Download Slajd 1 - Ministerstwo Zdrowia

List of reimbursed
medicines
Warsaw
October 2007
Table of contents:
I.
Types of reimbursement:
II.
Criteria for reimbursement and price settlement
III.
Updating the lists of reimbursed medicines
IV.
Rules for introducing medicines into reimbursement lists
and withdrawing them
V.
Application of limitations in indications for the use of a
medicine in individual diseases
I. Types of reimbursement:
→ ‘Open’ reimbursement
→ Hospital care
Therapeutical programmes
→ Intended for most expensive therapies
→ Intended for small patient populations
→ Intended for indications with clearly defined criteria – inclusions and exclusions of patients
→ Monitoring of the number of patients and therapy effectiveness (planned)
→ Medical technologies of proven clinical effectiveness
→ Medical technologies which are most cost-effective among the available options
→ Taking the public payer budget into account
→ Improvement of the reporting and financial settlements system – monitoring of patients in PT in
accordance with the rules of clinical register! and verification of the legitimacy of financing
technologies after 1-3 years on the grounds of factual data (plans for the future)
Rules of reimbursement and price settlement in Poland
1. The rule of reimbursed medicines list – a positive list of reimbursed
medicines applied in Poland
2. The rule of introducing medicines into reimbursed medicines list and
withdrawing them
3. The rule of reimbursement levels
4. The rule of settlements of reimbursed medicines prices
5. The rule of co-financing by the patient
II. Criteria for reimbursement and price settlement
↓
-
Act of 27 August 2004 on health
care services financed from public
funds
(Dz. U. of 2004 No 210, item 2135, as
amended).
-
Law of 24 August 2007 amending the Act on health care
services financed from public means and on the
amendment of certain other Acts, published on 14
September 2007
(Dz. U. No 166, item 1172).
↓
-
Act of 5 July 2001 on prices
(Dz. U. of 2001 No 97, item 1050, as amended)
Reimbursement criteria
- The need to ensure social health
protection
- Accessibility of medicines
- Safety of use
- The significance of the medicine in
combating diseases bearing high
epidemiologic and civilisational risk
- The influence of medicine on direct
treatment costs
- Payment possibilities of the entity
obliged to finance the services from
the public funds
Article 36 (5) of the Act on health
care services financed from public
funds
Article 37 (2) of the Act on health
care services financed from public
funds
Criteria for price settlement
- Price levels in countries with a
similar level of national income per
head
- Price competitiveness
- The influence of the medicine of
direct treatment costs
- The size of realised supply in the
period preceding the lodging of the
application or information and
declared for the later period
Article 7 (3) of the Act on prices
Criteria for price settlement
Article 7 (3) of the Act on prices
- Production costs
- Proven efficacy of the
medicine
- The significance of the
medicine in combating
diseases bearing high
epidemiologic and
civilisational risk
Criteria for price settlement
- Wholesale margin
calculated by a wholesale
entrepreneur on the basis of
institutional wholesale price is
8.91%; if interest rates set by
Monetary Policy Council are
decreased by more than 30% in
relation to the level as of the day
of the entry into force of the Act,
the margin should be decreased
by at least 10%
- Retail margin calculated on the
basis of wholesale price
(depending on wholesale price
expressed in zloty)
Article 7 (3) of the Act on prices
III. Updating the lists of reimbursed
medicines
Law of 24 August 2007 amending the Act on health care services financed from public
means and on the amendment of certain other Acts, published on 14 September 2007
(Dz.U. No 166, item 1172)
Article 36 (6) and Article 37 (3) – introduction of the duty
to update reimbursement lists at least every 90 days.
IV. Rules for introducing medicines into
reimbursement lists and withdrawing them
Starting point 1.
The medicine is placed in a register held by
thePresident of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products
Starting point 2.
→ Lodging reimbursement applications with the Minister of Health:
→ For introducing the medicine in the list
(Article 39 of the Act on services)
↕
→ For settling the institutional price
(Article 6 of the Act on prices)
The most important elements of the application
- The name of the applicant
- Data concerning the medicine
-Proposed price
-Proven availability of the medicine at the moment of lodging the application
-Obligation to ensure the continuity of supply
-Daily cost of therapy
-Average cost and time of a standard therapy
-Justification of the application and proposed price
-Analysis of clinical efficacy and cost effectiveness
and, if applicable:
-Average sales price in the Republic of Poland
in the last two years, broken into individual years
-authorisation number and a copy of the marketing authorisation
Stage I – examination of the application in formal terms
The application is submitted to the Minister of Health
↓
The Minister of Health assesses the applications in formal terms.
