Baltijas Statistika 2016-2018
Baltijas Statistika 2016-2018
on Medicines
2016–2018
Vilnius 2019
Edited by:
Lithuanian State Medicines Control Agency
Linas Savaikis
Published by:
State Medicines Control Agency of Lithuania
139A Zirmunu str.
LT-09120 Vilnius
Lithuania
[email protected]
www.vvkt.lt
When using or quoting the data included in this issue, please indicate the source.
ISBN 978-609-462-139-0
Contents
Preface .......................................................................................................... 5
1. Facts about the Baltic countries .............................................................. 7
2. Medicinal products regulation and pharmaceutical
services in the Baltic countries ................................................................ 8
2.1 Procedures of marketing authorisation of medicinal
products in Baltic States ...................................................................... 8
2.2 Marketing authorisation licences ........................................................ 9
2.3 Non-authorised medicinal products .................................................... 9
2.4 Medicinal products mark-up . ............................................................ 10
2.5 Generics market . ............................................................................... 14
2.6 Retail and hospital pharmacies and wholesalers................................ 15
3. Drug reimbursement systems in the Baltic countries.............................. 18
3.1 Description of the reimbursement systems........................................ 18
3.2 Changes in the reimbursement systems
(during the period of 2016–2018)...................................................... 22
3.3 Reference price systems .................................................................... 23
4. Materials and methods used for the Baltic Statistics
on Medicines......................................................................................... 26
4.1 Data collection in the Baltic States .................................................... 26
4.2 ATC/DDD methodology and interpretation of
drug sales statistics............................................................................. 27
4.3 Factors affecting the interpretation of drug utilization data . ............ 28
5. Cost of drugs as a share of total health care expenditure
in the Baltic countries ........................................................................... 29
5.1 The medicinal products market ......................................................... 28
5.2 Sale of drugs according to the ATC main groups
(DDD/1000 inhabitants/day) ............................................................. 31
5.3 Sale of drugs according to the ATC main groups (turnover) .............. 32
6. Sales statistics 2016–2018 ..................................................................... 35
Expert comments on Consumption of anti-diabetic medications............... 52
Expert comments on Consumption of antibacterials for systemic
use medicines in Lithuania........................................................................ 106
Expert comments on Consumption of non-steroidal anti-inflammatory
and antirheumatic medicines in Latvia in 2016-2018................................ 127
Expert comments on Consumption of psycholeptics in Lithuania............. 147
Expert comments on Consumption of medications for treatment
of chronic obstructive disease (COPD) in Latvia in 2016-2018.................. 161
7. Top 15 of prescription-only medicines in 2018 ......................................175
8. Top 15 of over-the-counter medicines in 2018 ......................................176
9. Top 15 most used ATC 3rd level groups in 2018 ......................................177
10. Contacts ...............................................................................................178
11. References ...........................................................................................179
Preface 5
Preface
This book is the 3rd edition on the consumption of medicines in three Baltic States
over a three-year period. This consumption analysis enables evaluation of habits
of medicines use, also changes and trends in this particular region. The first edition
of „Baltic Statistics on Medicines 2010-2012“ was published in 2013 by Estonia.
The second edition of „Baltic Statistics on Medicines 2013-2015“ was published in
2016 by Latvia. In 2019 Lithuania took responsibility to publish the third edition
that includes statistical data from 2016 to 2018.
It is worth to mention, that all three Baltic countries regularly assembles national
statistics on consumption of medicines. Medicines in this publication are classified
in accordance with the Anatomic Therapeutic Chemical (ATC) classification system
and consumption is expressed as defined daily doses per 1000 inhabitants per day
(DDD). It is a recommendation from World Health Organisation.
All three countries had very similar development during last three decades, af-
ter these countries become independent. Countries have built very stable health
care systems. All Baltic States have joined the European Union (EU). Lithuanian,
Latvian and Estonian medicines agencies have been operating in compliance with
EU and national legal acts, have been participating in various joint-actions and
collaborations not even at the EU level, but also worldwide.
6 Preface
Consumption data of Lithuania, Latvia, and Estonia were analysed in various aspects.
What is new in this edition – that there were included conclusions and remarks of
experts, doctors on consumption changes in concrete ATC groups during 2010 -2018
period in connection with reimbursement changes and changes in treatment guide-
lines. You can find remarks of experts on consumption changes of drugs used in
diabetes (ATC group A10), antibacterials for systemic use (J01), anti-inflammatory
and antirheumatic products (M01), psycholeptics (N05) and drugs for obstructive
airway diseases (R03).
The book also contains a short description of the pharmaceutical market, regulatory
requirements, medicinal product reimbursement systems in all three countries. In
this book we can find many similarities and also several important differences in
consumption of medicines in the countries. Data show that in all countries we can
see the increase of consumption of medicines.
All three Baltic countries were also compared by other aspects: statistics of various
licences, wholesalers, financial aspect (turnovers) and many other aspects, which
you will find while reading this book.
In order to ensure that the resulst are comparable and representative, specialists
from the medicines agencies in Lithuania, Latvia, and Estonia were in a very close
collaboration with each other.
Facts about the Baltic countries 7
Total health expenditure (2017, 1 003 mln 3 009 mln 2 385 mln
euro)
Medicinal products turnover (2018, 325 mln 365 mln 635 mln
wholesale, VAT excluded, euro)
these committees. Furthermore, five auxiliary members have been elected to each
committee based on their scientific competence.
For each application the Committees will elect a rapporteur and a co-rapporteur
from among their members to carry out the evaluation of the application with the
aid of the resources made available by the medicines agencies of the Member States.
