NHS BioValue: The Potential for a Landmark UK NHS Real World Evidence Study on Biosimilars

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1 NHS BioValue: The Potential for a Landmark UK NHS Real World Evidence Study on Biosimilars Angela McFarlane Market Development Director, QuintilesIMS Angela.McFarlane@QuintilesIMS.com Copyright 2016 QuintilesIMS. All rights reserved.

2 QuintilesIMS Survey August 2017: Future Attractiveness of UK to Global Pharma 1/3 of global clients responded: 74% (23/31) believe that Brexit has impacted the attractiveness of the UK market. 91% (21/23) of whom believe that Brexit makes the UK market less attractive for product launches. 67% (14/21) of those considering the UK less attractive for product launches would launch later if launching; a third of whom would consider launch >2 years later. 52% (16/31) believe Brexit has made the UK less attractive for clinical trials Despite concerns over Brexit, 55% (17/31) of respondents stated that the UK will be a first/early launch country Attractiveness of the UK market to the global pharmaceutical industry - interim results (August 2017) 2

3 On average, UK has the highest penetration of biosimilars across the EU5 countries: Europe, Japan & Canada- Biosimilar share of molecule treatment days Biosimilar treatment day share (June 2017) Country infliximab insulin glargine etanercept rituximab EU5 High penetration EU UK 77.7% 3.7% 53.3% 7.6% France 31.4% 3.8% 4.3% - Germany 44.0% 6.5% 35.2% 8.5% Italy 55.3% 14.9% 10.3% - Spain 42.3% 7.6% 2.9% - Finland 93.1% 3.3% - - Norway 97.7% 3.2% 80.9% - Poland 100.0% 23.4% 16.5% - Denmark 97.4% 5.1% 76.9% - Japan 4.1% 33.8% - - Canada 2.5% 0.3% 0.2% - High uptake Low uptake Source: QI MIDAS Restricted MTH June

4 3 of the Top 10 UK medicines by spend represent a ~ 890 million opportunity for biosimilars Rank Product Molecule Corporation Sales MAT Apr 17 ( Mil) % Change 1 Humira Adalimumab Abbvie % 2 Eylea Aflibercept Bayer % 3 Seretide Fluticasone/Salmeterol GlaxoSmithKline % 4 Lipitor Atorvastatin Pfizer % 5 Lyrica Pregabalin Pfizer % 6 Spiriva Tiotropium Bromide Boehringer Ingelheim % 7 Lucentis Ranibizumab Novartis % 8 Mabthera Rituximab Roche % 9 Symbicort Budesonide/Formoterol AstraZeneca % 10 Herceptin Trastuzumab Roche % IMS 2017: data accessed 13 June

5 UK Biosimilar Uptake based upon QuintilesIMS MIDAS data highlights variability in uptake: 600, ,000 70% Biosimilars penetration (MAT July 2017) 80% 70% 90% 80% 70% Biosimilar uptake post launch Units 400, , ,000 42% 60% 50% 40% 30% 20% Biosimilar penetration (%) 60% 50% 40% 30% 20% 100,000 10% 10% 0 INFLIXIMAB ETANERCEPT RITUXIMAB 2% 0% 0% M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 M25 M26 M27 M28 M29 Origionator Biosimilar Biosimilar penetration INFLIXIMAB ETANERCEPT RITUXIMAB Key facts: Etanercept has seen higher biosimilar penetration than Infliximab at the same stage Though Rituximab biosimilar has been on the market for 4 months, it has the highest share at this point compared to Infliximab and Etanercept Source: IMS MIDAS (MAT April 2017) 5

6 QuintilesIMS analysis show further variability in trust conversion to biosimilar medications: Source: IMS Health. HPA analysis (qtr ending July 2017) 6

7 There is considerable variation in speed of uptake and penetration among those trusts using >50% biosimilar Etanercept: the opportunity lost Etanercept biosimilar usage Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Source: IMS Health. HPA, Feb 16 Jul 17 7

8 NHS BioValue: The Potential for a Landmark UK NHS Real World Evidence Study on Biosimilars that would Enhance the NHS England Commissioning Framework undertaken in collaboration with NIHR Copyright 2016 QuintilesIMS. All rights reserved.

9 NHS BioValue Vision: An RWE study that would look at the patient and service outcomes of NHS Patients switched from a biologic to a biosimilar in England The study would run up to end-2019 and capture: Patient Experience and outcomes in respect of engagement, consent, experience of initial and any subsequent switches and crucially are patients accessing treatment earlier in the pathway Service outcomes: are the initial financial benefits sustainable, how does the patient pathway change, what is the level of service impact overall Prescribing by brand consistency To develop a RWE study that will underpin the implementation of the NHS England commissioning Evaluation Framework and provide much greater insight than NOR-SWITCH in a large, ethnically diverse population over a three year window. 9

10 Can we learn and improve on NOR-SWITCH? What was the NOR-SWITCH Study? A randomised, double-blind study designed to evaluate the effects of a single switch from the original biologic (Remicade) to the biosimilar (Remsima/Inflectra) across six inflammatory diseases for which infliximab is approved. 500 patients enrolled to look at disease worsening, disease-specific outcomes, safety, immunogenicity, and cost-effectiveness, to see if any of these measures were affected among those patients who switched to the biosimilar. Patient cohort 155 Crohn's disease, 93 ulcerative colitis, 78 rheumatoid arthritis, 91 spondyloarthritis, 30 psoriatic arthritis and 35 plaque psoriasis. Patients were enrolled from 40 sites across Norway monitored for 52 weeks 10

