1 HEALTH ECONOMICS & MARKET ACCESS RESOURCE LIST Workshop by HealthEconomics.Com and Global Outcomes Group; for more information, visit: http://www.healtheconomics.com/heor-writing-workshop/ Faculty-recommended Health Economics & Market Access Medical Writing Resource List (in no particular order): HealthEconomics.Com website at http://www.healtheconomics.com contains thousands of resources on health economics, HTA, market access, and more. 4 Drivers for Successful Literature Reviews, UBC - November 05, 2014, found at: http://www.ubc.com/blog/4-drivers-successful-literature-reviews Bakst A, et al. Panel 7: Communication and reporting health economic information. Value in Health. 1999;2(2):103-106. Being mortal : medicine and what matters in the end. By Gawande Atul. New York; Metropolitan Books: Henry Holt & Company, 2014. Berger ML, Ed. International Society for Pharmacoeconomics and Outcomes Research). Health Care Cost, Quality, and Outcomes: ISPOR book of terms. Available at: http://ispor.org/publications/BooksIndex.asp. Or search on Amazon for a used copy. Blog by Bonny McClain, geared towards medical writers and providing details of specific tools used: www.dataanddonuts.org Bonk RJ. Conversance with fundamentals of health economics [AMWA Pocket Training]. AMWA website. www.amwa.org/pocket_trainings. Briggs A, Sculpher M. An introduction to Markov modeling for economic evaluation. Pharmacoeconomics. 1998;13(4):397-409. Chawla M. Towards a common goal: Health economics and medical writing. Powerpoint Presentation. Kinapse Ltd. 2013;Oct. Available from: http://www.healtheconomics.com/resource/towards-acommon-goal-health-economics-and-medical-writing/ 2 Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Found at: Husereau D, Drummond M, Petrou S, et al. Consolidated health economic evaluation reporting standards (CHEERS)—Explanation and elaboration: A report of the ISPOR health economic evaluations publication guidelines good reporting practices task force. Value Health 2013;16:231-50. Dant, Christopher. Writing The Biomedical Manuscript: A Systematic Approach. Powerpoint Presentation. Stanford Medical School. Manuscript Writing. Part I. Available from: http://medblog.stanford.edu/lane-faq/archives/Ms.Writing_I.ppt Detsky AS, Nagler IG. A clinician’s guide to cost-effectiveness. Am Coll Physicians. 1990;113:147-154. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. BMJ. 1996;313:275-283. Enhancing Communications for Health Outcomes (ECHO) Laboratory, multimedia communications laboratory ideal for message testing and for formative research at Dana-Farber / Harvard Cancer Center. More information: http://www.dfhcc.harvard.edu/index.php?id=1318&no_cache=1&tx_ttnews%5Btt_news%5D=780 Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network website http://www.equator-network.org/ Fairclough J et al. Incorporation of the Academy of Managed Care Pharmacy (AMCP) eDossier System to Enhance the Dossier Request Process, Poster Presentation, Drug Information Association (DIA) Medical Communications Workshop 2011: Navigating the Waves of Medical Communications, Carlsbad, CA (March 7-10, 2011). Fanshawe J. Health economics: too important to be left to health economists. Mediaxial. Available from: http://www.medaxial.com/articles/health_economics-too_%20important.pdf Gold MR et al, Eds. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996. Graf C et al for the International Society for Medical Publication Professionals Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330 doi: 10.1136/bmj.b4330 Hazard EH, et al. Can they hear us now (This second article on health economics will present several methods for effectively communicating the value of medicines to nonscientific audiences). Product Management Today. 