European Turmoil 2012: A Review of Drug Prices and Market Access Across Europe
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Agenda
1 Methodology
2 Innovative Drugs: Market Access, Prices and Impact of P&R
Policies
3 Off-patent Drugs and their Generic Counterparts
4 Conclusions and questions
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Methodology
PharmOnline International database, a product of IHS Global Insight
Prices Provided by official Sources (Ministry of Health, National Drug Agencies, Statutory Health Insurances...)
Discounts and rebates not included
42 countries included into the database
Monthly price updates, new drugs added each month
Like-for like
comparison of
ex-factory
prices across
pharmaceutical
markets
Prices Provided
by official
sources
Retail price
(+ VAT)
Retail price
(- VAT)
Wholesale
price
Ex-factory
price
- VAT
- wholesalers’
margin
- pharmacists’
margin
Copyright © 2012 IHS Global Insight. All Rights Reserved.
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 Sweden
Copyright © 2012 IHS Global Insight. All Rights Reserved.
• 5 countries
• Germany, United Kingdom, Norway, Denmark, Netherlands
Fast Pricing Procedures
• 10 countries
• Romania, Slovenia, Luxembourg, Belgium, Spain, Austria, Sweden, France, Slovakia, Finland
Launch sequencing strategies must be seen as a matter of priority to optimise
prices
• 11 countries
• Czech Republic, Italy, Ireland, Bulgaria, Cyprus, Estonia, Latvia, Greece, Hungary, Poland, Lithuania
Countries lagging behind in terms of
innovative drug pricing
Between 14%
and 33% of
sample
available
Less than12%
of sample
available
At least 41% of
sample
available
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
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Group 1: Fast Pricing Procedure
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
• Indirect price control and International Reference Pricing (IRP) completed while drug availability is restricted to a few markets (out of the markets of reference) explain why time to pricing is faster in those countries.
• Reimbursement either automatically granted and/or assessed at a later stage
Fast Pricing Procedures
Source: IHS from PharmOnline International, 2012
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Group 2: Launch sequencing strategies must
be seen as a matter of priority to optimise
prices
Romania Slovenia
Luxembourg
Belgium Spain
Austria Sweden France
Slovakia Finland
0
5
10
15
20
25
0% 20% 40% 60% 80% 100%
Nu
mb
er
of
Inn
ova
tive
Dru
gs
A
va
ila
ble
Percentage of Innovative drugs Funded
Number of Innovative Drugs Available and Funded
• Reimbursement decisions delay market access.
• mostly positive outcomes (Austria, France, Spain and Belgium, Slovakia)
• challenging (Romania, Slovenia, Luxembourg)
Launch sequencing strategies must be seen as a matter of priority to
optimise prices
Reimbursement
secured
Reimbursement
uncertainty
Source: IHS from PharmOnline International, 2012
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Group 3: Countries lagging behind in
terms of innovative drug pricing
Drug inclusion in
reimbursement lists rare
(i.e. Hungary: no addition
since May 2012)
Country Number of Innovative
Drugs Available
Czech Republic 8
Italy 9
Ireland 7
Bulgaria 6
Cyprus 6
Estonia 2
Latvia 2
Greece 2
Hungary 1
Poland 1
Lithuania 0
Interestingly, Italy lagging
behind. Regions urged to
improve access to
innovative drugs
• Mostly CEE countries and Baltic States
• Reimbursement lists often limited Innovation rarely available to patients
Countries lagging behind in terms of
innovative drug pricing
Source: IHS from PharmOnline International, 2012
Copyright © 2012 IHS Global Insight. All Rights Reserved.
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.
Top 5 EU: Prices Still Higher in Germany
Price 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
Source: IHS from PharmOnline International, 2012
Price differences are not too
large (Prices in France are on
average 15% below prices in
Germany)
Italy: results somehow distorted
with 3 case studies where prices
are the highest
France: increasingly stringent on
innovation innovation score -
ASMR ratings from I to III
enabling to secure higher prices
- granted to 3 drugs only.
Brand
Names Germany Italy Spain
United
Kingdom France
Gilenya 100 97 86 100 94
Vpriv 100 70 81 82 74
Ozurdex 100 86 87 87 87
Revolade 100 112 92 83 89
Onbrez
Breezhaler 100 62 91 91 73
Ilaris 100 90 100 113 100
Cimzia 100 74 77 63 62
Onglyza 100 99 94 58 83
Mozobil 100 111 98 95 101
Eporatio 100 138 95 122 93
Germany Italy Spain
United
Kingdom France
Index
average 100 94 90 89 85
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Price Cuts Target Innovative Drugs. On Average,
Prices Decrease in the top 5 EU pharmaceutical
markets
Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.
