Prior Auth Protocol

Prior Authorization Protocol

IRENKA^TM (duloxetine)

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:
- For use in the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), and chronic musculoskeletal pain
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), chronic musculoskeletal pain, or fibromyalgia
AND
- Medical justification must be provided why generic duloxetine administered as two 20 mg strength capsules cannot be used
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:
- Cymbalta (duloxetine) is FDA approved for the management of fibromyalgia.
Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
duloxetine 20 mg
20 mg PO BID
120 mg/day
* Requires Prior Authorization
Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit
Irenka
30-120 mg PO QD or divided BID
Length of Benefit
Product Availability:

Delayed-release capsule: 40 mg
References:

1. Irenka [Prescribing Information]. Baltimore, MD: Lupin Pharma; June 2015.

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
duloxetine 20 mg	20 mg PO BID	120 mg/day

Drug	Dosing Regimen	Authorization Limit
Irenka	30-120 mg PO QD or divided BID	Length of Benefit

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.