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Formulary Committee
of Russian Academy of Medical Sciences
Professor Pavel Vorobyev
Economy of equivalence:
new challenge
ALMOST INSOLUBLE PROBLEM
To contain budget
expenditures on
health care system while
improving the results
Remember – it is not an end in itself
Cost containment is limited by necessity
to follow the principle of equity in
providing medical care:
ensuring its accessibility,
including vulnerable groups
INCREASING CONTROLLABILITY OF
THE “MARKET OF DRUG CIRCULATION”
• One should recognize “market failure” in medicine
in general and particularly – in drug supply!
• Uncontrolled market relations lead to the
development of perverted, vicious schemes of
making money: patient's life becomes worthless
• Regulatory mechanisms of this “market” keep on
improving in all developed countries
• Significant differences in regulation are
determined by the lobbying of medical community
by “Big Pharma”
WHO
The specific nature of drugs requires a special
approach from the State and persons
involved in its selling, which differs from
principles of selling commercial products and
consumer goods
For instance, Government agencies should be
responsible for the regulation of
manufacturing, import, export, storage,
distribution and sales of drugs
Opinions diverged
Some experts insist that :
• State regulation of the pharmaceutical
market reduces price competition
• In terms of full liberalization this market would
function "correctly", like other consumer markets
• Supporters of the market do not notice the
existence of fundamental factors which provide
“singularity” of the drug “market” - its social
orientation
• Experience of many countries including Russia
shows that unregulated "market" harms interests of
poor people with rare diseases and members of
vulnerable groups
IT IS POSSIBLE TO CONTAIN DRUG
COSTS INFLUENCING ON:
• Medical care recipient - patient
• Health-care provider - physician
• Providers of medicines – pharmacy,
distributors
• Manufacturers of medicines
GENERAL MECHANISMS
OF CONTAINING DRUG COSTS
• Constraint of budget subsidies –
financial path
• Demand
management
–
administrative path
• Price (and allowances) control –
financial and administrative path
DIRECT MECHANISMS OF COST CONTROL
• Direct price control
• Negotiating prices at the national level
• Reference prices using comparison with
therapeutic analogues, generics and prices abroad
• Forced price cuts
• Conditions for facilitating the replacement of
brand-name products by generics
Indirect mechanisms of cost control
• Increased burden of co-payment for patient (for
example, program of self-treatment)
• Restrictions of consumption using lists of subsidized
(compensable) drugs and exclusion of unworthy drugs
• Transferring the responsibility to the physician –
budget keeper - (budget of prescription– physician has
a certain amount of money for all drugs, subsidized by
the State, and he ought to prescribe it for a certain
period)
• Transferring the responsibility both for financing and
price negotiation on insurance companies
PRICE CONTROL
• It is the most common way to limit the
cost of drug procurement that is widely
used by the Authorities
• Very often the list of essential
medicines was considered as a basis for
the policy of drug price control
• Direct mechanisms are used to monitor
expenditures
Pricing approaches at the level of distributors and
pharmacies
• Restricting trade allowances (wholesale and retail ) –
product-oriented allowance (reduction of allowance
on more expensive drugs), fixed allowance, maximum
allowance (either without separation on wholesale
and retail, or separate one – regional authorities)
 Co-payment (fixed payment for prescription of any
medication, payment of cost interests – 50% benefit,
defined sum of co-payment – max 1000 EURO, further
- free of charge)
 Per capita payment to the pharmacy from the State (it
was implemented in the “7 nosologies” system )
Generics
• Substitution of brand-name drugs on generics is regulated at
the legislative level in many countries
• In the USA legal protection of generics is provided by the
Drug Price Competition Act (Waxman-Hatch Act, 1984)
• WHO supports the focus on generics
• In the Netherlands, France, Italy, Spain and the UK state
authorities use motivation for prescription and
administration of generics
• German pharmacists had a daily norm of generics
prescription.
• In Denmark rules of trade markup for pharmacies have
come into force since April 1, 2005, they are intended to
eliminate the motivation to release more expensive drugs
There are differences between generics
• Identical molecules obtained by the same chemical
methods but using different technologies
• Bioequivalence studies are held when registering
• We compare two similar chemicals in the same or
insignificantly different dosage forms for oral
administration
• The curves for the compared drugs should be similar,
equivalent (but without coincidence )
• Generics
with
intramuscular,
subcutaneous,
intravenous or other routes of administration are not
tested for bioequivalence; only concentration of
substances in product and its chemical composition
(impurities) are studied, sometimes pharmacokinetics
is compared.
