• What can you as a pharmacist do to help your patients?

• What can our institution do to better control costs? • What policies could help moderate drug costs?• What role can the formulary play in these efforts?

Discussion QuestionsWhat to Do About High Drug Costs

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30th Nov. 2013

Wholesalers

Generics

Branded Drug Cos

PBMS

Insurers

Clinicians

Patients

Providers

Employers

Govt’Govt’

Many People Involved in Pharmaceutical Supply-Chain

30th Nov. 2013

WHAT is Economic Evaluation?

• Definition: Economic Evaluation is ...

the identification, measure, and comparison of the costs (i.e. resources consumed) and outcomes (clinical, economic, and humanistic) of interventions (pharmaceuticals, non-drug therapies, public health programs)

30th Nov. 2013

WHAT is Economic Evaluation?

• Economic Evaluation is NOT JUST economics

• Economic Evaluation is multi-disciplinary, it combines

• Economics

• Epidemiology

• Biostatistics

• Medicine

• Pharmacy

• ….

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Why study Economic Evaluation?

• The pressure of cost containment.

• The need for methods to evaluate medical interventions.

• Purpose of economic evaluation

efficient resource allocation

NOTE: equity is often not addressed

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Who uses Economic Evaluation?

• Managers in hospital or health care plans (formulary decision)

• Pharmaceutical companies

• Government / Policy makers

• Researchers

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Who uses Economic Evaluation? (cont.)

• Hospital managers (including HMOs and FFS) • What drugs should be included on the hospital

formulary? • Which drug delivery system is the best for the

hospital?

• Pharmaceutical companies • What is the best drug for a pharmaceutical

company to develop? • Shall the company continue a clinical trial?• What is the economic benefit of a new product?

30th Nov. 2013

Who uses Economic Evaluation? (cont.)

• Government • Which drugs should be included in a Medicaid

formulary? • Is it cost-effective for Medicare to cover annual

mammography?

• Researchers • All of the above • How to improve the analytical credibility of economic

evaluation ?

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Costs can be described in many ways

• Cost / unit (cost/tab, cost/vial)

• Cost / treatment

• Cost / person

• Cost / person / year

• Cost / case prevented

• Cost / life saved

• Cost / DALY (disability-adjusted life year)

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Outcomes

• Both positive and negative outcomes should be addressed

• Positive outcomes: drug’s efficacy measure

• Negative outcomes: ADR and treatment failure

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Pharmacoeconomics

• is a set of methods to evaluate the(ECHO)

1.Economic,

2.Clinical, and

3.Humanistic

4.Outcomes of pharmaceutical products and services(or any health care service)

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Outcomes Relationship

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Pharmacoeconomics allows us

to compare the economic resources consumed(inputs) to produce the health and economic consequences of products or services(outcomes).

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Application of Pharmacoeconomics:

• Pricing of a new drug• Re-pricing of an old drug• Generation of a data for promotional material• Legislative requirement for drug licensing and medical

reimbursement• Justify clinical pharmacy evaluation• Used to justify use of pharmacy products and

pharmaceutical care• Principle of Pharmacoeconomic also influences health

care decision making and individual patient care• Earlier clinical decisions were solely based on

outcomes. Now cost, outcome, humanistic• outcome are also considered

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Cost of drug:

• This is the total resources consumed in producing the drug or drug formulation. It is the amount paid to the suppliers.

• To evaluate the economics of drug therapy,cost is categorized into:

i. Direct cost.

ii. Indirect cost.

iii. Intangible cost

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Direct cost

i.) Direct medical cost This is what is paid for specialized health resources and

services. It includes the

– Physician’s salaries;

– Acquisition cost of medicine – Consumables associated with drug administration – Staff time in preparation and administration of medicines – Laboratory costs of monitoring for effectiveness and adverse

drug reactions.

ii.) Direct non medical cost This includes cost necessary to enable an individual receive

medical care such as lodging,special diet and transportation; lost work time(important to employers) such as acute Otitis media in pediatric patients with professional parents who lost work time during the treatment of their kid.

