Health economic study dr amir hamzah

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Health economic study dr amir hamzah

  1. 1. Health Economic Study in Malaysia Amir Hamzah Abdul Latiff MMed, MRCP, FACAAI Consultant Paediatrician & Clinical Immunologist/Allergist Pantai Hospital Kuala Lumpur President Malaysian Society of Allergy & Immunology (MSA))
  2. 2. The recommendation Recommendation 2 – HYDROLYSED FORMULA For infants at increased risk of allergic disease and who cannot be exclusively breastfed for the first 4 to 6 months, a hydrolysed formula appears to offer advantages to reduce the risk of cow’s milk protein allergy and allergic disease. (Strength of recommendation – A) 1. Partially hydrolysed whey formula and extensively hydrolysed casein formula reduce the risk of atopic dermatitis and cow’s milk protein allergy to regular cow’s milk protein formula. 47,48 2. When considering a hydrolysed formula, it is advised to choose one with reduced allergenicity that has been proven or confirmed. 47
  3. 3. Economic impact of using partially hydrolyzed whey infant formula versus standard cow’s milk formula in the prevention of atopic dermatitis (AD)
  4. 4. Some Definitions • Economics o Study of the allocation of scarce resources • Health Economics o Economic principles applied to healthcare • Pharmaco-economics o Economic principles applied to drug therapy • Economic Evaluation o main decision making tool in economics o Economic evaluation is about efficiency and is: ‘the comparative analysis of alternative courses of action in terms of both their costs and consequences’ (Drummond, 1997)
  5. 5. Types of economic evaluation • Cost minimisation analysis o Equal outcomes / clinical benefit assumed o Which has lowest overall total costs? • Cost Benefit analysis o Both costs and outcomes expressed in monetary value o Difficult to value all health benefits in monetary terms • Cost Effectiveness analysis o Outcomes expressed in natural units o Cost per “% drop in blood pressure” / cure • Cost Utility analysis o Outcomes expressed in QALYs o Cross disease comparisons possible o Considered current gold standard measure
  6. 6. Background & Objective
  7. 7. Background Although infants should be breastfed for as long as appropriate, some are not exclusively breastfed Infants who are not exclusively breastfed may be fed with standard cow’s milk formula (CMF) or alternate formulas, such as partially hydrolyzed-whey formula (pHF-W) Clinical trial data has shown that the incidence of atopic dermatitis (AD) is higher among healthy at-risk children initially fed with CMF vs. children fed pHF-W The economic impact of early feeding with CMF or pHF-W when considering the reduction in AD is unknown
  8. 8. Objective • To estimate the economic impact of feeding high-risk infants with partially hydrolyzed 100% whey based formula (pHF-W) instead of standard cow’s milk formula (CMF) for the first 4 months of life as an nutritional intervention in the prevention of atopic dermatitis (AD).
  9. 9. Lower Costs Higher Costs More EffectiveLess Effective Health Economic Evaluation
  10. 10. Lower Costs Higher Costs More EffectiveLess Effective Health Economic Evaluation
  11. 11. Health Economic Evaluation
  12. 12. Formula Cost How about other costs? Health Economic Evaluation
  13. 13. Formula costs and other costs For which non- economic advantages? AD treatment costs (Dietary, medical) Health Economic Evaluation
  14. 14. Health Economic Evaluation Costs Non- Economic Advantages Quality of life of children Formula AD (tests, visits, formula change, medicines) Quality of life of parents
  15. 15. Cost Effectiveness Ratio CER = (Increase in Cost) (Improved Effectiveness) CER = (Cost of Treatment 1 – Cost of Treatment 2) (Effectiveness of Treatment 1 - Effectiveness of Treatment 2)
  16. 16. Methods
  17. 17. Model Overview Model Overview Method Cost effectiveness (Markov) model using Microsoft Excel Intervention First 4 months of life, feeding with pHF-W vs. CMF [based on GINI study] Target population “At risk” (atopic heredity) healthy infants living in developed urban area who are not exclusively breastfed and who would otherwise receive CMF Cost considered All (“societal perspective”), regardless of who incurs these costs, per child Data sources Published literature, Opinion/data assumptions from KOLs, and Pricing and market share data from Nestle affiliates Analytical timeline Infant formula feeding for prevention of AD =4 months Full analytical horizon = 6 years Outcomes measures Cost, AD incidence, time spent post-AD diagnosis, AD symptoms-free days, quality adjusted life years (QALYs) Discount rate 3% per year for costs and clinical effects (i.e., QALYs)* Sensitivity analysis Univariate deterministic and multivariate probabilistic *In the model, costs and benefits occur at different time points. A common practice in cost–benefit analysis, called discounting, is to express all costs and benefits in terms of their present value by assigning smaller weights to those that occur further away in the future than to those occurring more recently. Discounting makes costs and benefits occurring at different times comparable.
