The WHO estimates that 20-40% of health spending is wasted. The core tool against that waste is Health Technology Assessment (HTA): systematically measuring the clinical, economic and social consequences of a technology to produce input for policy decisions. Türkiye's HTA ecosystem has institutionalised over the past decade — yet the most critical question remains open: is assessment decision-binding? This article covers the whole field, from HTA's conceptual frame through Türkiye's three-legged structure, the EU axis, and the company's evidence strategy.
What HTA is — and is not
HTA is a multidisciplinary, systematic evaluation of the direct and indirect consequences of a health technology (medicine, device, procedure, organisational model): clinical effectiveness and safety, cost-effectiveness, budget impact, ethical, legal and organisational dimensions, and patient and societal values. Its purpose is to determine the value of a technology and guide how it should be used in health systems. HTA is not a clinical guideline (that is guidelines' job) and not price negotiation (that sits at the payer table); HTA is the evidence base for both.
At the concept's heart sits value: beyond "does the technology work?", HTA asks "for whom, at what cost, against which alternatives, with what uncertainty?" It therefore draws on a broad evidence spectrum — from randomised trials to real-world data, from cost analyses to equity assessment.
The global architecture: lessons from countries where HTA is institutionalised
Institutional models differ. In England, NICE places HTA at the centre of decisions through technology appraisals and QALY-based cost-effectiveness thresholds, operating dedicated procedures (HST) for highly specialised technologies in rare diseases. In Germany, IQWiG/G-BA rest on added-benefit classification, with decisions at the Federal Joint Committee. In France, HAS conducts SMR and ASA assessments. In Italy, AIFA bridges innovation classification and economic evaluation into pricing negotiation. The common denominator: HTA bodies are structures with legal grounding, transparent procedures and decision output.
The turning point on the EU axis: Regulation 2021/2282
The EU Regulation on HTA (2021/2282) entered application in January 2025. It establishes joint clinical assessments (JCA) and joint scientific consultation mechanisms among member states; the first wave began with oncology and advanced therapy products. For global companies the consequence is clear: EU dossiers evolve from single-country to multi-country assessment, and the same evidence packages will serve as reference and source in other markets' files — Türkiye included. Turkish HTA practice will inevitably be influenced by the EU approach; companies should structure evidence production for JCA formats and adapt those formats to Turkish submissions as well.
Türkiye's three-legged HTA structure
Türkiye's HTA has taken shape around three institutions. TİTCK, as the regulatory agency, conducts pharmacoeconomic evaluations and feeds pricing studies. The SGK's HTA unit supports reimbursement decisions of the single largest public insurer with economic analyses. TÜSEB adds academic depth through analytical reports and strategic assessments, and plays a role in the rare-disease agenda with proposals such as accreditation of centres of excellence.
Yet peer-reviewed analyses show that Turkish HTA bodies have limited binding power and that how assessments feed decisions is not always transparent. Some published studies titled "HTA" are in fact market-price and budget-impact analyses, and full HTA reports incorporating effectiveness evaluation remain limited in number. The practical consequence is striking: the payer does not produce the evidence of value; the company does — and presents it.
Economic evaluation in the reimbursement file: the de facto HTA ground
Where HTA effectively operates in Türkiye is the economic sections of the SGK reimbursement application. The relevant part of the file covers cost-effectiveness analysis, budget impact analysis, local data supply and model adaptation. Application guidelines define expected analyses; but the depth of evaluation is proportional to the evidence quality of the file's sponsoring company. In other words, the "HTA standard" in Türkiye is de facto set by the quality of the file. This means a well-prepared file can steer the decision-maker — the company that fills the evidence gap also draws the frame.
Evidence hierarchy and real-world data
In HTA's evidence hierarchy, randomised controlled trials sit at the top; but reimbursement decisions are made in a real-world context: comorbidities, adherence, practice conditions, local costs. Türkiye's real-world data sources — e-Nabız, prescription data, hospital records, drug-utilisation monitoring systems — are maturing, with access rules being defined. The strategic consequence for companies: without local resource-use and patient-flow data, cost-effectiveness runs on assumptions and weakens under payer questioning. Focus-group studies, expert opinion and registry design are proven instruments for producing that data.
The company's evidence triangle: generate, model, narrate
- Evidence generation: without local data (resource use, prevalence, patient flow) HTA stays limited. Focus groups, expert opinion, registries and publication programmes are investment areas; data from early-access programmes (NPP, compassionate use) can be the triangle's first stone.
- Economic modelling: run budget impact and cost-effectiveness from the payer perspective with current SUT prices and FX assumptions; manage uncertainty through scenario and sensitivity analyses. Localising the model — adapting it to Turkish treatment practice — is the file's most technical and most fragile section.
- Narrative integrity: clinical evidence, economic value and unmet need converging in a single story. Advisory boards are where the story matures; policy studies jointly with specialty societies grow public ownership of the narrative.
