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SMC recommendation of self-injection formulation of abatacept

The Scottish Medicines Consortium (SMC) has announced that abatacept solution for subcutaneous injection (Orencia® SC) has been accepted for use within NHS Scotland, in combination with methotrexate (MTX), as a first-line biologic agent for adults with severe rheumatoid arthritis (RA), after failure with conventional disease modifying anti-rheumatic drugs (DMARDs).(1)

The Scottish Medicines Consortium (SMC) has announced that abatacept solution for subcutaneous injection (Orencia® SC) has been accepted for use within NHS Scotland, in combination with methotrexate (MTX), as a first-line biologic agent for adults with severe rheumatoid arthritis (RA), after failure with conventional disease modifying anti-rheumatic drugs (DMARDs).(1)
This means that abatacept is now the only biologic which is available in NHS Scotland in both self-injectable subcutaneous (SC) and intravenous (IV) formulations.(1,2) This recommendation also enables the use of abatacept earlier in the treatment pathway providing physicians with greater treatment options and benefitting the patients who suffer from this disabling chronic disease.
 
“This is great news for clinicians and therefore people with rheumatoid arthritis in Scotland, as abatacept offers an alternative to anti-TNFs as a first-line biologic therapy for RA. The convenience of self-administration in a subcutaneous formulation not only benefits patients but also improves cost effectiveness for the NHS” comments Professor Iain McInnes, Director, Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow.
Given that some patients prefer one route of administration for specific reasons, the availability of both formulations of abatacept addresses the needs and preferences of patients and physicians.(3) Abatacept not only reduces the signs and symptoms of RA and the progression of joint damage, it also improves the physical function of adult patients.(4)
Ailsa Bosworth, Chief Executive and Founder of NRAS (National Rheumatoid Arthritis Society) said “We very much welcome the news that an option to self-inject abatacept has been accepted by the SMC as there are many patients who would prefer the convenience of being able to self-inject at home rather than have to take time off work, or have to travel to the hospital for an infusion which, given the pain and mobility issues caused by RA, can be challenging.”
In Scotland, up to 217,000 people are affected by RA or osteoarthritis.(5) RA severely impacts on quality of life by causing chronic pain, stiffness, swelling and fatigue due to joint damage, making it difficult to move about freely.(6) The largest ever study of RA patients of working age in Scotland carried out by the National Rheumatoid Arthritis Society (NRAS) found that more than half of RA patients had to give up work prematurely. Of these patients, more than half gave up work within only one year of diagnosis with 80% stopping work within six years.(7) The total cost of RA in Scotland, including the cost to the health service and the cost associated with lost productivity, is estimated to be approximately £724 million per year.(8)
The European approval of the SC formulation of abatacept is based on the ACQUIRE study, the single largest phase III registrational trial of biologics in RA patients, as well as long-term efficacy and safety data from supporting phase II studies.(9) In ACQUIRE, the SC and IV formulations of abatacept were compared and shown to be similar in terms of efficacy and safety (non-inferiority comparison).(9)
Bristol-Myers Squibb has collaborated closely with SMC and the company is pleased to have met all the clinical and economic requirements needed to reach today’s decision. Amadou Diarra, VP and GM, Bristol-Myers Squibb, UK and Ireland said, ‘The announcement from the SMC marks an important milestone for clinicians and for patients in Scotland as they now have a convenient option to self-inject abatacept to treat this disabling chronic condition.’ Furthermore, Bristol-Myers Squibb is offering the SC formulation of abatacept through a home care delivery package which is fully funded by the company.
Abatacept, in combination with MTX, is licensed for the treatment of moderate to severe active RA in adult patients who responded inadequately to previous therapy with one or more DMARDs, including MTX or a tumour necrosis factor (TNF)-alpha inhibitor.(4)
References
  1. Scottish Medicines Consortium (SMC). Abatacept for 125/mg solution for subcutaneous injection in a pre-filled syringe (Orencia®), July 2013. SMC No. (888/13). Available at: www.scottishmedicines.org.uk
  2. Scottish Medicines Consortium (SMC). Abatacept for 250mg powder for concentrate for solution for infusion (Orencia®), March 2013. SMC No. (719/11). Available at: www.scottishmedicines.org.uk
  3. Scarpato S, et al. “Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study)” Rheumatology (2010) 49 (2): 289-294. doi: 10.1093/rheumatology/kep354. First published online: November 17, 2009
  4. Orencia® (abatacept) solution for infusion Summary of Product Characteristics (SmPC)
  5. The Scottish Inflammatory Diseases and Rheumatology Industry Group. Delivery of RA Services in Scotland: The View of Healthcare Professionals. Available at: http://www.morhamburn.com/wp-content/uploads/SIDRIG-REPORT.pdf (Last accessed: 19.03.13)
  6. National Rheumatoid Arthritis Society. What is RA? Available at http://www.nras.org.uk/about_rheumatoid_arthritis/ what_is_ra/what_is_ra.aspx (Last accessed 19.03.13)
  7. National Rheumatoid Arthritis Society. RA and work. 2010. Available at:http://www.nras.org.uk/ includes/documents/cm_docs/2010/j/j4660_ scottish_survey_doc_2010.pdf (Last accessed: 19.03.13)
  8. National Rheumatoid Arthritis Society. The economic burden of rheumatoid arthritis. Available at http://www.nras.org.uk/includes/ documents/cm_docs/2010/e/1_economic_ burden_of_ra_final_30_3_10.pdf (Last accessed 19.03.13)
  9. Genovese MC et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb non-inferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum 2011;63:2854-64. doi: 10.1002/art.30463


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