Publications

HEOR Publication Planning, Medical Writing, and Evidence Dissemination

As value evidence development teams continue to outsource the communications components of their work, FPC is well positioned to support clients with communications activities, including dossiers, publications, and supporting materials for field-based teams. A robust value evidence communications plan should include peer-reviewed publications, congress-facing materials, tools for market access and public affairs teams, and digital companion assets. Ultimately, we begin with the end in mind – we clearly understand medical and market access objectives – and use tools to educate (internally and externally), track progress, and evaluate knowledge transfer objectives.

Our three-step approach to HEOR writing:

1. Create strategic publications and communications plan
2. Ensure publication support value story and is compelling and credible to target audience
3. Ensure communications reflect regulatory and organizational regulations and guidelines

Trends in HEOR communications*:

• A solid understanding of payer engagement principles is a key imperative
• Persuasive, effective, and clear writing skills are a priority to HEOR/RWE professionals
• Collaboration between medical education and HEOR/RWE teams helps sales and access teams understand the usefulness and impact of HEOR/RWE
• Quality in value evidence writing is lacking, primarily due to poor quality value messages surrounding health economic, pricing, reimbursement, and market access outcomes
• ISPOR’s Consolidated Health Economic Evaluation Reporting Standards (CHEERS) has been endorsed by 12 journals, including European Journal of Health Economics, International Journal of Technology Assessment in Health Care, Journal of Medical Economics, and Value in Health
• New draft FDA guidance (Jan 2017), updating FDAMA 114, now provides a standard on communications with US payors on healthcare economic information (HCEI)
• EMEA’s Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) published guidance around RWE data collection and dissemination in March 2016
• All real-world evidence should be reported according to STROBE guidelines (PLOS Medicine), a 22 item checklist for observational studies to be included with HTA submissions

*Source: 2015 HealthEconomics.com HEOR Communications Poll