  18. 18. Key Model Parameters / Assumptions Key Model Parameters / Assumptions Age Groupings • <1 year • 1-6 years Treatment modality categories (for AD) • Dietary (change in infant formula) • Pharmacological • Combined dietary and pharmacological Maximum duration of formula use (age when formula feed ends) • 1 yr (hence: from 1 yr onward, treated pharmacologically only) AD severity categories • Mild • Moderate • Severe Body location • Model does not distinguish location of AD symptoms on body Medical perspective • Model considers paediatrician outlook Quantities of formula • Daily quantity of infant formula consumed adjusted for age-specific nutritional requirements and infant formula product labels
  19. 19. Model Concept Birth (No AD history) [A] Initiate CMF or pHF-W [B] AD episode on CMF or pHF-W [C] Switch to next formula 1 + add drug 1 [E] Switch to next formula 2 + add drug 1 [K] ADCS on next formula 1 [G] Switch to next formula 2 [H] Switch to next formula 1 [D] Stay on CMF or pHF-W, add drug 2 [M] Stay on CMF or pHF-W, add drug 3 [N] ADCS on CMF or pHF-W [L] Stay on CMF or pHF-W, add drug 1 [F] Initial AD episode (by severity) No Response Switch to next formula 2 + add drug 1 [J] No Response ADCS on next formula 2 [I] Response Response Flare Response Response Response Flare No Response No Response Flare Flare No Response Response Flare
  20. 20. No AD No AD No AD ModerateAD Severe Mild No AD fed with pHF-W for 4 months ModerateAD Severe Mild No AD fed with CMF for 4 months • Incidence of AD depends on formula • Choice of AD management depends on severity and age group • Response rates vary by therapy • Flares vary by severity Simplified Model Structure Dietary Pharmacologic or AD Controlled Flare Infant age 0 without AD responses incidence flares management Dietary+ Pharmacologic No Flare Start here
  21. 21. Model Inputs and Sources Model Input Source Incidence of AD von Berg et al, Allergy Clin Immunol, 2008 (GINI study) Utility of AD by severity Pitt et al, Br J Dermatol, 2006; Stevens et al, Br J Dermatol, 2005 Severity of AD (Proportion of AD patients mild vs. mod/severe) Approach to management of AD (use of formula change, medical, combo for AD treatment) Diagnostic testing upon initial development of AD Formula change - Change in initial formula for treatment (0-1 yr of age) Time to Formula switch Medical treatment used by age group Response rates to AD treatment (infant formula only and combination treatment) Response rates to 1st, 2nd and 3rd line medical treatment Probability of AD flare Hospitalization due to AD Resource utilization – Number of Physician visits Medical treatment used (specific products and quantities) Primarily: KOL survey, Secondarily: Nestle Malaysia (as needed) Daily quantity of infant formula consumed due to partial breastfeeding Infant Formula costs Physician visit costs Lab test costs Hospitalization costs Medical treatment costs Indirect costs Primarily: Nestle Malaysia *Model inputs and sources listed have been reviewed/discussed with Nestle and KOLs at a previous meetings.
