Rheumatoid Arthritis and Treat-to-Target

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Rheumatoid Arthritis and Treat-to-Target A Case of Need Encountering Opportunity Need RA affects approximately 1.5 million adults in the United States 1 20%-30% face permanent work disability if not treated within 2-3 years of RA diagnosis 2 ~40% have moderate to high disease activity 3 Opportunity Similarities exist between diseases managed with T2T strategies and RA 4 Chronic conditions Room for tighter control Measurable outcomes Challenges to applying T2T strategies in RA persist including limited measurement of functional status and disease activity 4,5 RA=rheumatoid arthritis; T2T=treat-to-target.

T2T Emerged as a Management Strategy for Chronic Conditions 4 T2T A Three-Dimensional Foundation Shared Decision Making Between Patient and Healthcare Professional 5,6 Specific targets Medication regimen Risk-benefit conversation Commitment to monitoring Patient education Specific, Sequentially Measured Goals a Diabetes: HbA1c test scores HbA1c 7% 7 Hypertension: systolic and diastolic 8,9 Systolic blood pressure <140 Diastolic blood pressure <90 Ongoing Reassessment and Adaptation of Treatment Follow-up physician appointments Evaluate treatment options In 1 study from the DREAM registry, treating to target in early RA was found to be cost effective compared with usual care 10 a Treatment targets are for illustrative purposes only; in clinical practice they are based on individual patients and their associated risk factors and comorbidities. DREAM=Dutch Rheumatoid Arthritis Monitoring; HbA1c=glycated hemoglobin. 2

Three Reasons to Consider the Implementation of T2T in RA Aggressive Treatment Is Possible 6 Many treatment options are available to manage RA RA treatment has feasible, achievable, and measurable goals, including remission, low disease activity, and improved quality of life Aggressive Treatment Produces Results 11 Intensive management of RA is associated with improvements in disease activity, radiographic disease progression, and physical function Early initiation of DMARD therapy has been shown to be associated with reduced joint damage and improved physical function ACR-Endorsed Tools to Measure Disease Activity, Including RAPID3, Are Available 12 RAPID3 is easily used in clinical practice Quick: can be completed in 3-5 minutes and scored in 5-10 seconds 12,13 Reliable: correlates with DAS28 and CDAI in clinical trials and clinical practice 13,a Valid: can be used to classify RA disease activity 12 Accessible: can be completed and scored by patients 13 a Correlation coefficients for DAS28 and CDAI are 0.658 and 0.742, respectively. DAS28 and CDAI are 2 other disease activity measures endorsed by ACR and used in clinical practice. 12,13 Reproduced with permission of NYU Hospital for Joint Diseases via Copyright Clearance Center 15 RAPID3, a patient assessment of functional status, pain, and overall well being, captures 2 of 6 RA quality measures included in the PQRS 13,14 ACR=American College of Rheumatology; DMARD=disease-modifying antirheumatic drug; ; PQRS=Physician Quality Reporting System. RAPID3=Routine Assessment of Patient Index Data 3. It is derived from 3 questions on the Multidimensional Health Assessment Questionnaire. 13 3

Measuring Disease Activity in RA May Benefit Multiple Stakeholders Patients 6,16 Improved communication with healthcare professionals Robust stream of disease information designed to engage patients, caregivers, and family members Healthcare Professionals Access to quantitative data that enables ongoing assessment of progress and potential need for treatment modifications 15 Medical Directors of Public and Private Payers, Specialty Pharmacies, Group Practices, Independent Practice Associations, and Accountable Care Organizations Ability to use a database of longitudinal disease activity scores to assess care quality and affect population health management modifications 15 Potential rewards and/or penalties associated with performance 17,18 Medicare Advantage plans with a performance rating of 4 stars or better receive payments from CMS 17 Eligible healthcare professionals and group practices to receive a 0.5% incentive payment beginning in 2015 for satisfactorily reporting PQRS measures under NQS domains 18 Payment adjustments will be applied to all eligible healthcare professionals who do not satisfactorily meet the quality measures for covered professional services 18 Quality measures are now linked to provider and health plan reimbursement 17,18 CMS=Centers for Medicare & Medicaid Services; NQS=National Quality Service. 4

