Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

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The slides from the IHS Healthcare and Pharma webcast held on 15 November, 2012 titled European Turmoil 2012: A Review of Drug Prices and Market Access Across Europe

Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

  1. 1. European Turmoil 2012: A Review of Drug Prices and Market Access Across Europe
  2. 2. Agenda 1 Methodology Innovative Drugs: Market Access, Prices and Impact of P&R 2 Policies 3 Off-patent Drugs and their Generic Counterparts 4 Conclusions and questionsCopyright © 2012 IHS Global Insight. All Rights Reserved.
  3. 3. Methodology  PharmOnline International database, a product of IHS Global Insight  Prices Provided by official Sources (Ministry of Health, National Drug Agencies, Statutory Health Insurances...) Prices Provided by official - wholesalers’ sources margin Like-for like comparison of Retail price Retail price Wholesale Ex-factory ex-factory (+ VAT) (- VAT) price price prices across pharmaceutical markets - VAT - pharmacists’ margin  Discounts and rebates not included  42 countries included into the database  Monthly price updates, new drugs added each monthCopyright © 2012 IHS Global Insight. All Rights Reserved.
  4. 4. Market Access  Methodology: price availability of 70 innovative drugs approved by the European Medicines Agency (EMA) between January 2011 and July 2012 was checked  Geographical scope: 26 EU countries + Norway Austria Denmark Greece lithuania Romania United Kingdom Belgium Estonia Hungary Luxembourg Slovakia Bulgaria Finland Ireland Netherlands Slovenia Cyprus France Italy Norway Spain Czech Republic Germany Latvia Poland SwedenCopyright © 2012 IHS Global Insight. All Rights Reserved.
  5. 5. Fast Pricing Procedures in a Limited Number of Countries, Where Reimbursement is Not Always Secured Market Access: availability of 70 innovative drugs approved by EMA At least 41% of • 5 countries Fast Pricing sample • Germany, United Kingdom, Norway, Denmark, Procedures Netherlands available Launch sequencing Between 14% strategies must be • 10 countries and 33% of • Romania, Slovenia, Luxembourg, Belgium, seen as a matter of Spain, Austria, Sweden, France, Slovakia, sample priority to optimise Finland available prices Less than12% Countries lagging • 11 countries of sample behind in terms of • Czech Republic, Italy, Ireland, Bulgaria, Cyprus, available innovative drug Estonia, Latvia, Greece, Hungary, Poland, pricing LithuaniaCopyright © 2012 IHS Global Insight. All Rights Reserved.
  6. 6. Group 1: Fast Pricing Procedure • Indirect price control and International Reference Pricing (IRP) completed while drug availability is restricted to a few markets (out of Fast Pricing the markets of reference) explain why time to pricing is faster in those Procedures countries. • Reimbursement either automatically granted and/or assessed at a later stage Reasons Fast time to market Estimated time to market Country Average time to market (in month) Germany 2.42 Denmark 3.09 United Kingdom 4.33 Norway 5.21 Average 3.76 Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  7. 7. Group 2: Launch sequencing strategies mustbe seen as a matter of priority to optimiseprices Launch sequencing • Reimbursement decisions delay market access. strategies must be seen • mostly positive outcomes (Austria, France, Spain and as a matter of priority to Belgium, Slovakia) optimise prices • challenging (Romania, Slovenia, Luxembourg) Number of Innovative Drugs Available and Funded 25 Number of Innovative Drugs Romania Slovenia 20 Luxembourg Reimbursement Belgium Spain Available 15 uncertainty Austria Sweden France 10 Slovakia Finland 5 Reimbursement secured 0 0% 20% 40% 60% 80% 100% Percentage of Innovative drugs Funded Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  8. 8. Group 3: Countries lagging behind in terms of innovative drug pricing Countries lagging • Mostly CEE countries and Baltic States behind in terms of • Reimbursement lists often limited  Innovation rarely innovative drug pricing available to patients Country Number of Innovative Drugs Available Czech Republic 8 Italy 9  Interestingly, Italy lagging Ireland 7 behind. Regions urged to Bulgaria 6 improve access to Cyprus 6 innovative drugs Estonia 2 Latvia 2 Greece 2  Drug inclusion in Hungary 1 reimbursement lists rare Poland 1 (i.e. Hungary: no addition Lithuania 0 since May 2012) Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  9. 9. Quick Time to Market with Secured Reimbursement Limited to a Few Countries In most countries, reimbursement for innovative drugs is commonly granted. However, their availability is limited. Italy: few innovative drugs available / reimbursement granted to half of them only.Copyright © 2012 IHS Global Insight. All Rights Reserved.
