Denosumab (Xgeva and biosimilars) prior authorization
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Prior authorization form and criteria for coverage of denosumab products (Xgeva and listed biosimilars) for HMSA Medicare Advantage members; used by prescribers to request approval via CVS Caremark Specialty. Affects prescribers, pharmacies, and CVS Caremark reviewers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Authorization criteria
Form defines separate question flows depending on whether patient is currently receiving a denosumab product.
Follow form flow: Q1 -> Q2/Q5
If the selected indication is Other the prior authorization form provides no further questions on the form and does not capture additional indication-specific data. Selection of “Other” therefore requires supplemental review and documentation to justify medical necessity for a non‑listed diagnosis; the provider must attest that supporting documentation is available for review by CVS Caremark or the benefit plan sponsor.
Initial Therapy
Initial therapy
When patient is not currently receiving denosumab:
Form ends after selection (Q5)
Continuation / Maintenance Criteria
Continuation / Maintenance Criteria
Provider action: Prior authorization submission required.
ALL of the following
- Is the patient currently receiving treatment with a denosumab product?
If no, use initial therapy criteria for new starts.
ANY of the following
- Prevention of skeletal related events in multiple myeloma or bone metastases from solid tumor (e.g., breast cancer, non-small cell lung cancer, thyroid carcinoma, kidney cancer, prostate cancer).
- Palliative care for bone metastases from thyroid carcinoma.
- Giant cell tumor of the bone.
- Hypercalcemia of malignancy.
- Treatment of osteopenia or osteoporosis due to systemic mastocytosis.
- Is the patient receiving benefit from therapy, defined as disease stability or improvement?
Documentation should include clinical assessment, imaging, or laboratory evidence of stability or improvement.
- If treating hypercalcemia of malignancy with Xgeva (denosumab 120 mg), document indication and response as applicable.
If therapy is not providing benefit or there is progressive disease despite treatment, continuation is not supported.
ALL of the following
- Provider attestation: I attest that the information submitted is accurate and that documentation supporting continuation is available for review by the payer or plan sponsor.
A signed attestation or electronic signature is acceptable.
- Documentation must be retained in the medical record and made available upon request.
ALL of the following
- Continuation assessment: Clinician must confirm ongoing clinical benefit (disease stability or improvement) and that treatment remains appropriate given current clinical status.
- If there is loss of benefit, consider therapy discontinuation or alternative treatments; include rationale in request.
ALL of the following
- Operational note: For patients switching between denosumab products (e.g., Prolia vs Xgeva), indicate product, dose, and clinical reason for switch; dosing schedules differ by indication and must be documented.
Provider Action / Documentation
Prior Authorization Required: Submit a prior authorization request indicating the patient is currently on denosumab and providing documentation of benefit. Failure to submit required documentation may result in denial.
- Required: current denosumab product name, dose, last administration date, and documentation of clinical benefit (stability or improvement).
- Required: provider attestation that information is accurate and records are available for review.
- If treating hypercalcemia of malignancy with Xgeva, indicate this specifically.
Provider Actions & Submission Requirements
Submit prior authorization to CVS Caremark (fax required)
A prior authorization request must be submitted to CVS Caremark for denosumab products; the form instructs providers to fax completed requests to 1-866-237-5512.
- Fax completed prior authorization form to CVS Caremark toll-free at 1-866-237-5512
- Questions: contact CVS Caremark at 1-808-254-4414
Provide accurate diagnosis and attest availability of supporting documentation
The provider must supply the most accurate diagnosis for the requested medication and attest that supporting documentation is available for review by CVS Caremark or the benefit plan sponsor.
- Provide the ICD-10 code in the form's diagnosis field
- Sign the attestation confirming documentation is available if requested
Non-submission risks non-coverage or delayed access
Failure to submit the completed prior authorization form to CVS Caremark at the listed fax number or to contact the Specialty Customer Care Team may result in the drug not being covered or delayed access.
- Non-submission to fax 1-866-237-5512 may lead to non-coverage or delays
- Contact Specialty Customer Care Team (CaremarkConnect) at 1-800-237-2767 for assistance
Requested Diagnosis / Coding
| ICD-10 code — free text field on form |
Site of Dispense / Administration
Specify dispense and administration site on the form
The form requires selection of where the drug will be dispensed and where it will be administered from a checklist of site-of-care options.
- Dispense site options include Office, Outpatient Hospital, Ambulatory Surgical, Inpatient Hospital, Pharmacy, and Other
- Administration site options include Ambulatory Surgical, Home, Inpatient Hospital, Office, Outpatient Hospital, and Pharmacy
Product / Biosimilar Options
Bilprevda listed as Xgeva alternative
Bilprevda is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Bomyntra listed as Xgeva alternative
Bomyntra is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Osenvelt listed as Xgeva alternative
Osenvelt is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Wyost listed as Xgeva alternative
Wyost is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Xbryk listed as Xgeva alternative
Xbryk is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Xtrenbo listed as Xgeva alternative
Xtrenbo is listed on the form as an alternative product choice to Xgeva (a denosumab product).
Key Definitions
Step Therapy / Prior Use Assessment
| Step | Requirement |
|---|---|
| 1 | |
| Assessment of prior denosumab use: Confirm whether the patient is currently receiving treatment with a denosumab product (Question 1 on the form). | |
| 2 | |
| Assessment of clinical benefit: Document whether the patient is receiving benefit from therapy, defined as disease stability or improvement (Question 3 on the form). | |
| 3 | |
| Approval requirement: Responses to Questions 1 and 3 (current use and benefit) are required before approving continuation of denosumab therapy. |
Background
Denosumab (product examples listed on the form: Xgeva and biosimilars) is indicated on the form for several oncology and related uses including prevention of skeletal‑related events in patients with bone metastases from solid tumors or multiple myeloma, palliative treatment for bone metastases (including thyroid carcinoma), management of giant cell tumor of bone, treatment of hypercalcemia of malignancy, and treatment of osteopenia or osteoporosis associated with systemic mastocytosis. The form captures whether the patient is currently receiving a denosumab product and, if so, whether the patient is receiving benefit defined as disease stability or improvement, which informs continuation decisions.
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