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Budget Impact Model Presentation Standards for Payer Audiences

ISPOR and ICER standards now jointly determine what budget impact analyses payers will accept.

Senior Correspondent · · 9 min read
Cover illustration for “Budget Impact Model Presentation Standards for Payer Audiences”
Market access and payer communications · October 5, 2026 · 9 min read · 2,097 words

Budget impact modeling asks something outside the remit of cost-effectiveness analysis: whether this particular budget can take on this intervention's cost, and how the budget changes if it does. Cost-effectiveness analysis instead expresses benefit as health gained for the money spent, a ratio that does not change with population size. Even a favorable ICER (incremental cost per health gain) leaves open the practical question of whether the payer can get through the first year after adopting it. An intervention may offer excellent value yet still exceed short-term budget capacity, and mixing up these analyses when speaking to payers quickly loses them, since their concern is not the treatment's abstract worth. They want to know how uptake would alter spending in the following year. Budget impact analysis does this by setting adoption against non-adoption, then estimating eligible patients, population size, expected share, adoption pace, costs for current and new therapies, and consequences including adverse events, admissions, and wider healthcare resource use.

The Structural Standards ISPOR Established

The way a budget impact analysis gets put together is set by structural requirements laid out in Value in Health's 2007 and 2012 ISPOR Task Force reports. The Task Force directs that a BIA mirror the outlook of the particular healthcare decision-maker it targets and be constructed from information on the size and features of that group, the existing and incoming treatment patterns, the comparative effectiveness and safety of those options, and the resource demands and costs as they bear on the decision-maker's real-world population. That necessity holds because a model built around the wrong group ends up answering a question that nobody in the room ever posed.

Time horizon works the same way. ISPOR guidance treats a span of one to five years as standard, set to fit how payers actually plan budgets rather than to capture everything the intervention does clinically over a lifetime. Payers work within annual budgets and quarterly spending reviews rather than multi-decade clinical projections, so a model spanning twenty years of results serves no purpose for those making funding decisions. Discounting works the same way but inverted: where CEA would discount, a BIA skips it entirely, a choice rooted in its focus on near-term affordability. Discounting serves to weigh value across extended periods, but a BIA operates within a short timeframe where such adjustment is irrelevant.

Perspective also has to match the budget owner’s true remit, from a payer accountable for a whole healthcare system to a limited provider-specific domain, for example pharmacy spending. Using a single countrywide result for a plan-level group fails that scoping rule, because those audiences oversee different budgets and face different constraints. The reporting cadence should therefore be yearly, quarterly, or aligned with the planning cycle used by that decision-maker.

ICER's Value Assessment Framework for U.S. Presentations

ISPOR lays down the global structural floor, and a domestic entity for evaluating worth adds another tier that today's payer submissions must satisfy. ICER pairs an assessment of enduring worth with a near-term look at whether payers can absorb the spending changes that follow a new intervention's arrival.

Under ICER's 2025 Reference Case, analyses report potential budget impact using the high end of the Health Benefit Price Benchmark, set at an evLY value of $150,000, based on estimated net pricing, with a placeholder price used if no net price estimate is available. After ICER reset the annual affordability cutoff in October 2025 for drug therapies, presenters relying on older guidance are grounding their case in figures that have been replaced. If expert forecasts show that five-year use of a new drug is apt to cross the relevant budget-impact line, the ICER assessment calls out near-term cost pressure and access concerns, making them an active payer-table negotiation point. For payer-facing U.S. decks, both standards now matter together: ISPOR determines model architecture, while ICER supplies the affordability yardstick for interpreting results.

The six inputs that determine whether a model's outputs are credible to a payer audience

Payers judge a BIM's trustworthiness by its six inputs, yet any mistake among them compounds throughout the entire projection period. An overestimated population figure for the first year never remains isolated to that initial period. Instead, it drives up all subsequent spending estimates that rely on that baseline.

