Improving the Outcomes of Oral Anticoagulation: Home Monitoring of Warfarin Therapy

1. Improving the Outcomes of Oral Anticoagulation:Home Monitoring of Warfarin Therapy Jack Ansell, M.D. Lenox Hill Hospital, NY September 22, 2009 Disclosures Consultant: Roche Diagnostics, ITC, HemoSense

2. The Dilemma of Anticoagulation Management • Warfarin has a narrow therapeutic window of effectiveness and safety. • Many factors influence a patient’s stability within that window. •Frequent monitoring is required to maintain patients in the therapeutic window. • Monitoring is labor intensive and complex. • Consequences • Increased adverse events with poor management • Physicians avoid warfarin use because of its complexity.

3. Oral anticoagulation is ALL about management The Desired Outcome: Benefits must be greater than RisksHospital Transition to Outpatient Outpatient Hemorrhage Reduction in risk of stroke or venous thromboembolism (VTE) Risks1,2 INR Benefits2,3 1. Ansell J et al. Chest. 2004;126:204S-233S. 2. Hirsh J et al. J Am Coll Cardiol. 2003;41:1633-1652. 3. Rothberg MB et al. Ann Intern Med. 2005;143:241-250.

4. Transition from Hospital to Ambulatory Care Settings

5. 8% 1% 10% 1% 1% 10% 69% How well does a University Hospital do in managing warfarin therapy? “Inpatient Warfarin Medication Utilization Evaluation” Treatment decisions involving inappropriate assessment of response • 349 records reviewed and assessed by established criteria • 647/2030 (31.8%) warfarin treatment decisions were deemed inappropriate Total = 647 decisions Initial dose too high (52 decisions) Initial dose too low (9 decisions) Different dose from home therapy (63 decisions) Continued home dose but should have been changed (6 decisions) Continued home dose but should have been held (4 decisions) Held dose when therapy shouldhave been restarted (66 decisions) PK/PD not taken into account (447 decisions)

6. Is the correct starting dose used? “Inpatient Warfarin Medication Utilization Evaluation” 35.3% (123/349) patients were initiated on warfarin in-house for the first time New starts (n=123) 42% Dose too high Dose ok 51% Dose too low 7%

7. New starts for VTE indication (n=47) What is the impact on outcomes? “Inpatient Warfarin Medication Utilization Evaluation”

8. Models of Chronic Anticoagulation Management • Routine Medical Care (Usual Care) AC managed by physician or office staff w/o any systematic program for education, follow-up, communication, and dose management. May use POC device or laboratory INR • Anticoagulation Clinic (ACC) AC managed by dedicated personnel (MD, RN or pharmacist) with systematic policies in place to manage and dose patients. May use POC device or laboratory INR • Patient Self-Testing (PST) Patient uses POC monitor to measure INR at home. Dose managed by UC or ACC • Patient Self-Management (PSM) Patient uses POC monitor to measure INR at home and manages own AC dose

9. Challenges With ConventionalLaboratory Testing • Patient issues • Time for traveling to office or laboratory • Ability to travel • Need for venous access • Labor-intensive and higher costs • Scheduling visits • Proper handling and delivery of sample • Documentation at several time points • Potential for communication delays • Laboratory to contact provider with results • Provider to contact patient with dosage adjustments Jacobson AK. In: Ansell JE, Oertel LB, Wittkowsky AK, eds. Managing Oral Anticoagulation Therapy. 2nd ed. St. Louis, Mo: Facts and Comparisons; 2003;45:1-6.

10. Technology Advances:Offers a new paradigm for monitoring since 1987 • Use of capillary whole blood1,2 • Allows fingerstick sampling2 • Appropriate for self-testing1 • Consistency of INR results1 • Portability1 • Can be done anywhere • Simplicity1 • Patient can easily perform test 1. Leaning KE, Ansell JE. J Thromb Thrombolysis. 1996;3:377-383. 2. Ansell JE. In: Ansell JE, Oertel LB, Wittkowsky AK, eds. Managing Oral Anticoagulation Therapy. 2nd ed. St. Louis, Mo: Facts and Comparisons; 2003;44:1-6.

