Michał Pilkiewicz Country Manager IMS Health Poland

Transcription

1 The Pharmaceutical Market in Poland - government regulation, pricing and reimbursement of medicines, in particular What is the influence on the market situation? Michał Pilkiewicz Country Manager IMS Health Poland

2 Agenda Pharmaceutical market in Europe and its segments in the Polish market Polish reimbursement system Role of VAT in the system 2

3 Poland in comparison with other European countries Indicators show that Poland ranks in one of the lowest places in comparison to the rest of Europe [MAT 03/2013] Indicator Position of Poland in comparison to analyzed countries Value for Poland Average from analyzed cohort Variation from the mean (for Poland) Total pharmaceutical market 6 from bn Pharmaceutical market per capita 25 from % Healthcare expenditure per capita* 22 from $ $ - 60 % Average price of innovative drug 23 from % Average price of generic drug 22 from % Patient co-payment level** 1 from % 34.4 % +32 pp Share of generic drug in sales 1 from % 43 % +26 pp Consumption of drugs per capita (Standard Units) 8 from SU SU +3.7% Source: Own calculations based on IMS MIDAS, Eurostat, OECD * Data for 2010 Y ** Data from

4 Indicators show that Poland ranks in one of the lowest places in comparison to the rest of Europe Comparison of the key indicators in MAT 03/2013 Indicator Position of Poland in comparison to analysed countries Value for Poland 1 st place in the ranking Last place in the ranking Total Pharmaceutical Market Pharmaceutical Market per Capita Healthcare Expenditure per Capita Average Price of Innovative Drug Average Price of Generic Drug 6 from bn Germany: 31.4 bn Estonia: 0.2 bn 25 from Switzerland: 525 Latvia: from $ Norway*: $ Estonia*: $ 23 from Denmark: 57.1 Poland: from Switzerland: 11.6 Bulgaria: 2.4 Patient Co-payment Level 1 from 13* 67.0 % Poland*: 67.0% Czech*: 25% Share of Generic drug in Sales Consumption of Drugs per Capita (standard units) 1 from % Poland: 69.0% Luxemburg: 22% 8 from SU Sweden: SU Croatia: 681 SU Source: Own calculations based on IMS MIDAS data, Eurostat, OECD * Data for 2010 year 4

5 Billion PLN Billion PLN Development of the retail and hospital market in Poland Up to 2012 the Polish pharma market grew at a rate of 6.1%. The hospital market is still recording positive growth. Retail market value in [bn PLN] 20 18, ,4 16, ,4 14,2 13, ,6 16,9 Hospital market value in [bn PLN] 3,5 3 2,9 2,7 2,6 2,5 2,3 3, ,5 1,7 1,8 2, CAGR : +6.1% 1 CAGR : +9.1% 0, PPG [%] PPG [%] Source: IMS Dataview 02/2013 Drugs EPhMRA A-V Retail and hospital market Ex-man prices 5

6 Billion Euro Reimbursement of drugs in Poland In 2012 NHF significantly cut the level of reimbursement for pharmacy drugs 3,0 2,5 2,0 1,5 pharmacy reimbursement drug programmes chemotheraphy ,05 0,07 0,16 0, ,33 0,16 0,26 0, New Reimb. Act 0,33 0, ,32 0,33 0,38 0,28 0,45 0, ,24 0,48 1,0 1,58 1,58 1,74 1,93 2,00 2,07 1,62 1,94 1,66 0,5 0, Financial Plan 2013 Forecast Source: NHF statements Fixed exchange rate 1 = 4.25 PLN 6

7 The introduction of the new reimbursement act in 2012 changed the Polish pharmaceutical market Reimbursement Act introduced on the 1 st of 1 January january 2012 Reimbursement Act introduced Main changes due to the introduction of new law Main changes due to the introduction of the new reimbursement act Fixed pharmacy and wholesalers Fixed pharmacy and wholesalers margins on reimbursed drugs margin Fixed prices for reimbursed drugs Fixed prices for reimbursable drugs Introduction of the Pay back system Introduction of Pay Back system Every two months a new list of reimbursed Every two months drugs is new published reimbursed by the list is Ministry published of Health by Ministry of A Health ban on all types of rebates across the Ban whole for any trade kind channel of rabates concerning through reimbursed drugs whole trade channel concerning A reimbursable ban on promotional drugs activities in pharmacies (reimbursed drugs) Ministry of Health grouped all Ministry reimbursable of Health products grouped into all Jumbo reimbursed Groups (currenlty products 311 into J.G.) Jumbo Groups 7

