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ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview
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ISR Reports - Comparative Effectiveness Research (CER) and Payers - Report Preview

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  • 1. US Payers: Comparative Effectiveness Research and Formulary Decision-making 115 page 30 high-level 98 graphs Data collected Quantitative report respondents and charts Dec 2011 questionnaire with 118 questions Use this report to…Maximize formulary placement and reimbursement levels.1. Develop both pre-approval and post-approval study protocols to yield data that formulary-decision makers want to use in their evaluations. • Learn which CER study types are gaining in importance and driving formulary decisions. • Learn what formulary decision-makers are skeptical of when using data from randomized controlled trials with a placebo and plan your clinical development studies to minimize their concerns.2. Prioritize your CER studies based on the therapeutic areas US payers view as being most in need of comparative effectiveness studies. • Asthma/ COPD, Arthritis/ Osteoporosis, Oncology, Diabetes, Hypertension, Mental health, and Heart diseasewww.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 2. www.ISRreports.com Industry Standard Research info@ISRreports.com IntroductionHow important is comparative effectiveness research (CER)? If you ask AstraZeneca the answer islikely to be: game-changing, over $2 billion USD worth of game-changing.In early September 2011, AZ released the findings from its SATURN trial which pitted theircholesterol-lowering product, Crestor, against Pfizer’s Lipitor in a head-to-head study with 1,300patients. The trial was designed to investigate a sub-segment of the population that AZ thoughtmight benefit more from Crestor than from Lipitor. The result showed Crestor did improve thepercent atheroma volume (PAV) greater than Lipitor, but not at a level that was statisticallysignificant. For the secondary measure, total atheroma volume (TAV), Crestor did demonstrate astatistically significant reduction compared to Lipitor. Sounds decent, not too bad, right? Not toobad unless you were an investor in AstraZeneca at the time. This study sent AZ down 3.3%. Or putanother way, AZ lost over $2B USD in market capitalization the day these results were released.It will come as a surprise to very few people that payers, managed care organizations (MCOs), areplaying more important roles in the delivery of pharmaceutical products. No longer is regulatoryapproval the only hurdle to commercial success. Regulatory approval is just the beginning; especiallyif you are bringing to market a me-too product or a product that is only marginally superior to thecurrent standard of care. Today, and likely more so in the future, the real hurdles will come frompayers in the form of where your product gets placed on their formulary. It is with this hypothesisthat ISR initiated the research that led to this report. It was developed to answer some very specificquestions around US payers and their views of comparative effectiveness research.The AZ example we highlighted previously will not be the last you hear of a pharma company’sfortunes moving with results of comparative effectiveness research. The data in this report highlightthat US payers desire more data from randomized controlled trials that utilize a comparatorproduct(s), not just a placebo. If they get their wish, it starts to put an even greater premium onpharma companies that can create truly innovative solutions/ products and get them to market first.If you are first, then you get to be the comparator. This puts you in the position of not having to win,you just can’t be beat and that is definitely a position of strength you want to be in.The following report is based on the data generated from 30 survey respondents. All respondentshave responsibility for decision-making as it pertains to formulary decision-making at theirorganization. As always, this report contains all of the data collected in our survey and all data areavailable in the Study Data section that follows the Study Findings section.www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 3. www.ISRreports.com Industry Standard Research Sample Report Pages info@ISRreports.com Formulary drivers Study types US payers are speaking loud and clear. They want more data from randomized controlled trials (RCTs) with a comparator product and less from RCTs using only a placebo. An interesting aspect of the data below is that US payers are being a bit realistic. They believe the degree of influence RCT trials with a comparator will have over formulary decisions in two years will still likely be less than they would desire. The graph below contains the responses when we asked respondents about their views about the current and future degree of influence on formulary decisions. And when we asked them, across the seven major therapeutic areas, to