Based on the reviews obtained, the committees will issue a scientific statement to
be submitted to the EU Commission for the actual decision-making process. The
marketing authorisation granted by the Commission is valid in every Member State
as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and
Norway.
n LATVIA
In exceptional cases the State Agency of Medicines issues a permit to wholesalers
for the distribution of the medicines authorised in other countries. The medicines
wholesaler bases its request for the distribution of the non-authorised medicines
on a request from a pharmacy or from a healthcare institution.
10 Medicinal products regulation and pharmaceutical services in the Baltic countries
n LITHUANIA
To ensure the availability of all the necessary medicines for the patients the use of
the non-authorised medicines is permitted under exceptional circumstances. The
non-authorised medicines may be used in the ambulatory care and at the hospital
on the basis of a special application from a doctor with signed informed consent of
the patient. The treating physician is responsible for prescribing, information and
safe use of the non-authorised medicines.
n ESTONIA
The level of maximum limits is required by law to allow the weighted average mark-
up of 7-10% in wholesale and 21-25% in retail sale of pharmaceuticals and should
be adjusted accordingly based on an annual market analysis by the Ministry of
Social Affairs. In practice the applied mark-up may be lower than this maximum,
which is frequent for the over-the-counter (OTC) pharmaceuticals. This is one of
the commercial possibilities for the wholesalers and pharmacies to attract clients.
n LATVIA
The principles for the determination of the price of the medicinal products are
described in the legislation.
The maximum wholesale mark-up is determined by the following formula:
Maximum wholesaler’s price = manufacturer’s price x correction factor + correction
sum in currency + VAT. The correction factor and correction sum shall be determined
on the basis of the manufacturer’s price (see Table 4).
n ESTONIA
Although there is no explicit regulation on the (mandatory) use of generics in Estonia
(i.e. generic substitution), there are some regulative measures in place, directing
doctors and patients towards the wider use of generics where these are available.
Doctors have to prescribe pharmaceuticals by their International Non-proprietary
Name (INN) as the default option; if prescribing by the trade name, they have to
document this in the medical record of the patient providing the justification and to
mark “not to substitute” on the prescription.
If the pharmaceutical has been prescribed by the INN, the pharmacist has to offer
different preparations to the patient, including the cheapest alternative for the
patient. In discussion with the patient the most appropriate preparation is to be
chosen.
The prevailing reference price system, establishing the reference price of a
pharmaceutical as the basis for the reimbursed amount, is a strong incentive to
accept substitution, as patients would have to pay the price difference between the
reference price and the reimbursed amount on top of their statutory out-of-pocket
payments.
n LATVIA
According to the Latvian legislation a physician may prescribe the medicinal product
by the trade name and the pharmacist is allowed to substitute it with an analogue if
the doctor has not forbidden this possibility on the prescription.
However, in case of the first prescription of a reimbursed medicinal product the
INN name of the medicinal product should be indicated on the prescription and the
pharmacist has to offer different preparations to the patient, including the cheapest
alternative for the patient.
n LITHUANIA
Several measures have been introduced in order to stimulate the use of generic
medicines.
According to the Lithuanian legislation the medicines should be prescribed by
the INN. The prescribing by the trade name is only allowed for the biological
pharmaceuticals. Some medicines with narrow therapeutic window may be
prescribed by the trade name after the decision of the specialists’ commission. All
pharmacies are obliged to provide data on prices to the patients on the screen and
are obliged to have the cheapest product in the store.
Medicinal products regulation and pharmaceutical services in the Baltic countries 15
n ESTONIA
In January 2019 there were 64 medicines wholesalers in Estonia and 3 of them
were specialised only in veterinary medicines. 18 wholesalers had both, human and
veterinary products wholesale licences.
In 2018, 29 wholesalers sold human medicines to general or hospital pharmacies
or to other institutions. Three major wholesalers covered 77% of human medicinal
products market: Magnum Medical (28%), Tamro Estonia (27%) and Apteekide
Koostöö Hulgimüük (21%). Followed by Roche Estonia (5%), Baltfarma (5%) and
Estonian Health Board (5%). The total market share of the other wholesalers
remained under 10%.
Table 11. Wholesalers of the medicinal products in Estonia
Together 57 60 64 67 64
At the beginning of 2019 there were 494 general pharmacies (including 163
structural units), 24 hospital pharmacies (including 1 structural unit) and 4
veterinary pharmacies in Estonia.
16 Medicinal products regulation and pharmaceutical services in the Baltic countries
Hospital pharmacies 24 24 24 24 24
Veterinary pharmacies 4 4 4 4 4
n LATVIA
In January 2019 there were 84 authorised human medicines wholesalers in Latvia.
10 of them had wholesale licences with special activity type that allows to distrib-
ute veterinary medicines as well.
Since January 1st 2011 the licences for the distribution of veterinary medicines are
being issued by the Food and Veterinary Service. Before that from 2008 till 2011
veterinary medicines wholesalers were licenced by the State Agency of Medicines.
In 2018, 50 wholesalers of human medicines distributed medicines to the pharma-
cies, health care institutions, medical practitioners and other recipients. Over 94%
of medicinal products market was covered by the eight major wholesalers: Recipe
Plus (33%), Tamro (18%), Magnum Medical (18%), Euroaptieka (13%), Olainfarm
(5%), Oribalt Rīga (previously Oriola Rīga) (3%), Vita-Farm (Baltfarma) (2%) and Uni-
farma (2%).
