Prolia (denosumab) Injectable Medication Precertification Request — Coverage Criteria
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Form and clinical data requirements for precertification of Prolia (denosumab) injections for Aetna members, used by prescribers and dispensing providers to request start or continuation of therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Prolia (denosumab)
Initiation and continuation criteria (form-based)
Information and clinical criteria requested to establish medical necessity for initiation or continuation of Prolia.
See Required documentation and Precertification required (documentation module).
Providers must mark the applicable indication section on the form.
Initiation — required clinical item-set
- Fracture history and BMD/FRAX: Document history of fragility/osteoporotic vertebral or hip fracture where applicable; record pre-treatment T-score category and pre-treatment FRAX scores for major fracture and hip fracture.T-score: categories (-2.5 or below; between -2.5 and -1; -1 or above); FRAX major >=20% threshold; FRAX hip >=3% threshold.
Use the form checkboxes to indicate exact values.
- Glucocorticoid-induced osteoporosis: If glucocorticoid-induced osteoporosis is indicated, document current or planned prednisone-equivalent dose >= 2.5 mg/day for >= 3 months.>= 2.5 mg/day for >= 3 months
- Prior osteoporosis injectable therapy: For postmenopausal osteoporosis the form asks whether the patient has failed prior injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, abaloparatide).
Mark Yes/No on form.
- Prior bisphosphonate trial or documented contraindication: Indicate whether the patient has had at least a 1-year trial of an oral OR injectable bisphosphonate or document a clinical reason to avoid bisphosphonates.At least a 1-year trial where applicable.
If avoiding bisphosphonates, providers must indicate reason(s) from form options (e.g., esophageal abnormalities, active upper GI disease, malabsorption, inability to sit/stand for 30–60 minutes, renal insufficiency with creatinine clearance <35 mL/min, history of intolerance, or other).
Continuation — required clinical item-set
- Evidence of clinical benefit: Document improvement or stabilization in T-score on bone mass measurement compared with prior measurement and/or no new fractures (e.g., no new fracture seen on radiography).
Form asks Yes/No for improved/stable T-score and for no new fractures.
- Duration of therapy and administration source: Indicate length of time patient has been receiving the medication (months) and whether drug was received via samples or manufacturer assistance program.
Form includes checkbox for sample/patient assistance program and months on therapy.
- Adverse effects: Report whether the patient has experienced any adverse effects during therapy.
Form requires Yes/No response.
Providers must indicate reason(s) on the form; these are documented reasons to avoid bisphosphonates rather than automatic exclusions.
The precertification form captures clinical reasons why a patient may need to avoid oral bisphosphonates. Providers should document any relevant contraindication or intolerance by selecting the appropriate reason(s) on the form, such as anatomic or functional esophageal abnormalities that impair tablet transit (e.g., achalasia, stricture, dysmotility), active upper gastrointestinal disease (e.g., dysphagia, gastritis, duodenitis, erosive esophagitis, ulcers), or documented or potential gastrointestinal malabsorption (e.g., gastric bypass, celiac disease, Crohn's disease).
Other form-listed reasons that justify avoiding oral bisphosphonates include inability to stand or sit upright for 30–60 minutes, inability to take the oral bisphosphonate at least 30–60 minutes before first food/drink/medication, renal insufficiency (creatinine clearance < 35 mL/min), a documented history of intolerance to an oral bisphosphonate, or other clinically explained reasons documented in the free-text field.
For continuation requests the form requires documentation demonstrating ongoing clinical benefit. Specifically, providers must indicate whether the patient has shown benefit by a bone mass measurement with improvement or stabilization in T-score compared with the prior study and whether there have been no new fractures on radiography. The form also requests the duration of therapy and whether any adverse effects have occurred.
Requests for continued coverage that do not provide the required documentation of benefit (stable or improved T-score, absence of new fractures) or that omit requested continuation fields may not support approval and could lead to denial or a request for additional information.
Coding and Clinical Thresholds
| Administration code(s) (CPT) | Field provided to list CPT administration codes |
| Primary ICD Code | Field to specify primary ICD diagnosis code |
| Secondary ICD Code | Field to specify secondary ICD diagnosis code |
| Other ICD Code | Field to specify other ICD diagnosis codes |
Precertification and Documentation Requirements
Precertification Required
Precertification is required for requests. Complete all fields on the two‑page Prolia (denosumab) precertification form (patient demographics, prescriber, dispensing provider/administration, product, diagnosis, and full clinical information). Include start or continuation date and signature/date on the acknowledgement. The plan may request additional information or clarification to evaluate requests.
- Use the Aetna Precertification Notification contacts: Phone 1-866-752-7021 (TTY:711); FAX 1-888-267-3277.
- For Medicare Advantage Part B, use the Medicare request form as noted on the precertification form.
Prior Bisphosphonate / Injectable Therapy Information
Document prior bisphosphonate and injectable osteoporosis therapy history clearly on the form. Indicate whether the patient has had at least a 1‑year trial of an oral OR injectable bisphosphonate, and if not, provide reason(s) for avoidance or intolerance. For postmenopausal osteoporosis document prior failure or intolerance to injectable therapies where applicable (e.g., zoledronic acid [Reclast], teriparatide [Forteo, Bonsity], abaloparatide [Tymlos]). Include durations (e.g., at least 1 year for bisphosphonates) and specifics of intolerance or contraindication (esophageal abnormalities, active upper GI disease, malabsorption, inability to take/tolerate dosing requirements, renal insufficiency with CrCl <35 mL/min, documented history of intolerance).
- Checkboxes on the form: Has the patient had at least a 1‑year trial of an oral or injectable bisphosphonate? (Yes/No).
- If Yes — document dates and agent(s) used and response.
- If No or if avoiding bisphosphonate — indicate clinical reason(s) (select from provided options or explain): anatomic/functional esophageal abnormalities, active upper GI problems, gastrointestinal malabsorption, inability to sit/stand upright for dosing, inability to take oral bisphosphonate before food, renal insufficiency (CrCl <35 mL/min), history of intolerance, or other (explain).
- For postmenopausal patients: indicate prior failure or intolerance to injectable osteoporosis therapy where applicable and document agent(s) and dates.
Fraud and Information Requests
Fraud warning and acknowledgement must be signed and dated by the requester. The form states that knowingly filing false or misleading information is a fraudulent insurance act subject to criminal and civil penalties. Maintain and submit complete, accurate clinical documentation; be prepared to provide additional records if requested.
- Request Completed By (Signature Required) and Date — must be present.
- Failure to provide complete and truthful information may result in denial and referral for fraud investigation.
Background
Prolia (denosumab) is indicated on the form for treatment of osteoporosis across common clinical scenarios captured for precertification: postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis (prednisone-equivalent dose >= 2.5 mg/day for >= 3 months is queried), and osteoporosis related to cancer therapy (e.g., adjuvant aromatase inhibitor therapy or androgen deprivation therapy). The form collects baseline measures used to establish risk and need for therapy, including pre-treatment T-scores, FRAX scores (major fracture and hip fracture thresholds), fracture history, prior bisphosphonate or injectable osteoporosis therapy, and documented reasons to avoid bisphosphonates.
The continuation section of the form requires evidence of ongoing benefit (improvement or stabilization in T-score or no new fractures) and length of prior therapy, and asks providers to report any adverse effects while on therapy.
Definitions and High-Risk Indicators
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