Biologicals & biosimilars; addressing the needs of patients and payers. The Role of Functioning Competitive Markets

Transcription

1 Biologicals & biosimilars; addressing the needs of patients and payers The Role of Functioning Competitive Markets

2 Agenda Why do patients and payers need biosimilars? How can we increase the uptake of biosimilars? What role can biosimilars play? 1 IMS Health Confidential

3 Why do patients and payers need biosimilars? Savings Patient access Competition The increasing use of biologicals 2 IMS Health Confidential

4 In the absence of competition, cumulative spending in the EU5 is expected to reach 47 billion over the period The Addressable Biosimilar Medicines Market in the EU5 and the US, EU DE BN US BN FR IT ES 5 9 UK Conversion rate: 1 USD = EUR (01/20/2016) Source: IMS Health, MIDAS, IMS Health Market Prognosis, IMS Institute for Healthcare Informatics, Dec 2015 Notes: Addressable market is calculated based on projected growth of originator market without biosimiliar entry. Growth rate is based on historical growth and analogue analysis. 3 Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

5 The value of biologic products losing patent exclusivity between 2015 and 2020 is significant EU5+US Sales of Key Biologics Scheduled to Lose Patent Protection in Moving Annual Total Sept 2015 (BN ) 10,8 DE ES FR UK 8,7 IT USA 6,9 5,3 4,2 3,9 3,2 0,3 LOEà Adalimumab Insulin glargine Etanercept Infliximab Rituximab Peg-filgras:m Trastuzumab Follitropin alfa Source: IMS Health, MIDAS, Dec Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

6 Cumulative savings over the next five years (EU5 and US) could range from between 49 billion to as much as 98 billion Savings potential from 8 Key Products with LOE % price reduction 30% price reduction 40% price reduction 98 Potential Savings BN Source: IMS Health, MIDAS, IMS Health Market Prognosis, IMS Institute for Healthcare Informatics, Dec Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

7 How can we increase the uptake of biosimilars? Education and incentives Biosimilar first prescribing (all naïve patients) Quotas Tenders Pricing Interchangeability/switching/substitution 6 IMS Health Confidential

8 Payers need to ensure that stakeholders are sufficiently educated on the benefits of biosimilars medicines and are appropriately incentivised Unlocking the Potential of Biosimilar Medicines Educate Physicians Patients Payers Biosimilar benefit Incentivise Physicians Pharmacists Manufacturers Source: IMS Health, IMS Consulting Group, Jan Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

9 Considerable variation across the EU exists in terms of payer policy approaches to biosimilars EU Payer Biosimilar Policies Most patients out of reach for manufacturers Competition averse Foster competition Many patients available for manufacturers to compete for National management passive (i.e. fixed biosimilar price reduction) No prescribing incentives No prescription quota Increased active management nationally (i.e. regular price adoption) Education of physicians by payers Biosimilar prescribing stimulated (quotas) Source: IMS Health, IMS Consulting Group, Jan Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

10 Germany (North Rhine): quotas for prescribing biosimilars Medicines agreement struck between German Health Insurance funds and statutory doctors associations EPO: Nephrologists expected to ensure at least 63% of the prescriptions are biosimilars TNF-alpha inhibitor class: Gastroenterologists: 11,5% Rheumatologists and dermatologists: 4,5% 9 9

11 Belgium: convention to increase uptake of biosimilar medicines Gentleman s agreement between Belgian government, hospital pharmacists, physicians and pharmaceutical industry Physicians voluntarily commit to increase uptake of biosimilar medicines Some Belgian physicians s1ll scep1cal about biosimilar medicines Biosimilars have to be considered for bio-naïve patients If no sign of increased uptake by July 2016, government will implement additional (legislative) measures 10 10

12 In Europe, biosimilar penetration has only been incremental in non-tender systems Europe EU5 penetration 10-24% in under a year Europe: Infliximab biosimilar market share Infliximab biosimilar uptake 100% 80% 60% 40% 20% 98% 94% 86% EU5 24% 20% 10% Tender system markets 23% 15% 0% M0 M2 M4 M6 M8 M10 M12 M14 M16 M18 M20 M22 M24 Denmark Poland Norway Italy UK Spain Germany France Other European countries 11 Source: IMS MIDAS monthly Dec 2015 ; Denmark data from MIDAS Monthly Restricted database; Bulgaria, Latvia excluded because only biosimilar manufacturers present in market

13 Presence on the market increases infliximab usage, and will eventually cut spending Index rela1ve to month before biosimilar launch 120% 110% 100% EU5 90% M0 M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 Months aver biosimilar launch Spend Volume Index rela1ve to month before biosimilar launch 180% 140% 100% 60% Av. Infliximab Price 12 20% M0 M2 M4 M6 M8 M10 M12 M14 M16 M18 M20 M22 M24 M26 Source: IMS Health MIDAD Monthly Jan 2016 Months aver biosimilar launch

14 In the EU5 markets, price reductions have varied considerably Global Spending and Growth, Price change since introduction in biosimilar accessible market Germany France Italy Spain UK 0 1% % -14% -13% -4% -24% -18% -8% % Epoetin GCSF % -80 Source: IMS Health, The Impact of Biosimilar Competition, Nov 2015 Note: Analysis based on publically available prices. 13 Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