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Indirect cost

• This is the cost incurred by the patient, family,friends or society. Many of these are difficult to measure,but should be of concern to society as a whole.

• This includes productivity loss in the society; unpaid care givers; lost wages; expenses of illness borne by patients, relatives, friends, employers and the government and; loss of leisure time.

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Intangible costs

• These are costs related with the patient’s pain and suffering; worry and other distress of the family members of a patient; effect on quality of life and health perceptions.

• For example patients of rheumatoid arthritis, cancer or having terminal illnesses in which quality of life is suffered due to adverse reactions of the drug treatment.

• These are difficult to measure in monetary terms but represent a considerable concern for both doctors and patients.

• Quality adjusted life year (QALY)is one method by which intangible costs can be effectively integrated in PE analysis

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Costs

• Direct costs: costs to deliver services topatient; both medical and non-medical

• Indirect costs: cost of treatment to patient or society

• Intangible costs: quality of life

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30th Nov. 2013

Types of Economic Evaluation

Cost of illness evaluation (COI)

Cost minimization analysis (CMA)

Cost benefit analysis (CBA)

Cost effectiveness analysis (CEA)

Cost utility analysis (CUA)

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Cost of Illness Evaluation

• Also termed, cost consequence model

• Description: Estimates the cost of a disease on a defined population

• Application: Provides a baseline against which various prevention/treatment options may be compared

• Example: Cost of peptic ulcer disease

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Cost Minimization Analysis

• Description: Identifies the least expensive/costly alternative assuming the alternatives are equal in either consequence or outcome

• Application: Can only be utilized when consequences or outcomes are identical

• Costs include more than the price of medsCosts of treatment failureCosts of adverse effectsDrug monitoring or other healthcare services

30th Nov. 2013

Cost Benefit Analysis

• Description: Measures benefit in monetary units and computes net gain following considering the costs of the intervention

• Calculated: Benefit ($)/Cost ($)

• Application: Compare programs or agents with different objectives

• Example: Clinical pharmacy service vs. other institutional service

• Determines whether benefits > cost

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Examples CBA

• AIDS prevention and awareness programs

• Smoking cessation intervention

• Diabetes drug adherence

• Breast cancer screening

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Cost Effectiveness Analysis

• Description: Compares alternatives based on a single therapeutic effect measured in physical units

• Calculated: Cost ($)/Clinical Outcome (not in $)

• Clinical Outcomes: Could consist of a higher positive effect, or less negative effect

• Application: Compare drugs/programs that differ in clinical outcomes but use same unit of benefit

• Example: Antihypertensive Drug A vs Drug B on mmHg blood pressure ($/mmHg)

• Application: Focus on Incremental Cost Effectiveness Ratio (ICER).

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Incremental Cost Effectiveness Ratio (ICER)

ICER = (C1 – C2) / (E1 – E2)

is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions. It is typically used in cost-effectiveness analysis. ICER is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment

where C1 and E1 are the cost and effect in the intervention or treatment group and where C2 and E2 are the cost and effect in the control care group.

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Difference in costConsider the four possible results arising in a CEA. First, if costs are lower and health benefits higher for one drug relative to another, the former is said to dominate and would be the preferred treatment (quadrant II). Second, the opposite applies, i.e. the new drug is more expensive and less effective, and thus is considered inferior and not recommended (quadrant IV).

The third and most common case is where the new drug is both more effective and more expensive than the standard (quadrant I); on the basis of ICERs, a judgment must be made regarding whether the additional benefits are worth the extra costs of the new drug and, therefore, whether it is ‘cost effective’ This might be defined by a previously agreed ICER threshold value. The fourth case is similar to the third, with the roles of the new therapy and the standard reversed (quadrant III); the question now is whether the extra benefits provided by the standard justify the additional costs of retaining it as the preferred treatment when the option of a new, cheaper but less effective drug exists

Asia Journal of Pharmaceutical and Clinical Research Vol2, issue 3, July-Sept 2009

The cost-effectiveness plane

Med Decis Making 1990 10:212–214.

