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How to Address Regional Market
Access Hurdles in Decentralised
European Countries
ISPOR Workshop 5
Prague, Czech Republic
Sunday, 7 November 2010
Discussion Leaders

Mondher Toumi
–

Claudio Jommi
–

PhD, MD, Professor of Decision Sciences,
University Claude Bernard Lyon 1, Lyon, France
Associate Professor, Università del Piemonte
Orientale and Pharmaceutical Observatory,
Cergas, University of Bocconi, Milano, Italy
Steven Flostrand
–
MBA, Business Development Director, CreativCeutical, Paris, France
2
Workshop Purpose
 To
review the process, evidence required,
and rationale for positive formulary listing
of new, innovative medicines at
regional/local level in decentralised EU
countries
3
Introduction: the power and influence
of regional decision-makers
Pr. Mondher Toumi
Universite Claude Bernard, Lyon I
Where is Regionalisation a
Factor in Determining Access?
5
Regionalisation is Widespread
6
Why is Regional Power Developing?
 Federal/central
government set a vision
while local/regional decide on
implementation
 Often
split short-term decision and longterm decisions
 Balance
of power and level of autonomy is
very different from one country to another
7
Balance of Power for Pharmaceuticals

Payers at a national level decide on
–
–
–

Price and reimbursement
National MAA
Recommendation
Payers at a regional level manage
–
–
–
–
Entry date
Local MAA
Prescription restrictions
Local recommendation
8
Formulary Listing and Regional
Access Remain Unaddressed
 Complex
and very atomised market
 One size does not fit all
 Rules not transparent
 Divergent requirements within the same
country
The industry has not yet succeeded in addressing
regional hurdles in a rational and systematic way as
done for national bodies
9
New Access Paradigm
 National
–
–
–
–
level
Benefit over next best alternative
Cost effectiveness
Treatment guidelines
Public-Health impact
 Regional
–
–
level
Cost containment
Local recommendation
10
Double Hurdle Reduces Market
Access
Regional
National
+/+
+/-
-/+
-/11
Market Access: Focus and
Priorities of Decision Makers
Political
National
Regional
Local
Budgetary
impact
Scientific
Budget Holder
Not Budget Holder
12
Market Access Stakeholder Opinions and
Actions Are Largely Driven by Price
Key stakeholder levels
National
Regional
Local
Hospital
Each level will be driven by price and therefore will share the same mindset:
a consistent approach will be important
There is also a continuum in terms of the level of detail that is required by the stakeholders
in each market
More technical
HAS NICE CDR
Less technical
Scotland
SMC
Canadian
provinces
13
Swedish
County
councils
Pharmaceutical
lead
Leverage at a Regional Level

Insight into regional government dynamics, decision
processes and related pharmaceutical decision bodies

Budgetary impact at the region level
–

Drug, Ambulatory, Hospital, Social services
Regional Public Health Initiatives
–
Mental Health, Breast cancer, AIDS etc.

