THE OPPORTUNITY FOR USING PATIENT-CENTRIC, COMPARATIVE EFFECTIVENESS AND OUTCOMES RESEARCH DATA: EVOLVING APPROACHES TO VALUE DEMONSTRATION AND PRICING IN THE GLOBAL HEALTH CARE MARKETPLACE Sue Ellen J. Kline, PhD, MS Principal Health Economist, Nucleus X Market Access, a Nucleus Global Company, Hamilton, NJ USA Emily C. Freeman, MSc, PhD Senior Research Scientist, Global Patient Outcomes and Real World Evidence, Patient Focused Outcomes Center of Expertise, Eli Lilly and Company, Indianapolis, IN USA Paul Hunt, MBA, President, Pricing Solutions Ltd, Toronto, Ontario, MSA Canada ISPOR 21 st Annual International Meeting, Workshop -Session IV Wednesday, 25 th May 2016 1:45 2:45 pm, Georgetown Ballroom Washington Hilton, Washington, DC USA 1 ISPOR 21 st Annual International Meeting Workshop -Session IV Today s Workshop This interactive workshop focuses on the growing importance of patient engagement for health care value demonstration Effectively incorporating patient-centered/reported data into strategy planning is high on the Global and increasingly the US radar screen Assessing patient-centered, real-world outcomes and comparative effectiveness is a key focus for pricing and access strategies During this Workshop you will be asked to: Contribute your opinions on patient-centricity Discuss qualitative and quantitative comparative effectiveness, outcomes and pricing analytic methods 2 2 1
Today s Agenda Workshop Introduction (SE Kline) Patient Care Perspective (E Freeman) Value Demonstration and Pricing (P Hunt) 3 3 2
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The Patient-centric Evolution(1) Early 1980 s generic and disease-specific healthrelated quality of life (HRQoL), quality of life (QoL) Predominantly in clinical trials and clinical research Often administered by a clinician Other types of analyses also available Treatment satisfaction, preference Time-trade off, willingness to pay, contingent valuation and conjoint analytic methodologies 10 10 5
The Patient-centric Evolution(2) The US Affordable Care Act Patient-reported, patient-centered outcomes research 2010 US Affordable Care Act (ACA)established the Patient Centered Outcomes Research Institute (PCORI) PCORI is the largest single financial supporter of clinical comparative effectiveness research consistently incorporating patients and other stakeholders throughout the process The ACA legislation seeks to improve: Patient satisfaction with treatment and the quality of health care; The overall health of the US population; and? Affordability The Triple Aim of US Health Care Reform 11 11 PCORI Sponsored Research (1) Recently Published Example: Ying Xian, Emily C. O'Brien, Gregg C. Fonarow et al., Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research: Implementing the Patient-Driven Research Paradigm to Aid Decision Making in Stroke Care, American Heart Journal. 170(1) (July 2015): 36-45. 12 12 6
PCORI Sponsored Research (2) Recently Published Example: Herman PM, Ingram M, Rimas H, Carvajal S, Cunningham CE. Patient Preferences of a Low-Income Hispanic Population for Mental Health Services in Primary Care, Adm Policy Ment Health. 2015 Sep 26. [Epub ahead of print] PubMed PMID: 26410547. 13 13 Impact for US Stakeholders (1) Continually evolving roles, relationships and experiences for patients, health care providers, payers Treatment satisfaction survey after office visit Multi-specialty, multi-level provider relationships Consolidation Do more with less while delivering high-quality care driving better outcomes 14 14 7
Radnor Family Practice - Patient Experience Survey 15 15 Impact for US Stakeholders (2) For health care providers, payers, manufacturers Moving from a volume based to a value based and patient-centric care system Providers incentivized to practice accountable care Payers focus on paying for better economic, clinical and humanistic outcomes Manufacturers increasingly challenged to demonstrate value Value demonstration needs to be? Comparative versus viable alternative treatment strategies 16 16 8
Today s Agenda Workshop Introduction (SE Kline) Patient Care Perspective (E Freeman) Value Demonstration and Pricing (P Hunt) 17 17 Today s Agenda Workshop Introduction (SE Kline) Patient Care Perspective (E Freeman) Value Demonstration and Pricing (P Hunt) 18 18 9
Value Demonstration for Optimal Market Access: Inseparable Price and Value Value Price 19 19 Value-Based Pricing Pricing is based on the perceived value of your products/services relative to other available treatment, therapeutic options 20 20 10
Pricing is a Key Core Competency 21 21 The patient journey can provide clues as to the economic, clinical and humanistic outcome benefits of your price/value proposition Patient journey (Help me!) Physician as gatekeeper Hospital/outpatient buyers as part of committee MCO payer as data interpreter Consider including patients as well as physicians, hospital and outpatient provider purchasers and MCO payers as part of your patient access strategies As you finalize your strategies, evaluate your price/value conclusions with KOLs and with interviews amongst knowledgeable respondents 22 22 11
