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Overview of Health Science Overview of Health Science Policy Council ActivitiesPolicy Council Activities

May 16, 2005

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OBJECTIVESOBJECTIVES•Describe Mission and

Membership•Discuss Structure and Activities•Present Outcomes for 2005

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OBJECTIVESOBJECTIVES•Describe Mission and

Membership

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MISSIONMISSION

To advise the Society on important science, research and policy issues in pharmacoeconomics and outcomes research

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MEMBERSHIPMEMBERSHIP

• Jon Clouse• Peter Davey• Michael

Drummond• Robert Epstein• Jean Paul Gagnon*• Bryan Luce• Eva Lydick

• Joel Hay• William McGhan• Donald Patrick• Jim Smeeding• Sean Sullivan• George Torrance• Milton Weinstein• Marilyn Dix-Smith

ISPOR Scribe - Daniel Klim*Chairman

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OBJECTIVESOBJECTIVES• Describe Mission and

Membership• Discuss Structure and

Activities

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STRUCTURESTRUCTURE• Council members identify and freely discuss wide ranging

issues at bi monthly meetings (Think Tank approach)• One month after meeting, lead constructs a draft brief

following approved format• After Council discussion at next meeting second draft

constructed• Final approval by Council and referral to Board for

discussion and action• Lead turns brief into Board action plan• Two weeks before meeting new issues submitted to

Committee Scribe

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COUNCIL FORMAT FOR TWO COUNCIL FORMAT FOR TWO PAGE BRIEF ON ISSUEPAGE BRIEF ON ISSUE• TITLE• DESCRIPTION• ANALYSIS • ALTERNATIVE RESPONSES • RECOMMENDED ACTION

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BOARD FORMAT FOR BOARD FORMAT FOR APPROVED ISSUE APPROVED ISSUE

• DEFINE ISSUE • DESCRIBE SPECIFIC TASKS AND/OR PRODUCTS

OF ACTION PLAN • PRIORITIZE THE INITIATIVES’ WORK ACTIVITIES

FOR CURRENT YEAR• PROVIDE CLARITY FOR OPERATIONALIZING THE

WORK ACTIVITIES, E.G., ORGANIZATION, TIMELINES, AND SUGGESTED WORK GROUP MEMBERS

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ACTIVITIESACTIVITIES• MEET EVERY TWO MONTHS• HELD SIX MEETINGS IN 2004/2005• DISCUSS CURRENT ISSUES• SURFACE NEW ISSUES AND GAUGE REACTION• REVIEW BOARD COMMENTS AND DISCUSS ACTION

PLAN• OPTIONAL – LEAD OR OTHER COUNCIL MEMBERS

PARTICIPATE IN IMPLEMENTATION OF ISSUE ACTION PLAN

• PRODUCED SIX ISSUES FOR BOARD

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OBJECTIVESOBJECTIVES• Describe Mission and

Membership• Discuss Structure and

Activities• Present Outcomes for 2005

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POLICY ISSUESPOLICY ISSUES• BOARD APPROVED

BRIDGING THE HEALTH MEASUREMENT GAP: MISSION IMPOSSIBLE: Lead – George Torrance -

ROLE OF OUTCOMES RESEARCH IN EVIDENCE-BASED HEALTH CARE DECISION-MAKING: Lead – Bryan Luce, Founder & Senior Research Leader, the

MEDTAP Institute at UBC

CONTINUOUS QUALITY IMPROVEMENT FOR COST EFFECTIVE HEALTH CARE RESEARCH AND GLOBAL POLICY: Leads – Bill McGhan, Professor, University of the Sciences

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POLICY ISSUESPOLICY ISSUES•BOARD APPROVED

DEVELOPING STANDARDS FOR DRUG COSTS IN PHARMACOECONOMIC STUDIES:

Lead – Michael Drummond, Director, University of York, Centre for Health Economics, Heslington, York

TRANSFERABILITY OF ECONOMIC DATA: WHEN DOES A DIFFERENCE MAKE A DIFFERENCE

Lead – Michael Drummond, Director, University of York, Centre for Health Economics, Heslington, York, Jim Smeeding, President JestaRx Group

