Basics of Basics of Pharmacoeconomics and Pharmacoeconomics and

Outcomes Research:Outcomes Research:Application to Patient CareApplication to Patient Care

Sara Shull PharmD, MBASara Shull PharmD, MBA

Preview Preview Economic conceptsEconomic concepts Data types & sourcesData types & sources Types of pharmacoeconomic analysesTypes of pharmacoeconomic analyses PerspectivePerspective Cost-effectiveness and incremental Cost-effectiveness and incremental

analysisanalysis Sensitivity analysisSensitivity analysis Steps to pharmacoeconomic literature Steps to pharmacoeconomic literature

evaluationevaluation Case studies for clinical practice and policy Case studies for clinical practice and policy

buildingbuilding

Opportunity CostOpportunity Cost

Time and money as resources can Time and money as resources can only be spent once – choice is only be spent once – choice is unavoidable.unavoidable.

O.C. is defined as the amount that a O.C. is defined as the amount that a resource could earn in its highest resource could earn in its highest valued alternative use.valued alternative use.

How do you invest your time?How do you invest your time? Why take valuable time to learn about Why take valuable time to learn about

pharmacoeconomics and outcomes pharmacoeconomics and outcomes research? research?

How Can PE and Outcomes How Can PE and Outcomes Enhance My Practice?Enhance My Practice?

PE is an aid to decision making with strong potential PE is an aid to decision making with strong potential to:to:

• Mitigate the influence of marketingMitigate the influence of marketing Puts practitioner in the driver’s seatPuts practitioner in the driver’s seat

• Help set practice prioritiesHelp set practice priorities

• Enhances position of practitioner from payer’s Enhances position of practitioner from payer’s perspectiveperspective

Medicare plans to decrease pay-out to stem tide Medicare plans to decrease pay-out to stem tide of budget deficitof budget deficit

Private payers actively are developing quality Private payers actively are developing quality “report cards” “report cards”

How Can PE and Outcomes How Can PE and Outcomes Enhance My Practice?Enhance My Practice?

• Statistically more likely to be Statistically more likely to be responsible for better success in clinical responsible for better success in clinical care by eliminating poor/ unnecessary care by eliminating poor/ unnecessary carecare

• Ethical frameworkEthical framework Fidelity to individual patients & Fidelity to individual patients &

stewardship to the public goodstewardship to the public good

Economics is:Economics is:

The study of how individuals & The study of how individuals & society end up choosing, with or society end up choosing, with or without the use of money, to employ without the use of money, to employ scarce resources that could have scarce resources that could have alternative uses, to produce various alternative uses, to produce various commodities & distribute them for commodities & distribute them for consumption now, now or in the consumption now, now or in the future, among various people and future, among various people and groups in society. Paul Samuelsongroups in society. Paul Samuelson

Pharmacoeconomics and Pharmacoeconomics and Outcomes ResearchOutcomes Research

Using data to distinguish your Using data to distinguish your practicepractice

Data about efficacyData about efficacy

clinical and humanisticclinical and humanistic

Data about costData about cost

resources consumed to achieve resources consumed to achieve efficacy endpoints (investment)efficacy endpoints (investment)

Efficacy DataEfficacy Data

Management of efficacy endpoints Management of efficacy endpoints based on evidence enables clinicians based on evidence enables clinicians to maximize prescribing skillsto maximize prescribing skills

Evidence-based healthcare is a Evidence-based healthcare is a determination of the mix of those determination of the mix of those services, drug products, and services, drug products, and procedures that maximise benefits procedures that maximise benefits and reduce risks.and reduce risks.

