Download 1. National market access 2. Market access

Market Access in Europe
Some EU overviews and England as a
worked example
Christian Hill and Mark Harries
MAP BioPharma
[email protected]
[email protected]
[email protected]
© MAP BioPharma Limited 2015
Why are there differences
amongst Member States?
Differential pricing in EU
© Can Stock Photo Inc. / RTimages
Differences across the EU make Market Access efforts
complicated, but are possible with effective coordination
Drug Lists
HTA requirements (formal like NICE or as part of contract)
Contracting Arrangements
Country
Germany
France
UK
Italy
Spain
Austria
Belgium
Czech Republic
Denmark
Finland
Greece
Hungary
Ireland
Netherlands
Norway
Poland
Portugal
Sweden
Switzerland
Positive
Negative
Price-volume
No
Yes
No
Yes
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
Yes
Yes
No
No
No
Yes
Yes
Yes
No
Yes
NA
No
No
Yes
No
Possible
Yes
Possible
Yes
Possible
NA
NA
No
Possible
NA
Yes
Preferred
Possible
Possible
Possible
Yes
Yes
Possible
Possible
Outcomes based
schemes
Possible
Yes
Possible
Preferred
NA
NA
NA
NA
NA
NA
NA
Possible
Possible
Possible
NA
NA
Possible
NA
Possible
Risk
Sharing
Possible
Possible
Yes
Yes
NA
NA
NA
NA
NA
NA
NA
Possible
Possible
Possible
NA
Yes
Possible
NA
Possible
Clinical Effectiveness,
Safety and Budget
Impact
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
ICER (cost /
QALY)
No
No
Yes
No
Yes
No
No
Yes
NA
NA
NA
Yes
Yes
Yes
NA
Yes
Yes
Yes
No
Cost
Minimisation
Analysis
Rarely
Possible
Rarely
Possible
Yes
Possible
Rarely
Possible
NA
NA
NA
Possible
Possible
Possible
NA
Possibly
Yes
Possible
No
Health
Economic
Simulation
Rarely
Emerging
Yes
Rarely
Yes
Yes
No
Yes
NA
NA
NA
Possible
Yes
Yes
NA
Yes
Yes
Yes
No
Differences across the EU
•
Medicine prices differ across EU due to factors which are
often beyond control of companies:
–
•
•
Price setting by authorities – national, not EU competence,
National health and pharma policies and priorities, Wholesale /
pharmacy margins, VAT rates, Pack sizes and distribution
channels, Exchange rate fluctuations
Member States compare and sometimes reference their
prices to other countries prices. Such comparisons must be
performed with great caution to avoid unanticipated impact
IRP – choice of country basket should take differences
between Member States into account:
–
Purchasing power, GDP per capita; Germany recently decided to
include the Czech Republic, Slovakia and Greece in the country
basket…The German price is again referenced by 19 other
Member States*
*P. Kanavos et al for European Parliament, ENVI „Differences in costs of and access to pharmaceutical products in EU”, 2011, p.80
Price Differences between Member States:
Reasons and Importance
•
Nationally dependent variables mean that prices are not directly comparable among Member States
–
–
•
•
•
•
•
wholesale / pharmacy margins, VAT rates, different pack sizes, distribution channels, exchange rate fluctuations, terms
of payment, national price-setting process/outcome by payors governments
All of which render any direct comparison inappropriate.
Prices are the result of complex evaluation/negotiation processes established by national rules
It is essential that the decision-making process for setting the price is objective and transparent which
underlines the importance of the Transparency Directive
A study by Kanavos et al (2011)1 – price differences largely due to the differences in national priorities
(even countries with equivalent income), pharmaceutical policies and market regulation
Example of successful differential pricing – vaccines have a differential pricing structure with reasonable
market prices in high income countries, low prices in Global Alliance for Vaccines and Immunisations
(GAVI) and intermediate prices in middle-income countries2
Danzon and Towse (2003)3 stress that differential pricing allows broader access for patients to innovative
products in a sustainable way while promoting innovation
1 P. Kanavos et al for European Parliament, ENVI „Differences in costs of and access to pharmaceutical products in EU”, 2011, available at
http://www.europarl.europa.eu/document/activities/cont/201201/20120130ATT36575/20120130ATT36575EN.pdf.