• COUNCIL DISCUSSION ACCELRATING USE OF COST EFFECTIVENESS AND OUTCOMES

DATA BY HEALTH CARE DECISION MAKERS Leads – Rob Epstein, Vice President of Medical Affairs, Medco, John

Clouse, Director, Pharmacoeconomic Evaluations, United Health Care, Jean Paul Gagnon, Director Public Policy, Sanofi-Aventis Pharmaceuticals

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NEW ISSUESNEW ISSUES• Anyone can submit issue to Science

Policy Council for development and discussion

• Members are open to ideas• Each issue will be discussed and

debated • Issue author will be recognized and

informed of issue status• Send issues to Jean Paul Gagnon at

jean.gagnon@aventis.com

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Bridging the Health Bridging the Health Measurement Gap: Mission Measurement Gap: Mission

Impossible?Impossible?

Donald Patrick, University of WashingtonEva Lydick, New Mexico

George Torrance, McMaster University, Innovus Research Inc., and Health

Utilities Inc.

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The IssueThe Issue

• There is no standard measurement of health• Different agencies use different methods

• WHO, Statistical Agencies, NICE, etc.• QALYs are not necessarily comparable

• SG, TTO, VAS • Public, Patients• EQ5D, HUI, QWB, etc.

• Should ISPOR propose a “reference case” method?

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AnalysisAnalysis• Is lack of comparability across studies a

problem?• Reference case does not preclude other

methods• How broadly to define the problem?

• QALY• QALY, WTP• QALY, WTP, HRQOL, PRO

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Tentative RecommendationsTentative Recommendations• ISPOR should take this on• Organize a special

workshop(s), consensus, publish

• Maintain and update over time

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Where Does Outcomes Research Where Does Outcomes Research fit into Evidence-Based Health fit into Evidence-Based Health Care Decision-Making?Care Decision-Making?

Bryan Luce

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Selected Organizations Selected Organizations Using EBMUsing EBM

• BCBS’s Technology Evaluation Center

• US Preventive Services Task Force • Clinical Practice Guidelines• CMS Medicare Coverage Advisory

Committee (MCAC)• AHRQ’s Evidence-Based Practice

Centers

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Organizations Using EBM Organizations Using EBM (Cont.)(Cont.)

• UK’s National Institute for Clinical Excellence (NICE)

• AMCP’s Format for Formulary Submission • Multiple MCOs

• OHSU Drug Effectiveness Review Project • 13 Medicaid Agencies • Consumers’ Union BestBuyDrugs website• AARP’s ResearchRx website

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Organizations Using EBM Organizations Using EBM (Cont.)(Cont.)

• CMS’s MMA: Comparative Effectiveness

• CMS Interim Coverage: PCT/Registries

• Institute of Medicine: EBM/Comparative Effectiveness Private-Public Initiative

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EBG in Practice: Three EBG in Practice: Three GroupsGroups

• The “efficacy” group

• The “effectiveness” group

• The “cost-effectiveness” group

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The EBG “Efficacy” The EBG “Efficacy” GroupGroup

• Mantra is “minimize bias”• Opt for maximizing internal validity of

studies at expense of generalizability• Examples of organizations:

• Cochrane Collaboration• OHSU’s Drug Effectiveness Review

Project Medicaid agencies (?), Consumers Union, AARP

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The EBG “Effectiveness” The EBG “Effectiveness” GroupGroup

• Mantra: “Is it effective in the real world?”• Opt for generalizability to populations and clinical

settings of interest (incl non-experimental evidence)• Examples of organizations:

• CMS (MCAC, MMA, PCT/Registry Interim Coverage Policy)

• AHRQ’s EPCs• BCBS TEC• Clinical Practice Guidelines• IOM’s Effectiveness Initiative

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The EBG Cost-The EBG Cost-Effectiveness GroupEffectiveness Group

• Mantra is “real world effectiveness and real world value for money”• Opt for generalizability often over

long haul and accuracy over precision• Examples of organizations:

• Academy of Managed Care Pharmacy• U.K.’s National Institute for Clinical

Excellence (NICE)• AHRQ’s EPCs

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• Specific Tasks: • 1. Recruit a senior advisory panel to

consist of both traditional clinical EBM experts (e.g. Cochrane participants) and HEOR researchers to recommend the objective to be achieved, to help define the problem and approach and to oversee the work plan and work products

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2. Review, describe and report on existing EBM applications by key organizations in US and the rest of the westernized world

3. Review and report on the EBM methods literature including how various parties define the of the words “evidence-based medicine”, “best evidence”, “systematic review” with the intention of defining these words for different contexts.

