pharmaceuticals and technologies for ncds - ega perspective · european citizens generic medicines...
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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
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6
Generic and Biosimilar medicines -
Main contributor for prevention and control of NCDs
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"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
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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
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In some European
countries, patients have
less access to biological
treatments for
Rheumatoid Arthritis (RA)
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What do we expect?
Horizontal long-term strategy for sustainable generic
and biosimilar medicines industry
WHO support on harmonisation of international standards
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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
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Case studies?
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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
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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
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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