Local Advocacy is a powerful leverage

Key opinion leaders

Local contracting
14
The Case of Italy
Claudio Jommi, MSc
Associate professor, Università Piemonte
Orientale, Novara, Italy
Director of the Pharmaceutical Observatory,
Cergas, Università Bocconi, Italy
How to address regional market access hurdles
in decentralised European countries
claudio.jommi@pharm.unipmn.it
claudio.jommi@unibocconi.it
Agenda
• Regionalisation and drug budget in the
Italian health care system
• Pharma regional policies impacting on
Market Access (MA)
• How to manage MA at the regional level
Claudio Jommi, Novara and Bocconi University
16
Overview: the role of regions in the
Italian health care system
•
Italy has a national health care system, based on a Beveridgian
structure, with 21 Regional Governments in between a Central
Government and 150 Commissioner Local Health Units + 80
Independent Hospitals
•
Regions decide the overall structure of their (regional) health care
system provided that essential level of care, defined at the central level,
is guaranteed
•
Regions are responsible for any deficit they incur on health care
expenditure. Should they incur in a deficit, they have either to cut costs
or to raise taxes
•
Drugs prices and reimbursement status (+ financial risk-sharing and
conditional price and reimbursement agreements) are decided by the
National Drugs Agency (AIFA); most of the other pharma policies are
decided by Regions
Claudio Jommi, Novara and Bocconi University
17
Overview: National (and regional) budgets
for drugs
• Budget on retail
market: 13.3% of total
health care funds;
possible deficit covered
by the industry and the
distribution (payback)
• Budget on hospital
market: 2.4% of total
health care funds;
“possible” deficit is
covered by the Regions
Source: Aifa, First semester 2010
Claudio Jommi, Novara and Bocconi University
18
Regional Pharma policies
which policies?
(Cost-sharing)
1. Distribution of drugs by hospitals to nonhospitalised patients
2. Regional formularies
3. Procurement
4. Prescribing mix
5. HTA Programmes
Claudio Jommi, Novara and Bocconi University
19
Regional Pharma policies
1. Distribution of drugs by hospitals
• Drugs included into a national list (PHT),
possibly extended by regions
– e.g. erythropoietin, interferon, blood derivate
• First therapeutic cycle after the discharge
– decided by regions
• Drugs used in specific setting (e.g. home
care)
– decided by regions
Claudio Jommi, Novara and Bocconi University
20
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b
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C
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Source: Aifa, 2010
10.8%
10.9%
12.1%
12.3%
12.4%
12.8%
13.8%
Northern and Central Regions
14.7%
15.0%
13.9%
12.5%
12.7%
13.7%
14.2%
14.7%
15.7%
16.4%
16.4%
17.2%
18.5%
18.8%
20.0%
Regional Pharma policies
1. Distribution of drugs by hospitals
Southern Regions
(% on retail public expenditure, 2009)
Claudio Jommi, Novara and Bocconi University
21
Regional Pharma policies
2. Regional formularies: where?
Bind ing regional formularies
No regional formularies
Binding sub -regional formularies
Source: Pharmaceutical Observatory, Cergas Bocconi
Claudio Jommi, Novara and Bocconi University
22
Regional Pharma policies
2. Regional formularies: what consequences?
Oncology drugs and regional formularies
Source: Aiom, Censis and Favo, 2010
Claudio Jommi, Novara and Bocconi University
23
Regional Pharma policies
2. Regional formularies: what consequences?
Oncology drugs, regional formularies and access to market
Source: Russo, P, Mennini, FS, Siviero PD et al, Annals of
Oncology, 21, 10, 19 October 2010, 2081-2087
Claudio Jommi, Novara and Bocconi University
24
Regional Pharma policies
3. Procurement policies
Regional Procurement
Procurement managed by
hospitals’ networks
Procurement managed by
hospitals
Procurement possibly
based on 4th ATC Level
Campania
Sicilia
Lazio
Lombardia
Emilia R
Puglia
Veneto
Piemonte
Toscana
Source: Aifa and Pharmaceutical Observatory, Cergas Bocconi, 2010.
The selected Regions account for 78% of total market
Claudio Jommi, Novara and Bocconi University
25
Regional Pharma policies
4. Prescriptions targets
Therapeutic reference pricing (not
possible anymore)
(PPI)
Prescription targets (volumes, mix)
(PPI, Statins, Antihypertensive drug,
SSRI, Macrolids)
Source: Pharmaceutical Observatory, Cergas Bocconi, 2010
Claudio Jommi, Novara and Bocconi University
26
Regional Pharma policies
4. Prescriptions targets
Targets recently given by AIFA
Class
Target
PPI
Off patent / Total PPI
Antihypertensive
Ace Inhibitors / (Ace Inhibitors +
Sartans)
Sartans
Off patent (Losartan)/ Total Sartans
Statins
Off patent / Total Statins
SSRI
Off patent / Total SSRI
Claudio Jommi, Novara and Bocconi University
27
Regional Pharma policies
4. Prescriptions targets (AIFA’s indicators)
Expected savings over total drugs expenditure
9.0%
8.0%
Northern and Central Regions
Southern Regions
7.0%
6.0%
Italy
5.0%
4.0%
3.0%
2.0%
1.0%
Source: Aifa, 2010
ol
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a
Sa bri
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a
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o
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ne
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s
L o ca n
m a
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i
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m
br
ia
0.0%
Claudio Jommi, Novara and Bocconi University
28
Regional Pharma policies
5. Regional HTA Programmes
HTA Programmes
Programme enforced by law
Used to take decisions
Preliminary Programmes
Source: Pharmaceutical Observatory, Cergas Bocconi, 2010
Claudio Jommi, Novara and Bocconi University
29
Regional Pharma policies
5. HTA Programme in Veneto
Horizon
Scanning
Drugs
IDAN/UVEF
Priority
Setting
Drugs
Formulary
Committee
(Commissione
PTORV)
Assessment
UVEF
Appraisal
Commissione
PTORV/UVEF
Policy
Formulary
Prescribing
Protocols
Medical devices
Medical
Devices
Committee
(CTDRM)
UVEF
CTDRM/UVEF
Procurement
CTDRM Commissione Tecnica per il Repertorio unico Regionale dei Dispositivi Medici IDAN Italian Drug
Assessment Network PTORV Prontuario Terapeutico Ospedaliero della Regione Veneto UVEF Unità di
Valutazione del Farmaco
Source: Pharmaceutical Observatory, Cergas Bocconi, 2010
Claudio Jommi, Novara and Bocconi University
30
Regional Pharma policies
5. HTA Programme in Veneto
Data Collected
UVEF Report
“Economic” Evidence
Clinical Evidence




