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 → I ntended 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 - Production costs - Proven efficacy of the medicine - The significance of the medicine in combating diseases bearing high epidemiologic and civilisational risk Article 7 (3) of the Act on prices

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 reimbursedcontaining a new substance substance ↓ ↓ ↓↓ ↓ If the application meets formal requirements, ← Evaluation Agency the Minister of Health forwards it to the for Medical Technologies Medicine Management Team.

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 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: post- infarction 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!