis C Direct-Acting Antivirals (DAAs)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective Date

Next Review DateMay 22, 2025

Key ActionEnsure requests meet the respective standard Hepatitis C Prior Authorization Policy criteria and provide documentation for non-preferred products.

POLICY UPDATE CHANGES

No material changes

20+Explicit scenario entries/exception rules

MultiplePreferred vs Non-Preferred products listed

Coverage Summary

This Preferred Specialty Management (PSM) program directs use of preferred hepatitis C direct-acting antivirals (DAAs) by genotype and specific clinical situations. Coverage requires that patients meet the respective standard Hepatitis C Prior Authorization (PA) policy criteria for the requested medication. The program directs patients to try a Preferred Product when appropriate, notes genotype-directed preferred products (e.g., Epclusa, Harvoni, Vosevi, Zepatier for specified genotypes), and states that exception criteria govern requests for non-preferred products (documentation required for non-preferred use). All approvals are for the duration specified in the respective standard Hepatitis C PA policy.

Combined Coverage Rules and Exception Criteria

General Policy Statement: Coverage requires meeting the respective standard Hepatitis C Prior Authorization Policy criteria; the program directs the patient to try one Preferred Product; requests for non-preferred products are reviewed using the exception criteria.

Documentation is required for use of a non-preferred product (examples: chart notes, prescription claims, receipts). All approvals provided for duration specified in respective standard Hepatitis C PA policy.

Preferred vs Non-Preferred Products by Genotype: Genotype-specific preferred and non-preferred products as listed; Preferred products should be used when appropriate; non-preferred require exception criteria.

Preferred, Genotype 1: Epclusa (brand), Harvoni (brand), Vosevi, Zepatier. Genotype 2: Epclusa (brand), Vosevi. Genotype 3: Epclusa (brand), Vosevi. Genotype 4: Epclusa (brand), Harvoni (brand), Vosevi, Zepatier. Genotype 5/6: Epclusa (brand), Harvoni (brand), Vosevi. Non-Preferred examples: Mavyret; sofosbuvir/velpatasvir (generic); ledipasvir/sofosbuvir (generic); Sovaldi for some genotypes/pediatric).

Exception Criteria - Epclusa (brand only): Approve for the duration specified in the standard Hepatitis C - Epclusa PA Policy if the patient has met the standard Hepatitis C - Epclusa PA Policy criteria.

Exception Criteria - Sofosbuvir/velpatasvir (generic only): Sofosbuvir/velpatasvir (generic only) is not approved; offer to review for Epclusa (brand only) using the standard Hepatitis C - Epclusa PA Policy criteria.

Exception Criteria - Harvoni (brand) and Ledipasvir/sofosbuvir (generic): Harvoni (brand only): Approve for the duration specified in the standard Hepatitis C - Harvoni PA Policy if the patient has met the standard Hepatitis C - Harvoni PA Policy criteria. Ledipasvir/sofosbuvir (generic only) is not approved; offer to review for Harvoni (brand only) using the standard Hepatitis C - Harvoni PA Policy criteria.

Exception Criteria - Sovaldi (sofosbuvir generic): Sovaldi is not approved for Genotype 2 or 3 chronic HCV pediatric patients (≥3 and <18) new start; offer to review for Epclusa (brand) using Epclusa PA criteria. Patients continuing therapy with Sovaldi: refer to standard Hepatitis C - Sovaldi PA Policy criteria.

Exception Criteria - Mavyret (multiple scenarios): Mavyret approvals and restrictions vary by genotype, age, and clinical history; Mavyret is approved for acute HCV (genotype 1-6) if patient meets Hepatitis C - Mavyret PA for PSM Policy criteria. For many treatment-naïve new-start scenarios across genotypes, Mavyret is not approved and the plan will offer review for Preferred alternatives (Epclusa brand, Harvoni brand, Zepatier, or Vosevi) as specified. Approval is possible if the patient meets the Mavyret PA for PSM Policy criteria AND meets prior-treatment/failure documentation requirements per the listed subcriteria.