Cost DataCost Data

Management of resource consumption Management of resource consumption enables patients to maximize enables patients to maximize purchasing power-purchasing power-• Individual level- managing insurance co-Individual level- managing insurance co-

paymentspayments• Group level- managing insurance Group level- managing insurance

premiums across groups and maximizing premiums across groups and maximizing the number of insured patientsthe number of insured patients

• Govt level- sustaining public programs Govt level- sustaining public programs

Value Is the Goal of PracticeValue Is the Goal of Practice

Minimizing the ratio of cost to Minimizing the ratio of cost to efficacy creates value- best return on efficacy creates value- best return on investmentinvestment

Enhances your ability to deliver a Enhances your ability to deliver a superior productsuperior product

Basic Value of Medical CareBasic Value of Medical Care

Evidenced by general trends:Evidenced by general trends:• Increased use of medical care and prescription Increased use of medical care and prescription

drugsdrugs• Mortality rates of certain diseases have Mortality rates of certain diseases have

significantly declinedsignificantly declined• Mean length of hospital stay has also declinedMean length of hospital stay has also declined

Despite this general evidence, few specific Despite this general evidence, few specific data regarding the actual costs and data regarding the actual costs and benefits attributed to drugs and medical benefits attributed to drugs and medical therapies existtherapies exist

ObjectivesObjectives

Objectives of pharmacoeconomics Objectives of pharmacoeconomics and outcomes research must and outcomes research must originate within three dimensions originate within three dimensions when considering results and value when considering results and value of healthcareof healthcare• Acceptable clinical outcomesAcceptable clinical outcomes• Acceptable humanistic outcomesAcceptable humanistic outcomes• Acceptable economic outcomesAcceptable economic outcomes

Types of Pharmacoeconomic Types of Pharmacoeconomic AnalysisAnalysis

MethodologyMethodology Cost measurement Cost measurement unitunit

Outcome unitOutcome unit

Cost minimizationCost minimization DollarsDollars Various- but Various- but equivalent in equivalent in

comparative groupscomparative groups

Cost benefitCost benefit DollarsDollars DollarsDollars

Cost effectivenessCost effectiveness DollarsDollars Natural units (life Natural units (life years, mg/dl blood years, mg/dl blood

sugar, LDL sugar, LDL cholesterol)cholesterol)

Cost utilityCost utility DollarsDollars Quality adjusted life Quality adjusted life yearsyears

Common Misconceptions When Common Misconceptions When Applying Pharmacoeconomic Applying Pharmacoeconomic

PrinciplesPrinciples

Cost-effective care is initially the cheapest alternative Cost-effective care is initially the cheapest alternative in a manner similar to other investments, least cost in a manner similar to other investments, least cost option may lead to greater costs downstreamoption may lead to greater costs downstream

Cost-effective care is outcome that generates Cost-effective care is outcome that generates “biggest” effect in a manner to similar investments, “biggest” effect in a manner to similar investments, smaller increments of outcome may be achieved at a smaller increments of outcome may be achieved at a lower overall costlower overall cost

PerspectivePerspective

The “point of view” considered in The “point of view” considered in economic analyses influences the economic analyses influences the outcomes and costs considered to be outcomes and costs considered to be most relevant:most relevant:• Provider Provider • PatientPatient• PayerPayer• SocietySociety

Comprehensive Definition of Comprehensive Definition of Cost-effectivenessCost-effectiveness

A therapy is deemed to be a cost-A therapy is deemed to be a cost-effective strategy when the outcome effective strategy when the outcome is worth the cost relative to is worth the cost relative to competing alternatives. In other competing alternatives. In other words, scarce resources are utilized words, scarce resources are utilized to acquire the best value on the to acquire the best value on the market. market.

Average Cost-effectivenessAverage Cost-effectiveness

Specifies the cost of an agent Specifies the cost of an agent required to achieve each unit of required to achieve each unit of effect. No comparison is made to effect. No comparison is made to alternative agents.alternative agents.Average cost-effectiveness Average cost-effectiveness

Cost of drugCost of drug

Resulting effect = Cost per unit of effect Resulting effect = Cost per unit of effect achieved achieved

Average Cost-effectivenessAverage Cost-effectiveness

Average cost-effectiveness of Agent AAverage cost-effectiveness of Agent A

$50.00 $50.00

50 units of effect = $1.00 per unit50 units of effect = $1.00 per unit

Average cost-effectiveness of Agent BAverage cost-effectiveness of Agent B

$150.00 $150.00

90 units of effect = $1.60 per unit90 units of effect = $1.60 per unit

Incremental Cost-effectiveness Incremental Cost-effectiveness AnalysisAnalysis

Makes comparisons to other Makes comparisons to other therapeutic options, standard of therapeutic options, standard of care, or “doing nothing” (placebo)care, or “doing nothing” (placebo)