  22. 22. Main Results
  23. 23. Model-based Estimated Time to AD Diagnosis 61% 75% 14% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 52 104 156 208 260 312 PercentsurvivingwithoutADdiagnosis Weeks since birth CMF pHF-W pHF-W reduces the proportion of patients developing AD by 14 percentage points
  24. 24. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 1 2 3 4 5 6 Cumulativeproportionofinfants developingADasreportedinGINI Years Cumulative Incidence of AD & Average Time Spent Post-AD Diagnosis CMF Time after AD =1.69 years pHF-W Time after AD =1.01 years 39% 14% pHF-W reduces the proportion of patients developing AD by 14 percentage points and reduces the time spend post-initial-AD diagnosis 25%
  25. 25. Cumulative Discounted Total Costs (Malaysian Ringgit $) $2882 $1766 Difference = $1116 $0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 0 52 104 156 208 260 312 Discountedcumulativecostsforanaverage infantenteringthemodel Weeks since birth PHF-W CMF pHF-W reduces the cumulative costs associated with AD by $1,116 at 6 years pHF-W is also less expensive over almost the entire period
  26. 26. Direct and Indirect Costs by Category (Malaysian Ringgit $) $- $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 CMF pHF-W Indirect Costs Hospitalization Nurse calls Lab tests Pharmacological treatments Visits Note: Indirect costs include time loss for taking care of AD child, travel to clinic, and time loss to go to the lab The cost of AD are largely driven by visit, pharmacological treatment, and indirect costs (each accounting for about 1/3 of costs) pHF-W reduces costs for all key categories
  27. 27. Discounted costs (Malaysian Ringgit $) per child CMF pHF-W Difference Direct $1,966 $1,216 -$750 Indirect# $916 $550 -$366 Total $2,882 $1,766 -$1,116 Undiscounted effects (per child) Percent with AD 39% 25% -14% Number of days with AD symptoms 93.04 55.11 -37.93 Quality-adjusted life-years 5.90 5.94 0.04 Cost effectiveness ratios (all discounted) Discounted incremental cost per AD case avoided Dominant Discounted incremental cost per AD day avoided Dominant Discounted incremental cost per quality-adjusted life yeargained Dominant Cost and Cost-Effectiveness # Indirect costs include time loss for taking care of AD child, travel to clinic, and time loss at the lab *Dominant means that pHF-W is less expensive and more effective than CMF pHF-W decreases costs, the risk of AD, and the number of days with symptoms, and increases QALYs Since it is less expensive and more effective, it is considered to be a “dominant” option in health economic jargon
  28. 28. Sensitivity Analyses
  29. 29. Univariate Sensitivity Analysis Tornado Chart of Cost Difference (pHF-W vs. CMF) The model results are most sensitive to the assumptions about the incidence of AD and the degree to which CMF is associated with a higher risk of AD than pHF-W
  30. 30. Multivariate Probabilistic Sensitivity Analysis -$2,500 -$2,000 -$1,500 -$1,000 -$500 $0 $500 0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20 ΔCost ΔQALY Median CI region Base Case Number of Simulations ran – 5,000 When the model is run 5,000 times, and each time with different inputs for each variable (which are selected according to a pre- specified, e.g. normal distribution), the results change both in terms of cost savings and QALY gained. The figure is above is a scatter plot of the net costs and net QALY differences for these 5,000 runs The base case results and median results across the 5,000 simulations are very consistent pHF-W is cost saving in almost all runs the cost savings range from $650 to $1464 per child; the QALY gains range from 0.017 to 0.079