2 P. Yadav, “Differential Pricing for Pharmaceuticals, Review of current knowledge, new findings and ideas for action”,
A study conducted for the U.K. Department for International Development (DFID), August 2010, p.28.
3 P.M. Danzon and A Towse (2003), „Differential Pricing for Pharmaceuticals: Reconciling Access, R&D, and Patents" International Journal of Health Care Finance and Economics, 3: 183-205, 2003
Implications of IRP
•
IRP – acts as a barrier to price adaptation based on a country’s
economic situation
•
IRP mechanically leads to a stronger price convergence
•
Some practices of cross-border reference pricing can also contribute to
a heavy distortion of prices especially in times of financial crisis e.g.
Greece!
•
This is especially the case in countries where the price is set based on
the lowest price in the country basket rather than on the average price
in the country basket.
•
Some practices of IRP may spill-over onto other countries and
decrease the global incentives to innovate
•
Companies may also consider the impact of launching a product in one
country on the revenues of the other country
Trends and the Future
•
Austerity is increasingly leading to restrictive pricing policy
–
•
Transparency directive
–
–
•
•
•
These countries should be excluded from country baskets as those prices /
rebates are set under exceptional circumstances, may be temporary and
should not be exported to other countries
Official list prices are already made public by Member States
The directive is aimed at guaranteeing transparent procedures and payor
decisions for pharmaceutical companies, not final prices
Ultimately, when IRP policy is aggressive, it directly impacts profitability
of product launch
Such developments impact the revenues of pharmaceutical companies
but also act as a delay to patient access to innovative treatments. The
ESMT White Paper (p.17) finds that fewer projects are developed in lowmargin therapeutic areas
It is essential to balance the impact of lower prices with the costs
associated with less innovation and with fewer products being launched1
1H.
Friederiszick, N. Tosini, F. de Véricourt, S. Wakeman, ESMT White Paper, „An Economic Assessment of the Relationship between Price Regulation and Incentives to Innovate in the
Pharmaceutical Industry, 2010, available at http://www.esmt.org/en/271562
Price level index for pharmaceutical products in 2005, EU25=100
Source: European Commission Directorate-General for Economic and Financial Affairs (DGECFIN); Costcontainment policies in public pharmaceutical spending in the EU By Giuseppe Carone et al 2012
Simulated savings due to a price convergence of countries with
above EU level prices to EU level prices
Source: European Commission Directorate-General for Economic and Financial Affairs (DGECFIN); Costcontainment policies in public pharmaceutical spending in the EU By Giuseppe Carone et al 2012
Germany – an example of free pricing at launch but a challenging
process overall
•
Germany is the largest EU state by population, the largest EU economy and accordingly the most important market for pharmaceuticals
within the European Union. For a long time manufacturers were effectively free to determine the reimbursement price of patented
drugs in the German health care system. In recent years, however, pricing and reimbursement in Germany has changed significantly. In
January 2011 a new system was introduced to determine the reimbursement prices of new active substances entering the German
market. This new system, known as the “AMNOG-System” foresees a 2-step procedure which new medicines have to undergo as soon
as they enter the German market.
•
The AMNOG-System is a quite recent concept (est. 2011) and is considered to be a “learning system” by the German legislator and the
administrative bodies involved. Also, in some parts the legal framework governing the system is not very dense and leaves room for
interpretation. Accordingly, many aspects are still being shaped and substantiated by court decisions, law decrees and, most of all, the
administrative practice of the authorities involved. This website has been designed to support you when navigating the system to
prepare the successful launch of innovative pharmaceuticals in Germany.
•
In 2012-2014, G-BA assessed 99 new technologies and decided 48% of products had no additional benefit, 25% had minor additional
benefit, 18% had considerable additional benefit and the remainder had unquantifiable additional benefit. No technologies have been
classified as having major additional benefit.