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4. Develop a consensus for the definitions of words and phrases above

5. Review and report on methods for combining disparate sets of evidence that include RCT evidence and outcomes evidence

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6. Convene a 2 day workshop of key opinion leaders who have different concepts of the EBM application and charge the group with engaging the issues and developing a consensus concerning the role that HEOR (including observational data, modeling, patient-reported outcomes, including patient preference) should play in different applications of EBM and the methodological and reporting solutions.

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Presenter:

William McGhan, PharmD, PhDUniversity of the Sciences

Philadelphia, Pennsylvania USA

ISPOR Health Science Policy Council

Continuous Quality Improvement for Continuous Quality Improvement for Cost-Effective Cost-Effective

HealthCare Research HealthCare Research and Global Policyand Global Policy

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• While most ISPOR members and practitioners are able to follow major economic indicators and the release of major economic papers, it has been suggested that a process be developed whereby ISPOR would systematically report on trends in the overall quality of cost-effectiveness studies and global policy.

Issue DescriptionIssue Description

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Issue Description (cont’d)Issue Description (cont’d)

• Recommendations and reports from ISPOR would be intended to advance international health care efficiency and quality and become a mainstay of our global effort to improve the economic and quality-of-life research and practice in various health care sectors.

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Analyzing the OptionsAnalyzing the Options• Reports should be continually fostered inside and

outside ISPOR that quantify the adequacy in the quality of publications and regional CEA analyses.

• ISPOR needs to monitor what qualitative, quantitative and statistical methods require modification, improvement or further development.

• It is important to monitor the quality of CEA guidelines being used by various journals, organizations and nations for analyzing new therapies and allocation of resources.

• Educational materials and forums need to be provided to improve CEA quality.

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Options for ActionOptions for Action• Commission a white paper on the state of CEA science & policy.• Generate report card system on the overall state of CEA science and

practice. • Issue periodic assessment reports on the overall quality of papers,

abstracts, journal guidelines, government guidelines. • Examine ISPOR awards program to assure that excellent reports and

research advances are recognized and encouraged (ranging from researchers, policy makers, to clinical practitioners?).

• Organize a special workshop on the topic bringing together representatives of the various stakeholders (e.g., Statistical Agencies, technology assessors, health economists, clinical researchers, health policy researchers, payers and regulators). Publish the results.

• Organize a special session on the topic at an upcoming ISPOR annual meeting.

• In relationship to improving economic modeling and transparency, it has been suggested that ISPOR become an online repository for published and “reference case” CEA models and perhaps databases for which print journals have inadequate space.

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A List of ISPOR Initiatives:A List of ISPOR Initiatives:How Well Are These Linked to Overall How Well Are These Linked to Overall Continuous Improvement?Continuous Improvement?

• Research Practices • · ISPOR Research Initiatives • - ISPOR Health Science

Initiatives • - ISPOR Quality of Life

Initiatives • - Pharmacoeconomic Guidelines • • · ISPOR Good Research Practices • - ISPOR Code of Ethics • - Modeling Studies • - Retrospective Database

Studies • - CEA with Clinical Trials • - Real World Data Task Force • - Budget Impact Analysis Task