Fundamental ratioFundamental ratio

Cost optionCost optionBB – Cost option – Cost optionAA

Effect optionEffect optionBB – Effect option – Effect optionAA

== Cost to achieve one unit of effectCost to achieve one unit of effect

Incremental Cost AnalysisIncremental Cost Analysis

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

Placebo Agent A Agent B

Cost

Incremental Effect AnalysisIncremental Effect Analysis

0

10

20

30

40

50

60

70

80

90

Placebo Agent A Agent B

Units of Effect

Comprehensive Incremental Cost-Comprehensive Incremental Cost-effectivenesseffectiveness

$150 - $50 $150 - $50 $100$100 90 – 50 units = 40 units 90 – 50 units = 40 units

== $2.50 per unit of effect achieved $2.50 per unit of effect achieved

Therefore, because Agent A is an available Therefore, because Agent A is an available alternative with a lower average cost per alternative with a lower average cost per unit of effect achieved, the cost-unit of effect achieved, the cost-effectiveness of using Agent B is diminished. effectiveness of using Agent B is diminished. The cost of Agent B is not in line with the The cost of Agent B is not in line with the product it delivers- a poor value. product it delivers- a poor value.

Grid Representing All Possible Grid Representing All Possible Relationships of Cost to Effect Between Relationships of Cost to Effect Between

Two Competing AlternativesTwo Competing AlternativesCost of alternative A Cost of alternative A relative to alternative relative to alternative

BB

LowerLower EqualEqual HigherHigher

Effectiveness Effectiveness alternative A alternative A relative to relative to alternative Balternative B

LowerLower+/-+/-

Trade Trade offoff

----

DominatedDominated

EqualEqual ++ ArbitraryArbitrary --

HigherHigher++

DominaDominantnt

+++/-+/-

Trade-offTrade-off

Measuring Efficacy Data VariablesMeasuring Efficacy Data Variables

What product (effect) can be consistently What product (effect) can be consistently expected from use of drug or health service?expected from use of drug or health service?

Usually determined from clinical trialsUsually determined from clinical trials• Seek direct relationship to morbidity and mortalitySeek direct relationship to morbidity and mortality

Survival/ deathSurvival/ death Myocardial infarction avoidedMyocardial infarction avoided

• May rely on surrogate probably related to final May rely on surrogate probably related to final outcome to enhance feasibility of analysisoutcome to enhance feasibility of analysis

Hemoglobin changesHemoglobin changes LDL cholesterol changesLDL cholesterol changes Intimal vessel wall thickness changes Intimal vessel wall thickness changes

• Randomized controlled clinical trial is gold Randomized controlled clinical trial is gold standard for deriving efficacy datastandard for deriving efficacy data

Measuring Cost Data VariablesMeasuring Cost Data Variables What resources are consumed to produce one What resources are consumed to produce one

unit of the effect?unit of the effect?Direct costsDirect costs

drug product acquisition costsdrug product acquisition costsdrug preparation & administration drug preparation & administration

costscostsdrug monitoring costsdrug monitoring coststreatment costs of adverse effectstreatment costs of adverse effects

Indirect costsIndirect costsexample of institution indirect costexample of institution indirect cost

Discounting CostsDiscounting Costs In order to draw most valid conclusion about In order to draw most valid conclusion about

costs generated over time to achieve an costs generated over time to achieve an effect in the future, it is necessary to effect in the future, it is necessary to consider that there is a time preference consider that there is a time preference associated with moneyassociated with money

Time-value of money adjustmentTime-value of money adjustment• Money in hand is worth more than the same Money in hand is worth more than the same

amount sometime in the future (we like to be amount sometime in the future (we like to be paid as soon as possible, but prefer to pay at the paid as soon as possible, but prefer to pay at the last possible moment) last possible moment)

• Therefore future costs must be adjusted to Therefore future costs must be adjusted to reflect present value.reflect present value.

A $1000 cost one year from now requires only $930.00 A $1000 cost one year from now requires only $930.00 in hand today assuming a 7% return on investment. in hand today assuming a 7% return on investment.

