NICE recommends hep C and bowel treatments
pharmafile | February 26, 2015 | News story | Sales and Marketing | AbbVie, Humira, J&J, JJ, Janssen, Merck, Remicade, Simponi, olysio
Three drugs to treat chronic bowel condition ulcerative colitis and one for hepatitis C will be funded by the NHS following final guidance recommendations by NICE.
The UK health watchdog says Merck’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Merck’s Simponi (golimumab) should be recommended as an option for treating moderate to severe ulcerative colitis.
Professor Carole Longson who is NICE’s health technology evaluation centre director, says: “This recommendation will benefit tens of thousands of people who live with this debilitating condition. We are very pleased that we can recommend all three drugs to treat ulcerative colitis. Those with the condition will have more options available to them and a greater chance of controlling their symptoms, so they can have a much better quality of life.”
An estimated 146,000 people in the UK live with ulcerative colitis 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 toilet.
Sporadic in nature, the condition disappears for months or even years at a time, but it is thought that half of people with ulcerative colitis will relapse at least once a year – and whilst it can develop at any age the peak age appears to be between 15 and 25-years-old.
On these approvals, Chris Probert who is a Professor of gastroenterology at the University of Liverpool and vice-chair of the clinical advisers committee for Crohn’s and Colitis UK, says: “This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis.”
Remicade, Humira and Simponi 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. Remicade is also licensed to treat children and adolescents aged 6-17 years.
This drug has also been in the news of late for its biosimilar version Remsima, which was just launched by Napp in the UK for the treatment of a range of illnesses including Crohn’s disease – which followed Hospira’s biosimilar monoclonal antibody launch just prior.
Meanwhile NICE has been extra busy of late, as along with its final guidance this week approving Gilead’s Sovaldi for hepatitis C, it has also given the final nod to Johnson & Johnson’s fellow hep C offering Olysio (simeprevir).
Olysio has UK marketing authorisation for use along with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C, but this latest guidance recommends its use in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.
Olysio was in fact one of the stars in J&J’s full-year sales results, and the drug has seen the introduction of a novel ‘pay if you clear’ pricing agreement with the NHS, whereby NHS England will only pay for Olysio if patients are effectively cured of the virus after 12 weeks of treatment, with Janssen (J&J’s pharma wing) refunding the cost for those who aren’t.
Brett Wells
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