By: Alison Golla, Clinical Project Manager
In order to gain market adoption, maximize reimbursement, land beneficial payer contracts, and remain competitive, medical device manufacturers must be able to demonstrate a “trifecta” of clinical evidence: 1) Clinical efficacy, 2) Patient-centered benefits/improved QOL, and 3) Cost-effectiveness. Read on for insight on the value of assessing cost-effectiveness through health economics and outcomes research (HEOR).
Clinicians, hospitals, patients, and payers each have their own interests in assessing treatment options – HEOR serves to quantify the economic (cost impacts) and clinical outcomes (effects/consequences) of healthcare interventions, helping manufacturers discern and relay the value of their product to each of these stakeholders. Increasingly, healthcare decision-makers and payers are requiring this kind of evidence to fully understand product value and its potential significance in real-world clinical practice.
Clinical outcomes may result from the disease itself or as a result of a treatment intervention. Economic outcomes refer to the direct and indirect costs for the clinical outcomes. In other words, what outcome(s) were achieved at what cost?
How HEOR Evidence Fits
HEOR allows researchers to assess the therapeutic response to device treatment within the context of an economic analysis to determine quantitatively how its exposure impacts healthcare resource utilization (HRU) and direct medical costs within a representative population of patients with the disease/condition of interest.
Although HEOR studies can be prospective or retrospective in nature, precise trial design is imperative, as results may vary widely as a function of trial approach and the analytical methods selected. Data obtained from well-designed studies can demonstrate the impact of a specific therapy on HRU (i.e., rate of hospitalizations, outpatient visits) as well as rate of clinical complications (i.e., infection, microvascular conditions) that reflect patient health status as compared to pre-device exposure (when each subject is their own control) or as compared to a patient cohort using an alternative treatment.
Develop HEOR Evidence Early
Anticipating the need for such data, HEOR is progressively being incorporated earlier into the regulatory (safety and effectiveness) study phases. These data can help further align the company’s regulatory and clinical evidence strategies with the reimbursement strategy for product value, coverage, and market access.
Strategic thinkers should consider how to build the collection of HEOR data into early regulatory trials to help reduce the cost and length of post-approval studies by providing cost estimates of treating these patients within a health system earlier in the development process. Factors to consider in the protocol include: type/length of health services needed, diagnostic tests, pharmacological/dosing interventions, etc. These early data help refine the outcomes of focus for future studies and identify unmet needs and knowledge gaps. These data can also be persuasive to payers and other providers who will ultimately make the final decision about new product adoption.
Using HEOR Evidence Effectively
HRU patterns, associated costs, and various clinical outcomes are determined by evaluating data (i.e., claims, records) with pre-specified diagnoses, procedural and/or billing codes (e.g., ICD10, CPT, HCPCS). Post-market research usually involves retrospective analysis of deidentified claims data from large national insurers for a specified timeframe. A favorable impact informs company decision-making and illuminates areas of focus for R&D, product differentiation and sales strategies, and the potential for additional marketing claims. Realization of negative impact compared to standard of care or competing products may be equally informative in highlighting areas for development and improvement. In either case, the company will have a much better idea of evidence development necessary for reimbursement success.
When employing HEOR as part of your clinical strategy, think about the following four considerations:
– What types of clinical events or complications those with the disease are at risk of developing?
– Does the device/therapy of interest have an impact on those complications?
– What are the true costs of treating those complications? Consider the chronicity and recurrence and how they may compound the economic impact and need for repetitive care.
– How may the device impact the costs of complications or advanced sequelae as compared to the standard or care, conservative therapies, or competing products?
Keep in mind that claims datasets only include “coded” services (e.g., CPT, HCPCS, etc.) and do not capture patient burden or indirect resource utilization. However, once the HRU and direct costs are known, you may consider patient-centered aspects including debilitation, pain and absenteeism and other indirect costs (transportation) and intangibles (psychosocial burden/QOL) that may amplify the economic impact.
In summary, HEOR is becoming a vital component of medical device clinical strategy to optimize market adoption and reimbursement by leveraging data to support product differentiation and communicating real-world product value.
If you have questions about how to incorporate HEOR into your strategies, contact RCRI at firstname.lastname@example.org or 952-746-8080 to be put in touch with an RCRI expert.