The Official News & Technical Journal Of The International Society For Pharmacoeconomics And Outcomes Research
ISPOR CORNER


Boards of Directors Take Action in 2006

Marilyn Dix Smith PhD, ISPOR Executive Director

ISPOR 2005-2006 Board of Directors (January 1-June 30, 2006): Peter J. Neumann, ScD, Tufts University School of Medicine; Past- President - Lieven Annemans, PhD, HEDM, Ghent University, HEDM and IMS Health; President-elect - Michael Drummond, PhD, University of York; Directors - Joyce Cramer, Yale University School of Medicine; Scott Ramsey, MD, PhD, Fred Hutchinson Cancer Research Center; Laurie Burke, MPH, RPh, FDA; Jens Grueger, PhD, Novartis Pharmaceuticals AG; Isao Kamae, MD, DrPH, Kobe University; Treasurer- Lorne Basskin, PharmD, Healthsouth Sunrise Rehabilitation Hospital; Executive Director - Marilyn Dix Smith, RPh, PhD, ISPOR. ISPOR 2006-2007
Board of Directors (June 1-December 31, 2006): Michael Drummond, PhD, University of York; Past- President - Peter J. Neumann, ScD, Tufts University School of Medicine; President-elect - Diana Brixner PhD, University of Utah, College of Pharmacy; Directors - Joyce Cramer, Yale University School of Medicine; Scott Ramsey, MD, PhD, Fred Hutchinson Cancer Research Center; Shu Chuen Li PhD, National University of Singapore, Department of Pharmacy Science; Uwe Siebert MD, ScD, University of Health Sciences, Medical Informatics & Technology; Marc Berger MD, Outcomes Research & Management, Merck & Company, Inc.; Treasurer- Lorne Basskin, PharmD, Healthsouth Sunrise Rehabilitation Hospital; Executive Director - Marilyn Dix Smith, RPh, PhD, ISPOR.

The ISPOR 2005-2006 and 2006-2007 Boards of Directors had yet another busy year in 2006. The Boards met six times (4 teleconferences and 2 face-to-face meetings). The Board approved the following:

ISPOR Vision 2010 Implementation Board Actions:
Five key areas were identified by the ISPOR Vision 2010 Implementation Task Force as presented by the ISPOR Vision 2010 Committee: Promote Education, International Growth, Foster Research Excellence, Reach Out to Decision Makers, Foster Medical Device, Diagnostics, and Biotechnology. The following are the Board actions for each key area.

• Foster Research Excellence Goal: “...the Society will have enhanced its reputation by fostering and recognizing excellence in our core disciplines, while maintaining its strength as a marketplace of ideas and opportunities for its members.” The Board approved: 1.The regular update of best research practices; 2. Review of qualifications of abstract reviewers; 3. Continue best practice training sessions at ISPOR meetings; 4. Continue to invite best methodologists and methodologists from other disciplines to present at ISPOR meetings; 5. Provide a booklet of procedures for the meeting program committee including a post-mortem teleconference to discuss strengths and weaknesses and improvements to the meeting.

• Reach Out To Decision Makers Goal: “...Society will...include individuals interested in the use of information on the costs and consequences of health care interventions as well as the processes by which health care decisions are made.” The Board approved: 1. An RFP that allows ISPOR participation or advisory groups to submit proposals for 'collaboration with health care decision makers' activities. The RFP should specify the budget requested (up $30,000 per RFP was suggested). Proposals are reviewed and approved by the Board. Results of the 'collaboration with decision makers' must be reported to the Board and/or at an ISPOR meeting after completion of the activity; 2. At each ISPOR annual meeting, one Invited Issue Panel must be designated for decision-makers to present health economic and outcomes issues important to them; 3. At each ISPOR annual meeting, a session by decision makers dedicated to decision maker issues will be presented.

• International Growth Goal: '...support the growth of regional entities (e.g. Asia, US, other regions) under an organizational structure that fosters the development and application of core disciplines, while encouraging local priorities and practices to guide practical translation and implementation' The Board approved: 1. For up to 2% of the ISPOR membership, ISPOR will waive the ISPOR membership fee for one year for individuals from economically developing countries and who meet the criteria; 2. Develop a proposal for global representation on the ISPOR Board of Directors; 3. Up to 3 International Fellowships are awarded each year with the objective to invest in key individuals who would further the activities of ISPOR in their region, with eligibility limited to individuals outside North America and the European Union who have met the selection criteria (i.e. plan on how to they will further the mission of ISPOR in their country/region). The award is complimentary registration and travel expenses to 2 consecutive ISPOR meetings. The requirements are that after the Fellowship period, the International Fellow must submit an article for publication in ISPOR CONNECTIONS outlining how he/she is furthering the mission of ISPOR in his/her country/region.

