Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteoporosis
Treatment: Evenity
The insurer denied Evenity.
The denial is overturned.

The patient is an adult female with osteoporosis. She went through menopause. She has tried and failed Evista, bisphosphonate and had insufficiency fractures on Prolia. Her 
recent bone density reveals ongoing osteoporosis. The request is for Evenity. The request was denied coverage by the health plan as not medically necessary. This denial is being appealed.

The requested Evenity is medically necessary.

Systematic reviews have confirmed that many drugs prevent fractures compared with placebo. In a 2019 meta-analysis of 107 trials evaluating pharmacologic therapies in postmenopausal women with osteoporosis, alendronate, zoledronic acid, risedronate, denosumab, romosozumab, and estrogen with progesterone reduced the risk of hip fracture (Barrionuevo et al.). Alendronate, zoledronic acid, risedronate, ibandronate, denosumab, abaloparatide, teriparatide, parathyroid hormone, romosozumab, raloxifene, bazedoxifene, lasofoxifene, estrogen with progesterone, tibolone, and calcitonin reduced the risk of vertebral fractures. The anabolic agents (teriparatide, abaloparatide, romosozumab) and denosumab were associated with the highest relative efficacy, although there are few trials directly comparing the drugs in preventing fractures. (Barrionuevo et al.).
Romosozumab (evenity) is an anabolic agent approved by the United States Food and Drug Administration (FDA) in 2019 based on trials showing a reduction in vertebral and nonvertebral fractures with romosozumab compared with placebo or with alendronate. Romosozumab is not considered initial therapy for most patients with osteoporosis. Possible candidates include patients with multiple fragility fractures, those at high risk for fracture who cannot tolerate any other osteoporosis therapies, or those who fail other osteoporosis therapies (fracture with loss of bone mineral density in spite of compliance with therapy).
Romosozumab is a monoclonal anti-sclerostin antibody. Sclerostin is produced by osteocytes and inhibits bone formation. In a phase II trial in postmenopausal women, all doses of a monoclonal anti-sclerostin antibody (romosozumab) increased bone density at the lumbar spine, total hip, and femoral neck (McClung et al and Genant et al.)]. In this one-year trial, 419 postmenopausal women with low bone mass (T-score between -2.0 and -3.5 at the lumbar spine, total hip, or femoral neck) were randomly assigned to subcutaneous romosozumab (variable dosing once monthly or once every three months), an active comparator (oral alendronate, 70 milligrams weekly, or subcutaneous teriparatide, 20 micrograms daily), or placebo injections (monthly or every three months). The greatest increase in lumbar spine bone density was seen in the group receiving romosozumab 210 milligrams monthly (11.3 percent compared with 4.1 and 7.1 percent in the alendronate and teriparatide groups, respectively). There was a transient increase in bone formation markers and a more sustained decrease in bone resorption markers, a pattern that has not been seen among available osteoporosis therapies. Romosozumab has also been evaluated in patients previously treated with alendronate. 
In review of the medical record, this patient has had poor response to bisphosphonate and had insufficiency fractures secondary to Prolia treatment. She continues with osteoporosis. The literature does support that she is a good candidate for the use of Evenity. This is a standard of medical practice, not for convenience, and has been proven to be safe and effective for her condition. Therefore, this meets the definition of medical necessity.