Sensitivity AnalysisSensitivity Analysis Conclusions drawn from an economic analysis Conclusions drawn from an economic analysis

may change, depending on the uncertainty of may change, depending on the uncertainty of cost and effects considered.cost and effects considered.

S.A., by altering important variables & then S.A., by altering important variables & then recalculating results, tests the validity of recalculating results, tests the validity of conclusions: conclusions: • Would Agent A still be most cost-effective if the Would Agent A still be most cost-effective if the

effect of Agent B was greater than measured in effect of Agent B was greater than measured in clinical trial?clinical trial?

• Would Agent A still be most cost-effective if the Would Agent A still be most cost-effective if the monitoring costs of Agent B were actually monitoring costs of Agent B were actually lower? lower?

S.A. becomes increasingly important as S.A. becomes increasingly important as assumptions are made to a greater degree.assumptions are made to a greater degree.

Steps to Pharmacoeconomic Steps to Pharmacoeconomic Literature EvaluationLiterature Evaluation

Evaluate:Evaluate:• The quality of the journalThe quality of the journal• Qualifications of authorsQualifications of authors• Title and abstract- unbiased?Title and abstract- unbiased?• Study methodologyStudy methodology

Perspective, study design, outcomes and appropriate Perspective, study design, outcomes and appropriate alternatives, costs and appropriate discounting, alternatives, costs and appropriate discounting, sensitivity analysis, & data sourcessensitivity analysis, & data sources

• Sponsorship- could bias be introduced?Sponsorship- could bias be introduced?• Incremental resultsIncremental results

What is the conclusion and does it differ between What is the conclusion and does it differ between subgroups? How much does allowance for subgroups? How much does allowance for uncertainty change conclusion? uncertainty change conclusion?

Vogengerg, FR editor. Introduction to Applied Pharmacoeconomics, 2001

Cases for DevelopmentCases for Development Formulary decision making (policy)Formulary decision making (policy)

• Appropriate place for eplerenone (InspraAppropriate place for eplerenone (Inspra®®) and spironolactone ) and spironolactone (generic) on Inpatient formulary of tertiary care academic (generic) on Inpatient formulary of tertiary care academic medical centermedical center

Clinical decision making for acute therapy (bedside)Clinical decision making for acute therapy (bedside)• Choosing between low molecular weight heparin or Choosing between low molecular weight heparin or

unfractionated heparin for the treatment of acute proximal deep unfractionated heparin for the treatment of acute proximal deep vein thrombosisvein thrombosis

Clinical decision making for chronic therapy Clinical decision making for chronic therapy (bedside)(bedside)• Choosing between selective cyclooxygenase inhibitor and Choosing between selective cyclooxygenase inhibitor and

traditional non-steroidal anti-inflammatory agent for traditional non-steroidal anti-inflammatory agent for management of osteoarthritis painmanagement of osteoarthritis pain

Other suggestions? Other suggestions?

Treatment of Pain Resulting from Treatment of Pain Resulting from OsteoarthritisOsteoarthritis

Pain results in significant disability and resource utilizationPain results in significant disability and resource utilization• affects 15% of US populationaffects 15% of US population• results in > 100,000 hospitalizations annuallyresults in > 100,000 hospitalizations annually

NSAIDs NSAIDs • effective pain reliefeffective pain relief• 24 – 30% the cost of Cox-II inhibitors24 – 30% the cost of Cox-II inhibitors• associated with a significant risk of adverse effectsassociated with a significant risk of adverse effects

Dyspeptic symptomsDyspeptic symptoms More serious non-dyspeptic effects- symptomatic ulcers, ulcer hemorrhage, More serious non-dyspeptic effects- symptomatic ulcers, ulcer hemorrhage,

ulcer perforationulcer perforation Cox- II inhibitors Cox- II inhibitors

• effective pain relief effective pain relief • substantially more expensive than NSAIDssubstantially more expensive than NSAIDs• associated with lower risk of GI side effectsassociated with lower risk of GI side effects

How should I treat my patient?How should I treat my patient?

NSAIDs are inexpensive compared to NSAIDs are inexpensive compared to Cox-II inhibitor:Cox-II inhibitor:• But won’t the more expensive agent pay But won’t the more expensive agent pay

for itself many times over by preventing for itself many times over by preventing an expensive GI bleed in my patient? an expensive GI bleed in my patient?

