29/04/2016. Biosimilars An NHS perspective. Aim. Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast April 2016

Transcription

1 Biosimilars An NHS perspective Maggie Dolan Regional Pharmacy Procurement Specialist South East Coast April 2016 Aim The changing medicines landscape driving patient access to medicines the Biosimilar Medicine Challenges Ongoing considerations 2 1

2 Medicines are changing Value of generic medicines to the NHS Health Economy 12.2billion saved in That is the extra cost if all community pharmacy prescriptions had been fulfilled as branded products Generic medicine usage is 75.20% of all prescriptions in primary care Secondary care (hospital) spend on generics 250m /annum Contracting for generic medicines delivered a 30million cost saving to Trusts across England in 2014/2015 Branded to Generic maximum point of savings Automatic substitution to generics in secondary care 4 2

3 Generics - Supporting patients access to life changing medicines Generics at transition 70-90% price reduction Biosimilars - 40%? More competitive pricing / wider availability Cash releasing contracting allows :- investment in new and innovative medicines the NHS to treat more patients Learnings from the biologic therapies prior to 2015 a) EPO an established market with many brands, rapid price reductionquestionable opportunity for biosimilars b) GCSF market rapidly went generic as it was a product used short term (i.e. no switching of existing patients) with a direct measure of effectiveness. So biosimilar took over. (wholesale introduction based on price similar to generics) c) Growth Hormone. Brands have maintained product differentiation with device design and needleless systems This has prevented penetration of biosimilar. Very different adoption approaches across the NHS (no standardisation) No join up between policy, national and local strategies /duplication of effort 3

4 It s the loss of exclusivity that drives biosimilar interest All these products will lose patent protection in EU by 2020 Global Sales (MAT 06/2014), US$ billion Total ~ US$ 79 billion Adalimumab (Humira) Insulin Glargine (Lantus) Etanercept (Enbrel) Infliximab (Remicade) Rituximab (Mabthera) Pegfilgrastim (Neulasta) Ranibizumab (Lucentis) Insulin Aspart (Novomix, Novorapid) Bevacizumab (Avastin) Interferon Beta-1A (Avonex, Rebif) Trastuzumab (Herceptin) Glatiramer Acetate (Copaxone) EU expiry date US expiry date (extended) Expired 2018 Expired Expired Not considered existing biosimilars such as Epoetin Alfa expired in EU, but still patent protected in the US Source: IMS MIDAS, 06/2014, Rx bound, IMS Patent focus 7 Uptake of biosimilars across Europe 4

5 Pharmacey MSG Biosimilars Group Purpose To devise a strategy to ensure the NHS makes best use of Biosimilar whilst Tasks medicines which has patient safety as a priority supporting a robust Biosimilar market Membership 4 Nations NICE, CMU, Trusts, Commissioners CCGs, NHSE Specialist Pharmacy Services - Regional Procurement, QA, MI Assess Pipeline engage with suppliers Understand barriers to uptake / behaviour of the originators? Provide resources for NHS/ patient educational opportunities Support clinical engagement and contracting Collect data on uptake / implementation Pharmaceutical Industry Sector Board - Biosimilars NHS CoSolutions mmercial

6 Need for policy alignment NHS England Clinical and Scientific Policy and Strategy Group - Biosimilars Chaired by Chief Pharmacist (Dr Keith Ridge ) Membership includes MHRA ABPI BGMA NICE NHS providers NHS Commisioners Activities to date Biosimilars Q/A document (July 2015) National workshops (March 2016) to support development of a toolkit to support local uptake 12 6

7 Key messages agreed by partnership organisations Messages disseminated to NHS stakeholders On NHSE web almost 1000 downloads to date What is a Biosimilar Medicine? 13 Analysis of uptake Clinician buy in essential education support from clinical pharmacists Patient engagement critical share comms/ documentation across Trusts Protected time to switch patients Share the savings locally INVEST TO SAVE 14 7

