What is HEOR consulting, and what does a HEOR consultancy deliver?
HEOR consulting (health economics and outcomes research) turns clinical and real-world data into the economic evidence payers, HTA bodies and formulary committees require before they list, reimburse or tender a therapy. A HEOR consultancy builds the models — cost-effectiveness, cost-utility and budget impact — designs the outcomes and real-world evidence studies that feed them, and writes the value dossiers and HTA submissions that carry the argument. BioNixus delivers HEOR services for pharma and medtech teams across the GCC, wider Middle East and Europe, with every model calibrated through primary research with the physicians, pharmacists and payer advisors in the target market.
- Economic modellingCost-effectiveness, cost-utility (cost per QALY) and budget impact models built or adapted to local epidemiology, treatment mix and formulary pricing.
- Outcomes and real-world evidenceBurden-of-illness, treatment-pattern, resource-utilisation and patient-reported outcome studies designed to close the evidence gaps a committee will probe.
- Evidence synthesisSystematic literature reviews, indirect treatment comparisons and local-data gap analyses that define which comparator and endpoints the submission must address.
- Value dossiers and HTA submissionsSFDA Economic Evaluation System dossiers in Saudi Arabia, UAE DOH/DHA formulary files, AMNOG, NICE and AMCP-format submissions, plus committee response and resubmission support.
HEOR consulting from BioNixus: locally calibrated economic models, outcomes research and payer-ready dossiers for GCC, MENA and European market access decisions, project-priced from $10,000 to $60,000.
Executive decision framework
How we approach HEOR consulting
Local assumptions determine credibility
When a formulary committee or national HTA body reviews an economic submission, the first question is always whether the underlying assumptions reflect their own healthcare system. A model populated with local Saudi or UAE prevalence figures, drawn from primary research with practising physicians rather than published Western registries, carries substantially more weight than a global template with country adjustments bolted on at the last minute. BioNixus embeds primary market research into every HEOR project we run. Before a single model cell is built, our qualitative and quantitative research teams have spoken to the physicians, pharmacists, and formulary advisors who will ultimately evaluate the submission. We use those conversations to calibrate treatment pathways, line-of-therapy assumptions, resource utilisation rates, and patient subgroup definitions. The economics that emerge are not assumptions — they are findings. That distinction is the difference between a model that survives committee scrutiny and one that is sent back for clarification.
One robust case outperforms a broad claim
It is tempting to build an HEOR argument that covers every indication, every patient subgroup, and every possible competitor simultaneously. In practice, diffuse economic arguments fail to move committees because no single member of the formulary panel sees a clear, specific case for action. BioNixus recommends a focused approach: identify the indication with the strongest clinical evidence base, the most favourable local epidemiology, and the highest unmet need signal from primary physician research, then build an economic case for that indication that is fully auditable from first principles. Sensitivity analyses can explore adjacent scenarios, but the base case should be so clearly defined that any committee member can retrace the logic in ten minutes. This disciplined approach builds institutional trust. Once one indication is listed, the credibility asset created by a rigorous first submission makes subsequent extensions substantially easier to advance through the same decision-making bodies.
Evidence must serve every internal audience
Health economics outputs are too often produced for a single technical audience — the market access team — and then struggle to gain traction with medical affairs, commercial leadership, or regional finance. BioNixus designs every HEOR engagement so that the core evidence package can be translated into formats that serve all internal stakeholders simultaneously. The technical model and full dossier satisfy the market access and regulatory teams. An executive summary with scenario-based decision trees equips the commercial and finance leadership. A simplified visual aid deck gives field access managers the talking points they need for institutional visits. Arabic-language versions of key outputs ensure that locally hired access teams can use the materials without depending on headquarters translation. When every function that touches reimbursement is working from the same underlying evidence, the submission process moves faster and the response to committee feedback is more coherent and consistent.
BioNixus market research
Scope a HEOR consulting engagement
Book a 30-minute briefing to align on objectives, stakeholders, and timeline before we build the proposal.
Delivery priorities
- Budget impact model development using locally sourced GCC and MENA epidemiology, treatment mix data, and formulary-consistent pricing assumptions validated through primary physician research.
- Cost-effectiveness and cost-utility analysis designed to meet payer and HTA evidence thresholds across Saudi Arabia, UAE, Kuwait, Qatar, and broader MENA markets.