8 6 months The reimbursement process [part 1/2] Process Single P&R assessment and negotiations with MNF by the MoH s Economic Committee Description Single pricing and reimbursement application is filed with the Ministry of Health following EMA authorisation. Non-reimbursed products can be priced freely. Responsibility for pricing and reimbursement decisions lies with the Minister of Health, however, he/she is required to consider the recommendation of the Economic Committee Reimbursement A single positive reimbursement list was introduced in January 2012; the reimbursement list is updated every 2 months The Economic Committee makes three main recommendations regarding reimbursement: Level of reimbursement: 100% and no co-payment;100% with fixed co-pay; 75%; 50%. Any reimbursement restrictions (e.g. certain populations) Timeframe for reimbursement: 2, 3 or 5 years As part of the process, the manufacturer must provide a budget impact analysis for the National Health Fund (NFZ) Special drug programmes exist for the supply of non-reimbursed drugs on a named patient basis Single P&R assessment and negotiations with MNF by the MoH s Economic Committee Pricing The Economic Committee considers the following criteria: AOTM recommendation Max and min MSP in Poland over the previous 12 months Max and min MSP in EU and EFTA over the previous 12 months, where the product was reimbursed Information on discounts, rebates etc in EU/EFTA Cost of treatment vs alternative therapy options Budget impact for National Health Fund (NFZ) Cost threshold per QALY/life year gained max 3X GDP per capita For new drugs with at least one therapeutically equivalent alternative, MSP cannot exceed 75% of MSP of the alternative (if one product) or MSP of the reference (cheapest) drug in the same reference price reimbursement group. The MNF must sell at the agreed MSP in the retail sector. 8

9 2 months The reimbursement process [part 2/2] Process Description Final P&R decision made by the MoH The final decision is made by the Minister of Health, although it is expected that the Minister s decision will be based on the recommendation from the Economic Committee Creation/ update of the internal reference price group The creation of reference price groups is at the discretion of the Minister of Health A reference price group may be formed for products with different INNs but with similar therapeutic effect if they are reimbursed for the same indication and have similar efficacy Patented branded drugs may be included with generic products with similar therapeutic effects Possibility to approve the creation of a new group if differences in the mode of administration or the dosage form of the drug are considered to have a substantial influence on the health benefit provided or offers greater efficacy The reference prices calculated based on the wholesale selling price (WSP) of the lowest priced drug (defined at DDD) with at least 15% market share (by volume) for 3 months prior to the reference list price update Following the introduction of the first reimbursed alternative, the reference price is automatically set at the WSP of the alternative Drugs priced below the reference price are reimbursed at the actual price Approved price changes (reference or otherwise) may be made once every two months. There is no assessment of decreases. 9

10 From TOP 20 innovative drugs, 13 were reimbursed in Poland, 4-5 years after market launch TOP 20 original products sold in the EU-15. The share of the 20 TOP products in the EU-15 accounts for 24.7% of the total sales, in Poland 15.7% (by value)* Brand Launch year (EU15) On average, it takes 3-5 years to launch an innovative drug on the Polish market (following its launch on the EU-15 market). ABILIFY 2004 AVONEX 1997 CRESTOR 2002 CYMBALTA 2004 ENBREL 2000 HUMIRA 2003 KEPPRA 2000 LANTUS 2000 LIPITOR 1997 LOVENOX 1987 LUCENTIS 2006 LYRICA 2004 NOVORAPID 1999 SERETIDE 1998 SEROQUEL 1997 SINGULAIR 1997 SPIRIVA 2001 SYMBICORT 2000 TRUVADA 2005 VYTORIN 2004 On average, it takes 4-5 years to add an innovative drug to the reimbursement list (after its market launch). After how many years was it launched on the Polish market (8) products 1-2 years (10) products 3-5 years (2) products >5 years After how many years was it reimbursed (1) product 1-2 years (8) products 3-5 year (3) products >5 years (3) Products are included in drug programmes (5) Products are not reimbursed Source: IMS MIDAS & DataView * share of sales (by value) in pharmacy market, class (A-V) MAT 12/

11 23 of the TOP 30 innovative drugs are available on the hospital market TOP 30 innovative drugs on the hospital market in Europe in MAT 06/2013 Hospital market Number of available innovative drugs from the analysed cohort TOP30 innovative drug market value (hospital) Per capita spending on the TOP 30 innovative drugs Italy m 54.2 UK m 44.9 Spain m 51.2 France m 34.1 Germany m 17.9 Switzerland m 54.4 Belgium m 34.8 Austria m 31.9 Poland m 5.5 TOP 30: TRASTUZUMAB, RITUXIMAB, TENOFOVIR DISOPROXIL, INFLIXIMAB, BEVACIZUMAB, EMTRICITABINE, ADALIMUMAB, ETANERCEPT, RANIBIZUMAB, EFAVIRENZ, PEMETREXED, LENALIDOMIDE, IMATINIB, BORTEZOMIB, NATALIZUMAB, ENOXAPARIN SODIUM, CETUXIMAB, DARBEPOETIN ALFA, OCTOCOG ALFA, CASPOFUNGIN, ECULIZUMAB, LAMIVUDINE, DARUNAVIR, BOSENTAN, EPOETIN ALFA, ABACAVIR, LINEZOLID, PEGFILGRASTIM, ATAZANAVIR, EPTACOG ALFA (ACTIVATED) Source: IMS MIDAS 06/2013 & DatavieW 06/2013 Eurostat 11