Veterinary medicines
wholesalers (only veterinary 23 23 24 30 28
medicines)
In the beginning of 2019 there were 840 retail pharmacies (including 80 structural
units) and 31 hospital pharmacies in Latvia. 55% of all retail pharmacies are located
in the 9 largest cities of Latvia - 34% in Riga, 5% in Daugavpils, 4% in Liepaja, 3%
in each Jelgava and Jurmala, 2% in each Rezekne and Ventspils and 1% in each
Jekabpils and Valmiera.
Medicinal products regulation and pharmaceutical services in the Baltic countries 17
Hospital pharmacies 34 33 33 32 31
n LITHUANIA
In 2018, 40 out of 125 wholesalers sold medicines to the general or hospital phar-
macies or to other institutions. The following 6 wholesalers cover 94% of the me-
dicinal product market: UAB “EVD” (32%), UAB „LIMEDIKA“ (26%), UAB „Nemuno
vaistinė“ (20%), UAB „Tamro” (8%), UAB „ARMILA“ (5%) and UAB „Medikona“ (3%).
The market share of the other wholesalers made up 6% of the total market.
Veterinary medicines
wholesalers (only veterinary 40 45 42 42 41
medicines)
Hospital pharmacies are funded by the hospitals and do not dispense medicines
to outpatients. Not every hospital has a hospital pharmacy for inpatients; however
the majority of health care providers have ordinary community pharmacies on the
premises.
Hospital pharmacies 47 47 44 44 44
n LATVIA
The general principles of the reimbursement system of pharmaceuticals are set in
the legislation. The reimbursement of pharmaceuticals shall be provided according
to the character and severity of the disease. The following categories are applied:
100% reimbursement - for chronic, life threatening diseases or diseases causing
irreversible disability, where the use of pharmaceuticals ensures and maintains the
patient’s life functions,
75% reimbursement - for chronic diseases, for which the maintenance of the
patient’s life functions are aggravated without the use of pharmaceuticals,
50% reimbursement – for diseases where pharmaceuticals maintain or improve the
patient’s health and for vaccines.
20 Drug reimbursement systems in the Baltic countries
All drugs for the same indication are reimbursed at the same rate. For the
pharmaceuticals for which the reference price is calculated the reimbursement rate
is applied to the reference price.
The pharmaceuticals eligible for the reimbursement are listed in the Positive List
elaborated by the National Health Service (NHS) of Latvia.
The Positive List consists of three parts – List A, List B and List C according to the
following basic principles:
• List A includes pharmaceuticals, which have several preparations of
the same therapeutic effectiveness within the scope of the INN or the
pharmaco-therapeutic group and medical devices of the same type;
• List B includes pharmaceuticals and medical devices, without an authorised
alternative;
• List C includes pharmaceuticals, costs of which exceed 4270 € per patient
per year and special medical restrictions cannot be applied to reduce the
expenditure.
n LITHUANIA
The state health care system is intended to serve the entire population, and the
Health Insurance Law requires all permanent residents to participate in the
compulsory health insurance scheme without an option to opt-out. Compulsory
health insurance covers almost all inhabitants. Compulsory health insurance
provides a standard benefits package for all beneficiaries. There is no positive list
of health services provided in the state-financed health care facilities. Emergency
care is rendered free of charge to all permanent residents irrespective of their
insurance status. Drugs prescribed by a physician are reimbursed according to the
reimbursement lists. Expensive hospital medicines are centrally purchased by the
National Health Insurance Fund.
There are two reimbursement lists, A and B.
List A covers pharmaceuticals for specific diseases in three reimbursement
categories:
100% reimbursement: Covers the most serious and expensive diseases, including
oncology, diabetes, haemophilia, schizophrenia, asthma etc.
At 90% and 50% reimbursement level are reimbursed only a few diseases.
Reimbursement from the disease-based list A accounts to approximately 95% of
the country`s total pharmaceutical reimbursement.
22 Drug reimbursement systems in the Baltic countries
n ESTONIA
The decision making of active substances to be added to the positive list was moved
from the Ministry of Social Affairs to the Health Insurance Fund in the beginning
of 2018. The procedure itself remained practically unchanged. There were no
major changes in the reimbursement system during this period in Estonia. New
active substances are still added to the list of reimbursed medicines quarterly. The
prescription fee was unified for all the reimbursement categories. Before it was
1.27€ for 100% and 75% reimbursed medicines and 3.19€ for 50% reimbursed
medicines, now it is 2.5€ for all reimbursement classes.
n LATVIA
Since August of 2018 the Positive list is updated monthly.
Until 1st September 2018 the prices of the interchangeable medicines whose price
was more than 100% higher than the price of the cheapest medicine within INN had
to be reduced to 100% price difference threshold or by 20%.
n LITHUANIA
From 2015 to 2018 the expenditure on pharmaceuticals and medical devices
covered by the NHIF has increased from 213 to 248 million Euros (average annual
growth 4,1 %). The patients co-payments decreased during this period from 54 to
40 millions Euros.
Seeking to reduce the level of out of pocket payment and improve the accessibility and
affordability of medicines, the Minister of Health has approved the Pharmaceutical
Policy Guidelines in August of 2017. The main goals of Pharmaceutical Policy
Guidelines are:
1. to improve an access to innovative medicines having high therapeutic value for
people suffering from severe diseases;
Drug reimbursement systems in the Baltic countries 23
Implemented measures:
• The uniform 5% VAT rate for all prescribed medicines has been
established since 1st January 2018 (previously 5% VAT tariff was applicable
for reimbursed pharmaceuticals and 21% VAT tariff for non-reimbursable
medicines). The reduced VAT rate resulted in decreased patient’s
expenditure on medicines. During the 1st quarter of 2018 patients
expenditure for the prescribed non-reimbursable medicines decline by
3.2 million EUR.
