Eli Lilly’s Alzheimer’s disease offering Kinsunla is poised to face a tough road ahead in the U.K. While the region’s Medicines and Healthcare products Regulatory Agency (MHRA) signed off on an approval for certain patients, England’s drug price watchdog conversely found the med's cost-effectiveness profile not worthy of reimbursement through the National Health Service (NHS).

The National Institute for Health and Care Excellence (NICE) declined coverage for Kisunla in a draft guidance, deeming it too costly for the “relatively small benefit it provides,” the regulator said in a release.

“For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money,” said Helen Knight, director of medicines evaluation.

NICE’s independent committee weighed “all available evidence” and concluded that while Kinsula treatment can slow down cognitive decline by four to seven months, “this is just not enough benefit to justify the additional cost to the NHS,” Knight added. The cost-effectiveness estimate came out to five to six times more than what NICE typically declares an acceptable use of NHS resources.

“I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed,” Knight said.

At the same time, the MHRA granted Kisunla a marketing authorization to treat mild cognitive impairment and mild Alzheimer’s disease-related dementia in patients who have only one copy of the apolipoprotein E ε4 allele or who don’t carry it at all. England’s eligible patient population is estimated at 70,000 of the 982,000 people living with dementia in the U.K, according to NICE.

"People around the world want and deserve access to treatment options for this disease,” Ilya Yuffa, head of Lilly International, noted in a company press release. “This approval in Great Britain is another significant step to ensure patients with Alzheimer's disease can receive treatment with this new class of amyloid targeting therapies, which could give them more time in the early symptomatic stage of the disease to do what matters most to them.”

The mixed decisions align with Eisai and Biogen’s rival Leqembi’s experience in the U.K. While MHRA similarly approved that med in August for a limited population, NICE declined to provide coverage for the same reasons it cited in its Kisunla snub.

In the U.S., Leqembi and Kisunla hold broader FDA approvals that cover patients with early symptomatic Alzheimer’s disease. Both treatments also carry a boxed warning for amyloid-related imaging abnormalities, known side effects that may have given NICE pause as the regulator pointed to “significant health risks” in its Lilly guidance.

NICE will issue its final recommendation on the Lilly drug once the consultation period ends in late November, after which the independent committee will consider all responses and additional analyses at a second meeting. Lilly and NHS have been asked to provide further information to address “areas of uncertainty” in the currently available evidence.