12. What are the outcomes with Home Monitoring?

13. Thromboembolism with PST or PSM vs Control psm What is the control group pst Heneghan et al. Lancet 2006;367:404

14. Thromboembolism with PST or PSM PSM Usual Care PST AMS Heneghan et al. Lancet 2006;367:404

15. Major Hemorrhage with PST and PSM vs Control Heneghan et al. Lancet 2006;367:404

17. Improving AC Outcomes at the Time of Discharge 128 patients randomized to home POC monitoring (n= 60) or UC (n=68) after discharge. POC testing on d 2,4,6,8 vs UC on d 8 Adverse events up to day 90 Jackson et al. J Intern Med 2004:256:137

18. Who is able to perform Home Monitoring?

19. Considerations for Patient Selection Willing to: Learn and perform testing procedure Keep accurate written records Communicate results in timely fashion Able to: Participate in a training program to acquire skills/competencies to perform self-testing Generate an INR Understand implications of test result Maintain records Reliable to: Perform procedure with acceptable technique to obtain accurate results

20. The THINRS Trial: Design = ACC • Purpose: Compare HQACM with PST to HQACM alone on major health outcomes • Patient population: Atrial fibrillation or mechanical heart valve • Participating Centers 28 VA Med Ctrs with ACC of > 100 patients • Two parts: Part 1: Training and home testing for 2-4 weeks Part 2: Competency assessment and, if capable, randomization to HQACM every 4 weeks or PST every week Matchar. Amer J Med 2002;113:42-51

21. The THINRS Trial: Design A key attribute of this trial is that “everyone” was trained for PST and those who were deemed capable, then randomized to either PST or ACC management Matchar. Amer J Med 2002;113:42-51

22. The THINRS Trial: Intervention & Outcomes Anticoag Clinic Dose management Anticoag Clinic Dose management Interventions: HQACM (monthly INR) Designated, trained staff person Local standard management algorithm PST (Weekly INR) Interactive value response reporting system with web-based local monitoring Outcomes: Primary time to first major event (stroke, major bleed, death) Secondary time in range, satisfaction, quality of life Matchar. Amer J Med 2002;113:42-51

23. The THINRS Trial: Participants 3,644 Trained 78 did not pass training 3,566 home with meter for 2-4 weeks 508 dropped out 3,058 competency assessment 136 did not pass assessment or dropout 2,922 randomized 2,922 / 3,644 = 80% Passed Competency Matchar. Amer J Med 2002;113:42-51

24. Summary from THINRS: Outcomes • 80% of screened subjects demonstrated PST competency and were randomized • approx. 4 out of 5 pass • Patients were less likely to pass PST, if • Older, h/o CVA, poor cognition, low literacy, poor manual dexterity Matchar. Amer J Med 2002;113:42-51

25. Summary from THINRS: Outcomes: Stroke, Bleed, Death PST HQDM

28. Summary from THINRS • 80% of screened subjects demonstrated PST competency and were randomized • approx. 4 out of 5 pass • Patients were less likely to pass PST, if • Older, h/o CVA, poor cognition, low literacy, poor manual dexterity • Outcomes (TTR & AEs) were improved to a small degree with PST

29. How Does Home Monitoring Achieve Good Outcomes ? • Access to testing • Frequency (convenience), timeliness • Greater Time-in-Range • Consistency of testing • Instrument & thromboplastin • Consistent Results • Awareness of test results • Knowledge, empowerment, compliance • Greater Time-in-Range

30. Managing Home Monitoring?

31. Trusting the INR Result

32. Ortho 1.00 BFA DADE 1.03 BFA Behring 1.08 BFA Pacific Hem 1.20 BFA IL Test 1.43 BFA 5.5 DADE 1.96 BFA 5 Ortho 1.00 ACL DADE 1.03 ACL 4.5 Behring 1.08 ACL Pacific Hem 1.20 ACL 4 IL Test 1.43 ACL 3.5 DADE 1.96 ACL 3 Ortho 1.00 MLA DADE 1.03 MLA 2.5 Behring 1.08 MLA Pacific Hem 1.20 MLA 2 IL Test 1.43 MLA 1.5 DADE 1.96 MLA Trusting the INR ResultThromboplastin — Reagent Combinations and observed variation in INR Courtesy A. Jacobson

