Transcript presentation

Greece: Action Plan on Pricing and Reimbursement
of Pharmaceuticals
LSE Health, London School of Economics
Athens, 28 August 2013
Outline
1. Background and process
2. Action Plan Overall Objectives
3. Action Plan Key Highlights
4. Action Plan Objectives and Activities
• Establishing a National Drug Policy
• Pricing policy
• Reimbursement rules and criteria
• Prescribing & rational use
• Dispensing
• Cost sharing
5. Proposed Timelines (to be discussed)
2
1. Background and Process
• How did we get to this point - A personal trajectory
– Assessment mission, P&R cttee – observer (December 2012)
– Reviewer of assessment mission report on behalf of WHO-EURO (April 2013)
– Task Force for Greece contact (May 2013)
– Action Plan for P&R of pharmaceuticals on behalf of TFGR (end-May 2013)
– Meeting with institutional stakeholders (MoH, EOF, EOPYY), as part of special P&R
cttee, to discuss problems of current system and obtain buy-in for specific actions
(11 June 2013)
– Preparation of draft Action Plan (1 June – 25 August, 2013) and informal
consultations
3
2. Action Plan Overall Objectives
•
•
•
•
•
•
•
Strong institutions (significant element of urgency)
Quality of care responsive to population needs
Retain the benefit of universal access (availability and affordability)
Obtain value for money and ensure efficiency (cost-effectiveness)
Maximise health gain (outcomes) with reliance on best practice
Provide incentives for preventive health care
Connectivity between institutions and actions/components (e.g. supply
and demand)
• Credibility, to be achieved through
–
–
–
–
Robustness in evaluation
Simplicity
Stability
Predictability
• Financial and fiscal sustainability (take into account constraints)
• Industrial policy
• Monitoring and evaluation
4
3. Action Plan Key Highlights – Bird’s eye view
1. Institutional strengthening and/or establishment of strong
institutions with clear remit, roles and responsibilities, ToRs,
tasks and background support
1.
2.
Pricing of pharmaceutical products (EOF)
Reimbursement of and coverage decisions for pharmaceutical products (EOPYY)
2. Inter-connectivity across and within institutions and functions
1.
2.
Between competent authorities (e.g. EOF & EOPYY)
Within functions (e.g. link supply- with demand-side)
3. Comprehensiveness and linkages as part of national drug policy
1.
Price-setting, reimbursement, prescribing, dispensing, cost-sharing
4. Increased reliance on and inclusion of modern tools (for the
Greek setting) and techniques to achieve objectives
1.
2.
3.
Clinical guidelines and protocols
Price-volume agreements, HTA, risk-sharing
Negotiation skills (potentially)
5. Capacity-building/training to strengthen and improve skills in a
variety of new tools
5
4. Action Plan Objectives and Activities
6
4.1. A National Pharmaceutical Policy
7
A National Drug Policy - Why is it
needed?
• to present a formal record of values, aspirations,
aims, decisions and medium- to long-term
government commitments;
• to define the national goals and objectives for the
pharmaceutical sector, and set priorities;
• to identify the strategies needed to meet those
objectives, and identify the various actors
responsible for implementing the main
components of the policy;
• to create a forum for national discussions on
these issues.
Objectives of a National Drug Policy
• The general objectives of a national drug policy are
to ensure:
• Access: equitable availability and affordability of
essential drugs
• Quality: the quality, safety and efficacy of all
medicines
• Rational use: the promotion of therapeutically
sound and cost-effective use of drugs by health
professionals and consumers.
• Other national objectives and metrics: As needed
for the Greek context
4.2. Pricing policy
10
Pricing policy – Governnance and Process
Interests/Options
•Pricing committee – Strong
Governance
–
–
–
–
–
Who has responsibility? (EOF)
Who participates?
How many?
What stakeholders are represented?
What are its terms of reference?
•
•
•
Pricing
Re-pricing & Updates
Price (and volume) database
Actions needed
(a)Technical Assistance
•Help establish a functioning Pricing
Cttee with appropriate staff levels and
competences and an appropriately
staffed secretariat to perform
necessary tasks related to pricing of
pharmaceutical products, maintain and
update data and databases, and link
above tasks with regulatory process
– What skills mix is needed?
•Pricing cttee – Process
– What are the documents mnfs need to
submit? Cross-validation
– How long does the validation process
last for? Compliance with EU directives
– What data sources does it use?
