The State became important stakeholder in the...
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2018 Ukrainian Pharmaceutical Forum
The State became important stakeholder in the
pharmaceutical market of Ukraine
Gorlova Irina
SMD CEO
November 07-08, 2018
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State participation in medicines supply
• Out-clinic treatment • Affordable Medicines
project
• Start April 2017
• www.liky.gov.ua
• Full payment and co-payment for
3 main nosology – hypertension,
bronchial asthma and diabetes
• 23 molecules, with further
extension
• 6 179 pharmacies participating
the project (≈ 1/3)
• In-clinic treatment • NEML (National
Essential Medicines
List)
• Start January 2018
• Prioritized purchases of selected
molecules by health institutions,
compensated by State budget
• 400 + molecules, main list and
additional one
• Based on WHO’ Basic List of
Essential Medicines
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State spending accounted 16% in values LC, MAT 06 2018
Source: SMD Retail and State Purchases data
Values LC (UAH), period MAT June 2018
Market - state participation in purchase of medicines
HospitalCentralizedRegional subvensionRetail
UAH
58 Bln
Affordable medicines – 1 bln UAH
Insulins in retail – 0,6 Bln UAH
= 1,6 bln UAH
∑ of state participation
Hospital 2,4
Centralized 4,3
Reg. Subvention 0,4
Retail reimbursement 1,6
≈ 8,7 bln UAH
≈ 16%
0
5 000
10 000
15 000
20 000
25 000
30 000
0
500
1 000
1 500
2 000
2 500
3 000
Reta
il s
ale
s,
LC
MIO
Sate
purc
hases,
LC
MIO
Retail Hospital Regional tenders MOH & Centralized
• Total market makes 58 bln UAH in
purchase prices
• Share of state purchases = 16%,
including reimbursed part sold
through retailMarket dynamics per channels, values LC (UAH)
Market
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Market dynamics, MAT June 2018 vs MAT June 2017
Retail (all categories) 49 bln UAH. Grow due to Rx segment (both value and volume)
Centralized purchases through foreign
agencies (delivery) 4,3 bln UAH
Hospitals purchases 2,4 bln UAHGrowth of NEML purchases +25% in value and
volume!
Regional Subvention 0,4 bln UAHInsulins migrated to Retail!
+11%
Values LC
-3%
Volume Units
+132% +37%
-27%-24%
-57% -10%
Source: SMD Retail and State Purchases data
Values LC (UAH), period MAT June 2018
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Main groups of medicinal products, compensated by the state
Top groups, Mio UAH State PatientOncology and transplantology 1 111 1 515
Blood factors 868 156
Hypertension 793 2 029
Patient care prds 671 2 059
Diabet/Insulins 656 98
AIDS/HIV 529 7
Orphan diseases 518 0
Antibacterial, a/fungus 515 2 456
Hospital solutions 405 891
Diagnostics 338 354
Vaccines 273 154
Diabet/Oral 260 438
Narcotics/Analgesics 207 1 177
Others antiviral (influenza, herpes) 199 978
Hepatitis 132 9
Respiratory and antihistamines, others 129 5 164
Antithrombotic agents 123 1 203
Musculo sceletal disorders 121 3 816
Anti-asthma and copd products 114 1 104
Psycholeptics 113 1 001
TBC 113 4
Anaesthetics 104 83
Others 755 24 355
Oncology and transplantology
Blood factors
Hypertension
Patient care prds
Diabet/Insulins
AIDS/HIV
Orphan diseases
Antibacterial, a/fungus
Hospital solutions
Diagnostics
Vaccines
Diabet/Oral
Narcotics/Analgesics
Others antiviral (influenza, herpes)
Hepatitis
Respiratory and antihistamines, others
Antithrombotic agents
Musculo sceletal disorders
Anti-asthma and copd products
Psycholeptics
TBC
Anaesthetics
State Patient
Source: SMD Retail and State Purchases data
Values Mio LC (UAH), period MAT June 2018
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1
2
3
Diabetes – oral anti-diabetes – 3 INNs
Hypertension -17 INNs
Bronchial Asthma – 3 INNs
Affordable medicines - government
reimbursement program, full or partial
payment of medicines included in the
detailed budget list.
