1. Planning for Biosimilars: Infliximab Professor Ray Fitzpatrick Secondary Care lead Keele University Clinical Director of Pharmacy Royal Wolverhampton NHS Trust

2. NICE Recommendations for Biologics in the treatment of R.A   TNF inhibitors are recommended as options for the treatment of adults who have active R.A. (DAS28 >5.1 x2) and have undergone a trial of at least 2 DMARDS (normally 6 months) including Methotrexate   TNF inhibitors should only be continued if there is an adequate response at 6 months (DAS28 improvement >1.2)   Pathway = NSAIDs > DMARDs > TNF inhibitors + Mtx

3. National population62,649,000 Estimated number of males30,842,103 Estimated number of females31,806,898 Incidence of RA in men in the UK per 100,00024.5 Incidence of RA in women in the UK per 100,00054 Estimated number of men diagnosed with RA per year7,557 Estimated number of women diagnosed with RA per year 17,176 Estimated number of patients diagnosed with RA per year 24,733 Estimated number to start oral MTX per year (>44 yrs) 18,159 Rheumatoid Arthritis Patient Population

4. New R.A. Patients Starting a Biologic Estimated number of patients diagnosed with RA per year receiving oral MTX 18,159 Oral MTX failure rate21% Number of oral MTX failures3,813 Percentage of patients with stable baselines above DAS baseline >5.1 eligible for biologic therapy 1 76% Total number of new patients2899 1.Mainman H et al. Clin Rheumatol 2010;29:1093-1098

6. NICE Recommendations for Biologics in Crohns Disease   Infliximab or adalibumab are recommended as treatment options for adults with severe active Crohns whose disease has not responded or intolerant to conventional therapy (immunosuppressive and/or corticosteroid treatment)   Infliximab or adalibumab should be given as a planned course of treatment until treatment failure or until 12 months after start of treatment whichever is shorter. Then reassess.

7. Clinical Pathway Prednisolone Methylprednisolone or IV Hydrocortisone (5ASA if these are CI) Azathioprine or Mercaptopurine

9. Workshop 1. 1. Given what you now know consider possible options for the use of Infliximab biosimilar in your locality which could include (upto100%) switch, new patients only, or one speciality only. 2. 2. Using the usage data estimate the potential financial impact of your model assuming a 30% price reduction on the current Branded Infliximab hospital price. 3. 3. Consider what the barriers to change there may be in your locality 4. 4. What would be needed to overcome these barriers.