The HTA-ready organisation: how to build the access team?
An HTA-ready company plans reimbursement evidence from the development stage. Practical steps: (1) include HTA endpoints (quality of life, resource use) when designing the Phase III protocol; (2) build the global pharmacoeconomic model ready for Turkish adaptation; (3) start the local advisory-board and expert-opinion programme at least two years before launch; (4) keep reimbursement-file ownership in a single team (not fragmented); (5) build data infrastructure capable of rapid responses to payer questions.
Future scenarios for Turkish HTA
Three scenarios stand out. Slow institutionalisation: the current three-legged structure persists without added binding force; company evidence remains decisive. EU-aligned deepening: standards influenced by JCA formats, greater weight of the economic section in reimbursement files, and threshold debates entering the agenda. Rare-disease priority: as TÜSEB-supported centres of excellence and the rare-disease data system mature, structured HTA needs emerge in the rare field. All three share one conclusion: the capability to generate evidence will remain the determinant of market access.
Core concepts: ICER, QALY and the cost-effectiveness threshold
Knowing HTA's economic language is a precondition of file literacy. QALY (quality-adjusted life year): combines survival gain and quality of life in a single measure; one year in full health = 1 QALY. Cost-effectiveness analysis: compares the difference in cost and health outcomes between strategies. ICER (incremental cost-effectiveness ratio): the new therapy's incremental cost divided by its incremental QALYs — the answer to "what does one additional QALY cost". Threshold: the upper bound at which an ICER is deemed acceptable; England's £20-30k per QALY band is well known, and most countries do not publish explicit thresholds. Türkiye has published no official threshold; yet presenting the ICER with sensitivity ranges that can cover it is the standard of preparedness for payer questions. Budget impact analysis answers a different question: "if this product is listed, what annual load arrives on the payer's budget?" — it runs on population, prevalence and market-share assumptions and is often more decisive with payers than CE analysis.
Components of the evidence package: what belongs in the file?
Per international standards and Turkish practice, the economic section of a reimbursement file carries: Clinical evidence synthesis: pivotal-trial efficacy-safety results and the rationale for comparator choice. Local context data: Turkish prevalence/incidence, patient flow, current treatment practice (physician opinion/focus groups), resource use and unit costs (with current SUT prices). The economic model: a Turkish adaptation of the global model or a locally developed one; structure (Markov, decision tree, individual simulation), assumptions and sources presented transparently. Scenario and sensitivity analyses: base case + alternative assumption sets; which parameter drives how much of the result. Budget impact: multi-year projections from the payer perspective, together with alternative-payment scenarios. Expert opinion and advisory-board outputs: local validation of assumptions. If any component is weak, even the file's strongest section becomes open to challenge.
Local data sources: the veins feeding the model
In Türkiye, a pharmacoeconomic model's local inputs come chiefly from: SUT and the public tariff — the official source of unit costs (procedures, drugs, hospitalisation), used with a current date stamp; expert-opinion studies — focus groups for resource use (length of stay, outpatient frequency, laboratory) and treatment practice, with methodology and participant profile reported; published local studies and registries — disease-specific cohorts, society records, theses, used with quality appraisal; hospital data systems and e-Nabız — a potential source whose access rules are maturing; global clinical and epidemiological data — adapting global meta-analyses to Türkiye (age distribution, lower-mortality correction) is common practice, with the adaptation method transparent. In a good file, every unit cost and every assumption shows its source vein — the payer questions every number whose source it cannot see.
Common mistakes: nine points that weaken the file
- The comparator reflecting global guideline recommendations rather than Turkish practice.
- Unit costs taken from outdated SUT/FX assumptions.
- Patient-number estimates copying global prevalence unquestioned.
- Sensitivity analysis limited to one-way; missing scenario and probabilistic analyses.
- Model structure and transition probabilities left unsourced.
- Expert-opinion methodology (participants, format, analysis) unreported.
- Budget impact presenting market-share assumptions in a single scenario.
- Early-access/real-world data carried into the file without structure.
- File language remaining academic rather than translated into decision-maker language (budget, risk, manageability).
Frequently asked questions: HTA and file preparation
- Is presenting cost-effectiveness mandatory in Türkiye? Economic sections are expected in files; yet the depth of analysis is de facto set by file quality — the company presenting well draws the frame.
- Can I file without QALYs? Yes; but standard outcome measures are preferred for comparability, with the rationale stated.
- Is using the global model directly enough? No; without adaptation to Turkish treatment practice, resource use and costs, the model stays assumption-based and is challenged.
- Who determines the comparator? The filer proposes, the payer questions; local actual treatment practice is the strongest rationale.
- Why is sensitivity analysis so important? Showing which assumption drives the result answers the payer's uncertainty critique; one-way analysis alone is insufficient.
- When should the expert-opinion study run? Before the model is built — validating resource-use assumptions is a model input.