• The pricing methodology of subsidized medicines has been changed as
well in 2018. Tightened conditions for the inclusion of medicines into the
positive list played the significant role on the decline of the co-payments
since encouraged manufacturers and suppliers to offer cheaper medicines.
• More medicines started to be compensated by 90 or 100 percent. The
reimbursement level of medicines previously compensated by 80 %, was
increased to 100 % (except pharmaceuticals for cardiovascular diseases)
and the level of medicines for cardiovascular diseases by 90% in 2018.
Regulation of patient co-payment by setting the maximum possible co-
payment for package.
• The amendments of the pricelists are performed 4 times per year (instead
of former one);
• During 2018 the inter-institutional working group analysed the legal
framework and provided proposals concerning measures for reduction of
the OOP on medicines, odonatological services for low income people. The
amendments of the Law on Health Insurance concerning the exemption of
low incomes population from paying co-payments for subsidised medicines
and medical aids is presented to the Lithuanian Parliament.
n ESTONIA
The reference price is based on the internal price referencing, where the
pharmaceuticals are grouped on the basis of active ingredients (Anatomic
Therapeutic Chemical classification ATC-5 level), route of administration and
pharmaceutical form. Parallel traded pharmaceuticals have been incorporated into
the reference price system as well.
The procedures for setting manufacturer prices differ depending on whether the
pharmaceutical in questions is an innovative or a generic product.
24 Drug reimbursement systems in the Baltic countries
There are specific criteria for reimbursement of the parallelly traded pharmaceuticals:
the price for these has to be 10% lower than the price of the primary authorised
product on the market.
Statutory pricing – in combination with price negotiations – is applied to the
innovative and in-patent reimbursable pharmaceuticals in Estonia. The statutory
price levels are set according to the prices of the product in the reference countries
(Latvia, Lithuania, Hungary, Portugal, France and the country of origin). If applicable,
and similarity is proven, the prices of pharmaceuticals of similar effect are also
compared.
The Estonian Health Insurance Fund is the main authority involved in the pricing
decisions, receiving advice from the Pharmaceutical Committee.
If the price of the pharmaceutical is according to the opinion of the Pharmaceutical
Committee set too high, price negotiations with the manufacturer are started.
Negotiations are possible for the same pharmaceuticals and on the basis of the
same legal framework/procedure as statutory pricing.
n LATVIA
The reference price system is used in Latvia. The products are grouped into clusters:
• within the INN or
• within the pharmacotherapeutic group if there are no clinically relevant
differences in the effectiveness and side-effects for the same indication
and drugs are intended for the same patient group.
Products are clustered according to the pharmaceutical form and dosage. Then the
reference product for each cluster is identified (the cheapest pharmaceutical) and
on the basis of the price of the reference product the reimbursement price for each
pharmaceutical in the cluster is calculated.
n LITHUANIA
There have been a number of changes to the reference price system in Lithuania
in the recent years. The system is based on both external and internal reference
pricing measures. Previously, maximum reimbursement prices, or reference
prices, were set taking into account the lowest price on the Lithuanian market
and ex-manufacturers’ prices were negotiated taking into account prices in the
neighbouring markets, including Latvia and Estonia. With effect from 2002, phased
changes were introduced, to take into account the pricing of products relative to
that in other EU states. In 2004, a temporary external reference pricing mechanism
was based on a review of pricing in the then 15 EU member states (prior to the EU
accession of Lithuania and other countries included in this report). This identified
the lowest price in these states, to which 5% was added for Lithuanian pricing.
Drug reimbursement systems in the Baltic countries 25
From 2005, six countries deemed to have similar per capita income to Lithuania:
Latvia, Estonia, Poland, Czech Republic, Slovakia and Hungary are used to detect
reference price level. Under the revised approach, the declared manufacturer
price is compared with a level which is 95% of the average of that found in the
reference countries. In cases where the product is not on the market in some of
these countries, the average is taken from the markets in which it is present. In
cases where the product is not on the market in any of the reference countries, the
price of the product in the country of manufacture is used. From 2009 onwards,
Romania and Bulgaria were added to the list of reference countries.
Since July 2018, only patent-protected and off-patent medicines supplied by only
one producer are covered by the reference price system:
• Patent-protected drugs: the maximum reimbursement price (reference
price) for each INN and strength is determined with a reference to the
average of three lowest prices in EU.
For the purposes of determining the reference price, products are grouped by
the active ingredient and strength, with separate clusters drawn up for the same
route of administration and pharmaceutical form. Separate clusters are formed for
products for paediatric use. Given the nature of the system, patented products are
at the moment protected from the impact of internal price referencing, which in
effect results in reimbursement pricing at the level of the cheapest product in the
group.
For patent non protected medicinal products which are supplied by two or more
suppliers only internal reference system is used. Such products are clustered
by the active ingredient, with separate clusters drawn up for the same route of
administration and pharmaceutical form. Different strength products are clustered in
one cluster. There is introduced highest margin of patient co-payment and products
which exceed the highest co-payment aren’t included to the reimbursement system.
26 Materials and methods used for the Baltic Statistics on Medicines
n ESTONIA
Estonian State Agency of Medicines (SAM) is collecting and analysing drug utilization
data in Estonia.
According to the Medicinal Product Act and Decree of the Minister of Social Affairs
all wholesalers of medicinal products have to report their sales data quarterly to
SAM. The reports include the following data for each product: package ID, ATC
code, active substance(s), trade name, pharmaceutical form, strength, package size
and the manufacturer. The sales data are presented in monetary value and by unit
of volume (number of packages).
From these reports only the sale to end-consumers (retail and hospital pharmacies,
nursing homes etc) are used for calculating the medicines consumption.