Force

• Research & Communication Issues

• · General Pharmacoeconomics Research and Use Issues

• · Quality of Life Regulatory Issues

• · Health Science Research Use Issues/General

• · Use of Research in Decision Making

• · ISPOR Communications Task Force

• · ISPOR Abstract Quality Assurance Task Force

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65%

23%

43%

83%

89%

57%

65%

30%

50%

80%

93%

64%

84%**

46%**

68%**

73%**

52%**

74%**

69%**

82%**

82%**

73%**

0% 20% 40% 60% 80% 100%

Disclosed funding source

Presented study perspective

Societal perspective

Discounted both costs and QALYs

Identified modeling software

Calculated net costs

Stated year of currency

Reported incremental ratios

Performed sensitivity analyses

Compared to results of relatedCEAs

Discussed limitations

1976-1997 1998-2001

N = 305 N = 228* p<0.1 ** p<0.05

Source: P. Neumann, N..V. Olchanski; A.B. Rosen; D. Greenberg; R. Chapman; P.W. Stone; J. Nadai. ARE PUBLISHED COST-UTILITY ANALYSES IMPROVING? (Poster) ISPOR: Arlington, VA, May 18-21, 2003.

Changes in CEA Report Quality Over Time

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METHODS INDICATORS

0

100

200

300

400

1998 1999 2000 2001 2002 2003 2004

Ab

str

ac

ts

Markov

Bootstrap

Sensitivity

Bayes

ConfidenceIntervals

Discounting

METHODS INDICATORS

0

100

200

300

400

1998 1999 2000 2001 2002 2003 2004

Ab

str

ac

ts

Markov

Bootstrap

Sensitivity

Bayes

ConfidenceIntervals

Discounting

CONTENT ANALYSIS ISPOR ABSTRACTSCONTENT ANALYSIS ISPOR ABSTRACTSCONTENT ANALYSIS ISPOR ABSTRACTSCONTENT ANALYSIS ISPOR ABSTRACTS

Source: 1. Smith MD and McGhan WF. ISPOR 10th International Meeting(Poster) Washington, DC. May 15-18, 2005. 2. www.ispor.org/research_study_digest/index.asp (N=4605 abstracts)

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CONTINUOUS QUALITY IMPROVEMENT

Guidelines

Design

InterventionMeasurement

Analysis

Feedback

EconomicsPRO/QOLOutcomes

Guideline

InterventionMeasure

Analysis

Feedback

Design

CEA / CUAPRO / QOLOutcomes

McGhan WF and Briesacher B. Implementing Pharmacoeconomic Outcomes Management. PharmacoEconomics. Vol 6 (5): 412-416.

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REFERENCESREFERENCESReed SD et al. Conducting economic evaluations alongside multinational

clinical trials: Toward a research consensus. American Heart Journal. March 2005;149:434-43.

Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM. The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997. Annals of Internal Medicine. 2000; 132(12):964-72.

Neumann PJ, Greenberg D, Olchanski NV, Stone PW, Rosen AB. Growth and quality of the cost-utility literature, 1976-2001. Value in Health. 2005;8(1):3-9.

Rosen AB, Greenberg D, Stone PW, Olchanski NV, Neumann PJ. Quality of Abstracts of Papers Reporting Original Cost-Effectiveness Analyses. Medical Decision Making. In press.

Neumann PJ, Greenberg D, Olchanski NV, Stone PW, Rosen AB. Growth and quality of the cost-utility literature, 1976-2001. Value in Health. 2005;8(1):3-9.

Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM. The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997. Annals of Internal Medicine. 2000; 132(12):964-72.

Rosen AB, Greenberg D, Olchanski NV, Chapman RH, Neumann PJ. Reporting of Key Data in Abstracts of Cost-Utility Analyses. Abstract SMDM, Chicago, IL, October 19-22, 2003.

McGhan WF and Briesacher B. Implementing Pharmacoeconomic Outcomes Management. PharmacoEconomics. Vol 6 (5): 412-416, 1994.

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TRANSFERABILITY OF TRANSFERABILITY OF

ECONOMIC DATA:ECONOMIC DATA:

WHEN DOES A DIFFERENCEWHEN DOES A DIFFERENCE

MAKE A DIFFERENCE?MAKE A DIFFERENCE?

Michael Drummond Centre for Health

Economics University of York

United Kingdom

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OUTLINE OF THE ISSUESOUTLINE OF THE ISSUES• Several factors, varying from location to

location, are thought to limit the transferability (generalisability) of economic data.

