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An empirical study comparing health technology assessment reports for drugs vs. medical devices

An empirical study comparing health technology assessment reports for drugs vs. medical devices. Britni Wilcher Associate Research Fellow in Health Technology Assessment University of Exeter Medical School, UK. Collaborators. Oriana Ciani Rod Taylor . Anoukh van Giessen. Objectives.

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An empirical study comparing health technology assessment reports for drugs vs. medical devices

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  1. An empirical study comparing health technology assessment reports for drugs vs. medical devices BritniWilcher Associate Research Fellow in Health Technology Assessment University of Exeter Medical School, UK

  2. Collaborators • OrianaCiani • Rod Taylor • Anoukh van Giessen

  3. Objectives To compare HTA reports of drug and medical devices for the treatment of cardiovascular disease at a number of levels: Nature of evidence Treatment effect HTA methods Adoption Recommendation Approach to address uncertainty

  4. Study design & methods • Study design: Systematic Review • Data collection & analysis • Stage 1 – Selection and screening of reports • Stage 2 – Data extraction • Stage 3 – Data analysis • Quantitative • Qualitative (e.g., future research recommendation, methods adopted to address technology specific issues)

  5. Preliminary Results: Selection of HTA Reports

  6. Preliminary Results: Key Characteristic of Reports • 1. Calculated with Fisher exact test

  7. Preliminary Results: Nature of Evidence • Calculated with Mann-Whitney • Includes systematic reviews, pooled analyses, meta-analyses, and HTA reports • Includes rapid reviews and sources of evidence that do not fall into the above mentioned hierarchy of evidence categories • Significant p-value

  8. Preliminary Results: Nature of Evidence 3 1 • Calculated with Fisher exact test • Significant p-value • Components of EUnetHTA HTA Core Model®

  9. Preliminary Results: Methods • p-value calculated using fisher exact test • Mean (standard deviation) reported; AMSTAR total score: low quality = 0 - 3, medium quality = 4 - 7, high quality = 8 – 11 • p-value calculated using Mann-Whitney U Test • Significant p-value

  10. Preliminary Results: Uncertainty Highlights - Handling of uncertainty in the included HTA reports

  11. Preliminary Results: Treatment Effect

  12. Preliminary Results: Adoption Recommendation Policy recommendations yielded from included HTA reports

  13. Strength & Limitation • We believe this to be the first empirical comparison of drug and device HTA reports • The results must be contextualized as they represent CVD interventions reflected in English-language publications in the CRD HTA database.

  14. Preliminary Conclusions • Device HTA reports compared to Drug HTA reports appear to be: • less likely to include RCT vs observational evidence than drug reports but are similar in nature of economic evidence • systematic review and economic evaluation methods are lower quality • less likely to provide a detailed description of technology and current health indication but more likely to consider organisational issues • equally likely to handle uncertainty

  15. Thank you! Email: b.wilcher@exeter.ac.uk

  16. BACK-UP SLIDES

  17. Research Question 1: Nature of Evidence 1.1. What is the nature of evidence included in the HTA reports on medical devices compared to drugs for cardiovascular disease? 1.2. What is the scope and nature of outcomes assessed in HTA reports on drugs relative to HTA reports on devices for cardiovascular disease?

  18. Research Question 2a: HTA Methods 2.1. Do the methods (e.g., systematic review, economic modelling, meta-analysis) applied in HTA reports on medical devices differ from drugs for cardiovascular disease?  2.2. Do HTA reports on medical devices and drugs for cardiovascular disease consider and adopt methods to evaluate technology specific challenges?

  19. Research Question 2b: Uncertainty 2.3. What methods are used to address data uncertainty in HTA of medical devices compared to drugs for cardiovascular disease?

  20. Research Question 3: Treatment Effect 3. Is the magnitude of treatment effects seen in HTA reports of medical devices comparable to drugs?

  21. Research Question 4: Adoption Recommendation 4. Is the final technology adoption recommendation in reports on medical devices less likely to be positive than HTA reports of drugs for cardiovascular disease?

  22. Stage 1: Selection and screening of reports Phase 1: Identification • Period: 2003 – 2013 • Cardiovascular indication • Cardiac • Cerebrovascular • Peripheral Phase 2: Screening 2 reviewers independently screened all titles & abstracts. Excluded if: Primary indication non cardiovascular disease Surgical procedure w/o device Diagnostic/Prognostic Non-drug/device Guidelines Abbreviated review Not publically available Not in English

  23. Stage 2: Data Extraction • Section 1: General Information • 16-items • Section 2: Nature of Evidence • 16-items • Section 3: HTA Methods • 4-items • Section 4: Quality of Review (Systematic Review & Economic Evaluation) • 21-items • Section 5: Technology specific considerations • 2-items • Section 6: Uncertainty • 4-items • Section 7: Results • 3-items • Section 8: Conclusions • 2-items

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