Place in therapy
Existing guidelines
Clinical studies
Other HTA Report




Economic evaluation studies
Cost per DDD / per
therapeutic cycle
Impact on drug budget
Budget Impact Analysis
Other HTA Report
The industry is requested to give information to
perform a BIA at the Regional level
Claudio Jommi, Novara and Bocconi University
31
How to manage MA
1. Selecting most important markets
Claudio Jommi, Novara and Bocconi University
32
How to manage MA
2. Clustering Regions (1)
Regional pharmaceutical expenditure over
health care funds (2009) compared with
Italian average (17.9%): the target is 15.7%)
Health care deficit / Pharma deficit
Regional per capita health care deficit (2001 – 2008)
compared with Italian average (540 Euros, Target = 0)
0
Critical
15.7%
Most
critical
Lazio
Lombardia
Less critical
Critical
Claudio Jommi, Novara and Bocconi University
33
How to manage MA
2. Clustering Regions (2)
Retail pharma deficit / Hospital pharma deficit
Pharma hospital expenditure over
health care funds (Target = 2.4%)
Pharma retail expenditure over health care funds
(Target = 13.3%)
Most of the
Southern
Regions
7.0%
5.0%
3.0%
9.0%
10.0%
11.0%
12.0%
13.0%
14.0%
15.0%
16.0%
1.0%
Claudio Jommi, Novara and Bocconi University
34
How to manage MA
2. Clustering Regions (3)
Critical therapeutic categories
the example of antiulcer drugs
(2009, DDD/1,000/die)
Source: Aifa, 2010
Claudio Jommi, Novara and Bocconi University
35
How to manage MA
3. Supporting appropriately Regions
Advanced Regions
(eg Veneto)
• Providing data required
(regional BIA)
• Advocating for a broader
utilisation of economic
evaluation
• Stressing critical issues
deriving from cost per DDD
/ therapeutic cycle
• Participating, if possible, to
cost analysis using
regional administrative
databases
Less advanced Regions
(most of the Southern Regions)
• Providing, if possible
educational programmes
on HTA, Economic
Evaluation and BIA
• Advocating for (i) a focus
on health care spending
deficit instead of pharma
budget and (ii) a broader
utilisation of BIA
Claudio Jommi, Novara and Bocconi University
36
How to manage MA
3. Supporting appropriately Regions (2)
For all Regions
• Promoting collaboration instead of creating
conflicts between regions and hospitals and
between clinicians and other professionals
(hospital director-general and pharmacists)
• Supporting guidelines that have been issued by
independent actors to perform economic analysis
(eg the Italian Association of Health Economics
(AIES) has recently - http://www.aiesweb.it/
issued guidelines for economic evaluation
studies, addressed to regulatory authorities)
Claudio Jommi, Novara and Bocconi University
37
The Case of England
Steven Flostrand
Creativ-Ceutical
Description of PCT structures
152 Primary Care Trusts
in England
PCTs provide or buy
primary and community
services, and are
involved in
commissioning
secondary care
Responsible for ~80% of
the NHS budget
39
PCT vs. National Responsibilities
National Responsibilities
PCT Responsibilities
Licensing via the MHRA
Pricing, profit controls, via
the PPRS
Technology appraisal via
NICE
PAS negotiation via NICE
Standards of care via NSFs
Formulary decisions via
Drug & Therapeutic
Committees
Prescribing mix
PAS administration
Access rules
Procurement
Use of non-NICE reviewed
drugs
40
Case Study:
PCT Clustering in England
Our client launch a next-generation drug,
replacing its own blockbuster that had lost
patent protection
Uptake of the new drug varied
–
–
–
Despite significant efforts, sales in the UK remained very low
Sales levels were unequal across the different PCTs
Differences did not correlate to commercial effort levels
Creativ-Ceutical was retained to evaluate the
PCT landscape to determine the source of
differences, and to recommend strategies to
optimise resource allocation and growth
41
Initial Findings
Significant local barriers to drug usage were found
–
–
–
–
Limits to prescribing within drug class
Different levels of PCT interest in treating the disease
Different resources to manage the disease
