Health care policy and its tools – drug policy
Introduction to pharmacoeconomic:
structures of economic evaluations
Pharmacoeconomic methods and its principles
SYLLABUS of 5th LECTURE
18. 11. 2019
PharmDr. Bc. Dana Mazankova, Ph.D.
Drug policy and its tools
1. Finances allocating (cash flow allocating)
2. „Fellowship“ of patient / participating of patient
3. Support of effective drug using
A DRUG POLICY is the policy, usually of a
government, regarding the control and
regulation of drugs consumption by a
population, using following tools:
1. Finances allocating (cash flow allocating)
Primary care physicians:
Finantial limits per patient
Secundary care physicians:
Finantial limits per service
Tertiary care (hospitals):
Fixed finantial limits
Finantial limits per diagnosis
Primary, secundary and tertiary care physicians:
Specialization limitations for drugs prescription
- limits (physician`s specialization) are defined in Drug Tariff
Indication limitations for drugs prescription
- limits (patient`s indication) are defined in Drug Tariff
- in some drugs: Dual reimbursement
(according to patient`s defined indications)
2. „Fellowship“ / participating of patient
Primary care – pharmacies:
Assesment of drug reimbursement
1.covered drugs
2.non-covered drugs
Switching
Category Rx
- drug is safe
(no risk of abuse
- drug is long period on
the market
- suitable dosage form
and dosing for self
medication by patient
- drug indication suitable
for self medication by
patient
Category OTC
(Over The
Counter Drugs)
Fee for prescription – in a physician
Fee for prescription – in a pharmacy
- fee for prescription
- fee for every prescribed drug on prescription
3. Support of effective using of drugs
Generic prescription
- INN name (international non-proprietary name)
Generic substitution
Pharmacoeconomic evaluation
Generic drugs
- copies of brand-name drugs
- the same in:
1. dosage form
2. safety
3. strength
4. route of administration
5. quality
6. intended use
Perspective of patient:
Therapeutical equivalence
Demonstration of biological ekvivalence of generic drug:
- farmakokinetic parameters
- AUC
- cmax
- tmax
Reciprocal convertibility of brand-name drug and generic
drug
Generic substitution
= substitution of a prescribed branded drug by a different
form of the same active substance (generic drug)
Generic substitution is not recommended in
1. Aspect of active substance
- Active substances with narrow therapeutic index
- Active substances with non-linear kinetic
- Active substances with poor solubility
- Drugs with more active substances
- Drugs with active substance, that has more indications
2. Aspect of dosage form
- Solutions and powders for dosage inhalators
- Topic dosage forms with high effective substances
- Released dosage forms
3. Aspect of patient
- Hypersensitive patient
- Patients with diabetes mellitus
- Asthmatic patients
- Depression or psychosis patients
- Patients after organ transplantation
- Polymorbid and geriatric patients
Pharmacoeconomic evaluation
Pharmacoeconomic research is used to:
- identify, measure and compare
- costs, risks and benefits of programs, health care services or therapies
- and determine, which alternative produces the best health outcomes
Criteria for selecting suitable pharmacoeconomic method
Research Question Appropriate method Outcomes
measure
Interpreting
study results
Similar therapies Cost minimization analysis
(CMA)
Equal Choose program with
lowest cost
Different therapies Cost-benefit analysis (CBA) Finantial Benefit-to-cost ratio
of greater than 1.0
Different therapies
resulting in clinical
comparable patient
outcomes
Cost-effectiveness analysis
(CEA)
Non-finantial Lowest cost per
unit of effectiveness
Similar therapies affecting
quality of life
Cost utility analysis (CUA) QALYs Lowest cost per
unit „QALY“
Cost minimization analysis (CMA)
- Inputs (costs): monetary units
- Outputs: no measure (assumed to be equal)
- use when otcomes (benefits) of two or more alteranatives are same (equal)
Cost-benefit analysis (CBA)
- Inputs (costs): monetary units
- Outputs: monetary units
- for comparison of costs and benefits of program or treatment alternative
(alteranatives are not equal)
- costs and benefits are expressed as a ratio (benefit-to-cost ratio)
• B:C ratio > 1: program or treatment is of value
• B:C ratio equals 1: benefits equal the costs
• B:C ratio < 1: program or treatment is not economically beneficial
Cost-effectiveness analysis (CEA)
- Inputs (costs): monetary units
- Outputs: natural clinical units
- where outcomes are one-dimensional:
- physical units
- natural units
- Equivalence principle - equivalent:
 10 years of life saved for 1 patient = 1 year of life saved for 10 patients
(mesure outcome: number of years of life saved)
 1 year of life saved for patient with hypertension = 1 year of life saved for patient
with cancer
(mesure outcome: number of years of life saved)
- results of CEA are expressed as a 2 ratios:
1. average cost-effectiveness ratio (ACER)
- total cost of treatment alternative divided by its clinical outcome (effectiveness)
ACER = health care costs (€)
clinical outcome (not in €)
2. incremental cost-effectiveness ratio (ICER)
- additional cost and additional effectiveness gained when one treatment alternative
(alterantive A) is compared with the next best treatment alternative (alterantive B)
ICER = health care cost A (€) – health care cost B (€)
effect A (%) – effect B (%)
Cost utility analysis (CUA)
- Inputs (costs): monetary units
- Outputs: Quality of life
- if we want to include a measure of patient preference or quality of life when
comparing competing treatment alternatives
Measure outcomes:
1. QALY (Quality-Adjusted Life Years)
quality ratio (scale)
2. HYE (Health-Year Eqivalent)
3. DALE (Disability-Adjusted Life Expectancy)
4. Willigness to pay