CurrentBlue Cross Blue Shield - IowaPolicy 05.05.53

Kisunla (donanemab) coverage criteria for Alzheimer's disease

Defines benefit, prior authorization, and medical necessity criteria for Kisunla (donanemab) for treatment of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyKisunla (donanemab) coverage criteria for Alzheimer's disease

Policy CodePolicy 05.05.53

Change TypeNo material changes

Effective DateOct 11, 2025

Next Review DateAug 1, 2025

Key ActionSubmit prior authorization with baseline cognitive assessments, amyloid confirmation (PET or CSF), and recent brain MRI.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial auth

6 mofirst reauth

≥50age criterion

PET/CSFamyloid confirmation

J0175billing code

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

Initial Therapy

Authorization of 12 months may be granted for treatment of Alzheimer's Disease (AD) when all of the following criteria are met:

Initial Approval: Member is 50 years of age or older OR if under 50 has a pathogenic mutation in APP, PSEN1, or PSEN2 or other clinical documentation supporting early onset AD; diagnosis of mild cognitive impairment due to AD or mild AD dementia; objective baseline cognitive impairment documented by one of the following: Clinical Dementia Rating–Global Score (CDR‑GS) of 0.5; Mini‑Mental State Examination (MMSE) score 21–30; Montreal Cognitive Assessment (MoCA) score ≥16; or St. Louis University Mental Status Exam (SLUMS) score ≥16; confirmation of amyloid pathology by PET scan OR cerebrospinal fluid (CSF) demonstrating elevated phosphorylated tau (P‑tau) and/or total tau (T‑tau) with reduced Aβ42 or specified abnormal ratios; recent brain MRI within 1 year prior to initiation to evaluate for pre‑existing amyloid‑related imaging abnormalities (ARIA); ApoE‑ε4 genotype testing performed prior to initiation OR prescriber has informed the member that genotype testing has not been performed and risk status cannot be determined; member and/or provider currently participating in a provider‑enrolled AD patient registry (e.g., ALZ‑NET); if on antithrombotic therapy (antiplatelet or anticoagulant), member has been on a stable dose for at least 4 weeks prior to initiation.

From Criteria for Initial Approval sections

Continuation Therapy (first reauthorization)

Authorization of 6 months (first reauthorization after the initial 12-month approval period) may be granted when all of the following are met:

First Reauthorization: Member met all initial authorization criteria at the time of initial approval; MRI monitoring and ARIA management applied per radiographic severity: dosing may continue or should be suspended until MRI demonstrates radiographic resolution/stabilization and symptoms resolve depending on ARIA‑E or ARIA‑H severity and clinical symptoms as specified in the ARIA management guidance; member continues to have an elevated amyloid plaque level per Centiloid criteria (not less than 11 Centiloids on a single PET scan or 11 to less than 25 Centiloids on two consecutive PET scans).

ARIA management rules and Centiloid requirement referenced

Continuation Therapy (ongoing)

Authorization of 12 months (reauthorizations beyond initial 18 months of therapy) may be granted when all of the following are met:

Ongoing Reauthorization: Member met all initial authorization criteria at the time of initial approval; member has CDR‑Global Score of 0.5 or 1; member demonstrates a positive clinical response defined as stabilization or slowing of disease progression documented by the same assessment tool used at baseline (examples include MMSE decline of ≤3 points per year, MoCA score ≥16, SLUMS score ≥16); member continues to have an elevated amyloid plaque level per Centiloid criteria (not less than 11 Centiloids on a single PET scan or 11 to less than 25 Centiloids on two consecutive PET scans).

From Continuation of Therapy section

This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the applicable contract language and the Federal Employee Program; verify member benefits and any contract exclusions or limitations before applying this policy.

The policy references the National Coverage Determination for monoclonal antibodies directed against amyloid for treatment of Alzheimer's disease but does not quote or restate exclusions from that NCD. No other explicit exclusions are provided in the cited references.

Kisunla (donanemab) is considered not medically necessary for members who do not meet the specific medical necessity criteria set forth elsewhere in this policy.

The referenced material includes citations and guidance documents but does not contain explicit statements that list additional or separate not medically necessary conditions beyond those expressed in the policy criteria.

Procedure Codes and Diagnostic Thresholds

Procedure / HCPCSHCPCS

J0175

Centiloid amyloid plaque level — PET centiloid thresholds for eligibility

Centiloid threshold (single PET)Not less than 11 Centiloids on a single PET scan

Centiloid threshold (two consecutive PETs)11 to less than 25 Centiloids on 2 consecutive PET scans

Use contextRequired for continuation reauthorization to demonstrate persistently elevated amyloid plaque level

Prior Authorization, Documentation, and Dosing Rules

Prior Authorization

Prior Authorization Required

Prior authorization required for diagnostic confirmation and treatment initiation. Initial requests must include genetic testing results when early-onset Alzheimer disease is suspected and documentation supporting the diagnosis (including baseline cognitive assessments and evidence of amyloid pathology). Continuation requests require recent cognitive assessment and brain MRI as specified.

Initial requests: include genetic testing results if early-onset AD suspected; baseline cognitive assessment (MMSE, MoCA, CDR‑GS, or SLUMS); documentation of amyloid pathology (CSF or PET).
Continuation requests: recent (within 1 year) cognitive assessment and brain MRI results prior to specified maintenance doses (per policy dosing schedule).
Prior authorization required for amyloid confirmation, cognitive baseline documentation, and MRI/genotype submission.

