Limited Coverage Drugs - Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir

Effective March 23, 2017, PharmaCare will no longer approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, PharmaCare will continue coverage until their current Special Authority expires.

Generic Name

ombitasvir-paritaprevir-ritonavir and dasabuvir, with or without ribavirin (Moderiba™)

Please see Special Notes regarding access to Moderiba.

Strength

12.5 mg/75 mg/50 mg (ombitasvir-paritaprevir-ritonavir) and 250 mg (dasabuvir)

Form

tablet

Special Authority Criteria

Approval Period

 For the treatment of chronic hepatitis C genotype 11 in:

 

  • Treatment naïve and experienced2,3 patients with genotype 1b, non-cirrhotic

12 weeks

OR

 

  • Treatment naïve and experienced2,3 patients with genotype 1b, with compensated cirrhosis4

12 weeks in combination with ribavirin (Moderiba™)

 

OR

  • Treatment naïve and experienced2,3  patients with genotype 1a, with no cirrhosis

OR

  • Treatment naïve patients with genotype 1a, with compensated cirrhosis4

OR

  • Treatment experienced2,3  patients with genotype 1a, with compensated cirrhosis4, and who have relapsed or had a partial response to pegIFN and ribavirin (pegIFN/RBV)

OR

 

  • Treatment experienced2,3  patients with genotype 1a, with compensated cirrhosis4, and who have had a previous null response to pegIFN and ribavirin (pegIFN/RBV)

24 weeks in combination with ribavirin (Moderiba™)

AND

Who meet ALL the following criteria:

  1. Drug is prescribed by a hepatologist, a gastroenterologist, infectious disease specialist or other physician experienced with treating hepatitis C.
  2. Lab-confirmed hepatitis C genotype 1, subtype 1a and 1b. All patients who had their genotype 1 subtype diagnosis prior to May 1, 2012, require a new genotyping test (see Note #5 below). HCV genotyping must be repeated for treatment-experienced patients.
  3. Patient has a quantitative HCV RNA value within the last 6 months.
  4. Fibrosis stage is F2 or greater (Metavir scale or equivalent). Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (such as AST-to-Platelet Ratio Index (APRI) or Fibrosis-4 (FIB-4) score) either alone or in combination.
  5. Patient is not currently being treated with another HCV antiviral agent.

NOTES:

  1. For patients who meet the eligibility criteria above, clinicians are encouraged to choose ombitasvir-paritaprevir-ritonavir and dasabuvir (Holkira™ Pak), with or without ribavirin (Moderiba™) (for information regarding  Moderiba™, see Special Notes section below), as one of the preferred options over interferon-based regimens. This recommendation is based on evidence that Holkira™ Pak offers advantages in some patient populations, including potentially higher SVR rates, improved tolerability, elimination of the need for concomitant interferon therapy, and shorter course of therapy. 
  2. For treatment-experienced patients:
  • “Prior relapsers are defined as those with undetectable HCV RNA at the end of previous peginterferon/ribavirin (PegIFN/RBV) therapy but with a subsequent detectable HCV RNA during follow-up.
  • Partial responders” are defined as those with a decrease of HCV RNA ≥ 2-log10 IU/mL from baseline at week 12 on previous PegIFN/RBV therapy and detectable HCV RNA at the last measurement on treatment.
  • “Null responders” are defined as those with a decrease of HCV RNA < 2-log10 IU/mL from baseline at week 12 on previous PegIFN/RBV therapy and detectable HCV RNA at the last measurement on treatment.

     3. The following patient groups are not eligible for coverage:

  • Patients who have received previous NS3/4A protease inhibitors-based regimens (i.e., telaprevir, and simeprevir-based regimens).
  • Patients who have received previous sofosbuvir-based regimens including ledipasvir-sofosbuvir.

     4. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score =A (5-6).
         Coverage requests for patients with compensated cirrhosis requires the submission
         of a liver biopsy report or transient elastography (FibroScan®).

     5. Based on information from BC Center for Disease Control (BCCDC) genotyping
         tests performed before May 1, 2012, need to be repeated. HCV genotype tests
         performed after May 1, 2012, used a different technology that improves the accuracy
         of the subtyping result.

     6. Special Authority requests for re-treatment will not be considered.

     7. HIV/HCV co-infected patients are covered under the criteria listed above.

 

Practitioner Exemptions

  • None

Special Notes

  • For patients whose coverage was approved before March 23, 2017, PharmaCare will continue coverage until their current Special Authority expires.
  • In exceptional cases, requests that do not meet established criteria may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases.
  • No dose adjustment of Holkira™ Pak is required in patients with mild, moderate or severe renal impairment. Holkira™ Pak has not been studied in patients on dialysis (see Holkira™ Pak product monograph).
  • Holkira™ Pak may be used in combination with ribavirin (Moderiba™). Moderiba™ is not covered by PharmaCare, however it is provided at no cost to the patient by the manufacturer only when prescribed in combination with Holkira™ Pak. Moderiba™ is provided by the manufacturer throughAbbVie Care. Please contact AbbVie for more information. Note that a prescription will be required for the Moderiba™.
  • Please note than ribavirin (Ibavyr™) continues to be an eligible PharmaCare benefit for patients requiring this medication in combination with other treatments for chronic HCV infections.

Additional Information

Special Authority Request Form(s)