Posts Tagged HEOR

Value Communication is Not Fit for Purpose in Biopharma

Value communication (VC) is essential for a successful market access strategy that aims to bring interventions to patients. It is no longer enough to simply show that an intervention is effective. VC must also focus on health economics and outcomes research (HEOR), market access, regulatory decision making, epidemiology and real-world evidence (RWE) while aligning with the interests of the stakeholder.

In a recent blog for Pharma Intelligence, Don Creighton, head of US Market Access for ICON and now Managing Director, Life Sciences Practice with Huron, bemoaned the state of VC, saying, “…companies fall short in communicating their value message consistently to all comers.”1 “All comers” refers not only to payers but also to patients, providers, advocacy groups, government bodies and society as a whole.

At the heart of communicating value messages are the people doing it. It is key to attract and retain top talent who understand the science of value demonstration, while using training to promote technical and soft skill sets that support the effective communication of VC to different audiences. Little research has been done in either the HEOR or the medical communications industry to investigate the drivers and barriers in VC as well as training needs. HealthEconomics.Com’s Value Communications survey (contribute your opinion here) identified barriers and gaps in VC that may render this industry function currently not fit for purpose.

Dr. Patti Peeples, CEO of HealthEconomics.Com, commented on this deficiency, saying: “The value communications process in our industry is not fit for purpose, because we do not have sufficient understanding of the needs, techniques, or effectiveness of these VC tools. It’s imperative that we investigate this from the perspective of the developers, the communicators, and the recipients of value evidence, and build in learning systems to measure how well we are achieving our VC objectives”.

A survey to identify key challenges and opportunities in value communication

To better understand the challenges and opportunities in communicating value, HealthEconomics.Com conducted an online survey of 139 individuals involved in developing, communicating or assessing the clinical, economic and humanistic value of pharmaceuticals and medical devices.

The Value Communication Survey represented a wide variety of companies, countries, and job functions as they relate to evidence development and communication.

Click to view a larger image.

Outsourcing was lower than expected among respondents

Surprisingly, 38.4% of all respondents did not outsource any of their work in VC, which is lower than average compared with HEOR research outsourcing. It is possible that this survey’s outsourcing rate is low because of factors like high outsourcing costs for tool development, increased in-house ability, or lack of outsourcing availability. This could be an area for further research.

(a) Customer groups were defined as customers who respondents had developed tools for either frequently or sometimes. Click to view a larger image.

The increasing need for VC tools mirrors the recently enacted 21st Century Cures Act on the use of RWE and patient experience data (PED) and the FDA RWE Framework released in December 2018.3,4 There is an increasing need for individualized VC tools for a diverse group of stakeholders, ranging from providers to private/public payers to patients.

More than 80% of respondents were interested in additional training in VC tool development and usage.

Among respondents, training was most needed in three main areas: writing skills, technical data and customer centricity.

Click to view a larger image.

Interestingly, a number of respondents identified social media and direct email marketing as commonly-used methods of value communication. This was confirmed by a 2016 Deloitte Review highlighting how companies are providing patients with digital engagement services.5 This goes beyond patients with a Capgemini Consulting survey of 866 providers finding that nearly half preferred digital communication including email and web portals.6 It will be key for any training to address this emerging area.

What is the perspective of value communication recipients?

Comments from individuals on the receiving end of value communication (e.g., payers, advocacy groups) focused on technical content, asking for improvement in health outcomes, trial result extrapolation and RWE. A Human Research Ethics Committee member from an association asked for “[clearer] health outcomes [to be] presented” while a manager of economics at an HTA agency wanted, “extrapolation beyond trial results [including] indications, setting, country, [and] length of follow up.”

It will be key for value communication personnel to be well-trained on the technical side of clinical and HEOR/RWE methodologies, in addition to the soft skills needed to deliver this information.

Respondents found tools like models and analyses most effective in value communication. Several also mentioned their preference for the web and webpage links.

What’s Next?

To conclude, evidence-based data is powerful in giving us ways to address the barriers in value communication identified by this survey, especially through training designed specifically to upskill value developers and communicators on the technical and soft skills of value communication.

As pharmaceuticals move away from volume to more value-based strategies, it is also developing into a digital environment with multichannel communication strategies. Value communication has to keep up. Developing the technical, writing and customer-centric knowledge of employees will provide a high return on investment, ensuring that patients have access to the products they need.

Further research remains to be done on value communication, including better defining product lifecycle-specific value communication tools and identifying the type of evaluation metrics that would be useful in measuring value communication effectiveness and ROI.

Dr. Peeples will be speaking more on this topic at two upcoming conferences:

Keynote Speaker, “The Value of a Drug – What it Means, Why it Matters, and How to Communicate it,” at 9 a.m. Wednesday, Feb. 20, at the 18th Annual International Publication Planning Meeting.

Workshop Leader, “ Building your Clinical Value Story/Value Dossier”,
at 9:25 a.m. and 10:15 a.m., April 17, 2019 at 15th Annual International Society of Medical Publications Professionals (ISMPP) .

If you are involved in evidence development, translation, or communication, and have any feedback about this topic or would like Dr. Peeples to speak to your group, please reach out to info@healtheconomics.com.


[1] Looney, W. Repositioning Market Access: A Function Fit For Purpose In A New Era Of Costly Cures. Pharma Intelligence (2018). Available at: https://pharmaintelligence.informa.com/resources/product-content/repositioning-market-access-a-function-fit-for-purpose-in-a-new-era-of-costly-cures.

[2] ISR Reports. Benchmarking the Pharma Industry’s HEOR Function. (2017). Available at: https://www.isrreports.com/wp-content/uploads/woocommerce_uploads/2017/09/2017-Benchmarking-the-Pharma-Industrys-HEOR-Function-2nd-Edition-Enterprise.pdf.

