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Prior Authorization Protocol
VIEKIRA PAK, VIEKIRA XR (dasabuvir copackaged with paritaprevir/ritonavir/ombitasvir)

HNMC
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of chronic hepatitis C (CHC) confirmed by detectable serum HCV RNA by quantitative assay in patients with genotype 1a or 1b. Genotype is required to determine length of approval.

    AND

    • Failure or clinically significant adverse effects to Zepatier (grazoprevir/elbasvir)

    AND

    • Patient is 18 years of age or older
    AND
    • Any of the following clinical states identify candidates for treatment:
      • Evidence of Stage 2 or greater hepatic fibrosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater OR Transient elastography (Fibroscan.), score greater than or equal to 7.5 kPa; OR FibroSure. (also known as FibroTest) score of greater than or equal to 0.48; OR APRI score greater than 0.7; OR FIB greater than 3.25.
      • Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end- organ manifestations (e.g. vasculitis), or kidney disease (e.g. proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis).
      • Persons with hepatocellular carcinoma with life expectancy greater than 12 months
      • Pre- and post-liver transplant, or other solid organ transplant
      • HIV-1 co-infection
      • Hepatitis B co-infection
      • Other coexistent liver disease (e.g. nonalcoholic steatohepatitis)
      • Type 2 diabetes mellitus (insulin resistant)
      • Porphyria cutanea tarda
      • Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease)
      • Men who have sex with men with high-risk sexual practices
      • Active injection drug users
      • Persons on long-term hemodialysis
      • Women of childbearing age who wish to get pregnant
      • HCV-infected health care workers who perform exposure-prone procedures
    Criteria for Reauthorization/Continuation of Therapy:
    • Initial authorization criteria have been met, and
    • Evidence of lack of adherence may result in denial of treatment reauthorization.
    • Missed medical appointments related to the hepatitis C virus may result in denial of treatment authorization
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
    • Patients with decompensated cirrhosis (Child Pugh Class B or C).
  4. General Information:
    • In the PEARL-IV trial,patients with genotype 1a who were treated with Viekira Pak without ribavirin had inferior results when compared to patients treated with Viekira Pak plus ribavirin.
    • Viekira Pak is not recommended for use in patients with decompensated cirrhosis.
    • Viekira Pak has not been studied in subjects who have failed prior treatment with another NS5A inhibitor, NS3/4A protease inhibitor, or NS5B inhibitor.
    • There are currently neither published studies nor AASLD guidelines supporting the use of Viekira Pak in patients with hepatocellular carcinoma (HCC). Sovaldi (sofosbuvir) is currently approved by the FDA for some patients with HCC.
    • The use of Viekira Pak in combination with drugs which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. The concurrent use of Viekira Pak with amiodarone has been shown to increase drug levels (both the maximum concentration and area under curve) of amiodarone by more than 20%.
    • Patients should be evaluated for readiness to initiate treatment. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. Caution should be exercised with patients who have a history of treatment failure with prior hepatitis C treatment due to non-adherence with treatment regimen and appointments. Patients should be educated regarding potential risks and benefits of hepatitis C virus therapy, as well as the potential for resistance and failed therapy if medication is not taken as prescribed.
    • Evidence of lack of adherence may result in denial of treatment reauthorization.
    • Lost medications will not be replaced and may result in denial of treatment authorization. Replacement of stolen medications will require documentation and will be adjudicated on a case-by-case basis.
    • Missed medical and lab appointments may result in denial of treatment authorization.
    • Retreatment may be considered where there is evidence that such retreatment will improve patient outcomes according to AASLD guidelines.
    • HIV/HCV-coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications.
    • Viekira Pak and Technivie are contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C).
    • Investigational services are not covered except when it is clearly documented that all of the following apply:
      • Conventional therapy will not adequately treat the intended patient's condition;
      • Conventional therapy will not prevent progressive disability or premature death;
      • The provider of the proposed service has a record of safety and success with it equivalent or superior to that of other providers of the investigational service;
      • The investigational service is the lowest cost item or service that meets the patient's medical needs and is less costly than all conventional alternatives;
      • The service is not being performed as a part of a research study protocol;
      • There is a reasonable expectation that the investigational service will significantly prolong the intended patient's life or will maintain or restore a range of physical and social function suited to activities of daily living;
      • All investigational services require prior authorization. Payment will not be authorized for investigational services that do not meet the above criteria or for associated inpatient care when a beneficiary needs to be in the hospital primarily because she/he is receiving such non-approved investigational services.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Zepatier

