Role of HIT Vendors in Promoting Safe Use of Biosimilars

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1 Role of HIT Vendors in Promoting Safe Use of Biosimilars Session #312, February 22, 2017 Stella Stergiopoulos, MS, MPH; Senior Project Manager, Tufts CSDD Thomas Felix, MD, Medical Director, R&D Policy; Global Regulatory Affairs and Safety, Amgen, Inc. 1

2 Speaker Introduction Thomas Felix, MD Add Speaker Photo Here Medical Director, R&D Policy; Global Regulatory Affairs and Safety Amgen, Inc. 2

3 Speaker Introduction Stella Stergiopoulos, MS, MPH Senior Project Manager Tufts Center for the Study of Drug Development (CSDD) 3

4 Conflict of Interest Thomas Felix, MD Employee and holds stock in Amgen, Inc. 4

5 Conflict of Interest Stella Stergiopoulos, MS, MPH Has no real or apparent conflicts of interest to report. 5

6 Agenda Biologics and Biosimilars: An Overview Legislative and Regulatory Activity Biosimilar Naming Substitution Tracking of Adverse Events Review of current Adverse Event reporting experiences of Pharmacies, Practices and Integrated Delivery Networks Impact of Biosimilars on Healthcare Information Technology Vendors Summary and Open Discussion 6

7 Learning Objectives Assess impact of current biologic and biosimilar legislation and regulations (biosimilar naming, state substitution, reporting) on your organization, institution and/or product Evaluate current Adverse Event reporting experience and impact on reporting of biologics and biosimilars through review of research conducted by Tufts University Center for Drug Development Discuss framework of what needs to be done by stakeholders to capture to support specific product identification, ensure precise product tracking and allow for accurate, efficient reporting and tracing of Adverse Events associated with biologics 7

8 Polling Question Current Experience with Biosimilars? Extensive Experience (Prescribing, Dispensing, Tracking of Adverse Events) Moderate Experience Limited Experience (Have heard about them, but have not yet prescribed, dispensed or done any tracking of Adverse Events) 8

9 An Introduction of How Benefits Were Realized for the Value of Health IT Treatment/Clinical: Improved Clinical Documentation and Overall Improved patient safety Electronic Secure Data: Improved access for data research Data Reporting 9

10 News about Biologics and Biosimilars is everywhere 10

11 Why Are Biologics so Important? Biologics hold great promise for providing a lower cost treatment option for chronic diseases Source: IMS Health Global Trends in Medicine. 11

12 Biologics: What are they? Definition* Manufacturing Competitive products* Small Molecules a group of atoms joined by chemical bonds; the smallest amount of a substance that possesses its characteristic properties. Molecule based. Chemical synthesis Predictable chemical process Identical copies possible Stable Generic Molecules Biologic Compounds A preparation that is synthesized from living organisms or their products, especially a human or animal protein, such as a hormone or antitoxin, that is used as a diagnostic, preventive, or therapeutic agent. Made in living cells Unpredictable manufacturing process Difficult / impossible to create identical copy Unstable Biosimilars * Source: 12

13 Biosimilars: What are they? Definition* Rules on Substitution Generic Molecules Generic equivalent. A drug that is no longer under patent protection, which may be produced by any manufacturer who follows good manufacturing protocols. Identical to the innovative original drug Interchangeable and therefore substitutable without prescription in all states (considered therapeutically equivalent) Hatch-Waxman Act (1984) 13 Biosimilars A biopharmaceutical which is produced by a different manufacturer after the expiration of the patent and marketing exclusivity of an original innovative biological product (e.g., a therapeutic monoclonal antibody). Highly similar to original biologic. Not always therapeutically equivalent and interchangeable (different active ingredient) 1. Biosimilars: analytical studies show product is highly similar 2. Interchangeable Biosimilar: Requires biosimilarity AND switching from original biologic does not impact safety or efficacy

14 Current Regulatory Activity around Biosimilars Biosimilar Naming Biosimilar Substitutions and Interchangeability Biosimilar tracking and reporting for ADEs FDA final guidance on Non-Proprietary biologic product naming released January 2017 Different naming conventions across regulatory agencies Different rules across countries Legislation in 18 states FDA Draft Guidance released January 2017 Limitations with FDA s Medwatch Limitations for reporting (at hospitals; private practice; retail pharmacies) 14

15 Biosimilars: Legislative and Regulatory Activity Biosimilar Naming FDA released draft guidance on nonproprietary biologic product naming (Sept 2015) Biosimilar Substitutions and Interchangeability Legislation in 26 states FDA Draft Guidance expected in 2017 Biosimilar tracking and reporting for adverse drug events (ADEs) 15 It s all about patient safety and holding manufacturers accountable

16 FDA Guidance on Biologic Naming An FDA-designated suffix be added to the nonproprietary biologic name Suffix would be composed of a random set of 4 lowercase letters Changing the names of 6 existing reference and biosimilar products Add suffix to the nonproprietary name Example: Nonproprietary name of reference product: replicamab-cznm Biosimilar of that product: replicamab-hixf Guidance seeks to address 2 main issues: Help prevent inadvertent substitution and provide support for after-market safety monitoring of all biologic products. 16