• Promote Education Goal: ...regarding “core disciplines” in which educational activities are implicitly included:...development of regional entities, ...fostering research excellence, ...focus on biotechnology, medical devices and diagnostics. The Board approved: 1. Develop a program to enable ISPOR local chapters to apply for support for ‘train the trainer’ sessions, invited lectures, or short courses. Local chapters are eligible to submit a request for educational training every other year; 2. Develop educational activities for health care decision makers and individuals from medical devices, diagnostic, and biotech organizations; 3. Encourage fostering degree and nondegree programs in pharmacoeconomics/health economics and outcomes research by increasing the number of countries represented in the ISPOR Educational Directories.

• Foster Outcomes Research For Medical Device And Diagnostics And Biotechnology Goal: “..actively recruit members focused on biotechnology products, …medical devices, and diagnostics.” The Board approved: 1. Continue with the development of the Medical Device & Diagnostics Councils and the Biotechnology Council; 2. Work with the Councils to develop a strategy for increasing ISPOR membership in these sectors; 3. Through the Councils, identify specific issues in both methodology and use of economics evaluation for coverage and reimbursement decisions for devices and biotechnology products; 4. At each ISPOR annual meeting, one Invited Issue Panel must be dedicated to medical device, diagnostic, or biotechnology issues.

Financial Actions:
• 2006 budget approved. • The Board approved that 1) not more than 25% of long-term funds should be in equity, 2) operating funds should be one year's operating expenses, and 3) $150k in the operating funds is transferred to long-term funds. • The Board approved that, with regard to prohibited investments, direct investment in companies who principle business is the manufacture or sale of pharmaceuticals, medical devices, or diagnostics is prohibited. • The current ISPOR Treasurer, Lorne Basskin, ISPOR Treasurer (2004-2007), indicated that he will not be seeking another term as Treasurer. The Board agreed that members interested in the Treasurer 2007-2010 send a letter of interest, curricula vitae, and requisite experience to the Board by January 1, 2007.

Award Actions:
• ISPOR Board of Directors Service Awardees, Avedis Donebedian Lifetime Achievement Awardee, Bernie O'Brien New Investigator Awardee, Research Excellence Awardees, Distinguished Service Awardees (Student Chapter Presidents, Committee/Task Force/Special Interest Group Chairs as well as past Committee/Task Force/Special Interest Group Chairs, who produced a tangible product such as a paper) were approved. For Awardees, see: http://www.ispor.org/awards/index_.asp and http://www.ispor.org/awards/service/distinguish.asp
• The Board approved the change in the Bernie J O'Brien New Investigator Award nominee criteria from 'no more that 5 years from their entry level, salaried position in the field of pharmacoeconomics and outcomes research (PE & OR)' to 'no more than 7 years from their first job in the field of PE & OR inclusive of any post-doctoral or other fellowships'
• A new International Fellowship Award was approved by the Board. For information about this Award, see: http://www.ispor.org/awards/IntlFellowship.asp

Value in Health Actions:
• The Board supports dedicated sections (classifications) to Value in Health (ViH) and, since ViH should reflect the interests of the membership, presentations at ISPOR meetings/congresses are a barometer of that interest. In addition, at the discretion of the co-editors, papers in areas under-represented should be encouraged.
• The Board approved the renewal of the 4-year contract between ISPOR and Josephine Mauskopf as Value in Health Editor-in-Chief, effective May 1, 2006
• With a dramatic increase in submissions to Value in Health in 2006, the Board approved Adrian Levy PhD, Martin Backhouse PhD, and Kerstin (Chris) Bingefors as Value in Health co-editors.
• For the time period September 2004-September 2006, the average time for coeditors to make their first decision on a manuscript was 206 days. The Board recommended that, with the purpose to attract top quality papers, effective January 2007, (for all new manuscripts) a goal of 100 days for co-editors' time for first decision be established and that the Editor-in-Chief identify resources or actions to accomplish this goal.

Student Actions:
• The ISPOR Student Chapters at Dalhousie University (Halifax, Canada); University of Cincinnati (Cincinnati, Ohio, USA), and Thomas Jefferson University (Philadelphia, PA, USA) were approved.
• Upon request by the ISPOR Student Council, the Board approved the Outstanding ISPOR Student Chapter of the Year Award to recognize ISPOR Student Chapters which provide exemplary service to its university, community and ISPOR, which include a plaque and funding of $500 annually to the Outstanding ISPOR Student Chapter to be used to support an invited lecturer for the chapter
• Upon request by the ISPOR Student Council, the Board approved the ISPOR Student Chapter Research Competition Award to foster chapter teamwork and recognize research excellence. Annual competition at the ISPOR International Meeting testing knowledge in pharmacoeconomics and outcomes research, which includes a plaque and funding of $500 annually, as registration fee and travel reimbursement to an annual meeting, to the winning chapter of the ISPOR Student Chapter Research Competition.

