Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

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. There is evidence supporting the superiority of anabolic agents, such as abaloparatide (Tymlos), over antiresorptive agents in reducing vertebral fracture risk in very high fracture risk patients. The guidelines identify patients at very high fracture risk as those with a recent fracture within the past year, those with fractures while on approved osteoporosis therapy, those with multiple fractures, those with fractures while on drugs causing skeletal harm such as long-term glucocorticoids, those with a T-score less than -3.0, those at high risk of falls or with a history of injurious falls, and those with a probability of major osteoporosis fracture greater than 30% and of hip fracture greater than 4.5% as determined by the Fracture Risk Assessment Tool (FRAX) (or other validated fracture risk algorithm. The guidelines note that bone mineral density testing may be appropriate every one to two years, with the goal of monitoring osteoporosis therapy to identify those with significant bone loss. In this case, the records do not reflect that the patient is at the very high risk for fracture for which the guidelines recommend abaloparatide (Tymlos) as initial therapy. The records note that the patient is currently on alendronate, which is the appropriate initial therapy for patients who are not categorized as being very high risk for fracture. The records show that this patients average bone mineral density at the lumbar spine is stable and has improved at the left hip, suggesting that the patient is having an adequate response to alendronate. Given that the patient is not at very high risk of fracture, and as her bone mineral density is stable at the lumbar spine and improved at the left hip, indicative of an adequate response to current treatment, the requested medication is not medically indicated. Therefore, Tymlos is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in rheumatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.