Prior Auth Protocol

FDA Approved Indications:

For the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis.

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

A trial of Harvoni is required (Member must meet prior authorization criteria for and use Harvoni unless contraindicated)

AND

Chart note documentation and copies of lab results are required

AND

Prescribed by or in consultation with a gastroenterologist, hepatologist or infectious disease physician.

AND

One of the following clinical states to identify candidates for treatment:
- Evidence of Stage 2 or greater hepatic fibrosis defined by one of the following:
  - Liver biopsy confirming a METAVIR score F2 or greater
  - Transient elastography (Fibroscan) score greater than or equal to 7.5 kPa
  - FibroSure (also known as FibroTest) score of greater than or equal to 0.48
  - APRI score greater than 0.7
  - FIB greater than 3.25
  - ARFI score of greater than 1.34 m/s
  - MRE score of greater than 3.20 kilopascals
  - HepaScore ≥0.55
  - FibroMeter ≥ 0.411
- 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).
- 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) Fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and causes a substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months
- Men who have sex with men with high-risk sexual practices
- Patients with a current injectable substance abuse disorder and actively participating in treatment
- Persons on long-term hemodialysis
- Women of childbearing age who wish to get pregnant
- HCV-infected health care workers who perform exposure-prone procedures

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 who have failed to respond to previous protease inhibitor (Olysio, Victrelis) based therapy.
Patients with decompensated cirrhosis (Child Pugh Class B or C).

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.
The FIBROSpect II is a commercially available test that combines hyaluronic acid, tissue inhibitor of a metalloproteinase-1 (TIMP-1), and alpha-2-macroglobulin in a predictive algorithm for fibrosis stages (F2 to F4). An index score of greater than 0.42 is classified with the presence of stage F2 to F4 fibrosis, but is unable to differentiate amongst each of the fibrosis stages F2, F3 and F4.
APRI and FibroSpect II have the lowest specificity values compared to FibroSure, FibroScan, ARFI and MRE
Dosing for patients with HCV/HIV co-infection should follow the dosage recommendations in the table below
Viekira Pak has not been studied in subjects who have failed prior treatment with another NS5A inhibitor, NS3/4A protease inhibitor, or NS5B inhibitor.
Viekira Pak is not recommended for use in patients with decompensated cirrhosis
The use of Viekira Pak in combination with drugs that 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%.
Child-Pugh Score:

	1 Point	2 Points	3 Points
Bilirubin	Less than 2 mg/dL Less than 34 umol/L	2-3 mg/dL 34-50 umol/L	Over 3 mg/dL Over 50 umol/L
Albumin	Over 3.5 g/dL Over 35 g/L	2.8-3.5 g/dL 28-35 g/L	Less than 2.8 g/dL Less than 28 g/L
INR	Less than 1.7	1.7 - 2.2	Over 2.2
Ascites	None	Mild / medically controlled	Moderate-severe / poorly controlled
Encephalopathy	None	Mild / medically controlled Grade I-II	Moderate-severe / poorly controlled. Grade III-IV

Diagnostic criteria for chronic fatigue syndrome was developed by an expert committee convened by the Institute of Medicine on the basis of a comprehensive literature review and input from patient, advocacy, and research communities. These diagnostic criteria state that symptoms should persist for at least 6 months and be present at least half the time with moderate, substantial, or severe intensity to distinguish chronic fatigue syndrome from other diseases.
Viekira Pak and Technivie are contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C).

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
*Harvoni^R (sofosbuvir/ledipasvir)	One tablet PO QD	8 to 24 weeks
*Epclusa	Without cirrhosis or with compensated cirrhosis, treatment naive or treatment experienced: One tablet PO QD	12 weeks
*Epclusa plus ribavirin	With decompensated cirrhosis (Child-Pugh class B or C) treatment naive or treatment experienced: One tablet PO QD plus weight based ribavirin	12 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Genotype 1a, treatment naive or previous treatment with peg-interferon + ribavirin, without cirrhosis	Viekira Pak/Viekira XR + Ribavirin	12 weeks
Genotype 1a, treatment naive or previous treatment with peg-interferon + ribavirin, with cirrhosis	Viekira Pak/Viekira XR + Ribavirin	24 weeks
Genotype 1b treatment naive or previous treatment with peg-interferon + ribavirin, without cirrhosis	Viekira Pak/Viekira XR	12 weeks
Genotype 1b treatment naive or previous treatment with peg-interferon + ribavirin, with cirrhosis	Viekira Pak/Viekira XR	12 weeks
Genotype 1 post liver transplant with normal liver function and mild fibrosis (F0-F2)	Viekira Pak/Viekira XR + Ribavirin	24 weeks

Product Availability:

Viekira Pak: dasabuvir 250 mg tablets 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.

References:

Viekira [Prescribing Information]. North Chicago, IL: Abbvie Pharmaceuticals Corp; October 2015.
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.
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.
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;20:1973-1982
Ferenci P, Bernstein D, Lalezari J et al. ABT-450r-ombitasvir and dasabuvir with or without ribavirin for HCV. NEJM May 22, 2014; 370;20:1983-1992
American Association for the Study of Liver Disease Recommendations for Testing,Managing, and Treating Hepatitis C; September 2016. (accessed at: http://www.hcvguidelines.org)
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
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
Institute of Medicine of the National Academies. Beyond Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome Redefining an Illness. Report Brief, February 2015. Available at: https://iom.nationalacademies.org/~/media/Files/Report%20Files/2015/MECFS/MECFS_ReportBrief.pdf, accessed October 7, 2015.
Viekira XR [prescribing information]. North Chicago, IL: Abbvie Pharmaceuticals Corp; June 2016.