Evenity denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that an enrollee has requested authorization and coverage for Evenity. Current medical literature indicates that the management of male osteoporosis mirrors the management of postmenopausal osteoporosis in women in clinical practice. Researchers explain, “Osteoporosis, a disease classically attributed to postmenopausal women, is underappreciated, underdiagnosed, and undertreated in men. However, it is not uncommon for osteoporotic fractures to occur in men. About 40% of fractures occur in men with an incidence that has increased over the years. After a first fracture, the risk of a subsequent episode, as well as the risk of death, is higher in the male than in the female population.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Evenity®. According to the Endocrine Society clinical practice guideline, the pharmacological treatment for osteoporosis is recommended for male patients over 50 years of age who have experienced a spine or hip fracture, those with a T-score of -2.5 or less, and those with a high risk of fracture because of low bone mineral density (BMD) and/or clinical risk factors. Evenity is a humanized monoclonal antibody that binds and inhibits sclerostin to increase bone formation and decrease bone resorption. Evenity has shown efficacy in the treatment of postmenopausal osteoporosis in female patients and is thus U.S. Food and Drug Administration (FDA)-approved for this condition.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Evenity for postmenopausal osteoporosis. The U.S. Food and Drug Administration (FDA) approved Evenity to treat osteoporosis in postmenopausal female patients at high risk of bone fracture. One study evaluated the efficacy of Evenity in vertebral and nonvertebral fracture risk reduction and found that at month 12, patients who received Evenity had a 73% lower risk of new vertebral fracture and a 36% lower risk of clinical fracture than those who received placebo. Evenity has been determined to have a 75% lower risk of new vertebral fracture than placebo at 24 months.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Evenity. Evenity is a humanized immunoglobulin G2 monoclonal antibody administered monthly via subcutaneous injection. Evenity is indicated for use as initial therapy in patients with very high fracture risk, including those with a T-score less than –3, a T-score less than –2.5 with fragility fracture history, or severe or multiple prior vertebral fractures. It may also be used as an alternative agent in patients with high fracture risk in whom first-line therapies are ineffective or cannot be used. In this case, the records do not indicate that the patient has been on osteoporotic medication.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Evenity, then check the rights and deadlines that apply to your plan.