Estonian SAM has been collecting and analysing the data since 1994. Statistics on
medicines are annually published at the Agency’s website (www.ravimiamet.ee).
n LATVIA
Statistical data regarding consumption of human medicines in Latvia is collected
and processed by the State Agency of Medicines (SAM). In accordance with the
Pharmaceutical Law and Regulations of the Cabinet of Ministers all wholesalers
of medicines are submitting their sales data (including data regarding parallel
imported and parallel distributed medicines) on a monthly basis by uploading to
the Agency’s database. The reports include the following information: medicinal
product identification code in accordance with medicinal product register; trade
name; price per package; number of packages sold for the particular price and
consumer group to which the product was sold.
Only the sales data of medicines sold to the final recipients (pharmacies, healthcare
institutions, medical practitioners and other recipients) are used for calculating
medicines consumption statistics. Latvian SAM has been collecting and analysing
the data since 2001. The national report on statistics on medicines consumption is
annually published on the Agency’s website (www.zva.gov.lv).
n LITHUANIA
Lithuanian State Medicines Control Agency (SMCA) is responsible for collection and
analysis of drug utilization data in Lithuania.
According to the Pharmaceutical Law and Order of the Head of State Medicines
Control Agency all wholesalers of medicinal products have to report their sales data
monthly to SMCA. The reports include the following data: a number of wholesaler’s
licence, package ID of medicinal product, and the number of packages sold. The
Materials and methods used for the Baltic Statistics on Medicines 27
Thus, in the ATC system all plain metformin preparations are given the code A10BA02.
Medicinal products are classified according to the main therapeutic use of their main
active ingredient, on the basic principle of assigning only one ATC code for each
pharmaceutical formulation (i.e. similar ingredients, strength and pharmaceutical
form). A medicinal product can be given more than one ATC code if it is available in
two or more strengths or formulations with clearly different therapeutic uses.
The Defined Daily Dose (DDD) is the assumed average maintenance dose per day for
a drug used for its main indication in adults.
28 Materials and methods used for the Baltic Statistics on Medicines
A DDD will only be assigned for drugs that already have an ATC code. DDDs are not
established for topical products (e.g. dermatologicals), sera, vaccines, antineoplastic
agents, allergen extracts, general and local anaesthetics and contrast media.
It should be emphasised that the defined daily dose is a unit of measurement and
does not necessarily reflect the recommended or Prescribed Daily Dose (PDD).
Doses for individual patients and patient groups will often differ from the DDD and
will necessarily have to be based on individual characteristics (e.g. age and weight)
and pharmacokinetic considerations.
Drug consumption data presented in DDDs only give a rough estimate of
consumption and not an exact picture of actual use. The DDD provide a fixed unit of
measurement independent of price and dosage form (e.g. tablet strength) enabling
the researcher to assess trends in drug consumption and to perform comparisons
between population groups.
Drug consumption figures are usually presented as numbers of DDDs/1000
inhabitants/day. Sales data presented in DDD/1000 inhabitants/day provides a rough
estimate of the proportion of the population within a defined area treated daily with
certain drugs. For example, the figure 10 DDDs/1000 inhabitants/day indicates that
1% of the population on average gets a certain treatment daily.
The use of a drug expressed as DDD/1000 inhabitants/day is derived by calculating
the overall amount of a drug being used over a specified period of time (e.g. a year)
and dividing this by the DDD multiplied by the population and the number of days
in the period. Amount used in 1 year*1000
DDD/1000 inhabitants/day =
DDD* population* 365(days)
Collecting and publishing drug utilization statistics are critical elements in the process
of improving the prescription and dispensing of medicines. For drug utilization
statistics to have the best possible impact on drug use, the statistics need to be used
in a focused and active manner.
All figures presented in this publication are based on the ATC/DDD version valid from
January 2016.
More detailed information can be found at www.whocc.no.
n ESTONIA
As shown below, the Estonian human medicines market showed a steady increase
from 2014 to 2018 reaching 325 mln euros (excl. VAT).
n LATVIA
Medicines sales over the last 5 years has increased in Latvia by 30% reaching 366
million euros (excl. VAT) in 2018.
30 Cost of drugs as a share of total health care expenditure in the Baltic countries
n LITHUANIA
In 2016 the human medicinal products market reached 595 mln euros (excl. VAT)
and had +18.5% increase. In 2018 market increased by 6.7% comparing to 2016,
reaching 635 mln euros (excl VAT).
Cost of drugs as a share of total health care expenditure in the Baltic countries 31
Estonia had the biggest consumption of medicines in 2018, which was 1148.72 DDD,
Lithuania consumpted 1106.11 DDD and Latvia – 953.92 DDD. Total consumption in
Estonia increased by 8%, in Lithuania by 8 % and in Latvia by 4%, when comparing
to 2015. Consumption of alimentary tract and metabolism drugs increased the
most in Lithuania (increase of 30.63 DDD) and in Estonia (16.99 DDD). However in
Latvia the most increase was in cardiovascular drugs – 31.76 DDD). What is more
only in Latvia we can see decrease of consumption in respiratory system drugs (-
7.79 DDD), genito urinary system and sex hormones (-5.2 DDD), antiinfectives for
systematic use (-1.12 DDD).
32 Cost of drugs as a share of total health care expenditure in the Baltic countries
When comparing consumption by different ATC groups, we can see that Estonia is
leading by consumption in all ATC groups, except for Cardiovascular drugs, Nervous
system drugs, Hormones and insulins and antiinfectives for systematic use where
Lithuania is leading.
n ESTONIA
In 2018, 4292 different medicinal preparation packages and 1347 active
substances were marketed in Estonia. Based on ATC classification antineoplastic
and immunomodulating agents had the greatest market share (20%), followed
by antiinfectives for systemic use (14%) and alimentary tract and metabolism
medicines (12%).