Cost Utility Analysis

• Description: Compares alternatives based on therapeutic effects measured in utility units (not physical units). Utility scores integrate patient preferences and quality of life/functional status

• Calculated: Cost ($)/QALY (quality adjusted life years)

• Application: Compares drugs/programs that are life extending with serious ADRs or those producing reductions in morbidity

• Example: Cancer chemotherapy regimens:

4 years at 25% QOL = 1 year at 100% QOL

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Considerations for Designing or Evaluating Pharmacoeconomic Studies

• Costs• E.g., Direct medical/nonmedical, indirect,

opportunity, intangible

• Perspective• E.g., Patient, Provider, Payer, Society

• Discounting-Value of money changes depending on when it is exchanged (i.e. Inflation)

• Sensitivity Analysis-Challenges results by altering certain variables independently

• Accuracy and transparency• E.g., Alternatives, study population, study design

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Cost-Effective ≠ Cost-Saving!!!

30th Nov. 2013

Cost-Saving vs. Cost-Effective

• Cost-saving• An intervention that has a lower total cost than an

alternative intervention

• Cost-effective• An intervention that is sufficiently effective relative

to its total cost when compared with an alternative intervention

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How Can PE and Outcomes Enhance My Practice?

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

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

• Help set practice priorities

• Enhances position of practitioner from payer’s perspective Medicare plans to decrease pay-out to stem tide of budget

deficit Private payers actively are developing quality “report

cards”

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Methodology Cost measurement unit Outcome unit

Cost minimization DollarsVarious- but equivalent in comparative groups

Cost benefit Dollars Dollars

Cost effectiveness DollarsNatural units (life years, mg/dl blood sugar, LDL cholesterol)

Cost utility DollarsQuality adjusted life years

Types of Economic Evaluation

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Common Misconceptions When Applying Pharmacoeconomic Principles

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

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

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Perspective

• The “point of view” considered in economic analyses influences the outcomes and costs considered to be most relevant: Provider Patient Payer Society

30th Nov. 2013

Treatment of Pain Resulting from Osteoarthritis

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

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

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

perforation

• Cox- II inhibitors

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

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

How should I treat my patient?

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

itself many times over by preventing an expensive GI bleed in my patient? Dyspeptic symptoms are decreased by 15% Clinically significant ulcer complications are reduced

by 50%

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

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

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

• How much can the risk of GI bleed be altered by using a Cox-II inhibitor instead of an NSAID?• What value is really purchased for the extra cost?• The relative risk reduction of GI complications with Cox-II

inhibitor catches our eye- but actual risk reduction is small 1-2% for overall ulcer complications 1% for serious hemorrhage and perforation

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

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Cost-effectiveness analysis

Population DrugTotal Annual

Cost

Qualys

GainedIncremental cost per Qualy gained

No Hx of GI ulcer

Naproxen $4,859 15.2613 -

Cox-II inhibitor $16,443 15.3033 $275,809

Hx of GI ulcer

Naproxen $14,294 14.7235 -

Cox-II inhibitor $19,015 14.8081 $55,803

Spiegel MR et al. Annals Internal Medicine 2003; 138:10(795-806) 30th Nov. 2013

Cardiovascular Effect of Cox-II Inhibitors

Population DrugAnnual

Cost

Qualys

GainedIncremental cost per Qualy gained

All patients

Naproxen $5,037 15.2539 -

Cox-II $16,620 15.2832 $395,324

Spiegel MR et al. Annals Internal Medicine 2003; 138:10(795-806) 30th Nov. 2013

Clinical Decision Making

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

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

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

30th Nov. 2013

Clinical Decision Making

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

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

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

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Cost-effective Outcomes

• Decrease drug–drug and drug–lab interactions

• Increase the percentage of patients in therapeutic control.

