Saudi Gastroenterology Association · Open course
Facilitator guide
For anyone teaching this course in a workshop or journal club: timings, discussion prompts and common misconceptions for each module.
1. What HTA is — and where it sits in Saudi Arabia
- 20 min
- Lecture
- 25 min
- Discussion
- 15 min
- Exercises
- 60 min
- Total
Discussion prompts
- Think of a product your hospital approved last year. Who made each decision between approval and the first patient treated?
- When would an HTA recommend spending more than the current practice?
- Which domains would you weight most for a drug, and which for a test?
Common misconceptions
Misconception: HTA exists to reject expensive drugs.
Correction: HTA estimates value. Many assessments recommend adoption, sometimes at a negotiated price.
Misconception: A guideline recommendation is the same as a coverage decision.
Correction: Guidelines rank clinical options; payers also consider cost, budget and equity.
Transition: Now that we know what HTA is for, the next step is the most important: framing the decision problem precisely.
Resources: HTAA glossary: ملف تقييم التقنية الصحية · Module 1 self-check bank
2. Framing the decision problem
- 20 min
- Lecture
- 30 min
- Discussion
- 25 min
- Exercises
- 75 min
- Total
Discussion prompts
- Rewrite “Is vedolizumab good for Crohn’s disease?” as a full PICOTS statement.
- Which comparator would your own hospital use, and does the trial literature include it?
- Name one surrogate endpoint in IBD and say how strong the link is to patient outcomes.
Common misconceptions
Misconception: Placebo is always the right comparator because it is the cleanest.
Correction: Placebo is cleanest for efficacy; decisions need the relevant active comparator.
Misconception: A longer horizon always makes the drug look better.
Correction: It makes the estimate more complete. Long horizons can raise or lower the ICER.
Transition: With the question fixed, we ask what the evidence says and how certain it is.
Resources: PICOTS worksheet (print from this page) · Module 2 self-check bank
3. Clinical evidence: synthesis, indirect comparison and certainty
- 25 min
- Lecture
- 30 min
- Discussion
- 35 min
- Exercises
- 90 min
- Total
Discussion prompts
- Why are head-to-head IBD trials so rare, and what does that do to HTA?
- Take the A vs B example and change the log SEs. How wide does the interval become?
- Which GRADE domain is most often the problem in IBD surgery outcomes?
Common misconceptions
Misconception: A higher point estimate means a better drug.
Correction: Decisions use the interval and certainty, not the point estimate alone.
Misconception: Network meta-analysis is equivalent to a head-to-head trial.
Correction: It depends on untestable similarity assumptions and is usually lower certainty.
Transition: Effect estimates are one input. Next we put them next to costs in an economic evaluation.
Resources: Calculators: QALY and NNT/cost per responder · Module 3 self-check bank
4. Economic evaluation: costs, QALYs and the ICER
- 30 min
- Lecture
- 35 min
- Discussion
- 40 min
- Exercises
- 105 min
- Total
Discussion prompts
- Use the calculators to find the price at which the ICER equals SAR 150,000.
- Which Markov states would you include for Crohn’s disease with perianal fistula?
- Why is a threshold not a rule?
Common misconceptions
Misconception: A cost-effective drug saves money.
Correction: Cost-effective means good value, not cheaper. Many cost-effective drugs raise total spending.
Misconception: The ICER is a fact about the drug.
Correction: It is a model output that depends on assumptions, comparator, horizon and prices.
Transition: Even a cost-effective technology can be unaffordable. Next we ask what it does to the budget.
Resources: Calculators: ICER, net benefit, threshold price, discounting · Simulator: appraisal committee
5. Budget impact and affordability
- 20 min
- Lecture
- 25 min
- Discussion
- 30 min
- Exercises
- 75 min
- Total
Discussion prompts
- Who pays and who saves when a hospital switches to a biosimilar?
- Which BIA input would you check first in a sponsor dossier?
- How would you phase access when demand exceeds the budget?
Common misconceptions
Misconception: If a drug is cost-effective, the payer must fund it.
Correction: Payers also face a budget constraint; affordability is a separate test.
Misconception: Biosimilar savings are automatic.
Correction: They require tenders, switching programmes and clinician and patient confidence.
Transition: The numbers are in. Now we discuss what the numbers leave out.
Resources: Calculators: budget impact, biosimilar savings · Module 5 self-check bank
6. Beyond the numbers: values, equity and deliberation
- 20 min
- Lecture
- 35 min
- Discussion
- 20 min
- Exercises
- 75 min
- Total
Discussion prompts
- Run the MCDA exercise in small groups with different weights. Does the ranking change?
- Which interests should disqualify a member from voting?
- How would you involve a patient with ulcerative colitis meaningfully, not tokenistically?
Common misconceptions
Misconception: MCDA removes subjectivity.
Correction: It makes subjectivity visible and consistent.
Misconception: Equity arguments are non-scientific.
Correction: Equity is a legitimate criterion; the requirement is to state it and apply it consistently.
Transition: Drugs are only one kind of technology. Tests, devices and algorithms need different evidence.
Resources: HTAA published process steps · Module 6 self-check bank
7. Devices, diagnostics and AI
- 25 min
- Lecture
- 30 min
- Discussion
- 35 min
- Exercises
- 90 min
- Total
Discussion prompts
- List the downstream consequences of a false-positive FIT in your service.
- What outcome would convince you that CADe is worth buying?
- Who is responsible for monitoring an adaptive algorithm after deployment?
Common misconceptions
Misconception: Higher detection always means better care.
Correction: It can include low-risk findings and add surveillance burden. Outcome links must be shown.
Misconception: AI is validated once and stays valid.
Correction: Performance changes with data, setting and updates and must be monitored.
Transition: Some uncertainty cannot be resolved before launch. Next: sharing risk and coming back to the decision.
Resources: Calculator: cost per additional detection · HTAA pathways for devices and diagnostics
8. Managed entry, real-world evidence and reassessment
- 20 min
- Lecture
- 30 min
- Discussion
- 25 min
- Exercises
- 75 min
- Total
Discussion prompts
- Design three registry variables needed to judge a conditional MASH therapy agreement.
- When is a confidential price compatible with public accountability?
- What would make you disinvest from a biologic?
Common misconceptions
Misconception: Managed entry always saves money.
Correction: Administration can outweigh gains; agreements must be evaluated too.
Misconception: Real-world evidence replaces randomised trials.
Correction: It complements them but is vulnerable to confounding.
Transition: This is the end of the course. Use the post-test and the simulator to consolidate.
Resources: Simulator: outcomes-based agreement · HTAA reassessment page