Value in healthcare is a continually changing concept. As the needs of different stakeholders evolve and gain in prominence, pharmaceutical companies must be prepared to address value from various viewpoints using a variety of different metrics.
The evolution of value in healthcare is a trend that has important implications for communications, particularly because ‘value’ is very much in the eye of the beholder. For a physician, value may centre around safety and efficacy whereas healthcare decision makers and regulators may place more emphasis on cost. Patients may place more value on cost when dealing with a chronic disease and quality of life when dealing with an end of life illness.
As patients play a more active part in their own care, physicians grapple with the ever-changing nature of medical science and payers are continually pushed by budgetary constraints, it’s important to understand that how you communicate value to the industry’s various audiences needs to be different.
Furthermore, these rapidly changing definitions of value have led to a convergence of clinical and health economics outcomes research (HEOR) communications, which are frequently presented together to deliver an integrated value narrative that is relevant to various stakeholders.
For the purposes of this article we’re talking about value communications supporting the treatment of disease.
It’s an area that has traditionally been centred on the twin concerns of efficacy and safety, which align with outcomes used to make regulatory decisions. Historically, value communications were geared towards physicians and, as the nature of prescribing has shifted, it has more recently expanded to encompass allied health professionals as well.
With the growing awareness of increasing healthcare costs, the audience for value communications expanded to including payers. Looking to the US, for example, this change has been driven by more active management of pharmacy cost categories – something that, perhaps 10-15 years ago, we really didn’t see as widespread.
This was, of course, followed by the rise of today’s prominent patient focus and the drivers for this are two-fold. Firstly, the increase in new treatments for disease areas where patients are traditionally strong advocates for themselves, for example in rare disease and oncology. Adding to this expansion of patient advocacy, we also see an increase in patient-reported outcomes (or even patient-focused outcomes) being collected during clinical trials that look beyond markers of disease to things like quality of life and functional status, and that’s where you start to see a pivot to more patient-directed communications.
Overlaying all of this is the ability of patients to access healthcare information through the internet. A July 2020 study by the Pew Internet & American Life Project found that 80% of US internet users, some 93 million people, have searched for a health-related topic online, such as information on a particular treatment or disease. Added to this, from a US perspective, are DTC advertising and managed care organisations (through prior authorisation and formulary management), which also have a role in leading patients to play a more active part in their care.
Together, these changes are evident in the shift to HEOR publications, which saw a 160% increase in the medical literature from 2005 to 2015. These publications are more geared towards payers and regulators than clinicians with many incorporating the patient voice. We would expect this increase in HEOR publications to continue to grow as healthcare continues to shift from being purely focused on safety and efficacy to more of a focus on value, as defined by not only physicians, but also payers and patients.
Consequently, the evolution of value to date requires pharma companies to increasingly consider more varied and diverse audiences in their value communications planning.
Pharma’s challenge is that it’s no longer enough to just prove that a product they are bringing to market is safe and effective – data must also be generated and communicated that evaluate cost effectiveness, budget impact and quality of life impacts.
But demonstrating these additional outcomes requires an additional line of communications and a re-framing of the conversation – plus new competencies and ways of thinking than would be applied within a traditional clinical efficacy and safety framework. Key players from both clinical and HEOR need to pull together to develop cohesive stories and narratives that highlight both clinical, economic and humanistic outcomes.
Traditional, data-rich, content-heavy approaches have to be broken down into smaller pieces that are easily digestible and more visual – acknowledging that what works well in print does not always work as well when viewed from a phone or tablet screen. Additionally, the broadening of pharma’s audience means that companies must adapt their materials for wider levels of health education, presenting data in ways that patients, payers and clinicians can understand.
A coherent value communication plan should be developed early in the drug development process and periodically updated throughout the product life cycle to ensure timely, ongoing communication with key stakeholders. Market access must be considered as regulatory approval alone does not guarantee uptake and widespread use of a product. As part of an evidence generation plan, the clinical, humanistic, and economic burden of disease should be clearly defined and disseminated. These data should be incorporated into dossiers that serve as a backbone for development of submission documents to health technology assessment bodies to support reimbursement. Evidence generation and dissemination should begin early in the approval process as healthcare decision makers are requesting information prior to drug approval as noted by the release of guidance by the Academy of Managed Care Pharmacy for an Unapproved Product Dossier in 2019.
There needs to be a broadening of scope, in terms of who’s sitting at the table, who’s driving the conversation and who’s framing the story, and all of this needs to take place much earlier in the planning and communications process. One of the challenges for pharmaceutical companies has been just getting the timing of strategic planning right, so that it can occur at a stage where it’s still possible to make changes that can influence the downstream value story.
