LUCERNE, Switzerland, August 13, 2015 /PRNewswire/ --
NICE recently published HTTA329 as a resource to help those NHS organisations in the UK which may be planning their approach to the use of biosimilars. MSD's response to this publication is below:
The evidence base for switching stable Remicade® patients to biosimilar infliximab remains limited and inconclusive - data from small scale local observational studies with relatively small numbers of patients and short term duration have been shared at international congresses.,
MSD advocates the need for larger scale, more robust studies (i.e. randomized, double-blinded and properly powered) to provide more evidence on efficacy, safety and immunogenicity outcomes of switching stable Remicade patients.
Our position is consistent with that of scientific societies such as EULAR, ECCO, ESPGHAN and ACR, which state that the principal driver for decisions is sound scientific evidence and that patients responding to their therapy well should be allowed to continue their current biologic treatment.[3-6]
The NICE publication HTTA329 is a resource to help those NHS organisations in the UK which may be planning their approach to the use of Biosimilars. It does not represent mandatory guidance in the UK and does not carry the same authority as a reference document for other countries.*
MSD welcomes the emphasis from NICE on the need for brand name prescribing of biologics, informed patient consent for switching medicines, and the decision remaining with the prescribing clinician. We also welcome the statement that biosimilars and their originators are not interchangeable, and that patient outcomes should be monitored and recorded. However, the NICE document is not consistent with the professional and patient group positions in the UK, Europe, and USA, which state that stable patients should not be switched on the basis of cost alone.[3-6],[8-11]
While the examples from centres in the UK within this resource offer some methodology for the use of biosimilar infliximab in new and existing patients, they do not demonstrate the consequences of large-scale switching in terms of patient outcomes. MSD joins other stakeholders in awaiting further data from the monitoring and evaluation of patients in these two programmes. Until then, MSD believes it is premature to draw conclusions from these case studies.
*NICE's position statement in January 2015 states that biosimilars will be considered in the context of a Multiple Technology Appraisal, in parallel with their reference products in the indication under consideration, and this has not changed.
Notes to Editors:
At MSD we believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information visit http://www.msd-uk.com. The company is known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada. Everywhere else, we are known as MSD.
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- ECCO. Poster Presentations (2015): https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015.html
- EULAR. Session Index (2015). http://www.abstracts2view.com/eular/sessionindex.php
- EULAR. BIOSIMILARS: WHAT DO PATIENTS NEED TO CONSIDER? April 2015. Available from: http://www.eular.org/myUploadData/files/Biosimilars_2015.pdf
- Silvio Danese, Fernando Gomollon on behalf of the Governing Board and Operational Board of ECCO, (2013), ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD) , Journal of Crohn's and Colitis , 586-589 , 7
- de Ridder L., Waterman M, Turner D et al. ESPGHAN Paediatric IBD Porto Group. Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group. J Pediatr Gastroenterol Nutr Jul 6 2015 (in print). Available from: http://journals.lww.com/jpgn/Abstract/publishahead/Use_of_Biosimilars_in_Paediatric_Inflammatory.97858.aspx
- American College of Rheumatology. Position statement on biosimilars. March 2015 Available from: http://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ArticleType/ArticleView/ArticleID/33
- NICE. Introducing biosimilar versions of infliximab: Inflectra and Remsima. 31 July 2015. Available from : https://www.nice.org.uk/guidance/htta329
- British Society for Rheumatology. Position statement on biosimilar medicines (February 2015). Available from: http://www.rheumatology.org.uk/about_bsr/press_releases/bsr_supports_the_use_of_biolsimilars_but_recommends_measures_to_monitor_safety.aspx
- BSG. IBD Section Statement on Biosimilar drugs Available from: http://www.bsg.org.uk/images/stories/docs/clinical/guidance/biosimilars_final2014.pdf
- NRAS position paper on biosimilar medicines. Available from: http://www.nras.org.uk/data/files/About%20RA/How%20is%20RA%20managed/NRAS%20Biosimilars%20Position%20Paper%20Final.pdf
- CCUK. Biosimilars - potential new drug treatments for Inflammatory Bowel Disease. http://www.crohnsandcolitis.org.uk/whats-new/biosimilars-potential-new-drug-treatments-for-inflammatory-bowel-disease
- NICE. NICE's biosimilar position statement http://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/biosimilars-statement.pdf
Date of preparation: August 2015