Prolia denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Prolia injection (CPT code J0897) 60 mg, once every six months for a year.Medical literature supports that the requested medication is medically necessary. authors reviewed the pharmacology and major clinical trials and concluded that denosumab (brand name Prolia) is an efficacious and safe osteoporosis treatment option, with current data up to eight years of continued use showing continued improvement in bone density with sustained fracture risk reduction. They found that safety profiles overall are similar to placebo, with no new safety concerns in extension trials, though a theoretical increased risk of infection exists with receptor activator of nuclear factor-κB ligand (RANKL) inhibition.

Findings: The physician reviewer found that The patient has requested authorization and coverage for Prolia injections (60 mg every six months for two doses). While pharmacological treatment of patients with prevalent osteoporotic fractures is universally accepted, the treatment of patients at increased risk of fracture due to low bone mass is more controversial. Eriksen noted, “According to the World Health Organization criteria for assessment of dual-energy x-ray absorptiometry measurements, patients are considered to have low bone mass (osteopenic), when their bone mineral density T-score of the spine or hip lies between −1 and −2.5. Although fracture risk increases with decreases in bone mineral density, the vast majority of osteoporotic fractures occur in osteopenic patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Prolia (denosumab) subcutaneous injections. Osteoporosis is one of the most frequent diseases in postmenopausal women, leading to an increased fracture risk due to the physiologic loss of the bone protective effects of estrogen. Joint guidelines by the International Osteoporosis Foundation (IOF) recommend the use of dual energy x-ray absorptiometry (DEXA) screening early in the evaluation of bone health for patients with breast cancer. The IOF guidelines further recommend that antiresorptive therapy should be considered in all patients with a bone mineral density (BMD) T-score less than -2.0 or two risk factors including a BMD T-score less than -1.0.

The enrollee requested authorization and coverage for Prolia injections for osteoporosis. The patient’s internal medicine specialist indicated the enrollee cannot take Fosamax because of gastrointestinal upset. The recommendation was for the enrollee to start Prolia. The enrollee has very poor intravenous access and significant anxiety regarding intravenous catheter insertion. Prolia is used for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture; treatment of glucocorticoid-induced osteoporosis in women at high risk for fracture; and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Medical literature indicates Prolia is not considered initial therapy for most patients with osteoporosis.

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