15 EU Definitions Interchangeability (EU) The medical prac1ce of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical se\ng on the ini1a1ve, or with the agreement of the prescriber (1) Interchangeability (USA) The interchangeable product (determined by FDA) may be subs1tutable for the reference product without the authoriza1on of the health care prescriber. See: Biologics Price Compe11on and Innova1on Act of 2009, Pub. L , Sect , 124 Stat Mar. 23, Switching (EU) Decision by the trea:ng physician to exchange one medicine for another medicine with the same therapeu1c intent in pa1ents who are undergoing treatment Hospital:, decision is made by a mul:disciplinary team always including the clinical community (therapeu1c/formulary commidee) 14 (1) European Commission consensus paper 2013 : What you need to know about biosimilar medicines 14

16 What role can biosimilars play? Create headroom for expenditure on new innovative medicines Stimulate innovation with existing molecules Treat more patients within the same financial budgeted levels Increase patient access to modern medicines 15 IMS Health Confidential

17 Over the period , some 225 new active substances (NAS) are expected to come to market globally Global New Active Substances Available Since 1996 Cumulative Total Since year NAS Specialty Biologics Specialty Small molecules Traditional Biologics Traditional Small Molecules 15% Earlier NAS 47% 26% % Source: Global Medicines Use in Report by IMS Institute for Healthcare Informatics, Nov 2015 Note: Disease categories based on therapy areas and expected launches Orphan drugs are those to treat small populations with rare diseases, and are defined separately by U.S. FDA and the European Medicines Agency (EMA). Any medicine with an orphan designation for an approved use within the first year after global launch are categorized as Orphan. Half of designated orphan indications are granted more than a year after original approval. 16 Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets

18 Sovaldi only the first of several potential tsunamis Historic sales (Bn US$) Are these innovations sustainable? Hepatitis-C market $32 Bn 2015 Analyst forecast (Bn US$) Immuno-Oncology $18-22 Bn Respiratory biologics $6-8 Bn Source: IMS Health Analytics Link consensus analyst forecast; Drug analyst consensus; IMS Health MIDAS Q4 2015; Analyst forecast (Bn US$) PCSK9 inhibitors? $5-7 Bn

19 Biosimilars provide access to modern treatments at lower costs as well as potentially creating headroom for use of new innovative treatments. Opportunity to lower costs, e.g. price reductions of 30-60% generating significant savings Make room for increased expenditure on innovative drugs reaching the market by IMS Health Confidential

20 Oncology and Autoimmune targeted by biosimilars Biosimilar pipeline by phase 2015 Pre-clinical to registration Biosimilar pipeline by therapy area 2015 Pre-clinical to registration No. of biosimilars in development Preclinical 23 Phase I 1 Phase II 35 biosimilars in late stage development 23 Phase III 12 Pre-Reg/Reg Oncologics 28 Autoimmune 25 HGFs 10 Immunosuppr. 7 Erythropoietins 3 Sex Hormones 3 Antidiabetics 3 Growth Hormones 3 Dermatologics 2 Multiple Sclerosis 2 Others Number of biosimilars in development * 19 Source: IMS Health R&D focus Dec 2015; Not exhaustive

21 Several factors will influence the uptake of biosimilars in Europe 2 nd /3 rd Generation products may pose a major threat Therapy areas with chronic disease will be more dependent on switching existing patients Therapy Area Dynamics Physician Behavior Varying confidence in biosimilars, some being very open to use / others are more cautious Clinical results will be a key driver influencing the prescriber Regulatory approval process still optimising Biologic substitution regulations left to the country member states Regulatory Decisions Biosimilar Penetration Payer Influence Greater willingness to experiment and learn from each other Greater interventionism Biosimilar tenders becoming increasingly competitive Strategic pricing strategy Capitalization on the continuing patients if biosimilar approved as non interchangeable Switching patients to protected formulation / device enhancement Maintaining competitive promotional efforts Originator company Biosimilar Company Decision Diverse marketing strategies, emphasizing education around the quality, safety and efficacy Strategy not limited to promotion as a lowercost option. Abasaglar Number of biosimilar competitors will influence discounts from the originator price 20

22 Three key outcomes from the use of biosimilars long-term Market opportunity for biosimilar players Huge financial incentive in pursuing this growing market Cost Savings (~20-30% vs. Originator) and better patient healthcare management Payer will Patients seeking access Affordable Access to breakthrough therapies leading to better health outcomes 21

23 22 Thank you!