33. Optimal Frequency of INR Monitoring*Test Interval vs % In Range % in Range More Frequent testing increases % in range Days Between Tests Summary 18 published studies: PST Coalition Report, July 2000

34. Barriers to PST/PSM • Lack of physician awareness or acceptance1,2 • Fear it will lead to unintended self-management3 • Implementation of PST/PSM3 • Reimbursement3 1. Jacobson AK. In: Ansell JE, Oertel LB, Wittkowsky AK, eds. Managing Oral Anticoagulation Therapy. 2nd ed. St. Louis, Mo: Facts and Comparisons; 2003;45:1-6. 2. Roche Diagnostics. CoaguChek System: Why Use? Available at: http://www.coaguchek-usa.com/information_for_professionals/why_use/content.html. Accessed May 12, 2006. 3. Wittkowsky AK et al. Pharmacotherapy. 2005;25:265-269.

35. Barriers to INR Patient Self-Testing (PST): National Survey of Anticoagulation Practitioners1Cost of Device Main Barrier Survey Respondents (%) Provider Barriers to PST 1. Wittkowsky AK et al. Pharmacotherapy. 2005;25:265-269.

36. Willingness to Pay for PST is low • Few patients are willing to pay for self-testing, despite the benefits of weekly testing. • Those willing to pay for PST stated an average of $18 per month as the acceptable out-of-pocket expense for home testing with a POC device. Proprietary information

37. CMS did the right thing by approving reimbursement, but they did it the wrong way As of March 19, 2008 CMS expanded coverage to patients with VTE and chronic AF

38. Medicare National Coverage Policy for Home PT/INR Testing (as of July 2008) Medicare will cover the use of home INR monitoring for chronic, oral anticoagulation management for patients with mechanical heart valves (non-porcine), chronic atrial fibrillation, or venous thromboembolism . The monitor and the home testing must be prescribed by a treating physician and all of the following must be met: Patient anticoagulated for at least 3 months Patient must undergo face-to-face educations program and demonstrate correct use of device Patient continues to correctly use device Self-testing no more frequently than once per week More information at: http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6313.pdf

39. Oral Anticoagulation Patient Self-Testing: Consensus Guidelines for Practical Implementation. Managed Care 2008;17(#10, Suppl 9):1-9

40. What is an IDTF ? CMS defined a new entity independent of a hospital or physician’s office in which diagnostic tests are performed by licensed or certified non-physician personnel under appropriate physician supervision. This entity is called an Independent Diagnostic Testing Facility (IDTF). The IDTF may be a fixed location, a mobile entity, or an individual non-physician practitioner and in all cases must comply with the applicable laws of any state in which it operates.

41. IDTF’s… How They Work Manages INR Prof fee $9/mon Doctor Train fee $191 Rx INR Patient CMS Inst teach IDTF Tech fee $140/mon Serv + Inst INR Inst sent Inst order Device Manufacturer

42. Communication with patient doing home monitoring Oral Anticoagulation Patient Self-Testing: Consensus Guidelines for Practical Implementation. Managed Care 2008;17(#10, Suppl 9):1-9

43. PST dosed by internet expert system vs AMS RCT (cross-over) of 162 patients, followed for 6 months; mean age 59 yr (16-91), 80% male with diverse indications. Daily time to manage 80 patients 10-45 min (mean 23.2 min) Ryan et al. J Thromb Haemost 2009;7:1284

44. Conclusions . . . Anticoagulants (oral and parenteral) top the list for adverse events. Management of warfarin therapy is often poor, even in the best of circumstances. The transition from inpatient to outpatient anticoagulation is a critical transition that requires labor intensive systems and processes for successful implementation. POC INR technology can play an important role in facilitating such care. Anticoagulation management models include Routine or Usual Care, Anticoagulation Clinics, and PST/PSM (home monitoring) Point-of-care (POC) provides an alternative to laboratory testing that is easy, portable, and accurate and allows for testing either by physician or patient POC home monitoring can be done either with physician management or patient self-management Home monitoring requires systems in place to implement and manage results. IDTFs can perform much of the implementation and follow up tracking of results