- Value dossier construction that integrates clinical evidence, real-world data, and economic modelling into a single coherent narrative aligned to committee evaluation criteria.
- HTA submission support including evidence gap analysis, dossier structuring, committee response preparation, and resubmission strategy after initial rejection.
- Payer evidence strategy workshops that align internal medical affairs, market access, and finance teams on a shared economic narrative before external submission.
- Comparative effectiveness research design incorporating local standard-of-care data gathered through qualitative and quantitative primary market research with treating physicians.
- Budget impact scenario modelling for tender and procurement negotiations, including sensitivity analyses on uptake curves, market share assumptions, and alternative pricing scenarios.
- Value communication materials development — executive summary decks, payer visual aids, and field access briefing documents converted from technical model outputs into decision-ready formats.
- Reimbursement strategy advisory covering formulary positioning, listing tier negotiation, risk-sharing arrangement design, and outcomes-based contract frameworks for GCC markets.
- Cross-market HEOR evidence adaptation for clients needing to align a global evidence package with the specific evidentiary expectations of multiple GCC and European payer audiences simultaneously.
HEOR services
HEOR services BioNixus provides
Most "HEOR services" enquiries are really one of eight workstreams. Each is scoped as a standalone project or combined into a launch evidence programme; all of them draw on primary physician, pharmacist and payer research rather than desk assumptions.
Cost-effectiveness and cost-utility modelling
De novo or adapted decision-tree and Markov models producing incremental cost-effectiveness ratios and cost per QALY against the comparator the local committee actually uses, with probabilistic sensitivity analysis and a transparent, auditable workbook.
Budget impact analysis
Three- to five-year budget impact models for a national payer, insurer pool, hospital group or tender authority, with uptake curves, market-share displacement and price scenarios validated through in-market physician research.
Real-world evidence and outcomes studies
Retrospective chart reviews, prospective registries and physician-reported treatment-pattern studies that supply the local resource-use, adherence and outcomes inputs global models lack. See our real-world evidence service.
Systematic literature review and indirect treatment comparison
PRISMA-aligned reviews, network meta-analysis and matching-adjusted indirect comparisons where head-to-head trials do not exist, documented to the standard HTA reviewers expect.
Burden of illness and patient-reported outcomes
Epidemiological, economic and humanistic burden studies, utility elicitation and PRO instrument deployment in Arabic and English to establish unmet need and quality-of-life impact.
Value dossiers and HTA submissions
Global value dossier localisation, SFDA EES economic evaluation dossiers, UAE formulary files, AMNOG benefit dossiers, NICE appraisal support and AMCP Format submissions, including committee Q&A and resubmission strategy.
Payer value communication
Payer objection research, value-message testing with formulary decision-makers, executive summaries, visual aids and field access briefs translated from model outputs.
Embedded or retained HEOR support
For teams without an in-market health economist, BioNixus provides retained HEOR capacity: model maintenance, annual updates, tender-cycle budget impact refreshes and ad-hoc committee responses, scoped as a monthly or quarterly arrangement.
How engagements are built
Three typical HEOR engagements, step by step
These blueprints show what BioNixus builds, which inputs come from primary research and what the client receives. Scope, market and therapy area change the inputs; the structure stays the same.
Budget impact model for a specialty biologic entering the Saudi Unified Drug Formulary
Question: what does listing cost the national payer over three years, and under which price and uptake scenarios does it stay within the committee's tolerance? Inputs: local prevalence and diagnosed/treated rates, current treatment mix from a quantitative survey of treating specialists, SFDA-registered prices, NUPCO tender history. Build: Excel budget impact model with displacement logic, scenario and sensitivity tabs, and an EES-aligned technical report. Output: model, technical report, committee summary and Arabic executive brief; first draft in three to four weeks from objective lock.
Cost-utility adaptation of a global model for UAE DOH and DHA formulary listing
Question: does the global cost-per-QALY case hold when the comparator, resource use and prices are replaced with Abu Dhabi and Dubai values? Inputs: local standard of care and line-of-therapy mapping from qualitative physician interviews, hospital resource-use estimates, emirate-level pricing, utilities checked against regional literature. Build: adapted model with a documented input-substitution log, deterministic and probabilistic sensitivity analysis, and a gap register for data the market still lacks. Output: adapted model, adaptation report, formulary-ready value summary and payer visual aid.