24 Science-driven conceptual approach - Science-driven knowledge-based approach Biosimilar Biosimilar Slide Dr. Peter Richardson EMA, DIA London Nov. 2015

25 Comparability exercise has become the scientific norm for biosimilar development Lower Clinical EMA slide DIA London 2015, adapted PK/PD Sensitivity to Differences Preclinical Biological characterization Higher Physicochemical characterization Quality the founda1on of biosimilars The role of clinical trials is to confirm biosimilarity 24

26 Extrapolation of indications is based on the clinical experience with the reference product and the entire similarity exercise Source: Sandoz Reference Biosimilar Structural attributes Biological functions Human PK / PD Less sensitive indications Sensitive indication H I G H L Y S I M I L A R Safety and Connected to the H I G H L Y S I M I L A R efficacy reference product established by and its findings on H I G H L Y S I M I L A R clinical studies in safety and efficacy all approved by a robust indications J U S T I F similarity I E D exercise H I G H L Y S I M I L A R SIMILARITY SPACE Extrapolation is a logical consequence of the biosimilar concept that has been successfully implemented in the EU 25

27 Biosimilar Candidates under evaluation January applications for biosimilar medicines under evaluation by CHMP Enoxaparin sodium (2) Insulin Glargine (1) Etanercept (1) Infliximab (1) PEG-filgrastim (2) Rituximab (1) Adalimumab (2) 26 Source: EMA website (January 2016) & GaBI Online

28 Key therapeutic areas covered by current and future biosimilars Ac:ve substance Key therapeu:c areas covered by current biosimilars Ac:ve substance Key therapeu:c areas to be covered by future biosimilars Somatropin Pituitary dwarfism Prader-Wili syndrome Adalimumab Crohn s disease Rheumatoid arthri1s Epoe1n Filgras1m Infliximab Follitropin alfa Insulin glargine Turner syndrome Anemia Follow-up of cancer treatment Consequences of chronic kidney failure Neutropenia Follow-up of cancer treatment Hematopoie1c stem cell transplanta1on Rheumatoid arthri1s Crohn s disease Ulcera1ve coli1s Psoriasis Psoria1c arthri1s Ankylosing spondyli1s Anovula1on Diabetes mellitus Bevacizumab Cetuximab Etanercept Insulin aspart Insulin lispro PEG-filgras1m Ranibizumab Rituximab Trastuzumab Colorectal cancer Lung cancer Colorectal cancer Head and neck cancer Rheumatoid arthri1s Psoria1c arthri1s Plaqua psoriasis Ankylosing spondyli1s Diabetes mellitus Diabetes mellitus Neutropenia Follow-up of cancer treatment Hematopoie1c stem cell transplanta1on Macular degenera1on B-cell non-hodgkin s lymphoma Breast cancer Source: EMA website April

29 Review of switching between therapeutic proteins Review of switching studies of biological medicines (originator-originator or originator-biosimilar) Somatropin: 13 studies, 415 subjects (adults & children) Epoetin: 35 studies, 11,249 subjects Filgrastim: 10 studies, 374 subjects Review 193 ADR reports for currently approved biosimilars EPO 46 Filgrastim 118 Growth hormone 29 Data on frequency of switching is scarce, but no evidence that switching to and from different biological medicines leads to safety concerns No indication of safety issue resulting from switching between products à No signal of switch-related adverse effects 28 à No data that switching induces increased immunogenicity 28 Ebbers et al. The safety of switching between therapeu1c proteins. Expert Opinion on Biological Therapy 2012:12(11);

30 Interchangeability of biosimilar medicines Supported by national authorities Medicines Evaluation Board MEB (The Netherlands) 1 : Exchange between biological medicines (regardless of whether they are innovator products or biosimilar medicinal products) is permitted, but only if adequate clinical monitoring is performed and the patient is properly informed. Finnish Medicines Agency Fimea (Finland) 2 : Biosimilar medicines are interchangeable with their reference products under the supervision of a health care person. Paul Ehrlich Institute (Germany) 3 : Biosimilars can be used in the same way as the reference products to which they have shown equivalence. This implicitly covers both patients who have not yet received biological therapy as well as patients who previously received the originator molecule. 1 Are biosimilar medicines interchangeable? MEB position (2015). 2 Interchangeability 29 of biosimilars Position of Finnish Medicines Agency Fimea (22/2/2015). 3 Position of Paul-Ehrlich-Institute on interchangeability of biosimilar medicines (2015). 29

31 Pricing policies for biosimilar medicines Descrip1on of biosimilar P&R pathway Source: Foxon G et al (2014). Are EU payers adapting biosimilar pricing and reimbursement approval processes to optimize healthcare savings? Poster presented at ISPOR European Congress Amsterdam 30 30

32 NICE guidance on introducing a biosimilar infliximab Tips from the NHS for managing the introduction of biosimilars Identify clinical and pharmacy champions to take the lead in introducing biosimilars Consult all stakeholders (including patients) to ensure confidence in using biosimilars Provide information on EMA licensing process for biosimilars Extrapolation and equivalence Manufacturing process and intra-product manufacturing changes Identify the potential cost-saving and re-investment opportunities Seek formal approval at the local formulary committee once there is clinical consensus to include biosimilars on the formulary Collect baseline data and agree metric to be collected during and after the introduction of biosimilars Submit data to national audits and registries Prescribing should be done by brand name to ensure that there is no unintended substitution of drugs at the pharmacy level Source: 31 NICE (2015) Introducing biosimilar versions of infliximab: Inflectra and Remsima (available at: hdp://guidance.nice.org.uk/hda329) 31