• Full payment or co-payment
• Receipt is a financial document
• 6179 pharmacies participate the project
• Program budget – 1 bln UAH
Affordable Medicines – reimbursement project
Launch date 01/04/2017
www.liky.gov.ua
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17 INNs
• Annual sales – UAH 764 Mio, 911
Mio DDD
• DDD sales growth +115%• Simvastatin +999%
• Losartan +386%
• Isosorbide Dinitr +375%
• Metoporolol, Nitroglycerin,
Digoxin –”0” growth
Growth in DDD is significant
Prices’ effect … (DDD cost)
Import
Affordable Medicines – Success Story
Hypertension
0
50 000 000
100 000 000
150 000 000
200 000 000
250 000 000
300 000 000
Sale
s in D
DD
AMIODARONEAMLODIPINEATENOLOLBISOPROLOLCARVEDILOLCLOPIDOGRELDIGOXINENALAPRILI MALEASFUROSEMIDEHYDROCHLOROTHIAZIDEISOSORBIDE DINITRATELOSARTANMETOPROLOLNITROGLYCERINSIMVASTATINSPIRONOLACTONEVERAPAMIL
AMIODARONE AMLODIPINEATENOLOL BISOPROLOLCARVEDILOL CLOPIDOGRELDIGOXIN ENALAPRILI MALEASFUROSEMIDE HYDROCHLOROTHIAZIDEISOSORBIDE DINITRATE LOSARTANMETOPROLOL NITROGLYCERIN
911 Mio
DDD
+115%
Local
0,00
2,00
4,00
6,00
8,00
10,00
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
AMIODARONE AMLODIPINE BISOPROLOL CARVEDILOL CLOPIDOGREL
ENALAPRILI MALEAS LOSARTAN METOPROLOL SIMVASTATIN SPIRONOLACTONE
-37%
0,00
1,00
2,00
3,00
4,00
5,00
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
AMIODARONE AMLODIPINE ATENOLOL BISOPROLOL
CARVEDILOL CLOPIDOGREL DIGOXIN ENALAPRILI MALEAS
FUROSEMIDE HYDROCHLOROTHIAZIDE ISOSORBIDE DINITRATE LOSARTAN
METOPROLOL NITROGLYCERIN SIMVASTATIN SPIRONOLACTONE
VERAPAMIL
-3%
Source: SMD Retail data
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3 INNs
• Annual sales – UAH 255
Mio, 123 Mio DDD
• DDD sales growth +74%
• Metformin +115%
• Gliclazide +58%
• Glibenclamide +4%
Growth in DDD is significant
Prices’ effect … (DDD cost)
Import
Affordable Medicines – Success Story
Oral anti - diabetes
0
5 000 000
10 000 000
15 000 000
20 000 000
25 000 000
30 000 000
35 000 000
Sale
s in D
DD
GLIBENCLAMIDE GLICLAZIDE METFORMIN
GLIBENCLAMIDE GLICLAZIDE
METFORMIN
123 Mio
DDD
+74%
Local
0,00
0,50
1,00
1,50
2,00
2,50
3,00
3,50
4,00
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
GLICLAZIDE METFORMIN
-5%
0,00
0,50
1,00
1,50
2,00
2,50
3,00
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
GLIBENCLAMIDE GLICLAZIDE METFORMIN
-17%
Source: SMD Retail data
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3 INNs
• Annual sales – UAH 101 Mio,
36 Mio DDD
• DDD sales growth +27%
• Beclomethazone +100%
• Budesonide +605%
• Salbutamol +9%
Growth in DDD is significant
Prices’ effect … (DDD cost)
Import
Affordable Medicines – Success Story
Bronchial Asthma
0
1 000 000
2 000 000
3 000 000
4 000 000
5 000 000
6 000 000
7 000 000
8 000 000
9 000 000
10 000 000
Sale
s in D
DD
BECLOMETASONE BUDESONIDE SALBUTAMOL
BECLOMETASONE BUDESONIDE
SALBUTAMOL
36 Mio
DDD
+27%
Local
0,00
2,00
4,00
6,00
8,00
10,00
12,00
14,00
16,00
18,00
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
BECLOMETASONE BUDESONIDE SALBUTAMOL
Budesonide -38%
Total import + 20%
0,00
0,50
1,00
1,50
2,00
2,50
2017Y/Q1 2018Y/Q2
DD
D c
ost,
UA
H
SALBUTAMOL
+24%
* Prices are within of Wholesalers-Retail prices’ Register
Source: SMD Retail data
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Source: SMD database of pharmacies, data on pharmacies participating the AM project (www.liky.gov.ua)
SMD calculations
Affordable Medicines (AM) – Success Story
Influence into Pharmacies
Pharma Chains categoriesNumber of
chains# POS
