Pharma Maket Access - Southeast Europe & Turkey

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 1

Zdravko Mauko, Farmavita Regulanet

for Pharma Market Access Conference, Opatija, 5th – 7th June 2013

Pharmaceutical Market Access Across Southeast Europe & Turkey



Southeast Europe & Turkey

Croatia – 4,5 mn Serbia – 7,2 mn Bosnia &

Herzegovina – 4,1 mn

Macedonia – 2,1 Montenegro-0,6 Kosovo – 2,3mn Albania – 2,8 mn Bulgaria – 7,6 Romania – 22,4 Turkey - 79,75

Total market of about 130 million citizens.



Croatia

Marketing Authoristions - ICH Guidelines, CTD format- From 1st July harmonized with EU- NP, CP, MRP, - EU MAH , EU QPPV, local PV

support

Unauthorised Imports- Compassionate use- Named patient list - Clinical trials, research - Urgent general population

need

Healthcare Expenditure- Population 4.5 million citizens, GDP 80.33 bill. USD- HE was 7.8 % of GDP in 2010 - Croatian pharmaceutical market size is comparable to

Bulgaria- Drug expenditure per capita (DEPC) is 128€ , similar to

that of Poland- Market growth is hindered by economic crisis- Phramaceuticals sales projection for 2012 is 1.26bn

USD, -5.8% from 2011



Croatia – P & R

Wholesale Price • sum of manufacturing price and custom service price, without VAT• Wholesale margin up to 8.5%

Criteria for wholesale price determination are:• level of comparative wholesale price• pharmacoeconomic study• reference price (Italy, France, Slovenia / Czech, Spain)

Retail Price - Retail margin is 10 to 35%, except for AIDS, cancer , long lasting

treatments and epidemics (may be 2%) - 5% VAT

Reimbursement List – Croatian Health Insurance Institute (HZZO) - Pharmacoeconomic study – Innovative medicines- Budget impact analysis – first generics, without innovative - Price determination – generics



Serbia

Healthcare Expenditure- Population 7,2 million citizens, GDP 28.01 bill. EUR- HE was 9.6% of GDP in 2007 - approximately at the level of Denmark (9.8%), Greece

(9.6%), and Iceland (9.3%) - 63.8% public health care exp.- Total expeniture per capita – 348 €- per capita consumption of drugs EUR 179 per capita in

2012

Marketing Authorizations- ALIMS- ICH Guidelines, CTD format- MA from other country – not accepted- NP – standard regulatory pathway- Local MAH , local QPPV

Unauthorized Imports- Compassionate use - Named patient list - Urgent general population need- On request of insititution



Serbia – P & R

Wholesale Price • sum of manufacturing price and custom service price, without VAT• + wholesale margin up to 6 % proposed to RZZO

Criteria for wholesale price determination are:• level of comparative wholesale price• pharmacoeconomic study• reference price (Italy, Croatia, Slovenia)

Retail Price - Retail margin is 12 % + VAT

Reimbursement List - Serbian Health Insurance Institute (RZZO) - Pharmacoeconomic study – Innovative medicines- Price determination – generics (Regulation on the Criteria for

Establishing Medicinal Products Prices (Official Gazette No. 87/2010))- Determined onece a year, updated qurterly



Bosnia and Herzegovina

Marketing Authorizations- ALMBIH- ICH Guidelines, CTD format- MA from other country – not accepted- NP – standard, generic regulatory pathway- Local MAH , local QPPV

Unauthorized Imports- Compassionate use - Named patient list - Urgent general population need- Clinical trial, research

