HARVONI (sofosbuvir/ledipasvir)

HARVONI (sofosbuvir/ledipasvir)

SELF-ADMINISTRATION - ORAL 

Indications for Prior Authorization:

• Chronic Hepatitis C Virus (HCV) - Indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV)]:

  • Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

  • Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin

  • Genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin

All of the following must be met as a condition for coverage:
 

1. Request for chronic HCV, genotype 1, treatment-naive without cirrhosis (8 or 12 weeks):

• Dose does not exceed one tablet (90 mg of ledipasvir, 400 mg of sofosbuvir) once daily; AND

• Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

• Medical records (e.g., chart notes, laboratory values) document all of the following:

  • HCV genotype 1

  • Patient does not have cirrhosis (i.e., F0 – F3)

  • Patient is treatment-naïve (i.e., never been treated for HCV); AND

• Medical records document ONE of the following:

  • Current, detectable pre-treatment HCV RNA viral load (VL) is less than 6 million IU/mL, and request for 8 weeks of treatment

  • Current, detectable pre-treatment HCV RNA VL is equal to or greater than 6 million IU/mL and request for 12 weeks of treatment; AND

• Patient is not receiving Harvoni in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase); AND

• For Harvoni ABA (generic Harvoni) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Harvoni (ledipasvir/sofosbuvir)
   

2. Request for chronic HCV, genotype 1, 4, 5, or 6, treatment-naive with no decompensated cirrhosis (12 weeks):

• Dose does not exceed one tablet (90 mg of ledipasvir, 400 mg of sofosbuvir) once daily; AND

• Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

• Medical records (e.g., chart notes, laboratory values) document all of the following:

  • HCV genotype 1, 4, 5, or 6

  • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

  • Patient is treatment-naïve (i.e., never been treated for HCV)

  • Patient does not have decompensated cirrhosis (i.e., Child-Pugh Class B or C); AND

• Patient is not receiving Harvoni in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase); AND

• For Harvoni ABA (generic Harvoni) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Harvoni (ledipasvir/sofosbuvir)
   

3. Request for chronic HCV, genotype 1, 4, 5, or 6, decompensated cirrhosis, ribavirin eligible (12 weeks):

• Dose does not exceed one tablet (90 mg of ledipasvir, 400 mg of sofosbuvir) once daily for 12 weeks; AND

• Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

• Medical records (e.g., chart notes, laboratory values) document ALL of the following:

  • HCV genotype 1, 4, 5, or 6

  • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

  • Patient has decompensated cirrhosis (i.e., Child-Pugh class B or class C)

  • Will be used in combination with ribavirin (RBV); AND

• Patient is not receiving Harvoni in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase); AND

• For Harvoni ABA (generic Harvoni) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Harvoni (ledipasvir/sofosbuvir)
   

4. Request for chronic HCV, genotype 1, 4, 5, or 6, post-liver transplant (12 weeks):

• Dose does not exceed one tablet (90 mg of ledipasvir, 400 mg of sofosbuvir) once daily for 12 weeks; AND

• Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

• Medical records (e.g., chart notes, laboratory values) document all of the following:

  • HCV genotype 1, 4, 5, or 6

  • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

  • Patient is a liver transplant recipient; AND

• Medical records document ONE of the following:

  • Patient is without cirrhosis or has compensated cirrhosis (i.e., Child-Pugh Class A)

  • Patient has decompensated cirrhosis (i.e., Child-Pugh class B or class C) and will be used in combination with ribavirin (RBV); AND

• Patient is not receiving Harvoni in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, and the NS5B polymerase); AND

• For Harvoni ABA (generic Harvoni) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Harvoni (ledipasvir/sofosbuvir)
   

5. Request for chronic HCV, genotype 1, 4, 5, or 6, decompensated cirrhosis, ribavirin ineligible OR prior Sovaldi or NS5A-based treatment failure (24 weeks):

• Dose does not exceed one tablet (90 mg of ledipasvir, 400 mg of sofosbuvir) once daily for 24 weeks; AND

• Prescribed by or in consultation with a hepatologist, gastroenterologist, or infectious disease (ID) specialist; AND

• Medical records (e.g., chart notes, laboratory values) document all of the following:

