Biosimilars contracting in the NHS. Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast

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1 Biosimilars contracting in the NHS Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast

2 Aim Introduction Managing the Medicine Budget in the NHS The Biosimilar Medicine Challenges Questions to consider 2

3 Managing the Medicine Budget Cost effective prescribing promoting generics prescribing few exceptions individual patient treatment reviews formulary/medicine management/treatment protocols exploiting commitment within a therapeutic class contracting patient pathways End of Brand patent oral medicines (primary /secondary care) immediate competition / 80-90% price reduction / 6 plus suppliers IV (hospital ) products 1-4 suppliers / slower to market/ 30-70% price reduction Automatic substitution/market management / patent cliffs CASH RELEASING TO INVEST IN NEW MEDICINES / TREAT MORE PATIENTS 3

4 Biosimilars- protein based medicines EMA- a biosimilar is a medicine which is similar to a biological medicine which has already been authorised,used in general at the same dose to treat the same disease FDA a biosimilar is a biological product which is highly similar to a US licenced product not withstanding differences in clinically inactive components, for which there are no clinically meaningful differences from the originator made or derived from living organisms using biotechnology that can bind to specific targets in the body Account for more than 15% of the pharmaceutical market By 2015 predicted to account for 40-50% by value 4

5 The Future Medicines Pipeline The future medicines pipeline is full of biosimilars which are about to be launched and brought to the market Year 2012 Enoxaparin, Bemiparin 2013 Rituximab, Imatinib, 2014 Infliximab, Dalivizumab, Somatropin, Traztuzumab, 2015 Adalimumab (may be 2018), Bevacizumab 2016 Certolizumab Note that the dates above are patent expiry and not Biosimilar product launches 5

6 PMSG Biosimilars Group Lessons from Gcsf, Growth Hormone, Erythropoetin Variable uptake across EU Purpose To devise a generic strategy to ensure the NHS makes best use of Biosimilar medicines which has patient safety as a priority whilst supporting a robust Biosimilar market Membership Provider, Commissioners, MI, QA,NICE, Tasks Assess pipeline engage with suppliers Engage with key stakeholders Understand the barriers to uptake Effective communication across the NHS 6

7 ABPI POSITION PAPER Recommendations 1: All biologic/biosimilar prescriptions should be written by brand name and not by International Nonproprietary Name (INN) 2: A biologic or biosimilar must only be substituted with the knowledge and consent of the treating physician 3: Patients should be kept fully informed about their medication and should be consulted if any changes to their treatment are made 4: The summary of medicinal product characteristics (SmPC) should clearly indicate the source of information contained within it, such as relevant clinical studies or that it has been derived from evidence about the originator product 5: Biosimilar medicines should be subject to health technology assessment processes in the UK 6: Tenders which are undertaken involving biological medicines should not seek to source a single product only. 7: Extrapolation of indications for biosimilar products should be evaluated on a case by case basis 7

8 Anti TNF spend - National 8

9 Contracting Generics transition then into timetable Branded into Tranche A or B depending on molecule Biosimilars on a case by case basis To provide market intelligence to support the effective tendering of Biosimilar medicines at SHA (or equivalent) level that complies with all current policy, legislation and guidance. All regions will look for price reductions as soon as these are available Need to review timetables of awards current and in the future ability to accept price reviews 9 Price reductions will stimulate therapeutic reviews

10 Questions Are current biologic molecules biosimilars of themselves? Will biosimilars be seen as a new treatment options in class rather that generics? Will they be substituted in existing patients? Will they be therapeutically interchangeable in terms of clinical data? Is Clinical Contracting the way forward? Can the NHS afford not to use biosimilars? THANKS FOR LISTENING 10