ISCTM 13th Annual Scientific Meeting 21-23 February 2017 The Fairmont, Washington DC Regulatory Opportunities and Challenges in Europe: From Registries to PRIME and Return Luca Pani, M.D. CHMP, SAWP Member, European Medicine Agency, London – UK Dept. of Psychiatry and Behavioural Sciences – Univ. of Miami – USA Chief Scientific Officer – EDRA Publishing Company – Milan - IT [email protected]@Luca__Pani
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ISCTM 13th Annual Scientific Meeting21-23 February 2017
The Fairmont, Washington DC
Regulatory Opportunities and Challenges in Europe:
From Registries to PRIME and Return
Luca Pani, M.D.CHMP, SAWP Member, European Medicine Agency, London – UK
Dept. of Psychiatry and Behavioural Sciences – Univ. of Miami – USA
Chief Scientific Officer – EDRA Publishing Company – Milan - IT
The Italian Medicines Agency Strategy:A range of Managed Entry Agreements (MEAs)
Reimbursement
(without conditions)Refusal
Outcome based
MEAsMonitoring registers
AIFA notes
Therapeutic
plan
Payment by
results
Risk sharing
Oncologicals
Antidiabetics
Psoriasis
Orphans
Cardiovascular
Antireumatics
Volume
agreements
Managing uncertainty relating
to clinical benefit and cost-
effectiveness
Managing budget
impactManaging utilisation to
optimize performance
Non-Outcome based
MEAs
Cost sharing
Budget cap
44
Figure 6.3: Objectives Member States are trying to achieve through MEAs overall and at
country level
Legend: BI: Limit budget impact, CE: Address uncertainties regarding the cost-effectiveness, Use: Monitor use
in clinical practice, Access+CE: Improve patient access and cost-effectiveness. BE: Belgium, CY: Cyprus, CZ:
Czech Republic, EN: England, IT: Italy, LT: Lithuania, MT: Malta, NL: Netherlands, PT: Portugal, SE: Sweden
As shown in
Figure 6.4 the objectives countries are trying to achieve in different disease areas seem to
be distributed across different disease areas proportionally to the number of agreement in
each objective group and the number of agreement per ATC-group. The only objective
which appears to be disproportionately represented among oncological and immune-
modulating treatments is cost-effectiveness. This is not surprising as these types of drugs
30,5%
18,6% 26,0%
7,4%
15,2%
0,4% 1,8%
BI
CE
BI+Use
Use
BI+CE
CE+Use
BI+CE+Use
0
50
100
150
200
250
IT PT NL LT CZ SE EN BE CY
BI+CE+Use
CE+Use
BI+Use
BI+CE
Use
CE
BI
MEAs in EU vs. MEAs in Italy
85% of all Italian Registries are
associated with a MEA; PbRs are
the most frequently used schemes.
Managed entry agreements for pharmaceuticals: the European experience Alessandra Ferrario and Panos Kanavos
• Long-term and comparative effectiveness
• Place in therapy
• Long-term safety profile
Clinical
• Future costs
• Cost-effectiveness
• Measures of QoLEconomic
• Number of eligible patients
• Market share
• Treatment durationUtilisation
• Overall impact on healthcare budget Financial
Even if cost effectiveness
analysis did provide a
reliable way forward, there
is still a budgetary
problem to be
considered.
(Bach, N Engl J Med 2015).
MEAs allow value-based pricingnegotiations under Uncertainty
Xoxi E, Agenda item 4 - Real world evidence data collection Italian Experience on Registries, Commission expert group on "Safe and Timely Access to Medicines for Patients" (STAMP) Brussels, 10 March 2016
Specific MEA for each therapeutic indication (Bach, Jama 2014)
“when costs are essentially the same but benefit differs widely, value si not
the same” crude metric value cost / Years of life gained