CVS Caremark prior authorization form for denosumab (Prolia) and listed biosimilars — coverage criteria
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This document is a CVS Caremark prior authorization form used by HMSA to collect clinical and administrative information required to authorize coverage for specific specialty osteoporosis medications (Prolia and listed biosimilars) for HMSA members. It affects prescribing clinicians and staff submitting authorization requests.
No material clinical or coverage changes in this revision.
Coverage decision logic
Indication-specific coverage and decision tree
Authorization decisions are determined by indication and require meeting the branching criteria on the prior authorization form.
If the provider selects the diagnosis option Other on the form, the form directs: No Further Questions. This indicates the form does not define an authorization pathway for diagnoses outside the listed indications and no additional branching criteria on this form will be used to evaluate the request.
Requests that do not meet the objective risk thresholds (e.g., pretreatment DEXA T-score ≤ -2.5 or the FRAX thresholds of major fracture > 20% or hip fracture > 3% where applicable) must instead document an inadequate response or intolerable adverse event to at least a 1-year trial of an oral or injectable bisphosphonate or a clinical reason to avoid bisphosphonates. If those step criteria and supporting documentation are not provided, the form’s logic does not support approval for initial therapy.
Codes, product list, and clinical thresholds
| No codes listed |
| Prolia | Prolia |
| Bildyos | Bildyos |
| Conexxence | Conexxence |
| Enoby | Enoby |
| Jubbonti | Jubbonti |
| Ospomyv | Ospomyv |
| Stoboclo | Stoboclo |
Criteria for initiating therapy
Initial therapy criteria
Covered when ALL of the following indication‑specific initial conditions are met (or when a documented failure/intolerance to first‑line therapy is provided).
Requirements to continue therapy
Continuation therapy requirements
Continuation requests are approved when the applicable continuation pathway on the form is satisfied.
Prior therapy and step requirements
| Step | Requirement | Documentation required | Coverage status |
|---|---|---|---|
| 1 | Provider must document an inadequate response or intolerable adverse event to at least a 1-year trial of an oral or injectable bisphosphonate (or have a clinical reason to avoid bisphosphonates) when indicated by the form branching | Submit supporting documentation of prior bisphosphonate therapy duration and outcome (inadequate response or intolerable adverse event) or documentation of clinical reason to avoid bisphosphonates | |
| 2 | If branch logic directs (based on DEXA/FRAX or indication), provider must document prior inadequate response or intolerance to prior injectable osteoporosis therapy (e.g., Forteo, Bonsity, Tymlos, Evenity) or exhaustion of allowed therapy duration | Submit supporting documentation of prior injectable therapy, reason for intolerance or exhaustion of allowed duration (e.g., treatment dates, adverse event notes) | |
| 3 | When DEXA T-score is borderline (between -1.0 and -2.5) and FRAX thresholds are below decision cutoffs, form requires documentation of prior bisphosphonate trial or clinical reason to avoid bisphosphonates | Submit pre-treatment DEXA T-score, FRAX major and hip fracture scores, and documentation of prior bisphosphonate trial outcome or clinical justification to avoid bisphosphonates | |
| 4 | For glucocorticoid‑induced osteoporosis branches, if patient is on ≥2.5 mg/day prednisone (or equivalent) for ≥3 months and DEXA/FRAX criteria do not alone meet approval, prior bisphosphonate trial documentation is required | Submit documentation of glucocorticoid dose and duration plus prior bisphosphonate trial outcome or clinical reason to avoid bisphosphonates; include DEXA and FRAX as requested |
What providers must do
How to submit prior authorization
Submit prior authorization requests using the HMSACOM CVS Caremark prior authorization form. Fax completed forms to CVS Caremark toll-free at 1-866-237-5512. For prior authorization questions, contact CVS Caremark at 1-808-254-4414. For patient eligibility, copay, or medication delivery questions contact CaremarkConnect at 1-800-237-2767.