•
A high proportion of G-BA decisions have been of no or unquantifiable benefit indicating that obtaining a high price in Germany is
challenging
The UK
A more detailed review
Topics
1. An alternative guide to the NHS
2. It’s not as bad as you think though
3. Financial background to medicines in UK
4. NICE consultations, long grass and the doughnut
5. Rare diseases, HST and Chinese whispers
© MAP BioPharma Limited 2014
Alternative guide to the NHS
http://www.kingsfund.org.uk/projects
/nhs-65/alternative-guide-new-nhsengland
It’s not as bad as you think:
Compare us to the US
http://kevinbrady.house.gov/uploade
dfiles/obamacarechart.pdf
PPRS context (pricing agreed on behalf of all UK nations)
Total medicines expenditure / growth
Figure 13. Elements driving the change in total medicines expenditure
(£ million): Baseline scenario
16,000
2,444
15,592
15,500
15,000
168
629
£m per annum
14,500
13,581
558
14,000
-353
13,500
13,000
-1,435
12,500
12,000
11,500
2011
Start and end
Substitution
Biosimilars
Overall underlying growth
Source: Authors’ estimates
Future launches
Generic entrants
LoE products
2015
Projecting Expenditure on Medicines in the
NHS ; Phill O’Neilla, Jorge Mestre-Ferrandiza,
Ruth Puig-Peirob and Jon Sussexa ; OHE
Research Paper 13/02 April 2013
Each of the three other nations in the UK has a slight variation on the English
model which impacts on market access
Although funded centrally from national taxation, NHS services in England, Northern Ireland, Scotland
and Wales are managed separately
Northern Ireland:
• Funded by the NI Executive through its
Health Department
• The Health and Social Care Board (HSCB)
manage funding, commission services, and
work with the HSC trusts
• The 6 HSC trusts are responsible for
management of services at a local &
regional level
Southern Ireland:
• The Health Service Executive (HSE),
responsible for provision of healthcare
in Ireland, follows guidance from the
National Centre for
Pharmacoeconomics (NCPE)
Wales:
• Managed through 7 local health boards
(LHBs), each deliver NHS services for local
area
• Wales follow NICE and AWMSG guidance
Scotland:
• Managed through 14 health
boards
• GPs and pharmacy are
contracted through health
board but work in community
health partnerships based on
local authority boundaries
• Guidance from SMC and SIGN
• MTA Guidance from NICE
English NHS Organisation – an enormous organisation
© MAP BioPharma Limited 2014
There are two broad stages to successful market access in England
1. National market access
2. Market access commercialisation
Launch
Phase II/III
Key desired outcomes
Positive NICE (HTA*)
and associated national
implementation
incentives
* HTA = Health Technology Assessment
Local action
plan to adopt
new product
Desired rate
of
commercial
uptake
Stage 1
National market access begins pre-phase III and continues after launch
Go/ no go
decision
Before start of phase III
or -4 years launch
On start of
phase III or -3
years launch
Go/ no go
decision
-6 months
launch
Key desired outcome: positive NICE HTA and associated
national implementation incentives
Post-launch,
pre-NICE &
post-NICE
Launch +3
months
Launch +12-18
months
Outcomes/ milestones:
1.
2.
Ensure appropriate
endpoints for EMEA and 3.
HTA included in Phase III
4.
Selection for NICE
appraisal
Flagged for NICE
guidelines
On radar of national
service development
makers
On radar of national
clinical opinion leaders
Patient Access
Scheme (PAS) price
approved
Favourable position in
regional HTA guidance
Favourable position in
NICE HTA
Favourable position in NICE
guidelines, quality standards,
and incentives e.g. Quality
Outcomes Framework (QOF),
commissioning for Quality &
Innovation (CQUIN) &
National Clinical Guidelines
Stage 1
…with a range of decision makers and influencers requiring a
joined-up approach across the UK operating company…
Before start of phase III
or -4 years launch
Ensure appropriate
endpoints for EMEA
and HTA included in
Phase III
NICE
Decision makers
&
influencers:
Typical activities
should include:
• Global ad
boards
1.
2.
3.
4.
On start of
phase III or -3
years launch
Selection for NICE appraisal
Flagged for NICE guidelines
On radar of national service
development makers
On radar of national clinical
opinion leaders
-6 months
launch
Patient Access Scheme
(PAS) price approved
NICE
PharmaScan
National Horizon
Scanning Centre
(NHSC)
Department of
health (DoH)
Patient Access
Scheme Liaison
Unit (PASLU)
• Input data into
PharmaScan etc.