indicate their preferred data sources, the data becomes even more skewed in favor of RCTs using a comparator. Relative importance of study types – Summary “While we understand that each evaluation is unique, over the past 24 months when you have been making decisions in your P&T committee regarding pharmaceutical products, how much influence did data from the following sources have in your decision-making? Please ensure your responses add to 100%. Then, over the next 24 months when you will be making decisions in your P&T committee regarding pharmaceutical products, how much influence will data from the following sources have in your decision-making?” (Base = 30 respondents) Mean Health economic outcomes research Meta-analysis of data sets (usually data from randomized controlled studies) Patent-centric studies (QoL, adherence, Past 24 months functional measures, ease of use) Next 24 months Prospective observational studies (registry) Randomized controlled trials with a comparator 30% product 39% Randomized controlled trials without a comparator product, placebo-only Retrospective observational studies (database analysis, health claims) 0% 10% 20% 30% 40% 50%www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 4. www.ISRreports.com Industry Standard Research Sample Report Pages info@ISRreports.com Product types: First-in-class, Transitional, Me-too The analysis below illustrates respondents’ views on the relative importance of the different study types for the three classes of drugs. MCO formulary decision-makers place more importance on on-going post-approval registry studies measuring safety for first-in-class products than for transitional or me-too products. Along the same lines for fist-in-class products, respondents place more importance on ongoing post-approval registry studies measuring safety than they do for those measuring efficacy. Study types and drug types: the importance of safety “How important is it to your P&T committee when you are evaluating a First-in-class: Transitional or follow- on: Me-too/ marginally differentiated product that the product dossier include..?” (Base = 30 respondents) % Extremely Important 63% The registration filing contains data comparing the 73% product to a leading competitor 27% A study measuring Health Economic Outcomes/ 23% cost effectiveness 27% 13% An ongoing post-approval registry study 23% measuring safety 50% 10% Me-too A retrospective data-mining analysis measuring 17% efficacy and safety 17% Transitional 10% An ongoing post-approval registry study 17% measuring efficacy 27% 7% A formal program to promote product adherence 7% 7% 0% 20% 40% 60% 80% 100%www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 5. www.ISRreports.com Industry Standard Research Sample Report Pages info@ISRreports.com This matrix plots the relative growth rate of CER study types by the degree to which respondents indicated the importance they have in their formulary decision-making process. Studies in the upper right of the matrix will exhibit both strong growth and have a considerable influence in formulary decision in the next two years. Studies plotted include: • Placebo-controlled trials demonstrating an important or unique benefit or harm of a particular drug • Short-term head-to-head trials that use surrogate (efficacy) measures • Cohort, case-control, or before/after studies with broad applicability and comprehensive measurement of benefits/ risks • Long-term head-to-head controlled trials focusing on a subset of relevant benefits or risks • Case series and case reports • Short-term head-to-head trials focusing on tolerability and side effects • Before/after or time-series studies demonstrating an important or unique benefit or harm of a particular drug • Natural history (or conventionally treated history) studies that observe the outcomes of a cohort but do not compare the outcomes among different treatments • Patient-centric Quality of Life measures • Adherence studies • Health economics outcomes research 100% Two year out use in formulary decision-making 80% Placebo- controlled 60% 40% 20% 0% -20% 0% 20% 40% 60% Two year growth in percentage terms -20%www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 6. www.ISRreports.com Industry Standard Research info@ISRreports.com Sample charts and graphs Aggregated therapeutic area view of current and desired study type impact on P&T formulary decisions “With respect to (insert therapeutic area), when your organization is making P&T formulary decisions how much influence do the following study types have in your decision-making?” “With respect to (insert therapeutic area), when your organization is making P&T formulary decisions, what is your desired mix of data?” (Base = 30 respondents) Studies in alphabetical order100% • Health economic outcomes 7% research 10% • Meta-analysis of data sets 80% (usually data from randomized controlled studies) 60% • Patent-centric studies (QoL, adherence, functional measures, ease of use) • Prospective observational 