[3] 114th Congress. 21st Century Cures Act, Public Law No: 114-255. (2015).

[4] FDA. Framework for FDA’s Real-World Evidence Program. (2018). Available at: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf.

[5] Lush, M., Rosner, D., Zant, C. & Notte, S. Patient engagement strategies in a digital environment: Life sciences companies respond to changing patient expectations. Deloitte Review Issue 18 (2016). Available at: https://www2.deloitte.com/insights/us/en/deloitte-review/issue-18/patient-engagement-strategies-changing-patient-expectations.html.

[6] Rose, W., Hasan, S., Saitta, J. A. & Kim, C. Tracking the Shift From Volume to Value in Healthcare. Capgemini Consulting (2017). Available at: http://www.volumetovaluestudy.com/docs/Tracking the Shift From Volume to Value in Healthcare.pdf.

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Key Elements of a Real-World Evidence Generation Plan: Integration of Product Support Activities

Shelby Corman
Shelby Corman
Pharmerit International

Real-world evidence is a key component of value demonstration for pharmaceuticals, diagnostic agents, and medical devices throughout the product lifecycle. Planning for real-world evidence needs early in the pre-launch period can allow for seamless integration of health economics and outcomes research to support product value and market access.

  1. Start with the “aspirational” product value story and work backwards

It is necessary to plan your real-world evidence generation strategy early in the product development process, so that the correct and most impactful data can be collected and analyzed to support the product’s value story. A set of aspirational value messages can help guide evidence generation strategies, including those for real-world evidence. A literature-based “match and gap” analysis can be used to determine whether aspirational messages are supported by existing literature, and then evidence generation strategies can be tailored to fill key data gaps.

Choosing the appropriate study design and planning for the time required to execute are important. Secondary data sources (such as administrative claims data) are readily accessible, and analyses can be completed in 3 to 6 months, but essential elements such as disease staging and severity are often missing. Primary data collection is often required to obtain data elements for stratification of patients, such as biomarker results or rationale for treatment decisions. Retrospective chart reviews can generate results in 6 to 12 months and can be combined with a patient-reported outcome (PRO) survey in a hybrid design to provide a snapshot of quality of life or patient preference. Prospective study designs usually take 12 months or longer to generate results but create opportunities to collect longitudinal quality of life or other health outcomes data.

  1. Establish the disease burden

Demonstrating the clinical, economic, and humanistic burden of a disease is a key need early in the development process and sets the stage to inform stakeholders regarding the potential value of a product. For rare diseases, this can mean raising awareness of the disease, estimating incidence and prevalence, and characterizing the population with the disease. Data for more common illnesses may be available but out of date. Estimating the economic burden of disease is especially important to a payer audience, in order to justify resources required to adopt new technologies.

Real-world evidence on the epidemiology and burden of disease should be communicated in peer-reviewed publications, incorporated into global and payer dossiers, and used to populate economic models. An accurate estimate of disease incidence and prevalence is crucial to understand the budget impact of the adoption of new technologies.

  1. Identify current treatment patterns and unmetneeds

Understanding the current standard of care for the target patient population and, by extension, the unmet patient needs expected at the time of launch, is essential for an informed market access strategy. Retrospective studies to identify current market share are required to populate budget impact models and can be used to drive the selection of comparators for cost-effectiveness models.

Further exploration of patient characteristics and clinical outcomes associated with current treatments can support a value narrative centering on unmet needs. For example, real-world evidence of early treatment discontinuation due to adverse events with existing therapies can support value messages for products with improved adverse event profiles. Such a finding could also highlight the need for the integration of qualitative research or patient-reported outcomes assessments in your real-world evidence generation strategy to further characterize the burden of adverse events on patients.

  1. Determine the key economic drivers

A solid economic value story is crucial to reimbursement in some countries and plays a supporting role in others. As such, data needs for economic models are a key consideration for real-world evidence generation plans.

The scope of real-world evidence needed depends on the complexity of the disease process and its treatment, and in turn the complexity of the model. Real-world studies can be used to quantify the cost of treatment success or failure, stratify medical costs by disease severity, and identify the incremental cost of adverse events.

Early economic models, typically designed and executed during phase II development, can be powerful tools for ensuring a solid evidence base for subsequent payer-facing models. Gaps in data required to populate cost-effectiveness and budget impact models, such as treatment pathways and healthcare resource utilization, can be identified early and addressed using real-world studies.

  1. Support clinical effectiveness

From a product development perspective, the role of real-world studies has historically been limited to the post-marketing setting, in which they have been used to fulfill post-marketing commitments, confirm safety and effectiveness in a broader patient population than that studied in clinical trials, and assess comparative effectiveness of treatments. These studies are important components of an evolving value proposition for a product, which can be communicated to decision-makers in the form of publications and incorporation into value dossiers.

In the United States, the 21st Century Cures Act has the potential to significantly reshape how real-world evidence is used in the development of new health technologies. The Cures Act, signed in December 2016, gives the Food and Drug Administration (FDA) two years to develop a framework for using real-world evidence. Guidance has been developed for medical devices, noting that real-world data could be used for purposes such as generating hypotheses to be tested in prospective studies, as a historical or concurrent control group, and as evidence to support biomarker validity, among others. Similar guidance is in develop for drugs and biologics.

Conclusions

Real-world evidence can support product value directly, by raising awareness of the disease burden and unmet needs, and indirectly, by providing inputs for economic models and identifying opportunities for additional qualitative or patient-centric research. Understanding the role of real-world evidence in the overall product value strategy and coming up with a solid plan early in the product development process can help justify the need for resources to conduct these studies in the face of competing priorities.

Contact Pharmerit for more information on Real-World Evidence.

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