EXTENDING THE USE OF BIOSIMILAR DRUGS:
ARE WE WILLING TO ACCEPT THE UNCERTAINTY
RELATED TO SWITCHING IN ORDER TO IMPROVE
PATIENT ACCESS TO MODERN MEDICINES?
Tomas Tesar, PharmD, PhD, MBA, MSc
Member of the Reimbursement Committee of the Slovak MoH
on behalf of Union Health Insurance Fund, Bratislava, Slovakia
Position:
Biosimilars are interchangeable with their reference
products under the supervision of a health care person.
•
Uncontrolled exchange between biologicals (whether originators or
biosimilars) must be avoided.
•
A patient must receive adequate clinical monitoring and clear
instructions.
•
New patients can be treated with a biosimilar right away.
1
In 2013, a ECCO survey showed that a minority of IBD
specialists was aware and confident about the benefits and
issues of biosimilars.
ECCO survey 2015 vs. 2013
2013
2015
Little or no confidence in using biosimilars
63%
19,5%
Interchangeability
6%
44,4%
Should carry distinct INN
66%
35%
Main concern: immunogenicity
69%
69%
• Switches between biological products are common and
usually not problematic, e.g. in the context of hospital
tendering processes.
• Risk of adverse effects can be expected to be similar to
the risk associated with changes in the manufacturing
process of any biological products.
2
Competition drives down the price
Epoetin (EPO)
Price per TD 2015/
Year before Biosimilar entrance
TOTAL MARKET
Portugal
-61%
Slovakia
-52%
Poland
-49 %
Granulocyte colonystimulating factor (G-CSF)
Price per TD 2015/
Year before Biosimilar entrance
TOTAL MARKET
Slovakia
-59%
Bulgaria
-58%
Slovenia
-50 %
Source: IMS Health: The Impact of Biosimilar Competition
Competition drives down the price
Human growth hormone
(HGH)
Price per TD 2015/
Year before Biosimilar
entrance TOTAL MARKET
Finland
-47%
Poland
-47%
Slovakia
-31 %
Anti-tumor necrosis factor
(Anti-TNF)
Price per TD 2015/
Year before Biosimilar
entrance TOTAL MARKET
Sweden
-21%
Bulgaria
-19%
Denmark
-15 %
Source: IMS Health: The Impact of Biosimilar Competition
3
Lower prices increase patient access
in countries with low initial usage
Epoetin (EPO)
Price per TD 2015/
Year before Biosimilar
entrance
Volume TD 2015/
Year before Biosimilar
entrance
Romania
-36%
460%
Bulgaria
-46%
120%
Poland
-49%
186%
Human growth
hormone (HGH)
Price per TD 2015/
Year before Biosimilar
entrance
Volume TD 2015/
Year before Biosimilar
entrance
Romania
-27%
177%
Czech Rep.
-20%
54%
Poland
-47%
78%
Source: IMS Health: The Impact of Biosimilar Competition
Lower prices increase patient access
in countries with low initial usage
Granulocyte colonystimulating factor
(G-CSF)
Price per TD 2015/
Year before Biosimilar
entrance
Volume TD 2015/
Year before Biosimilar
entrance
Romania
-48%
498%
Bulgaria
-58%
1016%
Slovakia
-59%
371%
Anti-tumor necrosis
factor (Anti-TNF)
Price per TD 2015/
Year before Biosimilar
entrance
Volume TD 2015/
Year before Biosimilar
entrance
Bulgaria
-19%
131%
Czech Rep.
-12%
53%
Slovakia
-8%
78%
Source: IMS Health: The Impact of Biosimilar Competition
4
A sustainable biosimilar market
Payers claim: “A sustainable biosimilar market is a market in which
biosimilars create financial savings without jeopardizing the current
treatment standards.”
Biosimilar manufacturers claim: “A sustainable biosimilar
market is a predictable market supporting the co-existence of
biosimilar manufacturers and a price-volume combination that
enables continuous investment in further innovation.”
Source: Simon-Kucher & Partners; Payers’ price & market access policies supporting a sustainable biosimilar
medicines market
Criteria designed to reflect how both payers and manufacturers view
the ideal sustainable biosimilar medicines market:
•
•
•
•
•
•
•
•
•
High biosimilar share
Payer guidance on biosimilars vs. originators
Fair price level for biosimilar
Commercial attractiveness
Acknowledgement of high complexity of biologics within P&MA
process
Maintaining healthy competition in the long-term
Low effort needed to monitor and enforce policy
Parallel sourcing from multiple manufacturers
Earlier and broader use of biosimilar in additional patient segments
Source: Simon-Kucher & Partners; Payers’ price & market access policies supporting a sustainable biosimilar
medicines market
5
A sustainable biosimilar medicines market is one that
provides continued benefits to all stakeholders:
•
•
•
•
increased access for patients,
more treatment options for physicians,
sustainability healthcare budgets for payers,
business opportunities for manufacturers.
IMS estimated cumulative savings in EU5 and the US
around 50 billion euros to 100 billion euros over the
next five years.
(8 key products losing exclusivity protection in 2016-2020
for price reduction between 20 and 40%)
6
Thank you for your attention
7