The HTA Process Step by Step: From Topic Selection to Decision

A medicine can be licensed as safe and effective and still not reach patients. Between the regulator’s approval and the first reimbursed prescription sits a different set of questions: does it work better than current care, by how much, at what cost, and should the health system pay for it? The HTA process is how health systems answer them.

INAHTA, HTAi and partner organisations define health technology assessment (HTA) as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. For the concept, see our introduction to what health technology assessment is. This guide covers the mechanics: who does what, in what order, and with what output.

Labels vary, from assessment and appraisal to review and HTA evaluation. The seven HTA steps below describe the typical route for a new medicine; devices and diagnostics often follow a variant.

Step 1: Topic selection – what triggers an HTA

An HTA starts when a technology is selected for evaluation. For new medicines the trigger is often automatic, linked to authorisation or launch; for devices, diagnostics and older treatments, agencies must prioritise.

The World Health Organization counts horizon scanning, topic selection and scoping among the functions of an HTA mechanism. In practice, selection differs by system:

• England: since 29 May 2024, NICE has used one NICE-wide topic prioritisation process. New medicines that meet the criteria of the UK’s 2024 voluntary scheme go straight to technology appraisal; other topics, including devices and diagnostics, are prioritised by the NICE prioritisation board.
• Germany: the law is the trigger. The company must submit its dossier no later than the day a new medicine is first placed on the market, or within four weeks of approval of a new indication.
• France: companies request an HAS evaluation after marketing authorisation; in some cases the ministry or health insurance refers products, and HAS can act on its own initiative.
• Canada: a sponsor files an application with CDA-AMC, Canada’s Drug Agency (known as CADTH until 2024), sometimes before Health Canada approval.
• European Union: eligibility for a joint clinical assessment is set by law, starting with cancer medicines with new active substances and advanced therapies from 12 January 2025.

Step 2: Scoping and the PICO question

Scoping turns a topic into a question that evidence can answer. Most HTA bodies frame it as a PICO: the population, intervention, comparators and outcomes that matter for the decision.

NICE’s scope, for example, defines the population and care pathway, the technology, the comparators and the main outcome measures. It also sets the economic analysis, by default from an NHS and personal social services perspective, and flags subgroups and equality issues. The draft scope is consulted on for 28 or 14 days, sometimes with a scoping workshop.

In Germany, the pivotal scoping choice is the zweckmäßige Vergleichstherapie, the appropriate comparator therapy against which added benefit is measured. Companies can request paid G-BA advice on the comparator and required studies, ideally before phase III trials start. At EU level, Regulation (EU) 2021/2282 requires the scope of a joint clinical assessment to cover the patient population, interventions, comparators and health outcomes that Member States need.

PICO and opportunity cost are introduced in Module 1: What HTA Is and Why It Exists.

Step 3: Evidence submission by the manufacturer

For medicines, the manufacturer usually prepares the main evidence package, called a dossier or company submission, because it holds the trial data. Patients, clinicians and other stakeholders add their own evidence and experience.

A typical submission contains a systematic review of the clinical evidence, any indirect comparisons the PICO requires and, where the agency asks for one, an economic model, often a Markov or partitioned survival model. Requirements differ:

• NICE expects the company submission within about 8 weeks of the invitation, covering the clinical and economic questions in the scope; clinical and patient experts are also nominated.
• Germany’s AMNOG dossier must cover the approved indications, medical benefit, added benefit over the appropriate comparator therapy, the number of patients who could benefit, treatment costs to statutory health insurance and requirements for quality-assured use. The legal list contains no cost-effectiveness analysis.
• CDA-AMC calls for input from patient and clinician groups before filing, and sponsors submit an economic evaluation and a budget impact model.

Cost-effectiveness says nothing about affordability, which is why payers also look at budget impact analysis.

Step 4: Independent assessment of clinical and economic evidence

Assessment is the scientific review of the evidence. Reviewers ask whether the studies are valid and relevant to the PICO, how large the effect is against each comparator, how certain that estimate is, and whether the cost-effectiveness results are credible.

Clinical assessment

The clinical review checks risk of bias, the fit between trial and decision populations, the endpoints and the robustness of any indirect comparison, using methods taught in Module 4: Evidence Synthesis. The EU joint clinical assessment sits entirely in this step: its report describes the relative effects on health outcomes and their certainty, and must not contain a value judgement.

Economic assessment

Where economics is in scope, assessors critique the company’s model: its structure, inputs, extrapolation and the resulting incremental cost-effectiveness ratio (ICER). They check how results change under uncertainty, including with probabilistic sensitivity analysis.

Assessors are usually independent of both the company and the final decision. At NICE, an external assessment group critiques the submission, and the company can check its report for factual accuracy. In Germany, the G-BA commissions IQWiG, the Institute for Quality and Efficiency in Health Care, whose assessment must be published within three months of the dossier deadline. CDA-AMC review teams prepare a clinical report and an economic report.