2007;18(12), December. HTA Roadmap: http://www.ispor.org/HTARoadMaps/Default.asp International Committee of Medical Journal Editors (ICMJE) recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals: updated December 2014. Available from: http://www.icmje.org/icmje-recommendations.pdf 3 ISPOR Good practices for outcomes research and use in health care decisions - HEALTH ECONOMIC EVALUATION PUBLICATION GUIDELINES – CHEERS: GOOD REPORTING PRACTICES http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp Malone DC, Sullivan SD, Veenstra DL. Determining cost values for health care resources in pharmacoeconomic studies. Formulary. 2011;36(4):294-299. Mealing S. Medical writing and health economics/market access: a health economist’s view. Guest Editorial. Medical Writing. 2013; 22(3):192-193. Medical illuminations : using evidence, visualization, and statistical thinking to improve healthcare. By Howard Wainer. Publisher: Oxford ; New York, NY : Oxford University Press, 2014. Medina RD, Khetia D, Topiwala PJ, Willey VJ, Sloskey GE, Langhoff W. “Evaluating the Value of Clinical and Economic Evidence-Based Information from Dossier Submissions Using the Academy of Managed Care Pharmacy (AMCP) Format”, Poster Presentation, Drug Information Association (DIA) Medical Communications Workshop 2011: Navigating the Waves of Medical Communications, Carlsbad, CA (March 7-10, 2011). Moher D, Schulz KF, Simera I, Altman DG. Guidance for Developers of Health Research Reporting Guidelines. PLoS Medicine. 2010 Feb 16;7(2):e1000217. Moore-Totten J, Tam I. Strategies for Complying with Version 3.0 of the AMCP Dossier Format, Poster Presentation, Drug Information Association (DIA) Medical Communications Workshop 2011: Navigating the Waves of Medical Communications, Carlsbad, CA (March 7-10, 2011). Motheral B et al. A checklist for retrospective database studies—report of the ISPOR Task Force on Retrospective Databases. Value Health. 2003;3(2):90-97. Neumann PJ, Bliss SK. FDA Actions Against Health Economic Promotions, 2002–2011. Value in Health. 2012;15(6):948 – 953. Neumann PJ, Rosen AB, Weinstein MC. Medicare and cost-effectiveness analysis. N Engl J Med. 2005;353(14):1516-1522. Peeples P, Drake T. “SPLAT! How HEOR Communication Tools Fall Flat With Your Customers – But Don’t Have To!”, tHEORetically Speaking blog, February 13, 2015. Peterson AM, et al. A checklist for medication compliance and persistence using retrospective databases. Value Health. 2007;10(1):3-12 PRISMA - Preferred Reporting Items for Systematic Reviews and Meta-Analyses, an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses, found at http://www.prisma-statement.org/. This includes following the Preferred Reporting items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The PRISMA statement outlines an industry standard for systematic reviews. The PRISMA Statement consists of a 27item checklist (http://www.prisma-statement.org/statement.htm ) and a four-phase flow diagram 4 (http://www.prisma-statement.org/2.1.4%20-%20PRISMA%20Flow%202009%20Diagram.pdf). It is an evolving document that is subject to change periodically as new evidence emerges. In fact, the PRISMA Statement is an update and expansion of the now-out dated QUOROM Statement. This website contains the current definitive version of the PRISMA Statement. The PRISMA Explanation and Elaboration document (http://www.prisma-statement.org/usage.htm) explains and illustrates the principles underlying the PRISMA Statement. It is strongly recommended that it be used in conjunction with the PRISMA Statement. Rascati KL. Essentials of Pharmacoeconomics , Second Edition. Philadelphia: Lippincott, Williams, & Wilkins, 2014. Rothermel C, Peeples P. “Getting Published. The Last Stage of the Research Process”. Podcast, HealthEconomics.Com CONNECTED COMMUNITY™ Podcast Series, 2014. http://www.healtheconomics.com/home/connected-community-podcasts/connectedcommunity-podcast-caitlin-rothermel-of-medlitera/ Rothermel C. What is health economics and outcomes research? A primer for medical writers. AMWA Journal. 2013;28(3):98-103. Rothermel C. “Model Naked: Some Thoughts on Transparency in Health Economics Writing”, tHEORetically Speaking blog, February 18, 2014, http://healtheconblog.com/2014/02/18/model-nakedsome-thoughts-on-transparency-in-health-economics-writing Symonds T, Hackford C, Abraham L. A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012. Value Health. 