Ensure validity
– What are its outputs and how are they
11
reported? IT connectivity
•(b) Legislation
•Establish its function in legislation
along with ToRs, data sources,
governance and processes, staff
competences, remit and include in
EOF organogram
Pricing & price setting policy – Overall guiding principles
Objectives
•
•
•
•
•
•
•
•
•
Fairness
Transparency (with IT connectivity)
Robust process (disputed by certain stakeholders)
Availability (no shortages)
Affordability and cost to payer and society
Administrative simplicity
Timeliness (publication of price lists)
Stability
Predictability
12
Pricing policy – Branded, originator, in-patent products
Interests/Options
Actions needed
(a) Technical Assistance
• External price referencing
– Objectives
•
•
•
•
•
Fairness, effectiveness, transparency,
simplicity, access, stability predictability
Staff levels and competences
Overall admin capacity
Pricing data and databases
Define purpose in relation to
reimbursement
• Other operational criteria of
EPR: frequency of updates,
avoidance of launch delays, etc
– Remit:
•
Price setting + monitoring + re-pricing
– Coverage
•
New drugs, including orphans, possibly
biosimilars
– Operational responsibility: EOF
– Purpose (determines other
parameters)
•
To guide (NOT set) reimbursement
– Operational requirements
•
staff levels & competences
– Basket (several options):
•
(b) Legislation
Euro only, possibly minus Cyprus/Malta?
Other currencies esp. if fixed pegs?
• May Need re-calibration of ERP
to be enshrined into legislation
13
Pricing policy – Branded, originator, in-patent products
Interests/Options
Actions needed
(a) Technical Assistance
• External price referencing
– List price limitations/cannot capture
•
•
•
•
• Define characteristics of EPR
system
• Define purpose in relation to
reimbursement
• Build awareness on list price
limitations
Confidential agreements in most countries
Applicable to expensive products
An increasing number of expensive/orphans
>>> These need to be addressed at
reimbursement level
– Average of 3 lowest? Lowest?
– Three country rule for pricing?
– Frequency of updates?
•
•
•
What is the purpose?
Implications for stability and predictability
Fusing need for reasonable price with some
implicit industrial policy, e.g. Twice annually
for first 2 years post-launch, annually
thereafter
• Consider other pricing options over
the longer-term?
– HTA
14
Pricing policy – Branded, originator patent-expired
products and generic products
Interests/Options
Actions needed
(a) Technical Assistance
• Continue with External Price
Referencing at least over the
•
medium-term, incl. biosimilars
•
• Reduction of originator brand price
to generic level (-50%)?
– Through patent expiry
•
•
How to identify correct patent?
– Through data exclusivity
•
Legal issues if DE expiry before patent expiry?
– Access issues
– Shortages
•
•
How are biosimilars to be treated?
How to treat patent-expired
originator brands from a pricing
perspective?
If patent expiry is a criterion then
manufacturers need to submit data
related to their patent expiry
Data exclusivity expiry needs to be
explored from a legal perspective
(b) Legislation
How many generics for -50% to take effect?
– Strength of generic competition postpatent expiry
• Biosimilars
• Other aspects related to
generics
• Pricing model for generic
medicines
– Will managed competition work?
15
Pricing policy – OTC medicines
Interests/Options
Actions needed
(a) Technical Assistance
•Clear definition of an ‘OTC product’
that falls outside the jurisdiction of
reimbursement?
•Can OTC products be reimbursed if
prescribed?
•Establish an OTC-switch framework
•Pricing options
–
–
–
–
EPR rules
Market prices
Principles that control excessive profits
Availability of OTCs;
• Competence on OTC products
that clearly defines OTCs and
separates them from
reimbursement by EOPYY
• Establish criteria for the
reimbursement of select
products that are classified as
OTCs; OTC switch
• Pricing, availability
• What OTCs to include in + list?
(b) Legislation
16
• Need OTC policy in national
legislation or amendments to
existing policy?
4.3. Reimbursement rules and criteria
17
Reimbursement policy – Governance
Interests/Options
Actions needed
•Positive List and Reimbursement (a) Technical Assistance
committee – Governance
•
•What people?
•What stakeholders to be represented
–
MoH, EPYY, EOF,
pharmacologist/pharmacist, medical
practitioner, health economist, patient
representative
•
•What ToRs
•What skills
•Where is it based and who has oversight
•Who is it accountable to
•Establish functioning appeals process
•
Appropriate governance structure
with clear accountability and
reporting criteria; backup support &
secretariat
Relevant sub-committees
(Negotiations [in future]; Appeals,
etc)
incorporation into EOPYY
organogram
(b) Legislation
•
18
Introduce legislation on this;
ringfence competence on
reimbursement to the relevant
competent authority
Reimbursement policy – Processes
Interests/Options
Actions needed
•Positive List and Reimbursement (a) Technical Assistance
Committee – Processes
•
Appropriate processes with clear
accountability and reporting criteria
•What documents does the list cttee need
to consider putting a drug on the list?
(b) Legislation
•What are the appraisal criteria?
• Introduce legislation on this
•Do decisions made by the List cttee need
to come out in a FEK? (delays)
•Are there clear criteria assigning drugs to
ATC4 and ATC5?
