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
- Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following: Mini-Mental State Examination (MMSE) score of 20 to 30; Montreal Cognitive Assessment (MoCA) score of 17 to 30; Saint Louis University Mental Status (SLUMS) score of 17 to 30
- Submission of medical records (e.g., chart notes, laboratory values) documenting the presence of amyloid beta pathology, as evidenced by positive amyloid positron emission tomography (PET) brain imaging
- Submission of medical records confirming baseline brain magnetic resonance imaging (MRI) has been completed within 12 months prior to initiating treatment
- Submission of medical records (e.g., chart notes) confirming follow-up brain magnetic resonance imaging (MRI) has been completed after the initiation of therapy
Key Coverage Criteria
- Kisunla (donanemab-azbt) is proven for the treatment of Alzheimer's disease (AD) when all of the following criteria are met: For initial therapy: Diagnosis of one of the following based on National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria: Mild cognitive impairment (MCI) due to Alzheimer's disease; or Mild dementia due to Alzheimer's disease; and Presence of amyloid beta pathology has been confirmed; and A baseline brain magnetic resonance imaging (MRI) has been compl [...]
- Kisunla (donanemab-azbt) is medically necessary for the treatment of Alzheimer's disease (AD) when all of the following criteria are met: For initial therapy: Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following: Mini-Mental State Examination (MMSE) score of 20 to 30; Montreal Cognitive Assessment (MoCA) score of 17 to 30; Saint Louis University Mental Status (SLUMS) score of 17 to 30; and Submission of medical records (e.g., chart notes, laborato [...]
- For continuation of therapy (reauthorization): Diagnosis of Alzheimer's disease; and Follow-up brain MRI has been completed after the initiation of therapy; and Not used in combination with other Aβ mAbs for Alzheimer's Disease (e.g., Leqembi); and Kisunla dosing is in accordance with the United States Food and Drug Administration approved labeling; and Reauthorization is for no more than 12 months
- Continuation: One of the following [Note: diagnoses based on NIA-AA criteria]: Patient has mild cognitive impairment (MCI) due to Alzheimer's disease; or Patient has mild dementia due to Alzheimer's disease; or Both of the following: Patient has progressed into moderate or severe stages of dementia due to Alzheimer's disease and Prescriber attests that the patient has shared in decision-making to continue Kisunla therapy
- Continuation: Amyloid PET imaging requirements: - If patient has received Kisunla therapy for less than or equal to 6 months: Post-treatment amyloid PET brain imaging is positive for amyloid based on visual read; or Prescriber attests that amyloid PET imaging will be performed prior to 18 months of total treatment to assess for the effect of Kisunla treatment on amyloid plaque. [...]
- Continuation: ARIA-related criteria: Submission of medical records confirming follow-up brain MRI has been completed after initiation of therapy; and Either ARIA has not been observed on MRI; or ARIA has been observed on MRI and Prescriber attests that continuation of therapy with Kisunla is appropriate based on the severity of the patient's clinical symptoms; and Either Follow-up MRI demonstrates radiographic resolution and/or stabilization; or Prescriber attests that continuation of therapy wi [...]
12 Active Policies
UHC-POL-kisunla — Kisunla (Donanemab-Azbt)
UMR-POL-UMR-kisunla — Kisunla (Donanemab-Azbt)
SUREST-POL-SUREST-kisunla — Kisunla (Donanemab-Azbt)
BCBSIL-RX501.177 — Donanemab-azbt
BCBSMT-RX501.177 — Donanemab-azbt
Related Codes
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