Step 5: Appraisal and committee deliberation

Appraisal is where a committee interprets the assessment and makes a value judgement: given the evidence, its uncertainty and the context, should the technology be recommended, for whom and on what terms?

Committees weigh the size and certainty of the benefit, severity and unmet need, cost-effectiveness, budget impact and the views of patients and clinicians. At NICE, the cost per QALY gained is judged against a range of £25,000–£35,000, applied from April 2026. In Germany, the output is a rating of added benefit on a six-level scale, from major added benefit down to less benefit than the comparator.

Who sits at the table matters. Germany’s G-BA, the Federal Joint Committee, brings together representatives of doctors, dentists, hospitals and health insurance funds; patient representatives attend but cannot vote. France’s Transparency Committee includes doctors, pharmacists, methodologists and patient and user representatives.

Because appraisal involves judgement, how discussion is run matters too. A joint HTAi/ISPOR task force published good practice guidance on deliberative processes in 2022. Reading an appraisal critically and writing a defensible recommendation are the focus of Module 14: The Practitioner’s Workshop.

Assessment vs appraisal: what is the difference?

Assessment asks what the evidence shows; appraisal asks what it means for a decision in a particular health system. Assessment should be as scientific and reproducible as possible. Appraisal openly involves value judgements, and the final decision often sits with yet another body.

The terms are used inconsistently. Gsteiger and colleagues argued in 2024 for reading them as a science/value dichotomy: assessment is a predominantly technical exercise, while appraisal interprets evidence in a local context of disease burden, alternatives, budget and ethics. The EUPATI toolbox adds a third phase, decision-making, which it notes rarely belongs to the HTA body itself.

Step 6: Recommendation, reimbursement decision and price negotiation

Appraisal produces a recommendation or rating; the decision sets whether the technology is funded, for whom, at what price and on what conditions. Some recommendations have legal force; others are advice, followed by price negotiation.

In the EU, Council Directive 89/105/EEC gives national authorities 90 days for a pricing decision and 90 days for a reimbursement decision, and no more than 180 days in total where the two run in sequence. Four typical routes:

1. Binding recommendation. When NICE recommends a technology as an option, the NHS in England must make it available, normally within 3 months. NICE’s five categories are recommended, optimised, recommended for use with managed access, only in research, and not recommended. See our guide to the NICE technology appraisal process.
2. Benefit rating, then negotiation. In Germany, the company negotiates a reimbursement amount with the GKV-Spitzenverband, the federal association of statutory health insurance funds. Without agreement within six months of the G-BA resolution, an arbitration board decides within three months. The amount applies from the seventh month after launch.
3. Clinical ratings that drive coverage and price. In France, the SMR rating (clinical benefit) determines whether and at what rate a medicine is reimbursed, with the rate set by UNCAM, the national health insurance union. The ASMR rating (clinical added value, I to V) feeds price negotiation with CEPS. Ministers make the final decision.
4. Non-binding advice, then joint negotiation. In Canada, CDA-AMC recommendations, such as “reimburse with clinical criteria and/or conditions” or “do not reimburse”, are not binding. After a positive one, the pan-Canadian Pharmaceutical Alliance (pCPA) may negotiate for federal, provincial and territorial plans, and each plan decides.

Step 7: Implementation, managed entry and reassessment

An HTA decision is rarely final. Implementation turns it into real access, managed entry agreements allow funding while uncertainty is resolved, and reassessment updates the decision when new evidence appears.

The international HTA Glossary, citing Klemp and colleagues, describes managed entry as a conditional arrangement between manufacturer and payer that enables earlier reimbursement while uncertainty about performance is addressed. Examples:

• England: “recommended for use with managed access” is a NICE recommendation category.
• Germany: the G-BA can time-limit a resolution and require data collection alongside routine use for orphan medicines and those with conditional or exceptional-circumstances authorisations, reviewed at least every 18 months. For orphan medicines, added benefit is deemed proven by the authorisation until statutory insurance sales exceed €30 million in 12 months; full evidence is then required.
• France: since 1 July 2021, HAS has also ruled on early access for presumed innovative medicines, and it can re-evaluate medicines or whole therapeutic classes.
• Canada: CDA-AMC runs resubmissions and reassessments of drugs it has already reviewed.

Reassessment closes the loop: a new indication, a price change or new trial data can start the HTA process again.

HTA process examples: NICE, G-BA/IQWiG, HAS, CDA-AMC and the EU JCA

All five systems use the same building blocks but divide them differently. The main differences are who assesses, how central cost-effectiveness is, and whether the recommendation binds the payer. The table reflects published rules as of October 2026.

NICE and CDA-AMC review an economic evaluation as standard; Germany’s standard route links price to added benefit; France requests an efficiency opinion only for selected products. Only the EU JCA stops at assessment.

Why the health technology assessment process matters

Knowing the HTA process shows where a decision is really shaped. Problems raised at appraisal often start earlier: a comparator the trial did not include, an outcome the agency does not accept, or uncertainty the evidence cannot reduce. For manufacturers, that argues for planning evidence around the likely PICO well before launch.