CurrentMass General Brigham Health PlanPolicy N/A

Prolia (denosumab) — Prior Authorization and Coverage Criteria

Defines prior authorization, coverage criteria, and limits for Prolia (denosumab) under Mass General Brigham Health Plan for medical and pharmacy benefits affecting commercial/exchange members, including treatment of osteoporosis, glucocorticoid‑induced osteoporosis, and bone‑mass preservation during certain cancer therapies.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProlia (denosumab) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 11, 2025

Next Review Date

Key ActionObtain prior authorization and submit documentation showing indication, prior bisphosphonate trial or intolerance, and evidence of high fracture risk.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearauthorization duration

Commercial/Exchangeplans covered

Prior authprogram type

Includes glucocorticoid‑inducedindications covered

Coverage Criteria for Prolia (denosumab)

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Initial therapy for osteoporosis (postmenopausal women and men)

Covered when ALL of the following are met:

Initial osteoporosis criteria: Indication of treatment or prevention of osteoporosis

Prior bisphosphonate requirement: Inadequate response to an adequate trial of, or adverse reaction to, ONE oral bisphosphonate

High fracture risk: One of: contraindication to ALL oral bisphosphonates; history of fracture within the past 12 months; history of fractures while on osteoporosis therapy; history of fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); history of multiple fractures; T-score less than -3.0; high risk for falls; history of injurious falls; very high fracture probability by FRAX or other validated fracture risk algorithm

Treatment/prevention of glucocorticoid‑induced osteoporosis

Covered when ALL of the following are met:

Glucocorticoid-induced osteoporosis criteria: Indication of treatment or prevention of glucocorticoid-induced osteoporosis

Chronic glucocorticoid use as determined by claims for >5 mg prednisone equivalent daily for 2–3 months in paid claims history>5 mg prednisone equivalent for 2–3 months

Prior bisphosphonate requirement: Inadequate response to an adequate trial of, or adverse reaction to, ONE oral bisphosphonate

High fracture risk (glucocorticoid): Member is at very high risk for fracture indicated by at least ONE of: contraindication to oral bisphosphonates; history of fracture within the past 12 months; history of fractures while on osteoporosis therapy; history of fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); history of multiple fractures; T-score less than -3.0; high risk for falls; history of injurious falls; very high fracture probability by FRAX or other validated fracture risk algorithm

Increase bone mass during adjuvant cancer therapy

Covered when ALL of the following are met:

Cancer therapy bone mass preservation: Indication to increase bone mass in members at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer or androgen deprivation therapy for non-metastatic prostate cancer

Prior bisphosphonate or contraindication: One of: inadequate response to an adequate trial of, or adverse reaction to, ONE bisphosphonate; contraindication to ALL oral and injectable bisphosphonates

Continuation of therapy

Covered when criterion met:

Continuation: Resubmission by prescriber will infer positive response to therapy

Authorizations renewed per policy duration

Authorization is not intended for members who obtained the product as samples or through the manufacturer's patient assistance programs. Members who are new to the plan and currently receiving Prolia may be considered for continuation only if the therapy was not supplied as samples or via the manufacturer assistance program.

Coding and Clinical Thresholds

Affected codes (document references affected codes generically)mixed

affected codes

inv-07: T-score

T-score thresholdT-score less than -3.0

ContextUsed as one of the criteria indicating very high risk for fracture in initial osteoporosis coverage

Applies toPostmenopausal women and men being considered for Prolia for osteoporosis

inv-08: Glucocorticoid exposure

Glucocorticoid exposure definition>5 mg prednisone equivalent daily for 2–3 months as determined from paid claims history

ContextRequired evidence for diagnosing chronic glucocorticoid‑induced osteoporosis under the policy

UseCounts toward meeting the chronic glucocorticoid use criterion in the glucocorticoid‑induced osteoporosis coverage set

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Prolia. Members new to the plan who are currently receiving Prolia may be authorized (authorization not available for products obtained as samples or via manufacturer's patient assistance programs).

Contact: All Plans Phone: 877-519-1908 Fax: 855-540-3693 (Specialty/Medical)
Prolia is also available on the pharmacy benefit — see the MassHealth Drug List for coverage and criteria.

Step Therapy

Step Therapy / Prior Bisphosphonate Requirement

Requires inadequate response to, or intolerance/adverse reaction to, ONE adequate trial of an oral bisphosphonate prior to approval. Alternatively, authorization may be granted if the member has a contraindication to ALL oral bisphosphonates.

Step therapy: trial of ONE oral bisphosphonate (adequate dose and duration) or documented intolerance/adverse reaction
Exception: contraindication to all oral bisphosphonates

Documentation Required

Required Documentation

Prescriber must provide documentation demonstrating the indication for treatment (e.g., osteoporosis, glucocorticoid‑induced osteoporosis, treatment to increase bone mass with aromatase inhibitor or androgen deprivation therapy) and clinical details supporting fracture risk.

Documented indication and clinical rationale
Supporting data: fracture history, T-score, FRAX or other validated fracture risk score, history of falls, prior treatment history

Denial Risk

Denial Risk — Missing Criteria or Documentation

Authorization will be denied if documentation does not demonstrate that the member meets the drug‑specific criteria (including prior bisphosphonate trial or documented contraindication, and evidence of very high fracture risk when applicable).

Denial triggers: missing prior bisphosphonate trial info, lack of clinical evidence for high fracture risk, therapy obtained only via samples or manufacturer assistance programs

Key Definitions and Risk Categories

inv-14: Very high risk for fracture

Primary definitionPresence of at least one high‑risk feature: history of fracture within the past 12 months; fractures while on osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm (e.g., long‑term glucocorticoids); T‑score < -3.0; high risk for falls or injurious falls; or very high fracture probability by FRAX or another validated algorithm

Alternate featuresContraindication to all oral bisphosphonates (or to all oral and injectable bisphosphonates for cancer‑therapy indication) may indicate very high risk

ApplicationOne of these features satisfies the 'very high risk for fracture' requirement across initial and glucocorticoid‑induced osteoporosis criteria sets

inv-15: Chronic glucocorticoid use

Claims evidence threshold>5 mg prednisone equivalent daily for ≥2–3 months in paid claims history

Role in coverageMeets the policy definition of chronic glucocorticoid use for glucocorticoid‑induced osteoporosis criteria

DocumentationMust be demonstrable from claims records submitted as part of prior authorization documentation

OpenPayer

Prolia (denosumab) — Prior Authorization and Coverage Criteria

Coverage Criteria for Prolia (denosumab)

Coding and Clinical Thresholds

Provider Requirements and Authorization Actions

Background on Denosumab (Prolia)

Key Definitions and Risk Categories