11 Gaps within NOR-SWITCH that NHS BioValue could address Real world evaluation of the clinical scenario of multiple switches throughout the course of treatment Capturing in real time any concerns patients about such a switch? How much information are patients given by their Dr about the switch, what a biosimilar is? What does meaningful informed consent look like around switching? Is the NHS adequately tracking and tracing biologic and biosimilar medicines critically, ensuring brand name prescribing? Switching a stable patient from a biologic medicine to a biosimilar for non-medical reasons, and long-term impact on higher costs Effect of switching from originator to biosimilar without delay and meeting NHSE CF targets 11

12 A study of this nature could support the monitoring and data collection stages of NHS England s Commissioning Framework NHS England s Commissioning framework for biological medicines (Sept 2017) 12

13 QI has national data to supplement local analysis and help commissioners implement NHS England s Commissioning framework for biological medicines (Sept 2017) Consideration of patient experience on their medicine (for both naïve patients and those who have been switched from another biological medicine) Patient outcomes: PROMS Financial benefit Challenges to implementation Documentation of management decisions Commissioners and clinicians should consider which national and local databases and registries may be used and provide guidance on requirements for appropriate monitoring. If a new biological medicine, including a biosimilar medicine, is introduced, baseline data and agreed indicators should be collected during and after its introduction. 13

14 The outputs of the analysis will generate evidence to support the implementation of NHSE Framework and possibly a change to NICE Guidelines Potential analysis outputs Benchmarking within trust Benchmarking across participating trusts Pathway variation analysis Recommendations for most efficient pathway adoption Implementation support 14

15 NHS BioValue Illustrative Anti-Inflammatory RWE Questions Although the Study would be across all indications Impact on the Patient Outcomes and Service Questions: What is the overall patient experience before, during and after the switch process? How are the financial upsides being recognized and is there any evidence that headroom is being created to enable patients with inflammatory disease to access such therapies earlier in the pathway? Can we compare utilisation of biosimilars by clinical directorates-so comparing usage amongst rheumatologists, dermatologists, gastroenterologists? Are there any differences in healthcare resource utilisation levels/costs for treating patients with a biosimilar vs an originator biologic: surgical procedures, planned and unplanned admissions, co-medications? 15

16 NHS BioValue Programme Illustrative RWE Questions Is the financial promise sustainable, such that manufactures feel UK is viable What are all the costs of switch Are the NHSE commissioning framework principles being adopted Is there variation across patient cohorts /social class in access to biologic/biosimilars in line with NICE? What is the level of variation in treatment effect? What do we know & not know about how biosimilars are being used in multi-indication heterogeneous population, incl. possible atypical risk profile What can we learn from regions who have gone faster in adoption than others with biosimilars Future Financial Sustainability Variation and Equity Descriptive Study Biosimilars Patient Experience Treatment Pathways Medicines Optimisation Capturing and benchmarking point at which patients are being allowed to access such medicines under NICE Pathways? What differences exist between use of biosimilars in a primary and secondary care setting? Can we identify those who might benefit from a biosimilar earlier in the pathway? What do we know about strategies to engage difficult to reach populations to date What is the impact of the NHS England commissioning Framework on the uptake and is there variation between directorates and Trusts What impact will the RMOCs have on driving uptake across the region Adherence: Biosimilars taken as per prescriber expectation What is the patient experience of the change in medicine How does this vary between directorates, trusts How does the patients view change over time in respect of being moved to a biosimilar QuintilesIMS Confidential 16

17 NHS BioValue Programme Potential Outcomes for Industry Demonstrate the potential of NHS data assets when mined properly for global trial and RWE investment Diverse population of UK attractive feature for trial recruitment Make the case that biosimilars are creating headroom for funding of innovative medicines Demonstrate attractiveness of UK as trial site-research delivers improved outcomes, hard evidence base Identify and address any equity and access issues to biosimilars medicines. This would help build evidence for wider societal benefits of biosimilars Future Financial Sustainability Variation and Equity Descriptive Studies Outcomes for Industry? Medicines Optimisation Clinical Effectiveness & Treatment Pathways Patient Experience RWE insights of where & how biosimilars are being used in live populations Largest ever study looking at all outcomes proving beyond reasonable doubt the value of biosimilars across all pathways Position UK as unique in its capture of patient experience across the different pathways Supporting patients making an informed decision about their treatment options and how that might change Highlight issues on uptake of the biosimilars and create an evidence base that will potentially lead to NICE guidelines being changed-allowing patients earlier access to innovation QuintilesIMS Confidential 17

18 The Potential of NHS BioValue? NHS BioValue could be a landmark RWE study of a type previously unseen-large patient numbers, ethnically diverse patients across all indications Will deliver tangible patient, clinician and commissioner outcomes at pace and scale Improved use and uptake of such innovative medicines earlier in the pathway that can form the evidence base required by NICE to consider changing its guidelines Will identify very quickly any non-brand prescribing The Study would demonstrate the value of biosimilars and the NHS as having the worlds richest de-identified & integrated health & social care data as exemplified by places such as Greater Manchester At a time when global pharma is nervous about the UK market NHS BioValue will be an exemplar of what can be achieved in partnership with the NHS It would epitomise the recommendations of the Life Sciences Industrial Strategy to develop a globally competitive life sciences ecosystem supported by collaboration across NHS, Industry and researchers to deliver health and wealth 18

19 Angela McFarlane Market Development Director QuintilesIMS

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

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