J0175, Injection, donanemab-azbt, 2 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Citation(s) to the applicable standard medical reference compendium entry (if coverage being claimed via compendia).
- Two copies/references of peer‑reviewed professional journal articles that present data confirming safety and efficacy for the proposed off‑label use (both required when relying on medical literature).
- Documentation that the drug is FDA‑approved and that the member is an HCSC member residing in Ohio (to establish applicability of § 3923.60).
- Acceptable evidence includes high-quality peer-reviewed randomized, double-blind, placebo-controlled clinical trials (examples of journals cited: JAMA, NEJM, Lancet).
Key Coverage Criteria
- Coverage of FDA‑approved drugs when prescribed for an off‑label 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.
- Coverage of FDA‑approved drugs for an off‑label indication when medical literature support demonstrates safety and efficacy confirmed in two articles from major peer‑reviewed professional medical journals.
- Donanemab-azbt (Kisunla) for the treatment of Alzheimer's Disease (initial therapy) when ALL policy-specified criteria for initiation are met.
- Prescribed by or in consultation with a neurologist or neuropsychiatrist.
- Individual aged 50 years or older.
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease (AD) or mild AD dementia.
12 Active Policies
UHC-POL-kisunla, Kisunla (Donanemab-Azbt)
RX501.177, Donanemab-azbt
BCBSIL-RX501.177, Donanemab-azbt
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
BCBSMT-RX501.177, Donanemab-azbt
Related Codes
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