CurrentAnthem HealthKeepers Plus Medicaid products (Virginia) | HealthKeepers, Inc.Policy N/A

Prior Authorization Form for Denosumab (Prolia/Xgeva and biosimilars)

A prior authorization form used by Anthem HealthKeepers Plus Medicaid products in Virginia to request coverage for denosumab products (Prolia, Xgeva, and multiple biosimilars). The form documents member, prescriber, diagnosis, and specific clinical criteria required to approve an initial 6-month supply or a 12-month renewal.

Policy Summary

PayerAnthem HealthKeepers Plus Medicaid products (Virginia)

PolicyPrior Authorization Form for Denosumab (Prolia/Xgeva and biosimilars)

Policy CodePolicy N/A

Change TypeAdministrative form (no material changes)

Effective Date

Next Review Date

Key ActionProvider must submit one completed PA form per member with all requested information and supporting documentation; incomplete forms will delay PA and submission does not guarantee coverage.

POLICY UPDATE CHANGES

No material clinical/coverage changes — this is an administrative PA form with no listed policy changes.

6-monthInitial approval duration

12-monthRenewal approval duration

MultipleDenosumab biosimilars listed

Policy summary

This administrative Prior Authorization (PA) form is used to request coverage for denosumab products (Prolia, Xgeva, and multiple denosumab biosimilars/bioequivalents) for Anthem HealthKeepers Plus Medicaid products in Virginia. The form documents member, prescriber, diagnosis, drug, and clinical criteria to determine eligibility for approved indications including osteoporosis, glucocorticoid‑induced osteoporosis, cancer‑related bone loss and prevention of skeletal events, giant cell tumor of bone, and hypercalcemia of malignancy.

The purpose of the form is to capture clinical eligibility and required prescriber attestations (for example, calcium/vitamin D supplementation, absence of hypocalcemia, pregnancy status, and that denosumab will not be combined with other listed agents) and to request prior authorization. Providers must submit one completed PA form per member with supporting clinical documentation; incomplete forms may delay processing and submission does not guarantee coverage.

ScopePrior authorization form for denosumab products (Prolia, Xgeva, and multiple biosimilars) used by Anthem HealthKeepers Plus Medicaid in Virginia; documents member, prescriber, diagnosis, and clinical criteria for initial and renewal approvals.

Initial approval duration6-month

Renewal approval duration12-month

Denosumab biosimilars listedMultiple

Policy statusCURRENT

Age (adults)>= 18 years

Giant cell tumor min age>= 12 years and skeletally mature

Prednisone equivalent>= 2.5 mg daily and expected >= 3 months

FRAX riskMajor fracture >= 20% or hip fracture >= 3%

Refractory hypercalcemia levelAlbumin-corrected calcium > 12.5 mg/dL (3.1 mmol/L)

Renal insufficiency thresholdCreatinine clearance < 30-35 mL/min

Initial criteria — Prolia and biosimilars (osteoporosis indications)

General initial request criteria for Prolia and biosimilars (6-month approval)

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age>= 18 years
Member is supplementing with 1,000 mg of calcium and at least 400 IU of vitamin D daily
Member does not have hypocalcemia
Confirmation that the member is not pregnant
Provider attests requested product will not be used in combination with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides
Applies only to nonpreferred products: For nonpreferred agents, member had therapeutic failure to the preferred Prolia bioequivalent
Member meets ONE of the following indication groups
- Osteoporosis
  - If biological female, member is post-menopausal; or member is biological male
  - Member is at high risk for fracture
    High risk defined below
  - Diagnosis evidence (ONE of)
    T-score by DXA ≤ -2.5 measured at lumbar spine, femoral neck, total hip, or forearm (33% radius) site
    History of fragility fracture to the hip or spine, regardless of T-score
    T-score by DXA between -1.0 and -2.5 measured at lumbar spine, femoral neck, total hip, or forearm (33% radius) AND history of fracture of proximal humerus, pelvis, or distal forearm

ref

Initial criteria — Xgeva and biosimilars (oncology and other indications)

