The presentation summarises recent changes implemented or being discussed in pricing and reimbursement/HTA systems in France, Germany and the UK. In Germany and France, the emphasis of the recent reforms is centred around the evidence requirements and, in particular, the use of comparator and head-to-head trials. In the UK, however, VBP is about the weighting given to the evidence and the social value of a drug. Overall, emphasis is increasing on 'proving' innovation and/or an additional health benefit as a precondition for a price higher than competitors.

1. Mechanisms for Setting
Medicines Prices
New Trends in Europe ‒ Changes in France,
Germany and the UK
Jorge Mestre-Ferrandiz
Nuevos procedimientos de fijación de precios y financión
de medicamentos tras el RDL 16/2012
Cambrios en el sistema de fijación de Precios
Madrid, 13 December 2013

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3. Conference Agenda
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4. Agenda
Recent and on-going changes in:
• France
• Germany
• UK
Common themes
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5. France
• Current reforms being implemented in France are
part of an on-going discussion around
pharmaceutical regulation, prompted by what has
been termed the “Mediator scandal”
• Focuses on improving pharmacovigilance and
pharmaceutical regulation
• But also new requirements around comparators
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6. France – Comparators
• New regulations also include a decree changing the
comparator requirement for new medicines
introduced to the French market – this can be viewed
as part of an on-going trend in France
• Manufacturers are required to provide evidence demonstrating that
the new drug has an additional benefit against an active comparator
as well as placebo
• The Transparency Committee is becoming stricter in its application of
the SMR and ASMR criteria
• Some uncertainties still exist around how comparator
requirements will be implemented in practice
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7. France – Ratings
• Long history of SMR/ASMR rating
• Determines copayments (SMR) and pricing (ASMR)
• SMR: absolute medical value
• ASMR: relative medical value
• Possibility of integrating the SMR/ASMR rating into
one index (relative therapeutic index: Index
Thérapeutique Relatif, ITR)
• Future role of economic evaluations – methods
guideline published in October 2012
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8. Germany
• AMNOG represents a paradigm shift in the way new
drugs launched in Germany are assessed and priced
• Came into effect on 1 January 2011
• The main difference pre- and post-AMNOG is the
lack of free pricing
• After nearly two years of AMNOG, some tweaks to
the system – see later
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9. Germany – AMNOG Process
Source: Gerber et al. 2011
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10. AMNOG – Timelines
1. The manufacturer submits a comprehensive value dossier to the decision-making body, the
Federal Joint Committee (GBA) – focusing on clinical / health gain and added value
2. The GBA, the IQWiG (or another commissioned third party) has three months to determine
the additional clinical benefit of the new drug relative to appropriate therapeutic
alternatives (Early Benefit Assessment)
3. The manufacturer then can comment on the review in a hearing process. GBA analyses the
hearing comments received and, after another three months, passes a resolution as to
whether or not the new drug has an additional benefit
4. If a drug is categorised as having “no additional benefit”, it is priced according to similar
drugs in the same therapeutic reference group
5. If the drug provides an additional benefit, the GBA (or the IQWiG) assesses the extent of
additional benefit proven, by patient group. The size of the additional benefit is categorised
on a six point scale (a “major” improvement corresponds to a score of 1 while a “smaller
benefit” corresponds to a score of 6)
6. The manufacturer and the National Association of the Statutory Health Insurance Funds
(GKV-SV) then negotiate a reimbursement price
7. If no agreement is reached, an arbitration board has three months to determine a price
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11. AMNOG – Key Issues (1)
Comparator definition
• The definition of the appropriate comparator is based on
very formal requirements that sponsors cannot negotiate
with the GBA
• In most circumstances, if the comparator used does not
correspond to the one selected by IQWiG/GBA, the drug
will be deemed as having no added value and be
reimbursed at the reference price. This has been one of
the most important reasons for market withdrawals.
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12. AMNOG – Key Issues (2)
• Process is transparent
• Some greater pragmatism from the decision body
• Assessments can be mechanistic and formulaic
• Price transparency to be implemented soon
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13. UK – VBP (1)
Value based pricing (VBP) is the pricing scheme that will replace the current
Pharmaceutical Price Regulation Scheme (PPRS) in the UK from 1 January
2014
• Decisions about what principles will be applied and how has not yet been decided
• The Government will set a cost-effectiveness threshold structure that applies weights to
the benefits provided by new medicines that determine the “value” of a new drug
VBP operationalisation might imply:
• Identifying the health gain and other attributes of the technology that are deemed to be
of value
• A means of measuring and valuing those attributes for each particular medicine
• A way of aggregating the relevant benefits and costs
• A decision rule to convert the overall measure of value into a maximum price the health
care system would be willing to pay
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14. UK – VBP (2)
The Government has established which attributes of a medicine it believes
deliver value to society:
• Improving health across the NHS
• Tackling diseases with the greater “burden of illness” (BoI)
• Demonstrating greater therapeutic innovation and improvements (TII)
compared with other products
• Demonstrating wider societal benefits (WSBs)
The criteria to measure the value of each element will be decided by the
Government:
• The value provided by health gains most probably still will be measured by
QALYs
• BoI might be weighted by the severity of the disease
• TII might reflect different dimensions, e.g. unmet need, rarity
• WSBs might include the savings in the indirect costs of care borne by patients
and their caregivers
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15. UK – VBP (3)
How and who will determine the appropriate value based price
of a new drug based its cost-effectiveness ratio still is unknown
Other aspects of VBP that potentially could provide important
opportunities or pose significant challenges for industry are:
• Stability of the new system
• Transparency and confidentiality of price negotiations
• Speed of assessment
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16. UK – VBP (4)
• Joint DH/ABPI statement (3 August
2012) ‒ number of points and principles
that need to be taken into account in
the new arrangements
• Examples:
• Our joint aim is to achieve a negotiated
agreement for the new arrangements,
including value based pricing
• The Government and ABPI are
committed to strengthening the UK
environment for life sciences
• …ensure stability and predictability in
the framework for pricing of existing
branded medicines…aiming for an
agreement that will operate for five
years
• …important that there is a common
branded medicines pricing policy across
the UK
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17. Common Themes
• In Germany and France, the emphasis of the recent reforms is
centred around the evidence requirements and, in particular,
the use of comparators and head-to-head trials
• In the UK, however, VBP is about the weighting given to the
evidence and the social value of a drug
• Overall, increasing emphasis is being placed on proving
innovation and/or an additional health benefit in order to get
a high(er) price (relative to comparators)
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18. To enquire about additional information and analyses, please
contact Dr. Jorge Mestre-Ferrandiz at jmestre-ferrandiz@ohe.org
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