Romosozumab (Evenity) for Postmenopausal Osteoporosis — Coverage Criteria
Customize your policy alerts
Sign up for Blue Cross Blue Shield - Iowa Policy 05.02.78 alerts
Get alerted when Policy 05.02.78 changes without checking for updates manually.
Monitor payer policy activity
Covers criteria, documentation, and prior authorization requirements for romosozumab (Evenity) in postmenopausal women at high risk for fracture for Wellmark Blue Cross and Blue Shield members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Romosozumab (Evenity)
Initial Therapy
Authorization of a total of 12 months may be granted to postmenopausal members with osteoporosis when ANY of the following are met:
fragility fracture definition provided in-line
Initial Approval Criteria - T-score/FRAX branch
- a: Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk).
Examples listed in policy
- b: Member has had an inadequate response or intolerance to previous injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, denosumab products, abaloparatide).
Examples listed in policy
- c: Member has had an inadequate response or intolerance to previous oral bisphosphonate therapy.
See Appendix A for clinical reasons to avoid oral bisphosphonates
Continuation Therapy
Continuation of Therapy
Applies to all members, including new members requesting continuation
Authorization for romosozumab (Evenity) is limited to a total of 12 monthly doses. If ongoing osteoporosis treatment is still clinically indicated after completing 12 months of romosozumab, the policy specifies transitioning to an anti‑resorptive agent for continued therapy.
Treatment beyond 12 monthly doses is not supported by this policy and, therefore, is not covered for the listed indications.
Coding and Risk Thresholds
| J3111 | Injection, romosozumab-aqqg, 1 mg |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required. Initial approval may be granted for up to 12 months when criteria for postmenopausal osteoporosis are met.
- Prior authorization required for initiation and continuation of therapy.
- Initial approvals: up to 12 months when criteria for postmenopausal osteoporosis are met.
Therapy Sequencing / Trials
Policy requires trials of or documentation of intolerance/inadequate response to other osteoporosis therapies in certain situations before approval.
- Documentation of prior trial and inadequate response or intolerance to oral bisphosphonates when applicable.
- Documentation of prior trial and inadequate response or intolerance to injectable osteoporosis therapies (e.g., zoledronic acid [Reclast], teriparatide [Forteo, Bonsity], denosumab products [Prolia, Jubbonti], abaloparatide [Tymlos]) when applicable.
- Appendix A lists clinical reasons to avoid oral bisphosphonates (these may justify skipping an oral bisphosphonate trial): achalasia, strictures/dysmotility, active upper GI disease, malabsorption, inability to remain upright 30–60 minutes, inability to take before first food/drink/medication, renal insufficiency (CrCl <35 mL/min), history of intolerance to oral bisphosphonate).
Required Documentation for Prior Authorization
Submit chart notes or medical record documentation to support the authorization request.
- History of fragility fractures, if present (e.g., low-trauma fracture from standing height).
- Pre-treatment T-score (DXA) and, when applicable, FRAX fracture probability.
- Chart notes, medical record documentation, or claims history supporting prior osteoporosis medications tried and response/intolerance.
- If oral bisphosphonate trial is not documented, include clinical rationale (see Appendix A reasons to avoid oral bisphosphonates).
Documentation Triggers for Denial
Failure to submit requested documentation may result in denial of the authorization request.
- Missing chart notes or medical record documentation of fragility fracture history may trigger denial.
- Absence of pre-treatment T-score or FRAX probability (when applicable) may trigger denial.
- Lack of documentation of prior medication history or inadequate response/intolerance may trigger denial when such trials are required by the criteria.
Definitions and Risk Thresholds
Background
Romosozumab (Evenity) is FDA‑approved for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The approval covers patients with prior osteoporotic fracture, multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. Use per the labeling is limited to 12 monthly doses; if continued osteoporosis therapy is needed after a 12‑month course, transition to an anti‑resorptive agent should be considered.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.