CurrentCareSourcePolicy N/A

Neurology Kisunla Utilization Management Medical Policy

Defines CareSource's coverage stance and utilization management position for Kisunla (donanemab-azbt) for treatment of early Alzheimer's disease, including authorization criteria and conditions not recommended for approval; applies to CareSource members in North Carolina.

Policy Summary

PayerCareSource

PolicyNeurology Kisunla Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 24, 2024

Key ActionDo not expect an approval pathway; the policy states no authorization criteria and recommends against approval due to insufficient efficacy and safety concerns.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not recommendedCoverage stance

InsufficientEfficacy conclusion

36%ARIA incidence

6%Symptomatic ARIA

n=1,736Pivotal trial

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Not recommended for approval

Covered when ALL of the following are met

Not recommended for approval: Due to safety concerns and the lack of clinically significant efficacy data, approval is not recommended for Kisunla.

Policy states no recommended authorization criteria; clinical trials (TRAILBLAZER-ALZ2 and TRAILBLAZER-ALZ) showed statistically significant but not clinically meaningful differences on iADRS and CDR-SB and demonstrated safety concerns including ARIA.

Kisunla has not been evaluated in patients with certain high‑risk neuroimaging findings and use in these circumstances is not recommended. Specifically, do not use Kisunla in patients with a history of prior cerebral hemorrhage > 1 cm in greatest diameter, more than four cerebral microhemorrhages, more than one area of superficial siderosis, severe white matter disease, or vasogenic edema because these conditions were not evaluated in clinical trials and may increase risk of harm. Enhanced vigilance for amyloid‑related imaging abnormalities (ARIA) is recommended during early dosing, as most ARIA events occurred during titration.

Coverage is not recommended for any circumstances that are not explicitly listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available; until then, use outside the described situations is not supported by the current evidence base.

Overall, the available evidence is insufficient to demonstrate a clinically meaningful benefit with Kisunla. The policy concludes that current efficacy information does not show clinically significant improvement and, combined with demonstrated safety concerns in trials, approval is not recommended in the absence of additional supporting clinical trials.

Provider Requirements, Prior Authorization, and Denial Reasons

Prior Authorization

Prior authorization requirement

None — no prior authorization criteria specified for Kisunla.

Step Therapy

Step therapy

None specified.

Documentation Required

Required imaging surveillance

A recent (within 1 year) MRI of the brain is required prior to initiating treatment. Enhanced clinical vigilance and MRI surveillance are recommended during treatment: obtain brain MRI prior to initiation and again at the second, third, fourth, and seventh infusions to monitor for asymptomatic ARIA.

MRI within 1 year prior to initiation
Repeat MRI at 2nd, 3rd, 4th, and 7th infusions

Denial Risk

Primary reason for denial

Primary reason for denial: lack of clinically significant efficacy data and demonstrated safety concerns in clinical trials; current evidence is insufficient to determine meaningful benefit and safety risks have been observed.

Denial Risk

High-risk imaging findings

High-risk imaging findings that contraindicate coverage or warrant non-approval include: intracerebral hemorrhage > 1 cm in greatest diameter, >4 cerebral microhemorrhages, >1 area of superficial siderosis, severe white matter disease, vasogenic edema, or other significant hemorrhagic/vascular abnormalities on MRI.

Intracerebral hemorrhage > 1 cm in greatest diameter
More than 4 cerebral microhemorrhages
More than one area of superficial siderosis
Severe white matter disease
Vasogenic edema or other significant vasculopathy

Product and Clinical Background

Kisunla (donanemab) is an amyloid beta–directed monoclonal antibody developed for the treatment of early Alzheimer’s disease (mild cognitive impairment or mild dementia stage) in patients with biomarker evidence of amyloid pathology. Clinical trial programs evaluated its effect on amyloid‑related imaging abnormalities and cognitive/functional outcomes; however, the policy notes that current efficacy data are insufficient to demonstrate clinically meaningful benefit and that safety concerns, particularly ARIA, were observed.

Key Terms and Definitions

Early Alzheimer's disease — definition and staging (MCI or mild dementia)

TermEarly Alzheimer's disease (mild cognitive impairment or mild dementia)

Clinical featuresSubtle problems with memory and thinking that may be noticeable to the individual or family but do not yet interfere with everyday activities

Biomarker requirementBiomarker evidence of Alzheimer’s pathology (e.g., abnormal amyloid beta on PET or CSF; decreased glucose metabolism on PET)

Disease stage examplesMild cognitive impairment due to Alzheimer’s disease or mild dementia stage

Population estimate (context)Estimated 5–7 million older Americans may have mild cognitive impairment due to Alzheimer’s disease (background context)

ARIA — definition of ARIA-E and ARIA-H and relevance

DefinitionAmyloid related imaging abnormalities (ARIA) comprising ARIA‑E (edema/effusion) and ARIA‑H (microhemorrhage and superficial siderosis) detectable on MRI

Clinical relevanceARIA has been observed with donanemab (Kisunla) and may be symptomatic or asymptomatic; enhanced vigilance is recommended during initial dosing

Incidence in pivotal trialRadiographic ARIA (including asymptomatic) observed in 36% of patients treated with Kisunla vs. 14% with placebo

Symptomatic ARIASymptomatic ARIA occurred in 6% of patients treated with Kisunla (52/853) in the pivotal trial; ~85% of affected patients had resolution of clinical symptoms

Imaging surveillanceObtain brain MRI within 1 year before initiating treatment and before the 2nd, 3rd, 4th, and 7th infusions to evaluate for ARIA