  • HCV genotype 1, 4, 5, or 6

  • Detectable serum HCV RNA levels by quantitative assay in the last 6 months

  • Patient has decompensated cirrhosis (i.e., Child-Pugh class B or class C); AND

• Medical records document ONE of the following:

  • Patient is ribavirin ineligible

  • Both of the following:

    • Prior failure (defined as viral relapse, breakthrough while on therapy, or non-responder to therapy) to Sovaldi or NS5A-based therapy (see additional information for examples)

    • Will be used in combination with ribavirin; AND

• Patient is not receiving Harvoni in combination with another HCV direct-acting antiviral agent (e.g., inhibitors of the NS3/4A protease, the NS5A protein, or the NS5B polymerase); AND

• For Harvoni ABA (generic Harvoni) only:  Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to brand Harvoni (ledipasvir/sofosbuvir)
   

Coverage Duration:

• 8 weeks, 12 weeks, or 24 weeks as determined to be medically necessary (see above).

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Resistance testing: NS5A RAS testing can be considered for genotype 1a-infected, treatment-experienced patients with and without cirrhosis being considered for Harvoni.

• Child-Pugh (CP) score calculation = sum of points from 5 categories:

  • Encephalopathy: None = 1 point; Grade 1 and 2 = 2 points; Grade 3 and 4 = 3 points

  • Ascites:  None = 1 point; slight = 2 points; moderate = 3 points

  • Bilirubin: under 2 mg/ml = 1 point; 2 to 3 mg/ml = 2 points; over 3 mg/ml = 3 points

  • Albumin: greater than 3.5mg/ml = 1 point; 2.8 to 3.5mg/ml = 2 points; less than 2.8mg/ml = 3 points

  • Prothrombin Time* (sec prolonged): less than 4 sec = 1 point; 4 to 6 sec = 2 points; over 6 sec = 3 points

• Severity of cirrhosis classification using Child-Pugh (CP) calculation:

  • Child-Pugh A: 5 to 6 points - good hepatic function

  • Child-Pugh B: 7 to 9 points - moderately impaired hepatic function

  • Child-Pugh C: 10 to 15 points - advanced hepatic dysfunction

• Examples of drug classes:

  • NS5A protein inhibitors include:

    • daclatasvir (Daklinza)

    • elbasvir (component of Zepatier)

    • ledipasvir (component of Harvoni)

    • ombitasvir (component of Viekira Pak)

    • pibrentasvir (component of Mavyret)

    • velpatasvir (component of Epclusa, component of Vosevi).

  • NS3/4A protease inhibitors include:

    • glecaprevir (component of Mavyret)

    • grazoprevir (component of Zepatier)

    • paritaprevir (component of Viekira Pak)

    • simeprevir (Olysio)

    • voxilaprevir (component of Vosevi)

  • NS5B polymerase inhibitors include:

    • sofosbuvir (Sovaldi, component of Harvoni, component of Epclusa, component of Vosevi)

    • dasabuvir (component of Technivie)

• Warnings and precautions:

  • Risk of Hepatitis B Virus Reactivation: test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.  Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up.

  • Bradycardia with amiodarone coadministration: coadministration of amiodarone with Harvoni is not recommended.  In patients without alternative, viable treatment options, cardiac monitoring is recommended

• Contraindication:

  • If Harvoni is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.  Refer to the ribavirin prescribing information for a list of contraindications for ribavirin

• Drug interactions

  • Use of Harvoni with amiodarone is not recommended

  • P-gp inducers (e.g., rifampin, St. John’s wort): use of Harvoni with P-gp inducers is not recommended

  • Frequent monitoring of international normalized ratio (INR) values is recommended in patients receiving warfarin

  • Consult the full prescribing information prior to use for potential drug interactions

Policy Updates:

• 02/15/2022 – Updated policy approved by P&T.

• 09/04/2018 – Reviewed by P&T.

References:

1. Tsoris A, Marlar CA. Use Of The Child-Pugh Score In Liver Disease. [Updated 2021 Mar 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542308/

2. Harvoni Prescribing Information. Gilead Sciences, Inc. Foster City, CA. March 2020.

3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. September 2021. http://www.hcvguidelines.org/full-report-view. Accessed January 02, 2022.