Pfizer’s Velsipity heading for NHS use in ulcerative colitis

Up to 25,000 people with ulcerative colitis (UC) in England could be in line for treatment with Pfizer’s once-daily oral therapy Velsipity, after NICE recommended its use by the NHS.

The new guidance emerged on the same day that Velsipity (etrasimod) was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for moderately to severely active UC, a few weeks after it was cleared by the European Commission.

NICE said it was able to carry out a rapid review of the S1P receptor modulator thanks to a recently adopted simpler technology appraisal process that cut around eight weeks off the timeline.

Velsipity has been cleared by the MHRA for use in patients aged 16 and over who have had an inadequate response, lost response, or were intolerant to either conventional therapy or biological treatment.

It’s not the first drug in the class to become available for patients with moderate to severe UC, as Bristol-Myers Squibb’s first-to-market Zeposia (ozanimod) was recommended for NHS use in adult patients with the disease in 2022.

Velsipity and Zeposia are both being offered to the NHS at a discount to their ex-VAT list prices of £11,000 and £17,910 per person, per year, according to NICE guidance documents. Pfizer’s drug becomes an option for young people with UC, which is generally diagnosed in people between 15 and 25 years old.

The decisions on Velsipity are based on results from the ELEVATE UC clinical trials programme, which found a clinical remission rate of 32% after 52 weeks compared to 7% for placebo, along with improvements on secondary measures, including the total inflammatory bowel disease questionnaire score, which measures health-related quality of life.

“Severe ulcerative colitis is a debilitating lifelong condition,” said Helen Knight, director of medicines evaluation at NICE. “Etrasimod provides a new convenient and effective treatment option that will make a positive difference for thousands of people.”

People with UC can experience the condition differently, but some of the most common symptoms include diarrhoea, fatigue, cramping pains, loss of appetite, and weight loss, said Pfizer.

“Today’s guidance is a step forward for eligible patients, giving them access to another treatment option to manage their symptoms,” commented Lynn Clay, specialty care lead at Pfizer UK.

“We are delighted that the NICE recommendation is available now that GB marketing authorisation has been received.”

Velsipity was the cornerstone of Pfizer’s $6.7 billion acquisition of Arena Pharmaceuticals, which was completed in 2022. Analysts at Leerink have suggested that peak sales of the drug could eventually top $1 billion.