Participate AM
project
Share of POS participating
AM project
1st 300+ POS 5 2 020 318 16%
2nd 150 to 230 POS 11 1 986 807 41%
3rd 100 to 150 POS 9 1 114 376 34%
4th 50 to 100 POS 17 1 149 381 33%
5th 10 to 50 POS 164 3 445 1 062 31%
6th less than 10 POS 1176 6 419 1 945 30%
Entrepreneurs 6 974 2 151 31%
• Market share of AM in total market ≈ 4%
• In successful pharmacies, participating the project, it
makes up to 20% out of the turnover
• Growth of overall turnover due to the fact, that patient
comes to the pharmacy for free of charge medicine and
buy additional products
Q2/2017 Q3/17 Q4/17 Q1/18 Q2/18 Q3/18
AM pr Other prds
20%
5%
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Affordable Medicines – Success Story
Pro and Contra
Pro
It happened! The state became powerful
player in pharma market and the Receipt
became a financial document
The most socially significant diseases
with complications affecting the working
ability of the population; mainly for socially
unprotected citizens
Pharmacies participating the project has
new source of sales increase. Patient
comes to the pharmacy for free medication
makes additional purchases. Share of
AM in such pharmacies up to 25% of
turnover.
Contra
It is still minor 1 bln UAH vs 45 bln UAH
retail market (only 5% in values but 10% in
volume (Standard Units) among Rx)
Financial challenges - funding outages
(end and beginning of fiscal year); bigger
problem in financing is in areas with the
lowest income vs. budget allocation per
capita
The current choice of INNs covers only
part of the treatment protocol
Expansion of new nosology?
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2 323 SKUs
INNs
≈ 400 in NEML
341 in the market
205 ATC4
National Essential Medicines List - is a list of medicines
with proven efficacy that is necessary to ensure the
immediate needs of medical care for the population in health
care facilities for treatment at the expense of state and local
budgets. The Ukrainian National List is based on the Target
List of Essential Medicines developed by the World Health
Organization
• Free of charge and/or with co-payment for out-patient
treatment of certain population groups
• The demand for procurement of medicinal products is
determined by types of medical care in accordance with
the procedure established by the Ministry of Health.
• As soon as the demand is fully satisfied, customers
may purchase medicinal products that are registered in
Ukraine in accordance with the law and are not included in
the specified NEML.
National Essential Medicines List (NEML) in current issue (July 01, 2017).
Compulsory since 01/01/2018
https://www.kmu.gov.ua/ua/news/250149531
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National Essential Medicines List (NEML) values and volume
∑ NEML
≈ 5,1 bln
UAH
Total current value of NEML = 5,1 bln
UAH:
Hospital 1,6
Centralized 1,9
Reimbursement 1,6 (Retail
Insulins and Affordable
Medicines)
Current volume in DDD = 40 bln DDDs
Potentially Retail unmet needs for in-
clinic treatment in sum of 9 bln UAH
and 450 bln DDDs
NEML and the market
Source: SMD data
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National Essential Medicines List (NEML)
grouped by ATC1 in DDD
NEML and the market
Current NEML in DDD
(40 bln DDD)
The state compensates mainly antibacterial (J),
narcotics/analgetics and non-steroid anti-
inflammatory. Three groups make 90% of
current NEML purchases.
Potential NEML in DDD
(450 bln DDD)
J and A makes half in potential NEML (retail).