  10. 10. Top 5 EU: Prices Still Higher in GermanyPrice Differences Not too Large Manufacturer price comparison (Price Index) of the 10 most recently approved innovative drugs available in each of the top 5 European pharmaceutical markets United Germany Italy Spain France Kingdom  Price differences are not too Index large (Prices in France are on 100 94 90 89 85 average average 15% below prices in Germany) Brand United Germany Italy Spain France  Italy: results somehow distorted Names Kingdom Gilenya 100 97 86 100 94 with 3 case studies where prices Vpriv 100 70 81 82 74 are the highest Ozurdex 100 86 87 87 87  France: increasingly stringent on Revolade 100 112 92 83 89 innovation  innovation score - Onbrez ASMR ratings from I to III 100 62 91 91 73 Breezhaler enabling to secure higher prices Ilaris 100 90 100 113 100 - granted to 3 drugs only. Cimzia 100 74 77 63 62 Onglyza 100 99 94 58 83 Mozobil 100 111 98 95 101 Eporatio 100 138 95 122 93Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  11. 11. Price Cuts Target Innovative Drugs. On Average, Prices Decrease in the top 5 EU pharmaceutical markets Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the top 5 European pharmaceutical markets Price Changes (2011-2012), 10 Average Price Changes (2011-2012), innovative drugs 10 innovative drugs 21% 4% 36% 40% 1% 5% 65% Germany Italy France Spain -0.8% -5% -0.2% -4% 100% 74% -12% -13% 64% 60% 31% -19% 4% Germany Italy (19) United France (57) Spain (21) (30) Kingdom -31% (21) Average price change Average price cut no change price cut price increase Average price increase Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.Copyright © 2012 IHS Global Insight. All Rights Reserved.
  12. 12. AMNOG Pricing Reform: Barrier to Market Access, Towards Lower Prices Finalised price negotiation: Brilique, Esbriet, Zytiga Price negotiation (63%, 17 drugs) On going (14 drugs) 27 drugs evaluated Price 4 drugs: market Cuts withdrawal Dossier Filed: 38 drugs Reference pricing (37%, 10 drugs) Effective reference On-going pricing: 6 drugs evaluation: 11 drugsSource: IHS from G-BA and PharmOnline International, October 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  13. 13. Case Study Brilique: Highest Price in Germany Despite Price Negotiation with the GKV  Brilique’s price recently negotiated in Germany. The outcome was positive for Astra Zeneca (3% price cut)  Brilique now available in the top 5 EU pharmaceutical markets Brilique, 90 mg, Manufacturer price per film-coated tablet (Euro) €1.4 €1.2 €1.0 €0.8 €0.6 €0.4 €0.2 €0.0 Germany Italy United Spain France Kingdom Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  14. 14. CEE: Relatively High Prices in the CzechRepublic, Low Prices in Other Countries Manufacturer price comparison (Price Index) of the 10 most recently approved innovative drugs available in each of the following CEE pharmaceutical markets: Czech Republic, Hungary, Slovakia, Romania and Poland. Germany, Spain and France used as benchmark. Czech Germany Republic Spain France Hungary Romania Slovakia Poland Index Average 100 80 75 72 72 67 65 61  Aside from the Czech Republic, Brand Czech prices at least Names Germany Republic Spain France Hungary Romania Slovakia Poland 28% lower than ADVAGRAF 100 57 41 54 38 41 39 34 in Germany HEPSERA 100 90 77 86 81 72 72 78 BARACLUDE 100 73 63 48 122 57 60 60 DUOTRAV 100 92 92 92 68 85 73 63 AVASTIN 100 96 94 81 82 83 80 89 APIDRA 100 74 68 61 56 57 57 55 ALIMTA 100 69 62 61 58 58 55 44 FASLODEX 100 102 101 82 91 87 90 78 ABILIFY 100 39 56 49 31 40 38 29 EMEND 100 105 98 102 91 86 86 80Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  15. 15. CEE price changes: Price Cuts TargetInnovative Drugs. Slovakia and Poland HitHarder Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the CEE pharmaceutical markets mentioned below. Price Changes (2011-2012), 10 Average Price Changes (2011-2012), innovative drugs 10 innovative drugs 5% 2% 2% 1% 1% 20% Czech Romania Hungary -1% Poland Slovakia Republic -3% 83% 83% -6% 100% -7% 95% -9% 80% -11% 9% 17% 9% -19% Czech Romania Hungary Poland (16) Slovakia Republic (23) (20) (24) (26) Average Price Change Average Price Cut no change price cut price increase Average Price Increase Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.Copyright © 2012 IHS Global Insight. All Rights Reserved.