Overarching Principles and Patient Commitment Set T2T Strategy in Motion 6,19 Principles Give Dimension to T2T in RA 6 Engage and educate the patient: set the stage for shared decisions with healthcare professionals Establish a primary target: arrive at the desired target of low disease activity or near remission Treat, assess, and adjust: after treatment, assess disease activity and adjust therapy accordingly to optimize outcomes 1. Set the Target 2. Treat Focus on inflammation: abrogate inflammation as a means of achieving treatment targets Optimum Interactions Between Healthcare Professionals and Patients May Facilitate Patient Commitment 19 Underscores the importance of understanding, accepting, and adhering to established goals 4. Adjust 3. Assess T2T in RA: A Strategy in Motion 6 Delivers T2T recommendations in a patient-friendly manner that empowers patients to participate in informed decisions about treatment Initiates patient-healthcare professional dialogue about the risks and benefits of tight control as an approach to managing RA T2T is guided by principles to achieve tighter control 5

Key Recommendations: Pfizer Support Can Help Drive RA T2T Success Potential Targets and Recommendations 6 Primary target: state of clinical remission (ie, absence of signs and symptoms of significant inflammatory disease activity) Alternative target: low disease activity Pfizer is ready to help with patient education resources, including instructions for filling out RAPID3 Drug therapy assessment: at least every 3 months and adjusted based on approach to target Regular measurement and documentation: as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3-6 months) for patients in sustained low disease activity or remission Decisions based on measurement: clinical practice guided by valid composite measures of disease activity Patient education: patient understanding of the treatment target and the strategy planned to reach it References: 1. Sacks JJ, Luo YH, Helmick CG. Prevalence of specific types of arthritis and other rheumatic conditions in the ambulatory health care system in the United States, 2001-2005. Arthritis Care Res (Hoboken). 2010;62(4):460-464. 2. Rindfleisch JA, Muller D. Diagnosis and management of rheumatoid arthritis. Am Fam Physician. 2005;72(6):1037-1047. 3. Pappas DM, Lampl K, Kremer JM, et al. Poster presented European League Against Rheumatism; 12-15 June 2013; Madrid, Spain. 4. Solomon DH, Bitton A, Katz JN, Radner H, Brown EM, Fraenkel L. Review: treat to target in rheumatoid arthritis: fact, fiction, or hypothesis? Arthritis Rheumatol. 2014;66(4):775-782. 5. Curtis JR, Sharma P, Arora T, et al. Physicians explanations for apparent gaps in the quality of rheumatology care: results from the US Medicare Physician Quality Reporting System. Arthritis Care Res (Hoboken). 2013;65(2):235-243. 6. Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631-637. 7. American Diabetes Association. Standards of medical care in diabetes-2014. Diabetes Care. 2014;37(suppl 1):S14-S80. 8. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. 9. Feldman RD, Zou GY, Vandervoort MK, Wong CJ, Nelson SA, Feagan BG. A simplified approach to the treatment of uncomplicated hypertension: a cluster randomized, controlled trial. Hypertension. 2009;53(4):646-653. 10. Vermeer M, Kievit W, Kuper HH, et al. Treating to the target of remission in early rheumatoid arthritis is cost-effective: results of the DREAM registry. BMC Musculoskelet Disord. 2013;14:350. doi:10.1186/1471-14-350. 11. Verstappen SM, Jacobs JW, van der Veen MJ, et al. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis. 2007;66(11):1443-1449. 12. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012;64(5):640-647. 13. Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008;35(11):2136-2147. 14. Centers for Medicare & Medicaid Services website. Physician Quality Reporting System. http://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/pqrs/measurescodes.html. Accessed February 3, 2015. 15. Pincus T, Skummer PT, Grisanti MT, Castrejón I, Yazici Y. MDHAQ/RAPID3 can provide a roadmap or agenda for all rheumatology visits when the entire MDHAQ is completed at all patient visits and reviewed by the doctor before the encounter. Bull NYU Hosp Jt Dis. 2012;70(3);177-186. 16. Margolius D, Bodenheimer T. Controlling hypertension requires a new primary care model. Am J Manag Care. 2010;16(9): 648-650. 17. Kaiser Family Foundation. Medicare Advantage Plan Star Ratings and Bonus Payments in 2012. http://kaiserfamilyfoundation.files.wordpress.com/2013/01/8257.pdf. Accessed February 3, 2015. 18. Centers for Medicare & Medicaid Services website. Physician Quality Reporting System. http://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/ PQRS/index.html?redirect=/PQRS. Accessed February 3, 2015. 19. de Wit MP, Smolen JS, Gossec L, van der Heijde DM. Treating rheumatoid arthritis to target: the patient version of the international recommendations. Ann Rheum Dis. 2011;70(6):891-895. 6 TRA746716-01 2015 Pfizer Inc. All rights reserved. June 2015