Dyspeptic symptoms are decreased by 15%Dyspeptic symptoms are decreased by 15% Clinically significant ulcer complications are Clinically significant ulcer complications are

reduced by 50%reduced by 50%

Risk of GI bleed: How Much Can It Risk of GI bleed: How Much Can It Be Altered?Be Altered?

Not all osteoarthritis patients have an equal Not all osteoarthritis patients have an equal risk of developing a GI bleedrisk of developing a GI bleed• Is paying extra for GI protection justified in all Is paying extra for GI protection justified in all

patients?patients? How much can the risk of GI bleed be How much can the risk of GI bleed be

altered by using a Cox-II inhibitor instead of altered by using a Cox-II inhibitor instead of an NSAID?an NSAID?• What value is really purchased for the extra What value is really purchased for the extra

cost?cost?• The relative risk reduction of GI complications The relative risk reduction of GI complications

with Cox-II inhibitor catches our eye- but actual with Cox-II inhibitor catches our eye- but actual risk reduction is smallrisk reduction is small

1-2% for overall ulcer complications1-2% for overall ulcer complications 1% for serious hemorrhage and perforation1% for serious hemorrhage and perforation

Spiegel MR et al. Annals Internal Medicine 2003; 138:10(795-806)

Cost-effectiveness analysisCost-effectiveness analysis

PopulationPopulation DrugDrug Total Total AnnualAnnual

CostCost

QualysQualys

GainedGainedIncremental Incremental

cost per cost per Qualy Qualy gainedgained

No Hx No Hx of GI of GI ulcerulcer

NaproxenNaproxen $4859$4859 15.261315.2613 --

Cox-II Cox-II inhibitorinhibitor

$16,443$16,443 15.303315.3033 $275,809$275,809

Hx of GI Hx of GI ulcerulcer

NaproxenNaproxen $14,294$14,294 14.723514.7235 --

Cox-II Cox-II inhibitorinhibitor

$19,015$19,015 14.808114.8081 $55,803$55,803

Spiegel MR et al. Annals Internal Medicine 2003;138:10(795-806)

Cardiovascular Effect of Cox-II Cardiovascular Effect of Cox-II InhibitorsInhibitors

How do cardiovascular problems affect my choice How do cardiovascular problems affect my choice of using Cox-II inhibitors or NSAIDs?of using Cox-II inhibitors or NSAIDs?

PopulationPopulation DrugDrug AnnualAnnual

CostCostQualysQualys

GainedGainedIncremental Incremental

cost per cost per Qualy gainedQualy gained

All All patientspatients

NaproxenNaproxen $5,037$5,037 15.253915.2539 --

Cox-IICox-II $16,620$16,620 15.283215.2832 $395,324$395,324

Spiegel MR et al. Annals Internal Medicine 2003;138:10(795-806)

Clinical Decision MakingClinical Decision Making

Risk reduction for GI complications Risk reduction for GI complications seen with Cox-II inhibitors is unlikely seen with Cox-II inhibitors is unlikely to offset their increased cost in the to offset their increased cost in the management of average risk patients management of average risk patients with osteoarthritis painwith osteoarthritis pain• With no history of GI bleed, choose With no history of GI bleed, choose

naproxennaproxen• With history of GI bleed, choose Cox-II With history of GI bleed, choose Cox-II

inhibitorinhibitor

Clinical Decision MakingClinical Decision Making

In all patients with osteoarthritis, the In all patients with osteoarthritis, the decision to use Cox-II inhibitor should decision to use Cox-II inhibitor should be made with awareness of the effect be made with awareness of the effect of the added risk for cardiovascular of the added risk for cardiovascular events on cost-effectivenessevents on cost-effectiveness• Currently, there is not enough Currently, there is not enough

information available, but it may be information available, but it may be prudent to avoid these drugs in patients prudent to avoid these drugs in patients with cardiovascular history, even in with cardiovascular history, even in patients with history of GI bleedpatients with history of GI bleed

Treatment of Acute Deep Vein Treatment of Acute Deep Vein ThrombosisThrombosis

VTEVTE• > 200,00 new cases reported annually in US> 200,00 new cases reported annually in US• Mortality attributed to PE 100 – 200,000 deaths annuallyMortality attributed to PE 100 – 200,000 deaths annually

