Q5139, Injection, eculizumab-aeeb (bkemv), biosimilar, 10 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Documentation that the therapy is supported by FDA-approved labeling and/or nationally recognized authoritative references (examples: MCG, DrugDex, NCCN).
- For drug therapy, documentation of the proposed dose, frequency, and duration and citation of at least one authoritative source supporting those parameters.
- Providers and members must consult the member's benefit plan, summary plan description, or contract to determine any required documentation, exclusions, or limitations.
- Citation or copy of the relevant entry from the HHS‑adopted standard medical reference compendia showing the use is recognized as safe and effective.
Key Coverage Criteria
- Requested therapy must be proven effective for the relevant diagnosis or procedure.
- Drug therapy is covered when the proposed dose, frequency, and duration are consistent with recommendations in at least one authoritative source.
- Coverage of any FDA‑approved drug when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U.S. Department of Health and Human Services (HHS).
- Coverage of an off‑label drug use supported by medical literature when safety and efficacy are confirmed in two articles from major peer‑reviewed professional medical journals presenting data supporting the proposed use.
- Coverage considered when supported by high-quality evidence such as randomized, double-blind, placebo-controlled clinical trials.
- Preference for evidence published in major peer-reviewed journals (e.g., JAMA, NEJM, Lancet) or equivalent high-quality study designs.
1 Active Policy
RX501.066, Eculizumab and Associated Biosimilar(s)
Related Codes
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