Prior Auth Protocol

FDA Approved Indications:

Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drugs (NSAID) associated gastric ulcers.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of Rheumatoid arthritis, osteoarthritis or for other chronic painful/inflammatory conditions where NSAIDs are warranted.

AND

Failure or clinically significant adverse effects to 2 preferred proton pump inhibitors (PPIs) in combination with a prescription dose NSAID

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:

Black Box Warning: Naproxen, a component of Vimovo, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Vimovo is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass surgery. NSAIDS, including naproxen, a component of Vimovo, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
PPIs rabeprazole (Aciphex^R)	20 mg PO QD to BID	40 mg
Dexilant^R(dexlansoprazole)*	30 - 60 mg PO QD	60 mg
lansoprazole (Prevacid^R)*	15 - 30 mg PO QD to BID	60 mg
esomeprazole (Nexium^R)*	20 - 40 mg PO QD to BID	80 mg
omeprazole (Prilosec^R)	20 - 40 mg PO QD to BID	80 mg
pantoprazole (Protonix^R)	40 mg PO QD to BID	80 mg
omeprazole/sodium bicarbonate (Zegerid^R)*	20 - 40 mg PO QD	80 mg
NSAIDs diclofenac (Voltaren^R)	50 mg PO TID	200 mg/day
etodolac (Lodine^R)	400-500 mg PO BID	1200 mg/day
fenoprofen (Nalfon^R)	400 mg PO TID to QID	3200 mg/day
ibuprofen (Motrin^R)	400 - 800 mg PO TID to QID	3200 mg/day
indomethacin (Indocin^R)	25 - 50 mg PO BID to TID	200 mg/day
indomethacin SR (Indocin SR^R)	75 mg PO QD to BID	150 mg/day
ketoprofen (Orudis^R)	25-75 mg PO TID to QID	300 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 (Daypro^R)	600 - 1200 mg PO BID	1800 mg/day
piroxicam (Feldene^R)	10 - 20 mg PO QD	20 mg/day
salsalate (Disalcid^R)	500 - 1000 mg PO TID	3000 mg/day
sulindac (Clinoril^R)	150 mg - 200 mg PO BID	400 mg/day
tolmetin DS (Tolectin DS^R)	400 - 600 mg PO TID	1800 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Vimovo (naproxen/ esomeprazole)	375/20 - 500/20 mg PO BID	Length of Benefit

Product Availability:

Tablet: naproxen/ esomeprazole 500 mg/20 mg, naproxen/ esomeprazole 375 mg/20 mg

References:

Vimovo [Prescribing information] Deerfield, IL:Horizon Pharma USA, Inc.; December 2014.
Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com Accessed June 29, 2015.
Micromedex^R Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 29, 2015.