Local Chapter Actions:
• The following local chapters were approved: Brazil Chapter, Chinese Medical Doctor's Society - Pharmacoeconomics Chapter, Turkish Society for Clinical Pharmacology Chapter, Thailand Chapter, India Chapter, and Mexico Chapter.
• The Board will approve all Chapter Annual Reports in March of each year.

Organizational Actions:
• Background: There is a perception that ISPOR is an industry-driven organization. To respond to this perception, the Board developed a declaration of independence, which is at the ISPOR website at: http://www.ispor.org/finsupport.asp

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR), a nonprofit 501(c)(3) public organization for educational and scientific purposes [as defined by the United States Internal Revenue Service], exists to foster excellence in the science of pharmacoeconomics and health outcomes research and its use in health care decisions. ISPOR welcomes participation from individuals and organizations that share its mission, including academic institutions, the pharmaceutical, biotechnology and devices industries, public and private health insurers, governments, and NGOs. Financial support for ISPOR's core operations are supplied by its members through membership dues. Meetings, Congresses, and Conferences are supported through registration fees and event and corporate sponsorship. Corporate, government, and nonprofit organizational sponsors are welcome and are recognized by the Society in the meeting brochures and other postings. Meeting content, including contributed issue panels, workshops, and research and plenary sessions are determined by independent evaluators selected from the diverse membership of the society. These processes are wholly independent from financial support. ISPOR retains the right to exclude sponsors or programs that do not reflect its mission and values. ISPOR adheres to the principles on conflict of interest promulgated by the International Committee of Medical Journal Editors and adopts core content from their "uniform principles" for all submissions to its meetings, its journal, Value In Health, and its technical & news journal, ISPOR CONNECTIONS. All contributors to public presentations at its meetings and to ISPOR-sponsored publications must declare sources of support and potential conflicts of interest.

• The Board recommended changes to the ISPOR Organization chart as follows and at the ISPOR website at: https://www.ispor.org/orgchart.asp.

Meeting Actions:
• The Board approved the revised Guidelines for Workshops at ISPOR meetings, which is at the ISPOR website at: http://www.ispor.org/meetings/va0507/ submission_instr.asp.
• Background: From time to time, Board Members have expressed concerns that certain organizations use their involvement in ISPOR activities to market their products and services. Whilst acknowledging that the exchange of information and the promotion of goods and services is an important feature of ISPOR meetings, the concern is that activities presented as scientific discourse may, in fact, be covert marketing exercises. One particular area of concern is the workshop sessions at ISPOR meetings. The current guidelines for Workshop submissions already state that 'the workshop should NOT appear to be advertising the presenter's company's services or products'. However, some reviewers of workshop proposals have suggested that many of these are still 'thinly disguised marketing exercises'.
ISPOR recognizes that a primary purpose of workshops is to allow the presenter(s) to demonstrate their competence in a topic or subject area. However, those signing up for workshops expect a scientific discourse, so it is important that these are not used as a marketing platform for the presenter's company's products or services. Therefore, those evaluating workshop proposals have been asked to take the following factors into account when making their assessments: 1. The workshop presentation should contain original scientific content and not just report on the routine use of a single instrument or tool; 2. Examples should be drawn from a number of sources and not just the presenter(s)' own studies; 3. Preference should be given to proposals that involve presenters from more than one organization and more than one sector. In addition, ISPOR will seek feedback from workshop attendees on the issue of marketing content. These evaluations will be taken into account when considering future proposals from the same presenters.'

Special Interest Group / Committee / Task Force / Council / Consortium Actions:
• Special Interest Groups: The Board approved that the term for the SIG or Working Group Chair is 2 years and renewable based on performance as demonstrated by at least one 'work product' during the 2-year term and consistent communication with Working Group Chairs or SIG Leadership Group and ISPOR staff. The Board approved the following evaluation criteria for evaluating SIG communications and SIG productivity.
Evaluation Criteria for Communications: SIG Chair: Communication with each Work Group a minimum of one time each 3 months. Communication with the Reference Group at least one time each 6 months. These contacts may be in coordination with Work Group Chairs; Work Group Chair: Communication with the Work Group members a minimum of one time each 2 months. Communication with the Reference Group at least one time each 6 months. Communication with the SIG Chair a minimum of one time each 2 months. At least 2 group meeting discussion summaries are issued each year.
Evaluation Criteria for Productivity:
Each Work Group within a SIG: 1.Delineation of specific products and time line for completion within the first 6 months after initiation; 2. Outline of plan for product development within 12 months of initiation; 3. Draft of a product within 18 months of initiation; 4. Delivery of a product within 24 months of initiation (Note: A Work Group may continue if new goals are defined, or may be dissolved after delivery of a product.)