Evidence gap analysis and real-world study design for a biosimilar tender in the GCC
Question: which outcomes and cost arguments will move a tender committee weighing a biosimilar against the originator and other entrants? Inputs: systematic review of switching and persistence evidence, payer and procurement interviews on evaluation criteria, physician research on switching barriers. Build: evidence gap matrix, prioritised study plan (chart review or physician-reported outcomes), budget impact scenarios by tender lot. Output: gap analysis, study protocol, tender value narrative and a 30/60/90 evidence plan.
Scope, timelines and pricing
What HEOR consulting costs and how long it takes
BioNixus prices HEOR work by project, inside the same published band as our other primary research: $10,000 to $60,000. A single-market budget impact model with primary-research validation of its inputs sits toward the lower-middle of the band; a de novo cost-utility model with a systematic review, probabilistic sensitivity analysis and a full HTA dossier sits toward the top. Multi-market programmes are quoted as linked projects so each market can start when its data is ready.
Three things move the price: the number of markets and payer audiences, whether a model is adapted or built from scratch, and how much primary research is needed to replace missing local inputs. Three things do not: report length, number of slides, or the number of internal stakeholders who need a version of the output — every engagement ships the technical model, a committee-ready summary and a stakeholder version by default.
Timelines: a first-draft decision model including local assumption validation is typically ready three to four weeks after objective lock; a complete value dossier with evidence synthesis runs eight to twelve weeks. You receive a costed proposal within 48 hours of a scoping call, with scope, sample, timeline and price fixed before work starts.
Why a regional HEOR consultancy
BioNixus HEOR consulting versus global HEOR consultancies
Global HEOR consultancies are built for multi-country HTA programmes run from London, Boston or Basel. Their models are rigorous, their timelines and minimums reflect that scale, and their local inputs for Saudi Arabia, the UAE, Egypt or Turkey are usually literature proxies or regional averages. When a committee in Riyadh or Abu Dhabi asks where a prevalence or resource-use figure came from, a proxy is the weakest possible answer.
BioNixus is the regional specialist alternative: a health-economics and primary-research team working in 48 countries, with Arabic–English fieldwork in-house and 120+ projects a year for pharma, medtech and healthcare clients. Every model input that can be measured locally is measured — through physician surveys, payer interviews or chart review — and documented so the committee can trace it. Engagements start at $10,000, not at a global retainer, and a senior research lead stays on the project from scoping to committee response.
For global teams, the practical arrangement is a split: keep the global HEOR partner for the core model and the mature-market submissions, and brief BioNixus for the GCC, MENA and emerging-market adaptations and the primary research that populates them. The hub page on healthcare market research explains how the research and market access services fit together.
Planning research in Saudi Arabia?
Primary research, market access & HEOR. A 30-minute scoping call, then a costed proposal within 48 hours.
What happens on the call
- We pin down the decision your research has to support.
- We check feasibility: respondent types, countries and timeline.
- You receive a costed proposal within 48 hours of the call.
Regional payer & HTA landscapes
United States
The US has no centralized, government-run HTA body equivalent to NICE. Coverage and reimbursement decisions are made independently by commercial insurers, state Medicaid programs, pharmacy benefit managers (PBMs), and integrated delivery networks, each applying its own formulary and utilization-management criteria.
The Institute for Clinical and Economic Review (ICER), a non-governmental organization, has become the closest equivalent to a de facto value-assessment body — its comparative-effectiveness reports and value-based price benchmarks are widely referenced by payers even though ICER has no regulatory authority and its recommendations are not binding. Manufacturers submit clinical and economic evidence to US payers primarily using the AMCP Format for Formulary Submissions (currently Version 4.1), which also supports Pre-Approval Information Exchange so payers can begin coverage planning before launch.
United Kingdom
The National Institute for Health and Care Excellence (NICE) is the primary HTA body for England and Wales, and its technology appraisals directly drive NHS coverage decisions. Assessment centers substantially on cost-effectiveness expressed as cost per quality-adjusted life year (QALY) gained, alongside clinical-expert input, patient testimony, and real-world evidence.
NICE confirmed that, starting in April 2026, its cost-effectiveness threshold range rises for the first time in twenty years, from £20,000–£30,000 per QALY to £25,000–£35,000 per QALY — a change NICE itself estimates will result in three to five additional medicines being recommended per year.
