Disclosures. KVN serves as a consultant for the life sciences industry. MW is employed by GSK

Transcription

1 One of These Patients is Not Like The Others: Development and Application of a Tool for Health Care Decision Makers to Assess and Consider Heterogeneity in Coverage Decisions An ISPOR Workshop Jennifer S. Graff, PharmD, Director, National Pharmaceutical Council Karen Van Nuys, PhD, Senior Research Economist, Precision Health Economics Michael X. West, PhD, Senior Payer Medical Science Liaison, GlaxoSmithKline May 21, 2013 Disclosures JG is employed by the National Pharmaceutical Council, a policy research organization supported by the nation s major research-based pharmaceutical companies KVN serves as a consultant for the life sciences industry. MW is employed by GSK 1

2 Environmental contest: bridging the gap between heterogeneity research and decision-making Demonstrate a framework illustrating how and when applying average CER results to individual patients is problematic for decision-makers Interactive discussion Workshop Description Audience application of the model Considerations of heterogeneity in formulary decision-making The Average Patient is based upon the results of many Kent D. American Scientist 2007;95:

3 If it were not for the great variability among individuals, medicine might as well be a science and not an art. Sir William Osler, The Principles and Practice of Medicine 1892 Variation in Treatment Response Matters A treatment that is safe and effective for some does not mean that it is safe and effective for all BUT A treatment that is not safe and not effective for some does not mean that it is not safe and not effective for all 3

4 Our Understanding of Biology is Growing Exponentially Genome-wide Associations Reported through March 2010 Baker. Nature 2012;487:7407. Manolio TA. N Engl J Med 2010;363: Age Gender Disease severity There are Many Causes of Treatment Variability Use of concomitant medications Care setting Comorbidities Environment (e.g., diet) and then there are genetics 4

5 Methods to Analyze Heterogeneity of Treatment Effect are Advancing Increasing Recognition of the Importance Of Individual Treatment Variation AHRQ AMCP Dossier 3.1 Comparative Effectiveness of Medications to Reduce Risk of Primary Breast Cancer Remaining Issues: While the efficacy has been demonstrated it is not clear which women in clinical practice would optimally benefit from risk reduction More specifically, CER addresses patient's preferences, their healthrelated quality of life and other outcomes important to them. It also emphasizes generating evidence regarding subgroup differences, also known as treatment heterogeneity. 5

6 Less Than 1 in 3 Plans Routinely Consider Treatment Response Diversity in Medical Policy N= 47 How often do you consider heterogeneity for setting the following types of medical policy? Safeguards to Accommodate Individual Patient Differences at a Policy Level Medicare Part D Protected Classes and Criteria All or substantially all drugs Private Payer Benefit Design and Management Coverage of the medication class oral contraceptives, branded antidiabetic medications, Coverage of individual medications Specific medication, tier status and structure Utilization Management Quantity limits Step edits Prior authorization Section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 (Pub. L. No , 122 Stat. 2494, ) 6

7 Individualized Care Exists When Predictable Markers Exist 13 According to our records, you had the same illness 200 years ago in a previous life. That qualifies as a preexisting condition. Copyright permission Randy Glasbergen 7

8 Consideration of Heterogeneity in Newly Forming State Exchanges is Unknown IMPLICATIONS FOR EVIDENCE DEVELOPMENT AND COMMUNICATION 8

9 Audience Discussion Populations Individuals 9