Pharmaceuticals and technologies for NCDs -

EGA perspective

Pieter Dylst, PhD - Health Economics Officer

Geneva, 17 June 2015

EGA Vision 2020

2

To provide sustainable access to high quality

medicines for all European patients

EGA Vision 2020

3

Generic Medicines – A Cornerstone of

Healthcare Sustainability

4

Every year generic medicines

bring in savings over

€40 BN to the EU

More than

350 manufacturing sites

employing over

160,000 European citizens

Generic medicines account for

55% 21% of dispensed of pharmaceutical

medicines expenditure

7% of turnover to R&D

exporting to more than 100 countries outside the EU

One of the

Most

Competitive

Sectors in

Europe

Biosimilar medicines – Key facts

5

6

Generic and Biosimilar medicines -

Main contributor for prevention and control of NCDs

7

"Developing a rare, orphan or specialty therapy is

increasingly preferred given the easier hurdles in term of

development and regulations"

"Yet 80% of Healthcare spending is due to

long-term chronic diseases affecting million"

"The majority of approved drugs are now orphan or

specialty drugs affecting smaller populations"

Source: Zerhouni E (Sanofi - 2015 ) – Presented at EMA 20th Anniversary

Generic medicines are taking increased share in all markets

8 Source: IMS Health

Generic medicines –

Prevention through appropriate early use

9

Relative DOT sales before patent

expiry vs. Population weighted

average of 18 countries

DOT volume increase in

+/- 3-year period

DOT volume increase in

+/- 2-year period

DOT volume increase in

+/- 1-year period

Spain

138.4%

1% -2% -2%

Germany 1% 1% 2%

UK 8% -4% -12%

France 10% 8% 5%

Belgium 12% 13% 18%

Sweden

46.0%

29% 18% 7%

Norway 31% 27% 14%

Finland 47% 31% 14%

Netherlands 51% 41% 29%

Lithuania 78% 46% 53%

Latvia 96% 51% 17%

Denmark 100% 68% 37%

Hungary

27.8%

120% 101% 67%

Italy 192% 114% 37%

Estonia 357% 211% 108%

Romania 450% 300% 179%

Slovakia 487% 316% 177%

Czech Republic 646% 520% 363%

Source: Kaló, Vámossi, Harsány (2014). Investment aspects of generic drug policies in countries with severe resource constraints. Poster presented at ISPOR Annual European Congress in Amsterdam

Clopidogrel days of treatment volume increase before and after generic entry

10

Biosimilar Filgrastim : 83% volume, 44%

increase in patient access

Source: IMS MIDAS 2013

Biosimilar filgrastim: 30% more patient

access to “gold standard” earlier in

Europe

Biosimilar medicines - Increasing patient access

Biosimilar medicines – Opportunity to meet unmet medical needs

11

In some European

countries, patients have

less access to biological

treatments for

Rheumatoid Arthritis (RA)

12

What do we expect?

Horizontal long-term strategy for sustainable generic

and biosimilar medicines industry

WHO support on harmonisation of international standards

13

Continued support of the worldwide establishment of

appropriate standards for biosimilar medicines

Appropriate and rigorous pharmacovigilance systems for

biosimilar medicines in the world (like in EU)

Support and monitoring of correct enforcement of GMP

guidelines

Enhanced collaboration of GMP inspections between

countries

Sustainable environment for generics and biosimilars industry

14

Increase stability of pricing for generic and biosimilar

medicines

Establish framework to allow off-patent competition

Efficient regulatory framework reducing complexity

without undermining high quality of assessment

Remove barriers for market entry and provide incentives

where necessary

15

Case studies?

16

Thank you!

17

Back-up slides

Generic medicines will represent a larger share of the market

in volume and value terms

18 Source: IMS Health

Generic medicines - Increasing patient access

19 Source: IMS Health

Generic medicines enhance access to medicines, reducing

inequality, directly leading to improved patient outcomes

20

Hypertension patients

treated in Europe Projection for EU28, 2013

Prevalence: total hypertension 40% of

population aged above 15 years;

19% - treated hypertension

Total number of treated patients:

82 million

Patients treated by generic medicine:

48 million

Generic share: 59%

ATC classes: C2 anti-hypertensive

Source: Euro Barometer; BMC Public Health - Internal

estimate based on IMS MIDAS

Diabetes patients

treated in Europe Projection for EU28, 2013

Prevalence: 8.5%, adult population aged

above 15 years

Total number of treated patients:

36 million

Patients treated by generic medicine:

20 million

Generic share: 54%

ATC classes: A10 drugs used in diabetes

Source: International Diabetes Federation (IDF), Diabetes

Atlas; European Community Health Indicators (ECHI)

Internal estimate based on IMS MIDAS

Authorities are taking a short-term approach

to cost-containment measures

21

External Reference

Pricing

Internal Reference

Pricing

Discount/ Rebates

Payback and Clawback Policies

Price Cuts/ Freezes

Retail Tendering

Short-term

cost

measures

National level

At the same time, the regulatory burden is increasing…

with complexity and cost

22

National + EU level Pharmaco-vigilance

Legislation

Medicines in the

environment

Falsified Medicines Directive

Clinical Trials

Regulation

Variations Regulation

Generic &

biosimilar

medicines