CurrentCignaPolicy V030126

Denosumab (Prolia and biosimilars) prior authorization for osteoporosis and related indications

This form and policy govern prior authorization and clinical documentation requirements for Cigna-covered denosumab products (Prolia and biosimilars) for treatment of osteoporosis, cancer therapy–related bone loss, glucocorticoid-induced osteoporosis, giant cell tumor of bone, and related indications; it affects prescribing providers and facilities obtaining coverage from Cigna.

Policy Summary

PayerCigna

PolicyDenosumab (Prolia and biosimilars) prior authorization for osteoporosis and related indications

Policy CodePolicy V030126

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the prior authorization form selecting the denosumab product and provide indication-specific clinical information including T-score or fracture history, prior bisphosphonate trials or reasons for intolerance, and renal function.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysresponse time

855-840-1678fax

800-882-4462urgent phone

Accredopreferred pharmacy

Coverage Criteria for Denosumab Products

Policy Summary

PayerCigna

PolicyDenosumab (Prolia and biosimilars) prior authorization for osteoporosis and related indications

Policy CodePolicy V030126

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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Coverage Criteria

Coverage is considered when indication-specific documentation meets the following grouped criteria

Indication selection: Provider selects one of the listed indications (postmenopausal osteoporosis; osteoporosis in men; bone loss in patients at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer; bone loss in patients receiving adjuvant aromatase inhibitor therapy for breast cancer; glucocorticoid-induced osteoporosis; prevention of osteoporosis; giant cell tumor of the bone; or other)

Form requires explicit indication selection

BMD or fracture evidence: Either a T-score ≤ -2.5 at the lumbar spine, femoral neck, total hip, or 33% (one-third) radius OR low bone mass (T-score between -1.0 and -2.5) with prescriber-assessed high risk for fracture OR history of osteoporotic/fragility fractureT-score thresholds as defined

Provider must check applicable boxes and supply T-score when relevant

Prior therapy or contraindication to bisphosphonates: Either prior trial of IV bisphosphonate (zoledronic acid [Reclast] or ibandronate IV [Boniva]) OR prior trial of at least one oral bisphosphonate (examples: alendronate, risedronate, ibandronate) with inadequate efficacy after a trial duration of 12 months OR significant intolerance to oral bisphosphonates OR inability to take oral bisphosphonates due to swallowing difficulty, inability to remain upright, or pre-existing GI condition (e.g., esophageal lesions, ulcers, strictures, achalasia)oral bisphosphonate trial >= 12 months for efficacy assessment

Form asks about prior IV bisphosphonate and specific examples of oral products, documents intolerance or inability reasons

Renal evaluation when applicable: If severe renal impairment or chronic kidney disease is present (example: creatinine clearance <35 mL/min), the patient must have been evaluated for chronic kidney disease–mineral and bone disorder (CKD‑MBD) to reduce risk of denosumab-induced hypocalcemiaCrCl <35 mL/min example

Form asks whether CKD‑MBD evaluation was performed when severe renal impairment is reported

Cancer therapy–related criteria: For prostate cancer bone loss: documentation that prostate cancer is not metastatic to bone AND patient is receiving androgen‑deprivation therapy or has undergone bilateral orchiectomy. For breast cancer bone loss: documentation that breast cancer is not metastatic to bone and whether the patient is receiving aromatase inhibitor therapy. For premenopausal patients, documentation if receiving estrogen deprivation therapy.

Form lists examples of ADT, aromatase inhibitors, and estrogen deprivation therapies to document

Co-therapy exclusions/combination therapy: Denosumab must not be given in combination with teriparatide (Forteo), abaloparatide (Tymlos), oral bisphosphonates, IV bisphosphonates (e.g., zoledronic acid, ibandronate IV), calcitonin nasal spray, or romosozumab (Evenity). Concomitant calcium and vitamin D supplements are allowed.

