Download - Clinical Development
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Welcome
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Cost benefit issues in clinica
development
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synopsis
Clinical development
Economics in clinical trials
Cost benefit issuesTypes of cost
Strategies in clinical
development and OutcomesResearch
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synopsis
Strategy in multicentric trials
Loops in cost n benefit issues
Principles of Cost EvaluationStudies
Cost-Benefit Analysis
Cost Effectiveness AnalysisCost utility analysis
Practical Considerations in CostEvaluation Studies
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Clinical development
Clinical development is a blanket termused to define the entire process ofbringing a new drug or device to themarket. It includes drug discovery /product development, pre-clinicalresearch (microorganisms/animals)
and clinical trials (on humans). ...
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economics as a king inclinical research
the identification, measure,and comparison of the costs
(i.e. resources consumed)and outcomes (clinical,economic, and humanistic)
of interventions(pharmaceuticals, non-drugtherapies, public healthprograms)
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When a cost play role inCT
1. Define objective: which regimenshould be of prime choice
2. Identify ways to achieve theobjective
3. Identify and measure drug cost ofeach option
4. Identify and measure benefits(clinical outcome) of each option
5. Calculate and interpret the benefits
6. Perform sensitivity analysis : check
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When a economics comesinto a play
Three basic questions arise:What goods and services shall weproduce?How shall we produce them?Who shall receive them
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Answers
economics addresses thesequestions primarily from theperspective of efficiency
maximising the benefits fromavailable resources (or ensuringbenefits gained exceed benefits
forgone).
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outline
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Cost-benefits issuesCosts bene
Research complex break
therapies
Manufacturing molecule repla
therapy
Quality control of molecule assurquality
Preclinical evaluation anal
the risks
Application for IND qualit
Clinical evaluation lo
the risks
phases-I
Phase-II
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Types of costs
Costs vs. Charges
Direct costs
? medical vs. nonmedical
Intangible costs
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Direct costs
In the developing amoleculeIn pre clinical evaluation of
a moleculeIND (investigational NewDrug) application
Clinical developmentProtocol designingCRO selectionpatents
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Direct medical
Acquisition cost of drug ( price) Supplies to administer drug Supply management cost
Professional services cost Other direct costs
ADR treatment In and out patient treatment of
poor response Emergency room use Hospital over head costs Laboratory services
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Direct non-medical
Patient time cost for treatment orinterventionFormal and informal caregiver
timeTransportation
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Intangible cost
the cost of pain and sufferingresulting from a disease,condition, or intervention.
S i i li i l d l d
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Strategies in clinical development andOutcomes Research
Cost
Higher SameLower
Higher Evaluate AcceptAccept
Benefits
Same Reject Indifferent
Accept
Lower Reject RejectEvaluate
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Loops in cost n benefitissues
Benefits may some time be broken
into
Value if healthy time gained
Saving in treatment cost
Other savings or benefits
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Strategy in multicentrictrials
There has been growing concern that the
pooled (i.e., average) economic results
from multinational trials may not bereflective of the results that would be
observed in individual countries that
participated in the trial
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Transnational differences in morbidity/mortalitypatterns; practice patterns (i.e., medical
service use); and absolute and relative prices
for this service use (i.e.,
price weights)
Thus decision makers may find it difficult to
draw
conclusions about the value for the cost of the
Strategy in multicentrictrials contd.,
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Types of economicanalysis in clinical trials
Cost - efficiency Studies - Whatshould it cost?
Cost-of-illness Studies (COI) -Economic burden of illness
Cost Evaluation StudiesCost Benefit Analysis (CBA)Cost Effectiveness Analysis (CEA)Cost Utility Analysis (CUA)
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Principles of CostEvaluation StudiesAll relevant costs and benefits
should be counted
Purpose of evaluation is tocompare alternative used ofresources
Measurement is incremental
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Cost-Benefit Analysis
Evaluates the value of all resources
consumed in implementing a program or
intervention against the value of the outcome
in terms of dollars
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Cost Benefit Analysis
All costs and health effects areexpressed in monetary terms(i.e., must put a $ value on a yearof life)
Cost Benefit -> all benefits minusall costs, sometimes call Social
Return on Investment
Cost Benefit Ratio -> All benefits
divided by all costs, sometimes
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Cost EffectivenessAnalysisCEA is a method to determine
which program or treatment
accomplishes a given objective atthe least cost.
