1. Budget Impact Analysis Mairin Ryan Director of Health Technology Assessment

2. Science Patient wishes Industry claims Decision making “HTA is a decision support tool” Multidisciplinary process, summarises information about –Safety –Clinical and cost-effectiveness –Budget impact –Organisational impact / resource implications –Social and ethical issues related to use of a health technology in a systematic, transparent, unbiased and robust manner Budget Impact Analysis

3. Tool to predict the financial impact of the adoption and diffusion of a new technology into a healthcare system with fixed resources Addresses affordability Analysis of the added financial impact of a new health technology for a finite period of time

4. Any intervention used to promote health, diagnose or treat disease, or used in rehabilitation or long-term care, e.g. Health Technologies Organisational & support systems DrugsMedical devices Surgical proceduresDiagnostics

5. Why conduct BIA? Required to make an informed reimbursement decision –New technology may have increased acquisition costs –New technology may have cost-offsets e.g. Adverse effects, inpatient days –New technology may have different impact on different cost centres e.g. drug costs, laboratory costs, staff costs,

6. Issues to consider in BIA Perspective Technology Comparator Timeframe Target population Costing Outcomes BIA Model Uncertainty Reporting

7. Perspective Perspective: viewpoint from which study is conducted e.g. payer, health sub-budget, society –Payer perspective considers costs falling on health (and social) care system only –Only costs falling on e.g. drugs budget –Societal perspective considers other costs e.g. Cost of accessing healthcare, Lost productivity due to accessing healthcare or ill health, unemployment benefits, income taxation

8. Technology Sufficient information to differentiate from comparators –Treatment indication –How it will be used, –What benefits it will deliver, –What else is needed to enable use e.g. healthcare staff, training requirements, adjunctive interventions, healthcare setting, capital investment

9. Comparator Preferred comparator is “routine care” –Technology most commonly used for that indication in your healthcare setting –More than one comparator (weighted average) –Comparator may include technology without marketing authorisation for that indication (must have efficacy and safety evidence) –No intervention may be appropriate choice

10. Timeframe Represents the time horizon over which resource use will be planned e.g. 5 years –Time to “steady state” depends on rate of diffusion or uptake of the technology –Slow diffusion may be due to capacity issues, learning curves –Long time to peak effect with chronic diseases, screening programmes, vaccinations etc. –Need to consider technological issues e.g. battery replacement etc.

11. Target population Individuals with a given condition who might avail of the technology within the time horizon –Epidemiology to inform reporting of prevalence, incidence, mortality (open cohort) –Report absolute size of target population –Estimate uptake based on proportion suitable for intervention, adherence and persistence data, market analysis, expert opinion –Report frequency of healthcare use e.g. episodes of care –Subgroups

12. Costing Costs included depend on perspective –Direct medical costs –Indirect medical costs –Indirect non-medical costs Three steps to estimate cost –Identify resource use that may change –Quantify extent of changes –Measure costs of changes

13. Resource use Costs directly associated with intervention plus adjunctive interventions e.g. concomitant meds, adverse events, administration costs (staff, setting), Cost offsets include reduced adjunctive interventions, reduced healthcare consumption Costs not directly related to intervention excluded e.g. other healthcare costs due to extension of life

14. Quantify resource use changes Depict treatment sequence / clinical care pathway Trial & observational data Expert opinion

15. Costs –Unit cost databases, administrative databases, microcosting analyses focussing on changes in resource use –Unit cost inflation (consumer price index) –Costs from other country (purchasing power parity) –Capital costs e.g. equipment, ICT, accommodation, maintenance (depreciation) –Staff costs e.g. mid point of scale, include administrative and pension overheads

16. Clinical outcomes Relevant outcomes are those which influence use of technology (effectiveness, safety, uptake, etc) and need for further treatment ( e.g. implantable device failure requiring further surgery) –Effectiveness: RCT data, meta-analysis, observational data –Safety: RCT, patient registries. All AEs of economic significance included e.g. Hospitalisation, impact on adherence, persistence etc.

