Prior Auth Protocol

FDA Approved Indications:

Daklinza is an NS5A inhibitor indicated for use with sofosbuvir for the treatment of chronic HCV genotype 1 or 3 infection.

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 1, 2 or 3. Baseline viral load by quantitative assay including genotype and treatment status of patient (treatment naive or treatment experienced) are required.

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

Used in combination with Sovaldi (sofosbuvir)

AND

For genotype 1: A trial of Harvoni is required (Member must meet prior authorization criteria for and use Harvoni unless contraindicated)

AND

For genotype 1a with cirrhosis, laboratory testing confirming the absence of NS5A resistance-associated polymorphisms at amino acid positions M28, Q30, L31 and Y93

OR

For genotype 2, 3: Failure or clinically significant adverse effects to Epclusa (sofosbuvir/velpatasvir)

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.

General Information:

For patients infected with HCV Genotype 1a with cirrhosis: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.
Strong CYP3A4 inhibitors are: atazanavir/ritonavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, saquinavir, telithromycin, voriconazole.
Moderate CYP3A4 inducers are: bosentan, dexamethasone, efavirenz, betravirine, modafinil, nafcillin, rifapentine.
Per the August 2015 AASLD updates, Daklinza plus Sovaldi is a treatment option for patients with GT 1 and 2 diseases. For GT 2 disease, the option is for patients who cannot tolerate ribavirin.
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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Harvoni* (sofosbuvir/ledipasvir)	One tablet PO QD for 12 weeks	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
Daklinza, Sovaldi	GT1 treatment naive or treatment experienced with Peg-IFN/RBV with or without protease inhibitor, and without cirrhosis: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	12 weeks
Daklinza, Sovaldi	GT1 treatment naive or treatment experienced with Peg-IFN/RBV with or without protease inhibitor, and with cirrhosis: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD with or without weight based RBV	24 weeks
Daklinza, Sovaldi	GT1 with decompensated cirrhosis (including those with hepatocellular carcinoma): Daklinza 60 mg PO plus Sovaldi 400 mg PO QD with RBV	12 weeks
Daklinza, Sovaldi	GT1 with decompensated cirrhosis (including those with hepatocellular carcinoma) and intolerant to RBV: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	24 weeks
Daklinza, Sovaldi	GT2, treatment naive without cirrhosis, AND, unable to tolerate RBV: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	12 weeks
Daklinza, Sovaldi	GT2 who are not eligible to receive IFN, in whom previous treatment with Sovaldi/RBV has failed: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD with or without RBV	24 weeks
Daklinza, Sovaldi	GT3, treatment naive or treatment experienced with Peg IFN/RBV without cirrhosis: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	12 weeks
Daklinza, Sovaldi	GT 3, treatment naive or treatment experienced with Peg IFN/RBV with cirrhosis: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	24 weeks
Daklinza, Sovaldi	GT 3 who are not eligible to receive IFN, in whom previous treatment with Sovaldi/RBV has failed: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD with RBV	24 weeks
Daklinza, Sovaldi	GT 1, 2 or 3 infection in the allograft, including those with compensated cirrhosis: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD with RBV	12 weeks
Daklinza, Sovaldi	GT 1, 2 or 3 infection in the allograft, including those with compensated cirrhosis and intolerant to RBV: Daklinza 60 mg PO plus Sovaldi 400 mg PO QD	24 weeks
Daklinza, Sovaldi	Reduce dosage to 30 mg PO QD with strong CYP3A4 inhibitors and increase to 90 mg PO QD with moderate CYP3A inducers.	This field intentionally left blank

Product Availability:

Tablets: 30 and 60 mg

References:

1. Daklinza [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Company; February 2016.

2. Nelson DR, Cooper JN, Lalezari JP et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015;61:1127-1135.

3. Wyles DL, Ruane PJ, Sulkowski MS et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. New Engl J Med. 2015 July 21 [epub ahead of print].

4. Recommendations for testing, managing, and treating hepatitis c. Updated August 7, 2015. Available at: http://www.hcvguidelines.org/full-report-view.

5. 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.