Third Time Lucky? Eli Lilly and Eisai Get Another Shot At English Funding For Alzheimer’s Drugs

In an unusual decision by NICE, the health technology assessment institute for England is giving Eli Lilly and Eisai a third chance to persuade it to reimburse their respective disease-modifying treatments for Alzheimer’s disease, Kisunla (donanemab) and Leqembi (lecanemab). The move comes after NICE for the second time provisionally recommended against making either drug available via the National Health Service because they are too expensive.

Both companies said they were disappointed by the latest rejections but that they planned to work with the institute to demonstrate that their amyloid-targeting drugs are a cost effective use of NHS resources.

NICE’s recommendations are in the form of draft guidance documents for Kisunla and Leqembi that are now out for consultation until 27 March, ahead of a third meeting of the institute’s appraisal committee on 14 May.

Lilly told the Pink Sheet that it would provide NICE with “new evidence” and said it “remains confident in the clinical efficacy and cost-effectiveness of donanemab and the value that it can bring to patients, their caregivers and to the NHS.”

Eisai, which developed Leqembi with Biogen, said in a statement that it recognized that introducing a new class of medicine was “not always straightforward.”

It also said that it remained “committed to working collaboratively with NICE and the NHS to enable eligible people living with early AD [Alzheimer’s disease] in England and Wales to access lecanemab as soon as possible.”

Concerns Over Cost-Effectiveness

Leqembi and Kisunla were approved for marketing by the UK drug regulator, the MHRA, last August and October respectively.

When they were approved, NICE published draft guidance for each product, saying that its appraisal committee had decided that the medicines showed too little benefit to justify the significant additional cost to the NHS of providing and administering them.

Both draft guidance documents were published for consultation and the committee asked for some additional evidence to be provided. The committee has since considered the additional evidence but “unfortunately this has confirmed that the medicines are not currently cost effective and the committee’s recommendation remains that they should not be provided on the NHS at this time,” NICE said.

The institute noted that the benefit either drug provided was relatively small, but the cost for providing them was high (including fortnightly infusions in hospital for Leqembi or monthly infusions in hospital for Kisunla, and intensive monitoring for side effects).

Another Chance

Through the latest consultations, launched today, NICE said it was “providing the companies and other stakeholders the opportunity to submit new evidence or commercial proposals that might address the issues that have so far been a barrier to the use of these new treatments in the NHS.”

The cost-effectiveness estimates for Kisunla and Leqembi “remain substantially higher than NICE can consider an acceptable use of taxpayers’ money and NHS resources,” the institute continued. “The evidence presented so far shows neither donanemab nor lecanemab provide enough benefit to justify the substantial resources the NHS would need to commit to implement access to them, even with a managed access arrangement.”

NICE said that stakeholders “are particularly encouraged to comment on the committee’s latest conclusions regarding managed access arrangements and evidence requirements.”

It explained that managed access arrangements “can facilitate NHS patients using promising and potentially cost-effective medicines for a fixed period, at a discount to manage the uncertainty to the NHS, while further evidence is gathered on how those medicines can be provided and how well they work outside clinical trials.”

Lilly & Eisai Remain Upbeat

Lilly told the Pink Sheet that it was disappointed with the latest draft decision “as it does not consider the full value of donanemab. For example, Lilly believes that the use of the EQ-5D tool to measure caregiver quality of life does not adequately reflect the impact of caring for a loved one with Alzheimer’s disease, especially in the later stages of the disease course.”

The company said it “has provided a managed access data collection proposal which we believe is sufficient to address key uncertainties highlighted by NICE. We remain committed to working closely with NICE to address any remaining questions ahead of the third appraisal committee meeting.”

Eisai said it was “encouraged by NICE’s decision to convene a third committee meeting as it enables further evaluation of lecanemab and how it could be introduced to the NHS.”

It added that substantial changes were needed “to improve Alzheimer’s disease management and lecanemab is just one part of the bigger picture. To facilitate change, the NHS will need to prioritise those impacted by dementia and consider not just individual treatment costs but diagnostic and management pathways collectively, so people living with Alzheimer’s disease can benefit from innovative treatments now and in the future.”

The company told the Pink Sheet that NICE had determined that a managed access program for Leqembi “would not resolve all of the uncertainties that a time-limited agreement would allow.”

Eisai added that it was “unable to comment further on the details of the confidential discussions around this topic with NICE at this time.”

List Prices

The list price of Leqembi is £275 ($355) for 200mg solution for infusion and £545 for 500mg solution or infusion (excluding VAT). According to NICE’s draft guidance, Eisai had a commercial arrangement that would have applied if the drug had been recommended by NICE.

The list price of Kisunla concentrate for solution for infusion is confidential until published by the Department for Health and Social Care. The company had a commercial arrangement, which would have applied had the drug had been recommended. Lilly noted that Kisunla is given every four weeks up to a maximum duration of 18 months where people can stop treatment earlier if amyloid clearance is confirmed.

Neither Kisunla nor Leqembi is approved for marketing in the EU.

Leqembi was recommended for approval by the EMA recently, and is awaiting final approval by the European Commission. A marketing application for Lilly’s drug has been under review by the European Medicines Agency since August 2023.

Both drugs are already approved for marketing in the US and other countries.