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HEALTH ECONOMICS & MARKET ACCESS RESOURCE LIST Workshop by and Global Outcomes Group; for more information, visit: Health Economics & Market Access Medical Writing Resource List (in no particular order): website at contains thousands of resources on health economics, HTA, market access, and more. 4 Drivers for Successful Literature Reviews, UBC - November 05, 2014, found at: 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: . Or search on Amazon for a used copy.Blog by Bonny McClain, geared towards medical writers and providing details of specific tools used: Bonk RJ. Conversance with fundamentals of health economics [AMWA Pocket Training]. AMWA website. 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: 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: 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: the QUAlity and Transparency Of health Research (EQUATOR) Network website - 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: 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.b4330Hazard 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: 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: ISPOR Good practices for outcomes research and use in health care decisions - HEALTH ECONOMIC EVALUATION PUBLICATION GUIDELINES – CHEERS: GOOD REPORTING PRACTICES - 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):3-12PRISMA - 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 . 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 27-item?checklist?( ) and a four-phase?flow diagram (). 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 ()?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, CONNECTED COMMUNITY? Podcast Series, 2014. ? 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, 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-of-Life 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: HTA OrganizationsInternational Network of Agencies for Health Technology Assessment (INAHTA) – Network for Health Technology Assessment (EUNetHTA) – for Healthcare Research & Quality (AHRQ) Technology Assessment Program – des technologies et des modes intervention en sante (AETMIS) – Government HTA – Cross Blue Shield (BCBS) Technology Evaluation Center – Agency for Drugs and Technologies in Health (CADTH) – Agency for Health Technology Assessment (DAHTA) – Institute for Health and Care Excellence (NICE; UK based) – Institute for Health Research (NIHR; UK based) – Health Care Authority (HCA) Health Technology Assessment Program – DatabasesCentre for Reviews and Dissemination – ()The Cochrane Library: Technology Assessment Database –()TRIP Database – ()Systematic Review ResourcesThe Cochrane Collaboration – ? of York guidance – database of systematic reviews – Intercollegiate Guidelines Network ?(SIGN) search filters for different study types: critical appraisal checklists – of Recommendations Assessment, Development and Evaluation (GRADE) Working Group – ? for Medicare & Medicaid Services (CMS)—StatisticsMedicare, Medicaid, CHIP essentials and health plansNational Health Expenditure Data, Innovation Center, Fee schedules for physicians, hospitals, etcPrescription drug coverageDemonstration projectsElectronic health records and e-prescribingMedicare & You yearly report for patients () Kaiser Family Foundation— Medicaid and Medicare Fact Sheets and PrimersMarket TrackersHealth Insurance ExchangesChildren’s Health Insurance Program (CHIP)Affordable Care Act Issues for 2015 Health policy insightsOthersAAPC (ICD-10, coding)— Medical Association (coding, solutions for practice)— (insights)— Agency for Healthcare Research and Quality— Guidelines on P&T— for Corporate Health Risk Management (payer-side insights)— of Health Care Journalists (resources, blogs, webinars)— Health (insights)— Alliance (insights)— Center for Value-Based Insurance Design (U of MI)— Fund—Congressional Budget Office—CPM HealthGrades (hospital info, quality, performance)— (insights, Center for Health Solutions)— Dept of Health & Human Services (ASPE Issue Briefs)— Serono (drug marketplace digests)—Express Scripts—The Lab, Scripts/Medco—The Drug Trend Report, care issuesHealth Industries Research Companies (managed oncology, specialty pharma, quality)— Institute of Medicine (quality, issues)— (tax payer provisions)— Commission (safety, quality, hospital accreditation)— Joint Commission on Health Care (costs)—McKesson (reimbursement, specialty pharma, cost trends)— Association of Community Health Centers (research, policy issues)— National Business Coalition on Health (employer fees/penalties)— Conference of State Legislatures (state-specific information on health)— National Pharmaceutical Council (research library, issues)— Price Waterhouse Coopers (insights)— —Part D and MA plan cost information— Leapfrog Group (employer-based coalition on quality, safety, transparency)— RPM Report (insight on regulation, FDA, CMS)— Healthcare (provider, employer info)— Verisk Health (infographics, resources, blog)— answers.ideas Reporting Standards1. Observational StudiesSTROBE – Strengthening the Reporting of Observational Studies in Epidemiology2. Systematic Reviews and Meta-analyses PRISMA – Preferred Reporting items for Systematic Reviews and Meta-AnalysesMOOSE – Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group Economic EvaluationsCHEERS – Consolidated Health Economic Evaluation Reporting Standards Statement Randomized Controlled TrialsCONSORT – Consolidated Standards of Reporting TrialsQUOROM – Quality of Reporting of Meta-Analyses checklist Comparative Effectiveness ResearchGRACE – Good ReseArch for Comparative EffectivenessResearch Standards5. > Research Tools > Good Practices for Outcomes Research Indexa. 