• These factors include differences in relative prices, practice patterns, availability of healthcare resources, community values for health states.

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OUTLINE OF THE ISSUESOUTLINE OF THE ISSUES(Continued)(Continued)

• Existing guidelines for economic evaluation (formal and voluntary) take differing positions on the relevance and admissibility of data from outside the country of interest.

• Too much flexibility could lead to misleading cost-effectiveness estimates; too much restriction could lead to unnecessary duplication of research.

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OUTLINE OF THE ISSUESOUTLINE OF THE ISSUES(Continued)(Continued)• A recent review of economic evaluations of

drugs conducted in Western Europe has shown that: there are variations in cost-effectiveness

from country to country; the differences are not systematic; they depend on the methods employed by

the analyst; the implications of these variations for

decision-making are not clear.

Barbieri et al. Value in Health 2005; 8(1): 10-23.

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ISPOR’s PLANSISPOR’s PLANS• To tackle the following issues:

Which elements of economic data vary most from setting to setting?

Given the known variability, what would be reasonable guidelines for accepting (or not accepting) data from outside the country of interest?

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ISPOR’s PLANS ISPOR’s PLANS (Continued)(Continued)

• Review existing national guidelines to extract more detail on transferability recommendations.

• Analyse the studies in the Barbieri et al review in more detail, to identify more precisely the variation (from place to place) in the key parameters.

• Organise an issues panel at a future meeting, involving researchers and decision-makers, to discuss these findings.

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DEVELOPING STANDARDS DEVELOPING STANDARDS

FOR DRUG COSTS IN FOR DRUG COSTS IN

PHARMACOECONOMIC PHARMACOECONOMIC

STUDIESSTUDIES

Michael Drummond University of York

Jim Smeeding University of Texas &

JestaRx Group

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OUTLINE OF THE ISSUESOUTLINE OF THE ISSUES• Drug costs (of the study drug and

comparator) are major cost drivers in pharmacoeconomic studies.

• The cost of the drug regimen involves not only the price but also the impact of wholesale discounts, pharmacy on-costs and assumptions about wastage.

• In the USA, the Center for Medicare and Medicaid Services (CMS) is proposing to base reimbursement on Average Sales Price (ASP).

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OUTLINE OF THE ISSUES OUTLINE OF THE ISSUES (Continued)(Continued)• Until recently most cost studies in the USA

have quoted Average Wholesale Price. ASP factors in discounts and rebates.

• In addition, there is a growing theoretical literature, often linked to discussions about patent protection, that suggests that the market prices for drugs are not good approximations to the social opportunity costs.

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JANUARY 1, 2005 – ASP PLUS 6%JANUARY 1, 2005 – ASP PLUS 6%

• Policy: - Average Sales Price plus 6% (ASP plus

6%) shall apply to payment(s) for drugs and biologicals (under Medicare Part B – HCPCS) that are furnished on or after January 1, 2005. No Grace Period

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ASP METHODOLOGY:ASP METHODOLOGY:PHARMACEUTICAL SALES DATAPHARMACEUTICAL SALES DATA

Calculated Quarterly (calendar):3rd Quarter 2004 ASP for January 1, 2005

implementation;4th Quarter 2004 ASP for April 1, 2005 Implementation.

Average Sales Price for each NDC, along with the number of units sold (Weighted Average).

Average Sales Price shall include: volume discounts, prompt pay discounts, cash discounts, charge backs, and rebates to the first point of sale.

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PROS & CONSPROS & CONSPros:• Market driven (not set by manufacturer or other

source).• Factors in discounts, rebates.

Cons:• Very difficult to establish an ASP which is fair to all

providers.• Very difficult to maintain – contracts are continually

changing with status of product.• Variation from quarter to quarter.• Difficult to capture all discounts (early payment, etc).• ASP data – One Quarter Lag at beginning of New

Quarter.

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ISPOR’s PLANSISPOR’s PLANS• To establish a Task Force or Working Group

to develop standards for drug costs in pharmacoeconomic studies.