Healthcare Expenditure- Population 4,35 million citizens, GDP 24.80 bill. USD- HE was 9.8% of GDP in 2006 - Pharmaceutical market 125mill. EUR- Prescription drugs expenditure: 32 mill.$ (9 USD per

capita) - 60% hospital / 40 % non-hospital sales - large amounts of money are spent on prescription drugs

which, in fact, have no appropriate value for therapy



Bosnia & Herzegovina – Pricing

Pricing - controled by ALMBIH

Price is controlled by the Agency for Medicinal Products and Medical Devices of

Bosnia and Herzegovina: • Article 84. of Medicinal Products and Medical Devices Act• Calculating and Reporting the Prices of Medicinal Products (Official Gazette of

the Bosnia and Herzegovina No. 82/11)

Wholesale Price • sum of manufacturing price and custom service price, without VAT• + wholesale margin up to 8 % proposed to ALMBIH

Criteria for wholesale price determination are:• level of comparative wholesale price• pharmacoeconomic study• reference price (Serbia, Croatia and Slovenia / Austria or Italy)

Retail Price - Retail margin is 10 – 25 % + VAT



Bosnia & Herzegovina – Reimbursement

Reimbursement Lists – 10 cantons • two federal essential lists in two Entities of B&H

(R. Srpska and BiH Federation)• Other cantonal essetial lists

Specific creiteria: • The obligatory including of domestic

pharmaceutical industries;• Experience in the therapeutic use of drug in

FB&H;• Manufacturer’s declarations of acceptance of

drug prices established by the Federal list of essential drugs.

Health care services are not transferable between the two entities. Persons insured in the various cantons have a different rights and different approach health care services, especially in tertiary care. Fragmented health care system limits the equitable access to health services for all citizens in FB&H.



Macedonia

Marketing Authorizations- REGLEK- ICH Guidelines, CTD format- MA from EU – priority reviuwe - standard, generic, hybrid, established- Local MAH , local QPPV

Unauthorized Imports- Compassionate use - Named patient list - Urgent general population need- On request of insititution

Healthcare Expenditure- Population 2.04 million citizens, GDP 20.35 bn. USD- HE was 8.2% of GDP in 2006 - drug consumption is not monitored closely- Estimate of pharmaceutical market vary from US$ 40

million to US$ 300 million- 3 local manufacturers provide an estimated 25 % of

market and are able to provide the full range of essential drugs needed



Macedonia – P & R

Pricing

Criteria for wholesale price determination are:• reference price (Croatia, Serbia, Slovenia, and Bulgaria) • level of comparative wholesale price

• 100 % for first gneric• 78% for following generics

• Lowest defined price at Macedonian market• Therapeutic group

Legal frame: Regulation on Establishing the Criteria for Determining the Reference Price of Medicine (Official gazette No. 158/09); New Draft

Reimbursement List – HCI Fund- Referent prices are determined at least once a year. The date of the calculation

of the reference price is January 10th every year

Tenders• Law on Public Procurement (Official gazette No. 136/07)• Bureau of public procurements



Kosovo

Marketing Authorizations- KMA- ICH Guidelines, CTD format- MA from EU – priority review 30d - standard regulatory pathway- Local Authorised person required

Unauthorized Imports- Compassionate use - Named patient list - Urgent general population need

Healthcare Expenditure- Population 2.1 million citizens, GDP 13,56 bn USD- HE was 3 % of GDP - The annual per capita government expenditure in health

care is only 35 € (the lowest in Europe)- Health insurance system has not yet been established. - The private sector in health care has grown in the recent

years and is predominantly focused on diagnosis and treatment.



Kosovo – P & R

Pricing• There is no price control and price registration in place

Reimbursement List • There is not yet established a reimbursement system.• It has been drafted some proposition of legislation but not yet approved by the

parliament.• Every year the MOH formulate an Essential Drug List based on the need of the regional

hospitals. After that list is formed, the tender is published.• Usually there are not enough drugs procured by tender so patients have to by everything

themselves.

Tenders• Usually tenders are announced centrally. MOH distributes medicines among healthcare

institutions.• Additionally every healthcare institution has its own budget and allowed to open the local

decentralized tenders.• list of medicinal products allowed for purchasing by funds of Kosovo State Budget is

provided in official website of the MOH of Kosovo called as Essential Drug List.• Any person or company (resident and non-resident) can participate in state tender.



