Prior Auth Protocol

Prior Authorization Protocol

ESBRIET^R (pirfenidone)

NATL

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.

FDA Approved Indications:
- The treatment of Idiopathic Pulmonary Fibrosis (IPF)
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
AND
- Prescribed by or in consultation with a pulmonologist
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:
- Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with Esbriet in all patients, then monthly for the first 6 months and every 3 months thereafter
- Patients who miss 14 or more days of Esbriet should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage
Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
Ofev (nintedanib)
150 mg PO BID approximately 12 hours apart, taken with food
300 mg/day
* Requires Prior Authorization

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Ofev (nintedanib)	150 mg PO BID approximately 12 hours apart, taken with food	300 mg/day

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Esbriet (pirfenidone)	Day 1-7: 267 mg PO TID with food Day 8-14: 534 mg PO TID with food Day 15+: 801 mg PO TID with food Maximum: 9 capsules (2403 mg) /day	Length of Benefit

Product Availability:

Esbriet capsule: 267 mg
References:

1. Esbriet [Prescribing Information]. Brisbane, CA: InterMune, Inc.; October 2014.
2. Ofev [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2014.

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.