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 I6. APA Style Guidea. Summary available: Disclaimer: This list is not exhaustive. Helpful Hint: Google is your friend.Journals and other Publications (for complete list and hyperlinks, visit () AHA NewsAmerican Journal Of BioethicsAmerican Journal of Health Economics American Journal Of Managed CareAmerican Journal Of Medicine (“The Green Journal”)American Journal Of Public HealthAnnals Of Internal MedicineAnnals Of PharmacotherapyApplied Health Economics And Health PolicyBandolier: Evidence-Based JournalBMC Health Services ResearchCancer News On The NetCDC Morbidity And Mortality WeeklyClinical TherapeuticsCost Effectiveness And Resource AllocationCurrent Medical Research OpinionDisease Management And Clinical OutcomesEconomics And Human BiologyEuropean Journal Of Health EconomicsExpert Review OfPharmacoeconomics And Outcomes ResearchFormularyFrontiers In Pharmacoeconomics And Health OutcomesHealth And Quality Of Life OutcomesHealth Economics Knowledge At WhartonHealth Economics ReviewHealth Facilities Management MagazineHealth Informatics JournalHealth Services ResearchHealthcare Innovation And Integrated Care JournalHealthcare Reimbursement MonitorInternational Journal Of Health Care Finance And EconomicsInternational Journal Of Health Policy And ManagementInternational Journal Of Technology Assessment In Health CareISPOR ConnectionsJournal Of American Medical AssociationJournal Of Biomedical InformaticsJournal Of Clinical EpidemiologyJournal Of Development EffectivenessJournal Of Drug AssessmentJournal Of Evaluation In Clinical PracticeJournal Of Health EconomicsJournal Of Healthcare FinanceJournal of Managed Care & Specialty PharmacyJournal of Managed Care Medicine Journal Of Medical EconomicsJournal Of Mental Health Policy And EconomicsJournal Of Occupational And Environmental MedicineJournal Of Pharmaceutical Health Services ResearchJournal Of Pharmacy TechnologyJournal Of Postgraduate MedicineJournal Of Risk AnalysisJournal Or Euromed PharmacyJournals In Medical InformaticsKnowledge At Wharton Health EconomicsLDI Health EconomistManaged Care MagazineManaged Care Weekly Watch Weekly NewsletterManaged Healthcare Executive Medical Decision-MakingMedical Letter On Drugs And TherapeuticsNew England Journal Of MedicineOnline Journal Of Nursing InformaticsPharmacoeconomicsPharmacy TimesPharmacy Week JournalPreventing Chronic DiseasePublic Health Reports OnlineQuality Of Life ResearchRisk Analysis JournalSpecialty Pharmacy TimesStatistics In MedicineStatistics In MedicineStudies In Health Technology And InformationThe Journal Of The Economics Of AgeingEnsuring message communication in Market access Value dossiersKarin Hawkinson Scientific Director, Payer Communications, EvideraKey considerations to make sure your dossier is on trackRemember your goalRemember your audienceMarket 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 customersYour audience may be:Internal pharma company affiliatesExternal payers, decision makers, or clinical advisorsEnsure your message is incorporatedSelect and translate the informationPresent the relevant informationFocus on the value storyIdentify what distinguishes the productConsider what is needed for each audienceTalk to your clientConsider what is relevant for that particular productTranslate the informationMake sure you have enabled your audience to understand the informationWays to ensure translationGet back to basics: ask yourself what is relevantList the key points and rework from thereCut the text in half and reworkPresent the information differently (table/figure)Make sure you understand the topic by acquiring the necessary knowledgeMake the format work for youSegment the information into appropriate chunksPut the segments in a logical orderShow the relationships among segmentsProvide a home for all relevant informationGroup similar information in a table, where the data can be comparedMove more detailed information to an appendixConsider adding section summariesIncorporate the ‘so what’Providing the ‘so what’ is the most important technique to develop an effective dossierThe ‘so what’ for a piece of information can include:Describing the consequencesProviding the contextExplaining the backgroundMaking the connections ................
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