CurrentHawaii Medical Service Association (HMSA)Policy N/A

CVS Caremark prior authorization form for denosumab (Prolia) and listed biosimilars — coverage criteria

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.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyCVS Caremark prior authorization form for denosumab (Prolia) and listed biosimilars — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization via the CVS Caremark form and fax required supporting documentation (DEXA, FRAX, prior bisphosphonate trial) to 1-866-237-5512.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10+decision nodes on form

Multiplelisted products

DEXA/FRAX/prior TXkey clinical data requested

Fax requiredsubmission channel

Coverage decision logic

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Indication-specific coverage and decision tree

Authorization decisions are determined by indication and require meeting the branching criteria on the prior authorization form.

Requested drug selection: Provider selects the requested product (Prolia or listed biosimilars). Selection of Jubbonti routes to a different branch per the form; other product selections continue to the standard branches.

Postmenopausal osteoporosis branch: Follow branch questions #5–#17: approve if continuation previously authorized by HMSA/CVS or if any of the following initial criteria are met: history of fragility fracture; pretreatment DEXA T-score ≤ -2.5; or for T-score between -1.0 and -2.5, a FRAX major fracture >20% or hip fracture >3%. If FRAX scores are below thresholds, approval requires documented inadequate response or intolerable adverse event to ≥1 year of oral or injectable bisphosphonate or a clinical reason to avoid bisphosphonates.

Osteoporosis in men branch: Follow branch questions #20–#24: approve if continuation previously authorized by HMSA/CVS or if patient has vertebral/hip fracture, pretreatment DEXA T-score ≤ -2.5, or for T-score between -1.0 and -2.5 meet FRAX thresholds or document inadequate response/intolerance to ≥1 year bisphosphonate or clinical reason to avoid bisphosphonates.

Glucocorticoid-induced osteoporosis branch: Follow branch questions #100–#109: requires current or planned glucocorticoid therapy ≥2.5 mg/day prednisone-equivalent for ≥3 months (documentation required). Approve if continuation previously authorized by HMSA/CVS, history of fragility fracture, pretreatment DEXA T-score ≤ -2.5, or if T-score between -1.0 and -2.5 with FRAX major >20% or hip >3%. If FRAX below thresholds, approval requires documented inadequate response/intolerance to ≥1 year bisphosphonate or clinical reason to avoid bisphosphonates. For continuation, documentation that T-score has improved while on therapy may be required.

Other diagnosis: If diagnosis selected as 'Other' the form indicates 'No Further Questions' and no authorization pathway is defined on this 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

Requested ICD-10ICD-10

No codes listed

Drug product list (brand names)NDC|mixed

Prolia	Prolia
Bildyos	Bildyos
Conexxence	Conexxence
Enoby	Enoby
Jubbonti	Jubbonti
Ospomyv	Ospomyv
Stoboclo	Stoboclo

inv-06: DEXA T-score — discrete value options

DEXA T-score ≤ -2.5Pretreatment DEXA T-score less than or equal to -2.5 (submit documentation).

DEXA T-score between -1.0 and -2.5Pretreatment DEXA T-score greater than -2.5 and less than -1.0 (form directs to apply FRAX thresholds or additional criteria).

DEXA T-score ≥ -1.0Pretreatment DEXA T-score greater than or equal to -1.0 (form indicates No Further Questions or not meeting osteoporosis threshold depending on branch).

inv-07: FRAX major fracture — > 20% or < 20%

FRAX major fracture > 20%Pretreatment FRAX 10-year probability for any major osteoporosis-related fracture greater than 20% (submit documentation; in several branches >20% meets criteria).

FRAX major fracture < 20%Pretreatment FRAX major fracture probability less than 20% (form directs to further questions or different branch logic).

Use with DEXA for borderline T-scoresFor T-scores between -1.0 and -2.5 the form requires FRAX major fracture >20% to proceed to approval pathways; otherwise additional requirements apply.

inv-08: FRAX hip fracture — > 3% or < 3%

FRAX hip fracture > 3%Pretreatment FRAX 10-year probability for hip fracture greater than 3% (submit documentation; >3% meets criteria in multiple branches).

FRAX hip fracture < 3%Pretreatment FRAX hip fracture probability less than 3% (form directs to further questions or additional requirements).

FRAX hip used with DEXA and FRAX majorHip FRAX is applied when T-score is borderline (between -1.0 and -2.5) to determine eligibility per the form logic.

inv-09: Glucocorticoid dose trigger — ≥ 2.5 mg/day prednisone (or equivalent) for ≥ 3 months

Glucocorticoid dose thresholdCurrent or planned glucocorticoid therapy at a dose ≥ 2.5 mg/day prednisone (or equivalent) for at least 3 months; documentation of dose and duration must be submitted.

