Eli Lilly’s Kisunla Approved for Alzheimer’s, Faces NHS Funding Hurdle
On October 23, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted approval to Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb), Kisunla, for treating patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease in Great Britain. However, the excitement of this breakthrough was quickly tempered when the National Institute for Health and Care Excellence (NICE) simultaneously announced that Kisunla would initially not receive coverage for use within the NHS. The rejection was based on concerns regarding an unfavorable risk-benefit profile and insufficient cost-effectiveness.
A Disappointing Dual Announcement
For many Alzheimer’s patients and advocates, NICE’s decision was disappointing yet unsurprising. This marks the second occasion in 2024 where a drug deemed critical for combating Alzheimer’s disease has faced an uphill battle for NHS funding on the same day it was approved by the MHRA. Just months prior, in August 2024, Eisai/Biogen’s anti-Aβ mAb, Leqembi, had the same fate—approved for MCI and mild Alzheimer’s disease but not recommended by NICE due to cost concerns and safety issues.
NICE’s preliminary recommendations indicate that the review process is ongoing and that further data is still required. Stakeholders are eager for additional evidence regarding both the drug’s efficacy and its associated costs. Notably, queries around the average duration of treatment with Kisunla and outcomes upon cessation of therapy remain central to the discussions.
Cost and Efficacy Landscape
In evaluating Kisunla, NICE has expressed concerns regarding cost-effectiveness, a crucial element in approving treatments in the UK NHS framework. Given that Kisunla is not intended for indefinite use—a departure from traditional Alzheimer’s therapies—experts speculate that it might present a significantly lower total lifetime cost compared to Leqembi.
A post-authorization safety study is already in the pipeline, planned by the MHRA to assess long-term effects. Observations gleaned from landscapes outside the UK, particularly in the US where both Leqembi and Kisunla are available, could significantly influence the ongoing evaluation process.
Market Potential and Future Outlook
According to data from leading analytics firm GlobalData, in eight major pharmaceutical markets—including the US, UK, Japan, and several European nations—sales projections for Leqembi and Kisunla are substantial. Forecasts suggest Leqembi could amass approximately $3.5 billion in sales by 2030, while Kisunla may generate about $2.0 billion in the same timeframe.
This expected market performance is indicative of a growing demand for innovative Alzheimer’s treatments as the global population ages and cases of dementia continue to rise.
Expert Opinions
“Both Kisunla and Leqembi represent significant advancements in our understanding of Alzheimer’s treatments. However, the questions of cost and safety must take precedence if we are to integrate these therapies into everyday medical practice effectively,” stated Dr. James Larkin, a neurologist specializing in dementia research.
Furthermore, stakeholders await NICE’s detailed evaluations and their implications for patient access to life-altering therapies.
Implications for Patients and Healthcare Providers
While the developments around Kisunla raise hopes among patients living with Alzheimer’s disease, they also highlight the complexities of securing NHS funding amidst rigorous cost assessments. The NHS’s reluctance to fund these treatments underlines the financial barriers that can exist, adversely impacting patient access.
As the situation unfolds, the healthcare community is urged to uphold dialogue surrounding these innovative therapies while pursuing solutions that prioritize both efficacy and affordability.
Engage with Us
As discussions develop regarding Kisunla and its potential impact on Alzheimer’s treatment strategies, we invite your thoughts and experiences. What are your views on the funding decisions made by NICE? Share your insights in the comments below or engage with us on social media.
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