A – mainly Ranitidine and enzymes
33%
18%11%
11%
10%
8%
3%
3% 2% 1%0%
J A N H R M C B G P S L D K V
78%
2%10%
1%
1%
3%1%
3%0%0% 1%
RE
TA
ILS
TA
TE
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National Essential Medicines List (NEML)
main challenges and imperfection
• Structure – Main & Additional
List? What is the difference?
• Being based on WHO list, not
fully reflect the structure of
consumption
• INN selection – some
important INNS are not
included
Legal
aspects
How to work in
accordance with
NEML?
• Calculation of real demand
and unmet needs in clinics?
• Based on historical
purchases
• Based on number of
patients vs diagnosis;
protocols vs formulars.
• Need to be worked out
based on market data
• Only essential products with
the biggest consumption
in hospitals should be
compensated under
conditions of insufficient
budget
• Historical purchases do
not reflect demand in
clinics. As out-of-pocket
purchases for in-clinic
treatment are traditional
• Only MIS implemented
under e-health project
can help to calculate
demand
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National Essential Medicines List (NEML)
example Antibiotics
RankINNs ranked by DDD
MAT June 2018NEML BASIC NEML ADDITIONAL
1 LEVOFLOXACIN 1
2 AZITHROMYCIN 1
3 AMOXICILLIN 1
4 AMOXICILLIN+CLAVULANATE 1
5 DOXYCYCLINE 1
6 CIPROFLOXACIN 1
7 CLARITHROMYCIN 1
8 CEFUROXIME
9 MOXIFLOXACIN 1
10 OFLOXACIN 1
11 CEFIXIME 1
12 CHLORAMPHENICOL 1
13 NORFLOXACIN
14 CEFPODOXIME
15 LINCOMYCIN
16 AMPICILLIN 1
17 TETRACYCLINE
18 CEFALEXIN 1
19 GENTAMICIN 1
20 ERYTHROMYCIN 1
21 BENZYLPENICILLIN 1
22 AMIKACIN 1
23 LINEZOLID 1
24 GATIFLOXACIN
25 MIDECAMYCIN
26 CEFTRIAXONE 1
27 JOSAMYCIN
Source: SMD Retail and State purchases data, recalculated in DDD
Marked with red are not
included into NEML, marked with yellow
are included into NEML additional
Levofloxacin annual volume in DDD is
equal to 96 bln DDD
Mainly parenteral forms (92%)
The state compensate only 10% of all
DDD consumed by patients.
83 96
34
85 90
0
20
40
60
80
100
120
0
50 000
100 000
150 000
200 000
250 000
Purc
hase p
rice p
er
pack
Sale
s, pack
LEFLOCIN INFUSION 0.5 % 100 ML 1 YURIA-PHARM, UKR
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National Essential Medicines List (NEML)
example Antibiotics
RankINNs ranked by DDD
MAT June 2018NEML BASIC NEML ADDITIONAL
1 LEVOFLOXACIN 1
2 AZITHROMYCIN 1
3 AMOXICILLIN 1
4 AMOXICILLIN+CLAVUL. 1
5 DOXYCYCLINE 1
6 CIPROFLOXACIN 1
7 CLARITHROMYCIN 1
Source: SMD Retail and State purchases data, recalculated in DDD
J01C1 Oral broad
spectrum penicillins
(Amoxicillin+Clavulanate/ Amoxicilline)
42%
J01F0 Macrolides and similar types
(Azithromycin, Clarithromicin)
31%
J01G1 Oral fluoroquinolones (Cipro-,
Levofloxacin)14%
J01D1 Oral cephalospori
ns (Cefuroxim,
Cefixim)10%
J01D2 Injectable
cephalosporins
(Ceftriaxone)2%
J01G2 Injectable
fluoroquinolones
(Levofloxacin)
1%
Market GPs Prescriptions
6 out of 7 leading antibiotic INNs that are
included into NEML basic are mainly oral
forms.
And there sales are driven by out-patient
GPs’ prescriptions and used for out-patient
treatment.
Should they be in NEML basis?
Source: SMD Prescription data, May June 2018