Prior Auth Protocol

Prior Authorization Protocol

ORKAMBI^TM (lumacaftor/ivacaftor)

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:
- Treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation in the CFTR gene
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of cystic fibrosis
AND
- Presence of homozygous F508del mutation in an FDA-cleared CF mutation test
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:
- The efficacy and safety of Orkambi have not been established in patients with CF other than those homozygous for the F508del mutation
- If the patients genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene
Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
This field intentionally left blank. This field intentionally left blank. This field intentionally left blank.
* Requires Prior Authorization

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
This field intentionally left blank.	This field intentionally left blank.	This field intentionally left blank.

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Orkambi	Ages 12 years and older: 2 tablets of lumacaftor 200 mg/ ivacaftor 125 mg PO Q12h Age 6 to 11 years: 2 tablets of lumacaftor 100 mg/ivacaftor 125 mg PO Q12h	Length of Benefit

Product Availability:

Tablet: lumacaftor 200 mg/ivacaftor 125 mg, lumacaftor 100 mg/ivacaftor 125 mg
References:

1. Orkambi [Prescribing Information]. Boston, MA: Vertex Pharmaceuticals Incorporated; September 2016.

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.