A scientist looks at scans at the Memory Centre at the Department of Readaptation and Geriatrics of the University Hospital in Geneva, Switzerland. The Canadian Drug Expert Committee is recommending that lecanemab should be publicly reimbursed with conditions.DENIS BALIBOUSE/Reuters
Canada’s Drug Agency, in a reversal from its original position, is now recommending that public drug plans cover a disease-modifying medication for Alzheimer’s disease but with conditions.
The agency, which provides non-binding recommendations for drug reimbursement, released an updated draft recommendation and report on Thursday for lecanemab, an antibody drug that can slow cognitive decline in Alzheimer’s patients.
In the report, an expert committee at the agency said it had reconsidered its initial review from February in which it recommended against public funding for lecanemab over efficacy and safety concerns. Now, the Canadian Drug Expert Committee (CDEC) is recommending that lecanemab should be publicly reimbursed with conditions.
“Given the evidence reviewed during the initial deliberation and the newly submitted evidence that was discussed during the reconsideration meeting, CDEC concluded that lecanemab may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value,” the committee concluded.
The conditions include that patients must be 50 and older with a clinical diagnosis of mild cognitive impairment or mild dementia owing to Alzheimer’s disease. Additionally, patients must not be homozygous for the APOE4 gene variant, which is the highest genetic risk factor for late-onset Alzheimer’s disease.
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Reimbursement should be continued after the initial six months of treatment, and then every 12 months, if additional conditions are met, including evidence of continuing benefit and that patient safety is ensured through required MRI monitoring. The committee noted that pricing must also be significantly reduced.
Health Canada approved lecanemab last October but its high cost – $30,000 a year for an average patient – has been a significant barrier to access. The CDA’s updated recommendation, however, sets the stage for public funding to cover the medication.
If CDA recommendation is finalized, it will likely trigger the pan-Canadian Pharmaceutical Alliance, a body that represents provincial, territorial and federal drug plans, to begin confidential price negotiations with the drug manufacturer.
In May, Health Canada approved donanemab, a second drug that targets the underlying cause of Alzheimer’s disease, although it is unclear if public drug plans will cover it. It is currently under review by CDA.
Neither donanemab nor lecanemab are cures; they slow cognitive decline, which allows patients to remain longer in mild stages of the disease.
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It is estimated that 772,000 Canadians have dementia, a number that is projected to more than double by 2050 because of Canada’s aging population. Dementia is the umbrella term for loss of memory and thinking skills; Alzheimer’s is its most common cause.
Lecanemab is recommended for adult patients with mild cognitive impairment or mild dementia. It is delivered by intravenous infusion twice monthly. Patients who have declined beyond those stages do not meet Health Canada’s qualifications for the drug.
Tokyo-based Eisai Co., Ltd. developed lecanemab, sold under the brand name Leqembi, in partnership with American pharmaceutical company Biogen Inc.
In February, the CDEC concluded that evidence in favour of the drug was imprecise and unclear, making it “challenging to conclusively determine a clinically meaningful benefit of lecanemab in reducing cognitive or functional decline in the intended patients.”
It also noted that frequent MRI scans would be required to monitor for rare side effects, including microbleeding and swelling in the brain. The committee cited this as a concern because of “MRI capacity constraints that exist in various provinces across the country.”
The committee said in Thursday’s report that during the reconsideration process it received new information to address “an important clear gap in evidence” and received feedback from clinical specialists and groups, patient advocacy organizations and public drug plans.
Improved access to MRIS to monitor for side effects and improved access to dementia assessment to determine patient eligibility must still be addressed, said the CDEC.