Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Fibromyalgia
Treatment: Amrix [cyclobenzaprine extended release (ER)]
The insurer denied coverage for Amrix (cyclobenzaprine ER).
The denial is overturned.

The insurer has denied coverage for Formulary Exception for Amrix [cyclobenzaprine ER (extended release)]. In their Final Adverse Determination letter, they write that the policy states that this medication may be approved when the member is unable to take the required number of formulary alternatives for the given diagnosis due to an intolerance or contraindication or the member has tried and failed the required number of formulary alternatives for the given diagnosis due to an intolerance or contraindication or the member has failed the required number of formulary alternatives. Formulary alternatives are: carisoprodol 350 mg (milligrams), chlorzoxazone 500 mg, cyclobenzaprine 5 mg, 10 mg tablets, metaxalone 800 mg, methocarbamol. Requirement: 3 in a class with 3 or more alternatives, 2 in a class with 2 or more alternatives, or 1 in a class with 1 alternative. 

In an appeal letter, it is stated that the patient has tried and failed 2 of the preferred alternatives (generic cyclobenzaprine and metaxalone). The patient has been stable on the requested brand medication Amrix for fibromyalgia for about 10 years. The preferred alternatives are indicated for musculoskeletal conditions or muscle spasm, and not for fibromyalgia which is more complex.

This is a patient with a history of fibromyalgia. The patient has tried and failed generic cyclobenzaprine and metaxalone. The patient has been doing well on Amrix (cyclobenzaprine ER) for about 10 years. The request is for the continued use of Amrix, which is under review.

The formulary drugs would not likely cause the patient an adverse reaction.

However, fibromyalgia is a disease that is very hard to treat, as every patient responds differently to the treatment, and treatment should be tailored to each patient. The patient has been doing very well on Amrix for about 10 years; thus, it is recommended to continue the same medication. Recommended duration of approved therapy is for 12 months.      

The formulary drug have not been ineffective based on the patient's clinical history, due to the patient being stable on the requested drug for about 10 years. There is simply no indication for a non-medical switch at this time.     

"Evidence-based guidelines for the treatment of fibromyalgia were published in 2004. A review of evidence was performed by 13 methodological experts. These guidelines state that the 'strongest evidence for medication efficacy' in fibromyalgia is for cyclobenzaprine and amitriptyline." (2)

"To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia (FM). In this phase III, randomized, controlled trial of patients with FM, treatment with TNX-102 SL was associated with significant reductions in daily pain and was safe and well tolerated." (1)

"Fibromyalgia syndrome (FMS) is a pain disorder with an estimated prevalence of 1-5% [percent]. It is associated with a variety of somatic and psychological disorders. Its exact pathogenesis is still unclear but is involved with neural over sensitization and decreased conditioned pain modulation (CPM)." (3)                                                       

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The non-formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Amrix (cyclobenzaprine ER) to treat fibromyalgia is reversed.