It remains outside the scope
• Products of biological origin: their effect
may be related with development of
primary product from some substrate,
its further refine
• Major groups: coagulation factors VIII,
insulin, heparins, anticytokine drugs,
antibiotics
Generics
• Comparison of analogues is topical: generics,
therapeutic analogues (including biologicals )
• Effects may depend on the shell or the filler
• All the studies should be done in actual practice
• It is necessary to provide an independent public
examination of effectiveness, safety and
pharmacoeconomics data of the product
Economic effect of the generic substitution
(HIV/AIDS – annual triple therapy
Stavudine + Lamivudine + Nevirapine)
Medecins Sans Frontier (2001) ‘A matter
of life and death: The role of patents in
access to essential medicines’
In Russia there are no such differences
in the cost!
• Cellcept and its generic Maycept differ in 15%
• Velcade and its generic Milanfor differ in 30%
• Enalapril prices in Moscow pharmacies differ from
в 4 rubles to 120 rubles (2 times!)
The allowable difference in bioequivalence and
pharmacokinetics between brand-name drug and
generic product is 15%
Reference prices are
opposed to the free
market price
System of reference prices
(contract, agreed, calculated prices)
Tool for measuring the maximum compensation for
medicines based on the availability of similar
drugs in the market
• Covering the cost of medicines by manufacturer
• It may cover trade allowances partially or
completely
• Preferable and the most common way to control
costs of drug provision
The effect of the reference pricing introduction
Cochrane systematic review
• 10 studies (most from Canada)
• Application of drugs increased by 60% - 196% (5
studies)
• Application of “co-payment” drugs decreased by
19% - 45% (4 studies)
• There were no harm to health or increased
consumption of health resources
Aaserud M, Austvoll-Dahlgren AAA, Kösters JP, Oxman AD, Ramsay C, Sturm H.
Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing
policies. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD005979.
DOI: 10.1002/14651858.CD005979.
Studying different methods
of reference pricing
COMPARISON OF TWO SYSTEMS OF REFERENCE PRICES:
• 1-st method – one price for the various
NSAIDs with unique INN
• 2-nd method – one price for NSAIDs with different
INN
RESULT:
• 1-st method – saving 5.7 million dollars
• 2-nd method – saving 22.7 million dollars
• The position of health is not clear
Health Serv Res. 2005 October; 40(5 Pt 1): 1297–1317.
Alberta (Canada): since 1995 uniform price equal to
the price of Cimetidine has been introduced
CMAJ. 1999 August 10; 161(3): 286–288.
Cimetidine, Ranitidine, Famotidine, Nazatidine, Omeprazole
• Proportion of prescriptions for all drugs decreased
by 43-65% , cimetidine prescriptions increased by
410%
• The total number of prescriptions decreased by 5%
• The cost of all drugs decreased by 33-75%, the
cost of cimetidine increased by 392%
• Total costs decreased by 37%
Models of reference pricing
(The European experience of the common market)
• Formal model of establishing reference prices: foreign
drug prices are accepted as comparison prices. This
approach allows to achieve lower prices in all groups
of drugs. To tell the truth it is not clear what we
would do if prices in all countries became the same
and there were nothing to compare.
• Semi-formal model - analysis of drug prices in
neighboring countries is used in pricing negotiations
with the manufacturer
• Informal model, when international prices are taken
into account in individual cases, for individual drugs,
as in the case of setting the reference price, so in case
of pricing negotiations with the manufacturer
Options of reference pricing
• Comparison of generic costs to establish reference
prices is used in France, Italy and Spain
• Prices of therapeutic analogues are used in Germany,
it allows to include several active substances of one
therapeutic class in the price comparison group to
establish reference prices. A single cluster of
therapeutic analogues which includes both generic
and brand-name products is made, and the unique
reference price is established for the entire cluster
• It is possible to carry out the analysis of generic
internal market in Russia – our situation is
significantly different from European - drugs in the
"free sale" and its prices actually are not regulated
Comparative evaluation of the cost of medicines , rub.
