Updated BSG guidance recognises clinical and cost value of biosimilar medicines
Cambridge, 22 February 2016 – Napp Pharmaceuticals Limited. welcomes the revised British Society of Gastroenterology (BSG) guidance that includes an updated position towards the use of biosimilar infliximab.1 The guidance now states that patients can be prescribed Remicade® (originator infliximab, MSD), Remsima® (infliximab, Celltrion) or Inflectra® (infliximab, Hospira) and that the choice of infliximab should take into account the cost of the medicine and its administration.1
Importantly, the guidance also states that patients who are in stable remission on originator infliximab therapy can be switched to biosimilar infliximab at the same dose and interval.1 In February 2015, the annual NHS spend on all anti-tumour necrosis factor-α (TNFα) biological medicines alone was reported to be £918.45 million2 and this is set to continue to increase, so there is a significant financial need for the successful uptake of biosimilar medicines in the UK. Switching stable patients to a biosimilar alternative represents a prime opportunity for the NHS to reduce its biological medicines spend without impacting patient care and outcomes.
“This change is a statement of intent which reinforces the fact that biosimilars are to be treated as interchangeable with originator brands and provide a huge opportunity to the NHS from a budget perspective”, said Andrew Roberts, Head of Market Access, Napp Pharmaceuticals Limited. “The new guidance will add to the wealth of data and existing recommendations from bodies such as NICE and the SMC and should provide clinicians and commissioners with the confidence to secure faster uptake of biosimilar medicines at a local level. But this is not just good news for NHS budgets, the availability of more cost effective biological medicines also means widening the availability of treatments to NHS patients.”
Back in February 2015, BSG did not recommend switching existing stable patients on originator infliximab due to the lack of clinical evidence, including real world data, for patients with Inflammatory Bowel Disease. However, the new guidance recognises the growing wealth of global patient data from observational studies to date, demonstrating that switching from originator infliximab to biosimilar infliximab provides equivalent efficacy and safety.1
“Guidelines from professional groups such as the BSG are crucially important in providing confidence for clinicians and patients in the use of biosimilar medicines in the UK,” said Dr Fraser Cummings, Consultant Gastroenterologist at University Hospital Southampton (UHS). “These medicines provide the NHS with a significant opportunity to invest in improving patient care and widening the range of treatments available for patients whilst making significant cost savings.”
The new guidance also echoes the findings of the recently published Carter Report, which urges Trusts to reduce their medicine bill through best choice and from actively monitoring market developments, such as the launch of biosimilar products. The Carter Review specifically highlights biosimilar infliximab as a prime opportunity for the NHS to make prescription cost reductions.3
Andrew Roberts added: “At Napp we recognise the importance of delivering value-based innovation to the NHS. Through initiatives such as supporting the development of local gainshare agreements, as well as making our biosimilar infliximab available at a price in excess of 60% less than the list price of the originator, we have worked hard at a local level to support faster integration of biosimilar medicines. Of course, other infliximab products
available in the UK (Remicade and Inflectra) are also available at locally agreed NHS contract prices which are lower than the list price.”
“With the Accelerated Access Review report also due for publication in the coming months, we hope that the groundswell of data, recommendations and clinician confidence around biosimilar medicines will translate into wider patient access for biosimilar infliximab and the significant number of other biosimilar medicines on the horizon.”
– Ends –
Notes to editors:
Key recommendations from the new BSG guidelines include:1
- Patients starting infliximab treatment can be prescribed Remicade® (originator infliximab, MSD), Remsima® (infliximab, Celltrion) or Inflectra® (infliximab, Hospira)
- The choice of infliximab preparation should take into account the cost of the drug and its administration
Patients who are in stable remission on Remicade® (originator infliximab,MSD) therapy can be switched to Remsima or Inflectra at the same dose and dose interval.
- This should be done after discussion with individual patients, with the explanation of the reason for switching (usually on the grounds of benefit to the overall service by reduction in drug costs and administration)
About biosimilar infliximab
Biosimilar infliximab medicines are a type of biological medicine called an anti-TNF∝. Infliximab binds and blocks tumour necrosis factor-∝ (TNF∝), an inflammatory substance naturally produced in the body that is over-produced in a range of inflammatory conditions. Two biosimilar infliximab medicines (one of which is marketed by Napp) have been authorised by the European Medicines Agency (EMA) for the same indications as the originator infliximab, in the following disease areas:
- Adult Crohn’s disease
- Paediatric Crohn’s disease (6 – 17 years)
- Ulcerative colitis
- Paediatric ulcerative colitis (6 – 17 years)
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a privately owned UK organisation based in the heart of the Cambridge science community, and part of a worldwide network of independent associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s, and we are committed to improving patient outcomes and ensuring the sustainability of healthcare. We are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, oncology and inflammatory disorders.
For more information, please visit http://napp.co.uk/.
- BSG Guidance on the Use of Biosimilar Infliximab CT-P13 in Inflammatory Bowel Disease. British Society of Gastroenterology. February 2016. Available at: http://www.bsg.org.uk/clinical/news/bsg-guidance-on-the-use-of-biosimilar-infliximabct-p13-in-ibd.html [Accessed February 2016]
- IMS Health, XBPI/HPAI Combined Audit, Cash (£), MAT February 2015.
- Operational productivity and performance in English NHS acute hospitals: Unwarranted Variation. An independent report for the Department of Health by Lord Carter of Coles. February 2016. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499229/Operational_productivity_A.pdf. [Accessed February 2016]