Prior Auth Protocol

FDA Approved Indications:

Osteoarthritis
Rheumatoid arthritis
Juvenile rheumatoid arthritis in patients 2 years and older
Acute pain
Primary Dysmenorrhea
Ankylosing spondylitis

Health Net Approved Indications and Usage Guidelines:

Diagnosis of rheumatoid arthritis, osteoarthritis, acute pain or chronic painful/inflammatory conditions where non-steroidal anti-inflammatory drugs (NSAIDs) are warranted.

AND

Patient demonstrates risk for developing NSAID-induced gastrointestinal (GI) complications (must have at least one of the following risk factors):
- History of GI bleeding (chart note documentation required)
- History of complicated PUD: (chart note documentation required)
  - GI perforations
  - GI obstructions
  - GI bleeding
- Concurrent use of one of the following:
  - oral prednisone, prednisolone, dexamethasone
  - warfarin (Coumadin^R), platelet inhibitors (e.g., Plavix^R, Ticlid^R) or other anticoagulants (e.g., Brilinta^R, Effient^R, Xarelto^R, Eliquis^R)
- Age greater than 60

OR

Patient has recently failed or had clinically significant adverse effects to 2 or more NSAIDs in prescription doses, documented through pharmacy claims or other means AND patient is not currently on other NSAIDs

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 risk vs. benefit of COX-II therapy should be individualized based on patient's previous GI history, other co-morbid conditions (e.g. angina, ischemic heart disease, MI, coronary artery disease, stroke), age, concurrent medications (e.g. warfarin, oral corticosteroids), duration and dose.
Celebrex has been associated with an increased risk of serious adverse cardiovascular (CV) events in a long-term placebo controlled trial. Based on the currently available data, FDA has concluded that an increased risk of serious adverse CV events appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs). FDA has requested that the package insert for all NSAIDs, including Celebrex, be revised to include a boxed warning to highlight the potential increased risk of CV events and the well described risk of serious, and potentially life-threatening, gastrointestinal bleeding.
The role of Celebrex in pre-term labor requires further controlled trials.
It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in familial adenomatous polyposis (FAP) patients. It is also not known whether the effects of Celebrex (at 400 mg BID) treatment will persist after Celebrex is discontinued. The efficacy and safety of Celebrex treatment in patients with FAP beyond six months have not been studied. In February 2011, the indication for FAP was removed from Celebrex.
The efficacy and safety of Celebrexfor Juvenile rheumatoid arthritis has not been studied beyond six months. The long term cardiovascular toxicity in children exposed to Celebrex has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to Celebrex or other COX-2 selective and non-selective NSAIDS.

Therapeutic Alternatives:

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

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Celebrex	Osteoarthritis 200 mg PO QD (or 100 mg BID) Rheumatoid arthritis 100 - 200 mg PO BID Juvenile Rheumatoid arthritis (2 years old and older) >10 kg to < 25 kg: 50 mg PO BID >25 kg: 100 mg PO BID Dysmenorrhea Initially 400 mg PO , followed by 200 mg if necessary on the 1st day. Thereafter, 200 mg BID as needed Acute pain Initially 400 mg PO, followed by 200 mg dose if necessary on the 1st day. Thereafter, 200 mg BID as needed. Ankylosing spondylitis Initial, 200 mg PO QD or 100 mg BID; if no effect occurs after 6 weeks increase to 400 mg daily (single or divided doses)	Length of Benefit

Product Availability:

Capsules: 50 mg, 100 mg, 200 mg, and 400 mg

References:

Celebrex [Prescribing information] New York, NY: Pfizer; January 2013.
The Medical Letter, Vol 41, Issue 1045.
Lanza F. A guideline for the treatment and prevention of NSAID-induced ulcers. AJG 1998;93:2037-2046.
Goldstein J. Prevention of nonsteroidal anti-inflammatory drug-induced gastropathy. Am J Man Care 1998;4:687-697.
Fries JF. Nonsteroidal anti-inflammatory drug-associated gastropathy. Am J Med 1991;91:213-222.
American College of Rheumatology Subcommittee on Osteoarthritis Guidelines: Arthritis Rheum 43(9):1905-15, 2000.
American College of Rheumatology 2010. Arthritis and Rheumatism. September 2010:62(9):2569-2581
Singh J, Furst D, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. May 2012;64(5):625-639..
Yeomans ND. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal anti-inflammatory drugs. N Engl J Med 1998;338:727-734.
Silverstein, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal antiinflammatory drugs for osteoarthritis and rheumatoid arthritis (CLASS Study). JAMA 2000;284:1247-1255.
Mukherjee. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286:954-959.
Juni, et al. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs. BMJ 2002;324:1287-1288.
Solomon DH, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004;109(17):2068-2073.
DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. http://www.thomsonhc.com. Accessed May 27, 2015.
COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). Available at: http://www.fda.gov/cder/drug/infopage/COX2/default.htm. Accessed May 27, 2015.
Celebrex. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/a399002.htm?q=celebrex&t=search&ss=text&p=1#_hit . Accessed May 27, 2015.