Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute pelvic pain.
Treatment:  Naproxen 550 mg (milligrams) OR (oral) TABS (tablets).
The insurer denied Naproxen 550 mg OR TABS.  
The denial is upheld.

The patient is an adult female, who has dysmenorrhea happening five days prior to her menses. She underwent evaluation including vaginitis testing and ultrasound. The plan is for naproxen for the pain. The naproxen has been denied because the patient has not tried and failed the formulary options Diclofenac Sodium 50 milligram or 75 milligram tablet, Celecoxib 50 milligrams, 100 milligrams, or 200 milligrams, naproxen 250 milligrams, 375 milligrams or 500 milligrams, Nabumetone, Piroxicam, Etodolac and Meloxicam tablets. This is being appealed.

The proposed treatment is not medically necessary.

Non-steroidal anti-inflammatory drugs (NSAIDs) more effectively treat dysmenorrhea-related pain compared with placebo. A meta-analysis including 80 trials reported that non-steroidal anti-inflammatory drugs were more effective than placebo for patients with primary dysmenorrhea (odds ratio [OR] 4.37, 95% (percent) CI (Confidence Interval) 3.76-5.09, 35 trials for comparison) (Marjoribanks et al.). However, non-steroidal anti-inflammatory drugs were also associated with a 30 percent increased likelihood of adverse effects overall (OR 1.29, 95% CI 1.11-1.51, 25 trials) and a nearly 60 percent increased risk of gastrointestinal side effects (OR 1.58, 95% CI 1.12-2.23, 14 trials). Most of the adverse effects were mild.

Although the above meta-analysis and other studies did not report efficacy differences across nonspecific non-steroidal anti-inflammatory drugs, others suggest that differences exist and that fenamates (mefenamic acid, tolfenamic acid, flufenamic acid, meclofenamate, bromfenac) may have slightly better efficacy than the phenylpropionic acid derivatives (ibuprofen, naproxen) (Milsom et al.). Both fenamates and phenylpropionic acid derivatives inhibit prostaglandin synthesis, but fenamates also block prostaglandin action, which may account for their enhanced effectiveness in some studies. At least one network meta-analysis has reported that fenamates and phenylpropionic acid derivatives provided better pain relief compared with aspirin (Feng et al). Per the literature, there is insufficient data on which to base a recommendation for one class of agents or the other.

Smith and Kaunitz begin treatment with a phenylpropionic acid derivative prescribed at the upper end of the dose range. These drugs are relatively inexpensive, available without prescription, easy to dose, and of demonstrated efficacy. They prescribed ibuprofen 400 to 600 milligrams every four to six hours or 800 milligrams every eight hours to a maximum dose of 2400 milligrams per day, starting with the onset of symptoms or menses, and continue this dose for two or three days based on the patient's usual symptom pattern. In the above meta-analysis (Marjoribanks et al), some of the included studies did not indicate when participants initiated non-steroidal anti-inflammatory drugs, others stated "at onset of pain," while others specified "at onset of symptoms". The United States Food and Drug Administration packaging insert for ibuprofen indicates the drug should be started "for the treatment of dysmenorrhea, beginning with the earliest onset of such pain". For individuals whose symptoms do not adequately improve with two to three months of phenylpropionic acid treatment, the next recommendation is to prescribe a fenamate (e.g., mefenamic acid 500 milligrams initially followed by 250 milligrams every six hours, with treatment typically limited to three days). In review of the literature, there is evidence for the use of non-steroidal anti-inflammatory drugs in the setting of dysmenorrhea, including naproxen. However, the literature does not state that one anti-inflammatory is better than another. Therefore, because there are formulary alternatives that would be an option for management, the request is not medically necessary.