Note

Dosing Limits May Apply

Approvals may be subject to dosing limits consistent with FDA labeling and evidence-based guidelines. Reviewers may apply limits based on approved dosing schedules, total duration, and other clinical guidance.

Key Terms and Test Definitions

Kisunla (donanemab) — indication summary and treatment stage

IndicationKisunla (donanemab) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease

Treatment stage for initiationTherapy should be initiated in patients with mild cognitive impairment (MCI) or mild dementia

Population basisInitiation recommendation is based on the population studied in clinical trials

ARIA MRI Classification — ARIA-E and ARIA-H radiographic severity

ARIA-E mildFLAIR hyperintensity confined to sulcus and/or cortex/subcortical white matter in one location

ARIA-E moderateFLAIR hyperintensity 5 to 10 cm, or more than one site of involvement; each measuring ≤10 cm

Background and Context

Donanemab (branded Kisunla) is an amyloid beta-directed monoclonal antibody indicated for the treatment of Alzheimer's disease. It is intended for use in patients at the mild cognitive impairment or mild dementia stages, consistent with the populations studied in clinical trials, and requires objective cognitive assessment and confirmation of brain amyloid pathology prior to initiation.

Policy Timeline and References

2024-10-13original_effective_date

Policy originally became effective on October 13, 2024.

2025-08review

Policy reviewed (most recent review noted August 2025).

2025-10-11current_effective_dateLatest

Current policy effective date updated to October 11, 2025 (document last reviewed October 11, 2025).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyKisunla (donanemab) coverage criteria for Alzheimer's disease

Policy CodePolicy 05.05.53

Change TypeNo material changes

Effective DateOct 11, 2025

Next Review DateAug 1, 2025

Key ActionSubmit prior authorization with baseline cognitive assessments, amyloid confirmation (PET or CSF), and recent brain MRI.

SourceLink

On This Page

Denial Risk

Not Medically Necessary / Denial Risk

Kisunla (donanemab) is considered not medically necessary for members who do not meet the policy criteria. Denials may be issued when required documentation (genetic testing for suspected early‑onset AD, baseline cognitive testing, or evidence of amyloid pathology) is not provided or when clinical criteria are not met.

Kisunla (donanemab) — not medically necessary if criteria not met.
Denial risk when required documentation or diagnostic confirmation is missing.

Documentation Required

Required documentation for initial and continuation requests includes: genetic testing results (for early‑onset AD suspicion), medical records supporting the diagnosis and treatment rationale, baseline and follow‑up cognitive assessment scores (MMSE, MoCA, CDR‑GS, or SLUMS), and evidence of amyloid pathology (CSF assays or PET imaging).

Initial requests: genetic testing results if early‑onset AD suspected; baseline cognitive assessment (MMSE, MoCA, CDR‑GS, or SLUMS); documentation of amyloid pathology (CSF or PET).
Continuation requests: most recent cognitive assessment (within 1 year) and MRI prior to specified doses; MRI reports should be submitted for doses per protocol.

Note

Documentation Aids and References

References and assessment tools commonly used to support documentation include MMSE, MoCA, CDR‑GS, SLUMS, CSF biomarker assays (e.g., Elecsys phospho‑tau), and amyloid PET imaging. These tools are cited in the policy references and should be used to substantiate clinical findings.

Cognitive assessment tools: MMSE, MoCA, CDR‑GS, SLUMS.
Biomarker assays: CSF phospho‑tau (Elecsys) and amyloid PET imaging.
Policy references include NCD for monoclonal antibodies directed against amyloid and relevant diagnostic guideline publications.

ARIA-E severeFLAIR hyperintensity measuring >10 cm with associated gyral swelling and sulcal effacement; may be multiple sites

ARIA-H microhemorrhage mildFewer than 4 new incident microhemorrhages

ARIA-H microhemorrhage moderate5 to 9 new incident microhemorrhages

ARIA-H microhemorrhage severe10 or more new incident microhemorrhages

ARIA-H superficial siderosisSeverity defined by number of focal areas: mild = focal area; moderate = 2 focal areas; severe = 2 or more areas

Elecsys Phospho-Tau (181P) — CSF assay referenced

Assay nameElecsys Phospho-Tau (181P) — CSF assay

Use in policy contextReferenced as a cerebrospinal fluid biomarker assay compared to amyloid imaging

Reference yearElecsys Phospho-Tau (181P) CSF 2022-12 cited in references

MoCA — Montreal Cognitive Assessment definition

DefinitionMontreal Cognitive Assessment (MoCA): a brief screening tool for mild cognitive impairment

Score ranges (policy appendix)Mild cognitive impairment: 19–25; Mild dementia: 11–21; Normal: 26 and above

Use in continuation criteriaMoCA ≥16 is cited as an objective baseline/continuation threshold in this policy

MMSE — Mini-Mental State Examination definition

DefinitionMini‑Mental State Examination (MMSE): a cognitive screening instrument used to track cognitive decline

Continuation criterionMMSE decline of 3 points or less per year is considered evidence of positive clinical response for reauthorization

Reference contextMMSE cited in continuation of therapy criteria and referenced literature on tracking cognitive decline

2025-10-11current effective date

2024-10-13original effective date

50+minimum age for routine initiation

J0175listed billing code (HCPCS)