Albania

Marketing Authorizations- QKKB- Local Guidelines, CTD format- standard, abbreviated reg. pathway- 30d abbreviated, 210d standard- Authorised representative, local QPPV

Unauthorized Imports- Compassionate use / donation - Urgent general population need

Healthcare Expenditure- Population 2.8 million citizens, GDP 23,12 bn USD- HE was 2.6 % of GDP in 2010, 8.9% of national budget- The health system in Albania is mainly public but the

private sector is expanding rapidly.- The Albanian pharmaceutical market is estimated to be

around 130 million Euro.- Domestic pharmaceutical manufacturing in Albania is

rather underdeveloped.



Albania – Pricing

Pricing• Controled by Drug Pricing Commission, a unit located at the Ministry

of Health• This commission approves every year the „CIF prices” for the

imported drugs and the fabrication prices for the domestic drugs. The prices are declared every year, within the 30 September.

• requirements for the preparation of the letter on CIF price declaration is available in the website of the Ministry of health

• CIF prices in Albania are be compared to CIF prices of reference countries: Italy, Greece and Macedonia. The reference price is the lowest price among the three states.

• "CIF" prices are officially notified to the National Center for Drug Control, Health Insurance Institute, the General Customs Directorate and the General Directorate of Taxation.

• Wholesaler and pharmacy margines are also regulated



Albania – Reimbursment

• Reimbursement list is compiled by the Commission of Composition and Review of the Reimbursement List of Medicinal Products in the Ministry of Health

• Reimbursement provided by Health Insurance Institute (HII) • Each year, the alternatives in reimbursement list may be proposed by

associations of doctors or pharmacists, pharmaceutical manufacturers, representatives of pharmaceutical companies, physicians of the primary service, clinics of the University Hospital Center of Tirana, Drug Nomenclature Commission (DNC), or National Center for the Control of Drugs (QKKB) according to a format determined by the Pharmaceutical Department of the MoH.

• Legal frame : Order No 185/1 by the Minister of Health of 4 June 2012 on Approval of the Regulation on Methodology of Determination of Drug Prices and Administration Way of Price Declarations in the Republic of Albania



Bulgaria

Marketing Authorizations- BDA- ICH Guidelines, eCTD adn NeeS format- Stadard, abbreviated, literature - NP, CP, MRP, DCP- Local liason and PV person

Unauthorized Imports- Treatment of patient requested

by hospital- Product authorised in Eum but

not in Bulgaria- Hospital supply by “international

and national programs”

Healthcare Expenditure- Population 7.6 million citizens, GDP 103 bn USD

(2012est)- HE was 4 % of GDP in 2011, DEPC 85 €- National Health Fund pays EUR 34 per person each year

(average figure in Europe circulates around EUR 200)- Only 1/3 of Rx medicines are reimbursed - Currently 10 companies in Bulgaria hold nearly 55% of

the total medicine market- Pharma market was EUR 1 billion in 2012



Bulgaria – Pricing

National Council on Pricing and Reimbursement is established by the Minister of Health. It regulates „limit prices”.

The limit price is determined for:• For medicinal products included in the Positive List is the retail price • For medicinal products not included in the Positive list is the highest price on

which one medicinal product is sold on the market.• For OTC medicinal products the limit price is the highest retail price

determinated by the MAH and the Council.

