A potentially life-changing treatment has been recommended for
people with short bowel syndrome who are aged 1 year and above
after NICE published final draft guidance today (01 June 2022).
Teduglutide (also known as Revestive and made by Takeda) is
available for people who are in a stable condition following
surgery to remove an abnormal bowel.
In adults, this surgery may be needed for a range of conditions,
including Crohn’s disease. In premature babies and children, it
is often because of surgery for necrotising enterocolitis or
other conditions. Some children can be born with a short bowel.
Teduglutide helps to improve the absorption of nutrients and
fluid from the remaining intestine. The company estimates there
are around 70 people eligible for the treatment.
Short bowel syndrome is a chronic and potentially
life-threatening condition in which the body is unable to absorb
enough nutrients from food. The condition occurs when people do
not have enough small intestine, which is the part of the body
where most nutrients are absorbed during digestion.
Short bowel syndrome is currently treated by giving people
nutrients and fluids intravenously through a drip, also known as
parenteral support, alongside best supportive care. Best
supportive care can include treatments which control bowel
movements, fluid restriction and diet changes.
Clinical trial evidence shows that teduglutide reduces the number
of days a week people with short bowel syndrome need parenteral
support compared with placebo.
Helen Knight, interim director of medicines evaluation in
the NICE Centre for Health Technology
Evaluation, said: “Current
treatments for short bowel syndrome are lifesaving, but they can
be very complex, time consuming and can lead to severe
complications. People with short bowel syndrome currently need
parenteral support which can be required for as much as 14 hours
a day, 7 days a week.
“NICE’s independent appraisal committee heard that people with
short bowel syndrome often have very limited quality of life and
there is a heavy burden placed on them and their carers by having
to administer treatment at home. Clinical evidence showed
teduglutide can help give people with short bowel syndrome
greater normality by reducing the number of days per week people
would require parenteral support. I am therefore delighted we can
recommend teduglutide for some people with this condition.”
Caroyln Wheatley, Chair of PINNT (Support and advocacy
for people on home artificial nutrition)
said: “Today represents a landmark day for people
with short bowel syndrome. Living with short bowel syndrome is
incredibly difficult for people due to the current treatment
options that are available to us. While lifesaving, home
parenteral nutrition is a complex treatment that comes with
risks. It can severely impact quality of life. This treatment is
a game-changer because it will reduce the burden on people with
short bowel syndrome, their families and their carers.”
The recommended daily dose of teduglutide is 0.05 mg per kg body
weight. The dose will be given in millilitres (ml) of solution.
Teduglutide is injected under the skin (subcutaneously) once
daily. The injection can be self-administered or given by another
person such as your doctor or carer.
The list price of a 5 mg vial of teduglutide is £521.98. The list
price of a 1.25 mg vial of teduglutide is £260.99 (excluding VAT;
BNF online, accessed April 2022).
The company has a commercial arrangement (single discount patient
access scheme). This makes teduglutide available to the NHS with
a discount. The size of the discount is commercial in confidence.
The final appraisal document can be found here.