Cost-effectiveness analysis is amethod of comparing alternative
treatments in which the costs and
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Cost EffectivenessAnalysisCosts are expressed in monetary
terms
Benefits are expressed innatural units, e.g., life-years
Cost Effectiveness Ratio -> Costdivided by life-years (or othermeasure of benefit)
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Cost utility analysis
Evaluates the value of an
intervention or a program against
the value of the outcome in termsof quality-adjusted life years
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Cost Utility Analysis
Costs are expressed in monetaryterms
Benefits are expressed in quality-adjusted natural units, e.g.,quality adjusted life-years
Cost Utility Ratio -> Cost dividedby Quality Adjusted Life Years
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Practical Considerations inCost Evaluation StudiesSources of Cost Data
Technical Economic
Considerations
Statistical Considerations
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Potential Sources ofEconomic DataClinical trial forms/medical record
abstraction
Hospital bills
Health system cost-accountingsystems (e.g. HMOs)
Administrative claims data (e.g.
Medicare, Medstat)Patient/provider survey (e.g.
MEPS)
Cost scenario
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Some Technical EconomicIssuesAdjusting for price (unit cost)
differences
For different years
For different settings/locations
For different countries
(currencies)
(e.g. DCPP)
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example
Cost-Benefit Analysis of Folic AcidFortifiction
Cost Domains Included
Medical care
Developmental services
CORRECTING DEFECTS
Spina bifida: $349,133 Anencephaly: $485,016
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Cost of low level folic acid
fortification = $27.94 million per yr
Note: folic acid fortification can
mask vitamin B12 deficiency
Cost of surveillance of those with
undiagnosed vitamin B12 deficiency-$5 million per year
Bene ts o Fo c Ac
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Bene ts o Fo c AcFortification
Proportion of targetpopulation with inadequatefolate intake - 66%
Cases of birth defectsaverted: 191 spina bifida,113 anencephaly
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Folic Acid Fortification:Cost-Benefit AnalysisEconomic benefit of birth defects
averted: $121.5 million
Net benefit of fortificationprogram = $93.6 million
Benefit/Cost Ratio = 4.3
conclusion
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conclusionClinical trials may provide the best opportunity
for
developing information about a medical therapys
value
for the cost early in its product lifeWhen appropriate types of data are collected and
when they are analyzed appropriately, these
evaluations can provide data about uncertainties
related to the assessment of the value for the
cost of new therapies that may be used by policy
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ferences
www.uphs.upenn.edu/dgimhsr/prespharmacoeconomics05.pd
clinicaltrials.gov/ct2/show/NCT0
1140958
Novel approaches to incorporatingpharmacoeconomic
studies into...
www.ncbi.nlm.nih.gov/pubmed/20922340
lit f lif n
http://books.google.co.in/books?id=8wlpQgAACAAJ&dq=pharmacoeconomics+in+clinical+trials&hl=en&sa=X&ei=bB-OT8KiJ8XYrQfQ8c2SCQ&ved=0CDsQ6AEwAAhttp://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pdhttp://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pdhttp://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pdhttp://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://books.google.co.in/books?id=8wlpQgAACAAJ&dq=pharmacoeconomics+in+clinical+trials&hl=en&sa=X&ei=bB-OT8KiJ8XYrQfQ8c2SCQ&ved=0CDsQ6AEwAAhttp://books.google.co.in/books?id=8wlpQgAACAAJ&dq=pharmacoeconomics+in+clinical+trials&hl=en&sa=X&ei=bB-OT8KiJ8XYrQfQ8c2SCQ&ved=0CDsQ6AEwAAhttp://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.ncbi.nlm.nih.gov/pubmed/20922340http://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pdhttp://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pdhttp://www.uphs.upenn.edu/dgimhsr/presenta/.../pharmacoeconomics05.pd -
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Any questions
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