• Institutional Council: The Board approved a revised Institutional Council functions.
Mission: The Institutional Council of ISPOR supports the mission of ISPOR as a scientific and professional society. The purpose of the council is to proactively: a) Promote the development of the fields of pharmacoeconomics and outcomes research; b) Promote the application of pharmacoeconomics and outcomes research results in health care decision making; c) Promote enhancement of the quality of research by institutional members; d) Promote, support, and actively contribute to ISPOR as a premier scientific and professional society; and e) Act as an advisory body to the ISPOR Board. The Institutional Council will be an official entity within ISPOR and will not publicly take positions outside of ISPOR or use ISPOR's name, except with the explicit consent of the ISPOR Board.
Functions: The functions of the Institutional Council include: a) Encouraging and recruiting a diverse membership for the Council including providers, foundations, etc to broaden the base of support for the mission of ISPOR; b) Acting as a liaison with member institutions to keep them appraised of the affairs of ISPOR; c) Providing advice to the ISPOR Board; e) Inviting the ISPOR Board to request comments from the Council's on issues that would be germane to its members.

• Health Science Policy Council: The Board agreed to the following Health Science Policy Council policy & procedure: With regard to the Health Science Policy Council's role in responding to policy issues affecting ISPOR members: 1. If the Council is to draft a response, the Council will agree to a timeline requested by the Board; 2 If another group within ISPOR drafts a response to a policy issue (either independently or on behalf of the Board), the Council will review, if requested, and offer comments on a timeline requested by the Board. The Board requested that: 1.The Council develops a procedure to identify science policy issues and scientific issues (ideas) within the Council to inform the Board; 2. The Council submits an annual report; 3. The Council develops a charter (including chair rotation & membership, procedure for recognizing issues from ISPOR members external to the Council, identifying issue 'champions' external to the Council).

• Biotechnology Council: The Board approved the formation of a Biotechnology Council.

Health Science Actions:
• The Board approved that: 1. probabilistic analysis in economic evaluations, as a topic, is developed by the Council and 2. that, if the Council deemed necessary, the Council should develop a specific proposal for a new ISPOR modeling task force that would tackle a range of topics, such as probabilistic sensitivity analysis and take responsibility for updating the ISPOR modeling guidelines when deemed necessary.
• Background: The ISPOR Health Science Policy Council submitted the following issue: “What Drives Decision Makers When Basing Payment Decision on Cost per QALY Results” Actions requested was to organize a session at an Annual Meeting/Congress on this topic. The Board suggested that this topic be submitted as a Contributed Workshop, Contributed, or Invited Issue Panel for the next Annual Meeting or Congress.

ISPOR Comments to Public Policy
• The ISPOR Institutional Council drafted a letter to be sent from the ISPOR Board of Directors or President to the JAMA Editor-in-Chief concerning JAMA's recent Data Access and Responsibility Policy. Since this request was considered an ISPOR public policy statement, and, according to the ISPOR Policies and Procedures concerning public policy development, Board agreed that this letter is sent to the ISPOR membership for comment with a 30 day comment period and that the cover memo to ISPOR membership on this matter be written in an "agnostic" manner, (i.e. to reflect the fact that the Board is considering the issue but has not yet made a decision). Based on member comments, the Board approved a revised letter to JAMA concerning their policy on data access and responsibility. A response from JAMA Editor-in-Chief, Catherine DeAngelis, was then received July 2006. The Board felt that the Board does not need to respond to the JAMA letter and that the JAMA letter is placed on the ISPOR website. The JAMA editorial policy, the letter to JAMA Editor-in-Chief for the ISPOR Board of Directors, and the response JAMA letter are at the ISPOR website at: http://www.ispor.org/workpaper/ispor_comments/index.asp

• The Board approved the letter of comment to the proposed US Medicare Ruling on Use of Drug Claims Information for Outcomes Research drafted by the Leadership Group of the ISPOR Retrospective Database SIG. For the ISPOR letter of comment to the US Medicare Ruling on Use of Drug Claims Information for Outcomes Research, see: http://www.ispor.org/workpaper/ispor_comments/index.asp
• Background: The ISPOR Retrospective Database Special Interest Group developed comments to the US Center for Medicare and Medicaid Services' proposed ruling concerning the use of Medicare prescription information to evaluate its prescription drug program and for outcomes research purposes. Since ISPOR supports outcomes research and its use in health care decision and to promote public (government) awareness of ISPOR and its mission, it was felt that it is important for ISPOR to comment on the proposed change.

ISPOR Policy & Procedures Actions:
• The Board recognizes that from time-to-time the need to develop public policy statement that, for major policy statements, the Board agreed that the Board must approve these statements in a timely manner. An ISPOR public policy statement is any document that represents a consensus development by ISPOR members and issued on ISPOR stationery.


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