Instructions for Use

Instructions for Use

Nove Nordisk Real World Evidence - an industry perspective Novo Nordisk Real World Evidence an industry perspective OVER 175 RWE STUDIES 20 November 2018 Novo 2017 R&D spend Nordisk ~1.8 BILLION Corporate EUR Presentatio n 1 1 OBESITY EMPLOYS APPROXIMATELY DIABETES 43,000 PEOPLE 5 STRATEGIC PRIORITIES Diabetes Obesity Robin Evers Senior Vice President

Medical Affairs, Regulatory and Safety UP TO 40,000 PATIENTS IN CLINICAL TRIALS GROWTH DISORDERS Haemophilia Growth disorders Other serious chronic diseases 20 November 2018 SUPPLIER OF NEARLY HALF OF THE WORLDS INSULIN HAEMOPHILIA 27,700,000 PEOPLE USE OUR DIABETES CARE PRODUCTS Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Forward-looking statements Novo Nordisks reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation as well as the companys statutory Annual Report 2017 and Form 20-F, which are both filed with the SEC in February 2018 in continuation of the publication of the Annual Report 2017, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking statements. Words such as believe, expect, may, will, plan, strategy, prospect, foresee, estimate, project, anticipate, can, intend, target and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but are not limited to: Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisks products, product research, product development, product introductions and product approvals as well as cooperation in relation thereto, Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other

financial measures, Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and Statements regarding the assumptions underlying or relating to such statements. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations, delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recalls, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisks products, introduction of competing products, reliance on information technology, Novo Nordisks ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees, and failure to maintain a culture of compliance. For an overview of some, but not all, of the risks that could adversely affect our results or the accuracy of forward-looking statements in this presentation, reference is made to the overview of risk factors in The Risks of Doing Business on pp 40-43 of the Annual Report 2017. Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this presentation, whether as a result of new information, future events or otherwise. Important drug information Victoza (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only Saxenda (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only 2 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 RWE covers a wide range of studies based on a large toolbox of data sources RCTs Part of regulatory files

Not Notpart partof of regulatory regulatory files files Pragmatic clinical trials Database studies Non-interventional studies Surveys and chart reviews RCTs and RWE should be used complementarily 3 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Industry is engaged in RWE studies & RWEs are normally post-approval, with exceptions Pre-approval pragmatic RWE Post-approval large-scale CV RWEs CVD-REAL (Astra Zeneca)1 The Salford Lung Study (GlaxoSmithKline) 1

Population: Patients with chronic obstructive pulmonary disease Number of patients: 2,799 Setting: 75 general practices Treatment: fluticasone furoatevilanterol vs usual care Primary objective: rate of moderate or severe exacerbations Secondary objective: rate of primary care contact and secondary care contact Methods: electronic health records information and undisturbed routine clinical care 1) Vestbo et al, NEJM, 2016, 375, 13. Population: T2D patients Number of patients: 309,056 Treatment: New users of SGLT2 inhibitors Primary objective: hospitalization for heart failure and death Comparative Effectiveness of Empagliflozin in the US (Boehringer Ingelheim)2

Population: T2D patients Estimated enrolment: 80,000 Treatment: SGLT2 inhibitor Empagliflozin Primary objective: all-cause mortality, heart failure, major cardiovascular events 1) Kosiborod M et al. Circulation 2017;136:249259 2) https://clinicaltrials.gov/ct2/show/NCT03363464, accessed January 2018. 4 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Novo Nordisk uses different types of RWE studies Retrospective studies Prospective studies Survey Chart review Database study Noninterventional study Physician survey1 (Insulin degludec) EU-TREAT (Insulin degludec)2 EXTRA (IDegLira)3 EXPLORYS, US (Insulin degludec)4 Maccabi, IL (Insulin degludec)5

REFLECT (Insulin degludec)6 EVIDENCE (Liraglutide)7 Pragmatic trial LIRA PRIME (Liraglutide)8 DUAL VIII (IDegLira)9 RWE: real world evidence; IDegLira: Insulin degludec /liraglutide fixed combination 1. Harashima et al. Expert opinion on Pharmacotherapy 2016,5-11; 2. Siegmund et al. Diabetes Obs. Metab. 2018, 20 (3): 689-697; 3. Price et al. Diabetes Obes Metab. 2018;20(4):954-962; 4. Tibaldi et al. Diabetes 2018, Jul; 67 (Suppl. 1); 5. Cohen C et al. Diabetes Ther. 2017 Oct;8(5):1047-1055; 6. Data on file; 7. Gautier et al. Adv Ther. 2015 Sep;32(9):838-53 ; 8. Unger et al. Diabetes 2018 Jul; 67(Suppl. 1); 9. https://clinicaltrials.gov/ct2/show/NCT02501161 5 Nove Nordisk Real World Evidence - an industry perspective Novo Nordisk examples of RWE use in regulatory decision making 1 Rare disease Used patient registry to collect safety and efficacy information to support new indication and label update 2 Diabetes product Use in combination with other products; RCT evidence combined with RWE evidence to demonstrate safety and used in combination with a boarder use of concomitant medications 3 Diabetes product Evidence from RCTs, Electronic Medical Records (EMR) and RWE

study supported use of new product in an earlier line of treatment 20 November 2018 6 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 7 Real-world data completes the evidence base for degludec BEGIN TRIALS N=110001,2 SWITCH TRIALS N=12223,4 DEVOTE TRIAL N=76375 Single-arm study EU-TREAT STUDY N=25506 Comparative effectiveness research CONFIRM STUDY N=4056 Randomised controlled trial data:

RCT DATA CV OUTCOMES DATA Cardiovascular outcomes data: Real-world evidence: REAL-WORLD EVIDENCE 7 RCT: N=19859 Total: N>26000 RWE: N=6606 Total CV: cardiovascular; Degludec: insulin degludec; CVOT: cardiovascular outcomes trial; N=number of patients included in the investigated studies; RCT: randomised controlled trial; RWE: real world evidence 1. Ratner et al. Diabetes Obes Metab 2013;15:17584; 2. Wangnoo et al. J Assoc Physicians India 2014;62:216; 3. Lane et al. JAMA 2017;318:3344; 4. Wysham et al. JAMA 2017;318:4556; 5. Marso et al. N Engl J Med 2017;377:72332; 6. Siegmund et al. Diabetes Obes Metab 2018;20:68997; 7. Tibaldi et al. Diabetes 2018, Jul; 67(Suppl. 1); Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Phase 3 RCT1 T2D at high hypoglycaemia risk Nocturnal

Severe Noctu... Se 0 -20 -42 -80 Cardiovascular outcomes RCT2 T2D at high CV risk Nocturnal severe Severe Noctu... Se 0 -20 -40 -60 H y p o g ly c a e m ia r e d u c t io n ( % ) H y p o g ly c a e m ia r e d u c t io n ( % ) RCT evidence: a basal insulin reduces hypoglycaemia in type 2 diabetes -40 -46

-60 -40 -53 -80 CVOT: cardiovascular outcomes trial; T2D: type 2 diabetes 1. SWITCH II: Phase 3 trial with insulin degludec vs insulin glargine in people with type 2 diabetes at high risk of hypoglycaemia. Wysham et al. JAMA, 2017;318(1):45-56. 2. DEVOTE: cardiovascular outcomes trial with insulin degludec vs insulin glargine in people with type 2 diabetes at high CV risk. Marso et al. NEJM 2017;377:72332. 8 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 H y p o g ly c a e m ia r e d u c t io n ( % ) RWE evidence: EU-TREAT confirms RCT findings in wider population for Tresiba EU-TREAT RWE - Non-interventional study in T2D1 Nocturnal Severe Noctu... Se -90 -92 0 -20 -40 -60

-80 FPG: fasting plasma glucose; NS: non-significant; T1D: type 1 diabetes; T2D: type 2 diabetes 1. EU-TREAT study: Reduction in hypoglycaemia from baseline after 6 months. Schultes et al. Diabetes 2017;66 (Suppl. 1):A266; Siegmund et al. Diabetes 2017;66 (Suppl. 1):A267 9 Nove Nordisk Real World Evidence - an industry perspective Industry: Desired future use of RWE 20 November 2018 ? 10 Please rank the three most impactful areas of current and future RWE application within your organisation Source: Deloittes 2018 RWE Benchmarking Survey, p. 8, n=20 Note: The percentage denotes current and future application areas ranked amongst the top three by respondents and expressed as a percentage Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Current guidelines on RWE are limited and mostly focused on devices and areas of high unmet need U.S. Food and Drug Administration 24 pages guidance1 for medical devices

Ongoing guidance development: FDAs pre- and post-market requirements for How can real world evidence (RWE) better support regulatory decisions? European Medicines Agency 92 pages guidance2 applying primarily to treatments in areas of high medical need where it is difficult to collect data via traditional routes EMA is committed to enabling early patient access to new medicines 1. FDA: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry and Food and Drug Administration Staff, 2017 2. EMA: User guide for micro, small and medium-sized enterprises on the administrative and procedural aspects of the provisions laid down in regulation (EC) No 726/2004, that are of particular relevance to SMEs 11 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Potential regulatory uses of RWE study design / evidence collection 1. PASS Post-authorisation safety surveillance studies (CVOT) 2. 3. 4. 5.

Comparative efficacy versus other standards of care Broader populations versus RCT studies Safety in special populations (elderly, renal compromise) Combination therapy (safety and efficacy) 12 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 Increased collaboration must exist between stakeholders Ensure all stakeholders are engaged early dialogue Develop a common understanding and definition of the terminology Reach consensus regarding the relevance of RWD/RWE for answering different scientific questions Harmonise evidence requirements during different drug development and assessment phases Standardise and provide guidance on tools, methodologies and strategies for RWD collection and analysis 13 Nove Nordisk Real World Evidence - an industry perspective 20 November 2018 14 The Apis bull logo is a registered trademark of Novo Nordisk A/S

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