• Ad board to
understand reallife NHS
affordability/
positioning
• Meetings with
NHSC
• 1:1 national
advocacy
development
• Direct contact
with DoH,
PASLU
• Negotiating
price with
Global
Post-launch,
pre-NICE & postNICE
Launch +3
months
Favourable position in regional
HTA guidance
Favourable position in NICE
HTA
PenTAG,
GMMMG, Keele,
UKMi etc.
Academic
pharmacists,
KOLs
NICE
Academics
decision support
units, patient
groups, KOLs,
Royal Colleges
• Direct contact with
organisations
• Write submissions
(9-12 months)
• Bespoke
submissions
• 1:1s and meetings
to create bespoke
messages for all
stakeholder groups
Launch +12-18
months
Favourable position in NICE
guidelines, quality standards, and
incentives e.g. Quality Outcomes
Framework (QOF), commissioning for
Quality & Innovation (CQUIN) &
National Clinical Guidelines
NICE
Co-opted KOLs
National KOLs
• Co-ordinating
processes &
feedback with
commissioners
• National advocacy
development
Stage 2
Focussed multi-disciplinary market access commercialisation is then
essential to drive the desired rate of product uptake
Go/ no go
decision
-6 months – 2 years to launch during
NHS annual planning cycle deadlines
Milestones:
Local NHS planning cycle has new
product on radar and associated impact
on budget service configuration planning
and local priorities
Key outcome: desired rate of commercial uptake
0-90 days + 3 months
post NICE
Local action plan agreed on how
product is to be developed
For each planning cycle
Decision makers
& influencers:
Local CCG/ CSU
PharmaScan, national horizon
scanning & regional HTA
groups, local clinical KOLs
• Continue to input data into
PharmaScan etc.
Typical activities:
• Continue direct contact with
regional HTA
• Stakeholder mapping &
prioritisation of local
accounts
• 1:1 activity with MM & lead
commissioners using ABN
6-36 months post
launch
Implementation and monitoring
support
Review in light of each new competitor
Local CCG/ CSU
NICE & regional HTA groups,
local clinical KOLs
• Face to face activity from hybrid
clinical/ payer role
• Tools to help payers identify local
cost implications e.g. BIM
• Tools to support formulary
inclusion (which will be
mandated)
• Payer educational materials on
key concepts for evaluating
• Proactive support and
facilitation of creating costed
pathways, business cases &
service re-design
Local CCG/ CSU & clinical team
as agreed in local plan
• On going clinical/ payer field
role face-to-face with MDT
• Support on monitoring
progress, real world data,
case studies, learning sets
• Educational support
• Joint working and
partnership working
The roadmap for new medicines in NHS England may not always be obvious –
specialised medicines for example have a range of routes to reimbursement
NICE Highly
Specialized
Technologies
(HST)
Programme
Commissioning
Policy
© Can Stock Photo Inc. / RTimages
NICE Single
Technology
Appraisal
(STA)
Cancer
Drugs Fund
(CDF)
Individual
Funding
Requests (IFRs)
Commissioning
Through
Evaluation
Strategically there are many things to be considered as to which direction
you may or may not want to go
What do NICE do?
NICE - Explaining what was meant to change in 2014
•
•
•
Proposed addition of burden of illness and wider societal impact
These value elements are described as ‘modifiers’
NICE Appraisal Committees use these modifiers to help decide whether to recommend a
technology with an incremental cost effectiveness ratio above £20,000 per QALY
UK example of a changing environment: Wider societal
impact now kicked into the long grass
Current UK evaluation
requirements:
•
NHS and personal
social services (PSS)
perspective
•
No societal costs
included
•
All societal benefits
included (e.g. carer
disutility)
The Netherlands evaluation
requirements
•
Societal perspective
•
Some societal costs:
patient productivity
losses and unpaid
carer costs
•
All societal benefits
included (e.g. carer
disutility)
Sweden evaluation
requirements:
•
Societal perspective
•
All societal costs:
patient productivity
losses and
consumption; unpaid
carer costs
•
All societal benefits
included (e.g. carer
disutility)
VBA UK evaluation
requirements:
•
Societal perspective
•
Weightings based on
BoI
•
Wider societal impact
based on patient ability
to engage with society
Adapted from a slide provided courtesy of FIECON Ltd
NHS England Consultation – Issued 27 January 2015
90 day consultation period
£14bn
In prioritising treatments and interventions for the future
financial year, NHS England will observe the following sequence
• First Order
– NICE TA and HST
– Estimated budget impact for NICE approvals in 2015/16 = £270m
• Second Order
– NHS Constitution delivery requirements which affect specialised
services e.g. 18-week wait
• Third Order
– Developments to support national service strategies e.g. increase
access to transplantation
• Fourth Order
The Cancer Drugs Fund
– All other specialised services developments
currently remains
outside
Five stages have for treatments and interventions that might
typically be commissioned
5.
