CurrentAlaska MedicaidPolicy N/A

Evenity (romosozumab‑aqqg) prior authorization — Coverage criteria

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Criteria and authorization details for Alaska Medicaid coverage of Evenity (romosozumab‑aqqg) for treatment of osteoporosis in postmenopausal women at high risk of fracture.

Policy Summary

PayerAlaska Medicaid

PolicyEvenity (romosozumab‑aqqg) prior authorization — Coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document osteoporosis diagnosis, prior bisphosphonate and injectable therapy trials or intolerances, and that Evenity will be administered by a provider with calcium and vitamin D counseling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmax duration

3 monthsinitial approval

9 monthsreauthorization

210 mg/moquantity limit

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CurrentAlaska MedicaidPolicy N/A

Evenity (romosozumab‑aqqg) prior authorization — Coverage criteria

Customize your policy alerts

Sign up for all Alaska Medicaid policy alerts

Know when Alaska Medicaid releases new policies or updates existing guidance.

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Criteria and authorization details for Alaska Medicaid coverage of Evenity (romosozumab‑aqqg) for treatment of osteoporosis in postmenopausal women at high risk of fracture.

Policy Summary

PayerAlaska Medicaid

PolicyEvenity (romosozumab‑aqqg) prior authorization — Coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmax duration

3 monthsinitial approval

9 monthsreauthorization

210 mg/moquantity limit

Approval Criteria

Covered when ALL of the following are met:

Main criteria: 1. Patient is a postmenopausal woman at risk of fracture.

Main criteria: 2. Diagnosis of osteoporosis defined by a bone mineral density T-score ≤ -2.5 in the spine, femoral neck, total hip, or distal 1/3 radius, or a clinical diagnosis based on history of a low-trauma fracture and at high risk for fracture.

Main criteria: 3. Medication is being administered by a healthcare provider.

Main criteria: 4. Patient has had a trial of an oral bisphosphonate (e.g., alendronate) for ≥1 year with less than optimal results, has a contraindication to oral bisphosphonates, is unable to remain upright for at least 30 minutes, or is intolerant to two bisphosphonate manufacturers.

Main criteria: 5. Patient has failed or is intolerant to an injectable osteoporosis therapy (e.g., zoledronic acid).

Main criteria: 6. Prescriber has counseled the patient that calcium and vitamin D should be adequately supplemented throughout treatment.treatment duration ≤ 12 monthly doses

See duration and quantity limits

Additional exclusions and contraindications include patients who have had a myocardial infarction or stroke within the preceding year, patients with documented hypocalcemia, and any request for treatment courses that would exceed 12 monthly doses.

Use of romosozumab (Evenity) is not approved when the specified approval criteria are not met; failure to satisfy the coverage criteria will result in denial of authorization.

Coding and Clinical Thresholds

Bone mineral density T-score — clinical threshold value

Bone mineral density (BMD) T‑score threshold≤ -2.5 at spine, femoral neck, total hip, or distal 1/3 radius

Anatomic sites specifiedSpine, femoral neck, total hip, distal 1/3 of the radius

Use in clinical diagnosis alternativeClinical diagnosis based on history of low‑trauma fracture and high fracture risk is accepted as an alternative to BMD ≤ -2.5

High risk of fracture definition — criteria for identifying high-risk postmenopausal women

Primary definitionPostmenopausal women at high risk of fracture defined by a history of osteoporotic fracture or multiple risk factors for fracture

Alternative definitionPatients who have failed or are intolerant to other osteoporosis therapies

Context from FDA indicationIndicated for treatment of osteoporosis in postmenopausal women at high risk of fracture

Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required; time-limited approvals

Prior authorization is required for romosozumab (Evenity). Initial approval may be granted for up to 3 months; reauthorization may be granted for up to an additional 9 months, but total authorization must not exceed 12 monthly doses. Quantity limit: 2 × 105 mg syringes per month (210 mg total).

Initial Approval: up to 3 months
Reauthorization: up to an additional 9 months (total authorization cannot exceed 12 monthly doses)
Quantity limit: 2 × 105 mg syringes per month (210 mg total)

Step Therapy

Step therapy: prior bisphosphonate and injectable therapy required

Before Evenity is approved, the patient must have had a trial of an oral bisphosphonate (e.g., alendronate) for at least one year with less than optimal results, or have a contraindication to bisphosphonates, be unable to remain upright for at least 30 minutes, or be intolerant to two bisphosphonate manufacturers. The patient must also have failed or be intolerant to an injectable osteoporosis therapy.

Oral bisphosphonate trial ≥ 1 year with less than optimal results OR documented contraindication OR inability to remain upright ≥ 30 minutes OR intolerance to two bisphosphonate manufacturers
Failure of or intolerance to an injectable osteoporosis therapy (e.g., zoledronic acid)

Documentation Required

Required documentation of diagnosis and prior therapy

Prescriber must document the diagnosis of osteoporosis and evidence of prior therapy or trial history. Documentation must show a BMD T‑score ≤ -2.5 (spine, femoral neck, total hip, or distal 1/3 radius) or a clinical diagnosis based on a history of low‑trauma fracture, and record prior bisphosphonate and injectable therapy trials/intolerance. Prescriber must also document that Evenity is being administered by a healthcare provider and that calcium and vitamin D supplementation was counseled.

BMD T‑score ≤ -2.5 in spine, femoral neck, total hip, or distal 1/3 radius OR clinical diagnosis from low‑trauma fracture
Record of prior oral bisphosphonate trial(s) and reasons for failure/intolerance or contraindication
Record of prior injectable osteoporosis therapy failure/intolerance
Documentation that Evenity is administered by a healthcare provider and that calcium and vitamin D supplementation counseling occurred

Denial Risk

Denial triggers and exclusionary conditions

Authorizations will be denied if the approval criteria are not met or if exclusionary conditions are present. Denial triggers include a myocardial infarction or stroke within the preceding year, hypocalcemia, or treatment planned for more than 12 monthly doses.

Failure to meet all approval criteria
Myocardial infarction or stroke within the preceding year
Hypocalcemia
Requested treatment duration exceeding 12 monthly doses

Evenity (romosozumab‑aqqg) prior authorization — Coverage criteria

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Evenity (romosozumab‑aqqg) prior authorization — Coverage criteria

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Coverage Criteria for Evenity (romosozumab‑aqqg)

Coding and Clinical Thresholds

Provider Requirements and Authorization Process

Background