40% studies (registry) • Randomized controlled trials with a comparator product 20% • Randomized controlled trials without a comparator product, placebo-only 0% • Retrospective observational Current influence Desired mix studies (database analysis, health claims)www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 7. www.ISRreports.com Industry Standard Research info@ISRreports.com Sample charts and graphs TAs most in need of CER “Using the following disease conditions, please select which one you believe are most in need of high quality comparative effectiveness research.” (Base = 30 respondents) Extremely needed Needed Somewhat needed Not at all needed Arthritis, osteoporosis, osteoarthritis 10% 10% 10% 10% Asthma/ COPD 10% 10% 10% 10% Diabetes (Type I and II) 10% 10% 10% 10% Data available in report (Responses appear in alphabetical order) Heart disease, including high cholesterol 10% 10% 10% 10% Hypertension 10% 10% 10% 10% Mental health, including depression, bipolar 10% 10% 10% 10% Oncology 10% 10% 10% 10% 0% 20% 40% 60% 80% 100%www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 8. www.ISRreports.com Industry Standard Research info@ISRreports.com Full Report Table of Contents Copyright and Usage Guidelines 8 Methodology 9 Introduction 10 Study Findings 12 CER Market Dynamics 13 Definition 13 “In their words” 13 Influence of CER 15 Formulary placement influence 15 Data, data, and more data 16 Use of CER study types for formulary placement 16 Issues with RCT for efficacy 18 Rating the level of concern 18 Sub-segment/ population concerns 19 Summary and recommendations 20 Formulary drivers 23 Study types 23 Relative importance of study types – Summary 23 Use of CER study types for formulary placement - comparison 25 Aggregated TA view of current and desired study type impact on P&T formulary decisions 27 Importance of health economics and outcomes research 28 Product types: First-in-class, Transitional, Me-too 29 Study types and drug types: the importance of safety 29 Therapeutic areas 30 TAs most in need of CER 30 Oncology example: Current vs. desired study mix in P&T formulary decisions 31 Summary and recommendations 32 Study Data 34 Comparative Effectiveness Research trends 35 Definition “in their words” 35 CER influence in formulary placement - current 38 CER influence in formulary placement - future 39 Use of CER study types for formulary placement - current 41 Use of CER study types for formulary placement - future 43 Use of CER study types for formulary placement - comparison 45www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 9. www.ISRreports.com Industry Standard Research info@ISRreports.com Full Report Table of Contents Study type/ data source importance 49 First-in-class products 49 Importance for P&T committee product dossier 49 Transitional or follow-on products 50 Importance for P&T committee product dossier 50 Me-too/ marginally differentiated product 51 Importance for P&T committee product dossier 51 Comparison of study types and drug types 52 P&T committee decision-making 53 Study type formulary influence 53 Relative importance of study types – Past 24 months 53 Relative importance of study types – Next 24 months 55 Relative importance of study types – Summary 57 CER and therapeutic area assessment 58 Cross-therapeutic area need assessment 58 TAs in most need of CER 58 Arthritis, osteoporosis, osteoarthritis 59 Current influence of study types on P&T formulary decisions 59 Desired mix of study types on P&T formulary decisions 61 Summary: Current vs. Desired mix of study types on P&T formulary decisions 63 Asthma/ COPD 64 Current influence of study types on P&T formulary decisions 64 Desired mix of study types on P&T formulary decisions 66 Summary: Current vs. Desired mix of study types on P&T formulary decisions 68 Oncology 69 Current influence of study types on P&T formulary decisions 69 Desired mix of study types on P&T formulary decisions 71 Summary: Current vs. Desired mix of study types on P&T formulary decisions 73 Diabetes (Type I and II) 74 Current influence of study types on P&T formulary decisions 74 Desired mix of study types on P&T formulary decisions 76 Summary: Current vs. Desired mix of study types on P&T formulary decisions 78www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 10. www.ISRreports.com Industry Standard Research info@ISRreports.com Full Report Table of Contents Heart disease, including high cholesterol 79 Current influence of study types on P&T formulary decisions 79 Desired mix of study types on P&T formulary decisions 81 Summary: Current vs. Desired mix of study types on P&T formulary decisions 83 Hypertension 84 Current influence of study types on P&T formulary decisions 84 Desired mix of study types on P&T formulary decisions 86 Summary: Current vs. Desired mix of study types on P&T formulary decisions 88 Mental health, including depression, bipolar 89 Current influence of study types on P&T formulary decisions 89 Desired mix of study types on P&T formulary decisions 91 Summary: Current vs. Desired mix of study types on P&T formulary decisions 93 Study design/ data source analysis 94 Randomized controlled trials with a comparator product 94 Randomized controlled trials without a comparator product, placebo-only 95 Prospective observational studies (registry) 96 Retrospective observational studies (database analysis, health claims) 97 Meta-analysis of data sets (usually data from randomized controlled studies) 98 Health economic outcomes research 99 Patent-centric studies (QoL, adherence, functional measures, ease of use) 100 Aggregated TA view of current and desired study type impact on P&T formulary decisions 101 Randomized controlled trial concerns 102 Issues with RCT for efficacy 102 Rating the level of concern 102 Sub-segment/ population concerns 104 Adherence investments 105 Most valuable programs 105 Selecting the best investments 105 Respondent Demographics 108 Organization type 108 Job description 109 P&T Committee involvement: Clinical assessment 110 P&T Committee involvement: Value assessment 111 Geographic location 112 Industry tenure 113www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 11. www.ISRreports.com Industry Standard Research info@ISRreports.com Respondent profile This report is based on the data generated from 30 survey respondents. All respondents have responsibility for decision-making as it pertains to formulary decisions at their organization. Average industry tenure = 18 years Respondent titles Organizations surveyed ASSOCIATE VICE PRESIDENT CLINICAL PHARMACY ADVANTAGE HEALTH SOLUTIONS CHIEF COMPLIANCE OFFICER AETNA CHIEF OF PHARMACY AMERIGROUP CHIEF PHARMACY OFFICER BCBS OF HAWAII CLINICAL PHARMACIST BLUE CARE NETWORK OF MICHIGAN DIRECTOR OF PHARMACY BLUE CROSS & BLUE SHIELD DIRECTOR OF PHARMACY CENCAL HEALTH DIRECTOR OF PHARMACY COVENTRY HEALTH CARE OF FLORIDA DIRECTOR OF PHARMACY AND DIRECTOR OF HEALTH SERVICES COVENTRY HEALTHCARE DIRECTOR OF PHARMACY HEALTH CENTERS AND CLINICAL DAKOTACARE SERVICES AFFAIRS EMI HEALTH DIRECTOR OF PHARMACY SERVICES GROUP HEALTH COOPERATIVE DIRECTOR OF PHARMACY SERVICES HEALTH NET PHARMACEUTICAL SERVICES DIRECTOR PHARMACY CLINICAL STRATEGIES HEALTHSPRING DIRECTOR, PHARMACEUTICAL SERVICES HENRY FORD HEALTH SYSTEMS DIRECTOR, PHARMACY AND MEDICARE HUMANA HEALTH CARE DIRECTOR, PHARMACY CLINICAL STRATEGIES INLAND EMPIRE HEALTH PLAN DIRECTOR, PHARMACY SERVICES KAISER MEDICAL DIRECTOR MERCYCARE HEALTH PLANS MEDICAL DIRECTOR MOLINA HEALTHCARE OF WASHINGTON PHARMACY DIRECTOR MOUNT AUBURN CAMBRIDGE PHARMACY DIRECTOR INDEPENDENT PRACTICE ASSOCIATION PHARMACY MANAGER NEIGHBORHOOD HEALTH PLAN OF RI PRESIDENT PHARMACEUTICAL OPERATIONS AND SVP PHYSICIANS HEALTH PLAN PRESIDENT, CEO PHYSICIANS PLUS REGIONAL CLINICAL PHARMACY DIRECTOR PREMERA BLUE CROSS REGIONAL DIRECTOR OF CLINICAL PHARMACY PRIORITY HEALTH (N=2) SENIOR CLINICAL PHARMACY MANAGER PROVIDENCE HEALTH PLANS SENIOR MEDICAL DIRECTOR SELECTHEALTH VICE PRESIDENT, PHARMACY SERVICES THE INITIAL GROUP VP, PHARMACY SERVICESwww.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 12. www.ISRreports.com Industry Standard Research info@ISRreports.com Respondent profile P&T Committee involvement: Clinical assessment “Please indicate your level of involvement with your organization’s P&T committee activities as it relates to the clinical assessment/ review of pharmaceutical products.” (N=30) Decision-maker, on the P&T 100% committee for clinical review Influencer, provide data and 0% analysis to the P&T committee Implementer, ensure the decisions made in the P&T 0% committee are administered correctly I have no involvement with the clinical assessment review of 0% pharmaceutical products 0% 20% 40% 60% 80% 100% Job description “Which of the following most closely matches your job description?” (N=30) Pharmacist, Pharmacy Director 80% Medical officer 13% C-suite (CEO, COO, CFO) 7% Physician 0% Health Technology Assessment 0% Health economics, Analytics,… 0% Contracts/ Finance 0% Clinical scientist/ services 0% 0% 20% 40% 60% 80% 100%www.ISRreports.com Industry Standard Research Info@ISRreports.com
  • 13. www.ISRreports.com Industry Standard Research info@ISRreports.com To Order US Payers: Comparative Effectiveness Research and formulary decision-making… VISIT the report page on our website and click “Purchase Report” CALL us at +1.919.301.0106 x 705 E-MAIL us at info@ISRreports.com Licensing Options Please e-mail us at info@ISRreports.com for licensing and pricing. About Industry Standard Research Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise. For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email info@isrreports.com, or follow us on twitter @ISRreports. Send Us Your Feedback Because we are a service organization, we enjoy receiving feedback on our work. The good, the bad, the ugly – we encourage you to let us know what you think. Please e- mail any comments, questions, or suggestions.www.ISRreports.com Industry Standard Research Info@ISRreports.com

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