RWE Methods · HTA
Health Technology Assessment (HTA)
Health technology assessment is how payers and agencies judge whether a therapy’s value justifies its cost, before deciding to fund it.
HTA, and the real-world evidence that increasingly informs it, are central to the agenda at RWE Connect 2026 in Boston.
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What it weighs
What HTA Evaluates
HTA looks beyond whether a therapy works to whether it is worth funding. These are the dimensions it weighs.
Clearing it up
Regulatory Approval vs HTA
Approval and assessment answer different questions. One lets a therapy be sold; the other decides if it will be funded.
Regulatory Approval
- Is it safe and effective?
- Weighs benefit against risk
- Grants market authorization
- Answers: can it be sold?
Health Technology Assessment
- Is it worth funding?
- Weighs value against cost
- Informs coverage and price
- Answers: should we pay for it?
HTA draws on the evidence from HEOR and increasingly from real-world evidence.
How it works
The HTA Process
From a submitted dossier to a funding decision, HTA follows a structured path.
Who decides
Major HTA Bodies
Assessment is carried out by national and independent agencies, each with its own approach.
The RWE connection
How Real-World Evidence Strengthens HTA
Real-world evidence has become central to assessment, especially where trial evidence falls short. It is a core theme at RWE Connect 2026.
See the full real-world evidence guide and how it feeds market access.
The state of the field
The State of HTA in 2026
Assessment is evolving fast as systems harmonize and evidence expectations rise. These are the forces in play at RWE Connect 2026.
Who is in the room
Who Attends RWE Connect 2026
A senior, focused audience of the people who prepare for and respond to assessment.
Seniority is confirmed: 150+ attendees, around 60% at Director or VP level and above. The functional mix shown is indicative; confirmed registration splits are shared with sponsors from the live delegate list.
Explore
Explore Related Topics
HTA sits at the meeting point of evidence, economics and access.
Sponsor RWE Connect 2026
Meet the HTA and Market Access Buyers in Boston
The teams that prepare for and respond to assessment gather at RWE Connect 2026: 150+ attendees, around 60% at Director or VP level and above.
RWE Connect 2026
Get the RWE Study Methods Primer
A plain-English guide to the core RWE methods, including how real-world evidence supports HTA. See the methods, then meet the people applying them in Boston.
- What HTA evaluates and how
- How RWE strengthens assessment
- Where HTA is heading in 2026
Free. Instant download. No obligation.
Health Technology Assessment: Common Questions
What is health technology assessment?
Health technology assessment (HTA) is the process payers and agencies use to evaluate the clinical and economic value of a therapy before deciding whether, and at what price, to fund it.
What is the difference between HTA and regulatory approval?
Regulatory approval decides whether a therapy is safe and effective enough to be sold. HTA decides whether its value justifies public or payer funding. A therapy can be approved but not funded.
What does HTA evaluate?
Clinical effectiveness, cost-effectiveness, budget impact, safety, patient and social value, and organizational and ethical considerations.
What are the main HTA bodies?
Examples include NICE in the UK, IQWiG and G-BA in Germany, HAS in France, CADTH in Canada, ICER in the US and PBAC in Australia.
What is the HTA process?
Scoping the question, submitting the evidence dossier, clinical assessment, economic assessment, appraisal and deliberation by a committee, and a coverage recommendation.
How does real-world evidence support HTA?
Real-world evidence closes evidence gaps, shows real-world effectiveness, supports indirect comparisons and long-term outcomes, and underpins managed-entry and post-launch commitments.
What is the EU Joint Clinical Assessment?
A centralized EU clinical assessment that feeds national HTA decisions, phasing in from 2025 to reduce duplicate evaluations across member states.
What is an ICER threshold?
A willingness-to-pay threshold, expressed as cost per QALY, that some HTA bodies use as a benchmark for whether a therapy is considered cost-effective.
Who carries out HTA?
National and regional HTA agencies, payers and independent value-assessment organizations, supported by academic and consulting HEOR teams.
Is HTA the same as HEOR?
No. HEOR generates the economic and outcomes evidence, and HTA is the assessment process that evaluates it to inform funding decisions.
What is RWE Connect 2026?
RWE Connect 2026 is a two-day real-world evidence summit in Boston bringing together the RWE, HEOR and market access leaders who generate and apply real-world evidence, with 40+ speakers and 150+ attendees.
When and where is RWE Connect 2026?
14 to 15 October 2026 at the Hampton Inn by Hilton, Boston Seaport District, Boston, MA.