• Reduce the overall costs of the treatment by utilizing more efficient modes of therapy

• Reduce the unnecessary use of emergency rooms and medical facilities

• Contribute to better use of health manpower by utilizing automation, telemedicine,

• and technicians

• Decrease the incidence and intensity of iatrogenic disease, such as adverse

• drug reactions

J Clin Oncol 23(10):2123–9

Primary reason for pharmacist intervention

• Decrease potential adverse event

• Increase efficacy

• Reduced morbidity or mortality

• Symptom control

• Cost savings

• Decrease actual adverse drug effects

• Assist compliance

• Formulary reasons

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Change in drug therapy or management

• Change in dosage of drug

• Drug treatment initiated

• Drug treatment discontinued

• Alteration to patient monitoring

• Change from one drug to another

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Impact of pharmacist-initiated change in drug therapy or management quantified

British Journal of Clinical Pharmacology 57(4), 513-521

Benefit of pharmaceutical care

• The potential savings quantified arose from pharmacist-initiated interventions that resulted from only 3.8% of pharmacist’s clinical practice time.

• Benefits of other activities performed were not quantify : drug information, patient medication counselling, staff education, drug use evaluation, research, student education and training, dispensing and administrative.

• On the five areas quantified in this study : every dollar spent on a pharmacist, approximately $23 save.

British Journal of Clinical Pharmacology 57(4), 513-521

30th Nov. 2013

2nd ATS Workshop PCEHM guidelinesits application to critically ill patients should caution the following:

1. evidence for the effectiveness of interventions in the ICU is often lacking

2. care in the ICU often does not provide for a cure but stabilizes patients

3. ICU patients vary substantially, and the costs and outcomes associated with therapy vary depending on the type of ICU

4. ICU outcome measures are not suited for economic analyses and are often difficult to measure

5. assigning a value to the quality of end-of-life care and its impact on family members of ICU patients is difficult

6. costs are not define and measured in consistent ways

ATS: American Thoracic Society

PEGM: Panel on Cost-effectiveness in Health and Medicine

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For ICU pharmaceuticals v.s. economic

• This tactic for cost minimization runs the risk of determining drug therapy based only on acquisition costs.

• When competing drugs are considered therapeutically equivalent, may dilute the benefits of newer drugs

• We need to evaluate the impact of cost-reduction efforts on the quality of care

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Provide optimal pharmacotherapy at an appropriate cost in critically ill patients

• Anti-microbial

• Sedatives and neuromuscular blockers

• The Drug-Use and Disease-State Management (DUDSM) Program

CritCare Med 2003 Vol. 31, No. 1 (Suppl.)

30th Nov. 2013

Anti-microbial

• The percentage of the drug budget spent on antibiotics ranges from 10%-60% or >60%

• Even with a selective list of available drugs, there needs to be guidance on drug selection, dosing, and monitoring in the form of protocols or algorithms to enhance the chance of success.

• The patient is evaluated for conversion of parenteral to oral antibiotics after 48–72 hrs of intravenous antibiotic therapy.

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Sedatives

• A large percentage of ICU patients receive sedatives to treat agitation, and the costs of managing these patients are predicted to be high.

• The clinical and economic impact of sedatives in ICU patients, drug costs were significantly reduced in the protocol-driven group.

• Ventilator times and lengths of stay were shorter in the follow-up group, without a compromise in the quality of care.

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Neuromuscular blockers

• Minimizing the usage of neuromuscular blocker exposure is important because prolonged paralysis has been reported with these agents and the additional costs associated with this problem is in excess of $66,000 per patient.

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DUDSM Program

• The DUDSM program identifies therapeutic opportunities for optimizing drug use from analysis of high-volume drug use, cost, disease state, and resource utilization.

