1. Dee Donatelli RN, BSN, MBA SVP Hayes, Inc. May 2014 Copyright © 2014 Winifred S. Hayes, Inc.

2.  Provide an overview of how to use evidence to guide product utilization  Demonstrate how this process can be incorporated into a value analysis program to deliver high-quality medical care and achieve financial savings

3.  Describe evidence-based value analysis  Explain rationale for applying an evidence-based approach to purchasing products and services  Discuss benefits of applying evidence to real-life situations

4.  Focuses on cost to drive contracting and standardization strategies  Limits the variety of products used for same clinical application ◦ Physician Preference Items (PPI)  Eliminates misuse or wasteful consumption

5. Cost Evidence Patient outcomes and safety come to the forefront of the discussion

6.  Systematic process creates a forum that physicians understand and appreciate  Fact based, objective assessment  Purchasing and usage patterns are optimized  Sustained savings  Improved outcomes both financial and clinical

7. Evaluate quality and quantity of clinical evidence Engage physicians and other cliniciansAssess operational and financial impactValidate potential savings and outcomes Implement a tracking system

8. Team of Stakeholders Field Requests Review Evidence Assess Vendor Relationships Purchase Decision Capture Results and Communicate

9.  Keep clinical quality at the forefront of the process  Focus on high-cost supply-chain products  Include multiple stakeholders on the EBVA team ◦ Require executive support ◦ Recruit physician support  Hold team accountable  Track/monitor financial, operational, and clinical goals  Communicate progress

10. EBVA Example………

11. To control costs associated with the use of scaffolding (meshes) in hernia repair surgery Surgery techniques ◦ Open ◦ Laparoscopic Hernia ◦ Organ protrusion through weakening of connective tissue ◦ Inguinal, ventral, incisional Repair type ◦ Herniorrhaphy (Sutures) ◦ Hernioplasty (Scaffolding/Mesh)

12. Define problem statement Background research Perform literature search Preliminary review of the data Discuss strategy Refine problem statement Expand literature search Extract data Assess quality and quantity of evidence Assess clinical effectiveness Assess clinical safety Consider clinician preferences Make recommendations PHYSICIAN FOCUS on Clinical Outcomes

13. Define problem statement Background research Perform literature search Preliminary review of the data Discuss strategy Focus on Clinical Outcomes

14. Mesh materials Synthetics Polypropylene Polypropylene composites Other synthetics Biologics Human-based Animal-based

15. Impact of mesh material on outcomes (441) Observational (16) Comparative (19) Published literature: Hernia repair (10547) Biomechanics Animal studies Irrelevant products Duplicates Editorials, letters, etc.

16.  IHS rates: ◦ Proportion of patients with infection, hematoma, and/or seroma  Post-op pain rate: ◦ Proportion of patients with chronic pain  Recurrence rate: ◦ Proportion of patients with hernia recurrence

17. Define problem statement Background research Perform literature search Preliminary review of the data Discuss strategy Refine problem statement Expand literature search Extract data Assess quality and quantity of evidence Assess clinical effectiveness Assess clinical safety Consider clinician preferences Make recommendations

18. Quantity of Evidence # studiesInguinalIncisionalVentral Polypropylene1231 Polypropylene composite 611 Other synthetics312 Biologics011

19.  Large, multicenter, randomized controlled trials (RCTs)  Meta-analysis of grouped data  Smaller, single-site, RCTs (29%)  Nonrandomized controlled prospective studies (14%)  Nonrandomized controlled retrospective studies (11%)  Studies with historical controls  Observational studies (46%)  Consensus/expert opinion Strong Weak Strength of evidence

20.  Full or partial support from manufacturers ◦ Two RCTs comparing Atrium to Vypro ◦ One RCT comparing Prolene to Vypro ◦ One RCT comparing Prolene to Ultrapro ◦ One large observational study of Composix Kugel ◦ One small observational study of Veritas KEY: RCT(s), randomized controlled trial(s)

21. Clinical Effectiveness – Complications KEY: 3D, three-dimensional ; IHS, infection, hematoma, and/or seroma; TNC, trimethylene carbonate Published evidence: Inguinal hernia MaterialBrand name# Patients IHS rates # Studies Polypropylene 3DMAX (3D)1462.0%1 Atrium142 0.0%1 Prolene23-425 0%-9.2%7 Prolene PHS/PM Hernia Device (3D)150-1871.3%-1.6%2 Proloop Preshaped Plug with Onlay (3D)93 1.1%-6.5%1 Ventralex 0 Polypropylene composite Composix Kugel 0 Sepramesh 0 Ultrapro18-3820%-8.4%6 Ventralight ST 0 (e)PTFE Gore Dualmesh 0 Gore Mycromesh91-2460%-6.9%2 Polyethylene (polyester) Parietex3112.0%1 Parietex Progrip 0 Polyglactin 910 Vicryl 0 Polyglycolide/TMC Bio-A 0 Bio-A Plug (3D) 0 Biologic Allomax (human) 0 Veritas (bovine) 0 XenMatrix (porcine) 0

22. Clinical Effectiveness – Post-op pain KEY: 3D, three-dimensional ; TNC, trimethylene carbonate Published evidence: Inguinal hernia MaterialBrand name# Patients Post-op pain rate # Studies Polypropylene 3DMAX (3D)1462.7%1 Atrium142 4.0%1 Prolene23-425 4.7%-20%6 Prolene PHS/PM Hernia Device (3D)150-1873.2%-12%2 Proloop Preshaped Plug with Onlay (3D) 0 Ventralex 0 Polypropylene composite Composix Kugel 0 Sepramesh 0 Ultrapro18-3820%-18.9%6 Ventralight ST 0 (e)PTFE Gore Dualmesh 0 Gore Mycromesh91-2462.9%1 Polyethylene (polyester) Parietex3110.0%1 Parietex Progrip 0 Polyglactin 910 Vicryl 0 Polyglycolide/TMC Bio-A 0 Bio-A Plug (3D) 0 Biologic Allomax (human) 0 Veritas (bovine) 0 XenMatrix (porcine) 0

