Posts Tagged RWE

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 Data for more common illnesses may be available but out of date.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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Benchmarking Survey: Can we reduce procurement time in HEOR & RWE?

As healthcare moves towards an increased focus on outcomes and value, health economics & outcomes research (HEOR) and real-world evidence (RWE) are being used to guide value-based decisions, improve outcomes, reduce costs, and achieve market access. This move toward new ways of defining value has led to growth in the number and complexity of HEOR and RWE initiatives as well as increased diversity in the types of stakeholders involved in them.

Outsourcing of HEOR & RWE is increasing

As a result of expansion in HEOR/RWE initiatives, many companies are outsourcing to keep up. A 2017 survey conducted by ISR Reports found that companies outsource an average of 75% of their HEOR work, a trend driven by limited internal resources, lack of time, and the need to foster great credibility by using trusted third-party partners.1

To better understand the challenges and opportunities in the procurement and contracting of HEOR/RWE projects, HealthEconomics.Com and Scientist.com conducted an online survey of researchers and suppliers in HEOR, RWE and related areas with over 150 respondents. The HEOR and RWE Sourcing and Procurement Challenges and Opportunities Benchmarking Survey represented a wide variety of companies including biopharma/medical device (35%), research consultancies including CROs (37%), private payers/pharmacy benefit management companies (5%), and academia (7%). Forty percent of respondents were from large organizations with 1,000 or more employees. About one-third (31%) categorized themselves as a buyer of services, 38% were a supplier, and 25% were both a buyer and a supplier. 


Consistent with the ISR survey1, the HealthEconomics.Com and Scientist.com benchmarking survey showed that three-fourths (71%) of respondents outsource one-half or more of their work.

Contracting time is a challenge in HEOR & RWE procurement

One of the most serious stumbling blocks identified was long contracting times.

More than one-half (55%) of HEOR/RWE professionals found that average contracting time exceeded 2 months and 10% found that it exceeded 6 months.

Consequences of long contracting time

Long contracting times delay insights, impede market access, hinder decision-making by providers and payers, and may result in increased costs of drug development and commercialization. Ultimately, this leads to delays in how quickly an intervention gets to the patient. As one Medical Affairs professional from a consulting company put it: “[Procurement] takes a very long time, making [study] results less meaningful”.

Need for standardization

Many respondents grappled with overly complex administrative and legal processes during the HEOR/RWE sourcing and procurement process. Eighty percent of respondents (both buyers and suppliers) agreed that buyer requirements are not standardized. This finding was echoed by an editorial in Clinical Leader, stating, “HEOR procurement can be intricate due to the lack of standardized requirements and regulations.”2 This results in a longer period in the negotiation and set up phase of contracting before the actual work can even begin.

While both suppliers and buyers identified a more standardized and expedited contracting process as a major need, there were key differences in how their comments approached the issue.

Suppliers focused on problems with buyer processes with 8 out of 10 agreeing that it is difficult to navigate through the buyer’s procurement process. Seventy percent agreed that buyer compliance requirements hinder successful contracting.

Buyers focused on the time spent working with their own internal procurement team. A Director of Outcomes Research from a pharmaceutical company said that, “…timelines certainly are [affected] when having to jump through hoops to demonstrate why one supplier is needed over another”. Indeed, over 60% agreed that it is challenging to compare suppliers for a project.

A solution that simplifies administrative and legal requirements while allowing buyers to easily differentiate suppliers is clearly needed.

A marketplace solution for sourcing challenges

Scientist.Com, the world’s leader in scientific services marketplaces connecting buyers and suppliers, found that an online marketplace approach improved contracting time and saved money. As shown in the figure below, the online marketplace resulted in a first proposal within 7 days of a highly complex request, provided for easy comparison of 5 different suppliers, and resulted in a realized cost savings of >$20,000. Applying this approach to HEOR and RWE could result in a similarly expedited contracting process and the potential for cost savings.

Figure: Impact of Online Marketplace on Supplier Response Time and Costs
[source: Scientist.Com data on file]

HealthEconomics.Com and Scientist.com have partnered together to launch the HEOR & RWE Marketplace, an online solution that accelerates the sourcing and procurement process for researchers and suppliers of HEOR, RWE and market access services.3 By streamlining the process for buyers and sellers, the HEOR & RWE Marketplace will deliver reduced time to contract, quicker time to insight, and faster market access, while saving costs.

The HEOR & RWE Marketplace

Powered by two trusted life science brands

The HEOR & RWE Marketplace is comprised of a global network of suppliers with access to a host of data sources, and placing an order is simple:

  • Researcher places a request
  • The details of the request are sent to several qualified suppliers
  • Researcher receives responses within days
  • An experienced Research ConciergeTM team quickly narrows the pool of eligible suppliers
  • Researcher receives proposals to compare
  • Researcher selects the best one for the particular study
  • Researcher receives requested services upon internal approval and completed PO

As HEOR and RWE are increasingly required by payers and providers, outsourcing and procurement are critically important to the research process of evidence development. It is imperative that administrative, sourcing, and legal hurdles do not prevent much needed interventions from reaching patients. Solutions like a marketplace approach should be fully evaluated in terms of their ability to simplify procurement, reduce time to contract, deliver quicker time to insight and facilitate faster market access, while saving costs.


References:

  1. 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.
  2. Parikh, H. An Overview Of Offshoring HEOR. Clinical Leader (2015). Available at: https://www.clinicalleader.com/doc/an-overview-of-offshoring-heor-0001.
  3. HealthEconomics.Com, Scientist.Com Partner on RWE/HEOR Initiative. HealthEconomics.Com (2018). Available at: https://www.healtheconomics.com/industry-news/healtheconomics-com-scientist-com-partner-on-rwe-heor-initiative.

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