- Can early-access data be used in the file? Yes; structured (registered) data is the strongest form of local real-world evidence.
- Does the EU JCA process affect Turkish files? Evidence formats and expectations rise; packages ready for JCA format should be adapted to Turkish submissions too.
Organisational models: how to configure HTA capability?
Three models exist for the HTA-ready organisation. Central model: the access/HEOR team sits in one centre; consistency is high, therapeutic-area knowledge may weaken. Functional distributed model: HEOR capability in every product team with central methodological support; area knowledge strong, standard consistency at risk. Hybrid model: methodology (modelling, statistics) central; evidence strategy and stakeholder management in product teams. Whichever is chosen, four functions must be complete: evidence planning (which data, when, from whom), analysis production (model, budget impact), narrative and presentation (the file's story), stakeholder management (advisory boards, societies, payer meetings). In smaller organisations these functions are supported externally (consulting); even with outsourcing, ownership must stay inside — a team that does not know the file's story has no answer at the payer table.
Step by step: preparing the file's economic section
Preparation runs in seven steps. Step 1 — Decision context: the file strategy (first entry, expansion, price defence?) sets the economic section's emphasis. Step 2 — Comparator selection: the comparator set built on local treatment-practice data (expert opinion, prescription profiles), with rationale written. Step 3 — Local data supply: resource-use focus groups, prevalence analysis, patient flow; every datum's source documented. Step 4 — Model construction: adapting the global model or building locally; structure rationale and transition probabilities presented with sources. Step 5 — Analyses: cost-effectiveness, budget impact, scenarios; one-way + scenario + probabilistic sensitivity. Step 6 — Local validation: testing assumptions through advisory boards and expert opinion, with revisions. Step 7 — Narrative packaging: translating results into decision-maker language — executive summary, risk and uncertainty section, recommendations. The whole flow must begin at least 18 months before product approval; the economic section has to mature on the same calendar as the rest of the file.
A real-world data plan: evidence continues after launch
HTA evidence does not end with submission; the post-launch period is the evidence's continuation and must be planned. Short term (0-12 months): real-world effectiveness monitoring — central patient registry, utilisation patterns, early tolerability data; the material of renewal negotiations and payer questions. Medium term (1-3 years): long-term outcomes, survival updates, quality-of-life follow-up; the evidence base of indication expansions. Long term (3+ years): comparative effectiveness, complication prevention and total-cost evidence; the product's defence file. Three components must be institutionalised: data infrastructure (registry/e-Nabız integration), the analysis calendar (annual interim reports) and a publication strategy (local congress abstracts and papers raise the payer's information level). The company that stops evidence production at launch is defenceless in year two; the one that continues strengthens its hand at every renewal table.
Sources and key takeaways
Core sources: WHO HTA resources; the EU HTA Regulation (2021/2282) and JCA documents; peer-reviewed analyses of HTA in Türkiye; the SGK reimbursement-file guideline (economic-section expectations); NICE, HAS, IQWiG and AIFA method guides for comparison. Recommended monitoring: HTAi and ISPOR agendas, EU JCA announcements, national institutional reports (TİTCK, TÜSEB). Our key takeaways: (1) Türkiye has HTA institutions but limited binding force — the company produces and presents the value evidence; (2) the file's economic section is the de facto HTA ground; its standard is set by file quality; (3) JCA readiness should be adapted to Turkish submissions too; (4) without local data the model stays assumption-based — focus groups, expert opinion and registry investment are mandatory; (5) evidence does not end at launch: the real-world data plan insures every renewal table.
Practical summary: the six-monthly HTA-readiness checklist
Being HTA-ready is a habit, not a project; the six-monthly checklist has six items. (1) Evidence inventory: is local data (prevalence, resource use, patient flow) current for every filed product; which gap remains and how will it close? (2) Model health: has your economic model run on the latest SUT prices and FX rate; are sensitivity analyses (one-way, scenario, probabilistic) complete? (3) JCA fit: is your evidence package adaptable to the EU joint-assessment format; which endpoints are missing? (4) Stakeholder map: are your advisory board, society relations and payer contacts current; is there an expert-opinion study calendar? (5) Real-world plan: is post-launch data infrastructure (registry, reporting, publications) running; with what data will you approach the renewal table? (6) Organisation: does evidence ownership sit inside; despite outsourcing, can your team narrate the file's story? The list turns the reality that HTA in Türkiye is the company's job into institutional discipline; a firm closing its gaps at every check sits one step ahead at the payer table each time.
Conclusion
HTA in Türkiye is an ecosystem with institutions but limited binding power; that gap is an opportunity field for evidence-producing companies. In an era where the EU has moved to joint assessment, being HTA-ready is not a choice but a necessity. To build your evidence triangle through model adaptation, expert opinion and advisory-board work, see our pharmacoeconomic model adaptation service and reach out.