In June 2018, the guidance for “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” and “Medical Product Communications that Are Consistent with the FDA-Required Labeling—Questions and Answers” were released, changing the world as we knew it for the life sciences industry. The U.S. Food and Drug Administration opened the door to a new audience that had previously been off limits. Historically, pharmaceutical and device manufacturers erred on the conservative side when it came to communications with payors and similar organizations. This allowed for payers to make financial decisions for covered populations without being fully informed and pushed many life sciences companies to build their health economic information profiles in the dark.
|This article is featured in O'Dwyer's Oct. '19 Healthcare & Medical PR Magazine.|
While the availability of this guidance represents great news for pharma and device manufacturers, many of these organization are still cautious given the associated risk and potential for the chance that regulators view your communication as grossly inaccurate and/or lacking much-needed context. As communication consultants, it’s our call to duty to help guide our clients as they gear up for this new venture. But, before we get ahead of ourselves and begin brainstorming our best and biggest ideas, there are three questions to ask yourself and your client:
Do I truly understand the definition of healthcare economic information?
To make appropriate decisions, payors closely examine information such as effectiveness, safety, and cost-effectiveness of approved or cleared medical products when deciding on product selection, formulary management, and/or coverage and reimbursement decisions on a population basis.
Given the new guidance, life sciences companies can now provide any information that “conveys the economic consequences related to the clinical outcomes of treating a disease (or specific aspect of a disease) or of preventing or diagnosing a disease.” It could also include a comparative analysis to another drug, to another healthcare intervention, or to no intervention.
Today, recipients of this information can encompass technology assessment committees, pharmacy benefit managers, as well as individuals who wear many hats like a physician who also sits on a value analysis committee. Importantly, the FDA further clarified that value-based contracts are exempted from FDA reporting requirements. So, life sciences companies can use the submission of HCEI to encourage contracting discussions.
Further, the FDA guidance goes on to highlight some of the topics that would be acceptable to include in a communication with payors including adherence or compliance information, lengths of hospitals stays, dosing, duration of treatment and clinical outcome assessments, among other topics. You can package this up in the form of a budget impact model, evidence dossier, journal publication reprint, or even a payer brochure or overview presentation. Just ensure the information is not misleading or untruthful.
Has your client considered partnering with a payor on your communication efforts?
Collaboration is at its best when you put great minds together to address challenges that are difficult to solve individually. Given this new territory for life sciences companies, it would be beneficial to tap into the expertise and insights that payers themselves maintain. Because communication between the two have been non-existent for so long, there’s likely a trove of information that can be enlightening for all parties. For example, AstraZeneca recently partnered with the Commission for Case Manager Certification (CCMC) on educational toolkits to improve outcomes for cancer, diabetes, cardiovascular, and respiratory disease patients. The collaboration proved to be useful in providing a population healthcare management toolkit that brought clarity to managing these conditions and out-of-the-box support for many case managers.
How is your client communicating changes to the company’s standard operating procedures?
While a bit boring, SOPs are critical to day-to-day activities. When mapping out a process flow and potential areas for concern, you’ll need to consider how adding a new audience, like payors, affects the purpose of business processes. This process will be laborious, but once completed it will be the internal communications team’s role to manage this change and communicate it effectively.
Remember that asking your organization to change is a large request, so over-communicating should not be a deterrent. The communications materials should focus on the mission and reveal the opportunity that payors offer and where they fit in your prioritization of key stakeholders. The people selected to communicate the news should be excited and the information must relay content that employees care the most about.
It’s exciting to now have a new audience to tap into, new collaboration opportunities to consider and new strategies to put into place, though payor communications may be at first uncomfortable becoming informed. And taking your client through hat education journey, will help you both create smart and impactful programs.
Victoria Aguiar is a Senior Vice President at Bliss Integrated Communication within the Healthcare Practice. She specializes within the life sciences industry helping advocacy groups, biopharma, medical device, diagnostics, IT and research companies, think critically about marketing and communication initiatives that can help achieve business goals.