For Genotype 1 adults new start: if treatment-naïve, Mavyret not approved - offer Epclusa/Harvoni/Zepatier. Otherwise approve only if (i) Mavyret PA for PSM criteria met AND (ii) one of: a) prior pegylated interferon/ribavirin, Incivek, Olysio, or Victrelis AND completed Epclusa/Harvoni/Zepatier with documented failure to achieve SVR (documentation required); or b) prior Daklinza, Epclusa, Harvoni, or Zepatier; or c) prior Sovaldi + ribavirin ± interferon OR Sovaldi + Olysio. Similar structured rules apply for pediatric patients and genotypes 2,3,4,5/6. Specific renal impairment rules and genotype-unknown rules apply as detailed in exception criteria.

Exception Criteria - Vosevi and Zepatier: Vosevi: Approve for the duration specified in the standard Hepatitis C - Vosevi PA Policy if standard Vosevi PA criteria met; continuing therapy refer to Vosevi PA. Zepatier: Approve for duration specified in standard Hepatitis C - Zepatier PA Policy if Zepatier PA criteria met (genotype 1 or 4); continuing therapy refer to Zepatier PA.

Transplant and Special Populations: Mavyret approvals for transplant recipients and recurrent disease: Kidney transplant (genotype 1-6) new start: approve if patient meets Hepatitis C - Mavyret PA for PSM Policy criteria. Genotype 2 or 3 recurrent HCV post-liver transplant new start: approve if meets Mavyret PA for PSM criteria. Genotype 1,4,5,6 recurrent HCV post-liver transplant adults: approve if meets Mavyret PA for PSM AND has completed Harvoni with documented failure to achieve SVR; if prior Harvoni failure not documented, offer review for Harvoni (brand). Liver transplant recipient (any genotype) new start: approve if meets Mavyret PA for PSM Policy criteria.

Genotype unknown/no cirrhosis: Mavyret not approved - offer Epclusa (brand only). Genotype unknown/compensated cirrhosis: Mavyret may be approved if Mavyret PA for PSM criteria met.

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

All medications (Preferred and Non-Preferred) require meeting the respective standard Hepatitis C Prior Authorization Policy criteria. All approvals are provided for the duration documented in the respective standard Hepatitis C Prior Authorization Policy.

Prior Authorization

Preferred Product Trial/Offer

If the patient meets the standard Hepatitis C Prior Authorization Policy criteria but has not tried a Preferred Product, a review will be offered for the Preferred Product using the respective standard Hepatitis C Prior Authorization Policy criteria before approving a non-preferred product.

Documentation Required

Documentation for Non-Preferred Products

Documentation is required for use of a non-preferred product. Examples of acceptable documentation include chart notes, prescription claims records, and prescription receipts.

Chart notes
Prescription claims records
Prescription receipts

Denial Risk

Generic-only Products Not Approved in Some Cases

Some generic-only versions (for example, sofosbuvir/velpatasvir generic and ledipasvir/sofosbuvir generic) are explicitly not approved in the exception criteria. In those cases the policy directs offering to review the corresponding brand product (Epclusa or Harvoni) using the respective standard Hepatitis C PA criteria.

Drug Products Mentioned (brand/generic)

Drug Products Mentioned (brand/generic)mixed

Epclusa	sofosbuvir/velpatasvir (brand) - preferred in many genotypes
sofosbuvir/velpatasvir (generic)	authorized generic to Epclusa - non-preferred in many genotypes; not approved in generic-only exception guidance
Harvoni	ledipasvir/sofosbuvir (brand) - preferred in many genotypes
ledipasvir/sofosbuvir (generic)	authorized generic to Harvoni - non-preferred in many genotypes; generic-only not approved per exceptions
Mavyret	glecaprevir/pibrentasvir - non-preferred for many treatment-naïve scenarios; approved for acute HCV and certain prior-treatment/failure scenarios
Sovaldi	sofosbuvir (brand/generic) - non-preferred for many genotypes; pediatric limitations described
Vosevi	sofosbuvir/velpatasvir/voxilaprevir - preferred in many genotypes; approve if standard Vosevi PA criteria met
Zepatier	elbasvir/grazoprevir - preferred for genotypes 1 and 4 in many scenarios
Daklinza	daclatasvir - referenced in prior-treatment history
Incivek	telaprevir - referenced in prior-treatment history

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Preferred Specialty Management for Hepatitis C Direct-Acting Antivirals (DAAs)

Coverage Summary

Provider Actions / Prior Authorization

Drug Products Mentioned (brand/generic)

Background & Scope

Clinical Evidence & References

Definitions

Revision History