Purchasing departments said “prove it.” With our Endocuff-assisted colonoscopy device, we took the challenge and we are glad we did.
By Beth Wall, Director of Health Economics and Reimbursement, RN, MS, Olympus
“Prove it.” Hospital purchasing departments have good reason to ask medical device companies to provide proof that investments into new technologies will make good sense. But what and how should medical device companies be presenting such proof to their potential customers?
At Olympus, we recently had an opportunity to show the economic value of an investment in our ENDOCUFF VISION (Endocuff) technology – and the response from hospitals and other stakeholders has encouraged us to pursue additional economic value research for other products from many of our medical business units.
What we set out to prove
We knew from clinical data that our product, the Endocuff, improved adenoma detection rate (ADR), one of the most important indicators for prevention of interval colorectal cancer (defined as cancer that recurs between colonoscopy screenings).
The Endocuff device attaches to the distal end of a colonoscope, with multiple flexible “arms” that fold within the product during intubation and forward movement and open out when drawn backward, thereby flattening the bowel folds and controlling the field of view. Olympus Endocuff received FDA 510(k) clearance in 2016 for the claim that the device results in a statistically significant and clinically relevant improvement in ADR, as compared with unassisted colonoscopy, due to its design, which maximizes visualization of the mucosa. For each 1% increase in ADR, there is a 3% reduction in the risk of interval colorectal cancer (CRC).[i] ADR is shown through meta-analysis to be 14% higher with Endocuff-assisted colonoscopy compared to standard colonoscopy (29.8% vs. 25.8%).[ii], [iii], [iv]
But with all its clinical advantages, the Endocuff would still add a cost for each case, one that the healthcare provider or payor would have to absorb.
What our stakeholders needed, from payors to hospital purchasing departments to physicians who wanted to make a case for using Endocuff, proof of return on investment. We had a strong theory, based on reasonable assumptions, that cost savings and health benefits could be reflected in terms of the patient’s ability to avoid CRC and the associated medical and cancer treatment costs.
It was on us to make the case.
First, we engaged a third-party researcher
We identified the researchers at Guidehouse, and a team led by Tiffany Yu, whose experience in evidence development across a variety of indications has been shown to inform reimbursement and adoption discussions for payor and provider decision makers. We were interested in a partner with expertise in health economics and outcomes research (HEOR) and a proven record of rigorous research, as well as presentation experience at professional society conferences.
Second, we educated ourselves on the baseline: particularly WTP
The medical community’s work toward a “willingness to pay” (WTP) model has been a useful one. Between NICE, which is based in the U.K., and the analysis of health policy experts in the U.S., the thrust of such analysis has been to review the impact of quality adjusted life years (QALY) of patients with the use of the device.
In the case of Endocuff, facilities understand that while there could be a benefit to the device, it is not necessarily one that is measurable with each individual patient, as in the cases of patients with no adenoma detected. Given such uncertainties, it is necessary to measure the cost over the entire patient population and analyze the benefits.
Over time, as reflected in meta-analysis[v], the WTP per QALY threshold in the U.S. is at $50,000.
Third, we used economic modeling to assist in generating findings and the clinical study results were the starting point
To hasten patient benefit, it is useful to rely on models. Yu had identified the Markov model, with its origins based in gaming theory, as an ideal tool for this analysis. It is important to note that the model used clinical trial data, based on real world evidence, for its extrapolations. Starting with the multiple clinical studies that had showed that use of Endocuff during colonoscopy resulted in higher ADR, she could then draw models over time.
This model was developed in compliance and accordance with international guidelines[vi],[vii],[viii] that have been set to gauge the effectiveness of new innovations applied to healthcare. The model built for this economic study looked at CRC screening, treatment and outcomes for the average screening patient, beginning at age 50 over a lifetime — and compared these to patients screened with Endocuff-assisted colonoscopy.
CRC screening patients were tracked through health states representing screening (no CRC diagnosis), CRC diagnosis, metastasis, remission and death. Probabilities of transitioning between health states were applied annually. Patient outcomes included CRC incidence, CRC-related death, life years and QALY.
Three stakeholder perspectives were evaluated: the device purchaser, the health plan, and the fully integrated accountable care organization (ACO) responsible for both device and medical costs. These perspectives were considered separately and together. Lifetime Endocuff device costs were considered for the device purchaser; and lifetime medical costs were considered for the health plan. The fully integrated ACO was assumed to be responsible for device and medical costs.
Fourth, we published in a peer-reviewed journal
The model determined that use of Endocuff is expected to result in an absolute lifetime CRC risk reduction of 1.0%, representing a 22.7% relative risk reduction compared to standard colonoscopy. Estimates for Endocuff further indicated that for 102 patients screened, one interval CRC cancer is avoided and for every 526 patients screened, one CRC death is avoided.
In addition to clinical benefit, a cost analysis of Endocuff was conducted from different audience perspectives. For health plans and ACOs, Endocuff was shown to provide cost savings, reducing lifetime cost of care by $199 and $87, respectively. These savings were related to avoidance of CRC treatment initial costs and avoidance of treatment costs due to disease progression. The annual costs were based on average healthcare expenditures per Medicare beneficiary as reported by CMS. Annual costs for CRC patients by stage at diagnosis and phase of disease were from retrospective claims analyses.
From the medical device purchaser perspective, Endocuff lifetime costs were estimated at $112. The study further found that the incremental cost-effectiveness ratios (ICERs) for survival with Endocuff as compared to standard colonoscopy were $4,421 per life-year gained, $9,843 per QALY gained and $11,505 per avoided CRC case, far below the $50,000 WTP threshold commonly discussed in the U.S.
We also discovered that the ICER to avoid a CRC-related death was at $59,035, which extends beyond the WTP threshold. Healthcare providers or payors cannot be expected, based on current models or realities, to spend to the point of removing all risk of death, but these two are related, in that avoidance of CRC cases can be seen as death avoidance in themselves. The ICER $11,505 per avoided CRC is a WTP success story, and one that Endocuff users are happy to tell the GI community.
These results, in detail, are available in Clinico Economics and Outcome Research, November 2019, ceor-201328-cost-effectiveness-of-adding-endocuff-to-standard-colonoscop%20(1)%20(1).pdf
Fifth, we informed our customers
Our customers and their stakeholders have been resoundingly positive in their response to our effort.
We know that we raise the bar for ourselves and all the medical device industry as we make the effort toward economic proof around the benefits of already clinically proven beneficial devices. We are pleased that this can mean greater adoption of a device with important implications for the health of patients.
- Beth Wall, RN, MS, is the Director of Health Economics and Reimbursement at Olympus Corp. of the Americas
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