344 Form

1

Pharmacy Medical Policy Hepatitis C Medication Management Table of Contents • Related Polices

• Prior Authorization Information

• Summary • Policy

• Provider Documentation

• Individual Consideration • Policy History

• Forms

• References Policy Number: 344 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply to the following medications and can be found in Medical Policy #621A.

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 9/15/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

2

Summary This is a comprehensive policy covering prior authorization requirements for medications used for the treatment of Hepatitis C.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with hepatitis C virus (HCV) have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, or liver cancer21. Formulary status and coverage requirements for medications affected by this policy: Drug Formulary Status (BCBSMA Commercial Plan) Requirement Epclusa ® (velpatasvir / sofosbuvir) Covered, PA, QCD

PA required. See below for criteria. Harvoni ™ (ledipasvir / sofosbuvir) Covered, PA, QCD Vosevi ™ (sofosbuvir/velpatasvir/voxilaprevir) NFNC, PA, QCD Sofosbuvir/velpatasvir
(Authorized Epclusa Generic) Covered, PA, QCD Ledipasvir/sofosbuvir
(Authorized Harvoni Generic) Covered, PA, QCD Mavyret ™ (glecaprevir and pibrentasvir) NFNC, PA, QCD Sovaldi ™ (sofosbuvir) NFNC, PA, QCD Zepatier ™ (elbasvir and grazoprevir) NFNC, PA, QCD QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization; NFNC – Non-formulary / Non- Covered

Policy Length of Approval Varied, see criteria for each drug below.
Formulary Status All requests must meet the Prior Authorizations requirement and for non-covered medications, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient.
Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Prior Authorization Criteria Required Information for Prior Authorization Review
The following clinical information must be provided with the Prior Authorization request form for all drugs to treat hepatitis C: • Viral genotype and subtype; AND • Cirrhosis status; AND • Prior treatment for hepatitis C; AND • Viral Load. Epclusa ® Epclusa may be considered MEDICALLY NECESSARY when ALL of the following criteria is met:

3

1. Documented diagnosis of Chronic Hepatitis C Genotype 1, 2, 3, 4, 5, or 6; AND

2. Age > 3 years old or weight of at least 17 kg (over 37 pounds). If above criteria are met, approval for Epclusa will be given according to the following criteria: • Patients without cirrhosis and patients with compensated cirrhosis: o Approval given for up to 12 weeks of therapy.

   • Patients with decompensated cirrhosis: o Administered in combination with ribavirin, and o Approval given for up to 12 weeks of therapy. Sofosbuvir/velpatasvir – Authorized Epclusa Generic Sofosbuvir/velpatasvir, the authorized generic for Epclusa, may be considered MEDICALLY NECESSARY when ALL of the following criteria is met:

3. Documented diagnosis of Chronic Hepatitis C Genotype 1, 2, 3, 4, 5, or 6, AND

4. Age > 3 years old or weight of at least 17 kg (over 37 pounds). If above criteria are met, approval for Sofosbuvir/velpatasvir will be given according to the following criteria: • Patients without cirrhosis and patients with compensated cirrhosis: o Approval given for up to 12 weeks of therapy

   • Patients with decompensated cirrhosis: o Administered in combination with ribavirin, and o Approval given for up to 12 weeks of therapy. Harvoni TM Harvoni may be considered MEDICALLY NECESSARY when ALL of the following criteria is met:

5. Documented diagnosis of Chronic Hepatitis C Genotype 1, 4, 5, or 6, AND

6. Age > 3 years old.

   If above criteria are met, approval for Harvoni will be given according to the following criteria: • Patients who are treatment naïve with cirrhosis or treatment experienced* without cirrhosis: o Approval given for up to 12 weeks of therapy

   • Patients who are treatment naïve without cirrhosis
   o Approval given for up to 8 weeks of therapy

   • Patients who are treatment experienced* with cirrhosis: o Approval given for up to 24 weeks of therapy.

   Ledipasvir/sofosbuvir – Authorized Harvoni Generic Ledipasvir/sofosbuvir the authorized generic for Harvoni, may be considered MEDICALLY NECESSARY
   when ALL of the following criteria is met:

7. Documented diagnosis of Chronic Hepatitis C Genotype 1, 4, 5, or 6, AND
8. Age > 3 years old. If above criteria are met, approval for Ledipasvir/sofosbuvir will be given according to the following criteria: • Patients who are treatment naïve with cirrhosis or treatment experienced* without cirrhosis: o Approval given for up to 12 weeks of therapy

4

• Patients who are treatment naïve without cirrhosis
o Approval given for up to 8 weeks of therapy

• Patients who are treatment experienced* with cirrhosis: o Approval given for up to 24 weeks of therapy.