Unfractionated heparinUnfractionated heparin• Effective for treating VTEEffective for treating VTE• Daily cost for IV therapy is lowDaily cost for IV therapy is low• Requires close monitoring of clotting time/ dose titration and, Requires close monitoring of clotting time/ dose titration and,

therefore, hospitalizationtherefore, hospitalization

Low molecular weight heparinLow molecular weight heparin• Effective for treating VTEEffective for treating VTE• Daily cost for SQ therapy is highDaily cost for SQ therapy is high• Routine clotting time monitoring not required unless obese or Routine clotting time monitoring not required unless obese or

manifestations of renal compromise presentmanifestations of renal compromise present• Early discharge or outpatient treatment for VTE is possibleEarly discharge or outpatient treatment for VTE is possible

How Should I Treat My Patient?How Should I Treat My Patient?

Unfractionated heparin is a less Unfractionated heparin is a less expensive option compared to low expensive option compared to low molecular weight heparin. molecular weight heparin. • But won’t the more expensive agent pay But won’t the more expensive agent pay

for itself by bypassing routine for itself by bypassing routine coagulation monitoring? coagulation monitoring?

• Also, can’t I lower the risk of nosocomial Also, can’t I lower the risk of nosocomial infection and error by sending my infection and error by sending my patient home after establishing low patient home after establishing low molecular weight therapy?molecular weight therapy?

Cost-effectiveness AnalysisCost-effectiveness Analysis

Treatment Treatment settingsetting DrugDrug

Total Total costs of costs of

course of course of therapytherapy

QualysQualys

GainedGained

IncrementIncremental cost al cost

per Qualy per Qualy gainedgained

Both agents Both agents admin in admin in inpatient inpatient settingsetting

UnfractionaUnfractionated heparinted heparin $26,361$26,361 7.9787.978 --

Low Low molecular molecular

weight weight heparinheparin

$26,516$26,516 7.9987.998 $7,750$7,750

Low Low molecular molecular weight weight heparin heparin primarily primarily admin in admin in outpatient outpatient settingsetting

UnfractionaUnfractionated heparinted heparin $26,361$26,361 7.9787.978 --

Low Low molecular molecular

weight weight heparinheparin

$25,559$25,559 7.9987.998 Cost-Cost-savingsaving

Gould MK et al. Annals Internal Medicine 1999;130(10):789-799

Clinical Decision MakingClinical Decision Making

Decreased monitoring costs with low Decreased monitoring costs with low molecular weight heparins and the molecular weight heparins and the attenuated risk of future complications attenuated risk of future complications with these agents do result in cost-with these agents do result in cost-effective care. effective care. • The higher acquisition cost is justified.The higher acquisition cost is justified.

Treating the patient on outpatient basis Treating the patient on outpatient basis creates best value.creates best value.• Better outcomes are achieved at a lower Better outcomes are achieved at a lower

overall cost- the best possible situation. overall cost- the best possible situation.

Gould MK et al. Annals Internal Medicine 1999;130(10):789-799

Clinical Decision MakingClinical Decision Making

For patients that can receive in-home For patients that can receive in-home treatment and support, establish low treatment and support, establish low molecular weight heparin therapy on first molecular weight heparin therapy on first day of hospitalization, then send the day of hospitalization, then send the patient home. (analysis includes cost of patient home. (analysis includes cost of home health visits)home health visits)

For patients that must remain hospitalized, For patients that must remain hospitalized, low molecular heparin should be selected low molecular heparin should be selected before unfractionated heparin as therapy before unfractionated heparin as therapy for treatment of VTE. for treatment of VTE.