17. Why clinical outcomes? Need to determine use of technology and any cost offsets Provide data for planning resource use e.g. Reduced bed days Data on benefits to justify budget increases

18. BIA model Structure of model described All assumptions in model stated and sources acknowledged Validation described Model Baseline Scenario and New Technology Scenario Static model Dynamic model e.g. adjusted Cost- effectiveness model (population size, VAT, discount rate)

19. Budget Impact Analysis What is the difference between BIA and economic evaluation? ParameterBIAEconomic evaluation Underlying conceptAffordabilityValue for money Purpose Financial impact of introducing a technology Efficiency of alternative technologies Study timeframe Usually short-term (1 to 5 years) Usually long-term (e.g. lifetime) Health outcomesExcludedQuality adjusted life years DiscountingNo4% Result Total and incremental annual costs Incremental cost per unit of health outcome achieved

20. Uncertainty Scenario analysis to evaluate plausible scenarios Sensitivity analysis to evaluate uncertainty in budget estimates due to uncertainty in model and in key parameters

21. Uncertainty (ctd) Parameters to be examined: population size, uptake, costs (intervention and offsets) Univariate sensitivity analysis Multivariate sensitivity analysis Probabilistic sensitivity analysis

22. Reporting Report resource use for each year in natural units Disaggregated costs each year Report total and incremental costs for each year Report disaggregated by subgroup if appropriate Report scenario and sensitivity analysis including range for each parameter

23. Reporting Budget Impact Compares Robotic Hysterectomy versus mix of Laparoscopic plus Open Hysterectomy Incremental budget impact: Costs A – Costs B B Comparator / routine practice A Intervention Costs A Costs B Choice Year Incremental budget impact Median(95% CI) 1€0.49m(0.39 – 0.61) 2€0.81m(0.69 – 0.95) 3€0.95m(0.82 – 1.11) 4€1.08m(0.92 – 1.26) 5€1.15m(0.93 – 1.40) Total€4.48m(3.95 – 5.14)

24. Univariate sensitivity analysis for incremental budget impact of robotic hysterectomy

25. Budget impact of National Deep Brain Stimulation Programme Year Irish service (€m) Current service (€m) Difference (€m) Cumulative difference(€m) 1 1.21 (0.93-1.67)0.85 (0.62-1.20)0.37 (0.07-0.71) 2 1.22 (0.93-1.68)0.85 (0.62-1.21)0.37 (0.07-0.72)0.73 (0.13-1.41) 3 1.23 (0.93-1.70)0.86 (0.63-1.23)0.37 (0.07-0.72)1.10 (0.20-2.13) 4 1.23 (0.93-1.72)0.86 (0.62-1.24)0.37 (0.06-0.72)1.47 (0.26-2.85) 5 1.24 (0.93-1.74)0.87 (0.62-1.25)0.37 (0.06-0.73)1.84 (0.32-3.55)

26. Increased resource requirements by year for selected resources Resource Year 12345 Consultant neurosurgeon (hrs) 334344352355365 Consultant neurologist (hrs) 218214211210206 Specialist nurse (hrs) 270274277278281 Theatre time (hrs) 111112 113 Surgical bed days 225226227228 Outpatient appointments 7478818286 CT scans 3031 MRI scans 35

27. Contribution of cost elements to cost per patient in the proposed Irish service

28. Contribution of each procedure to the budget impact

29. Conclusions Budget impact analysis is important for reimbursement decisions Data used in CEA and BIA models Necessary to report total and incremental budget impact Standardised approach allows meaningful comparisons Methods used should be clearly explained and sufficient data provided to allow validation

30. References Guidelines for the Budget Impact Analysis of Health Technologies in Ireland 2013. www.hiqa.ie www.hiqa.ie Budget impact analysis – Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force www.ispor.org www.ispor.org Health Technology Assessment of robot-assisted surgery in Ireland. HIQA 2011. www.hiqa.iewww.hiqa.ie Health Technology Assessment of a Deep Brain Stimulation Service in Ireland. HIQA 2012. www.hiqa.ie www.hiqa.ie

31. Thank you mryan@hiqa.ie