Pfizer welcomes the decision from the National Institute for Health and Care Excellence (NICE) to support continued access to biologic disease-modifying anti-rheumatic drugs (DMARDs) such as Enbrel® (etanercept) for patients with severe rheumatoid arthritis (RA) in England and Wales. (1)
The Final Appraisal Determination (FAD) issued by NICE follows a technology appraisal reviewing the most commonly prescribed biologic DMARDs for the treatment of the condition.
RA affects approximately 690,000 people in the UK and has a devastating effect on patients’ lives. (2) It can often be aggressive and rapidly disabling, causing irreversible joint damage, which may lead to a loss of function, inability to work or carry out daily tasks. Up to four out of every 10 working people with RA lose their jobs within five years, three quarters of these are for reasons directly related to their condition. (3) One in seven quit work within one year of diagnosis. (3)
Since their introduction more than a decade ago, biologic DMARDs, such as etanercept, have revolutionised the treatment of RA by suppressing the key pathways involved in joint inflammation, bringing the potential not only to control inflammation, but also to prevent joint erosion in people with the condition. (4) During this time, etanercept has also demonstrated long-term efficacy and has been found to be cost effective across the spectrum of inflammatory diseases.
Dr Berkeley Phillips, Pfizer UK Medical Director, commented: “This is a good outcome for patients with severe RA, many of whom are of working age and rely on effective treatment to stay active. Both the evidence and clinical experience show that biologic DMARDs make a difference to patients’ lives by reducing inflammation, improving joint function and enhancing quality of life. It is disappointing that the recommendation has not been extended to patients with moderate disease in line with other European countries in order to improve the chance of remission for these patients as well. We are committed to developing medicines that make a difference to people’s lives and want to see UK patients being treated with the right medicines for them at the right time in the course of their disease.”
The goal of treatment for every RA patient whether they have moderate or severe disease, should be remission and earlier treatment with DMARDs has proven to be key to achieving this. Whilst the decision to continue providing these potentially life-changing treatments for those with severe RA is celebrated, an opportunity has been missed to bring England and Wales into line with the rest of Europe by extending their use to patients with a moderate form of the condition.
Enbrel is supported by a wealth of data including more than 350 trials, (5) extensive real-world patient registry data, (6,7,8) over 5700 publications, (9) more than one million patients treated (10) and 4.5 million patient-years of collective clinical experience. (11) Pfizer is committed to building on our heritage of providing innovative therapies and services to meet the needs of those living with inflammatory diseases.
- NICE, Draft quality standard for rheumatoid arthritis. Available at: https://www.nice.org.uk/guidance/qs33/documents/rheumatoid-arthritis-draft-quality-standard2 (last accessed August 2015).
- BSR, Simple Tasks – Rheumatology in the UK: The problem. The impact. The solutions. October 2013. Available at: http://www.rheumatology.org.uk/includes/documents/cm_docs/2013/w/white_paper_report.pdf (last accessed August 2015).
- London School of Economics. A common disease with uncommon treatment: European guidelines variations and access to innovative therapies for rheumatoid arthritis. June 2012. Available at: http://www.policy-centre.com/downloads/Guideline-Variations-Report-2012-Final.pdf (last accessed June 2015).
- https://clinicaltrials.gov/ct2/results?term=Enbrel&pg=1 (last accessed August 2015) .
- Hetland M et al. Direct Comparison of Treatment Responses, Remission Rates, and Drug Adherence in Patients With Rheumatoid Arthritis Treated With Adalimumab, Etanercept, or Infliximab Results From Eight Years of Surveillance of Clinical Practice in the Nationwide Danish DANBIO Registry Merete. Arthritis Rheum 2010;62:22–32.
- Iannone F et al. High rate of disease remission in moderate rheumatoid arthritis on etanercept therapy: data from GISEA, the Italian biologics register. Clin Rheumatol 2014;33:31–7.
- Morgan C et al. Treatment of rheumatoid arthritis with etanercept with reference to disease-modifying anti-rheumatic drugs: long-term safety and survival using prospective, observational data Rheumatology (Oxford) 2014;53:186–94.
- http://www.ncbi.nlm.nih.gov/pubmed/?term=etanercept (last accessed August 2015).
- Pfizer data on file (Core Claims Document, Section 188.8.131.52).
- Pfizer Data on File (PSUR Mar 2015).