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Table 11: Nonsteroidal Anti-inflammatory Drugs


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Drug Category: Pain and inflammation
Medication Class/Individual Agent: Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

I. Prior Authorization Requirements

Table 11: Nonsteroidal Anti-inflammatory Drugs

A.Non-Selective NSAIDs

Drug Name

PA Status

Clinical Notes

Acetic Acid Derivatives

Risk factors for NSAID-related GI toxicity:
  • age > 60 years, history of gastric or duodenal ulcer, history of GI bleed, perforation or obstruction, concurrent use of anticoagulants, aspirin (including low doses for cardiovascular prophylaxis), corticosteroids, high daily NSAID doses 

 

To avoid or minimize GI toxicity:

  • Lowest effective dose should be prescribed for the shortest possible duration.
  • GI toxicity may be lower with ibuprofen, naproxen, ketoprofen, diclofenac, and higher with indomethacin, flurbiprofen, and piroxicam.

 

If risk factors are present for NSAID-related GI toxicity as above, consider:

  • etodolac, nabumetone and meloxicam, all of which are preferential COX-2 inhibitors; however, with higher doses of etodolac and nabumetone, preferential inhibition of COX-2 is diminished.
  • highly selective COX-2 inhibitor (see table below). an antisecretory agent (PPI or misoprostol) with a non-selective NSAID.

 

Risk factors for NSAID-related renal toxicity:

  • preexisting renal disease, severe CHF, liver disease, or diuretic use

etodolac extended-releasePA (effective 2/15/10)

etodolac (Lodine #)

 
indomethacin extended-releasePA (effective 2/15/10)

indomethacin (Indocin #)

 

nabumetone (Relafen #)

 

sulindac (Clinoril #)

 

tolmetin (Tolectin #)

 

Anthranilic Acid Derivatives

meclofenamate

 

mefenamic acid (Ponstel)

PA

Enolic Acid Derivatives

meloxicam

 

meloxicam (Mobic #)

PA < 60 years

piroxicam (Feldene #)

 

Phenylacetic Acid Derivatives

diclofenac (Cataflam #, Voltaren # )

diclofenac (Zipsor )PA
diclofenac extended-release (Voltaren XR #)PA (effective 2/15/10)

diclofenac/misoprostol (Arthrotec)

PA < 60 years
diclofenac topical gel (Solaraze)PA (effective 2/15/10)
diclofenac topical gel (Voltaren gel)PA
diclofenac topical patch (Flector patch)PA

Propionic Acid Derivatives

fenoprofen 600 mg

 
fenoprofen (Nalfon) 200 mgPA

flurbiprofen (Ansaid #)

 

ibuprofen * (Motrin #)

 
ibuprofen injection H (Caldolor) 

ketoprofen

 
ketoprofen extended-releasePA (effective 2/15/10)

ketorolac (Toradol #)

PA > 20 units/month

naproxen * (Anaprox #, Naprosyn #)

 

naproxen controlled-release 375 mg and 500 mg (Naprelan CR)

PA
naproxen controlled-release 750 mg (Naprelan CR)PA 
naproxen extended-releasePA
oxaprozin (Daypro #) 

Salicylic Acid Derivative

diflunisal (Dolobid #) 

B. COX-2 (Highly Selective) NSAIDs

Drug Name

PA Status

Clinical Notes

celecoxib (Celebrex)PA < 60 years

Osteoarthritis(OA)/Rheumatoid Arthritis (RA) Dosing:

  • Celebrex: OA: 200 mg QD or 100 mg BID; RA: 100-200 mg BID

Sulfonamide Allergy:

  • Celebrex is a sulfonamide derivative. The labeling for Celebrex states that use is contraindicated in sulfonamide-allergic patients.
  

#   This is a brand-name drug with FDA "A"-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA "A"-rated generic equivalent.

*   The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.


II. Therapeutic Uses

III. Evaluation Criteria for Approval


II. Therapeutic Uses

FDA-approved:

  • acute pain
  • mild-to-moderate pain
  • osteoarthritis
  • primary dysmenorrhea
  • rheumatoid arthritis
  • juvenile rheumatoid arthritis - celecoxib and meloxicam only
  • familial adenomatous polyposis (FAP) - celecoxib only
  • ankylosing spondylitis - celecoxib only

Note: The above list may not be all inclusive of FDA-approved indications

Back | Table 11


III. Evaluation Criteria for Approval

  • All prior authorization requests must include clinical diagnosis, drug name, dose and frequency.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below).

Back | Table 11


Brand name nonselective NSAIDs and mefenamic acid (see Table A.)

  • Documentation of a clinically significant adverse event to at least 2 generic, nonselective NSAIDs is required. If appropriate, at least 1 of the 2 trial drugs must include the AB-rated generic of the requested brand-name product.

Back | Table 11


Ketorolac >20 units/month

  • Documentation of trials with all other less costly, safer alternatives (i.e., generic nonselective NSAIDs) is required.

Back | Table 11


Celebrex, meloxicam, and Mobic for < 60 years old

  • Documentation of the following is required:
    • risk for a clinically significant gastrointestinal event or history of a gastrointestinal event; and 
    • a clinically significant adverse event or inadequate response to at least two generic nonselective NSAIDs.

SmartPA: Claims for Celebrex will usually process at the pharmacy without a prior-authorization request if the member has a history of MassHealth medical claims for an appropriate diagnosis (see therapeutic uses) and:

  • a history of MassHealth pharmacy claims for at least two different generic NSAIDs, or;
  • a history of pharmacy claims for warfarin, antiplatelet drug, or oral corticosteroid in the last 30 days.

Back | Table 11


Brand-name Mobic

  • Documentation, including medical records, of a clinically significant reaction to the generic equivalent or to its inactive ingredients is required.

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Meloxicam suspension

  • Documentation of the following is required:
    • medical necessity for the suspension formulation; and
    • risk for a clinically significant gastrointestinal event or history of a gastrointestinal event  or a clinically significant adverse event or inadequate response to nonselective NSAIDs

Back | Table 11


Controlled-release and extended-release NSAIDs

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical necessity for an extended-release formulation over the immediate release equivalent.

Back | Table 11 


Arthrotec for members < 60 years

  • Documentation of the following is required:
    • medical necessity for the combination product; and
    • risk for a clinically significant gastrointestinal event or history of a gastrointestinal event or a clinically significant adverse event or inadequate response to nonselective NSAIDs.

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Flector topical patch

  • Documentation of the following is required:
    • acute pain caused by minor strains, sprains, and contusions:
    • documentation of medical necessity for a transdermal formulation; and
    • a daily dose of not more than two patches/day.

Back | Table 11


Solaraze

  • Documentation of the following is required:
    • Actinic Keratosis; and 
    • documentation of inadequate response to topical fluororacil and imiquimod.

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Voltaren gel

  • Documentation of the following is required:
    • osteoarthritis; and
    • documentation of medical necessity for a topical formulation or a clinically adverse event or inadequate response  to acetaminophen and at least two different generic nonselective NSAIDS.

Back | Table 11


Zipsor

  • Documentation of the following is required:
    • mild to moderate pain; and
    • documentation of inadequate response to generic diclofenac and at least one different generic nonselective NSAID.

Back | Table 11


†  Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.

Original Effective Date: 9/2002                                                    Last Revised Date: 02/2010


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Last updated 02/04/10


This information is provided by MassHealth.