Successfully communicating value presents pharma with an adaptability challenge and also a perspective challenge to take a more holistic view.
The new evolving definitions of value require a collaborative partnership between clinical and HEOR teams to keep pace and ensure a narrative is developed that is adaptable and relatable, and that can proactively identify data gaps and make recommendations for filling these gaps.
Collaborations work well when initiated early in strategy development, ensuring capture of all internal stakeholder perspectives, so that the entire team is invested in the data generation plan and the value narrative it supports.
Partnerships are key to successful value communications. When thinking about your overall product strategy and narratives, value must be woven throughout and that requires a synthesis of communications and HEOR.
Start early in strategy development to make sure all the different perspectives are captured, then revisit this often, and maintain clear lines of sight to the various activities that are going on as the product progresses. This is more challenging the closer you get to launch and commercialisation because of the high levels of noise and activity typically encountered during that stage.
Having a clear direction of travel from the outset is also important. It then becomes a bit easier to tick off the boxes as you go and ensure everyone’s aligned in terms of what the next stage of the messaging is or what the next iteration of the narrative is going to be.
This collaboration should not only occur on the pharma side, but also between pharma and their chosen service providers. This can help pharma teams ensure their service provider’s skills and competencies match and complement those they have internally so that true peer-to-peer interaction can be had.
There’s a need for medical communication experts that also have a background in health economics and outcomes research, so that they can fully understand not only the outputs from patient-centred studies and economic models, but also the methodologies used to derive the data. Familiarity with guidelines for reporting economic or quality of life studies are needed to ensure research is correctly reported and key data incorporated.
Incorporating a medical writer with HEOR experience into a project team can expedite dissemination of study data. Often scientists, by necessity, not only develop an economic model or patient-reported outcome measure, but also develop and submit the manuscript for publication. Whereas input from scientists is needed to summarise methods and results and provide context on study results, these scientists lack the expertise that a medical communications professional can provide. Medical writing professionals are experienced in medical communications and can facilitate the submission process, ensuring compliance with meeting or journal requirements as well as with company standard operating procedures.
Added to this, trained medical writers will also communicate in a voice and tone that resonates with the particular audience, improving the relatability of the value story and incorporating visual elements where needed. This also helps develop value communications that are scientifically sound, concise, relevant and engaging.
What we’re going to see happening is more of a merger of HEOR and medical communications expertise that brings together experts who know how to write manuscripts or value communication pieces, working more with scientists who then can focus on the methodology, results and interpretation and contextualisation of results.
Just as healthcare value is changing, so are the skills needed to understand the unique perspectives of HCPs, payers and patients and tailor value communications to them accordingly. Choosing service providers with experienced HEOR and medical communication professionals can benefit pharmaceutical companies in terms of compliance and efficiency that ultimately may decrease time to publication.
We need to be able to communicate effectively and efficiently to all stakeholders, and this will require further work on incorporating various perspectives, including the patient perspective, into value communications.
As the number of real-world and health economic studies in the published literature continues to grow, we should challenge ourselves to ask, ‘what do patients really value?’ It’s only by asking the right questions that pharma companies can correctly direct their endeavours to improve patient outcomes.
Armed with information tailored to its key stakeholders, the industry has an opportunity to change traditional medical communications, translating what can often be dense, data-rich outputs into more easily digestible and engaging pieces that are understood by various audiences.
As value communications continues to advance and grow to include clinicians, payers, regulators and patients the need for experienced communications experts is evident. Value in healthcare as defined today is not what we’re going to see in five or 10 years and communications experts with the skills to clearly present these data will be invaluable to pharma companies. Messages have to be simplified to incorporate a broader range of health education and expanded to include not only the clinical value but also the humanistic and economic value. Companies should expect that the use of visual communication will continue to grow, and new, innovative tools will be developed and introduced as mainstream as what is already a very dynamic field continues to evolve.
Annemarie Clegg is senior vice president, strategic services at Peloton Advantage and a medical professional with more than 15 years of scientific, medical strategy, publication planning, business development and integration experience. Before joining Peloton Advantage, Dr Clegg was senior vice president, global value communications and strategic services for ICON Commercialisation and Outcomes Division.
Beth Lesher is a director in the Strategic Market Access Center of Excellence, located in Pharmerit’s Bethesda, MD office. Dr Lesher has more than 20 years of medical writing experience in a variety of therapeutic areas. For the last 15 years, Dr Lesher has primarily focused on HEOR medical communications including the dissemination of information on economic models and patient-centered outcomes. Dr Lesher is a board-certified pharmacotherapy specialist and a member of the ACCP and the AMCP, serving on the Format Executive Committee.