CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Denosumab (Prolia) — Coverage Criteria for Osteoporosis

Covers clinical criteria and prior authorization requirements for denosumab (Prolia) in treatment of osteoporosis and related indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDenosumab (Prolia) — Coverage Criteria for Osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting chart notes including fracture history, baseline T-score, and FRAX probability for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

T-score ≤ -2.5osteoporosis threshold

≥ 2.5 mg/dayGIOP glucocorticoid threshold

FRAX ≥ 20% / hip ≥ 3%high FRAX

Coverage Criteria for Denosumab (Prolia)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

History of fragility fracture: Member has a history of fragility fractures

T-score or osteopenia with high FRAX: Member has a pre-treatment T-score ≤ -2.5 OR member has osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probability and meets ANY of the following: (a) indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk); (b) prior failure of or intolerance to injectable osteoporosis therapy (e.g., zoledronic acid, teriparatide, abaloparatide); or (c) prior oral bisphosphonate trial ≥ 1 year or a clinical reason to avoid oral bisphosphonate

Osteoporosis in men — Initial therapy

Authorization of 12 months may be granted when ANY of the following are met:

History of osteoporotic fracture: Member has a history of an osteoporotic vertebral or hip fracture

T-score/FRAX plus bisphosphonate trial: Member meets BOTH: (a) pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probability; AND (b) prior oral OR injectable bisphosphonate trial ≥ 1 year OR a clinical reason to avoid bisphosphonate

Glucocorticoid‑induced osteoporosis — Initial therapy

Authorization of 12 months may be granted when ALL of the following are met:

GIOP main criteria: 1. Member is currently receiving or will initiate glucocorticoid therapy at an equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months; 2. Member has had an oral OR injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate; 3. Member meets ANY of: (a) history of a fragility fracture; (b) pre-treatment T-score ≤ -2.5; or (c) osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probability

Continuation of therapy

Authorization of 12 months may be granted for members currently receiving the medication who meet one of the following:

Continuation — <24 months: Member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy

Continuation — ≥24 months: Member has received ≥24 months of therapy AND both: (1) member has experienced clinical benefit (improvement or stabilization in T-score since the previous bone mass measurement); AND (2) member has not experienced any adverse effects

All indications other than the listed FDA‑approved indications and compendial uses are considered experimental/investigational and not medically necessary. Requests for denosumab (Prolia) for conditions outside the FDA‑approved or compendial indications will generally be denied unless the use meets one of the specifically enumerated covered indications in Section I and satisfies the applicable clinical criteria.

Use of denosumab (Prolia) for indications not listed in Section I (the FDA‑approved indications and compendial uses) is considered not medically necessary. Providers should submit requests only for indications described in the policy and include documentation demonstrating the member meets the stated clinical criteria; requests for other indications will not meet medical necessity requirements.

Coding, Thresholds, and Definitions

High FRAX thresholds

High FRAX threshold — major osteoporotic fracture10-year major osteoporotic fracture risk ≥ 20%

High FRAX threshold — hip fracture10-year hip fracture risk ≥ 3%

FRAX calculation resource10-year probability; calculation tool available at https://www.sheffield.ac.uk/FRAX/

Glucocorticoid exposure threshold

Glucocorticoid exposure — primary thresholdPrednisone equivalent ≥ 2.5 mg/day for ≥ 3 months

FRAX adjustment for higher dosesMultiply FRAX major osteoporotic fracture score by 1.15 and hip fracture score by 1.2 when glucocorticoid dose > 7.5 mg/day (prednisone equivalent)

Context in GIOP criteriaGlucocorticoid exposure threshold required for GIOP initial therapy authorization

T-score threshold

Osteoporosis diagnostic T-scorePre-treatment T-score ≤ -2.5 (osteoporosis)

Osteopenia definitionPre-treatment T-score > -2.5 and < -1 (osteopenia)

Use in criteriaT-score thresholds applied across postmenopausal, male, and glucocorticoid-induced osteoporosis criteria

Provider Actions, Documentation, and Authorization Notes

Denial Risk

Non‑covered indications

Requests for indications not listed as FDA‑approved or compendial uses (see Section I: Indications and Compendial Uses) are considered experimental/investigational and are not medically necessary. Such requests will be denied.

Prior Authorization

Bisphosphonate trial or documented contraindication

Many approval paths require documentation of a prior trial of an oral or injectable bisphosphonate for at least 1 year. If a bisphosphonate cannot be used, submit documentation of a clinical reason to avoid bisphosphonate therapy (see Appendix A for acceptable clinical reasons).

Oral or injectable bisphosphonate trial duration: at least 1 year
If contraindication/intolerance: include supporting clinical documentation (see Appendix A)

Documentation Required

Required documentation for prior authorization

Submit supporting chart notes or medical record documentation to initiate prior authorization review. Documentation should include relevant history of fragility fractures, pre‑treatment T‑score, and FRAX fracture probability as applicable to the indication being requested.

Prior Authorization

12‑month prior authorization for approved indications

Prior authorization may be granted for up to 12 months for approved indications when the member meets the specific criteria in Sections III.A–III.E (postmenopausal osteoporosis, osteoporosis in men, glucocorticoid‑induced osteoporosis, breast cancer, prostate cancer).

Authorization length: up to 12 months for approved indications

Definitions and Clinical Notes

High FRAX fracture probability

High FRAX major/hip thresholds10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%

FRAX adjustment for glucocorticoids >7.5 mg/dayMultiply estimated FRAX major osteoporotic fracture score by 1.15 and hip fracture score by 1.2 when glucocorticoid treatment is >7.5 mg/day (prednisone equivalent)

Reference for calculationFRAX 10-year probability calculation tool: https://www.sheffield.ac.uk/FRAX/

Clinical reasons to avoid oral bisphosphonates

Esophageal abnormalitiesAnatomic or functional esophageal abnormalities (e.g., achalasia, stricture, or dysmotility)

Active upper GI diseaseActive upper gastrointestinal problems (e.g., dysphagia, gastritis, duodenitis, erosive esophagitis, ulcers)

MalabsorptionDocumented or potential gastrointestinal malabsorption (e.g., gastric bypass, celiac disease, Crohn's disease)

Inability to remain uprightInability to stand or sit upright for at least 30 to 60 minutes

Unable to take oral bisphosphonate before foodInability to take oral bisphosphonate at least 30 to 60 minutes before first food, drink, or medication of the day

Other clinical reasonsRenal insufficiency (CrCl <35 mL/min) or history of intolerance to an oral bisphosphonate

Policy Background

Denosumab (Prolia) is used to increase bone mass and reduce fracture risk in patients with osteoporosis or cancer therapy–associated bone loss. The policy recognizes its compendial uses such as prevention or treatment of osteoporosis during androgen deprivation therapy for prostate cancer and use in postmenopausal patients receiving adjuvant aromatase inhibitor therapy to maintain or improve bone mineral density. Uses outside these FDA‑approved or compendial indications are considered experimental/investigational and not medically necessary.