CurrentHawaii Medical Service Association (HMSA)Policy N/A

Denosumab (Xgeva and biosimilars) prior authorization

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.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyDenosumab (Xgeva and biosimilars) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prior authorization request to CVS Caremark (fax 1-866-237-5512) and attest that supporting documentation is available.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page count

7product choices

5diagnosis options (on therapy)

6site options

Coverage Criteria

Authorization criteria

Form defines separate question flows depending on whether patient is currently receiving a denosumab product.

Branch on current denosumab use: If patient is currently receiving treatment with a denosumab product, proceed to diagnosis selection (node 2) and assess benefit; if not currently receiving, proceed to alternative diagnosis selection (node 5).

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:

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyDenosumab (Xgeva and biosimilars) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prior authorization request to CVS Caremark (fax 1-866-237-5512) and attest that supporting documentation is available.

SourceLink

On This Page

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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.

Prior Authorization

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

Prior Authorization

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

Documentation Required

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

Denial Risk

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

Product / Biosimilar Options

Note

Bilprevda listed as Xgeva alternative

Bilprevda is listed on the form as an alternative product choice to Xgeva (a denosumab product).

Note

Bomyntra listed as Xgeva alternative

Bomyntra is listed on the form as an alternative product choice to Xgeva (a denosumab product).

Note

Osenvelt listed as Xgeva alternative

Osenvelt is listed on the form as an alternative product choice to Xgeva (a denosumab product).

Note

Wyost listed as Xgeva alternative

Wyost is listed on the form as an alternative product choice to Xgeva (a denosumab product).

Note

Xbryk listed as Xgeva alternative

Xbryk is listed on the form as an alternative product choice to Xgeva (a denosumab product).

Note

Xtrenbo listed as Xgeva alternative

Xtrenbo is listed on the form as an alternative product choice to Xgeva (a denosumab product).

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.

OpenPayer

Denosumab (Xgeva and biosimilars) prior authorization

Coverage Criteria

Initial Therapy

Continuation / Maintenance Criteria

Provider Actions & Submission Requirements

Requested Diagnosis / Coding

Site of Dispense / Administration

Product / Biosimilar Options

Key Definitions

Step Therapy / Prior Use Assessment

Background