CurrentAetnaPolicy N/A

Prolia (denosumab) Injectable Medication Precertification Request — Coverage Criteria

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.

Policy Summary

PayerAetna

PolicyProlia (denosumab) Injectable Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete all fields on the two-page precertification request, including patient demographics, prescriber/dispensing information, ICD codes, dose/frequency, and required clinical data.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesdocument length

1-866-752-7021Aetna precertification phone

1-888-267-3277Aetna precertification fax

requiredclinical info

Coverage Criteria for Prolia (denosumab)

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General requirements: Complete required form fields including administration setting, product dose/frequency, primary and secondary ICD codes, and prescriber/dispensing provider information.

See Required documentation and Precertification required (documentation module).

Indication-specific sections captured on form: Form includes indication-specific sections for: breast cancer (adjuvant aromatase inhibitor therapy), glucocorticoid-induced osteoporosis, osteoporosis in men, postmenopausal osteoporosis, and prostate cancer on androgen deprivation therapy.

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.

Operational note — documentation of bisphosphonate avoidance: If a clinical reason to avoid bisphosphonates is selected, indicate the specific reason from the form's list (e.g., esophageal abnormalities, active upper GI disease, gastrointestinal malabsorption, inability to sit/stand, renal insufficiency with creatinine clearance <35 mL/min, history of intolerance, or other).Creatinine clearance < 35 mL/min where renal insufficiency is claimed.

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 CPT codes (provider to supply)CPT

Administration code(s) (CPT)

Field provided to list CPT administration codes

Diagnosis codes (provider to supply)ICD-10

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

inv-06: Prednisone-equivalent glucocorticoid dose

Prednisone-equivalent dose>= 2.5 mg/day for >= 3 months

Documentation requiredForm asks whether patient is currently receiving or will initiate glucocorticoid therapy at this dose and duration

Applies toGlucocorticoid-induced osteoporosis indication on the form

inv-07: FRAX major fracture threshold

FRAX major fracture threshold>= 20%

Form capturePre-treatment FRAX for any major fracture recorded as less than 20%, greater than or equal to 20%, or unknown

Applies to indicationsPostmenopausal osteoporosis, osteoporosis in men, and other applicable indications listed on the form

inv-08: FRAX hip fracture threshold

FRAX hip fracture threshold>= 3%

Form capturePre-treatment FRAX for hip fracture recorded as less than 3%, greater than or equal to 3%, or unknown

Applies to indicationsPostmenopausal osteoporosis, osteoporosis in men, and other applicable indications listed on the form

inv-09: Very low T-score threshold

Very low T-score cutoff-3.0 or below

Form categories include-2.5 or below, between -2.5 and -1, -1 or above, or unknown; very low defined as -3 or below in very-high-risk indicators

Used to identifyIndicator of very high fracture risk on the form

inv-10: Creatinine clearance

Creatinine clearance threshold< 35 mL/min

Form useListed as a clinical reason to avoid oral bisphosphonates (renal insufficiency: creatinine clearance less than 35 mL/min)

Applies toAssessment of bisphosphonate contraindication on initiation sections

Precertification and Documentation Requirements

Prior Authorization

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.

Documentation Required

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.

Denial Risk

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.

OpenPayer

Prolia (denosumab) Injectable Medication Precertification Request — Coverage Criteria

Coverage Criteria for Prolia (denosumab)

Coding and Clinical Thresholds

Precertification and Documentation Requirements

Background

Definitions and High-Risk Indicators