Does Q5167 require prior authorization?

Yes, Q5167 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for Q5167?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`Q5167`, Injection, denosumab-qbde (enoby/xtrenbo), biosimilar, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Authorization is for no more than 12 months
Coverage determinations for off-label use require supporting peer-reviewed literature, specialty consultant advice as indicated, and reference to accepted standards of medical practice; documentation of these sources must be provided for review.

Provider requests to add an off-label use must be submitted in writing with supporting data consisting of either at least two Phase III trials demonstrating safety and effectiveness, or if no Phase III evidence exists, at least two large Phase II trials from different centers or other overwhelming Phase II evidence for rare diseases.

Trials cited must be published in national or international peer-reviewed journals (editorial committees comprised of physicians); abstracts and non-peer-reviewed or in-house publications are not acceptable.

Specific drug approvals require condition-specific documentation (e.g., biopsy confirmation for dense deposit disease, diagnosis of HHT with AVMs for bevacizumab, documentation of refractory status for infliximab uses, pretreatment evaluation and prior therapy failure for endometriosis).

For FDA-approved injectable drugs, records should document the injection date relative to the FDA approval date and that all other coverage requirements were met.

Key Coverage Criteria

Initiation of denosumab (for glucocorticoid-induced osteoporosis) requires: diagnosis of glucocorticoid-induced osteoporosis; high fracture risk; dosing per FDA labeling; authorization for up to 12 months. Reauthorization requires positive clinical response, FDA-label dosing, and up to 12 months.
Denosumab is proven for the treatment of postmenopausal patients with osteoporosis or to increase bone mass in patients with osteoporosis at high risk for fracture when all of the following criteria are met: Initial Therapy o Diagnosis of osteoporosis; and o Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy); and o Dosing is i [...]
NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
Off-label uses in anti-cancer chemotherapeutic regimens are covered when they meet the Medicare definition of a medically accepted indication per the Medicare Benefit Policy Manual (Pub 100-02, Ch.15, §50.4.5).
Medicare pays for an FDA-approved injectable drug when it was injected on or after the FDA approval date, is reasonable and necessary for the individual patient, and all other coverage requirements are met.

7 Active Policies

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

SUREST-POL-SUREST-denosumab-prolia-xgeva, Denosumab

UHC-POL-denosumab-prolia-xgeva, Denosumab

EVICORE-HPLAN-HEALTH_PARTNERS_PLANS-4BC80209CCC5, Q3 - 2026 Jefferson Health Plans MedOnc Master Drug List

EVICORE-HPLAN-CIGNA-729A536F50C8, Q3 - 2026 Cigna MedOnc Master Drug List.pdf

UMR-POL-UMR-denosumab-prolia-xgeva, Denosumab

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Q5167, Injection, denosumab-qbde (enoby/xtrenbo), biosimilar, 1 mg