  16. 16. Greece: Hit the Hardest, Lowest Prices Manufacturer price comparison (Price Index) of the 10 most recently approved innovative drugs available in Greece and each of the following CEE pharmaceutical markets: Czech Republic, Hungary, Slovakia, Romania and Poland. Czech Republic Hungary Romania Slovakia Poland Greece Average ranking 100 90 84 81 75 69 Brand Czech Names Republic Hungary Romania Slovakia Poland Greece ADVAGRAF 100 67 72 68 60 52 HEPSERA 100 91 80 80 86 65 BARACLUDE 100 168 79 82 83 66 DUOTRAV 100 74 93 80 69 53 AVASTIN 100 85 86 83 92 70 APIDRA 100 75 77 77 74 66 ALIMTA 100 83 84 79 64 61 FASLODEX 100 89 85 88 76 76 ABILIFY 100 79 102 96 73 98 EMEND 100 87 82 82 76 79 Source: IHS from PharmOnline International, 2012Copyright © 2012 IHS Global Insight. All Rights Reserved.
  17. 17. Greece: 9% Price Cut on Average Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the CEE pharmaceutical markets mentioned below. Average Price Changes (2011-2012), Price Changes (2011-2012), 10 10 innovative drugs innovative drugs 5% 4% 2% 1% 4% 20% 2% 1% 83% 83% Czech Romania Hungary -1% Poland Slovakia Greece 100% Republic -3% 95% 96% 80% -6% -7% -9% -9% -10% -11% 9% 17% 9% Czech Romania Hungary Poland Slovakia Greece -19% Republic (23) (20) (16) (24) (26) (26) Average price change Average Price Cut Average Price Increase no change price cut price increase Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.Copyright © 2012 IHS Global Insight. All Rights Reserved.
  18. 18. Low prices in CEE countries and Greece Trigger Drug Shortages Drug shortages reported in countries where prices are low: Greece, Slovakia, Hungary, Romania and the Czech Republic. – Kiovig in Shortage in Greece. Exported to Germany at a lower price Manufacturer Price Kiovig, Germany €400 €350 Manufacturer €300 price in Greece: €250 €201.5 €200 €150 €100 Manufacturer Price Baxter Manufacturer Price Importer Source: IHS from PharmOnline International, 2012.  International Reference Pricing Review in an attempt to increase price and prevent export (possible change in Slovakia)  Towards legislation to control parallel export, notably in case of drug shortagesCopyright © 2012 IHS Global Insight. All Rights Reserved.
  19. 19. Generics: Methods Used to Lower Prices and Trigger Competition • Fix price cut • Minimum price cut PRICE CAPPING • Launch sequencing Maximum Level price cut of reimbursement ± + Discounts IRP Market exclusivity (lowest price) MARKET FORCESCopyright © 2012 IHS Global Insight. All Rights Reserved.
  20. 20. Case Study: Zolmitriptan Patent expiry in Europe in 2012. Generics not available in all EU countries yet. Price Cut off- Price Cut Generic price Country patent drug Generic competition France 20% 60% No Germany Withdrawn 0%-86% Yes Spain 40% 40% No Few operators Italy 37% 51%-56% on the market UK 0% 0%-80% Yes Austria 0% 48% 1 operator only Sweden 0% 14%-77% Yes Netherlands 30%-40% 0-97% Yes Source: IHS from PharmOnline International, 2012.Copyright © 2012 IHS Global Insight. All Rights Reserved.
  21. 21. Conclusions  Increasing number of drugs coming off-patent. Savings generated will enable governments to fund new innovative drugs.  Nevertheless, P&R procedures will increasingly be challenging. Stronger restrictions on Innovative DrugsCopyright © 2012 IHS Global Insight. All Rights Reserved.
  22. 22. Conclusions: Stronger Restrictions on Innovative Drugs New Innovative Drugs On-Patent Innovative Drugs  Comparison over standard of  Price cuts could be triggered care will increasingly be taken once new therapeutic into account in: alternatives enter the market – Pricing  downward trend  Withdrawal from the – Reimbursement  restricted reimbursement list , decrease  Risk-sharing agreements could in reimbursement levels be used in a larger number of  Price cuts implemented for all countries (outcome based, drugs on the market (but not finance-based) genericised yet) International Reference Pricing will spread price cuts Rebates, discounts, clawbacksCopyright © 2012 IHS Global Insight. All Rights Reserved.

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