  31. 31. Model-Derived Cost of AD
  32. 32. Total Cost per Child with AD Notes: all costs are undiscounted; restricted means (as follow up ends at the end of age 6); expressed in Malaysian Ringgit. *Cost per year is not cost over 6-year follow up divided by 6 years – it is rather the cost over 6-year follow-up divided by the number of years post AD diagnosis. The same applies for the number of visits. Direct costs/child with AD over 6-year follow up* $5378 Total costs/child with AD over 6-year follow up* $7851 Direct costs/child with AD per year $1289 Total costs/child with AD per year $1882 Number of visits/child with AD over 6-year follow up:* GP and specialist 28.9 Number of visits/child with AD per year: GP and specialist 6.92 Number of visits/child with AD per year: GP 5.06 Number of visits/child with AD per year: Specialists 1.86 The cost of AD per child who develops AD over the 6-year period is $7851 The annual cost per year is $1,882 The number of visits over the 6-year period is approximately 29 The number of visits/year after AD develops is approximately 7, including 5 with GPs and 2 with specialists
  33. 33. Cross-country Comparisons
  34. 34. Estimated Annual GP Visits for Incident AD Case The average annual number of visits per incident AD case are estimated at approximately 4.24, 4.73, and 1.89 for Indonesia, Malaysia, and Singapore, respectively. Study Country Population Pub Year Mild Moderate Severe Total Chang and Sung U.S. Patients with an AD diagnosis 2005 1.74 Pharmerit Singapore >0-6 Years 2013 2.35 Barbeau and Lalonde Canada 6 months to 84 years 2004 2.31 3.19 5.74 3.59 Ngamphaiboon et al Thailand Children aged 0-5 2012 4 8 13 4.27a Ngamphaiboon et al Thailand Children aged 0-5 2012 4 8 12 4.58b Pharmerit U.S. >0-6 Years 2013 5.05 Mertens et al Germany >1 year (average 23) 2012 5.40 Pharmerit Malaysia >0-6 Years 2013 6.92 Pharmerit Indonesia >0-6 Years 2013 8.12 Pharmerit Philippines >0-6 Years 2013 11.06 Su et al Australia 4 mos-15yrs at dermatology clinic 1997 7.0 13.0 23.2 12.88 Taylor et al U.K. Paediatric patients with CMA who started nutrition with eHF 2012 13.1 Paediatric patients with CMA who started nutrition with AAF 2012 17.5 a – atopic dermatitis, not specific to cow’s milk allergy b – atopic dermatitis, specific to cow’s milk allergy Compares reasonably well with rest of literature
  35. 35. Literature Review – Annual AD costs a – atopic dermatitis, not specific to cow’s milk allergy b – atopic dermatitis, specific to cow’s milk allergy * Figure in parenthesis when excluding cost of GP visits Study Country Costs Age Severity Year of data Annual Cost (US$) Annual Cost (2013) (US$) Ngamphaiboon 2012 Thailand Direct Children aged 0-5 Alla 2010 175 184a Ngamphaiboon 2012 Thailand Direct Children aged 0-5 Allb 2010 310 338b Pharmerit Malaysia Direct 0-6 yrs All 2013 388 (308)* 388 (308)* Pharmerit Philippines Direct 0-6 yrs All 2013 433 433 Pharmerit Philippines Total 0-6 yrs All 2013 443 443 Su 1997 Australia Total 4 mos-15yrs Mild 1997 263 477 Pharmerit Malaysia Total 0-6 yrs All 2013 566 (486)* 566 (486)* Pharmerit Indonesia Direct 0-6 yrs All 2013 220 682 Pharmerit Indonesia Total 0-6 yrs All 2013 689 689 Ellis 2002 U.S. Direct Pediatrics NA 2001 450 705 Barbeau 2004 Canada Total 6 mos-84yrs All 2002 618* 742 Ellis 2002 U.S. Direct All NA 2001 580 910 Pharmerit U.S. Direct 0-6 yrs All 2013 945 945 Pharmerit Singapore Direct 0-6 yrs All 2013 958 958 Pharmerit Singapore Total 0-6 yrs All 2013 1,070 1,070 Fivenson 2002 U.S. Direct All (mean 17yrs) NA 1997 609 1,104 Ellis 2002 U.S. Direct Pediatrics NA 2001 740 1,160 Pharmerit U.S. Total 0-6 yrs All 2013 1,071 1,071 Su 1997 Australia Total 4 mos-15yrs Mod 1997 653 1,184 Fivenson 2002 U.S. Direct 0-4 yrs NA 1997 725 1,314 Ellis 2006 Multinational Total 2-17 yrs, conventional meds Mild- Mod 2004 1,253 1,725 Su 1997 Australia Total 4 mos-15yrs Sev 1997 1,001 1,815 Ellis 2002 U.S. Direct All NA 2001 1,250 1,960 Ellis 2006 Multinational Total 2-17 yrs, pimecrolimus Mild- Mod 2004 2,581 3,553 The annual cost of AD/child who develops AD (converted in $US) appears within range of other estimates
