Is continuation of Evenity (romosozumab-aqqg) 210 mg subcutaneous injection medically necessary for age-related osteoporosis without current pathological fracture after 12 months of treatment?

Continuation of Evenity After 12 Months is NOT Medically Necessary

Continuation of romosozumab (Evenity) beyond 12 monthly doses is not medically necessary and should be denied, as the FDA label explicitly limits treatment duration to 12 monthly doses because the anabolic bone-building effect wanes after this period, and the patient must immediately transition to an anti-resorptive agent to prevent bone loss and maintain fracture risk reduction. 1

Rationale for Non-Continuation

FDA-Mandated Treatment Duration Limit

• The FDA prescribing information for Evenity explicitly states under "Limitations of Use" that the anabolic effect wanes after 12 monthly doses of therapy, and therefore the duration of use should be limited to 12 monthly doses 1
• The drug label clearly specifies that if osteoporosis therapy remains warranted after 12 doses, continued therapy with an anti-resorptive agent should be considered 1
• This is not a guideline recommendation but a regulatory limitation based on the drug's pharmacodynamic properties 1

Evidence Supporting 12-Month Limit

• The pivotal FRAME trial demonstrated that romosozumab's bone-building effects are maximized within the first 12 months, after which the anabolic effect diminishes 2
• The American College of Physicians guidelines explicitly note that romosozumab use should be limited to 12 monthly doses because the anabolic effect wanes after this period 3
• Real-world observational data from 460 patients confirms that the standard treatment protocol is 12 months of romosozumab followed by transition to other agents 4

Mandatory Sequential Therapy Requirement

Immediate Transition to Anti-Resorptive Therapy

• The American College of Rheumatology strongly recommends that romosozumab must be followed by sequential anti-resorptive therapy to prevent bone loss 3
• Discontinuation of romosozumab without sequential therapy leads to significant bone loss, similar to what occurs with PTH/PTHrP discontinuation 3
• The guideline explicitly states that "ROM can be followed by DEN or BP" (denosumab or bisphosphonate) 3

Evidence for Sequential Therapy Benefits

• The FRAME Extension Study demonstrated that 12 months of romosozumab followed by 24 months of denosumab maintained fracture risk reductions through 36 months, with 66% relative risk reduction for vertebral fractures 5
• Patients who transitioned from romosozumab to denosumab showed continued BMD increases during the denosumab phase, maintaining the substantial BMD gains achieved during romosozumab treatment 5, 2
• The pivotal FRAME trial showed that after 12 months of romosozumab followed by 12 months of denosumab, vertebral fracture risk was reduced by 75% compared to placebo-to-denosumab 2

Appropriate Next Steps for This Patient

Patient's Current Clinical Status

• This patient has completed 12 months of Evenity treatment (started on the documented date) [@case details@]
• The patient has severe osteoporosis with T-scores of -2.8 (lumbar spine), -2.2 (left femur), -1.7 (right femur), and -4.2 (right wrist) [@case details@]
• The patient shows "modest improvement" over six years, indicating ongoing high fracture risk [@case details@]

Recommended Sequential Therapy Options

The patient should immediately transition to one of the following anti-resorptive agents:

• Denosumab 60 mg subcutaneously every 6 months - preferred option based on FRAME trial data showing optimal fracture risk reduction when following romosozumab 5, 2
• Alendronate 70 mg orally weekly or zoledronic acid 5 mg IV annually - alternative bisphosphonate options that are effective sequential therapy 3
• The American College of Rheumatology guidelines support either bisphosphonates or denosumab as appropriate sequential therapy after romosozumab 3

Critical Timing Consideration

• Sequential therapy should begin promptly after completing the 12th dose of romosozumab to prevent the bone loss that occurs when anabolic agents are discontinued without follow-up anti-resorptive therapy 3
• There should be no treatment gap between completing romosozumab and initiating the anti-resorptive agent 5

Safety and Monitoring Considerations

Cardiovascular Risk Assessment

• The FDA black box warning states that romosozumab may increase the risk of myocardial infarction, stroke, and cardiovascular death 1
• While this patient has completed treatment, any consideration of future osteoporosis therapy must account for cardiovascular risk factors 1

Supplementation Requirements

• The patient should continue adequate calcium and vitamin D supplementation during transition to anti-resorptive therapy 3, 1
• This supplementation requirement continues regardless of which sequential agent is selected 3

Determination

RECOMMEND NON-CERTIFICATION - Continuation of Evenity beyond 12 monthly doses does not meet medical necessity criteria based on FDA labeling limitations, clinical guidelines, and the established treatment paradigm requiring transition to anti-resorptive therapy. The patient requires immediate transition to denosumab or a bisphosphonate to maintain the bone density gains achieved and prevent fracture risk.