That compounding typically starts with the size of the population eligible. It needs an epidemiological basis, narrowing the overall diagnosed group to those genuinely suited for and apt to receive therapy, since oversizing that pool is a frequent route to projections that read as bloated and untrustworthy to payers.

Forecasts for adoption and market share carry similar importance. For every year, the model sets out paired views of the market: usual care if the new intervention is absent, and the expected mix once it launches. Since the analysis already accounts for therapies being replaced, uptake and share choices carry far greater weight for a BIA than a one-comparator decision does in CEA work. A systematic review in Journal of Managed Care & Specialty Pharmacy of BIMs in lung cancer reported widespread departures from best-practice standards, with poorly supported market-uptake assumptions appearing repeatedly as a notable weakness. That is why payers tend to challenge these inputs before almost anything else.

The third group of inputs covers expenses, encompassing direct intervention outlays under each scenario alongside downstream spending tied to complications, inpatient stays, specialist consultations, and wider medical resource consumption. These should be paired with practical monetary factors such as what patients pay out of pocket, whether generics exist, plus discounts, deductibles, distributor margins, and pharmacy charges. Without them, payers will assume the analysis mirrors the producer's financial reality.

A fifth input is how the treatment mix changes, separate from adoption forecasts. In a BIA, the full set of therapies is weighed, so the pattern of shifts away from current options is as important as adoption of the new therapy. As a result, a BIA can capture real-world care patterns that a single-comparator CEA tends to simplify.

Rather than a data point, the sixth input represents an architectural decision about whether to use a static or dynamic model. Their professional education curriculum teaches that this selection demands explicit rationale instead of serving as a preset option, while the 2026 ISPOR practical BIA training examines static versus dynamic frameworks as an independent technical subject.

What payers actually need from a presentation format and why most submissions fall short

Payers need a format that allows them to challenge the underlying assumptions and input their own data when it diverges from the manufacturer's figures. A slide deck that blocks this kind of testing loses all credibility with payers before they even consider the figures. Here, format serves as the vehicle for genuine transparency, a principle the professional standards directly reflect.

Reporting detail has to give an independent modeler enoughreproducethe work from the ground up, because that level of openness is the requirement itself, not a favor granted to expert reviewers. Cost data need enough decomposition for the payer to set those numbers against the real spending that shows up in its covered population. Rolled-up or summarized treatment costs on their own fall short, which on its own gives the payer cause to wonder how open the full analysis really is. Model developers should hand over an editable spreadsheet built in common software, letting the payer drop in its own real costs without altering the model's structure. Asking a payer to acquire specialized software just to open the file should be treated as a deal-breaking problem, not as a trivial annoyance.

Show annual findings in tables and charts, tailoring the breakout to each budget holder, for example by splitting drug spending from medical spending or using another division aligned with that payer's organization. Include an interactive, easy-to-follow model version alongside the presented materials. The ISPOR 2026 BIA course has learners work through two Excel-based examples, a static model plus a dynamic one, supported by templates distributed in advance for in-class and later use. The course design reflects the field's settled expectation: BIAs should be delivered in Excel files that users can interact with and adapt.

Evidence shows what is at risk when this is mishandled. Payers usually give BIMs only middling weight as economic support for choices about formulary access, while sponsorship concerns and poor transparency help explain why BIMs have so little influence over those decisions. Poor formatting is more than a surface flaw; it directly undermines confidence.

Validation and Credibility in the TRICARE Antidiabetic Formulary Model

Published in 2019 by the Journal of Managed Care & Specialty Pharmacy, the TRICARE antidiabetic formulary BIM remains among the strongest payer-validated cases on record, and its validation findings shape the presentation standards for all such models. The study assessed validity across three separate dimensions: face, predictive, and internal verification.

Of all parts of the case, the predictive validity check teaches the most. It showed that a specific utilization growth assumption was making the model perform poorly. Taking that assumption out of later models made them perform better. The validation process went beyond just confirming the model. It altered the model's outputs outright, revealing a mistake that neither face validity nor internal verification by itself could have caught.