  36. 36. Limitations and strengths • Model structure is simplification of reality but nevertheless attempts to capture treatment patterns and costs with a high degree of detail • Results are based on survey of KOLs • The impact on the AD child’s parent’s productivity loss while at work was only partially considered whereas the impact on the parent’s quality of life was entirely excluded • Longer-term impact of AD was excluded; that is, all costs were restricted to the first 6 years, hence means are somewhat biased • Costs for other allergies (e.g., allergic rhinitis) potentially affected by the use of pHF-W vs. CMF were also excluded • Cost of AD and number of visits for AD were within range of other published studies
  37. 37. Conclusions
  38. 38. • Over the 6-year follow-up period, use of pHF-W instead of CMF among high-risk infants results in: • costs savings (-$1,116) • avoided AD cases (-14% absolute percentage), • additional days without AD symptoms (+38 days), • Additional years without AD diagnosis (+0.68 years, i.e., just over 8 months), and • QALY gains (+0.04 QALYs). • pHF-W appears to be a cost effective strategy for the prevention of AD in high-risk infants.
  39. 39. Abstract Cost Effectiveness of Partially Hydrolyzed Whey Protein Formula in the Primary Prevention of Atopic Dermatitis in At-Risk Urban Infants in Malaysia Bhanegaonkar AJ 1, Horodniceanu EG1, Abdul Latiff AH2, Woodhull S3, Khoo PC3, Detzel P4, Ji J1, Botteman MF1 Objectives: To estimate the economic impact of feeding high-risk infants with partially hydrolyzed 100% whey based formula (pHF-W) instead of standard cow’s milk formula (CMF) for the first 4 months of life as a nutritional intervention in the prevention of atopic dermatitis (AD). Methods: A cohort Markov model was developed to simulate, from birth through age 6, the incidence and cost of AD in high-risk infants fed with pHF-W instead of CMF during the first 4 months of life. Data sources included published literature, market data, and key opionion leader inputs. Key modeled outcomes included reduction in AD risk, time spent post-AD diagnosis, AD-free days, quality-adjusted life years (QALYs), and costs. All results were discounted by 3% per year. Costs were expressed in 2013 Malaysian Ringgit ($). Results: Feeding high-risk infants pHF-W instead of CMF resulted in an estimated absolute 14 percentage point reduction in the risk of AD, a reduction in the time spent post-AD diagnosis of 8.16 months (95% CI: 5.40, 10.03) per child, and an additional 38 (95% CI: 16, 62) AD-free days per child. The AD-related cost estimates when feeding high-risk infants with pHF-W or CMF were $1,766 (95% CI: $1,389, $2,267) and $2,882 (95% CI: $2,531, $3,239) per child, respectively, resulting in a net difference in favor of pHF-W of $1,116 (95% CI: $650, $1464) per child. Considering those who do develop AD, the mean annual cost of AD was $1882 (across both arms) per child with AD. The mean cost of AD over the entire period was $7851 (across both arms) per child with AD. Conclusions: Using pHF-W instead of CMF in high-risk infants is expected to result in reduction in the burden of AD and save $1,116 per child.

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