The price for Positive List of Medicine is calculated as sum of:

1. lowest price for the same product paid by public health insurance funds of the Romania, France, Estonia, Greece, Slovakia, Lithuania, Portugal, Italy, Denmark, Finland, Slovenia or Spain

2. a wholesaler margin in size 7 %, 6% and 4 % percent of the stated price respectively for prices up to 10.00 leva, for price from 10 to 30 leva and for prices up to 30 leva

3. a retail margin in size 20%, 18% or 16% percent of the stated price respectively for same prices

SUM 1+2+3+20% VAT= „limit price”



Bulgaria – Reimbursement by NHIF

Positive List is 100% reimbursed by the state budget, there is no retail margin calculated

Special inclusion criteria:

- INN belonging to the medicinal product, which is paid by the public health insurance fund of one of the following countries: Romania, France, Estonia, Greece, Slovakia, Lithuania, Portugal, Italy, Denmark, Finland, Slovenia, Spain, Belgium, Hungary, Poland and Check Republic.

- There is shortage or alternative treatment

- a criteria for efficacy and benefit of the medicinal product

- A criteria for safety

- Pharmaco-economic indexes

- The medicinal product will be used for a treatment of disease with high risk to the society

The list of the reimbursed drugs is published on the Ministry of Health (Positive list) and on the web page of the NHIF. The Positive list update is twice monthly.



Romania

Marketing Authorizations- ANM- ICH Guidelines, CTD format- stadard, abbreviated, hybrid, estab.- NP, CP, MRP, DCP- Local liason person


(2012est)- HE was 5.6 % of GDP in 2010, DEPC 88€ - Pharmaceutical market was 1,55 bn EUR in 2006- Only 1/3 of Rx medicines are reimbursed - Rx drug market is 83%, of which 80% is reimbursed by

public healatcare system- The drug market is growing mainly due to the

introduction of new, expensive drugs

Unauthorized Imports- Compassionate use is an order

placed at physician's initiative, with the consent of the patient;

- When equivalent is not authorized

- Through authorized distributor



Romania – P & R

Pricing

The Pharmaceutical department in the Ministry of Public Health is in charge with the price approval.

Criteria for price determination are:• reference price = lowest price ffrom Czech, Bulgaria, Hungary,

Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece, Germany

Reimbursement – NHIH• Genric medicines 65% of originnator proice • Innovative medicines – not more than 35% more expensive than

gnerics at refrence country list. • List of reimbursable drugs contains 3748 products 100%

reimbursable, 1513 products 90% and 1032 products 50%• HC system still encounters massive delays in reimbursement.• In order to change the reimbursement system, doctors might receive

the right to manage reimbursement funds



Turkey

Marketing Authorizations- IEGM- ICH Guidelines, CTD format- MA from other country – not accepted- NP – standard regulatory pathway- Local MAH , local QPPV


(2012est)- HE was 6.7 % of GDP in 2010, DEPC 96 €- Rx market has reached 6,54 billion Euros in 2009- Original drugs has realized as 4,1 billion US$ in 2009- 90% of the drugs consumed are manufactured

domestically- foreign companies run 80% of this manufacturing

Unauthorized Imports- Compassionate use is an order

placed at physician's initiative, with the consent of the patient;

- When equivalent is not authorized



Turkey – P & R

Pricing• Ex-factory prices of pharmaceuticals are determined by applying the

lowest ex-factory price in the reference countries - Spain, France, Italy, Greece and Portugal

• The reference price is lowest official "sale price to wholesalers", excluding discounts

• Wholesale margin 2% to 9%, depending on product price• Retail price 12 to 25%, depending price of product • Generics – max. 66% of originator refrence price • Innovative medicines- PhEc Studies for first application globaly or

lowest refrence price

Reimbursement – Social Security Institution (SSI) • The reimbursement price of a product is the registered price of the

product by the Turkish Drug and Medical Device Institution.• Application (Reimbursement Dossier) should be submited to SSI



Thank you !

Zdravko Mauko

Farmavita Regulanet d.o.o.

Okicka desni odvojak 2

10430 Samobor

Phone: +385-1-3377 058

Mail: [email protected]

Skype: zdravko.mauko

Pharma Maket Access - Southeast Europe & Turkey

Health & Medicine

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