The takeaway for those sharing a BIM with payers is straightforward: spell out every face, internal, and predictive verification step applied to the model. Embedding those details directly in the main slides establishes trust and value for payers, instead of hiding them as an afterthought buried in an appendix. Such evaluations are still rare industry-wide, so when presenters omit them, payers notice, potentially reinforcing why these models see limited uptake during formulary reviews.

The customization imperative: why a national-level model cannot serve a plan-specific audience

The structural error seen most often in BIM presentations is putting one nationwide model in front of a payer whose remit is a specific plan, signaling that the manufacturer built the model for its own ends. ISPOR's localization rule, raised earlier as an abstract point about perspective, turns practical at this stage: the budget holder facing the model could be a payer overseeing a whole healthcare system, or a smaller body like one provider area, with the model's scope required to fit whichever applies.

The Journal of Managed Care Medicine study of high-risk percutaneous cardiac support devices, or pVADs, in heart failure patients shows this kind of scoping in practice. Instead of reducing spending to a single total, the model estimated the health-plan budget impact for each subgroup separately and in combination: patients with cardiogenic shock and patients undergoing high-risk PCI (percutaneous coronary intervention), reflecting their distinct cost patterns. It also examined resource use after patients left the hospital and found no signal of ongoing utilization, an insight that would be lost in a single national estimate but that a health plan would need for near-term post-discharge budgeting.

Such applied tailoring currently involves integrating inputs unique to each payer, weighing model parsimony against precision and plausibility, and framing outputs to match how a given budget holder plans. To teach these skills, the ISPOR 2026 BIA course centers its practical sessions on adapting models to actual decision contexts, making tailoring for individual payers an essential competency.

Sensitivity analysis and the transparency of uncertainty

The main concern with these structural standards is that their emphasis on simplicity can sacrifice precision: when a model is limited to one payer’s population, framed over a brief period, and appears in a modifiable spreadsheet, it deliberately reduces complex clinical and financial conditions into a simpler form. That is the tension sensitivity analysis resolves. A soundly constructed BIM avoids treating one point estimate as settled fact. Instead, it maps budget impact across plausible alternatives for the shakiest drivers, including how many patients qualify, how quickly the intervention is adopted, and what later costs are assumed, so the payer can see the effect of each change.

For a payer, the spread is more useful than one firm figure, since the actual choice depends on risk tolerance as well as the middle estimate. Seeing the possible budget impact span from best case to worst case helps a payer prepare contingencies, bargain for use-based pricing, or introduce coverage gradually, options that one aggregate number would hide. Being explicit about uncertainty supplies the practical basis for a payer’s budgeting choice under real-world limits, since enrollment estimates, adoption timing, and later spending cannot be pinned down as tightly as a single figure suggests. When sensitivity analysis is displayed with the base case, the payer can see which assumptions are sturdy and which remain uncertain, making it easier to rely on the stronger portions and prepare for the weaker ones.

Sources

  1. May 17: Budget Impact Analysis in Practice: A Hands-On Course on Strategic Conceptual Design, Model Building, and Communication - In Person at ISPOR 2026
  2. A Budget Impact Model to Estimate the Cost Dynamics of ...
  3. Budget Impact Analysis—Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force - ScienceDirect
  4. Principles of Good Practice for Budget Impact Analysis- Report of the ISPOR Task Force on Good Research Practices—Budget Impact Analysis
  5. Methodological Quality Assessment of Budget Impact Analyses for Orphan Drugs: A Systematic Review - PMC
  6. Value Assessment Framework - ICER
  7. ©Institute for Clinical and Economic Review, 2025 ICER Reference Case
  8. Using a Budget Impact Model Framework to Evaluate Antidiabetic Formulary Changes and Utilization Management Tools - PMC

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