Prior Auth Protocol

FDA Approved Indications:

Zipsor: For relief of mild to moderate acute pain
Zorvolex: For management of mild to moderate acute pain and osteoarthritis pain

Health Net Approved Indications and Usage Guidelines:

Mild to moderate acute pain

OR

Osteoarthritis pain

AND

Failure or clinically significant adverse effect to diclofenac and one other preferred non-steroidal anti-inflammatory drug (NSAID) at prescription doses

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:

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Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
diclofenac sodium (Voltaren^R)	50 mg PO TID	200 mg/day
etodolac (Lodine^R)	400 - 500 mg PO BID	1200 mg/day
fenoprofen (Nalfon^R)	200 mg PO Q4-6hr	3200 mg/day
ibuprofen (Motrin^R)	400 - 800 mg PO Q6-8hr	3200 mg/day
indomethacin (Indocin^R)	25 - 50 mg PO BID-TID	200 mg/day
indomethacin SR (Indocin^R SR)	75 mg PO QD - BID	150 mg/day
ketoprofen (Orudis^R)	25 - 50 mg PO Q6-8hr	300 mg/day
meclofenamate (Meclomen^R)	50 - 100 mg PO Q4-6hr	400 mg/day
meloxicam (Mobic^R)	7.5 mg - 15 mg PO QD	15 mg/day
naproxen (Naprosyn^R)	250 - 500 mg PO BID	1500 mg/day
naproxen sodium (Anaprox^R, Anaprox DS^R)	275 - 550 mg PO BID	1650 mg/day
oxaprozin	600 - 1200 mg PO QD	1800 mg/day
piroxicam (Feldene^R)	10 - 20 mg PO QD	20 mg/day
salsalate (Disalcid^R)	500 - 750 mg PO BID - TID, titrated up to 3000 mg/day	3000 mg/day
sulindac (Clinoril^R)	150 mg - 200 mg PO BID	400 mg/day
tolmetin (Tolectin^R)	200 - 600 mg PO TID	1800 mg/day
nabumetone (Relafen^R)	1000 mg QD	2000 mg/day
naproxen ER (Naprelan^R)	750-1000 mg PO QD	1500 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Zipsor	Acute pain 25 mg PO QID	Length of benefit
Zorvolex	Acute Pain 18 - 35 mg PO TID Osteoarthritis 35 mg PO TID	Length of Benefit

Product Availability:

Zipsor Liquid Filled Capsule: 25 mg

Zorvolex Capsules: 18 mg and 35 mg

References:

1. Zipsor^R [Prescribing Information]. Newark, CA: Depomed, Inc.;May 2016.
2. MicromedexHealthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 20, 2016.
3. Zorvolex^R [Prescribing Information]. Philadelphia, PA: Iroko Pharmaceuticals LLC; May 2016.