Cost of drugs as a share of total health care expenditure in the Baltic countries 33
n LATVIA
3569 different medicines containing 1373 different active substances and
combinations of authorised medicines were distributed in Latvia in 2018. When
comparing turnover of the main ATC groups of medicines during 2016 to 2018 the
antiinfectives for systemic use made up the largest part i.e. 16% of the market in
Latvia. Previously the largest share of the market was accounted for medicines
intended for treatment of cardiovascular system diseases which now holds the
third largest market share. The change in top positions is related to the entry of
new expensive medicines into the market.
In 2017 the second and the third most sold groups of medicines switched
places. Since then the second most sold group is the group of antineoplastic and
immunomodulating agents with the market share of 15.5% and the third largest
group is made of medicines intended for treatment of cardiovascular system
diseases with almost 14% of total market share in 2018. The fourth and the fifth
most sold groups of medicines since 2016 are medicines for treatment of alimentary
tract and metabolism diseases (12.5%) and medicines for treatment of nervous
system diseases (9%). The rest of the ATC groups covered about one third (33%) of
medicinal products market in 2018.
34 Cost of drugs as a share of total health care expenditure in the Baltic countries
n LITHUANIA
Lithuanian expenditure data is based on the NHIF database and depicts expenditure
for medicines reimbursement and not wholesale turnover as the Estonian and
Latvian data. OTC medicines and non-reimbursed medicines are not included on
the figure.
Sales statistics 2016–2018 35
Use of insulins
Of the anti-diabetic medications, only insulins can be used to treat both type 1 and
type 2 diabetes. As type 1 diabetes is a much less common disease, therefore,
insulins are used mostly by patients with type 2 diabetes. When observing the use
of insulins, it should be first noted that the total use of insulins has not increased or
even decreased over the last five years. At the same time, the number of patients
is on the rise due to the increased incidence of disease and greater life expectancy.
Thus, the opposite trend of the use of insulins suggests that the introduction of the
newer medications for type 2 diabetes delays the addition of insulins to the regimen
and may also reduce insulin doses and/or injections in combined regimens.
In Latvia, the total use of insulins is 10–20% lower than in Estonia and Lithuania,
which, in my opinion, refers to some obstacle in terms of starting and/or carrying
out insulin treatment.
The use of mixed insulin is very different: In Estonia, the use of medium and short
term combined insulins is extremely modest, however, it is rather frequent in Latvia
and, in Lithuania, their use frequency is almost five times higher than in Estonia.
safety in the last study (glimepiride v linagliptin, CAROLINA, ADA 2019), their
widespread use is very reasonable.
With regard to the new medication groups (SGLT-2 inhibitors, GLP-1 agonists),
the Estonian Health Insurance Fund has been the fastest to make compensation
decisions and, therefore, these medications have become available in Estonia a
little earlier. Thus, the use of these medications is also slightly higher in Estonia,
followed by Latvia and Lithuania.
These are precisely the medications for which the fastest growth potential can be
predicted in the coming years. This is thanks to positive results in cardiovascular
safety studies, where both groups have surprisingly led to decrease in the
incidence of cardiovascular diseases. Therefore, their use by diabetic patients
with a cardiovascular disease and also by those who are at high risk of having a
cardiovascular disease is fully justified.
In summary, it can be said that there are only minor differences in the use of anti-
diabetic medications in the Baltic countries, and these are mainly due to different
medication compensation systems.
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Only tobramycin and gentamycin are in the reimbursement list but according to
most guidelines they are mainly used in children infections, such as pyelonephritis or
pneumonia. These antibiotics may be used in hospitals, so the real consumption of
aminoglycosides might not be seen. The decrease of consumption of metronidazole
is also seen since 2010 (1.03 -> 0.32 DDD/1000 people).
The existing guidelines and the antibiotics in the reimbursement list are those
which are consumed the most over the years in Lithuania.
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1
J. Castellsague, N. Riera-Guardia, B. Calingaert, C. Varas-Lorenzo, A.Fourrier-Reglat, F. Nicotra, et al. (2012). Individual
NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies. Drug
Saf, 35, pp. 1127-1146
2
N. Bhala, J. Emberson, A. Merhi, S. Abramson, N. Arber, J.A. Baron, et al. (2013). Vascular and upper gastrointestinal
effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
Lancet, 382, pp. 769-779
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Its popularity may be explained by public awareness of these medicines and the wide
range of OTC products available. Ibuprofen is used to treat both short-term pain,
for example, headache, toothache, menstrual pain, muscle pain or postoperative
pain, and chronic pain, for example, pain related to rheumatoid arthritis and
osteoarthritis. The UK NICE guidelines recommend low-dose ibuprofen (up to 1200
mg per day) and naproxen (up to 1000 mg per day) as the first choice of NSAIDs.32
The data in Latvia indicates that naproxen is used rarely – 1.68 DDD/1000 inhabitants
per day (in comparison, ibuprofen consumption is 23.67 DDD/1000 inhabitants per
day), and its consumption shows a decreasing trend. Both of these medications
have similar effectiveness, but naproxen’s advantage is that it has a longer duration
of action and the lowest risk of cardiovascular adverse reactions among NSAIDs
therefore it might be a more appropriate choice for certain populations.
