Improving access to generic & biosimilar
medicines
in Bulgaria and in the EU
Sófia, 14th November 2013
Adrian van den Hoven
Director General
EGA – European Generic medicines Associations
1
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
2
The European Generic Medicines and Biosimilar Medicines
Association (EGA) is at the heart of Europe’s medicine
industry and is essential to EU Public Health.
1
Patients
2
Quality
3
Value
4
Sustainability
5
Partnership
The EU generic medicines industry is
highly committed to Europe’s health
Generic medicines bring savings of
54%
35€ Bn p.a.
in the EU 28
1000
More than
generic
companies directly employing
150,000
European citizens
Generic medicines account for
almost
volume
One of the
most
competitive
sectors in
Europe
21%
value
7% of turnover to R&D
exporting to more than 100
countries outside the EU
4
7 key therapy areas: 60% price decrease/ 200%
increase in number of treatment days
EVOLUTION OF EUROPEAN VOLUME WEIGHTED PRICE/TREATMENT DAY VS NUMBER OF TREATMENT DAYS
ACROSS 7 THERAPY AREAS
3.5
3
INDEX
2.5
2
1.5
1
0.5
Q2 2001
Q3 2001
Q4 2001
Q1 2002
Q2 2002
Q3 2002
Q4 2002
Q1 2003
Q2 2003
Q3 2003
Q4 2003
Q1 2004
Q2 2004
Q3 2004
Q4 2004
Q1 2005
Q2 2005
Q3 2005
Q4 2005
Q1 2006
Q2 2006
Q3 2006
Q4 2006
Q1 2007
Q2 2007
Q3 2007
Q4 2007
Q1 2008
Q2 2008
Q3 2008
Q4 2008
Q1 2009
Q2 2009
Q3 2009
Q4 2009
Q1 2010
Q2 2010
Q3 2010
Q4 2010
Q1 2011
Q2 2011
Q3 2011
Q4 2011
Q1 2012
Q2 2012
Q3 2012
Q4 2012
Q1 2013
0
VOLUME WEIGHTED PRICE/TD
NUMBER OF TREATMENT DAYS
Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators
and
© 2013,
oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012
IMS HEALTH
Generics provide increased access to
affordable medicines
EVOLUTION OF EUROPEAN NUMBER OF TREATMENT DAYS OF GENERICS VS. ORIGINAL BRANDS ACROSS 7
THERAPY AREAS
9
8
7
INDEX
6
5
4
3
2
1
Q2 2001
Q3 2001
Q4 2001
Q1 2002
Q2 2002
Q3 2002
Q4 2002
Q1 2003
Q2 2003
Q3 2003
Q4 2003
Q1 2004
Q2 2004
Q3 2004
Q4 2004
Q1 2005
Q2 2005
Q3 2005
Q4 2005
Q1 2006
Q2 2006
Q3 2006
Q4 2006
Q1 2007
Q2 2007
Q3 2007
Q4 2007
Q1 2008
Q2 2008
Q3 2008
Q4 2008
Q1 2009
Q2 2009
Q3 2009
Q4 2009
Q1 2010
Q2 2010
Q3 2010
Q4 2010
Q1 2011
Q2 2011
Q3 2011
Q4 2011
Q1 2012
Q2 2012
Q3 2012
Q4 2012
Q1 2013
0
GENERIC NO. OF TREATMENT DAYS
NON-GENERIC NO. OF TREATMENT DAYS
Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and
oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012
6
© 2013, IMS HEALTH
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
7
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 antihypertensives
Source: Euro Barometer; BMC Public Health - Internal estimate based on IMS MIDAS
8
Generic Medicines
generate savings
“(…)policies promoting the use of generic
medicines are often at the forefront in the
attempt to increase the cost-effectiveness of
medicinal products”. EC-FIN
“Policies to promote greater use of generic
medicines are likely to lower pharmaceutical
expenditure and enhance efficiency” –WHO
Report
Source: European Commission and Mrazek & Frank, 2004 in WHO - Health policy responses to the financial crisis in Europe report).
9
Lipitor generics help NHS save
£1m per day (in the UK), Pharma
Times, 15 May
The NHS saved more than £350 million in the
first 12 months after the patent expiration of
Pfizer’s Lipitor last year.
(…), now costs just £1.89 – the price tag for
Lipitor comes in at £13 for the same pack size
and dose, according to the British National
Formulary.