Germany
Germany's AMNOG process, in force since 2011, requires every new medicine with a novel active substance to undergo an early benefit assessment as soon as it enters the market. The manufacturer submits a dossier to the Federal Joint Committee (G-BA) at launch, arguing added benefit relative to a G-BA-defined comparator therapy.
The Institute for Quality and Efficiency in Health Care (IQWiG) — or the G-BA itself for orphan drugs — independently assesses that dossier, typically within about three months. After a stakeholder hearing, the G-BA issues a binding resolution on the extent of added benefit, and the manufacturer then negotiates a reimbursement price with the National Association of Statutory Health Insurance Funds within six months, or an arbitration board sets the price if no agreement is reached. Germany's pricing and rebate framework continues to evolve, so current guidance should always be checked against the latest G-BA and GKV-Spitzenverband publications.
Saudi Arabia / GCC
Saudi Arabia has moved from an informal, price-taker system to a formal HTA framework under its 2024 HTA Guidelines, jointly governed by the Saudi Food and Drug Authority (SFDA) and the Council of Cooperative Health Insurance (CCHI). As of July 2025, submission of a formal economic evaluation dossier — a budget impact analysis and/or a cost-effectiveness, cost-minimization, cost-utility, or cost-benefit analysis — became mandatory for high-cost or high-priority medicines.
Once priced through SFDA and reviewed under this HTA process, a product can be submitted for the Unified Drug List/Unified Drug Formulary managed by CCHI and the Ministry of Health, and — once listed — becomes eligible for public-sector procurement through NUPCO's centralized tendering mechanism. Saudi Arabia does not currently publish an official government-mandated cost-per-QALY threshold; an academic estimate of SAR 50,000–75,000 per QALY circulates in the literature as an informal reference point, but the researchers behind it are explicit that it is not derived from a Saudi-specific willingness-to-pay study and has not been formally adopted as policy. Other GCC markets (UAE, Kuwait, Qatar) do not yet operate a comparable formal national HTA/QALY-threshold process and typically rely on formulary- and tender-level review instead.
Proof & execution snapshot
3–4 weeks
Model delivery
Typical timeline from objective lock and primary data collection to first draft decision model, including local assumption validation with in-market physicians.
10+ markets
Market coverage
Active HEOR project experience across Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman, Egypt, Jordan, and select European HTA markets.
Payer-ready
Output format
Every engagement delivers both the technical model and translated stakeholder outputs — committee summaries, access briefs, and Arabic-language versions where required.
Planning research in Saudi Arabia?
Primary research, market access & HEOR. A 30-minute scoping call, then a costed proposal within 48 hours.
What happens on the call
- We pin down the decision your research has to support.
- We check feasibility: respondent types, countries and timeline.
- You receive a costed proposal within 48 hours of the call.
Explore next
HEOR Consulting — frequently asked questions
Is there a centralized HTA body in the US comparable to NICE?
No. The US has no single government-run HTA authority; coverage and reimbursement decisions are made independently by commercial insurers, state Medicaid programs, PBMs, and health systems. The Institute for Clinical and Economic Review (ICER), a non-governmental organization, has become the closest equivalent — its value-based price benchmarks and comparative-effectiveness reports are widely referenced by payers, including major PBMs, even though ICER has no regulatory authority and its recommendations are not binding.
What is the AMCP dossier, and when do US payers request it?
The AMCP Format for Formulary Submissions (currently Version 4.1) is the standard template manufacturers use to present clinical and economic evidence to US managed care organizations, PBMs, and health systems for formulary and coverage decisions. Version 4.1 also introduced templates supporting Pre-Approval Information Exchange (PIE), letting manufacturers share evidence on products or indications still under FDA review so large payers can begin coverage and budget planning ahead of launch.
How does NICE evaluate cost-effectiveness in the UK?
NICE's independent appraisal committees assess a new medicine primarily through cost-effectiveness expressed as cost per quality-adjusted life year (QALY) gained relative to current standard of care, but the process also weighs clinical-expert opinion, patient and carer testimony, and real-world evidence of how treatments perform outside trial conditions. From April 2026, NICE's cost-effectiveness threshold range rises from £20,000–£30,000 to £25,000–£35,000 per QALY, the first change to this range in two decades.
What changed with NICE's cost-effectiveness threshold in 2026?