*Treatment experienced is defined as patients who have failed treatment with either a regimen of peginterferon alfa and ribavirin or a regimen of an HCV protease inhibitor and peginterferon alfa and ribavirin Mavyret TM Mavyret may be covered when ALL of the following criteria are met:

1. Documented diagnosis of Chronic Hepatitis C Genotype 1,2,3,4,5 or 6, AND
2. Age > 3 years old, AND
3. For Genotype 1 or 4, 5 & 6: Previous treatment with, or contraindication to, Harvoni AND Epclusa, OR
   For Genotype 2 or 3: Previous treatment with, or contraindication to, Epclusa. If above criteria are met, approval for Mavyret will be given for up to 16 weeks of therapy. Sovaldi TM Sovaldi may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:
4. Documented diagnosis of Chronic Hepatitis C Genotype 2, 3, or 4 (including patients with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection when), AND
5. Age > 3 years old, AND
6. Administered in combination with ribavirin OR in combination with pegylated interferon and ribavirin, AND

7. For Genotype 1 or 4: Previous treatment with, or contraindication to, Harvoni AND Epclusa, OR For Genotype 2 or 3: Previous treatment with, or contraindication to, Epclusa. If above criteria are met, approval for Sovaldi TM will be given as follows: HCV Mono-infected and HCV/HIV-1 Co-infected Treatment Duration Genotype 1 or 4 Sovaldi TM + peg-interferon alfa + ribavirin Up to 12 weeks Genotype 2
   Sovaldi TM + ribavirin Up to 12 weeks Genotype 3
   Sovaldi TM + ribavirin Up to 24 weeks All Genotypes (Hepatocellular carcinoma awaiting liver transplantation) Sovaldi TM + ribavirin Up to 48 weeks or until liver transplant whichever soonest Vosevi TM Vosevi may be considered MEDICALLY NECESSARY when ALL of the following criteria is met:

8. Age > 18 years old, AND
9. Previous treatment with, or contraindication to, Harvoni AND Epclusa, AND
10. Patient does not have cirrhosis or has compensated cirrhosis (Child-Pugh A), AND either criteria 4 or 5 are met:
11. Documented diagnosis of Chronic Hepatitis C Genotype 1, 2, 3, 4, 5, or 6, AND

5

previously treated with an HCV regimen containing an NS5A inhibitor (ex: Harvoni, Epclusa, Zepatier); OR

5. Documented diagnosis of Chronic Hepatitis C Genotype 1a or 3, AND previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor (ex: Sovaldi). If above criteria are met, approval will be given for Vosevi TM for up to 12 weeks of therapy. Zepatier TM Zepatier ma may be considered MEDICALLY NECESSARY when ALL of the following criteria is met:

6. Documented diagnosis of Chronic Hepatitis C Genotype 1 or 4, AND
7. Age > 18 years old, AND

8. Previous treatment with, or contraindication, to Harvoni AND Epclusa. If above criteria are met, approval will be given for Zepatier as follows: Patient Population Treatment Duration Genotype 1a: Treatment-naïve or PegIFN/RBVexperienced without baseline NS5A polymorphisms ZEPATIER Up to 12 weeks Genotype 1a: Treatment-naïve or PegIFN/RBVexperienced with baseline NS5A polymorphisms ZEPATIER + ribavirin Up to 16 weeks Genotype 1b: Treatment-naïve or PegIFN/RBVexperienced ZEPATIER Up to 12 weeks Genotype 1a or 1b: PegIFN/RBV/PI-experienced ZEPATIER + ribavirin Up to 12 weeks Genotype 4: Treatment-naïve ZEPATIER Up to 12 weeks Genotype 4: PegIFN/RBV-experienced ZEPATIER + ribavirin Up to 16 weeks Other Information Blue Cross Blue Shield of Massachusetts (BCBSMA) members (other than Medex®; Blue MedicareRx, Medicare Advantage plans that include prescription drug coverage) will be required to fill their prescriptions for the above medications at one of the providers in our retail specialty pharmacy network.