Possible to test the strength of physicians gatekeeper role at different price points 40% Physician Forecast DRUG X Use Without Considering Costs Physician Forecast DRUG X Use at TEST PRICE POINT 38% 40% 22% 28% 10% 12% 10% 1st Line 2nd Line 3rd Line Not Used 1st Line 2nd Line 3rd Line Not Used Some physicians are more price sensitive than others Some physicians are very active and knowledgeable about healthcare prices (e.g. Dr. Peter Bach, DrugAbacus) 23 Those who think a new therapy/device has high clinical value are likely to be less price sensitive ISPOR 21 21 23 st st Annual International Meeting Value in the global health care market place is about delivering observable, measureable clinical and patient-centric benefits Customer Benefits Use Case Customer(s) 1 BLINDED type of clinical outcome with particular patient type, in treatment pathway Payer X X X X BLINDED type of clinical outcome with 2 Payer X X X X X X particular patient type, in treatment pathway 3 BLINDED type of clinical outcome with Payer X X X particular patient type, in treatment pathway BLINDED type of clinical outcome with 4 Payer X X X particular patient type, in treatment pathway 5 BLINDED type of clinical outcome with Payer X X particular patient type, in treatment pathway BLINDED type of clinical outcome with 6 Hospital X particular patient type, in treatment pathway 7 BLINDED type of clinical outcome with Payer, particular patient type, in treatment pathway Hospital BLINDED type of clinical outcome with 8 Payer X X X X X particular patient type, in treatment pathway X X Value can be assessed in different areas of Healthcare Drugs e.g. home administration Devices e.g. monitoring Information e.g. enabling fee-for-value 24 24 12
The financial value of specific healthcare information use cases is created by: 1. Increasing customers revenues 2. Decreasing customers expenses 3. Reducing customers capital requirements What financial value does a specific healthcare information use case deliver? How does this differ for payers vs. providers? 25 25 Fee-for-Value and paying for beneficial patient outcomes New drugs tend to have limited outcomes data at launch Efficacy data is very often on a clinical proxy rather than an observable clinical end-point e.g. PCSK9s for cholesterol lowering vs. cardiovascular events Fee-for-value approaches can be possible with suitable, robust data infrastructure Source: Wall Street Journal, May 11, 2016. 26 26 13
The Good, The Bad and The Ugly Not all methodologies should be treated equal in the global health care industry. In pricing research especially, methodologies can be Good some of the time, others, Bad at times, and some are Ugly all the time: Methods of Conducting Pricing Research Data Collection THE GOOD THE BAD THE UGLY Discrete Choice/Tradeoff Analysis Multivariate Regression Analysis (US) In-Market Tests Price Value Measurement Monadic Testing Defection Analysis (Won/Lost Analysis) Financial Value Measurement Van Westendorp (Price Sensitivity Meter) Price Laddering Full Profile Conjoint Analysis (rating & sorting) x Direct Questioning x Brand Price Tradeoff Analysis (BPTO) 27 27 The Value Demonstration Fairness Effect Health care purchasers are more sensitive to price when it is outside the range that they perceive as fair or reasonable All health care stakeholders must work together to ensure patient access 28 28 14
The Value Demonstration and Pricing Excellence Journey Evidence based value demonstration and pricing in the global health care market place is a process These processes are universal across diverse industries Increasingly, in addition to clinical trial data, key value demonstration variables include real-world, evidence based patient-centric comparative effectiveness data 29 29 Thank you for your participation today! The future ain t what it used to be Lawerence Yogi Berra (1925-2015) 30 30 15
Backup Slides 31 31 An Example: Humanistic Outcomes in Wound Care - Methods An English language only literature search of papers published between 1960 2012 was conducted (presented in March 2002 and updated May 2016) using a Boolean search strategy as follows: Venous ulcer, pressure ulcer, wound care and quality of life The literature was reviewed for manuscripts that included the assessment of patient-reported generic and diseasespecific humanistic outcomes Papers that simply mentioned the term quality of life and/or did not discuss QoL results in relation to wound care outcomes were excluded 32 32 16
An Example: Humanistic Outcomes in Wound Care - Results 1400 Number of Manuscripts Citing Quality of Life by Publication Year 1200 1000 800 600 400 200 0 1960-1979 1980-1990 1991-2001 2002-2012 Venous Ulcer Pressure Ulcer Wound Care 33 33 An Example: Humanistic Outcomes in Wound Care - Conclusions American Medical Directors Association presentation in 2002 updated May 2016: Most Qol assessment in patients with chronic wounds has been reported during the last ten years Little consensus for the definition of and the appropriate measurement methodologies/tools for patient-reported outcomes for chronic wounds historically existed Measurement of Qol in these patients provides another method to evaluate treatment success in addition to wound closure particularly in patients with difficult to and/or unwilling to heal wounds More patient-reported, humanistic research is needed about diseasespecific impact of chronic wounds to appropriately assess treatment options and optimize the clinical delivery of wound care solutions 34 34 17