New to Market Drugs Prior Authorization Criteria

FastPAth: New to Market Drugs Prior Authorization Criteria

Program Summary

For GenPlus formulary this criteria applies to Ocaliva and Zepatier.

For Commercial and Health Insurance Marketplace formularies this criteria does not currently have any targets.

OBJECTIVE The intent of the FastPAth prior authorization (PA) Criteria is to ensure appropriate selection of patients for treatment according to FDA approved product labeling. The PA defines appropriate use as use in patients who have a Food and Drug Administration (FDA) approved indication, who are receiving the FDA labeled dose, and who do not have any FDA labeled contraindications. Requests will be reviewed when patient-specific documentation has been provided.

TARGET DRUGS Ocaliva (obeticholic acid) Zepatier™ (elbasvir/grazoprevir)

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL The targeted drug(s) will be approved when ALL of the following are met: 1. The patient has an FDA approved indication for the requested agent AND 2. The patient does not have any FDA labeled contraindications to the requested agent AND 3. ONE of the following a. The quantity requested is within the set quantity limit OR b. The quantity (dose) requested is within FDA approved labeling and the prescribed dose cannot be achieved using a lesser quantity of a higher strength

Length of Approval: see table below Drug FDA labeled FDA labeled FDA labeled dose Quantity Limit Duration indications Contraindications (if applicable) of Approval Ocaliva Ocaliva is indicated Patients with complete The recommended 5mg tablet: 1 12 months (obeticholic for the treatment of biliary obstruction starting dosage is 5 tablet/day acid) primary biliary mg orally once daily in cholangitis (PBC) in adult patients who 10mg tablet: 1 combination with have not achieved an tablet/day ursodeoxycholic acid adequate biochemical (UDCA) in adults with response to an an inadequate appropriate dosage of response to UDCA, or UDCA for at least 1 as monotherapy in year or are intolerant adults unable to to UDCA. tolerate UDCA. If an adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of Ocaliva 5 mg once daily, and the patient is tolerating treatment, increase the dosage to 10 mg once daily

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© Copyright Prime Therapeutics LLC. 07/2016 All Rights Reserved ZepatierTM Zepatier is a fixed- Patients with moderate Genotype 1a: 28 tablets/28 days 12 weeks (elbasvir/grazo dose combination or severe hepatic Treatment-naïve or previr) product containing impairment (Child-Pugh PegIFN/RBV- elbasvir, a hepatitis C B or C) experienced without virus (HCV) NS5A baseline NS5A inhibitor, and OATP1B1/3† inhibitors, polymorphisms£ - grazoprevir, an HCV strong CYP3A inducers, Zepatier 1 tablet daily NS3/4A protease and efavirenz inhibitor, and is Genotype 1a: 28 tablets/28 days 16 weeks indicated with or If Zepatier is Treatment-naïve or without ribavirin for administered with PegIFN/RBV- treatment of chronic ribavirin, the experienced with HCV genotype 1 or 4 contraindications to baseline NS5A infection in adults ribavirin apply polymorphisms£ - Zepatier 1 tablet daily + ribavirin

Genotype 1b: 28 tablets/28 days 12 weeks Treatment-naïve or PegIFN/RBV experienced – Zepatier 1 tablet daily

Genotype 1a or 1b: 28 tablets/28 days 12 weeks PegIFN/RBV + NS3/4A protease inhibitor experienced – Zepatier 1 tablet daily + ribavirin

Genotype 4: 28 tablets/28 days 12 weeks Treatment-naïve – Zepatier 1 tablet daily

Genotype 4: 28 tablets/28 days 16 weeks PegIFN/RBV- experienced- Zepatier 1 tablet daily + ribavirin

†Organic anion transporting polypeptides 1B1/3. Examples of OATP1B1/3 inhibitors include atazanavir, cyclosporine, darunavir, lopinavir, saquinavir, tipranavir. This is not a comprehensive list of OATP1B1/3 inhibitors £ Polymorphisms at amino acid positions 28, 30, 31, or 93

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Drug FDA labeled indications FDA labeled FDA labeled dose Contraindications

Ocaliva Ocaliva is indicated for Patients with The recommended (obeticholic the treatment of complete biliary starting dosage is 5 mg acid) primary biliary obstruction orally once daily in adult cholangitis (PBC) in patients who have not combination with achieved an adequate ursodeoxycholic acid biochemical response to (UDCA) in adults with an appropriate dosage of an inadequate response UDCA for at least 1 year to UDCA, or as or are intolerant to monotherapy in adults UDCA unable to tolerate If an adequate reduction UDCA. in ALP and/or total bilirubin has not been achieved after 3 months of Ocaliva 5 mg once daily, and the patient is tolerating treatment, increase the dosage to 10 mg once daily 1. ZepatierTM Zepatier is a fixed- Patients with 1 tablet daily with or (elbasvir/gra dose combination moderate or severe without ribavirin zoprevir) product containing hepatic impairment elbasvir, a hepatitis (Child-Pugh B or C) C virus (HCV) NS5A inhibitor, and OATP1B1/3 inhibitors, grazoprevir, an HCV strong CYP3A NS3/4A protease inducers, and inhibitor, and is efavirenz indicated with or without ribavirin for If Zepatier is treatment of chronic administered with HCV genotype 1 or 4 ribavirin, the infection in adults contraindications to ribavirin apply

REFERENCES 1. Zepatier prescribing information. Merck. January 2016. 2. Ocaliva prescribing information. Intercept Pharmaceuticals. May 2016.

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