Formulary Committee Report, 2008
INN
Registered price
according to List of
essential medicines
Registered price
according to the DLO
Pharmacy price
(Moscow)
Price of the British
National Formulary
Captopril
Tab. 25 mg №20
from 6,00 tо
26,37
from 7,30 tо
10,00
from 4,22 tо
39,00
(Capoten from
57,00 to 160,00)
Capoten 164,00
Enalapril
Tab. 2,5 mg №20
from 3,89 to
47,99
12,54
from 4,09 tо
125,10
43,26
Atenolol
Tab. 50 mg № 30
from16,50 tо
48,00
from 8,40 tо
13,00
from 5,10 tо
50,00
55,20
Formoterol
Caps. for ing. 12
mcg, №30
825,35
488,73
from 611,50 tо
1098,48
602,14
Amoxicillin
Caps. 250 mg №20
46,25
from 13,50 tо
16,50
from 12,14 tо
45,00
57,68
Azithromycin
Caps. 250 mg №6
from 78,53 tо
220,00
from 75,00 tо
100,00
from 79,50 tо
590
553,32
Co-trimoxazole
Tab. 480 mg №20
from 10, 20 tо
39,91
from 9,20 tо
11,00
from 7,00 tо
25,90
271,92
DDD price on ACE inhibitors and sartans
(Drug Reference Book of the Formulary Committee RAMS, 2009)
INN
Captopril
Perindopril
Fozinopril
Hinapril
Enalapril
Valsartan
Irbesartan
Losartan
DDD (mg)
50
4
15
15
10
80
150
50
Цена DDD (RF – GB ) (rub.)
0,6 – 0,8
9,2 – 16,4
6,8 – 10,5
8,1
0,17 - 3,5
27,4 – 87,4
20,3 – 30,1
50,0 – 58,4
Drug Reference Book
of the Formulary Committee RAMS, 2009
It contains comparison of
prices for all essential drugs:
ONE STEP TO REFERENCE PRICES
Co-payment
• Promotes the use of cheaper generics
• Increases the responsibility of the medical care
customer for excessive consumption and impacts
on cost reduction
• Psychological aspects, marketing technology play
significant role
(for example, intimidation,
creating artificial shortage etc.)
The level of co-payment is very important
• The low co-payment level does not
influence
on
the
excessive
consumption
• Savings are covered by higher
administrative costs
In the Netherlands the 20% level of
co-payment with maximum payment
of 91 EURO per year was too low to
influence on prescribing costs
The level of co-payment is very important
• Excessively high level of co-payment leads to
the reduction in application of essential
medicines
It was found out that the limits in the number
of subsidized prescription drugs led to the
reduction of their consumption in the U.S.A.
These effects have not been observed in
Australia since the introduction of solid
commission; reduction did not extend to
essential medicines and was limited by
additional drugs
The level of co-payment is very important
• The influence of co-payment is
different in different groups of
patients: in terms of universal copayment system consumption of
drugs paradoxically increased in
patients with worse health (they
“take" a lot of drugs simultaneously)
Co-payment
Transferring part of the burden from the State to the
patient (mostly – «trade allowances»)
Basic approaches:
(1) Fixed fee for each prescription
(2) The percentage of the cost of dispensed drugs
(excluding expensive drugs and special cases)
(3) Combination of (1) and (2)
(+4) Establishing of an annual sum, higher costs are
compensated, population groups without copayment
Difficulties and problems of co-payment
• In the system "with percents" - co-payment of expensive drugs
(?)
• Access of vulnerable groups of patients to drugs is provided by
the state subsidies
• Constant consumption of drugs (chronic diseases),
epidemically significant diseases (for example, tuberculosis,
HIV) - subsidies
• Simplicity and convenience of the system
• Struggle against the problem of excessive consumption (?)
• Incitement of “supply of goods” in patients (purchasing drugs
for a long time or in large quantities)
• Inconvenient system of personified accounting for
sums ”subjected to annual deduction”
The effect of the reference pricing introduction
(Cochrane systematic review)
• 30 comparisons were found (in 21 studies)
• The widespread decline in public spending on drugs was
showed
• Along with other drugs, there is reduced consumption of
essential drugs
• The influence on health and consumption of health
resources is poorly investigated
• One study found out an increase in consumption of health
resources after the introduction of co-payment in
vulnerable group
In other words – there is no delight about co-payment
Austvoll-Dahlgren AAA, Aaserud M, Vist GE, Ramsay C, Oxman AD, Sturm H, Kösters JP,
Vernby Å. Pharmaceutical policies: effects of cap and co-payment on rational drug use.
Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD007017. DOI:
10.1002/14651858.CD007017.
CONCLUSION
• There is no evidence that any method is more
efficient in reduction of public spending on drugs
than the other one
• Formal measures do not always as effective as
Government would like it to be
• The search for optimal solutions for problems of
limiting growth of the health budget continues
• We need a comprehensive solution including the
following approaches: reference prices + price
controls + generics + forced price cuts + partial copayment of drug provider spending by consumers