Provider must attest whether other osteoporosis medications will be used concurrently; form lists prohibited concomitant agents

With the exception of calcium and/or vitamin D supplements, denosumab products (Prolia and biosimilars) should NOT be given with other osteoporosis medications. Examples listed on the form include teriparatide (Forteo), abaloparatide (Tymlos), oral bisphosphonates (for example, alendronate, risedronate, ibandronate), intravenous bisphosphonates (for example, zoledronic acid infusion [Reclast], ibandronate IV), calcitonin nasal spray (Miacalcin/Fortical), and romosozumab (Evenity).

Requests that do not document required prior therapy trials or acceptable reasons for not using bisphosphonates may be considered not medically necessary. The form specifically requires documentation of prior IV bisphosphonate use (zoledronic acid or ibandronate) or a trial of at least one oral bisphosphonate; when an oral bisphosphonate was used, the prescriber must document whether there was inadequate efficacy after a trial duration of 12 months (examples include ongoing significant BMD loss, lack of BMD increase, or an osteoporotic/fragility fracture).

If bisphosphonate therapy was not used, the prescriber must document a valid reason such as significant intolerance (for example, severe GI or musculoskeletal adverse events), inability to swallow or remain upright after oral administration, or a pre-existing GI condition that prevents oral bisphosphonate use. Additionally, when severe renal impairment is present, documentation of renal assessment (e.g., creatinine clearance) and evaluation for CKD-MBD is required.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required for Denosumab Products

Prior authorization is required for denosumab products (Bildyos, Jubbonti, Prolia). The prescriber must complete the Cigna prior authorization form selecting the specific denosumab product and provide indication‑specific clinical information.

Prior authorization form must identify physician and patient: DEA, NPI or TIN; Cigna ID; patient date of birth; patient name and address; prescriber signature and date.
Form must include the selected denosumab product and the requested dose, frequency, duration, and ICD‑10 diagnosis.

Documentation Required

Form Asks Whether the Patient Has Tried IV and Oral Bisphosphonates

The prior authorization form asks whether the patient has tried IV bisphosphonates (zoledronic acid [Reclast] and/or ibandronate IV [Boniva]) and whether the patient has tried at least one oral bisphosphonate product.

If oral bisphosphonate was tried, the form asks whether the prescriber documents inadequate efficacy after a 12‑month trial (examples: ongoing significant BMD loss, lack of BMD increase, or an osteoporotic/fragility fracture).
If oral bisphosphonate was not tried, the form captures reasons (significant intolerance, inability to swallow, inability to remain upright, pre‑existing GI condition, osteoporotic fracture, or severe renal impairment).

Denial Risk

Requests May Be Denied If Documentation Is Incomplete

Requests may be denied if the submitted documentation does not show prior trials of oral bisphosphonates or IV bisphosphonates when clinically required, or does not document intolerance, inability to take oral therapy, inadequate efficacy after at least 12 months, or other indication‑specific requirements (for example fracture history, T‑score, or renal evaluation when applicable).

For members with severe renal impairment, documentation of evaluation for chronic kidney disease mineral and bone disorder to reduce risk of denosumab‑induced hypocalcemia may be required.
Requests lacking required prescriber/patient identifiers or missing answers to the bisphosphonate trial/intolerance questions risk denial.

Documentation Required

Completed Prior Authorization Form Must Include Physician and Patient Identifiers and Indication‑Specific Clinical Information

A completed prior authorization form must include physician and patient identifiers and attestations and must be signed and dated by the prescriber.

Required identifiers: prescriber DEA, NPI or TIN; office contact and phone/fax; patient name, Cigna ID, date of birth, address, and phone.
Form must include the selected denosumab product, ICD‑10 diagnosis, dose, frequency, duration, indication‑specific clinical responses (T‑score, fracture history, bisphosphonate trial/intolerance details), and prescriber attestation/signature.

Bildyos 60mg	denosumab product listed on form
Jubbonti 60mg	denosumab product listed on form
Prolia 60mg	denosumab product listed on form

OpenPayer

Denosumab (Prolia and biosimilars) prior authorization for osteoporosis and related indications

Coverage Criteria for Denosumab Products

Requested Medications, Codes, and Key Parameters

Provider Actions and Prior Authorization Requirements

Background

Definitions and Thresholds