8 At the end of 2015, there were some 41 biosimilar medicines in the pipeline for four key original biologics Biosimilars in the Pipeline (PRX-106) Protalix Biocon BioXpress Etanercept Harvest Moon Adalimumab Filed Late Phase Early Phase Preclinical BioXpress FKB327 (Kyowa Kirin) M923 (Momenta) ABP501 (Amgen) PF (Pfizer) BioXpress Oncobiologics Avasthagen Tunex (Mycenax ) LBEC0101(LG Life) CHS-0214 (Coherus) LBAL (LG Life) GP2015 (Sandoz) ABP 710 (Amgen) NI-071 (Nichiiko) BOW15 (Epirus) GP2017 (Sandoz) MabionCD20 (Mabion) BI (BI) SB5 (Samsung) Biocon CHS-1420 (Coherus) (BOW050) Epirus SB4 (Samsung Bioepis) BI GS071 (Aprogen) SB2 (Samsung Bioepis) AP052 (Aprogen) ABP 798 (Amgen) GP2013 (Sandoz) PF (Pfizer) BioXpress Harvest Moon PF (Pfizer/Sandoz) CT-P10 (Celltrion) MK-8808 (Merck) Harvest Moon Infliximab Rituximab 15 Source: IMS Health, IMS Institute for Healthcare Informatics, Jan 2016 The Biologic / Biosimilar Challenges Branded medicine prescribing Question - Is this sustainable as the number of products increase exponentially? Issues prescriber knowledge stock holding in hospitals risk of unintended switching risk of medication errors 16 8

9 Contracting for Biosimilars in the UK Commercial Medicine Unit (CMU) in England (plus Scotland Ireland and Wales) The CMU /England model National specifications and processes ensures adherence to Public Procurement Law allows market management Generic and Branded contracts very different Branded processed in Tranches ie into subgroups where there is a potential for therapeutic competition Eg anti fungals / EPO / HIV drugs / Growth Hormone anti-tnfs Biosimilars -- - Branded into appropriate subgroups 17 Branded Contracting Not contracts but frameworks all products on the framework 2 year duration 4 supra regions North /South /Midlands /London staggered every 6 months with opportunity for a price review at 12 months Interim / transition agreements to allow new entrants to be included outwith the normal cycle to ensure no barrier to entry ONLY THE FIRST STEP --- then regional choice No product differentiation the driver is cost Evolutionary not written in Tablets of Stone 18 9

10 True product differentiation Ready to use products Extended shelf life of reconstituted products Different logistics models eg Homecare Different devices Patient apps to improve compliance and reduce waste Non promotional education and training 19 The funding paradigm in the NHS - whose budget is it? High costs drugs budgets held by commissioners Bills are sent to them for payment (pass through) Provider Trusts need to negotiate a share of the savings A very mixed economy of invest to share A direct comparison to the mixed uptake 20 10

11 Jan 14 Mar 14 May 14 Jul 14 Sep 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 29/04/2016 The UK uptake of infliximab is limited and concentrated Nationally, 23% of infliximab usage is biosimilar, with only 24 trusts using 50% or more of the biosimilar Infliximab use Trusts use of biosimilar 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% trusts 24 trusts REMICADE BIOSIMILAR % biosimilar versus originator infliximab usage Source: IMS Health. HPA, Oct-Dec 15 NAPP Indicators and measurement The national biosimilars group has agreed three indicators These will work together to help track how the introduction of biosimilar medicines is driving better value for the NHS and treatment option choices for patients through increased competition Collection method required Medium term ambition Already in use An indexed measure of enhanced value captured by Trusts in HoPMOP through the increased competition A measure of impact on the overall patient access to biologic treatment through the introduction of competition A tracking of the use of biosimilars by Trust with which to gauge the pattern of competition 11

12 Conclusions Clinician and patient buy in essential Opportunities for Champions and early adopters sharing good practice and ongoing education / peer review required Working effectively with biologics / biosimilars companies to mitigate barriers to introduction Contracting for medicines needs to be flexible to support competition and entry of new players and reflect the changing market Invest to save opportunities to Provider Trusts managing the change remove the funding barrier Robust data including patient outcomes data required to support the biosimilars agenda 23 12