Differences in PCT management with an impact on drug usage
Determining the drivers of drug usage differences required
an in-depth understanding of which PCT practice and
behaviour represent an opportunity to improve the drug
position
This required a proper typology of the PCTs, to improve
understanding of the landscape and support the strategy
to be implemented, to improve the level of positive
recommendation and use across priority PCTs
42
Available Information
A large number (>100) of
variables were available
for analysis from
company, public and
proprietary sources*
Primary Care Trust
differences across this
large range of variables
allow differentiation
A typology is possible that
allows strategic
segmentation and
targeting
POPULATION PROFILE
Age, Deprivation, Foreign-born, etc.
PRESCRIBING
Innovativeness index, Black triangle & AD
prescriptions, specific class and drug guidance, etc.
PATIENT MANAGEMENT
Medicine Management, ScriptSwitch (generic
substitution), Sophistication Index, etc.
ECONOMIC & FINANCIAL
Recurrent Baseline Allocation, Closing Distance from
Target, Draft Accounts Outturn Turnover, etc.
ORGANIZATION
Disease area as a priority, QOF ratio, disease
prevalence, etc.
43
* Health Direction OnerKey+ data, Datamonitor, IMS, public data from PCTs…
Methodology
England data analysis for 152 PCTs
For quantitative variables, a Principal
Components Analysis (PCA) was conducted
For qualitative variables, a Multiple
Classification Analysis (MCA) was conducted
Then a cluster analysis was conducted
44
Clustering Results for England
5 different PCT clusters were
identified for the 152 PCTs studied*
Cluster 1: n=20
Cluster 2: n=61
Cluster 3: n=4
Cluster 4: n=14
Cluster 5: n=53
* Cluster analysis is unique to each disease
and to the market context; results cannot be
applied elsewhere
45
Cluster Descriptions
Analysis revealed significant variation among PCTs driven by
demographic and disease incidence differences
46
Cluster Descriptions
Analysis revealed significant variation among the PCTs driven
by practice management and local initiatives
47
Cluster Descriptions
Analysis revealed significant variation among the PCTs driven
by other factors such as prescribing technology adoption
48
Cluster Summary Profiles
CLUSTER 1
CLUSTER 2
CLUSTER 3
n=20, pop=4 939 000
n=61, pop=17 499 000
N=4, pop=1 266 000
GPs are less concerned by
objectives or budget constraints,
and tend to prescribe category
drugs in a more autonomous
way
Concerned about disease area,
highest recognition of disease and
high category prescriptions.
Prescribing managed to optimize
both generic and innovative
medicines. Focused on financial
objectives and spend.
High focus on disease area but
few patients and low care;
disease poorly recognized and
treated. Doctors use innovative
medicines freely and PCTs are
significantly overspent.
CLUSTER 4
CLUSTER 5
N=14, pop=3 296 000
N=53, pop=23 868 000
Low focus on disease, low
disease recognition, lowest
prescribing of category per
patient. Concentrated on
practice management: highest
use of Scriptswitch, low use of
innovative medicines.
High level of disease recognition
and category prescriptions, but
disease not a priority. PCT focus
on cost-containment, with high
level of Scriptswitch use and
very low penetration of
49 innovative medicines
Cluster Potential Assessment
2 sources of leverage exist
–
–
Opportunities to increase the market share where
clusters are open to drug prescribing
Priorities are given by the cluster analysis
Opportunities to increase the total prescription
mass by exploiting
•
•
–
Level of disease recognition
Level of drug prescriptions per patient
Needs a specific sales analysis
50
Cluster Potential Assessment
CLUSTER 1 CLUSTER 2 CLUSTER 3 CLUSTER 4 CLUSTER 5
# PCTs
Total
population in
cluster
Level of
disease
recognition
# of Rx’s per
diagnosed
person per year
20
61
4
4 939 180 17 498 921 1 265 979
14
53
3 296 078 23 868 380
4.16%
5.62%
3.43%
4.53%
4.97%
11.36
15.01
15.69
10.52
14.47
51
Cluster Potential Assessment
