Is continuation of Evenity (romosozumab-aqqg) 210 mg subcutaneous monthly medically necessary for a patient with age-related osteoporosis and modest improvement after 12 months of treatment?

Continuation of Evenity Beyond 12 Months is NOT Medically Necessary

Evenity (romosozumab) must be discontinued after 12 monthly doses and transitioned to an antiresorptive agent, as the anabolic effect wanes after this period and continuation beyond 12 months is not indicated. 1

Rationale for Discontinuation

FDA-Mandated Duration Limitation

• The FDA label explicitly states that "the duration of EVENITY use should be limited to 12 monthly doses" because the anabolic effect wanes after 12 months of therapy 1
• The drug is approved only for a single 12-month course, not for continuation beyond this period 2, 3
• This patient has already completed the full FDA-approved treatment duration of 12 months 1

Required Sequential Therapy

• After completing 12 months of romosozumab, patients MUST transition to an antiresorptive agent (bisphosphonate or denosumab) to maintain bone density gains and prevent fracture risk 4, 2, 3
• Failure to transition to an antiresorptive agent after romosozumab results in loss of bone density gains 3
• The American College of Rheumatology strongly recommends that romosozumab be followed by bisphosphonate or denosumab therapy 4

Current Fracture Risk Assessment

The patient's current BMD T-scores indicate:

• Lumbar spine: -2.8 (osteoporosis)
• Right wrist: -4.2 (severe osteoporosis)
• Left femur: -2.2 (osteopenia/borderline osteoporosis)
• Right femur: -1.7 (osteopenia)

Despite "modest improvement," the patient remains at high fracture risk and requires continued osteoporosis therapy—but NOT continuation of romosozumab 4, 2

Recommended Management Algorithm

Step 1: Discontinue Evenity Immediately

• The patient has completed the maximum allowable 12-month course 1
• No additional romosozumab doses should be administered 2, 3

Step 2: Transition to Antiresorptive Therapy

Preferred sequential therapy options:

• Bisphosphonate (alendronate preferred): Oral weekly or IV yearly formulations 4, 2, 3
• Denosumab 60 mg subcutaneously every 6 months: Alternative if bisphosphonates are contraindicated or not tolerated 4, 5

The transition should occur immediately after the last romosozumab dose without a treatment gap 4

Step 3: Continue Calcium and Vitamin D Supplementation

• Maintain adequate calcium and vitamin D supplementation during antiresorptive therapy 2, 1

Critical Safety Considerations

Cardiovascular Risk

• Romosozumab carries an FDA black box warning for increased risk of myocardial infarction, stroke, and cardiovascular death 1
• The drug should not be used in patients with MI or stroke within the preceding year 1
• Cardiovascular events occurred in 2.5% vs 1.9% with romosozumab compared to alendronate 2

No Evidence for Second Course

• While one research study examined a second 12-month course of romosozumab after a treatment gap, this is NOT FDA-approved and should not be considered standard practice 6
• The study showed diminished BMD gains with a second course following denosumab compared to initial treatment 6

Common Pitfalls to Avoid

1. Do not continue romosozumab beyond 12 months thinking "more is better"—the anabolic effect is exhausted 1
2. Do not create a treatment gap between romosozumab and antiresorptive therapy—bone loss will occur 3
3. Do not use romosozumab as maintenance therapy—it is an induction agent only 2, 3
4. Do not overlook the severe osteoporosis at the right wrist (T-score -4.2)—this patient needs aggressive continued treatment with an antiresorptive agent 4, 2

Evidence Quality Assessment

The recommendation to discontinue romosozumab after 12 months is based on:

• FDA drug label (highest authority) 1
• 2023 American College of Rheumatology guidelines 4
• 2023 American College of Physicians guidelines 4
• Pivotal phase III trials (FRAME and ARCH) demonstrating efficacy only with 12-month treatment followed by antiresorptive transition 7, 5