Q5166, Injection, denosumab-desu (osvyrti/jubereq), biosimilar, 1 mg
HCPCS/CPT
Prior Authorization
Prior Auth Required
Code explicitly requires prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- 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.
Key Coverage Criteria
- 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.
- NGS covers denosumab (Prolia, Xgeva) for its FDA-approved and approved compendia uses.
- NGS covers intra-articular hyaluronans for their FDA-approved and approved compendia uses.
4 Active Policies
NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J6
NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK
EVICORE-HPLAN-CIGNA-729A536F50C8, Q3 - 2026 Cigna MedOnc Master Drug List.pdf
EVICORE-HPLAN-HEALTH_PARTNERS_PLANS-4BC80209CCC5, Q3 - 2026 Jefferson Health Plans MedOnc Master Drug List
Related Codes
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