12 Milllion EUR In recent years there has been a significant increase in NHF spending on chemotherapy and drug programmes NHF spending on drug programmes and chemotherapy in Reimbursement of the TOP 20 oncologic molecules Spending on drug programmes Top 20 active substances in L0 Std. chemotherapy N o class (ATC class); by value (PLN) MAT 06/ IMATINIB Yes 2 TRASTUZUMAB Yes 3 RITUXIMAB Yes 4 INTERFERON BETA-1B Yes 5 SUNITINIB Yes 6 ETANERCEPT Yes 7 INTERFERON BETA-1A Yes 8 NILOTINIB Yes 9 DASATINIB Yes 10 EVEROLIMUS Yes 11 CAPECITABINE Yes 12 BORTEZOMIB Yes 13 PEMETREXED Yes 14 DOXORUBICIN Yes 15 ADALIMUMAB Yes 16 FULVESTRANT Yes 17 LAPATINIB Yes 18 INFLIXIMAB Yes 19 GLATIRAMER ACETATE Yes 20 VINORELBINE Yes Active substance reimbursed in drug programmes in 2013 Source: NHF financial statements IMS Dataview 06/2013 Fixed exchange rate 1 = 4,25 PLN 12

13 Drug programmes in Poland 51 drug programmes are currently available for Polish patients TOP 5 drug programmes: 1. Breast cancer: m 2. Chronic myeloid leukaemia, CML: m 3. Multiple sclerosis: m 4. Hepatitis C virus, HCV: m 5. Renal cell carcinoma, RCC: 23,03 m TOTAL (all drug programmes in 2012): 444 m Examples of treated diseases: Chronic viral hepatitis B without deltaagent Cervical part of oesophagus Liver cell carcinoma Malignant neoplasm of bronchus and lung Skin of lip Malignant neoplasm of breast Malignant neoplasm of brain Multiple myeloma and malignant plasma cell neoplasm's Hypofunction and other disorders of pituitary gland Multiple sclerosis Crohn disease Source: NHF financial statements Fixed exchange rate 1 = 4,25 PLN 13

14 Milllion Eur Value Added Tax was introduced in 1993 Simulation of growth in patient expenditures in 2012 when Value Added Tax was increased by 1% 10% 8% 6% 4% 2% 0% Reimbursed drugs Non-reimbursed drugs 8% 8% 7% 7% 2% 4% 0% '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 ' Total VAT in 2012 on Rx and OTC drugs VAT 8% VAT 7% Amount of VAT (481 m ) corresponds to: - approx. 108% of the NHF annual spending on drug programmes - approx. 175% of the NHF annual spending on chemotherapy - approx. 30% of the NHF annual spending on pharmacy reimbursement Source: IMS Pharmascope 07/2013 Fixed exchange rate 1 = 4.25 PLN The simulation has taken into account: Rx and OTC drugs (A-Z) 14

15 Summary Macro and demographic factors will influence the future of the Polish pharmaceutical market and reimbursement system Economic growth implications Willingness-to-pay (NHF/patients) Demographic changes Global economic trends and GDP level will directly influence the NHF budget level in the coming years Healthcare trends in other countries will have a big impact on changes in the reimbursement system In some countries like Poland a private insurance system must be implemented in order to cover the system costs The new reform reduced the NHF budget for reimbursement in the retail sector The NHF s budget for drug programmes and chemotherapy will continue to growth Patients co-payment rose after the new reform and is very high Patients out-of-pocket expenditures are driving market growth The population will get older with fewer people paying social security contributions to the pension system Chronic disease treatment will be an additional cost for the NHF and patients Doctors behaviours will change accordingly to the patient age structure with a strong focus on generics. 60% of prescriptions will be for patients aged

16 Thank You Michał Pilkiewicz Country Manager Poland Disclaimer The analyses, their interpretation, and related information contained herein are made and provided subject to the assumptions, methodologies, caveats, and variables described in this report and are based on third party sources and data reasonably believed to be reliable. No warranty is made as to the completeness or accuracy of such third party sources or data. As with any attempt to estimate future events, the forecasts, projections, conclusions, and other information included herein are subject to certain risks and uncertainties, and are not to be considered guarantees of any particular outcome. All reproduction rights, quotations, broadcasting, publications reserved. No part of this presentation may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without the express written consent of IMS HEALTH IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries. 16