The State became important stakeholder in the...

2018 Ukrainian Pharmaceutical Forum

The State became important stakeholder in the

pharmaceutical market of Ukraine

Gorlova Irina

SMD CEO

November 07-08, 2018

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

http://www.liky.gov.ua/

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

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%


Values LC (UAH), period MAT June 2018

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


Values Mio LC (UAH), period MAT June 2018

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


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

3 INNs

• Annual sales – UAH 255

Mio, 123 Mio DDD

• DDD sales growth +74%

• Metformin +115%

• Gliclazide +58%

• Glibenclamide +4%



Import


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%


3 INNs

• Annual sales – UAH 101 Mio,

36 Mio DDD

• DDD sales growth +27%

• Beclomethazone +100%

• Budesonide +605%

• Salbutamol +9%



Import


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 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%



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?

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

https://www.kmu.gov.ua/ua/news/250149531

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

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


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


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


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

Thank you!

[email protected]

mailto:[email protected]

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