VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir, and dasabuvir)

VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir, and dasabuvir)

SELF-ADMINISTRATION - ORAL 

Diagnosis considered for coverage:

• Chronic Hepatitis C Virus (HCV) - Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):
  1. Genotype 1b without cirrhosis or with compensated cirrhosis
  2. Genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

*Limitations of Use: Viekira Pak is not recommended for use in patients with decompensated liver disease.

Coverage Criteria:

1. Request for chronic HCV, genotype 1a or mixed genotype 1, without cirrhosis and without liver transplant (12 weeks):

• Dose does not exceed two tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) daily and one tablet (dasabuvir 250 mg) twice 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 1a or mixed genotype 1

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

  • Patient does not have cirrhosis

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

• Used in combination with ribavirin; AND

• Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

  • Brand Epclusa (sofosbuvir/velpatasvir) or brand Harvoni (ledipasvir/sofosbuvir)

  • Mavyret (glecaprevir/pibrentasvir); AND

• Patient has not experienced failure with a previous treatment regimen that includes an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

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

2. Request for chronic HCV, genotype 1a or mixed genotype 1, with cirrhosis and without liver transplant (24 weeks):

• Dose does not exceed two tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) daily and one tablet (dasabuvir 250 mg) twice 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 1a or mixed genotype 1 infection

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

  • Patient has cirrhosis

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

• Used in combination with ribavirin; AND

• Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

  • Brand Epclusa (sofosbuvir/velpatasvir) or brand Harvoni (ledipasvir/sofosbuvir)

  • Mavyret (glecaprevir/pibrentasvir); AND

• Patient has not experienced failure with a previous treatment regimen that includes an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

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

3. Request for chronic HCV, genotype 1b, without liver transplant (12 weeks):

• Dose does not exceed two tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) daily and one tablet (dasabuvir 250 mg) twice 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 1b

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

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

• Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

  • Brand Epclusa (sofosbuvir/velpatasvir) or brand Harvoni (ledipasvir/sofosbuvir)

  • Mavyret (glecaprevir/pibrentasvir); AND

• Patient has not experienced failure with a previous treatment regimen that includes an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

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

4. Request for chronic HCV, genotype 1 (regardless of subgenotype), liver transplant recipient (24 weeks):

• Dose does not exceed two tablets (ombitasvir 12.5 mg/paritaprevir 75 mg/ritonavir 50 mg) daily and one tablet (dasabuvir 250 mg) twice 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

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

  • Patient is a liver transplant recipient

  • Normal hepatic function and mild fibrosis (e.g., METAVIR fibrosis score less than or equal to F2); AND

• Used in combination with ribavirin; AND

• Contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:

  • Brand Epclusa (sofosbuvir/velpatasvir) or brand Harvoni (ledipasvir/sofosbuvir)

  • Mavyret (glecaprevir/pibrentasvir); AND

• Patient has not experienced failure with a previous treatment regimen that includes an HCV NS3/4A protease inhibitor or an NS5A inhibitor (see additional information for examples); AND

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

Coverage Duration:

• 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:

• 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

• Warnings and precautions:

  • ALT elevations: discontinue ethinyl estradiol-containing medications prior to starting Viekira Pak (alternative contraceptive methods are recommended).  Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment.  For ALT elevations, monitor closely and follow recommendations in full prescribing information.

  • Risks associated with ribavirin combination treatment: warnings and precautions for ribavirin also apply to this combination regimen.

• Contraindication:

  • If Viekira Pak is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.

  • Patients with severe hepatic impairment

  • Co-administration with drugs that are: highly dependent on CYP3A for clearance; strong inducers of CYP3A and CYP2C8; and strong inhibitors of CYP2C8

  • Known hypersensitivity to ritonavir (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome)

• Drug interactions

  • The potential for drug interactions must be considered before and during treatment.  Consult the full prescribing information prior to and during treatment for potential drug interactions.

Policy Updates:

• 02/15/2022 – New policy approved 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. Viekira Pak Prescribing Information. AbbVie, Inc. North Chicago, IL. December 2019.
3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. March 2021. http://www.hcvguidelines.org/full-report-view. Accessed May 13, 2021.