Reimbursement of high cost drugs the Polish experience

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1 Reimbursement of high cost drugs the Polish experience 1. Poland and Polish health care system 2. AHTAPol tasks and activities Iga Lipska, M.D. Deputy Director Bogusława Osińska, M.D. Chief Specialist, HTA Department Agency for Health Technology Assessment in Poland AHTAPol 3. Reimbursement high-cost drugs by NHF in Poland therapeutical programs 4. NHF, AHTAPol: challenges and future developments Poland Polish health care system Centralised Health insurance system - taxes National Health Fund (NHF) 16 regional branches NHF concludes contracts with health service providers NHF budget for 2009 is 56,8 billion PLN (14 billion EURO) Drug reimbursement - 7,3 billion PLN (12,9%) Therapeutic drug programs - 1,3 billion PLN (2%) Introduction a new drug A registration of medicinal product (EMEA, URPL) A pharmaceutical company Reimbursement criteria: Reimbursement submission form MoH A pharmaceutical company MoH (Drug Management Team): reimbursement and price decision No Does an application fulfil formal requirements? Yes Recommendation of AHTAPol (assessment and appraisal process) Submission of new therapeutical program NHF NHF (Drug Management Departament): final decision necessity to provide health care for the society making medicines accessible safety importance of a drug in a treatment of conditions associated with high epidemiological threat influence of a drug on direct medical costs affordability for the public payer obliged to finance healthcare services Positive decision Reimbursement list Positive decision New therapeutical program New criteria according to a new reimbursement law: still in development

2 Pricing Approval Process criteria Production cost (provided by the manufacturer) Cost of daily treatment Cost of standardized therapy Risk-benefit ratio compared to alternative pharmaceuticals for that indication Therapy costs per day in comparison to products with the same efficacy Evaluation of the economic impact on the national health system Estimated sales of the new pharmaceutical product Prices in countries with similar GDP New criteria according to a new reimbursement law: elaborated under twinning project, date of coming into force still to be agreed AHTAPol a new institution in reimbursement process Created in 2005 (Ordinance by MoH Sept 2005) Steps undertaken to prepare the Law on AHTAPol establishment The Bill prepared and submitted for Parliament work Planned to come into force in 2009 (July?) AHTAPol tasks and activities AHTAPol tasks and activities Still a lot of discussions International collaboration! EUnetHTA, INAHTA, HTAi, ISPOR, GIN, WHO/HEN, MEDEV Drug reimbursement list (Transparency Directive!) Therapeutic programmes Non drug technologies Assessment of analysis in terms of credibility and quality Clinical effectiveness Cost effectiveness Budget impact analysis Consultative Council (CC) the role CC recommendations all recommendations drugs-reimbursement list drugs-therapeutic programs non-drug technologies HTA in decision making process Assessment, Appraisal and Decision taking Completely separated processes Assessment (in most cases quality control/audit of industry s submission) by Analytic Team Appraisal/value judgement by Consultative Council (CC) CC recommendations (8 possible types) Decision taking/final decision by Minister of Health Reimbursement high-cost drugs by National Health Fund in Poland Therapeutical program: definite medical indication for described target population for 1 medical indication program can cover a few drug technologies particular patient population in programs are separate sets

