The National Institute for Health and Care Excellence (NICE) says in draft guidance that infliximab, adalimumab and golimumab should not be recommended for routine use in the NHS to treat moderate to severe ulcerative colitis.

An estimated 146,000 people in the UK live with ulcerative colitis, a chronic condition in which the large intestine becomes inflamed. Symptoms vary, but may include bloody diarrhoea, abdominal pain, weight loss, fatigue and an urgent need to go to the lavatory.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The independent committee concluded that there is currently not enough evidence to prove that infliximab, adalimumab and golimumab is clinically and cost effective compared with other treatments currently available to ulcerative colitis patients on the NHS.

“NICE has now opened a consultation on the draft guideline for infliximab, adalimumab and golimumab, and welcomes the manufacturer and stakeholders to comment on the recommendations and if possible provide more information which could potentially enable NICE to make more positive recommendations.”

The condition can be sporadic, disappearing for months or even years at a time, but it is thought that 50% of people with ulcerative colitis will relapse at least once a year. It can develop at any age but the peak age is between 15 and 25 years old.

Infliximab (Remicade, Merck Sharpe & Dohme), adalimumab (Humira, AbbVie) and golimumab (Simponi, Merck Sharpe & Dohme) are all licensed to treat moderate to severely active ulcerative colitis in adults who have had an inadequate response to conventional therapy, or are unable to take such treatments. Infliximab is also licensed to treat children and adolescents aged 6-17 years.

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation until Wednesday 15 October 2014. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued. 

Final guidance on the use of infliximab, adalimumab and golimumab as treatments for ulcerative colitis is expected to be published January 2015. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

ENDS

For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.

Notes to Editors

Adalimumab:

• Adalimumab is administered by subcutaneous injection. The recommended induction dose regimen is 160 mg at week 0 and 80 mg at week 2. After induction treatment, the recommended dose is 40 mg every other week.
• If a person’s condition does not improve within 2-8 weeks of starting treatment with adalimumab, it is recommended that doctors stop prescribing the drug.
• The price of adalimumab is £352.14 for a pre-filled 40 mg pen or syringe, or a 40 mg/0.8-ml vial (excluding VAT; ‘British National Formulary’ [BNF] edition 67). Assuming the recommended dosage for adalimumab is followed, the cost of adalimumab induction therapy is £2113 and the monthly cost of adalimumab maintenance therapy is £704. Costs may vary in different settings because of negotiated procurement discounts.

Golimumab:

• Golimumab is administered by subcutaneous injection. Dosage depends on the patient’s body weight: for example, patients with a body weight of less than 80 kg should receive an initial dose of 200 mg, followed by 100 mg at week 2, and then 50 mg every 4 weeks. Patients with a body weight of 80 kg or more should receive an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks.
• Doctors should consider whether or not to continue with golimumab if a patient does not benefit within 12 to 14 weeks of starting treatment (that is, after 4 doses).
• The price of golimumab is £762.97 for a pre-filled 50 mg pen or syringe and £1525.94 for a 100 mg pre-filled pen (excluding VAT; BNF edition 67).
• Merck Sharp & Dohme has agreed a patient access scheme with the Department of Health. This will make the 100 mg dose of golimumab available to the NHS at the same cost as the 50 mg dose.
• Including the patient access scheme and assuming that the recommended dosage for golimumab is followed, the cost of golimumab induction therapy is £2289; the monthly cost of golimumab maintenance therapy is £763.

Infliximab:

• Infliximab is administered by intravenous infusion. The recommended dose of infliximab is 5 mg/kg at weeks 0, 2 and 6, then at every 8 weeks.
• If the treatment does not seem to be working within the first 14 weeks of treatment, it is recommended that continued infliximab therapy should be carefully reconsidered
• The price of infliximab is £419.62 for a 100 mg vial containing powder for reconstitution (excluding VAT; BNF edition 67). Assuming the patient weighs 77 kg and the recommended dosage for infliximab is followed, the cost of infliximab induction therapy is £5035; the monthly cost of infliximab maintenance therapy is £210. Costs may vary in different settings because of negotiated procurement discounts.