19
Reimbursement – Drug Lists
Interests/Options
•
Rationale for having several subreimbursement lists?
–
–
–
–
–
•
• TA in + list re-structuring?
Cost to insurer or to patient?
Reimbursement status?
Utilisation restriction(s)?
Setting restrictions?
Other?
(b) Legislation
•
Interest in simplifying current system
into a single positive list for all
reimbursed products?
–
–
–
–
•
Actions needed
(a) Technical Assistance
•
All products irrespective of price level or patent
status
All products irrespective of whether they are used
OP or IP
Uniform reimbursement policy for all insurees;
determine cost-sharing
Exclusion criteria from paying co-payments
ATC4 and ATC5 classification: re-visit
if further clarity needed
20
Legislation or procedure on
inclusion and exclusion in the
different lists
Competencies of Committees and
MoH
Reimbursement – Criteria for admission into + list
Actions needed
(a) Technical Assistance
Interests/Options
•
•
Clearly set reimbursement policy that
is simple to understand by insurees
and relies on universal principles by
the payer as well as being
administratively simple
Criteria for inclusion of new products
–
–
–
–
–
–
–
–
–
–
•
•
Clinical as a proxy to define value
Economic (price, cost effectiveness)?
Fiscal (budget impact)
Industrial policy?
Utilisation restrictions and patient eligibility
based on sub-populations? (sub-indication)
Positive reimbursement decisions
elsewhere?
Risk sharing? (MEAs)
Volume? (P/Q deals)
Overall budget cap? (define clawback)
Other (depending on each case)
•
Best evidence, practice and
capacity defining patient eligibility
and sub-populations
Best evidence, practice and
capacity on P/Q deals and risk
sharing
Best evidence, practice and
capacity on utilisation restrictions
(b) Legislation
-
-
21
Legislation or procedure on
inclusion and exclusion in the
different lists
Competencies of Committees and
MoH esp. re: the above
Reimbursement – Clinical benefit, value assessment and
HTA
Interests/Options
•
Value assessment
–
–
–
–
•
Actions needed?
(a)Technical Assistance
Criteria: safety, efficacy, quality;
Effectiveness? (registries)
Efficiency?  Cost-effectiveness
Other? BoD, severity
•Capacity building on HTA and
budget impact
•Set up (a) HTA function w/in
EOPYY or (b) HTA agency at arms’
length
•Generating evidence on
effectiveness
Clinical benefit/HTA and budget
impact
– How will this be implemented in
practice?
– Who will be in charge of this ?
– How will information from other
countries be used ?
– Integrated procedure or arms length ?
– Selection criteria: all drugs, drugs with
high clinical need, expensive drugs?
– Budget impact: how will this be done ?
– Monitoring ? Implementation?
– Patient registries
– Phase IV trials/studies
(b) Legislative interventions
•Legislation or procedure on inclusion of
HTA or the drug’s clinical benefit in the
reimbursement process
•Competencies and responsibilities
22
Reimbursement policy – Reimbursement price
Interests/Options
Actions needed?
(a) Technical Assistance
• Differentiation between patentprotected, patent-expired and
generic drugs
• Internal reference pricing at ATC4
and ATC5
• Develop competence on
negotiation skills and on other
pricing mechanisms (e.g. pricevolume agreements, risk
sharing, CED, OG)
– Functioning well?
• Fixed price (internal reference
pricing)
–
–
–
Groups/categories (ATC4-ATC5)
Multiple indications, or several substances
Reimbursement price calculation
-
Who is responsible for negotiating ?
What will be used in the negotiation process
?
What defines a good outcome for EOPYY?
(b) Legislation
• Legislation and procedure of
reimbursement price setting
• Non-fixed price (price negotiations)
• Empowerment of negotiators
- Procedure, on what basis
-
23
Reimbursement policy – tendering
Interests/Options
•Price observatory and lack of process;
governance? Not continuoulsy updated or
correctly updated. Tender prices available
– may need to be a closed database
•May want to explore tendering for outpatient drugs under conditions
–Patent expired
–Criteria? Price? Volume? Ability to supply?
–Who is the winner? Lowest price only or 2/3
lowest?
Actions needed
(a) Technical Assistance
•
(b) Legislation
•
•For in-patient drugs
–National?
–Regional?
–Hospital-based?
–Monitoring performance?
24
Capacity to evaluate options in
tendering, their implementation and
performance assessment
Framework for tenders in outpatient drugs
Reimbursement policy – risk sharing
Interests/Options
Actions needed
(a) Technical Assistance
• Dealing with risk and uncertainty:
risk sharing and MEAs?