NICE confirmed its long-standing £20,000–£30,000 per QALY threshold range moves to £25,000–£35,000 per QALY starting April 2026. A higher threshold makes it mathematically easier for a therapy priced above the old ceiling to be judged cost-effective, which NICE itself projects will lead to three to five additional medicine recommendations per year. Robust real-world and comparative evidence remains central to a successful appraisal regardless of the threshold shift.
What is AMNOG in Germany, and what does it require from a manufacturer?
AMNOG is the German law, in force since 2011, requiring every newly launched medicine with a novel active ingredient to undergo an early benefit assessment. The manufacturer must submit a dossier to the G-BA at launch demonstrating added benefit versus a G-BA-defined comparator; IQWiG (or the G-BA itself for orphan drugs) independently assesses that dossier, and the G-BA then issues a binding benefit determination that becomes the basis for the subsequent price negotiation with the German statutory health insurance association.
What is IQWiG's role versus the G-BA's in the German assessment process?
IQWiG (the Institute for Quality and Efficiency in Health Care) is the scientific body that independently evaluates the manufacturer's dossier and produces an expert report on the drug's added benefit — it does not make the final decision. The G-BA (Federal Joint Committee) is the decision-making body: it defines the appropriate comparator therapy, considers IQWiG's report alongside a stakeholder hearing, and issues the binding resolution that determines the drug's benefit category and therefore its price-negotiation position.
Does Saudi Arabia have a formal HTA process?
Yes — Saudi Arabia introduced formal HTA Guidelines in 2024, jointly administered by the SFDA and CCHI, and as of July 2025 a formal economic evaluation dossier (budget impact analysis and/or a cost-effectiveness/cost-utility/cost-minimization/cost-benefit analysis) became mandatory for high-cost or high-priority medicines. This sits alongside SFDA pricing review and precedes formulary listing (Unified Drug List/Unified Drug Formulary via CCHI/MOH) and NUPCO-tendered procurement.
Does Saudi Arabia publish an official cost-per-QALY threshold?
No official government-mandated threshold has been published. An academic estimate of SAR 50,000–75,000 per QALY circulates in the literature and industry commentary as an informal reference point, but the researchers behind that estimate are explicit that it is not based on a Saudi-specific willingness-to-pay study and has not been formally adopted as policy — submissions should treat it as indicative context, not a binding target.
How much does HEOR consulting cost?
BioNixus prices HEOR projects within its published band of $10,000 to $60,000. A single-market budget impact model with primary-research validation sits toward the lower-middle of the band; a de novo cost-utility model with systematic review, probabilistic sensitivity analysis and a full HTA dossier sits toward the top. Multi-market programmes are quoted as linked projects. A costed proposal follows within 48 hours of a scoping call.
What is the difference between HEOR consulting and market access consulting?
HEOR consulting produces the economic and outcomes evidence — models, real-world studies, evidence synthesis and dossiers. Market access consulting uses that evidence to secure pricing, listing and reimbursement: payer landscape mapping, stakeholder engagement, pricing strategy, tender planning and negotiation support. BioNixus offers both, and most launch programmes combine them so the evidence is built for the decision-makers who will actually read it.
What is embedded HEOR consulting?
Embedded or retained HEOR consulting gives a pharma or medtech team ongoing health-economics capacity without hiring an in-market economist: model maintenance, annual input updates, tender-cycle budget impact refreshes, committee Q&A responses and ad-hoc evidence reviews under a monthly or quarterly arrangement. BioNixus scopes embedded support for GCC and MENA affiliates whose global HEOR function cannot cover local committee timelines.
How long does a budget impact model take?
A first-draft budget impact model with locally validated inputs is typically ready three to four weeks after the objective is locked, including the primary physician research used to calibrate treatment mix and uptake. A complete value dossier with evidence synthesis and HTA formatting runs eight to twelve weeks. Timelines lengthen when new real-world data collection (chart review or registry) is required.
Do you provide HEOR services for medical devices and diagnostics as well as pharma?
Yes. Device and diagnostic submissions follow different evidence logic — procedure-cost offsets, length-of-stay effects, diagnostic accuracy and workflow time rather than drug acquisition cost — and BioNixus builds models and outcomes studies for medical device and in-vitro diagnostic manufacturers alongside pharmaceutical work, across the same GCC, MENA and European markets.