Similarly, medicines containing ketoprofen or a combination of naproxen and
esomeprazol had a low consumption in 2018 - 0.25 and 0.15 DDD/1000 inhabitants
per day, respectively. Over the last three years there has been a decreasing trend
in their consumption which may be explained by the availability and cost of these
medicines. In contrast, the consumption of dexketoprofen has increased by 30%
over the last three years. This may be due to the fact that in 2016 the first non
prescription dexketoprofen-containing medicines received marketing authorisation.
These medicines are characterised by rapid absorption and onset of action, and it is
hypothesized that dexketoprofen may have a lower risk of gastrointestinal adverse
reactions4.
Diclofenac is the second most popular product in the M01A subgroup in Latvia – in
2018 its consumption was 18.09 DDD/1000 inhabitants per day with some tendency
to decrease every year. Since 2013 when the European Medicines Agency added a
warning for diclofenac regarding increased risk of cardiovascular adverse events5 its
consumption in Latvia has decreased by roughly 13%.
Consumption of other products in this group, namely indometacin, ketorolac and
aceclofenac, practically has not changed over the last three years and remains
relatively low in 2018 at 0.16, 1.15 and 2.16 DDD/1000 inhabitants per day,
respectively. The lower popularity of these prescription medicines may be related
to their access and adverse reaction profile.
During this three-year period two COX-2 inhibitors or selective NSAIDs have been
consumed in Latvia – celecoxib and etoricoxib. These prescription medicines are
indicated for the symptomatic treatment of inflammation and pain caused by
arthritis and ankylosing spondylitis. The use of etoricoxib has increased from 2.19
in 2016 to 3.66 DDD/1000 inhabitants per day in 2018. Its consumption has tripled
3
https://www.nice.org.uk/advice/ktt13/chapter/evidence-context; Apskatīts: 30.05.2019
4
H. Gaskell, S. Derry, P.J. Wiffen, R. Moore (2017). Single dose oral ketoprofen or dexketoprofen for acute
postoperative pain in adults. Cochrane Database of Systematic Reviews, Issue 5. Art. No.: CD007355. DOI:
10.1002/14651858.CD007355.pub3
5
https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-new-safety-advice-
diclofenac_lv.pdf; Apskatīts 30.05.2019
Sales statistics 2016–2018 127
since 2013, and it may be related to the fact that several generic medicines entered
the market in 2016, making the medicines available at a lower cost. In 2018, this
was the third most popular M01A subgroup product. Advantage of COX-2 inhibitors
is their lower gastrointestinal adverse reactions63, but their overall consumption is
several times lower compared to other NSAIDs groups. However, their increased
risk for thrombosis makes them unfavourable choice for certain patient groups.
There is a steady decreasing trend in the consumption of glucosamine, nimesulide
and nabumetone and it remains relatively low at 1.7, 1.6 and 0.0041 DDD/1000
inhabitants per day, respectively. The actual consumption of glucosamine might be
higher because it is also available in nutritional supplements which consumption is
not tracked.
We cannot draw conclusions regarding patient demographics or doses to assess
safe and effective use of NSAIDs in Latvia, but such a high consumption of ibuprofen
and diclofenac compared to other choices may suggest that potentially there is
a room for improvement. Increasing consumption of OTC products may suggest
that there might be access barriers to health services. Studies conducted elsewhere
indicate number of problems associated with use of these medicines. For example,
coxibs, diclofenac and nimesulide are used much more widely by elderly people
than naproxen, which might be a safer option7 or patients tend to exceed the
recommended length of therapy8 thus exposing themselves to avoidable adverse
reactions. Taking into account the trends in consumption of these medicines, the
situation in Latvia could be similar and it might be useful to monitor use of these
medicines in more detail.
6
https://www.ema.europa.eu/en/news/european-medicines-agency-concludes-action-cox-2-inhibitors;
Apskatīts 30.05.2019.
7
Roberto, G., Bartolini, C., Rea, F., Onder, G., Vitale, C., Trifirò, G., … Italian Group for Appropriate Drug
prescription in the Elderly (I-GrADE) (2018). NSAIDs utilization for musculoskeletal indications in elderly
patients with cerebro/cardiovascular disease. European Journal of Clinical Pharmacology, 74(5), 637–643.
doi:10.1007/s00228-018-2411-y
8
K.A.J. Al Khaja, S. Veeramuthu, H.A. Isa, R.P. Sequeira (2017). Prescription audit of NSAIDs and
gastroprotective strategy in elderly in primary care. Int J Risk Saf Med. 29(1-2):57-68. doi: 10.3233/JRS-
170742.
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Antipsychotics (N05A)
18 antipsychotics are authorised in Lithuania and 13 of them (fluphenazine,
haloperidol, melperone, ziprasidone, flupentixol, clozapine, olanzapine, quetiapine,
tiapride, amisulpride, risperidone, aripiprazole, paliperidone) are fully reimbursed
for various psychiatric disorders. Reimbursed antipsychotics can only be prescribed
and subsequently continued by psychiatrist with an exception for tiapride which
can be continued by general practitioner. The majority of antipsychotics mentioned
above are reimbursed within licenced indications and only clozapine is restricted
for patients with resistant schizophrenia.
Over the 8 year period (2010-2018), the consumption of antipsychotics increased by
58% from 9.41 to 14.83 DDDs/1000 inhabitants daily. This change was mainly driven
by a constant increase in consumption of top 3 most commonly used antipsychotics
– quetiapine (1.46->3.30 DDDs/1000 inh. /d.), olanzapine (1.71-> 3.13 DDDs/1000
inh./d.) and haloperidol (1.81->2.30 DDDs /1000 inh./d.). During that period two
new drugs – aripiprazole and paliperidone – were included in the reimbursement
list and had some impact on increasing overall trend of antipsychotic consumption.