↓
If the application fails to contain the required information, the Minister of Health calls on the
applicant to make up the data necessary for the application to be processed.
(Until then, the processing date is suspended.)
↓
↓
Application for reimbursement of a medicine
containing an already reimbursed
substance
↓
If the application meets formal requirements,
the Minister of Health forwards it to the
Medicine Management Team.
Application for reimbursement of a medicine
containing a new substance
↓
↓
← Evaluation Agency
for Medical Technologies
Stage II – processing the application
by Medicine Management Team (1)
→ Legal base – the Team is provided for in the Act on prices;
→ The Team’s Rules of Procedure have been specified in the Order of the
Minister of Health;
The Team consists of 3 representatives of each: the Ministry of Health, the
Ministry of Finance, the Ministry of Economy and the President of the
National Health Fund (NFZ);
The Head of the Team can order the preparation of expertises
and other documents.
Stage II – processing the application
by Medicine Management Team (2)
The tasks of the team include preparing and presenting the Minister of Health with
opinions on the settlement of lists and institutional prices of medicinal products and
medical devices;
The Team prepares opinions based on criteria contained in the Act on Act of 27 August
2004 on health care services financed from public funds and in the Act on prices.
↓
Price negotiations
↓
The Team prepares opinions (recommendations) by way of resolutions
↓
The Minister of Health takes decision
↓
The decision is communicated to the applicant
Stage III – appeal
→
Appeal from the decision of the Minister of Health in
accordance with general rules provided for in the Code of
Administrative Procedure
→
Complaint to the Administrative Court
Stage IV– settlement of lists
Recommendations of the Medicine Management Team
accepted by the Minister of Health are a basis for updating
the lists.
Recommendations of the Team have no binding character,
but as a rule, the Minister of Health takes a decision in
accordance with the Team’s recommendations.
Stage V – the legislative route
1. Adoption of drafts of preliminary ordinances on reimbursement lists by the
Management of the Ministry of Health;
2. Social discussion and external arrangements;
3. Analysis of submitted comments;
4. Signing the ordinances by the Minister of Health (the ordinance on determining
institutional prices is signed in consultation with the Minister of Finance);
5. Publication of the ordinances in Dziennik Ustaw (Official Journal);
6. Entry into force of the ordinances.
Withdrawal of a medicine from reimbursement list
Article 39 (1)(c) of the Act on health care services financed from
public funds
The minister competent for health may verify, by way of an
ordinance, the legitimacy of keeping a medicine or a medical
device in a certain list.
Creation of price limits
In a group of medicines the reimbursement limit is determined at
the level of the lowest cost of DDD (Defined Daily Dose), defined
in the WHO index.
V. Application of limitations in indications for
the use of a medicine in individual diseases
Draft 15.10.2007
Ordinance
of the Minister of Health 1)
of ………………2007
on the list of diseases as well as on the list of medicines and medical
devices which on account of these diseases are prescribed free of
charge, on flat payment or on partial payment
Examples:
In the group of medicines used in schizophrenia in recurrence of
psychotic symptoms during neuroleptic therapy as a result of
documented, persistent lack of cooperation on the part of the patient:
-Risperidonum (medicinal product Rispolept Consta),
-On account of the manner of therapy which is not possible in the case
of other antipsychotic medications from the group of atypical
compounds.
Examples:
In the group of medicines used in hypercholesterolemia LDL-C over
130 mg/dl, remaining despite statin therapy in the case of: postinfarction state or coronary revascularization (percutaneous or
cardiosurgical), post-stroke state or TIA, state after peripheral
revascularization or peripheral amputation due to atherosclerotic
disease - familial hypercholesterolemia:
-Ezetimibum (medicinal product Ezetrol),
-Due to the lack of possibility to cover the whole population with open
reimbursement, it seems appropriate to provide access to a modern
medicine, decreasing blood lipids levels, to persons from high and very
high risk groups.
Thank you for your attention!