•
• For some drugs in ATC5
• Pre-conditions: ability to have a
functioning reimbursement list cttee
that can evaluate value of new
drugs based on certain criteria
•
• Outcomes based MEA
– CED
– OG
– DM
Increase capacity on a sustainable
basis on the various options
available to conduct risk-sharing
negotiations, their advantages and
disadvantages and the way they
could apply in the Greek setting
Skills of negotiators & other capacitybuilding
(b) Legislation
•
• Budget based MEA
– P/Q
– Price cap
– Dose cap
•
25
Legal framework needed to introduce
these in the list of criteria for
coverage decisions
Legal framework needed to empower
team of negotiators to negotiate on
behalf of the state/EOPYY
Reimbursement policy – Co-payments
•
•
•
•
Interests/Options
Actions needed
Clear definition of which
(a) Technical Assistance
disease areas go in each co- • Establish reimbursement criteria
applicable to all drugs and copayment level, and on what
payments for all insurees
criteria?
• Consider exemption criteria
Differential co-payments?
• Capacity-building
Increase in the burden to the (b) Legislation
patient seen since
• Re-think cost-sharing policy
November 2012, how can
this be further avoided ?
Negative list: 100% copayment, unless exemption
– clear definition on exemption to be
added with co-payment
26
4.4. Prescribing and rational use
27
Physician responsibility
Options
• Need to address prescription
volume which is main component
of high drug expenditure (esp.
antibiotics prescribing)
• Link prescribing to clinical
guidelines & protocols
• INN prescribing
–
–
Actions needed
(a)Technical Assistance
• Clinical protocol adaptation from
other settings based on clinical cost
effectiveness principles
• Develop expertise in non-financial
incentives and specific measures such
as PA; within-indication Rx
• Capacity-building
Retain compulsory nature and monitor
through Rx audits and feedback at regular
intervals
Apply changes in tertiary education of future
physicians?
(b) Legislation
• Retract limit of 2 drug
• Financial and non-financial
incentives
–
–
–
–
–
Prior authorisation
Drug budgets
Physician remuneration (e.g. P4P system
linked to clinical guidelines)
Other penalties/ sanctions?
Monitoring (electronic, audit)
28
prescriptons/per patient per month
• Any other legislation changes for
ensuring current and future INN
prescribing?
• Changing future physicians’ culture
by altering university education
• Strict promotional limits on
advertising
E-prescribing system
Options
• Ability to prescribe within indication
based on clinical and cost
effectiveness criteria
• Monitoring and review of
prescription patterns (by volume,
value, generic vs. branded,
antibiotics)
-
Audit reports
Publicly available transparent reports
Naming only outliers?
Actions needed
(a) Technical Assistance
• Prescribing guidelines/
protocols?
• Admin burden?
• How often to follow-up?
• Apply automatic blockage
mechanism once branded
prescriptions reach a specified
level?
(b) Legislation
• ?
29
4.5. Dispensing
30
Payment options and Generic Substitution
Options
Actions needed
(a) Technical Assistance
• Wide substitution rights to
pharmacists - Ensure that
pharmacists dispense the cheapest
generic alternative when available
• Overall pharmacy services –
complementarity principle
• Financial and non-financial
incentives
•Special case for domestically
developed generics?
• Methods of paying pharmacy
services and application to the
Greek reality
• Seek advice from other
countries with experience (e.g.
UK)?
(b) Legislation
• What legislative changes do we
need?
31
4.6. Cost sharing
32
Cost-sharing
Options
Actions needed?
(a) Technical Assistance
•How to define the level of patient
contribution that applies across
conditions?
• Simplify and consolidate taking into
account
– Exceptions? Based on what
•
•
•
•
criteria?
– Socio-economic criteria (e.g. income,
age)
– Burden of Disease (e.g. severity,
prevalence)
Staff levels and competences
Overall admin capacity
Databases
Other operational criteria:
frequency of updates, ensure
patient access
(b) Legislation
• As needed
•What about other cost-sharing
mechanisms?
-Deductibles, Coinsurance, Copayment
33
4.7. Other issues
34
Other issues
Interests/Options
Actions needed?
(a) Technical Assistance
1. Who provides information to
prescribers?
2. Are uniform standards of clinical
guidance available based on
1.
2.
•
•
•
•
EBM?
EBM and CE?
3. Is there a monitoring function to
measure performance based on
available data?
Information
Clinical guidelines
Monitoring
Performance measurement
(b) Legislation
• As needed
35
5. Timelines
36
Action Plan Timelines
• Objective 1 - National Pharmaceutical Policy: September 2013 –
February 2014
• 2. Objective 2 - Pricing: October/November 2013 – July 2014
• 3. Objective 3 - Coverage/Reimbursement decisions: November
2013 – October/November 2014
• 4. Objective 4 - Prescribing: January – November 2014
• 5. Objective 5 - Dispensing: January – July 2014
• 6. Objective 6 - Cost-sharing: January – August 2014
• Includes a max of 2 month slack per Objective
37