For patients living with Type 2 diabetes in the United Kingdom, a more convenient treatment option may be on the horizon after the country's drug price watchdog recommended Eli Lilly’s once-weekly insulin injectable, Onswik, for coverage on the National Health Service.
The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s drug cost assessor, determining whether a new drug’s price-to-benefit ratio merits coverage via the publicly-funded NHS. The agency's seal of approval for Onswik means hundreds of thousands of patients with type 2 diabetes could eventually make the switch to a weekly injection and reduce their annual injections by 85%, should Lilly's long-acting option score approval in the country.
The Onswik option could be particularly valuable to patients who need assistance with their insulin injection because of factors like sight loss, frailty, limited hand movement or difficulty following the necessary steps, according to final draft guidance from NICE issued early Thursday U.K. time.
Switching to weekly injections also could reduce those patients' dependence on caregivers and healthcare workers and offer more flexibility in their day-to-day lives, the drug value appraiser added.
A Lilly spokesperson told Fierce that the pharma is now "awaiting a decision from the MHRA on marketing authorization."
“This recommendation is an important step towards giving people with type 2 diabetes greater flexibility in how their condition is managed,” Douglas Twenefour, head of clinical at Diabetes UK, said in a press release. Younger patients with type 2 diabetes may also benefit from Onswik if the weekly schedule helps them balance treatment with their working life.
NICE based its recommendation on data from Lilly’s late-stage QWINT-1, QWINT-3, and QWINT-4 clinical trials. The results showed non-inferior A1C reduction with Onswik compared to daily insulin in patients taking insulin for the first time, patients who previously took daily insulin and patients who previously used daily insulin and mealtime insulin. Overall, Onswik controlled blood glucose as well as two commonly used daily insulins, insulin degludec and insulin glargine, and maintained a similar safety profile.
“This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding,” Helen Knight, director of medicines evaluation at NICE, said in a statement.
The endorsement comes at a time when several pharmas, including Lilly, have been critical of the agency’s cost-effectiveness evaluations and their influence on the prices paid for new medicines in the U.K.
Last year, Merck and AstraZeneca pressed pause on expansion plans in the U.K., citing an inhospitable environment for drugmakers. And Bristol Myers Squibb threatened to withhold a drug from the NHS if the agency wouldn’t match its U.S. price. By the end of 2025, corporations had pulled 2 billion pounds ($2.7 billion) in planned investments in the country.
The tension was partially resolved by a U.S.-U.K. pharma trade deal struck in December and finalized this spring. Under the deal, the U.K. is subject to 0% tariffs on pharmaceutical exports to the U.S. until 2029. In exchange, the NHS must raise spending on new medicines by roughly 25% and NICE must increase its price ceiling, paving the way for a higher cost-effectiveness threshold.
Onswick earned a favorable recommendation for type 2 diabetes treatment from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) earlier this summer, but the drug is still awaiting a final sign-off from the European Commission. Lilly could also see an FDA decision on its long-acting insulin by the end of year.