23. Clinical Effectiveness – Recurrence KEY: 3D, three-dimensional ; TMC, trimethylene carbonate Published evidence: Inguinal hernia MaterialBrand name# Patients Recurrence rate # Studies Polypropylene 3DMAX (3D)1460.7%1 Atrium142 0.7%1 Prolene23-425 0.6%-2.8%7 Prolene PHS/PM Hernia Device (3D)150-1872.1%2 Proloop Preshaped Plug with Onlay (3D)93 2.0%1 Ventralex 0 Polypropylene composite Composix Kugel 0 Sepramesh 0 Ultrapro18-3820%-4.3%6 Ventralight ST 0 (e)PTFE Gore Dualmesh 0 Gore Mycromesh91-2460%-0.41%2 Polyethylene (polyester) Parietex3110.0%1 Parietex Progrip 0 Polyglactin 910 Vicryl 0 Polyglycolide/TMC Bio-A 0 Bio-A Plug (3D) 0 Biologic Allomax (human) 0 Veritas (bovine) 0 XenMatrix (porcine) 0

24. Define problem statement Background research Perform literature search Preliminary review of the data Discuss strategy Refine problem statement Expand literature search Extract data Assess quality and quantity of evidence Assess clinical effectiveness Assess clinical safety Consider clinician preferences Make recommendations Clinical Safety

25.  Large number of adverse events per year ◦ 1 polypropylene ◦ 2 polypropylene composites ◦ 2 biologics  Composix Kugel Mesh ◦ Memory recoil ring could break and potentially lead to bowel perforation and/or chronic enteric fistula ◦ Permanently withdrawn from U.S. and other select markets (2012) NOTE: For a complete list of recalled products, visit the FDA website at http://www.fda.gov/Safety/Recalls/default.htm

27. KEY: 3D, three-dimensional; AE, adverse event; NRPL, no relevant published literature; TMC, trimethylene carbonate. *AEs not restricted to hernia repair. MaterialShapeRationale Polypropylene Flat AE incidence >10/yr* Post-op pain rate >10% for inguinal and incisional hernia in multiple studies 3D NRPL on post-op pain for inguinal hernia Flat AE incidence >20/yr Infection rate >20% for ventral hernia in 1 large observational study Polypropylene composite FlatPermanently recalled Flat No relevant published literature Flat AE incidence >20/yr Post-op pain rate >10% for inguinal hernia Flat No relevant published literature Polyethylene (polyester) Flat No relevant published literature Polyglactin 910 Flat No relevant published literature Polyglycolide/ TMC Flat No relevant published literature 3D No relevant published literature Biologic Flat No relevant published literature FlatAE incidence >20/yr FlatAE incidence >20/yr

28. KEY: (e)PTFE, expandable polytetrafluorethylene; TAPP, transabdominal prepreitoneal; TEP, total extraperitoneal “Spend” (primary) = ~$600K IndicationTechniqueShapeMaterialRecommendation Inguinal OpenFlatPolypropylenePrimary OpenFlat(e)PTFEAlternative Open3DPolypropylenePrimary Laparoscopic- TEP FlatPolyethylene (polyester) Primary Laparoscopic- TAPP 3DPolypropylenePrimary Incisional and Ventral Open Laparoscopic Flat(e)PTFEPrimary OpenFlatPolypropyleneAlternative

29. Define problem statement Background research Perform literature search Preliminary review of the data Discuss strategy Refine problem statement Expand literature search Extract data Assess quality and quantity of evidence Assess clinical effectiveness Assess clinical safety Consider clinician preferences Make recommendations Physician Preferences

30. Brand nameManufacturer Annual volume Annual cost 3DMAXDavol Inc., sub. C.R. Bard, Inc.3.6%0.5% Allomax (human)Davol Inc., sub. C.R. Bard, Inc.12.0%32.9%* AtriumAtrium Medical Corp.1.5%0.1% Bio-AW.L. Gore & Associates, Inc.0.4%0.1%* Bio-A PlugW.L. Gore & Associates, Inc.1.5%0.6%* Composix KugelDavol Inc., sub. C.R. Bard, Inc.1.2%0.7% Gore DualmeshW.L. Gore & Associates, Inc.17.2%10.1% Gore MycromeshW.L. Gore & Associates, Inc.1.1%0.7%* ParietexCovidien4.7%1.3% Parietex ProgripCovidien3.5%0.7% ProleneEthicon, Inc.4.7%0.2% Prolene PHS/PM Hernia DeviceEthicon, Inc.23.3%3.8% Proloop Preshaped Plug with Onlay Atrium Medical Corp.0.0% SeprameshGenzyme Corp.0.2%0.1% UltraproEthicon, Inc.1.0%0.1%* VentralexDavol Inc., sub. C.R. Bard, Inc.8.3%2.5% Ventralight STDavol Inc., sub. C.R. Bard, Inc.10.0%6.7% Veritas (bovine)Synovis Surgical Innovations0.1%0.7%* VicrylEthicon, Inc.0.0% XenMatrix (porcine)Davol Inc., sub. C.R. Bard, Inc.5.6%38.6% Total: ~800 $1.5M* * Estimates

31. Using evidence along with other data and information to evaluate a health technology and its role in providing essential functions that solve clinical problems or needs while improving clinical and financial outcomes.

32. ddonatelli@hayesinc.com 215.855.0615