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A new generic approach
       for scoping HTA
                                       9th HTAi in Bilbao June 2012
Iris Pasternack, Finnish Office for Health Technology Assessment at
                                               THL, Helsinki, Finland
The HTA Core Model

                              METHODOLOGICAL
       ONTOLOGY
                                 GUIDANCE
   Questions that an HTA
                                How to answer
      should answer
                                the questions


                    REPORTING
                    STRUCTURE
                   How to present
                    the answers



                                                2
Domains of the HTA Core Model
1. Health problem and current use of technology

2. Description and technical characteristics
3. Safety
4. Clinical effectiveness
5. Costs and economic evaluation
6. Ethical analysis
7. Organisational aspects
8. Social aspects
9. Legal aspects
                                                  3
   Drug eluting stents (DES) vs bare metal
    stents (BMS) in coronary artery disease
    (CAD)
   Multislice computed tomography (MSCT)
    coronary angiography vs current practice in
    CAD
   Three genomic tests (OncotypeDX,
    Mammaprint, Femtelle) versus current
    grading practice in breast cancer
   Pazopanib versus current practice in renal cell
    carcinoma: a rapid assessment

Scoping pilot projects first with
PICO
Case MSCT
  Patients with
  diagnosed CAD
                SPECT        Healthy    In screening
   PET In triage (ruling     people
                                    non-
          in, ruling out)           MSCT
Suspected           MSCT
case: high risk              Suspected case:
            In monitoring    low risk
  IVUS
           Suspected case:      ICA
           moderate risk
                                    In diagnosis
    Stress            MRI
    ECHO
   MSCT (technology)
   in ruling out CAD (intended use)
   in patients with low risk of having CAD
    (population and health condition)
   compared to non-MSCT (technology
    compared)
   for “better outcomes” (outcome)




Structured scope for MSCT project
   Social domain: What are the
    consequences of the technology on daily
    living?:
    ◦ “Should we only look at the differences
      between DES and BMS?” > No
    ◦ “Should we only look at the differences
      between pazopanib and sunitinib?” > Yes




Expanding C
   Safety domain: What are the direct harms
    of the technology to the patient?
    ◦ “Should we only report the results of studies
      examining radiation exposure of MSCT in
      patient with CAD?” >no
   Ethical domain: What are the possible
    consequences to patient autonomy?
    ◦ “Should we consider only the given 3 tests, or
      look at all prognostic tests in breast cancer, or
      prognostic tests in any cancer?” > probably yes



Expanding P and I
All cancer patients       All x-ray devices

   All breast cancer patients        All CTs

      Women with early               MSCT
       breast cancer




Expanding frame around PICO
elements
T          Use           Pop              D   C   O




     •Treatment          •Gender
           •First line   •Age
           •Second       •Low-high risk
           line          of having D
     •Diagnosing         •Low-high risk
     •Ruling in/out      of developing D
     •Screening          •etc
     •Monitoring
     •Assessing
     prognosis
     •Preventing


From PICO to “TUPDCO” (or TICO)
HTA Core Model Online
 „Intended use‟ is missing from PICO
 Outcomes are difficult to define for the
  whole project but they need to be outlined
 Extending frame does not necessarily
  imply deviation from scope




Conclusions

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A new generic approach for scoping HTA. Iris Pasternack.

  • 1. A new generic approach for scoping HTA 9th HTAi in Bilbao June 2012 Iris Pasternack, Finnish Office for Health Technology Assessment at THL, Helsinki, Finland
  • 2. The HTA Core Model METHODOLOGICAL ONTOLOGY GUIDANCE Questions that an HTA How to answer should answer the questions REPORTING STRUCTURE How to present the answers 2
  • 3. Domains of the HTA Core Model 1. Health problem and current use of technology 2. Description and technical characteristics 3. Safety 4. Clinical effectiveness 5. Costs and economic evaluation 6. Ethical analysis 7. Organisational aspects 8. Social aspects 9. Legal aspects 3
  • 4. Drug eluting stents (DES) vs bare metal stents (BMS) in coronary artery disease (CAD)  Multislice computed tomography (MSCT) coronary angiography vs current practice in CAD  Three genomic tests (OncotypeDX, Mammaprint, Femtelle) versus current grading practice in breast cancer  Pazopanib versus current practice in renal cell carcinoma: a rapid assessment Scoping pilot projects first with PICO
  • 5. Case MSCT Patients with diagnosed CAD SPECT Healthy In screening PET In triage (ruling people non- in, ruling out) MSCT Suspected MSCT case: high risk Suspected case: In monitoring low risk IVUS Suspected case: ICA moderate risk In diagnosis Stress MRI ECHO
  • 6. MSCT (technology)  in ruling out CAD (intended use)  in patients with low risk of having CAD (population and health condition)  compared to non-MSCT (technology compared)  for “better outcomes” (outcome) Structured scope for MSCT project
  • 7. Social domain: What are the consequences of the technology on daily living?: ◦ “Should we only look at the differences between DES and BMS?” > No ◦ “Should we only look at the differences between pazopanib and sunitinib?” > Yes Expanding C
  • 8. Safety domain: What are the direct harms of the technology to the patient? ◦ “Should we only report the results of studies examining radiation exposure of MSCT in patient with CAD?” >no  Ethical domain: What are the possible consequences to patient autonomy? ◦ “Should we consider only the given 3 tests, or look at all prognostic tests in breast cancer, or prognostic tests in any cancer?” > probably yes Expanding P and I
  • 9. All cancer patients All x-ray devices All breast cancer patients All CTs Women with early MSCT breast cancer Expanding frame around PICO elements
  • 10. T Use Pop D C O •Treatment •Gender •First line •Age •Second •Low-high risk line of having D •Diagnosing •Low-high risk •Ruling in/out of developing D •Screening •etc •Monitoring •Assessing prognosis •Preventing From PICO to “TUPDCO” (or TICO)
  • 11. HTA Core Model Online
  • 12.  „Intended use‟ is missing from PICO  Outcomes are difficult to define for the whole project but they need to be outlined  Extending frame does not necessarily imply deviation from scope Conclusions