The use of other antipsychotics did not change significantly in 2010-2018. Not
reimbursed antipsychotics (levomepromazine, chlorprotixene, zuclopenthixol,
sulpiride, cariprazine) accounted for only 5% of the total consumption.
The treatment of schizophrenia spectrum disorders is guided by the guidelines
which were approved in 2012 by the Ministry of Health. However, these guidelines
describe treatment with reimbursed antipsychotics only, while national or nationally
approved international guidelines which would provide recommendations for the
treatment of schizophrenia spectrum disorders with any available antipsychotics
are lacking. According to the existing guidelines, the treatment can be initiated with
any of antipsychotic except clozapine or long acting injectable products. Haloperidol
is recommended to be used as the first line medication for children younger than 15
years old, and risperidone is preferred for 15 years and older children. Since there
are no preferred first line agent for total patient population and given there were
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Anxiolytics (N05B)
Nine anxiolytics are available in Lithuania (diazepam, lorazepam, chlordiazepoxide,
medazepam, oxazepam, potassium clorazepate, bromazepam, clobazam,
alprazolam, buspirone), two of them – diazepam and lorazepam – are included
in reimbursement list. Diazepam and lorazepam are reimbursed within its
licenced indications but only for children, disabled or elderly patients, or those
with malignancies. In addition to that, diazepam is reimbursed for any patient
diagnosed with epilepsy or demyelinating diseases of the central nervous system.
The most consumed anxiolytics were lorazepam (13.70 DDDs/ 1000 inh. /d. in
2018), alprazolam (8.13 DDDs/ 1000 inh. /d. in 2018) and bromazepam (5.99 DDDs/
1000 inh. /d. in 2018) over the all analysed period. Thus, it can be concluded that
reimbursement has some impact on the choice which anxiolytic to prescribe.
Anxiolytics were the most consumed psycholeptics varying from 41.43 DDDs/ 1000
inh./d. in 2010 to 33.74 DDDs/ 1000 inh./d. in 2018. So, the total consumption
decreased by 19% with the most prominent drop observed in 2017 and 2018.
In 2017, Regional Health Insurance Fund conducted assessment of patterns of
anxiolytics prescriptions which aimed to assess compliance with the requirements
or relevant summary of product characteristics. This analysis showed that general
practitioners did not comply with the requirement to prescribe anxiolytics for
the shortest possible duration (not exceeding 4 weeks). After the publication of
results, Ministry of Health initiated discussions with the public and physicians to
inform about potential benzodiazepine harm with long-term use. Since there are
no restrictions to prescribe benzodiazepines in the reimbursement list or relevant
guidelines, information spreading is considered to have the major effect on
decreasing trends in anxiolytics use.
On the whole, hypnotics and sedatives remained the least consumed psycholeptics
compared to the anxiolytics and antipsychotics during the 2010-2018 period,
however, its consumption has steadily increased by 51% from 6.90 DDDs/1000 inh.
/d. to 10.41 DDDs /1000 inh./ d in 2018. The most consumed hypnotics and sedatives
were zolpidem (5.22 DDDs /1000 inh./ d.) and triazolam (1.65 DDDs /1000 inh./
d.) until 2017, when zoplicone (2.11 DDDs /1000 inh./ d.) became more popular
than triazolam. Since nitrazepam is reimbursed only for very narrow indication, its
consumption is expectedly low representing 0.44 DDDs /1000 inh./ d. in 2018.
There are no therapeutic guidelines for the use of hypnotics and sedatives, only
nitrazepam is included in the reimbursement list, therefore the choice of particular
drugs is considered to be influenced by other factors.
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10. Contacts
11. References
1. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD
methodology.
(http://www.whocc.no/atc_ddd_methodology/purpose_of_the_atc_ddd_system)
2. Pudersell, K., Vetka, A., Rootslane, L., Mathiesen, M., Vendla, K., Laasalu,
K.: PPRI Pharma Profile Estonia 2007. June; Pharmaceutical Pricing and
Reimbursement Information; Commissioned by the European Commission,
Directorate-General Health and Consumer Protection and Austrian Federal
Ministry of Health, Family and Youth.
(https://ppri.goeg.at/sites/ppri.goeg.at/files/inline-files/Estonia_PPRI_2007_4.
pdf)
3. Estonian Health Insurance. Health Insurance in Estonia.
(http://www.haigekassa.ee/eng/health-insurance-in-estonia)
4. Statistics Estonia. (http://www.stat.ee)
5. Estonian Statistics on Medicines.
(http://www.ravimiamet.ee/en/statistics-medicines)
6. Statistics on medicines consumption of Latvia
(http://www.zva.gov.lv/doc_upl/Zalu_paterina_statistika_2012-20130604.pdf)
7. Central Statistical Bureau of Latvia.
(http://data.csb.gov.lv/DATABASEEN/Iedz/databasetree.asp)
8. World Health Organization. Global Health Expenditure Database.
(http://apps.who.int/nha/database/PreDataExplorer.aspx?d=1)
9. The World Bank. Health expenditure per capita.
(http://data.worldbank.org/indicator/SH.XPD.PCAP/countries)
10. The Centre for Disease Prevention and Control of Latvia.
(http://www.spkc.gov.lv)
11. The National Health Service of Latvia.
(http://www.vmnvd.gov.lv)
12. Medicines consumption in Lithuania.
(http://www.vvkt.lt/Annual-Reports)
13. Statistics Lithuania (https://www.stat.gov.lt/)
14. National Health Insurance Fund (http://www.vlk.lt/sites/en)
15. Ministry of Health of the Republic of Lithuania (http://sam.lrv.lt/en/)