   Outpatient For services described in this policy, see below for products where prior authorization IS REQUIRED if the procedure is performed outpatient.

   Outpatient Commercial Managed Care (HMO and POS) Prior authorization is required. Commercial PPO and Indemnity Prior authorization is required.

6

Provider Documentation Requirements
Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.
The following clinical information must also be provided with the Prior Authorization request form for all drugs to treat hepatitis C: • Viral genotype and subtype, AND • Cirrhosis status, AND • Prior treatment for hepatitis C, AND • Viral Load. Individual Consideration (For Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines.

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Phone: 1-800-366-7778 Fax: 1-800-583-6289

We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met.

7

Policy History Date Action 09/15/2025 Updated Mavyret age due to FDA label expansion; removed discontinued drugs from references section. Updated Prior Authorization Information section. 7/2024 Update to add Vosevi to NFNC and to cover ledipasvir/sofosbuvir and sofosbuvir/velpatasvir. 11/2023 Reformatted Policy. 10/2023 Reformatted Policy and updated IC to align with 118E MGL § 51A. 7/2023 Reformatted Policy. 8/2022 Updated to remove Daklinza, Olysio, Technivie, & Viekira as they were discontinued from the market. 6/2021 Clarified coding and updated age for Epclusa ™. 6/2020 Updated to include age change for Epclusa ™. 2/2020 Updated to remove specialist prescriber required criteria. 11/2019 Updated to add Age updates for Harvoni™ and SovaldiTM 7/2019 Updated age for 12 and older for Mavyret. 2/2019 Updated to include at not covered the Authorized generics of Harvoni and Epclusa. 1/2018 Updated to include Mavyret as non-preferred. 11/2017 Updated to include Vosevi™ as part of the policy plus update Walgreens Specialty and added the Mass Standard PA form. 7/2017 Updated criteria for age change in SovaldiTM and Harvoni® plus added AllCare to Specialty Pharmacy list. 6/2017 Updated Pharmacy Ops address. 1/1/2017 Updated to include Epclusa® and Viekira XRTM 6/2016 Updated to add ZepatierTM and Remove VictrelisTM. 4/2016 Updated to include new Harvoni® indications and add DaklinzaTM & TechnivieTM. 7/2015 Added Genotype 1 to SovaldiTM table. 2/2015 Updated to include Harvoni® and Viekira PakTM and criteria. 1/2015 Updated to remove Pegylated Interferons requiring PA and changes to Olysio. 7/2014 Updated to include ICD-10 and added SovaldiTM and OlysioTM. 2/2014 Updated Onco360 name and removed Curascript in Specialty Pharmacy section. 1/2014 Updated to remove Blue Value. 1/2013 Updated coverage criteria for PegIntron® to require previous treatment failure with Pegasys.® 8/2012 Updated to include Pegasys® ProClick™.
11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
1/1/2012 New policy, effective 1/1/2012, describing covered and non-covered indications.

Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434

References

1. AASLD, IDSA, IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed June 10, 2014.
2. Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1207-1217.
3. Daklinza [package insert] Bristol-Myers Squibb Company. Princeton, NJ Accessed January 2016

8

4. Epclusa [package insert] Gilead, Forest City, CA ; June 2016
5. Harvoni [package insert] Gilead, Forest City, CA. Accessed October 2014.
6. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364(25):2405-2416.
7. Kwo PY, Lawitz EJ, McCone J, et al. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet 2010;376(9742):705-716.
8. Mavyret [package insert]. North Chicago, IL: AbbVie Inc.; June 2025.
9. Pearlman BL, Traub N. Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more. Clin Infect Dis 2011;52(7):889-900.
10. Poordad F, McCone J, Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1195-1206.
11. Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med 2011;364(25):2429-2438.
12. Sovaldi™ [package insert]. Foster City, CA: Gilead Sciences Incorporated; Dec, 2013.
13. Victrelis [package insert]. Whitehouse Station, NJ: Merck &Co, Inc.; May, 2011.
14. Vosevi [package insert] Gilead, Forest City, CA ; July 2017
15. World Health Organization. (n.d.). Hepatitis C. World Health Organization. https://www.who.int/news- room/fact-sheets/detail/hepatitis-c. Accessed January 2022.
16. Zepatier [package insert] Whitehouse Station, NJ: Merck &Co, Inc.; January 2016.
17. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364(25):2417-2428.