“Level of disease recognition” ≠ “prevalence” but
was used as a fair proxy of disease prevalence
Number of drug category prescriptions per person
with disease per year based on ratio
Denominator ≠ number of treated patients, but also
a fair proxy
Number of drug category prescriptions
Number of patients with disease
52
Sales Development Potential per
Cluster
CLUSTER 1
CLUSTER 2
CLUSTER 3
n=20, pop=4 939 000
n=61, pop=17 499 000
N=4, pop=1 266 000
Sales increase >20%
No sales increase
Sales increase >35%
CLUSTER 4
CLUSTER 5
N=14, pop=3 296 000
N=53, pop=23 868 000
Sales increase >10%
Minor sales increase
53
Case Study Conclusions
Cluster analysis identified real opportunities for
different business approaches
–
Two attractive clusters
•
•
–
–
–
Cluster 1 by direct GP targeting
Cluster 4 by second-line formulary inclusion
Cluster 3 was identified as respondent to disease education
Cluster 2 was identified as optimised with current efforts
Cluster 5 was identified for disinvestment
Our client was able to shift resources from
cluster 5 (primarily rural) to clusters 1 and 4
(primarily urban) and select more appropriate
market access efforts
54
From PCTs to GP Consortia… Will
Clustering be More or Less Important?
Current number of PCTs = 152
–
–
PCTs will be progressively abolished by 2013
GP consortia will shadow then replace PCTs
GP consortia size will vary
–
–
First examples cover from 40,000 – 70,000 lives
RCGP and GPC recommend 500,000 lives
Range of consortia*: from 102 to… 1002?
Regardless of their number, clustering will still
be important when addressing GP consortia
* Based on population in England of 51 million
55
The Case of Sweden
258,904
256,710
Sweden –
21 Counties
130,705
249,299
280,717
280,575
294,415
267,600
256,901
411,320
273,822
1,488,709
327,266
273,537
1,803,377
177,149
57,248
236,501
1,156,070
57
150,625
Three Pricing Principles
 Human
–
Equity of all human being and integrity of every
individual
 Need
–
and solidarity principle
People in greater needs take precedence for
pharmaceutical reimbursement
 Cost
–
Value Principle
effectiveness principle
Cost of medicines should be reasonable from
medical, humanitarian, and socio economic
perspective
58
P&R Processes
 No
–
–
price negotiations
TLV accept or reject the company price offer
TLV define restrictions of use and national
contracting
 County
Councils (CC) pay for all in-patient
medicines
 CC receive a government grant to cover
out-patient medicines
59
County Council Leverage (1/2)
 CC
do not decide on prices and
reimbursement and are not allowed to
negotiate rebates
 CC only influence volumes and type of
drug used (via incentives)
 Drug and Therapeutic Committee (DTC)
–
–
–
Define first line treatment options
Develop guidelines
Send “sales representatives”
60
County Council Leverage (2/2)





Guidelines on prescription volume
Substitution policies
Restriction on contact between Industry and
Medical Doctors
Cap on reimbursement of expenditure for doctors
invited to scientific conferences (50%)
Ban on sponsoring and participation to social
activities, etc.
This is county specific and a
source of controversy
61
Comparison of the Profiles of
County Councils in Sweden
62
Conclusions and Discussion
Regional Market Access
Discussion
 How
to address heterogeneous and
atomised regional markets?
–
–
–
–
Do you know your regional segmentation?
Do you have a typology of your market?
How do you address this issue?
Role of Corporate vs. (multi-country) Region
vs. Affiliates?
64
Potential Solutions
Strategy development at an international
level: HQ or Region (EU for example)
 Create a trans-national typology of Regional
Markets
 Define 5 to 7 different access strategies that
are consistent with marketing messaging, are
actionable and sustained by the evidence
 Deploy locally and share learning across
similar regional markets

65
Thank You!
Mondher Toumi PhD, MD,
Professor of Decision Sciences
University Claude Bernard Lyon 1
Lyon, France
Email: mondher.toumi@univ-lyon1.fr
Tel: +33 6 8666 3550
66