Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

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


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


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


• 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


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


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



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



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


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


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


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


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)




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.


CEE price changes: Price Cuts Target

Innovative Drugs. Slovakia and Poland Hit

Harder


9%

95%

17% 9%

5%

80%

83% 83%

100%

20%

CzechRepublic

(26)

Romania(23)

Hungary(20)

Poland (16) Slovakia(24)



2% 1%

-1%

-6%

-9%

-3%

-19%

-7%

-11%

2% 1%

CzechRepublic

Romania Hungary Poland Slovakia


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.



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.


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)



2% 1%

-1%

-6%

-9% -9%

-3%

-19%

-7%

-11% -10%

2% 1%

4%

CzechRepublic

Romania Hungary Poland Slovakia Greece


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.



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.


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


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.


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

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

Drug prices and_market_access_across_europe_webcast_european_turmoil_2012

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