10
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
11
In 2010, health spending fell in Europe
for the first time since 1975
Avg. EU-27 health exp. Growth rates from 2000 to 2011, public and total
Source: OECD, 2013
12
Pharmaceutical sector cuts
Health expenditure by function of care, OECD avg., annual growth
Source: OECD, 2013
13
Disruptive change :unsustainable market
environment
Governments take shortterm cost measures
Well-intended EU legislation
complexity and cost
Pharmacovigilance
Legislation
External reference pricing
Discounts/rebates, payback
and clawback policies
Price freezes and price cuts
Retail tendering
National level
Variations
Regulation
Generic and
biosimilars
medicines
Clinical
Trials
Regulation
Availability
of medicines
Falsified
Medicines
Directive
National +EU level
14
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
15
Making the Generic medicines
market grow
Therapeutic
guidelines
Increase savings
for the Bulgarian
health system
Prescription
quotas
Increase
doctors
prescription
of Gx
Eprescription
systems
Prescription
budget
16
Making the Generic medicines
market grow
Incentives for pharmacies to dispense
generic medicines
Establish remuneration linked to the level
of achievement of a substitution goal
Remuneration scheme that incentivises the
dispensing of the lower price medicines
Increase savings for the Bulgarian Health system
17
External Reference Pricing
Not for generics
Key risks when introducing ERP:
1.
2.
3.
4.
5.
Generic medicines prices below profitability level
Artificial downward price spiral (procurement and tendering)
Price linkage – ERP is applied twice
Inability to launch generics in some markets
Divergences in updating price lists
WHO : ERP not appropriate for generics
18
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
19
European biosimilar medicines industry
needs strong support to develop
Cumulative savings for 8 EU
countries, 2007-2020: between
Emerging markets for biologic
medicines represent
€11.8 up to 33.4 b€1
Specialty drugs are forecasted to
50% of all drug expenditure
in 20182
be
Biosimilar
medicines as
a major
opportunity
for EU
$15Bn
opportunity
Biosimilar Filgrastim increased
patient access
3
by
in the UK
44%
Source: 1. IGES study – 2. Prime Therapeutics & University of Minnesota College of Pharmacy, poster presented at AMCP San
Diego April 4 - 3: UK Filgrastim Volume (in Std. Units) increased by 44% between 2009 and 2012
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Adoption of biosimilars has increased access and
generated savings in the major EU countries
Estimates put annual savings in excess of €120 million in these countries
Total 10 countries
443M $
Fast uptake at launch, now mature
Consistent uptake
Cultural resistance but change undergoing
Fast growing due to market trends
Biosimilar replaced
originator supply
Source: IMS MIDAS, MAT 03/2013
Generic medicines and biosimilars generating savings beyond the medicines bill
21 © 2013, IMS HEALTH
MAT 03/2013
Future biosimilars offer more saving among newer
therapies: anti-TNF and Mabs
Top Biologic Therapy Area, Europe Sales
(MAT 12/2012)
Growth Hormones, 2,0%
Others, 15,9%
An - TNF, 15,2%
An neoplas c (Mabs),
13,4%
Cytosta c Hormones, 2,4%
Metabolic prods, 2,5%
(It includes old generation
insulins which are unlikely
to be targeted by
biosimilar players)
Immunoglobulins, 3,1%
Other Immunosuppr., 3,2%
Ocular
An neovascularisa on
Products, 3,3%
Insulins, 9,4%
g- CSF, 4,3%
Heparins, 6,2%
Vaccines, 4,4%
Interferons, 4,8%
EPO, 4,6%
Source: IMS MIDAS, Mar 2013
Generic medicines and biosimilars generating savings beyond the medicines bill
22 © 2013, IMS HEALTH
Blood Coagula on, 5,2%
Existing
EU approved
Biosimilars and the way ahead
Information for doctors : Clear, unbiased information on the
scientific concept of biosimilars, approval process, safety and
efficacy
Member States: Guidelines to incentivize physicians to prescribe
biosimilars; reimbursement rules for biosimilars uptake
Reimbursement: remove hurdles or delays to pricing and
reimbursement approval to increase savings and patient access
Advanced Manufacturing Rule: allow European based industry to
compete early in emerging markets; Bulgaria 10 % of EU
manufacturing
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
24
Europe is the global hub for high-quality
generic and biosimilar medicines
European countries with
generic medicines R&D and
manufacturing*
European countries with
generic medicines
manufacturing*
European Countries with
manufacturing sites of EU
approved biosimilars**
Source: *EGA Internal survey - **EMA
25
Industrial Policy
Emerging market opportunities
Source: IMS Health 2011
Emerging markets : 18% to 28% of the global medicines market from
2010- 2015
26
Market Loss of EU
Generic and Biosimilar
Medicines Industry
Date of international
competition
20 year patent
+ Up to 5 year SPC
Period of market loss
to EU companies
Executive summary
Patient access to high-quality medicines
The healthcare environment
Supporting the Generic medicines market
Savings through the use of Biosimilar medicines
Boosting Manufacturing
Conclusion
28
Stronger collaboration is needed to foster
industry and to compete at global level
Generate savings
Generic and
biosmilars
Medicines
Industry
EU and Member
States
authorities
Increase patient access
Jobs and Growth
29
Conclusion
Medicines provide huge value to patients and
healthcare systems
Stability of pricing for generic and biosimilar
medicines is needed
Well thought out regulations that achieve patient
safety and reduce complexity are key
It is time to support the generic
and biosimilar medicines industries
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благодаря
Adrian@egagenerics.com
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