2014 Jun;17(4):433-7. Stewart KA, Neumann PJ. FDA Actions against Misleading or Unsubstantiated Economic and Quality-ofLife Promotional Claims:An Analysis of Warning Letters and Notices of Violation. Value in Health. 2002;5(5):390-397. The visual display of quantitative information. By Edward R Tufte. Publisher: Cheshire, Conn. (Box 430, Cheshire 06410) : Graphics Press, ©1983. Thinking, fast and slow. By Daniel Kahneman. Publisher: New York : Farrar, Straus and Giroux, 2011. Whittington R. Health economists and medical writers: collaboration or collision? Medical Writing. 2013;22(3):174-177. Yang BM. Guidance for writing excellent research manuscripts for submission to Value in Health Regional Issues. Part 1. ISPOR News Across Asia Volume 3 No. 4 Winter 2014, ISPOR Asia Consortium Newsletter. Available at: http://www.ispor.org/consortiums/asia/Guidance-for-Writing-ExcellentResearch-Manuscripts-for-VIHRI.pdf HTA Organizations 5 International Network of Agencies for Health Technology Assessment (INAHTA) – http://www.inahta.org/ European Network for Health Technology Assessment (EUNetHTA) – http://www.eunethta.eu/ Agency for Healthcare Research & Quality (AHRQ) Technology Assessment Program – http://www.ahrq.gov/research/findings/ta/index.html Agence des technologies et des modes intervention en sante (AETMIS) – http://www.informa.msss.gouv.qc.ca/Details.aspx?Id=B8wIqr0vga8= Australian Government HTA – http://www.health.gov.au/hta Blue Cross Blue Shield (BCBS) Technology Evaluation Center – http://www.bcbs.com/blueresources/tec/ Canadian Agency for Drugs and Technologies in Health (CADTH) – http://www.cadth.ca/en German Agency for Health Technology Assessment (DAHTA) – http://www.dimdi.de/static/en/hta/dahta/ National Institute for Health and Care Excellence (NICE; UK based) – https://www.nice.org.uk/ National Institute for Health Research (NIHR; UK based) – http://www.nets.nihr.ac.uk/programmes/hta Washington Health Care Authority (HCA) Health Technology Assessment Program – http://www.hca.wa.gov/hta/Pages/index.aspx HTA Databases Centre for Reviews and Dissemination – (http://www.york.ac.uk/inst/crd/) The Cochrane Library: Technology Assessment Database – (http://onlinelibrary.wiley.com/o/cochrane/cochrane_clhta_articles_fs.html) TRIP Database – (http://www.tripdatabase.com/) Systematic Review Resources The Cochrane Collaboration – http://www.cochrane.org/ CRD/University of York guidance – http://www.york.ac.uk/inst/crd/pdf/Systematic_Reviews.pdf PROSPERO database of systematic reviews – http://www.crd.york.ac.uk/PROSPERO/ Scottish Intercollegiate Guidelines Network (SIGN) search filters for different study types: http://www.sign.ac.uk/methodology/filters.html SIGN critical appraisal checklists – http://www.sign.ac.uk/methodology/checklists.html Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group – http://www.gradeworkinggroup.org/index.htm Centers for Medicare & Medicaid Services (CMS)—cms.gov Statistics Medicare, Medicaid, CHIP essentials and health plans National Health Expenditure Data, http://www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/NationalHealthExpendData/index.html CMS Innovation Center, http://innovation.cms.gov Fee schedules for physicians, hospitals, etc Prescription drug coverage Demonstration projects Electronic health records and e-prescribing 6 Medicare & You yearly report for patients (http://www.medicare.gov/medicare-andyou/medicare-and-you.html) Kaiser Family Foundation—www.kff.org Medicaid and Medicare Fact Sheets and Primers Market Trackers Health Insurance Exchanges Children’s Health Insurance Program (CHIP) Affordable Care Act Issues for 2015 Health policy insights Others AAPC (ICD-10, coding)— https://www.aapc.com American Medical Association (coding, solutions for practice)—http://www.ama-assn.org Accenture (insights)— http://www.accenture.com/us-en/industry/health/Pages/health-index.aspx Agency for