-0.8% -0.2% -4%
-13%
-5%
-19%
-12%
-31%
1%
4%
Germany Italy France Spain
Average Price Changes (2011-2012), 10 innovative drugs
Average price change Average price cut
Average price increase
Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the top 5 European pharmaceutical markets
4%
74%
100%
64% 60%
31%
5% 36% 40%
65%
21%
Germany(30)
Italy (19) UnitedKingdom
(21)
France (57) Spain (21)
Price Changes (2011-2012), 10 innovative drugs
no change price cut price increase
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AMNOG Pricing Reform: Barrier to
Market Access, Towards Lower Prices
Dossier Filed:
38 drugs
27 drugs
evaluated
On-going
evaluation:
11 drugs
Reference
pricing (37%, 10
drugs)
Price negotiation
(63%, 17 drugs)
4 drugs: market
withdrawal
Effective reference
pricing: 6 drugs
Finalised price
negotiation: Brilique,
Esbriet, Zytiga
On going (14 drugs)
Source: IHS from G-BA and PharmOnline International, October 2012
Price
Cuts
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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
€0.0
€0.2
€0.4
€0.6
€0.8
€1.0
€1.2
€1.4
Germany Italy UnitedKingdom
Spain France
Brilique, 90 mg, Manufacturer price per film-coated tablet (Euro)
Source: IHS from PharmOnline International, 2012
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Source: IHS from PharmOnline International, 2012
Aside from the
Czech Republic,
prices at least
28% lower than
in Germany
CEE: Relatively High Prices in the Czech
Republic, Low Prices in Other Countries
Brand Names Germany
Czech Republic Spain France Hungary Romania Slovakia Poland
ADVAGRAF 100 57 41 54 38 41 39 34 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 80
Germany Czech Republic Spain France Hungary Romania Slovakia Poland
Index Average 100 80 75 72 72 67 65 61
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.
Copyright © 2012 IHS Global Insight. All Rights Reserved.
CEE price changes: Price Cuts Target
Innovative Drugs. Slovakia and Poland Hit
Harder
Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.
9%
95%
17% 9%
5%
80%
83% 83%
100%
20%
CzechRepublic
(26)
Romania(23)
Hungary(20)
Poland (16) Slovakia(24)
Price Changes (2011-2012), 10 innovative drugs
no change price cut price increase
2% 1%
-1%
-6%
-9%
-3%
-19%
-7%
-11%
2% 1%
CzechRepublic
Romania Hungary Poland Slovakia
Average Price Changes (2011-2012), 10 innovative drugs
Average Price Change Average Price Cut
Average Price Increase
Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the CEE pharmaceutical markets mentioned below.
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Source: IHS from PharmOnline International, 2012
Greece: Hit the Hardest, Lowest Prices
Brand Names
Czech 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
Czech
Republic Hungary Romania Slovakia Poland Greece Average ranking 100 90 84 81 75 69
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.
Copyright © 2012 IHS Global Insight. All Rights Reserved.
Greece: 9% Price Cut on Average
9%
95%
17% 9%
5%
80%
83%
96%
83%
100%
20%
4%
CzechRepublic
(26)
Romania(23)
Hungary(20)
Poland(16)
Slovakia(24)
Greece(26)
Price Changes (2011-2012), 10 innovative drugs
no change price cut price increase
2% 1%
-1%
-6%
-9% -9%
-3%
-19%
-7%
-11% -10%
2% 1%
4%
CzechRepublic
Romania Hungary Poland Slovakia Greece
Average Price Changes (2011-2012), 10 innovative drugs
Average price change Average Price Cut
Average Price Increase
Manufacturer price changes of the 10 most recently approved innovative drugs available in each of the CEE pharmaceutical markets mentioned below.
Source: IHS from PharmOnline International, 2012. Number of presentations taken into account mentioned in bracket.
Copyright © 2012 IHS Global Insight. All Rights Reserved.
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 in Greece:
€201.5
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 shortages
€100
€150
€200
€250
€300
€350
€400
Manufacturer Price Baxter Manufacturer Price Importer
Manufacturer Price Kiovig, Germany
Source: IHS from PharmOnline International, 2012.
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Generics: Methods Used to Lower
Prices and Trigger Competition
PRICE CAPPING
MARKET
FORCES
Maximum Level
of reimbursement
Market exclusivity
(lowest price)
Discounts ± +
• Fix price cut
• Minimum price cut
• Launch sequencing
price cut
IRP
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Case Study: Zolmitriptan
Patent expiry in Europe in 2012. Generics not available in all EU
countries yet.
Country
Price Cut off-
patent drug
Price Cut
Generic
Generic price
competition
France 20% 60% No
Germany Withdrawn 0%-86% Yes
Spain 40% 40% No
Italy 37% 51%-56%
Few operators
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.
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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 Drugs
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Conclusions: Stronger Restrictions on
Innovative Drugs
New Innovative Drugs
Comparison over standard of
care will increasingly be taken
into account in:
– Pricing downward trend
– Reimbursement restricted
Risk-sharing agreements could
be used in a larger number of
countries (outcome based,
finance-based)
On-Patent Innovative
Drugs
Price cuts could be triggered
once new therapeutic
alternatives enter the market
Withdrawal from the
reimbursement list , decrease
in reimbursement levels
Price cuts implemented for all
drugs on the market (but not
genericised yet)
International Reference Pricing will spread price cuts
Rebates, discounts, clawbacks
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