Economic data can be any data that tells a utility or benefit story. It can include health economics and outcomes research (HEOR) which measures and generates evidence of a product’s value and impact to support reimbursement and market access. But, for purposes of this blog post, we will use the term ‘economic data’ more broadly than the term HEOR.
Economic data is typically used for new and expanded market access strategies after a product has launched, but can be gathered prior to launch. This data can show the economic benefits vs. the harm or costs in comparison to other treatments. It can also display to payors or health system facilities the impact of a device for treatment, patient care outcomes or clinical management prior to the large-scale collection of clinical data.
Framing the data for the economic or value story is just as important as the data itself. Defining the unmet need, disease burden and the solution you are bringing to the healthcare system in a concise manner will qualify the engagement process. Each step in the process will need to be handled carefully to ensure appropriate timing and a constructive impression with payors.
The Benefits of Economic Data
Clinical evidence will be required for successfully launching new devices and technologies. But, usually both improved clinical and health economic data will guide payor decision-making. The importance of each component in your strategy will vary by the situation. At times, it is extremely powerful to be able to tip the scales or at times, it may be only supportive in nature—or, even minimally relevant—for certain devices and specialties.
Economic Data for Value Analysis Committee
New technologies used in the hospital will require approval from a Value Analysis Committee (VAC), comprised of medical staff and quality personnel. The VAC is the gatekeeper and acts much like a payor would in determining access to your products through a formal decision making process. The VAC will deliberate over the data provided. During this process, the VAC will analyze both the clinical and cost benefits as well as perform a comparison of similar products.
- Data is needed to show clinical utility or value of the procedure or technology to be compared to the current standard of care.
- Payors, providers and purchasers are generally all concerned with the clinical value of new products and services and will prioritize technologies that provide increased value. New technologies will need to demonstrate additional value compared to currently available technologies.
- Of course, from the perspective of payors and VACs, “value” is multifaceted and covers areas including: effectiveness of patient outcomes, clinical need, workflow, cost vs. benefit, benefit vs. harm, and a technology’s ability to treat a condition compared to other treatment alternatives.
- Payors often express their desire for health economics data for new technologies to demonstrate the value of the potential additional costs from the use of a device.
Economic Data in Coverage Communications with Payors
It is rare for a manufacturer to speak directly with a decision maker at a payor. A payor may agree to meet with a manufacturer if they see a need, such as a need for specialty education or if complaints exist in how claims are processed and reviewed. Meanwhile, a request to the payor must usually be communicated in writing, providing extensive supporting documentation so that the payor can review internally and without bias.
Many times, payors will review a Sponsor’s publications and make coverage decisions based on the publicly available evidence. While this is usually considered an accurate methodology, generalizations can be made in coverage decisions that differ slightly based on specific specialties, unique population characteristics, limitations and inaccurate comparisons. This is when payor engagements may be needed to correct a perspective or when subject matter experts are needed to educate on the topic. In this case, economic data can be used to sway or bring up a unique point.
Real-World Evidence as Part of Economic Data
Randomized Controlled Trials represent the gold standard for generating clinical data, but payors and providers also value Real World Evidence (RWE). That is, how does the product perform and what are the real costs and complications when the device is used outside of the investigative setting?
The burden of proof needed for payment/reimbursement for services and technologies is higher than that needed for U.S. Food and Drug Administration (FDA) clearance or approval.
The data generated from a robust clinical development plan based on careful analysis, and with the end in mind, will help get the attention of providers and payors related to early market adoption. It will also provide the platform for working with payors for post-market data for longer-term follow-up and outcomes. Data will pave the way for market access and future consideration for product enhancements and expanded indications.
How can NAMSA help?
NAMSA can help determine how economic data may play a role in gaining widespread access. From opening up policy for a broader patient population, serving as a defensive strategy for inadequate clinical evidence, or encouraging more educated payor decision making, NAMSA is here to help.
NAMSA reimbursement experts can assist you in mapping out value propositions and a subsequent data collection plan. We also offer strategic advice on how to prioritize value messaging and analyze the impact of your clinical and economic data to various stakeholders. Whether you come to us with a full breadth of data and outcomes, or you need help starting a plan, NAMSA can help.
NAMSA offers a full continuum of reimbursement services and solutions for new and existing medical technologies. Our team are experts in all aspects of reimbursement strategy, including: payer relations, medical policy research, coverage advocacy, HCPCS and CPT code applications and value proposition analysis.
To learn more about NAMSA’s Reimbursement Services, please visit: https://namsa.com/services/reimbursement/. Or, sign up for a complimentary consultation with one of our reimbursement experts by visiting: https://namsa.com/namsa-expertise/subject-matter-experts/.
Rebecca Lanquist
Rebecca Lanquist is a seasoned reimbursement professional with multiple years of experience in Medical Devices, Durable Medical Equipment and Remote Patient Monitoring. Her functional expertise include Reimbursement Strategy, Health Policy, Coverage, Billing Guides and Tools, Payer Relations for Limited Coverage Cases, DME Supplier Billing, Medicare and Stakeholder Incentives. Rebecca’s prior work include products in Urology, Skin and Wound Care, Physical Medicine and Rehabilitation, External Prosthetics and Orthopedics. Prior to NAMSA, Rebecca held positions at firms such as Ottobock Healthcare, Coloplast Corp. and Magellan Medical Technology Consultants .