Drug Selection for Inpatient Drug Selection for Inpatient Formulary AdditionFormulary Addition

Congestive heart failureCongestive heart failure• Afflicts > 4.6 million people in USAfflicts > 4.6 million people in US• Disease and cost burden rapidly Disease and cost burden rapidly

increasingincreasing• Primary reason for hospitalization in USPrimary reason for hospitalization in US• Length of stay & readmission significant Length of stay & readmission significant

cost driverscost drivers• High mortality rateHigh mortality rate

Inpatient ReimbursementInpatient Reimbursement

Most heart failure patients are Most heart failure patients are insured by Medicareinsured by Medicare

Medicare reimburses on prospective Medicare reimburses on prospective case basis; monetary amount case basis; monetary amount determined by diagnosisdetermined by diagnosis

Hospital is motivated to develop Hospital is motivated to develop cost-effective formulary with goal of cost-effective formulary with goal of decreasing mortality rate, hospital decreasing mortality rate, hospital length of stay, and preventing length of stay, and preventing readmissions readmissions

Formulary ConsiderationsFormulary Considerations

Two agents are effective & safe in Two agents are effective & safe in reducing the risk of death and reducing the risk of death and hospitalization of heart failure patients.hospitalization of heart failure patients.• Spironolactone (available on Inpt formulary)Spironolactone (available on Inpt formulary)

Daily cost is 50-90% lower than eplerenoneDaily cost is 50-90% lower than eplerenone Gynecomastia/ breast pain occurs in 10% of malesGynecomastia/ breast pain occurs in 10% of males

• Eplerenone (considered for formulary addition)Eplerenone (considered for formulary addition) More specific mechanism of actionMore specific mechanism of action Lower incidence of gynecomastia, but greater Lower incidence of gynecomastia, but greater

incidence of hyperkalemia requiring hospitalizationincidence of hyperkalemia requiring hospitalization

Indirect Comparison of Clinical Trial Indirect Comparison of Clinical Trial Results Results

VariableVariable SpironolactoneSpironolactone EplerenoneEplerenone

Relative risk of Relative risk of death due to death due to heart failureheart failure

75.2%75.2% 86.2%86.2%

Per patient cost Per patient cost of drug (36 of drug (36

months)months)$50.28$50.28 $1,230.00$1,230.00

Cost of drug per Cost of drug per death preventeddeath prevented $440.00$440.00 $53,000.00$53,000.00

Pitt B et al. The New England Journal Medicine 1999;341(10):709-717

Pitt B et al. The New England Journal Medicine 2003;348(14):1309-1321

Policy Decision MakingPolicy Decision Making

Eplerenone is not cost-effective across Eplerenone is not cost-effective across entire heart failure populationentire heart failure population

However, length of stay and readmission However, length of stay and readmission rates increase as severity of heart failure rates increase as severity of heart failure increasesincreases

Stratification of eplerenone efficacy Stratification of eplerenone efficacy indicates mortality and hospitalization indicates mortality and hospitalization rates fall more dramatically when heart rates fall more dramatically when heart function is more compromised (ejection function is more compromised (ejection fraction < 40%) fraction < 40%)

Policy Decision MakingPolicy Decision Making Extra cost of eplerenone may be justified in Extra cost of eplerenone may be justified in

sicker patients or in patients that cannot sicker patients or in patients that cannot tolerate cheaper spironolactone due to tolerate cheaper spironolactone due to gynecomastia/ breast paingynecomastia/ breast pain

Add eplerenone to Inpatient formulary but Add eplerenone to Inpatient formulary but limit use within these two patient limit use within these two patient populations onlypopulations only• Ejection fraction < 40%Ejection fraction < 40%• Cannot tolerate or fails spironolactoneCannot tolerate or fails spironolactone

Eplerenone is not allowed for treatment of Eplerenone is not allowed for treatment of hypertension (despite FDA indication) as hypertension (despite FDA indication) as many effective, safe alternatives are many effective, safe alternatives are available at significantly lower cost. available at significantly lower cost.

ConclusionConclusion

Time and money can only be spent once- Time and money can only be spent once- choice is inevitable. Whether done choice is inevitable. Whether done unconsciously or with a consistent process, unconsciously or with a consistent process, health care professionals are constantly health care professionals are constantly evaluating patient care choices & acting on evaluating patient care choices & acting on them. them.

Pharmacoeconomics and outcomes research Pharmacoeconomics and outcomes research can enhance the quality of your practice by can enhance the quality of your practice by strengthening your evaluation process and strengthening your evaluation process and increasing the probability that you deliver increasing the probability that you deliver better value in patient care.better value in patient care.