Planning for Biosimilars: InfliximabPlanning for Biosimilars: Infliximab

Professor Ray FitzpatrickProfessor Ray FitzpatrickSecondary Care lead Keele UniversitySecondary Care lead Keele University

Clinical Director of Pharmacy Royal Wolverhampton NHS Clinical Director of Pharmacy Royal Wolverhampton NHS TrustTrust

NICE Recommendations for Biologics NICE Recommendations for Biologics in the treatment of R.Ain 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

National population 62,649,000

Estimated number of males 30,842,103

Estimated number of females 31,806,898

Incidence of RA in men in the UK per 100,000 24.5

Incidence of RA in women in the UK per 100,000 54

Estimated number of men diagnosed with RA per year 7,557

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 PopulationRheumatoid Arthritis Patient Population

New R.A. Patients Starting a BiologicNew R.A. Patients Starting a Biologic

Estimated number of patients diagnosed with RA per year receiving oral MTX 18,159

Oral MTX failure rate 21%

Number of oral MTX failures 3,813

Percentage of patients with stable baselines above DAS baseline >5.1 eligible for

biologic therapy176%

Total number of new patients 2899

1.Mainman H et al. Clin Rheumatol 2010;29:1093-1098

NICE Recommendations for NICE Recommendations for Biologics in Crohns DiseaseBiologics 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.

Clinical PathwayClinical Pathway

Prednisolone Methylprednisolone or IV Hydrocortisone (5ASA if these are CI)

Azathioprine or Mercaptopurine

WorkshopWorkshop

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. 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. Consider what the barriers to change there may be in your locality

4. What would be needed to overcome these barriers.