17 Biosimilar Substitution A flurry of state-level activities New laws/regulations are emerging around biosimilar substitutions and physician notification Amending current statutes and pharmacy board generic substitution rules to accommodate biosimilars 28 states are considering or have passed legislation establishing standards for substitution of a biosimilar product FDA Draft Guidance around biosimilar substitution was expected in 2016; now delayed to

18 Biosimilar Substitution Notification AK In the past four years, at least 36 states have considered legislation establishing state standards for substitution of a biosimilar. Laws have been passed in 25 States and PR; 4 states have pending legislation WA OR NV CA ID UT AZ MT WY CO NM ND MN WI SD IA NE IL KS MO OK AR MS LA TX VT NY MI PA OH IN WV VA KY NC TN SC GA AL FL ME NH MA RI CT NJ DE MD DC HI 18 Source: National Conference of State Legislatures, State Laws and Regulations related to Biologic Medications and substitution of biosimilars, April 2016

19 Biosimilar tracking for ADEs Currently, there is no pending legislation around Tracking and reporting ADEs 19

20 US Health Care Professional Perspectives on Adverse Drug Event Reporting in the Hospital Setting and the Opportunity for Information Technology Stella Stergiopoulos, Tufts CSDD Carrie A. Brown, Tufts University Thomas Felix, Amgen Inc. Gustavo Grampp, Amgen Inc. Kenneth A. Getz; Tufts CSDD Results of study conducted by Tufts CSDD in 2015 and Recently published in the November, 2016 Issue of the Drug Safety Journal 20

21 What is the role of health information technology (HIT) in pharmacovigilance? Should not be a barrier to reporting adverse drug events (ADEs) Should link patient care, pharmacy and institutional safety systems Identifiable patient, reportable event, suspect drug (spontaneous reports) Should comply with government policies and standards Product-specific and batch-specific tracking of biological products 21

22 Tufts CSDD 2014 Survey of ADE Reporting Practices in the US 22

23 Phase 2: Survey findings identified a typical Hospital-based ADE reporting process flow 23

24 Human Growth Hormone: Lot number Completion Rates By Year Note: Represents Primary Suspect FAERS reports for HGH in the US is for Q1 Q3 only. 24

25 Human Growth Hormone: Drug Name Accuracy Completion Rates By Year Note: Represents Primary Suspect FAERS reports for HGH in the US is for Q1 Q3 only. 25

26 Insulin: Lot number Completion Rates By Year Note: Represents Primary Suspect FAERS reports for Insulin in the US is for Q1 Q3 only. 26

27 Insulin: Drug Name Accuracy Completion Rates By Year Note: Represents Primary Suspect FAERS reports for Insulin in the US is for Q1 Q3 only. 27

28 Polling Question Current experience with process of reporting ADEs? Extensive Experience Moderate Experience Limited Experience 28

29 Phase 2 Results: Reason for not reporting ADEs Based on your experience, how often do each of these reasons prevent health care providers from reporting ADEs to the FDA or the manufacturer? (n = 87) Lack of system integration was cited as a significant reason for not reporting ADEs (52%)* 29

30 Phase 2 Results: Reason for not reporting ADEs *Question was Based on your experience, how often do each of these reasons prevent health care providers from reporting ADEs to the FDA or the manufacturer? (n=87) Key details are spread among multiple data sources Drug details spread across 4 or more sources (46%, n=74) ADE details spread across 3 or more sources (51%, n=69) 30

31 Limited availability of important drug data elements in HIT systems Note: N = 63. Question was Which of the following data about the particular drug administered to a particular patient are routinely available in your electronic systems? Manufacturer (field or NDC code) and lot identifiers are scarce in most systems Bar code based systems may improve data capture 31

32 Study Summary Hospital IT systems are an essential source for recording and retrieving ADE and suspect drug information Presence of multiple systems that lack integration may be an obstacle to efficient ADE reporting Many systems may not capture drug identifiers other than brand and/or INN Recommendations: Improve access to information: Interoperability/integration of drug identifiers and ADE data from multiple systems System designs should permit use of brand names for biologics Integrate product-specific data from bar code based systems into other HIT systems to improve lot-level traceability 32

33 Biologics and Biosimilars: Impact on HIT Vendors Biosimilars are here and many more are coming to market Biosimilar substitution is not the same as generic substitution New rules are in place to notify prescribers when pharmacists substitute biosimiiars Point of Care tracking of biosimilar ADEs is essential EHRs and Pharmacy Information Systems must adapt to accommodate: Biosimilar drug names Receipt of substitution notification Receipt of expanded drug information from pharmacies on MedHx and RxFill Tracking and reporting of biosimilar ADEs at the point of care 33

34 An Introduction of How Benefits Were Realized for the Value of Health IT Treatment/Clinical: Improved Clinical Documentation and Overall Improved patient safety Electronic Secure Data: Improved access for data research Data Reporting 34

35 Questions for Essential Discussion 35

36 Questions Thomas Felix, MD, Medical Director, R&D Policy Global Regulatory Affairs and Safety, Amgen, Inc. Stella Stergiopoulos, MS, MPH; Senior Project Manager, Tufts CSDD Please complete online session evaluation: Session #312 36