• The DUDSM ICU guidelines focus on agent selection, indication for use, mode of administration, and monitoring process.

• Guidelines for new therapeutic entities are created to set practice patterns as agents are approved for general marketing vs. after practice patterns are established.

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The benefits of pharmacist in ICU

• SCCM best practice model document:

“the presence of a critical care pharmacist can decrease adverse drug events and reduce cost of care”

SCCM : Society of Critical Care Medicine

30th Nov. 2013

Flowchart of the formulary decision-making process

30th Nov. 2013

Application in the formulary process with CEA

• The CEA is constructed to identify the most cost-effective therapy when the goal is provide the highest-quality pharmaceutical care within a fixed budget.

• To be informative, the drug alternatives in the analysis should include all reasonable options and baseline comparator.

• It can be used to evaluate the economic impact of a formulary decision if head-to-head data are available.

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Cost and Effect measured

• Cost: measure in dollars and compared with the effects or improvements of treatments.

• Effect: final outcome and intermediate outcome.

- final outcome: lives saved, life-years saved,

cases prevented, rates of specific side effect

- intermediate outcome: the relationship

between the intermediate and final outcome

measure can be estimated.

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AMCP guide of formulary submission checklist

• Product information

• Supporting clinical information

• Supporting economic information

• Cost impact assessment

• Outcomes impact assessment

AMCP:Academy of Managed Care Pharmacy

30th Nov. 2013

Medication formulary system management

• Should be based on clinical, ethical, legal, social, philosophical, quality-of-life, safety, and pharmacoeconomic factors that result in optimal patient care.

• Must include the active and direct involvement of physicians, pharmacists, and other appropriate health care professionals.

• To declare that decisions on the management of medication formulary system should not be based solely on economic factors.

ASHP policy 9830

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Evidence of the economic benefit of clinical pharmacy services:

• Drug therapy evaluation (benefit:cost ratio=31.92:1)

• Drug information

• Adverse drug reaction monitoring(benefit:cost ratio=2988.57:1)

• Drug protocol management

• Medical rounds participation

• Admission drug histories

Pharmacotherapy 2003;23(1):113-132

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Evidence of the value of the pharmacist

• In a study evaluating the effect of pharmacists providing pharmaceutical care services on the economic outcomes of patient care, an average benefit of $16.70 of value to the health care system was realized for each $1 invested in clinical pharmacy services.

Pharmacotherapy 1996; 16(6):1188-208

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Evidence of the value of the pharmacist-for cost saved

• Pharmacists collaborating with physicians to care for high-risk patients reduced the number of prescriptions per patient and saved nearly $600 per year per patient in drug costs.

• Pharmacists providing disease management services in their community saved an average of $2700 per year per patient in total medical costs.

Journal of Family Practice. 1995; Nov.; 41(5):469-78

Clinical Therapeutics 1997 19(1); 113-23

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Evidence of the value of the pharmacist - for adverse events avoided

• As hospitals increased the number of pharmacists providing pharmaceutical care, medication errors have decreased by over 65%.

• Pharmacists providing pharmaceutical care services in an intensive care unit decreased adverse events by 66% and saved $270,000 by avoiding adverse events.

Pharmacotherapy. 2002:22(2):134-47

JAMA 1999 Jul 21; 282(3):267-70

30th Nov. 2013

Applications in Practice & Roles of the Pharmacist

• Assist in the design and implementation of research studies

• Evaluate pharmacoeconomic literature

• Apply results to clinical decision making Individual patient care Formulary/utilization management Disease management Resource allocation

30th Nov. 2013

抗癌藥物肥了企業　瘦了病患荷包？8月 25日，全球最大的生技公司安進（ Amgen）表示，將以 104億美元收購美國的奧尼克斯（ Onyx ），奧尼克斯的珍寶即為治療多發性骨髓瘤的 Kyprolis。隔天，英國藥廠阿斯特捷利康（ AstraZeneca）宣佈併購 Amplimmune ； Amplimmune正試圖找出觸發免疫系統對抗癌症的方式。