    Genotype 1a:
    Treatment-naive or PegIFN/RBV experienced without baseline NS5A polymorphisms at amino acid positions 28, 30, 31, or 93
    One tablet PO QD

    12 weeks

    Zepatier

    Genotype 1b:
    Treatment-naive or PegIFN/RBV experienced
    One tablet PO QD

    12 weeks

    Zepatier + ribavirin

    Genotype 1a:
    Treatment-naive or PegIFN/RBV experienced with baseline NS5A polymorphisms at amino acid positions 28, 30, 31, or 93
    One tablet PO QD plus BID ribavirin

    16 weeks

    Zepatier + ribavirin

    Genotype 1a or 1b:
    PegIFN/RBV/PI-experienced
    One tablet PO QD plus BID ribavirin

    12 weeks

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Viekira Pak
    [dosed as (paritaprevir/ritonavir/ombitasvir) Two tablets PO QD Plus (dasabuvir) One tablet PO BID]

    Genotype 1 CHC:

    Genotype 1a, treatment naive or previous treatment with peg-interferon + ribavirin, without cirrhosis:
     Viekira Pak/Viekira XR + ribavirin

    Genotype 1b treatment naive or previous treatment with peg-interferon + ribavirin, without cirrhosis:
     Viekira Pak/Viekira XR only

    Genotype 1b treatment naive or previous treatment with peg-interferon + ribavirin, with cirrhosis:
     Viekira Pak/Viekira XR

    12 weeks

    May be filled in quantities up to 28 days at a time
    Viekira Pak
    [dosed as (paritaprevir/ritonavir/ombitasvir) Two tablets PO QD Plus (dasabuvir) One tablet PO BID]

    Genotype 1a, treatment naive or previous treatment with peg-interferon + ribavirin, with cirrhosis:
     Viekira Pak/Viekira XR + ribavirin

    24 weeks

    May be filled in quantities up to 28 days at a time

    Viekira Pak
    [dosed as (paritaprevir/ritonavir/ombitasvir) Two tablets PO QD Plus (dasabuvir) One tablet PO BID]

    Genotype 1 CHC, Post liver transplant with normal liver function and mild fibrosis (F0 to F2):
     Viekira Pak/Viekira XR + ribavirin

    24 weeks

    May be filled in quantities up to 28 days at a time
  7. Product Availability:
    Viekira Pak: dasabuvir tablets 250 mg copackaged with paritaprevir 75 mg, ritonavir 50 mg, ombitasvir 12.5 mg tablets

    Viekira XR: extended-release tablets - dasabuvir 200 mg, ombitasvir 8.33 mg, paritaprevir 50 mg, ritonavir 33.33 mg

    Viekira Pak and Viekira XR are dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs.
  8. References:
    1. Viekira Pak [Prescribing Information]. North Chicago, IL: Abbvie Pharmaceuticals Corp; October 2015.
    2. Feld JJ, Kowdkey KV, Coakley E et al. Treatment of HCV with ABT-450r-ombitasvir and dasabuvir with ribavirin. NEJM Apr 24,2014;370;17:1594-1603.
    3. Zeuzem S, Jacobson IM, Baykal T et al. Retreatment of HCV with ABT-450r-ombitasvir and dasabuvir with ribavirin. NEJM Apr 24, 2014;370;17:1604-1614.
    4. Poordad F, Hezode C, Trinh R, et al. ABT-450r-Ombitasvir and dasbuvir with ribavirin for hepatitis C with cirrhosis. NEJM May 22, 2014;370;21: 1973-1982
    5. Ferenci P, Bernstein D, Lalezari J et al. ABT-450r-ombitasvir and dasabuvir with or without ribavirin for HCV. NEJM May 22, 2014;370;21: 1983-1992
    6. American Association for the Study of Liver Disease Recommendations for Testing,Managing, and Treating Hepatitis C; September 2016. (accessed at: http://www.hcvguidelines.org)
    7. European Association for Study of the Liver treatment guidelines April 2014 accessed at: http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C/index.html#p=4
    8. WHO guidelines for treatment of hepatitis C April 2014 accessed at: http://apps.who.int/iris/bitstream/10665/111747/1/9789241548755_eng.pdf?ua=1&ua=1.9
    9. Viekira XR [prescribing information]. North Chicago, IL: Abbvie Pharmaceuticals Corp; June 2016.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.