• To review current practice for estimating drug costs in pharmacoeconomic studies undertaken in major markets.

• To review the conceptual and methodologic literature on drug prices, patent protection and social opportunity costs.

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ACCELRATING USE OF COST ACCELRATING USE OF COST EFFECTIVENESS AND OUTCOMES EFFECTIVENESS AND OUTCOMES DATA BY HEALTH CARE DECISION DATA BY HEALTH CARE DECISION

MAKERSMAKERS

Rob Epstein, Vice President of Medical Affairs,Medco

John Clouse, Director, Pharmacoeconomic b, United Health Care

Jean Paul Gagnon, Director Public Policy, Sanofi-Aventis Pharmaceuticals

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ISSUE DESCRIPTIONISSUE DESCRIPTION• Health care decision makers not

incorporating CEA in decision-making• Inferior translation process, few decision

makers understand how to use CEA information

• Decision makers not getting information, e.g., don’t read “Value in Health”

• ISPOR not demonstrating value to decision makers

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REDEFINING COMPETITION IN REDEFINING COMPETITION IN US HEALTH CARE*US HEALTH CARE*•Healthcare competition today works on the

wrong level, players engage in zero-sum competition (dividing value rather than creating it)

•Players transfer costs onto one another, limit access to care, hoard information and stifle innovation

•Competition should occur at the level of preventing, identifying and treating patients’ conditions and disease

*Porter M, Olmsted Weisberg, E., June 2004

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FIXING HEALTH CARE COMPETITION*FIXING HEALTH CARE COMPETITION*• Increase transparency in pricing to reduce

cost shifting, discrimination and other inefficiencies

• Improving quality often substantially reduces costs

•Use information to support value-based competition

•Focus on value for patients, not just cost

*Porter M, Olmsted Weisberg, E., June 2004

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PORTER SUGGESTS THREE WAYS TO PORTER SUGGESTS THREE WAYS TO DEMONSTRATE VALUEDEMONSTRATE VALUE

•“Compete on it”, e.g., plug into, become part of decision making systems used by decision makers, i.e., work with PDPs, MAs, physicians, pharmacists, patients and others

• ISPOR should proactively design decision making system that includes all stakeholders and demonstrates value

• ISPOR should direct its promotional activities at insuring patients correctly use products and services

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ANALYSISANALYSIS

• Movement to accelerate availability of CEA, e.g., FMCP FORMAT program for collecting PE data

• However, no movement to translate data or show decision makers how to contrast and compare drugs or devices

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ALTERNATIVE RESPONSESALTERNATIVE RESPONSES• Develop training courses or Internet modules

that show decision makers using cases how to translate CEA data and together with other variables make decisions

• Develop model procedure with steps decision makers can follow to synthesize, understand and use CEA and outcomes data to select drugs and devices

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ALTERNATIVE RESPONSESALTERNATIVE RESPONSES

• Start process by using focus groups of stakeholders to: Describe and discuss how they arrive at

formulary or drug product decisions Suggest programs and tools needed to

effectively use CEA and other variables to make decisions

Use later as advisory panel to provide feedback on prototype translating tools and procedures

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RECOMMENDATIONSRECOMMENDATIONS• Build a solid set of procedures and tools that equip decision

makers with the skills to use CEA and other variables to make decisions

• Use focus group to build and then evaluate the prototype procedures, tools and educational program for using CEA with other variables to make decisions

• Offer tested program of procedures and tools to decision makers• Once launched develop newsletter for users of ISPOR’s decision

making procedure and tools program that shares tips for better decision making

• Work with AARP and CU to implement patient based procedures and tools for using CEA and other data to make decisions

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SummarySummary•Described Mission and

Membership•Discussed Structure and

Activities•Presented Outcomes for 2005

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REACTION & REACTION & DISCUSSIONDISCUSSION

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Contact InformationContact Information

Jean Paul GagnonJean Paul Gagnonjean.gagnon@aventis.com 800-648-9499 Ext 6379 jean.gagnon@aventis.com 800-648-9499 Ext 6379

sanofi-aventissanofi-aventis

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