Osteoporosis Rx 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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Forteo 20 mcg/dose pen injector. Buerba and colleagues compared the efficacy of the use of either bisphosphonates or Forteo on radiographic and functional outcomes of patients who underwent thoracolumbar spinal fusion. The authors concluded that Forteo was “associated with higher fusion rates than bisphosphonates.” In this patient’s case, there is a documented history of spinal fusion and a current indication for revision surgery. The patient’s provider has recommended treatment with Forteo to enhance the patient’s bone strength and increase of likelihood of hardware placement success during the planned surgery. Furthermore, treatment with Forteo is likely to health improve the patient’s bone mineral density.

Where the denial was upheld

Findings: The physician reviewer found that The patient has requested authorization and coverage for Evenity 210 mg syringes. Bandeira and colleagues note, “Monthly subcutaneous dosing of romosozumab reduces the risk of vertebral and clinical fractures in women with postmenopausal osteoporosis, with a favorable balance of benefits and risks.” However, the authors conclude, “Romosozumab is a promising emerging anabolic agent with a novel mechanism of action that may expand the options for treating osteoporotic patients at high risk of fracture.” Paik and Scott report, “In pivotal phase III trials (FRAME and ARCH), 12 months’ once-monthly romosozumab 210 mg significantly reduced vertebral and clinical fracture risk versus placebo and oral alendronate in postmenopausal women with osteoporosis.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tymlos. Findings: The American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis reports, “Approved agents with efficacy to reduce hip, nonvertebral, and spine fractures including alendronate, denosumab, risedronate, and zoledronate are appropriate as initial therapy for most osteoporotic patients with high fracture risk.” The guidelines further note that when starting treatment, it is appropriate to stratify patients by level of fracture risk, with those at very high fracture risk requiring more aggressive treatment to achieve an acceptable level of fracture risk.

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 Osteoporosis Rx, then check the rights and deadlines that apply to your plan.