General initial request criteria for Xgeva and biosimilars (6-month approval)

Covered when ALL of the following are met:

ALL of the following

Member will receive calcium and vitamin D as necessary to treat or prevent hypocalcemia
Member does not have hypocalcemia
Provider attests requested product will not be used in combination with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides
Applies only to nonpreferred products: For nonpreferred agents, member had therapeutic failure to the preferred Xgeva bioequivalent
Member meets ONE of the following indication groups
- Prevention of skeletal-related events in multiple myeloma or bone metastases from solid tumors
  - Member is 18 years of age or older>= 18 years
  - Member had inadequate response, contraindication, or intolerance to at least a 3-month trial of zoledronic acid>= 3-month trial
  - Member has metastatic breast cancer, metastatic castration-resistant prostate cancer, or metastatic lung cancer (SCLC or NSCLC)
- Giant cell tumor of bone
  - Member is 12 years of age or older and skeletally mature>= 12 years and skeletally mature

Drug / product names referenced on form

Drug/Product names referenced on formmixed

Prolia	Denosumab for osteoporosis (brand)
Xgeva	Denosumab for oncology indications (brand)
Bildyos	Denosumab biosimilar / bioequivalent referenced
Bosaya	Denosumab biosimilar referenced
Conexxence/Denosumab-bnht	Denosumab biosimilar referenced
Enoby	Denosumab biosimilar referenced
Jubbonti	Denosumab biosimilar referenced
Ospomyv/Denosumab-dssb	Denosumab biosimilar referenced
Stoboclo/Denosumab-bmwo	Denosumab biosimilar referenced
Aukelso	Denosumab biosimilar referenced (Xgeva equivalent)

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What the provider must do

Prior Authorization

Submit completed PA form

Provider must submit one completed PA form per member with all requested information and supporting documentation; incomplete forms will delay PA and submission does not guarantee coverage.

One completed PA form per member
Incomplete forms will delay PA
Submission does not guarantee coverage

Documentation Required

Clinical documentation required

Include supporting documentation for diagnosis, prior therapies, cancer status, supplementation, and labs to confirm no hypocalcemia.

DXA T-scores (site and value as specified on form)
Fracture history (hip, spine, proximal humerus, pelvis, distal forearm, other fragility fractures)
FRAX 10-year probabilities (major fracture ≥20% or hip ≥3%)
Details of prior bisphosphonate trials: agent, duration, and reason for failure or intolerance
Cancer/metastasis status for oncology indications (e.g., metastatic breast, castration-resistant prostate, lung cancer)
Confirmation of calcium (1,000 mg) and vitamin D (≥400 IU) supplementation as indicated
Laboratory results confirming absence of hypocalcemia (no hypocalcemia documented)

Prior Authorization

Prescriber attestation

Prescriber must attest the requested product will not be used in combination with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides, and must sign and date the form to confirm accuracy.

Documentation Required

Trials and failures

Document a 12-month trial and failure or intolerance to bisphosphonate therapy for osteoporosis indications. For oncology prevention (prevention of skeletal-related events), document at least a 3-month trial with inadequate response, contraindication, or intolerance to zoledronic acid. Failure is defined as decrease in T-score from baseline or a new fracture while on bisphosphonate therapy.

Billing Rule

Form fax submission

Completed form may be faxed to 844-512-7020 for PA processing.

Fax number: 844-512-7020

Definitions and operational notes

Failed clinical trialDecrease in T-score compared with baseline DXA or a new fracture while on bisphosphonate therapy.

High risk for fractureIncludes history of osteoporotic fracture, parental hip fracture, low BMI, rheumatoid arthritis, alcohol intake >=3 drinks/day, current smoking, history of oral glucocorticoids >=5 mg/day for >3 months (ever), among other factors on the form.