Apply with DEXA/FRAX or fragility fractureWhen glucocorticoid threshold met, approval may be based on fragility fracture, DEXA T-score, or FRAX thresholds as specified in form branches.

Continuation pathway references doseGlucocorticoid therapy question directs to continuation/initial branches (Yes continues to further bisphosphonate and fracture evaluations).

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).

Postmenopausal osteoporosis — objective thresholds: If pretreatment DEXA T-score ≤ -2.5, approval pathway is met; if T-score between -1.0 and -2.5, require FRAX major fracture >20% or hip fracture >3% to meet criteria.

Postmenopausal osteoporosis — clinical alternative: If DEXA/FRAX thresholds are not met, documented inadequate response or intolerable adverse event to at least a 1-year trial of an oral or injectable bisphosphonate OR a documented clinical reason to avoid bisphosphonates will satisfy initial therapy requirements (submit supporting documentation).

Osteoporosis in men — initial criteria: Approval requires history of vertebral or hip fracture OR pretreatment DEXA T-score ≤ -2.5 OR for T-score between -1.0 and -2.5 meet FRAX thresholds (major >20% or hip >3%); alternatively, documented inadequate response/intolerance to ≥1 year bisphosphonate or clinical reason to avoid bisphosphonates satisfies criteria.

Glucocorticoid-induced osteoporosis — initial criteria: Requires current/planned glucocorticoid therapy ≥2.5 mg/day prednisone-equivalent for ≥3 months (documentation required) plus one of: history of fragility fracture; DEXA T-score ≤ -2.5; or if T-score between -1.0 and -2.5 then FRAX major >20% or hip >3%. If FRAX below thresholds, documented inadequate response/intolerance to ≥1 year bisphosphonate or clinical reason to avoid bisphosphonates is required.

Requirements to continue therapy

Continuation therapy requirements

Continuation requests are approved when the applicable continuation pathway on the form is satisfied.

General continuation: If the requested medication was previously authorized by HMSA/CVS (provider indicates prior authorization on the form), the form often directs to 'No Further Questions' indicating an automatic continuation pathway; submit prior authorization details as documentation.

Glucocorticoid-induced osteoporosis continuation: For continuation requests in glucocorticoid-induced osteoporosis, provide current T-score and documentation that the T-score has improved while taking the requested drug; if improvement is documented, the form directs to 'No Further Questions'.

Continuation when prior clinical benefit demonstrated: Continuation may also be supported by documentation of clinical benefit such as improvement in DEXA T-score or absence of new fragility fractures while on therapy; submit supporting documentation as requested on the form.

Prior therapy and step requirements

Step	Requirement	Documentation required
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

Prior Authorization

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 Therapy

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

Documentation Required

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

Note

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

Denial Risk

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

Preferred products and intolerance pathway

Billing Rule

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

inv-16: Fragility fracture — definition and request for documentation

DefinitionFragility fracture: history of vertebral or hip fracture or fracture from low-level trauma; form asks for supporting documentation of such fractures.

Requested documentationSubmit supporting documentation (e.g., radiology or clinical records) confirming vertebral or hip fracture when indicated on form.

Effect on decisionA documented fragility fracture often leads to 'No Further Questions' indicating an eligibility pathway on the form.

inv-17: FRAX score — definition and use for 10-year probability metrics

FRAX score definitionEstimated 10-year probability of a major osteoporosis-related fracture or hip fracture; the form requires submission of FRAX scores for decision thresholds.

Major fracture metricFRAX 10-year probability for any major osteoporosis-related fracture is used with a >20% threshold in multiple decision branches.

Hip fracture metricFRAX 10-year probability for hip fracture is used with a >3% threshold in multiple decision branches.

inv-18: DEXA T-score — definition and referenced thresholds

DEXA T-score definitionBone mineral density T-score measured by dual-energy x-ray absorptiometry (DEXA); the form requests pretreatment T-score documentation.

Actionable thresholdsKey thresholds referenced: ≤ -2.5 (meets criteria in many branches), between -1.0 and -2.5 (requires FRAX or other criteria), ≥ -1.0 (not meeting osteoporosis threshold in many branches).

Use in multiple indicationsDEXA T-score is applied across postmenopausal osteoporosis, male osteoporosis, and glucocorticoid-induced osteoporosis branches per the form logic.