之所以有如此多生技公司跨足腫瘤醫學，原因有三。其一為醫界對癌症的理解快速進展；二十世紀時，癌症治療多半倚賴外科、放射線和化學治療，但現在看來像是發展未完全的療法。免疫療法已經從理論步入實務，基因組學的發展讓科學家得以找出引發癌症的特定變異，另一個令人興奮的領域則是表觀遺傳學。其二，監管機構已加快核准抗癌藥物的流程。美國食品藥物管理局 2012年核可的 39種藥物之中，有 11種是抗癌藥物。 Kyprolis

就是其中之一， Kyprolis甚至獲得了「加速核可」，作為多發性骨髓瘤病患的最後一道治療防線。第三項，也是最具爭議性的因素，就是抗癌藥物價格昂貴，特別是在美國； Kyprolis的典型療程需時 5個月，價格高達 5萬美元。

因此，大藥廠想藉由合夥和購併的方式，開發自己的抗癌藥物，這點並不令人意外。 Kyprolis最早是由一家名為 Proteolix的小公司所開發，後來這家公司被奧尼克斯收購，接著奧尼克斯又被安進購併。 2009年，必治妥施貴寶（ Bristol-Myers Squibb）以 24億美元買下Medarex，因為Medarex擁有一種實驗性的免疫療法藥物，目前該藥物的完整療程要價 12萬美元。

然而，雖然商機誘人，但也存在極高風險。就算是前景極佳的藥品，最終也有可能會以失敗收場。美國食品藥物管理局核可Kyprolis，但病人必須先試過至少兩種療法之後才能使用；高盛預估 Kyprolis年銷售可達 30億美元，前提是獲得美國以外的國家核可。阿斯特捷利康收購 Amplimmune，主因即為兩種仍處於早期測試的抗癌藥物；阿斯特捷利康的高層人員加萊（ Bahija Jallal）表示，想要在這個領域生存，就必須願意承受風險。

但長期而言，最大的問題在於，醫療保險業者和政府願不願意繼續付帳。奧尼克斯和拜耳（ Bayer）共享腎臟癌藥物 Nexavar的利潤，去年印度的監管機關給予某家當地企業「強制授權」，允許該企業銷售 Nexavar的複製品，而且價格比拜耳低廉許多。其他地區的回應則沒有那麼激烈，但藥廠的高額訂價已開始引發反彈，特別是在歐洲。 4月時，超過 100名慢性骨髓性白血病專家，聯名反對藥物的高昂價格。不過，目前安進仍可以繼續以高昂的價格銷售 Kyprolis

The Economist Newspaper Limited 2013

GUIDELINES FOR PHARMACOECONOMICS EVALUATIONS

1. The perspective of the study should ideally be applicable to the society.

2. Demographic characteristics of the target population should be identified.

3. Conceptual and practical reasons for choosing the comparator should be set out and justified.

4. Treatment paths of the options being compared should be identified and fully described.

5. The study should use recognized techniques of analysis and should be justified.

6. Clinical outcome measures should be identified.7. All relevant costs should be identified, collected and reported.8. Discounting should be undertaken considering the time lapse.9. Sensitivity of analysis should be conducted and reported.10. Comparisons with results from other studies are handled with

care

30th Nov. 2013

Conclusions

• Pharmacoeconomics can guide choices among alternative medications, treatment regimens and services based on a combination of costs and outcomes.

• Is a young science, which is still testing its methodology.

• The science will improve with application and value of the analysis to clinicians. Principle and methods balances the cost and outcomes and provides the best possible health care to the with available resources.

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

• Results and interpretation of pharmacoeconomic studies are influenced by the perspective of the study—there is no one “right” answer.

30th Nov. 2013

Thanks for Your

Attention !!