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202010-132239

2020

Fidelis Care New York

Medicaid

Orthopedic/ Musculoskeletal

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Fibromyalgia
Treatment: Savella (milnacipran)
The insurer denied coverage for Savella (milnacipran) to treat fibromyalgia.
The denial is overturned.

This is a female patient with a history of Crohn's disease, fibromyalgia, hypertension, seizures, and anxiety. The patient was seen by her rheumatologist for her fibromyalgia. The patient reported having body aches all day. The patient reported that physical therapy only resulted in a slight improvement of back pain. The patient appeared to be sleepy with a lack of eye contact. The patient has attention deficit hyperactivity disorder (ADHD) and Adderall was recently stopped, and she was having trouble focusing. The physician assistant recommended continuing with gabapentin, trying to get Savella approved, continuing with pain management, continuing with neurology recommendations, and following up with the rheumatologist within 8 weeks. The patient has failed Cymbalta in the past. At a recent office visit, the patient's current medications included cyclobenzaprine, gabapentin, Trileptal and Zoloft.

At issue is the medical necessity of the denial of coverage for Savella (milnacipran) to treat this patient's fibromyalgia. The alternatives offered by the insurer are used in fibromyalgia, so they are appropriate considerations. However, there are specific circumstances for this case that affect their utility.

The medication list at the recent office visit lists, among others, cyclobenzaprine, gabapentin, and Zoloft. The only one mentioned in notes is the gabapentin, and this review will be done assuming gabapentin is the only one currently being taken. Savella would not be mixed with Zoloft or nortriptyline with cyclobenzaprine.

Savella is a serotonin and norepinephrine reuptake inhibitor, and this medication has Food and Drug Administration (FDA)-approval for the treatment of fibromyalgia. As for the insurer's recommended/preferred medications, the use of tricyclic antidepressants (TCAs) such as nortriptyline and amitriptyline for pain management, while not FDA-approved, has been a longstanding well-studied use of these medications. As per review of the literature, a tendency for serotonin and norepinephrine reuptake inhibitors to work better than TCAs is noted. Their use is discussed in UpToDate articles on "Pharmacologic management of chronic non-cancer pain in adults" and "Serotonin-norepinephrine reuptake inhibitors (SNRIs): Pharmacology, administration, and side effects."

While Savella and the insurer's choices all share possible sedation/mentation and mood changes as side-effects, the risk is less with the serotonin and norepinephrine reuptake inhibitors, i.e., Savella when compared to TCAs. Thus, in this case, Savella would be a better choice for this patient. Savella is considered medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Savella (milnacipran) to treat fibromyalgia should be overturned. The medical necessity is substantiated.

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