Healthcare Research and Quality—http://www.ahrq.gov ASHP Guidelines on P&T— http://www.ashp.org/doclibrary/bestpractices/formgdlptcommformsyst.pdf Association for Corporate Health Risk Management (payer-side insights)— https://www.achrm.org Association of Health Care Journalists (resources, blogs, webinars)— http://www.healthjournalism.org Avalere Health (insights)—http://avalere.com Campbell Alliance (insights)—http://www.campbellalliance.com Center for Value-Based Insurance Design (U of MI)—http://vbidcenter.org Commonwealth Fund—www.commonwealthyfund.org Congressional Budget Office—cbo.gov CPM HealthGrades (hospital info, quality, performance)—http://www.cpmhealthgrades.com Deloitte (insights, Center for Health Solutions)—http://www2.deloitte.com/us/en/industries/lifesciences-and-health-care.html?icid=top_life-sciences-and-health-care Dept of Health & Human Services (ASPE Issue Briefs)—http://aspe.hhs.gov EMD Serono (drug marketplace digests)—www.emdserono.com/ Express Scripts—The Lab, http://lab.express-scripts.com Express Scripts/Medco—The Drug Trend Report, http://lab.express-scripts.com/drug-trendreport/introduction/year-in-review o Health care issues Health Industries Research Companies (managed oncology, specialty pharma, quality)— http://www.hirc.com Institute of Medicine (quality, issues)—http://www.iom.edu IRS (tax payer provisions)— http://www.irs.gov/Affordable-Care-Act/Affordable-Care-Act-TaxProvisions Joint Commission (safety, quality, hospital accreditation)— http://www.jointcommission.org Joint Commission on Health Care (costs)— 7 McKesson (reimbursement, specialty pharma, cost trends)—http://www.mckesson.com National Association of Community Health Centers (research, policy issues)— http://www.nachc.com/issues.cfm National Business Coalition on Health (employer fees/penalties)—http://www.nbch.org National Conference of State Legislatures (state-specific information on health)— http://www.ncsl.org/research/health.aspx National Pharmaceutical Council (research library, issues)— http://www.nationalpharmaceuticalcouncil.org Price Waterhouse Coopers (insights)—www.pwc.com q1Medicare.com—Part D and MA plan cost information—http://www.q1medicare.com The Leapfrog Group (employer-based coalition on quality, safety, transparency)— http://www.leapfroggroup.org The RPM Report (insight on regulation, FDA, CMS)— https://www.pharmamedtechbi.com/publications/rpm-report United Healthcare (provider, employer info)—http://www.uhc.com/united-for-reform Verisk Health (infographics, resources, blog)— www.answers.veriskhealth.com/ideas Reporting Standards 1. Observational Studies STROBE – Strengthening the Reporting of Observational Studies in Epidemiology 2. Systematic Reviews and Meta-analyses PRISMA – Preferred Reporting items for Systematic Reviews and Meta-Analyses MOOSE – Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group 3. Economic Evaluations CHEERS – Consolidated Health Economic Evaluation Reporting Standards Statement Randomized Controlled Trials CONSORT – Consolidated Standards of Reporting Trials QUOROM – Quality of Reporting of Meta-Analyses checklist 4. Comparative Effectiveness Research GRACE – Good ReseArch for Comparative Effectiveness Research Standards 8 5. ISPOR.org > Research Tools > Good Practices for Outcomes Research Index a. Example: Good Research Practices for Comparative Effectiveness Research: Defining, Reporting and Interpreting Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report—Part I 6. APA Style Guide a. Summary available: https://owl.english.purdue.edu/owl/resource/560/19/ Disclaimer: This list is not exhaustive. Helpful Hint: Google is your friend. Journals and other Publications (for complete list and hyperlinks, visit HealthEconomics.Com (http://www.healtheconomics.com/category/journals) AHA News American Journal Of Bioethics American Journal of Health Economics American Journal Of Managed Care American Journal Of Medicine (“The Green Journal”) American Journal Of Public Health Annals Of Internal Medicine Annals Of Pharmacotherapy