HEOR Consulting — GCC, Middle East & Europe

BioNixus builds budget impact models, cost-effectiveness models (including cost-utility and cost-minimisation variants), and hybrid models that combine decision-tree and Markov state-transition structures depending on the disease area. For GCC markets, the most frequently requested output is the budget impact model, because Saudi, Emirati, and Kuwaiti formulary committees typically prioritise the fiscal impact on their specific institution or national fund over abstract cost-per-QALY thresholds. We design models to work at national, regional, or institutional level depending on the submission target. All models are built in auditable spreadsheet environments with clearly documented assumptions, source references, and sensitivity analysis frameworks. Where clients already have an existing global model, we adapt it to the GCC context rather than rebuilding from scratch, incorporating locally sourced epidemiology and pricing data to calibrate the base case assumptions.

We use a combination of primary market research and secondary data review. On the primary side, our qualitative and quantitative research teams conduct structured interviews and surveys with physicians treating the target patient population in Saudi Arabia, UAE, Kuwait, and other relevant GCC markets. These conversations capture treatment pathway details, line-of-therapy sequencing, concomitant medication use, and resource utilisation patterns that are not captured in published literature. On the secondary side, we review published Gulf epidemiology where it exists, national health statistics from Saudi MOH, UAE DOH, and equivalent bodies, and regional pricing databases. When published local data is sparse — as it often is in smaller Gulf markets — we use physician survey findings as the primary calibration source and document the assumptions transparently so that committees can challenge them with their own institutional data if they choose.

A value dossier is a structured evidence package that presents the full clinical and economic case for a product to a payer, formulary committee, or HTA body. It typically includes a disease burden section, a clinical evidence summary, an economic model summary with scenario outputs, a budget impact projection, and a comparative effectiveness narrative. BioNixus recommends building a value dossier when a product is approaching formulary listing in a market with a formal committee review process — which in the GCC includes Saudi Arabia's NCBE, the UAE's DHA and DOH formularies, and national tender committees in Kuwait and Qatar. A dossier is also valuable earlier in the launch cycle as an internal alignment tool: it forces cross-functional agreement on the value story before any external submission occurs, which reduces the risk of inconsistent messaging between market access, medical affairs, and commercial teams during the listing process.

Yes, we support European HTA submissions for clients who need to bridge evidence developed in GCC or MENA contexts with the evidentiary expectations of European bodies. We have experience with the evidence standards applied by NICE in the UK, the HAS in France, and the AMNOG process in Germany, as well as multi-country submissions under the EU HTA Regulation joint clinical assessment framework. Our typical role in European submissions is evidence gap analysis, dossier structuring, and model adaptation rather than primary HTA authorship — we partner with established European health economics specialists for the full submission delivery where required. For clients launching a product in both GCC and European markets simultaneously, we can design an evidence architecture that serves both payer audiences from a single core evidence base, adapting the presentation and assumption sets for each regulatory context.

Timeline depends heavily on scope. A focused budget impact model with local assumption validation through primary physician research typically takes three to four weeks from objective lock to first draft, with one to two additional weeks for client review cycles and finalisation. A full value dossier including a cost-effectiveness model, budget impact tool, and narrative document typically takes six to ten weeks. HTA submission support is project-specific and can extend over several months if it includes committee response preparation and resubmission strategy. We recommend starting HEOR work at least twelve months before the anticipated submission date to allow time for primary data collection, model development, internal alignment workshops, and iterative refinement based on early payer engagement. Compressed timelines are possible but increase the risk that assumption validation is insufficient to withstand committee scrutiny.

Yes, and for most multinational clients this is the more efficient and cost-effective approach. We conduct a structured review of the global model to identify which assumptions are not transferable to the GCC context — typically epidemiology, line-of-therapy sequencing, resource utilisation unit costs, and comparator identity — and replace those with locally validated inputs. We document every adaptation transparently so that the global evidence team can see exactly what changed and why. The adapted model retains the structural architecture of the global version, which makes it easier for headquarters reviewers to validate and for in-market teams to maintain after we deliver it. Where the global model uses assumptions that are clearly inconsistent with GCC clinical practice, we flag this formally and recommend primary research to generate defensible replacements rather than simply substituting plausible numbers.

A standard BioNixus HEOR engagement delivers: the working model in an auditable and editable format, a technical report documenting all assumptions, data sources, and methodological choices, an executive summary suitable for presentation to internal leadership, a payer-facing summary deck adapted for committee presentation, and a field access brief that gives in-market access teams the key messages and scenario outputs they need for institutional conversations. For GCC markets we also deliver Arabic-language versions of the executive summary and payer brief. Where the engagement includes a value dossier, we deliver the full dossier document in both English and Arabic. All outputs include a stated assumptions register and a documented sensitivity analysis so that clients can respond quickly to any committee request for scenario recalculation.

HEOR and primary market research are deeply integrated at BioNixus. The treatment pathway assumptions, comparator definitions, and resource utilisation inputs that drive economic models are far more credible when they come from structured primary research with practising physicians rather than from literature estimates or global model templates. We therefore run HEOR projects in close coordination with our qualitative and quantitative research teams. A typical integrated engagement begins with qualitative depth interviews to map the treatment pathway and identify the key clinical decision points, followed by a quantitative survey to validate frequencies and proportions at scale, and then uses those findings directly as model inputs. The same physician contacts developed during the research phase can also serve as informal pre-submission sounding boards for the economic narrative, giving clients early signal about which arguments will land with local committees before formal submission.