Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

European Turmoil 2012: A Review of Drug Prices
and Market Access Across Europe

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 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...)

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 month

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


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 Lithuania


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, 2012


Group 2: Launch sequencing strategies must
be seen as a matter of priority to optimise
prices

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


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)

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.

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
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 93



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.

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 drugs

Source: IHS from G-BA and PharmOnline International, October 2012


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



CEE: Relatively High Prices in the Czech
Republic, Low Prices in Other Countries
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 80

CEE price changes: Price Cuts Target
Innovative Drugs. Slovakia and Poland Hit
Harder
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


Greece: Hit the Hardest, Lowest Prices
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


Greece: 9% Price Cut on Average

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


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 shortages

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
FORCES


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.


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


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, clawbacks

Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

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