Governance
1.
Scanning
3.
Building the
clinical case
4.
Impact
analysis and
consultation
2.
Planning
NHS England. Consultation Guide Investing in Specialised Services. 27 January, 2015
https://www.engage.england.nhs.uk/consultation/investing-in-specialised-commissioning/supporting_documents/invspecservconslt.pdf
Five stages have for treatments and interventions that might typically be
commissioned
• Coordinated at a Clinical Reference Group level
– There are two published outputs from this stage
• The list of potential clinical policies that are identified as ‘Not being
routinely commissioned’
• The list of potential service specifications for commissioning
1.
Scanning
Five stages have for treatments and interventions that might typically be
commissioned
• Where the National Programmes of Care, who coordinate the
work of the CRGs into strategic groupings such as cancer,
consider the proposals and select the ones that most fit the
programme’s strategic priorities
• This will create an Annual Work Programme
2.
Planning
Five stages have for treatments and interventions that might typically be
commissioned
• Building the clinical case: where the Clinical Reference Group
works with stakeholders, including patients and the public, to
define the clinical proposal
• An independent review of clinical evidence will usually be
commissioned
• Finally, a Clinical Appraisal Panel will form a view whether a
clinical case is made
3.
Building the
clinical case
Five stages have for treatments and interventions that might typically be
commissioned
• Where NHS England will develop, using the defined clinical criteria,
a service impact analysis and hence a financial impact analysis
• This will result in a final policy or service specification that can be
considered for commissioning
• The scale and duration of consultation will then be defined
• Suite of 6 documents
1.
2.
3.
4.
5.
6.
Provisional service specification
Activity projection report
Service impact analysis report
Finance impact analysis report
Draft specification
Engagement report
4.
Impact
analysis and
consultation
Five stages have for treatments and interventions that might typically be
commissioned
• Where the Clinical Priorities Advisory Group assures the Board
that the process has been completed and recommends a
priority order of commissioning
• The NHS England Board approves the prioritisation
• Commissioning against the priorities will be overseen by the
Specialised Commissioning Committee
5.
Governance
NHS England latest draft of the specialised commissioning
information pack – our concerns
• Equity
– 'NHS England will not confer higher priority to a treatment or intervention
solely on the basis it is the only one available.’
– This seems to be disenfranchising patient groups that currently have ‘no hope’
– Seems inconsistent with the DH’s own 'innovation health and wealth’ strategy
• Timeframe and backlog
– NHS England has openly struggled with the backlog of proposed
commissioning policies and service developments
– We welcome the transparent way that the process is laid out
– But framework should not be paralysing
NHS England latest draft of the specialised commissioning
information pack – our concerns
• NICE collaboration
– The CRG accountable commissioner will be expected to confirm that there is
no planned or in progress NICE appraisal
– Little evidence of consistency between the NICE appraisal process and that of
the NHS specialised services review process
– Companies left with the need to plan for both, due to lack of predictability of
the system
• Appeal
– 'The decision itself cannot be appealed.’ and 'A challenge that the correct
process has not been followed should be made in letter to the Director of
Specialised Commissioning.’
– Not clear how such a challenge would be handled and suggests that only a
‘Judicial Review’ style of appeal would be an option?
In conclusion
• Challenging – companies slowing down their access efforts to ‘test’
markets first
• Unpredictable – companies looking to other markets first
• Most important things are:
1.
2.
3.
Comparators choosing the wrong one or PBO as comparator can
lead to perception of no or little benefit
Clinical outcomes in terms of some surrogates vs. validated or
mortality measures – are outcomes meaningful?
Price – it’s not the most important thing, but it becomes increasingly
important without 1 and 2
Thanks to MAP BioPharma for
source material
Christian Hill and Mark Harries
MAP BioPharma
[email protected]
[email protected]
© MAP BioPharma Limited 2014