NICE recommends new ulcerative colitis treatment for NHS use

A new once-a-day pill has been recommended as an option for treating severe ulcerative colitis in England, with thousands of patients set to be eligible.

The National Institute for Health and Care Excellence (NICE) has published final guidance backing the treatment etrasimod (Velsipity)

“We are determined to continue getting the best care to patients fast”

Helen Knight

The move, on Monday, came on the same day that etrasimod was granted a licence by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Just over 25,000 people in England are eligible to receive it, according to NICE. Ulcerative colitis affects the colon and rectum and can cause recurring diarrhoea, arthritis, and osteoporosis.

The treatment, developed by Pfizer, helps reduce inflammation in the colon by helping to control the level of immune cells in the blood.

It has been recommended by NICE for patients aged 16 and over with moderately to severely active ulcerative colitis.

However, to be eligible they must have had an inadequate response, lost response or were intolerant to either conventional therapy or biological treatment.

NICE noted that clinical trial evidence has shown that etrasimod is more effective than placebo for treating moderately to severely active ulcerative colitis.

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Indirect comparisons suggest it is likely to work better than immunotherapy with adalimumab and may be similarly effective to other usual treatments for moderately to severely active ulcerative colitis.

The treatment was evaluated using a simpler technology appraisal process, meaning the guidance was available up to eight weeks faster than would have been the case under standard process.

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

“I’m very pleased we have been able to publish our final guidance recommending the treatment on the day the MHRA granted it a licence,” she said. “We are determined to continue getting the best care to patients fast.”

Julian Beach, MHRA interim executive director for healthcare quality and access, said: “We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”

An estimated 300,000 people across the UK have been diagnosed with ulcerative colitis. It can develop at any age but is most often diagnosed in people between 15 and 25-years-old.

The recommended dose of etrasimod is one 2mg tablet taken once daily. Etrasimod should be taken with food for the first three days. After this, etrasimod can be taken each day with or without food.

Etrasimod prevents lymphocytes from travelling from the lymph nodes into the blood. These Iymphocytes are involved in the immune response and inflammation that is linked to the development of ulcerative colitis.

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By reducing the number of lymphocytes circulating in the blood surrounding the large intestine, etrasimod helps to reduce bowel inflammation and the symptoms associated with the disease.

Pfizer has a confidential commercial arrangement in place that makes etrasimod available to the NHS with a discount.

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