--- title: "ICER, Incremental Cost-Effectiveness Ratio | MedTech Terms" description: "Cost per additional unit of health outcome (often QALY) versus comparator. Plain-English Reimbursement definition for MedTech teams, with examples and related t" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/icer#term", "name": "Incremental Cost-Effectiveness Ratio", "alternateName": "ICER", "description": "ICER = (Cost_new − Cost_comparator) / (Effect_new − Effect_comparator). A foundational HTA metric. 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Incremental Cost-Effectiveness Ratio [All terms](/terms) Reimbursement [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)ICER # Incremental Cost-Effectiveness Ratio Cost per additional unit of health outcome (often QALY) versus comparator. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ICER = (Cost\_new − Cost\_comparator) / (Effect\_new − Effect\_comparator). A foundational [HTA](/terms/hta) metric. The U.S. organization ICER (Institute for Clinical and Economic Review) produces influential value assessments. What the regulation says While not directly mandated by specific MedTech regulations like the EU [MDR](/terms/mdr-reporting) or FDA 21 CFR, the Incremental Cost-Effectiveness Ratio (ICER) is a critical metric in Health Technology Assessments ( [HTA](/terms/hta)), which often influence market access and reimbursement decisions. Regulatory bodies and payers consider HTA outcomes to evaluate the value proposition of new medical devices and treatments. ## What this means in practice Often confused with the U.S. organization of the same name. Manufacturers must distinguish between the math and the organization in commercial conversations. ## Examples - A manufacturer calculating the ICER for a new surgical robot compared to traditional open surgery to demonstrate its cost-effectiveness to a national health service. - A MedTech company using ICER results to justify the pricing of a novel diagnostic device during negotiations with private insurers. - During a health economic submission, a company provides an ICER analysis to a European HTA body to support inclusion of their device on a national reimbursement list. Common pitfalls - • Confusing the mathematical concept of ICER with the Institute for Clinical and Economic Review, an organization that performs HTA using ICER. - • Failing to consider the specific thresholds for cost-effectiveness that vary by country and payer. - • Not adequately accounting for all relevant costs and effects in the ICER calculation, leading to an inaccurate representation of value. - • Presenting ICER without appropriate context or sensitivity analyses, which can misrepresent the robustness of the findings. ## Frequently asked questions How does ICER relate to regulatory approval of a MedTech product? ICER does not directly impact regulatory approval, but it significantly influences reimbursement and market access post-approval. A favorable ICER can strengthen a product's value proposition for payers. Are there universal ICER thresholds for market access? What are common challenges in calculating ICER for MedTech products? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Reimbursement Health Technology Assessment(HTA) Systematic evaluation of clinical and economic value of a health technology. ](/terms/hta)[ Reimbursement Quality-Adjusted Life Year(QALY) Outcome metric combining length and quality of life used in HTA. ](/terms/qaly) ### More in Reimbursement · Same category [ Reimbursement 340B Drug Pricing Program(340B) Federal program providing discounted drugs to safety-net providers. ](/terms/340b)[ Reimbursement Ambulatory Payment Classification(APC) The Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient. ](/terms/apc)[ Reimbursement ASC Site-of-Service Shift Migration of procedures from hospitals to ambulatory surgery centers. ](/terms/asc-shift)[ Reimbursement Budget Impact Model(BIM) Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon. ](/terms/budget-impact-model) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICER· 1 AdvaMed· 1 AMA· 1 1. [1 ICER (US) Verified ICER · icer.org ](https://icer.org/) 2. [2 AdvaMed - Payment & Coverage Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 AMA CPT Resources Verified AMA · ama-assn.org ](https://www.ama-assn.org/practice-management/cpt) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Need cybersecurity expertise on a connected-device launch? Blue Goat Cyber helps MedTech teams ship connected products that hospital security teams will actually procure. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Reimbursement Acronym ICER Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=icer) Learn in 60 seconds Card Lesson Quiz Cost per additional unit of health outcome (often QALY) versus comparator. - · Often confused with the U.S. - · organization of the same name. - · Manufacturers must distinguish between the math and the organization in commercial conversations. Remember this Watch out: Confusing the mathematical concept of ICER with the Institute for Clinical and Economic Review, an organization that performs HTA using ICER. Related terms - [Quality-Adjusted Life Year(QALY) ](/terms/qaly) - [Health Technology Assessment(HTA) ](/terms/hta) You may also need Auto-suggested from Reimbursement and shared keywords. - [Budget Impact Model(BIM) ](/terms/budget-impact-model) - [Health Economics and Outcomes Research(HEOR) ](/terms/heor) - [NMPA Innovative Medical Device Pathway ](/terms/nmpa-innovation) - [Sample Size and Statistical Power ](/terms/sample-size-power) - [Ambulatory Payment Classification(APC) ](/terms/apc) - [New Technology Add-On Payment(NTAP) ](/terms/ntap) [All Reimbursement terms](/terms?cat=Reimbursement) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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