3 Reasons for creation therapeutical programs medical needs for treatment with innovative technologies; inaccessibility of patients to high-cost, innovative drugs; impossibility of using reimbursement policy tools like the lists of reimbursed drugs, specified by separate regulations of the Minister of Health; necessity of application of uniform criteria for qualification of patients for a therapeutic program (equal access) and treatment with innovative technologies enabling to monitor related expenses of the payer special requirements for health care providers (relevant number of specialists or medical facilities etc.) Structure of therapeutical program Therapeutical program planned and intended actions of health care (financed from public means) considered as clinical effective, cost effective and with proven safety profile, enabling to satisfy health needs and improvement health status of health care beneficiaries in the prescribed time Therapeutic program is introduced for a specific clinical indication Rules of structure of therapeutic programs financed by the National Health Fund provide financing one or more health technologies Application of new program New technology or new program can apply: the Minister of Health the national consultant in the appropriate medical speciality the director of the HTA Agency Priority in implementation of therapeutic programs Priority is given to therapeutic programs related to: clinically most important health technologies (from social perspective) most cost-effective health technologies among options or alternatives; health technologies, which can be financed within resources allocated in the NHF financial plan for financing of therapeutic plans Therapeutical Programs 2008 examples: AHTAPol recommendation examples: TP name Disease name Active substance Disease name Recommendation Treatment of breast cancer Treatment of large intestine cancer Treatment of brain glioma Treatment of chronic granulocytic leukemia Treatment of gastrointestinal stromal tumor (GIST) Treatment of malignant lymphoma Treatment of essential thrombocytosis Treatment of precocious puberty in children Treatment of spasticity in poliomyelitis Treatment of primary immunodeficiencies in children Treatment of multiple sclerosis TRASTUZUMAB IRINOTEKAN // FLUOROURACIL // CALCII FOLINAS TEMOZOLOMID IMATINIB or DASATINIB IMATINIB RITUXIMAB ANAGRELID LEUPROLELINUM or TRIPTORELINUM BOTULINE TOXIN TYPE A IMMUNOGLOBULINA INTERFERON BETA or GLATIRAMER trastuzumab interferon beta glatiramer bosentan, iloprost, epoprostenol, sildenafil, treprostinil tobramycin (inhaled) alfa glukozydaza nilotynib lenalidomid etanercept, adalimumab, infliksimab, leflunomid abatacept Breast cancer Multiple sclerosis Multiple sclerosis Pulmonary arterial hypertension Pulmonary infection (chronic) - patients with cystic fibrosis Pompe disease Myeloid leukemia Myeloma Rheumatoid arthritis Rheumatoid arthritis + (temporary) 1th - ; 2nd conditional recommendation + sildenafil, bosentan, prostacyclin analogues + (TP) - (reimbursement list) + for 1 subpopulation + -

4 Initiate technology In case of two or more health technologies as options for the treatment in the same medical indication: 1) based on their assessment of efficacy made by the AHTAPol (with proven lack of significant differences in clinical effectiveness) 2) no reasons that makes it inadvisable to prescribe a particular drug in individual cases, - treatment should normally be initiated with the least expensive drug (taking into account administration costs, required dose and product price per dose). Challenges and future developments price volume agreements; risk sharing agreements (outcomes guarantee) - rejestry kliniczne; payback arrangements; value based pricing (UK solution) - flexible pricing; non - commercial trials Adverse effects financing and monitoring Implemention of adverse effects treatment financing in chemotherapy (3 rd, 4 th degree in accordance with CNI CTC) Implemention of precise monitoring in IT system (highcost adverse effects related to active substances) Unused drugs (resignation of utilization) Planned changes - Improvement of reportaccounting system Similar to registers effectiveness data and high-cost events Similar to clinical trials monitoring medical documentation vs NHF data Contract values for TP in and prognosis for 2009 Problems with reimbursement decision making of expensive (innovative) drugs TP [mill. PLN , , , plan 2009 plan High cost of clinical trials Lack of credible evidence of clinical efficacy and effectiveness: Small population of patients Short time of observation in clinical trials Lack of information about results of clinically important outcomes (desirable and undesirable ones) Programy terapeutycz

5 Cost effectiveness tresholds P O L A N D UK G E R M A N Y F R A N C E UK cost effectiveness PKB per capita x PKB per capita 2PKB per capita 2007* treshold PKB per capita 2007* PKB per capita 2007* AHTAPol challenges AHTAPol: limited human resources difficulties in recruiting new experienced staff in fact AHTAPol has been engaged in analytical process since 2007 necessity of continuous training Insufficient development of patient registries in Poland lack of epidemiological data PKB = GDP With accordance to the rate of exchange on 22nd of Nov. 2008) Highly cost-effective technologies Cost-effective technologies Lowly cost-effective technologies (?) * Source: Oxford Economics 1 QALY < PLN 1 QALY PL 1 QALY P Political issues: power of the mass media in several situations patient associations often financed by pharmaceutical companies Dilemma: where is The cost-effectiveness threshold? high costly drugs (ex. orphan drugs): what shall we do in case of iinsufficient evidence? Thank you for your attention Questions???» i.lipska@aotm.gov.pl» b.osinska@aotm.gov.pl

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