Prior Auth Protocol

FDA Approved Indications:

For the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen

Health Net Approved Indications and Usage Guidelines:

Diagnosis of hepatitis C virus (HCV) genotype 1 or 4 infection confirmed by detectable serum HCV RNA by quantitative assay.

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^R), score greater than or equal to 7.5 kPa; OR FibroSure^R (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.

Coverage is Not Authorized For:

Treatment of HCV as monotherapy.
Quadruple therapy (Sovaldi+Olysio+peginterferon+ribavirin) combination
Patients with moderate or severe hepatic impairment (ChildPugh Class B or C).
Patients who previously failed therapy with a treatment regimen that included Olysio or a HCV NS3/4A protease inhibitor (e.g., Incivek, Victrelis or , paritaprevir [found in Viekira Pak])
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
Olysio is metabolized by the CYP enzyme, CYP3A; coadministration with moderate or strong inducers or inhibitors of CYP3A is not recommended as this may decrease or increase simeprevir concentrations, respectively. Simeprevir should not be coadministered with any of the following: milk thistle, St. Johns wort, HIV protease inhibitors (with or without ritonavir), efavirenz, etravirine, nevirapine, antiretroviral agents containing cobicistat, antimycobacterials (e.g., rifabutin, rifampin, rifapentine), macrolides, azole antifungals, ketolides, dexamethasone, anticonvulsants ( e.g. carbamazepine, phenytoin, phenobarbital, oxcarbazepine).

General Information:

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.
The use of Olysio in combination with pegylated interferon is no longer recommended by AASLD treatment guidelines.
Serious symptomatic bradycardia may occur in patients taking Olysio in combination with sofosbuvir (Sovaldi) and amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Olysio and Sovaldi:
- Counsel patients about the risk of serious symptomatic bradycardia
- Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
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.

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	Genotype 4: Treatment-naive 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
Zepatier + ribavirin	Genotype 4: PegIFN/RBV-experienced One tablet PO QD plus BID ribavirin	16 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Olysio* plus Sovaldi*	Treatment-naive patients with HCV genotype 1a infection without cirrhosis: Sovaldi 400 mg PO QD plus Olysio 150 mg PO QD with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg])	12 weeks May be filled in quantities up to 28 days at a time
Olysio* plus Sovaldi*	Treatment-naive patients with HCV genotype 1a infection with cirrhosis: Sovaldi 400 mg PO QD plus Olysio 150 mg PO QD with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg])	24 weeks May be filled in quantities up to 28 days at a time
Olysio* plus Sovaldi*	Treatment-naive patients with HCV genotype 1b infection and without cirrhosis: Sovaldi 400 mg plus Olysio 150 mg PO QD.	12 weeks May be filled in quantities up to 28 days at a time
Olysio* plus Sovaldi*	Treatment-naive patients with HCV genotype 1b infection and with cirrhosis: Sovaldi 400 mg plus Olysio 150 mg PO	24 weeks May be filled in quantities up to 28 days at a time
Olysio*	Treatment-naive, prior relapsers, and prior non-responders to Peg-IFN/RBV treatment with HCV genotype 4 infection: Olysio 150 mg PO QD with weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) and PEG-IFN	12 weeks May be filled in quantities up to 28 days at a time
Olysio* plus Sovaldi*	Patients with HCV genotype 1 infection who do NOT have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed: Sovaldi 400 mg QD plus Olysio 150 mg QD with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg])	12 weeks May be filled in quantities up to 28 days at a time
Olysio* plus Sovaldi*	Patients with HCV genotype 1 infection who do have cirrhosis, in whom prior PEG-IFN and RBV treatment has failed: Sovaldi 400 mg QD plus Olysio 150 mg QD with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg])	24 weeks May be filled in quantities up to 28 days at a time

Product Availability:

150 mg capsules

References:

1. Olysio, [Prescribing Information]. Titusville, NJ: Janssen, LP; October 2015.

2. Ghany MG, Strader DB, Thomas DL, Leonard SB. Diagnosis, Management, and Treatment of Hepatitis C: An Update. American Association for the Study of Liver Diseases. Hepatology. 2009. Volume 49, Number 9: 1335-1374.

3. American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) Recommendations for Testing, Managing, and Treating Hepatitis C June 2015: http://www.hcvguidelines.org/full-report-view