- Fax: 1-866-237-5512
- CVS Caremark phone: 1-808-254-4414
- CaremarkConnect: 1-800-237-2767
Step requirements: bisphosphonate trial and other prior therapies
Requests must document that the patient has had at least a 1-year trial of an oral or injectable bisphosphonate with supporting documentation of inadequate response or intolerable adverse event, or provide a clinical reason to avoid bisphosphonates. For patients meeting certain fracture risk thresholds (DEXA T-score ≤ -2.5, FRAX major fracture >20% or hip fracture >3%, or history of vertebral/hip fracture) the same bisphosphonate trial or contraindication requirements apply unless a qualifying fracture or risk threshold is met.
- At least 1-year trial of oral or injectable bisphosphonate (document inadequate response or intolerance)
- Clinical reason to avoid bisphosphonates (document rationale)
- Prior injectable osteoporosis therapy intolerance/exhaustion (e.g., Forteo, Tymlos, Evenity) — submit documentation
Required clinical documentation
Include required clinical documentation with the request: pretreatment DEXA T-score, pretreatment FRAX scores (major fracture and hip fracture), documentation of fragility fractures when present, and supporting records for prior therapy trials, adverse events, or reasons to avoid therapies. Specify the diagnosis (e.g., postmenopausal osteoporosis, osteoporosis in a male, glucocorticoid-induced osteoporosis) and submit relevant cancer therapy documentation when applicable (aromatase inhibitor or androgen deprivation therapy).
- Pretreatment DEXA T-score (submit report)
- Pretreatment FRAX scores (major fracture and hip fracture)
- Documentation of fragility/vertebral/hip fractures when applicable
- Records showing prior therapy duration, response, adverse events, or contraindications
- Documentation of prior authorization history if continuation request
Prescriber attestation
Prescriber or authorized signer must attest that the information provided is accurate and that supporting documentation is available for review. Include prescriber signature and date on the form.
- Prescriber attestation signature and date required
- Attestation: documentation available for review by CVS Caremark or benefit plan sponsor
Missing documentation may lead to denial
Incomplete or missing documentation (DEXA, FRAX, prior therapy evidence, fracture documentation, or prescriber attestation) may result in denial of the prior authorization request. Ensure all requested fields and supporting records are included to avoid delays.
- Missing DEXA/FRAX or prior therapy records may lead to denial
- Lack of prescriber signature/attestation may lead to denial
Dispensing and administration site
Specify site of dispense and administration on the form
Indicate on the form where the drug will be dispensed and where it will be administered by selecting the appropriate setting(s) provided.
- Select dispensing location (examples listed: Office, Outpatient Hospital, Pharmacy, etc.)
- Select administration site (examples listed: Home, Office, Outpatient Hospital, Pharmacy, etc.)
Preferred products and intolerance pathway
Document intolerance to preferred biosimilar (Jubbonti) and attribution to active ingredient
For requests involving Prolia or biosimilars, answer whether the member experienced a documented intolerable adverse event with the preferred product Jubbonti and whether the event is attributable to the active ingredient; submit documentation if claiming intolerance.
- Question 2 asks if member had a documented intolerable adverse event with Jubbonti; select Yes/No and continue as directed
- Question 3 asks if the adverse event was attributed to the active ingredient per prescribing information; submit supporting documentation when applicable
Policy background
This CVS Caremark prior authorization form is used to determine medical necessity for denosumab (Prolia) and the listed biosimilar products across the osteoporosis-related indications captured on the form (postmenopausal osteoporosis, osteoporosis in men, glucocorticoid‑induced osteoporosis, and bone loss associated with cancer therapy). The form collects key objective data — pretreatment DEXA T-score, FRAX major and hip fracture scores, history of fragility fracture, and prior therapy history — and routes the request through indication‑specific branching logic to establish whether the request meets thresholds for approval or requires documentation of prior bisphosphonate trial/intolerance.
Key clinical definitions
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