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Examining the quality of health economic analyses submitted to the Pharmaceutical Benefits Board in Sweden

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Abstract

This study assessed the quality of health economic documentation submitted to the Pharmaceutical Benefits Board (PBB) in Sweden. Two different instruments were used in the evaluation: the PBB checklist, which was constructed by the authors from the PBB guidelines for health economic evaluations, and the QHES, a validated quality assessment instrument. Some areas that seem especially problematic, or where the quality was particularly low are identified and discussed. Also, we present the cost per quality-adjusted life-year that the companies have presented and how this related to the PBBs decisions.

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References

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Acknowledgements

The authors thank two anonymous referees for helpful comments. The authors are all employed at the Pharmaceutical Benefits Board. No external sources of funding have been used.

Author information

Authors and Affiliations

  1. Pharmaceutical Benefits Board, Solna, Sweden

    Joakim Ramsberg, Stefan Odeberg, Andreas Engström & Douglas Lundin

  2. Pharmaceutical Benefits Board, Box 55, 17111, Solna, Sweden

    Joakim Ramsberg

Authors
  1. Joakim Ramsberg
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  2. Stefan Odeberg
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  3. Andreas Engström
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  4. Douglas Lundin
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Corresponding author

Correspondence to Joakim Ramsberg.

Appendices

Appendix 1

  1. 1.

    Which costs and revenues should be included?

    1. a.

      Has a societal economic perspective been used?

    2. b.

      Does the information reflect the situation in Sweden?

  2. 2.

    Choice of an alternative for comparison

    1. a.

      Are the comparators the most relevant alternative treatments in Sweden?

  3. 3.

    Choice of patient group

    1. a.

      Does the analysis include the entire patient population the subsidy application concerns?

    2. b.

      Have separate calculations been made for groups where the cost-effectiveness can be expected to differ?

    3. c.

      Is the number of patients in each group in Sweden estimated?

  4. 4.

    Analytical method

    1. a.

      Has a cost-effectiveness analysis been made?

    2. b.

      Are QALYs used as the measure of effect?

    3. c.

      If a cost-effectiveness analysis is not appropriate, has a cost-benefit analysis with willingness to pay as the measure of effect been performed?

  5. 5.

    Costs

    1. a.

      Have all relevant costs associated with treatment and illness been identified, quantified, and valued?

    2. b.

      Including the value of lost production (Using the human capital method)?

    3. c.

      Have costs for increased survival been included?

    4. d.

      Are unit costs and quantities presented separately?

  6. 6.

    Calculation of weights for quality of life adjustments

    1. a.

      Are the QALY weights based on standard gamble or time trade-off method? As second best rating scale?

    2. b.

      Are the QALY weights based on evaluations by persons in the actual health state?

  7. 7.

    Time frame

    1. a.

      Does the time horizon cover the period when the main health effects and costs arise?

  8. 8.

    Discounting

    1. a.

      Has the correct discount rate (3%) been used for both costs and effects?

  9. 9.

    Dealing with uncertainties in the results

    1. a.

      Have appropriate sensitivity analyses been made on central assumptions and parameters?

  10. 10.

    Using model analysis

    1. a.

      Is the model externally and internally validated?

  11. 11.

    Presentation of method and results

    1. a.

      Is the method used, assumptions made, and data used clearly shown?

    2. b.

      Has an incremental analysis been made?

  12. 12.

    Quality control

    1. a.

      Is the study peer reviewed and published?

    2. b.

      If not, has material been made available for quality control (for example, in the form of modeling tools, data, tables)?

    3. c.

      Are the names and places of work as well as the connection to the applicant company of the authors stated?

Appendix 2

  1. 1.

    Was the study objective presented in a clear, specific, and measurable manner? (7 points)

  2. 2.

    Were the perspective of the analysis (societal, third-party payer, etc.) and reasons for its selection stated? (4 points)

  3. 3.

    Were variable estimates used in the analysis from the best available source (e.g., RCT/best expert opinion/worst)? (8 points)

  4. 4.

    If estimates came from a subgroup analysis, were the groups prespecified at the beginning of the study? (1 points)

  5. 5.

    Was uncertainty handled by (a) statistical analysis to address random events, (b) sensitivity analysis to cover a range of assumptions? (9 points)

  6. 6.

    Was incremental analysis performed between alternatives for resources and costs? (6 points)

  7. 7.

    Was the methodology for data abstraction (incl. the value of health states and other benefits) stated? (5 points)

  8. 8.

    did the analytic horizon allow time for all relevant and important outcomes? Were benefits and costs that went beyond 1 year discounted (3–5%) and justification given for the discount rate? (7 points)

  9. 9.

    Was the measurement of costs appropriate and the methodology for the estimation of quantities and unit costs clearly described? (8 points)

  10. 10.

    Were the primary outcome measure(s) for the economic evaluation clearly stated and did they include the major short-term, long-term and negative effects? (6 points)

  11. 11.

    Were the health outcomes measures/scales valid and reliable? If previously tested valid and reliable measures were not available, was justification given for the measures/scales used? (7 points)

  12. 12.

    Were the economic model (including structure), study methods and analysis, and the components of the numerator and denominator displayed in a clear, transparent manner? (8 points)

  13. 13.

    Were the choice of economic model, main assumptions, and limitations of the study stated and justified? (7 points)

  14. 14.

    Did the author(s) explicitly discuss direction and magnitude of potential biases? (6 points)

  15. 15.

    Were the conclusions/recommendations of the study justified and based on the study results? (8 points)

  16. 16.

    Was there a statement disclosing the source of funding for the study? (3 points)

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Ramsberg, J., Odeberg, S., Engström, A. et al. Examining the quality of health economic analyses submitted to the Pharmaceutical Benefits Board in Sweden. Eur J Health Econ 5, 351–356 (2004). https://doi.org/10.1007/s10198-004-0246-1

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