Applied Health Economics And Health Policy Bandolier: Evidence-Based Journal BMC Health Services Research Cancer News On The Net CDC Morbidity And Mortality Weekly Clinical Therapeutics Cost Effectiveness And Resource Allocation Current Medical Research Opinion Disease Management And Clinical Outcomes Economics And Human Biology 9 European Journal Of Health Economics Expert Review OfPharmacoeconomics And Outcomes Research Formulary Frontiers In Pharmacoeconomics And Health Outcomes Health And Quality Of Life Outcomes Health Economics Knowledge At Wharton Health Economics Review Health Facilities Management Magazine Health Informatics Journal Health Services Research Healthcare Innovation And Integrated Care Journal Healthcare Reimbursement Monitor International Journal Of Health Care Finance And Economics International Journal Of Health Policy And Management International Journal Of Technology Assessment In Health Care ISPOR Connections Journal Of American Medical Association Journal Of Biomedical Informatics Journal Of Clinical Epidemiology Journal Of Development Effectiveness Journal Of Drug Assessment Journal Of Evaluation In Clinical Practice Journal Of Health Economics Journal Of Healthcare Finance Journal of Managed Care & Specialty Pharmacy Journal of Managed Care Medicine Journal Of Medical Economics Journal Of Mental Health Policy And Economics Journal Of Occupational And Environmental Medicine Journal Of Pharmaceutical Health Services Research Journal Of Pharmacy Technology 10 Journal Of Postgraduate Medicine Journal Of Risk Analysis Journal Or Euromed Pharmacy Journals In Medical Informatics Knowledge At Wharton Health Economics LDI Health Economist Managed Care Magazine Managed Care Weekly Watch Weekly Newsletter Managed Healthcare Executive Medical Decision-Making Medical Letter On Drugs And Therapeutics New England Journal Of Medicine Online Journal Of Nursing Informatics Pharmacoeconomics Pharmacy Times Pharmacy Week Journal Preventing Chronic Disease Public Health Reports Online Quality Of Life Research Risk Analysis Journal Specialty Pharmacy Times Statistics In Medicine Statistics In Medicine Studies In Health Technology And Information The Journal Of The Economics Of Ageing 11 Ensuring message communication in Market access Value dossiers Karin Hawkinson Scientific Director, Payer Communications, Evidera Key considerations to make sure your dossier is on track Remember your goal Remember your audience Market access value dossiers are designed to communicate the full picture of a product’s value— using a compelling value story—supported by the best available evidence to economically sensitive customers Your audience may be: Internal pharma company affiliates External payers, decision makers, or clinical advisors Ensure your message is incorporated Select and translate the information Present the relevant information Ways to ensure translation Focus on the value story Get back to basics: ask yourself what is relevant Identify what distinguishes the product List the key points and rework from there Consider what is needed for each audience Cut the text in half and rework Talk to your client Consider what is relevant for that particular product Present the information differently (table/figure) Translate the information Make sure you understand the topic by acquiring the necessary knowledge Make sure you have enabled your audience to understand the information Make the format work for you Segment the information into appropriate chunks Group similar information in a table, where the data can be compared Put the segments in a logical order Move more detailed information to an appendix Show the relationships among segments Consider adding section summaries Provide a home for all relevant information Incorporate the ‘so what’ Providing the ‘so what’ is the most important technique to develop an effective dossier The ‘so what’ for a piece of information can include: Describing the consequences Providing the context Explaining the background 12 Making the connections