UK watchdog seeks more data on Lilly's Foundayo as the weight-loss pill goes on private sale

Eli Lilly's oral weight-loss pill, Foundayo, is now available in Britain through private prescription, and England's health cost-effectiveness watchdog has asked Lilly for more information before deciding whether the National Health Service will cover it ^[1][2].

Foundayo, known chemically as orforglipron, launched in the UK on Monday, making Britain the first country in Europe where the oral treatment is available ^[1][2]. Britain's medicines regulator, the MHRA, authorised the drug on August 10 ^[1][2]. It is the second GLP-1 tablet cleared in the UK, after Novo Nordisk's Wegovy pill, which contains semaglutide ^[1][2].

The National Institute for Health and Care Excellence must assess the pill before it can become available on the state-run NHS ^[1]. Lilly said it is working with NICE during the agency's assessment of Foundayo for weight management access ^[1]. A NICE spokesperson said the agency requested further information on the drug after its first committee meeting, and that no date has been set for a second review ^[1].

Lilly said Foundayo will likely be priced between £100 and £120 ($136 to $164) a month, lower than the £330 monthly private price of its Mounjaro injection, which contains tirzepatide ^[1][2]. For comparison, private providers in the UK price the Wegovy pill from £74 to £129 a month for initial low doses, with most starting rates tied to multi-month subscription plans, and prices rising as patients move to higher doses ^[1].

In the US, self-pay prices for the Wegovy pill and Foundayo start at $149 a month and rise to $299 and $349 respectively at higher doses ^[1]. A new Medicare pilot offers selective access to the oral drugs at $50 a month ^[1].

Foundayo is authorised for adults with a body mass index of 30 or higher, or 27 to under 30 with at least one weight-related health condition ^[2]. It is also authorised to improve blood sugar control in patients with insufficiently controlled type 2 diabetes, the MHRA said ^[2]. The authorised schedule begins at 0.8 mg and increases through several levels up to 17.2 mg, with at least one month at each dose, and the tablet can be taken at any time of day with no food or water restrictions ^[2]. The most common side effects reported are nausea, constipation, diarrhea, vomiting, indigestion and abdominal pain, according to the MHRA ^[2]. It is prescription-only and can be obtained only from a registered pharmacy with a doctor's prescription ^[2].

Why it matters for patients

In the US, orforglipron has already been on the market since April, and Lilly reported $98 million in Foundayo revenue for the April-to-June quarter, its first period on sale in the US, within total company revenue of $23.0 billion, up 48% from a year earlier ^[2]. Nothing in the UK pricing or the NICE request changes US availability or the US self-pay prices reported for the pill ^[1].

For patients in England, the practical question is who pays. Because the pill is not yet assessed for NHS use, it can be obtained only through private providers, where Lilly expects a monthly cost of about £100 to £120 ^[1]. That is below the £330 monthly private price of Mounjaro, but above the cheapest starting rates listed for the Wegovy pill ^[1]. The UK now has two oral GLP-1 options on private sale; Novo Nordisk disclosed in early August that about 300,000 people in the country had started taking its pill ^[2].

What happens next

No date has been set for a second NICE committee meeting, so the timing of an NHS decision has not been disclosed ^[1]. Foundayo remains under review in the European Union, while the Wegovy pill has received a positive recommendation from the European Medicines Agency and is awaiting a final decision from the European Commission ^[1]. NICE said Novo Nordisk has not yet made an evidence submission for the Wegovy pill ^[1]. Whether or when either oral drug will be routinely funded on the NHS depends on those assessments ^[1].