Administrative Organization

Transcription

1 PATIENT DATA AND PATIENT REGISTRIES IN CENTRAL & EASTERN EUROPE Patient Registries as an Opportunity in Bosnia Herzegovina for Access to Medicines Speaker: Tarik Catic, MScPharm, PhD (c), President, ISPOR Bosnia Herzegovina Chapter Health Economics and Pharmacoeconomics Consultant Sarajevo, Bosnia Herzegovina ISPOR 16th Annual European Congress 2 6 November 2013 Dublin, Ireland Administrative Organization State level Bosnia and Herzegovina Entity level Federation of Bosnia and Herzegovina Republic of Srpska Brcko District Cantonal /regional level 10 Cantons 4 Regions

2 Health Care/Medicines Financing Federation of Bosnia & Herzegovina Federal Health Insurance Fund Cantonal Insurance Fund(s) Hospital Budgets Republic of Srpska Health Insurance Fund Hospital Budgets Brcko District Health Insurance Fund Hospital Budgets Pharmaceutical Key Stakeholders in B&H Institution ALIMSBH* Ministry of Civilan Affairs Responsibilities Marketing approval for medicines Pricing control (IRP) State Federation of B&H Republicof Srpska, B&H Coordinative role among entities and international organizations *Agency for medicines and medical devices of Bosnia and Herzegovina Federal Ministry of Health / Cantonal Minstries of Health FMoH Adopt Federal list of Essential medicines and set price 1. List A 100% RB and obligatory for Cantonal HIFs 2. List B different copayment levels and optional to Cantonal HIFs Adopt list of expensive drugs (CTx, MS, biologics etc) Federal Health Insurance Fund / Cantonal Insurance Fund Responisble for financing of Expensive drugs listed by Federal MoH Tender procurement procedure Health insurance fund Set list of mediciens used in primary health care Set list of expensive medicines (CTx, MS, biologics etc) Set prices and conduct tender procurement for expensive medicines Brcko District Health Insurance Fundn Set list of medicines used in primary health care and hospital medicine list

3 Expensive Medicines RB Process Federation of Bosnia & Herzegovina Republic of Srpska Step 1 Ministry of Health Inclusion into list of CTx Base for tender LOTs by INN/presentation Inclusion into list of CTx HIF / Commission for CTx Step 2 Federal HIF Tender (quantity and specific conditions specified) Tender (quantity and specific conditions defined; bi yearly tender) HIF Step 3 Federal HIF Orders by Hospitals (bi monthly) Orders from Hospitals collected by National Coordinator (monthly) HIF Deadlines are not defined in legislation In practice months Access to Medicines in Bosnia and Herzegovina Innovative Products Both entities adopt list of expensive medicines CTx Biologics Innovative medicines There is no orphan drug budget/list

4 Access to Medicines in Bosnia and Herzegovina Innovative Products Limitted number of innovative products is available either included into RB list or financed through the projects Market access for these drugs is delayed and mostly financed through projects and special secret agreements between HIFs and industry Restricted number of patients (patient cap?) Assigned budget for specific drug/indication (budget cap?) Special conditions/approvals by commissions appointed by HIF board (patient named programs?) Access to Medicines in Bosnia and Herzegovina Innovative Products CTx lists in FB&H and RS innovative products (biologics) imatinib rituximab trastuzumab bevacizumab erlotinib Federation of B&H* Republic of Srpska** * Products introduced into the list under special conditions and approval for therapy on patient base by special medical commission after medical documentation evaluation ** Products fully reimbursed Projects are highly valuable in MA strategy according to previous experiences (Federation of B&H) srpske.org

5 Patient Data and Registries (Focus on Federation of B&H) Legal framework Recently established law on health care records (2012) Ordinance on procedure and criteria for introduction of medicines into Federal list of medicines Responsible institutions Institute of Public Health Mostly dealing with epidemiology data Not on patient level Health Insurance Fund(s) Keep records on insured persons Patient records at primary care level and clinical centers/hospitals Keep records on treated patients All of these records are not used for outcomes research or published Lack of data analysis and centralisation of the system A lot of worthless paper work Patient Data and Registries (Focus on Federation of B&H) Law on health care records Defines Patient registries, patient data that should be collected and handling of data (confidentiality) and all evidences that are obligatory in health care eg. Record on visits to physicians and health services provided Record of special diseases like cancer, diabetes, CKD Record related to health insurance Ordinance on procedure and criteria for introduction of medicines into Federal list of medicines Patented (originator) drug manufacturer is required to establish proces (registry; patient data collection and analysis) to follow up proper use of drug, therapeutic outcomes, interactions and adverese eventss in 2 year period after drug is introduced into the List Good basis for establishing patient data practice and possible outcome research

6 Positive Movement Example 1 Introduction to e health care ID Launched in September 2013 in Canton Sarajevo as a pilot project Implemented by Cantonal HIF and MoH Patient data (disease history, treatments, lab tests, etc) stored and accessible at any health care center Possibility for patient outcomes research? Positive Movement Example 2 Disease registry Diabetes patient registry Project lead by ISPOR BH industry sposnored (launched in May 2013) Pilot project in one canton in Federation of B&H Disease registry following epidemiology data, therapy outcomes and related cost cost of diabetes study

7 Positive Movement Example 3 THE RENAL REGISTRY FOR BOSNIA AND HERZEGOVINA The Society for Nephrology, Dialysis, and Transplantation in Bosnia and Herzegovina has formed the Renal Registry and started gathering data in 1999 Data collected from all of the 20 centers in Bosnia and Herzegovina following the European renal registry standards Patient surveys includes groups of questions about the center itself (size, equipment, staff, water treatment), about the distribution of patients according to sex, age, primal renal disease, length and model of treatment, mortality, and about the number of kidney transplantations. Annual reports renal register The Use of Patient Data to Improve Access to Medicines Real World Evidence Patient registries, whether disease based or product focused, can provide invaluable data about the natural history of a disease under standard care practices and/or the safety and effectiveness of a product. These data can then be presented as evidence to: Meet safety requirements and manage benefits and risks Provide evidence to meet evolving coverage or reimbursement requirements Generate scientific evidence and publications Develop treatment guidelines Demonstrate good product stewardship

8 The Use of Patient Data to Improve Access to Medicines What can we get from patient registry? Generate knowledge and evidence (scientific presentations and publications) Demonstrate effectiveness or comparative effectiveness in different populations Meet post marketing commitments Generate evidence for coverage Monitor safety Manage risks and benefits Generate data for new indications or label extensions Change behavior Improve quality of care Prove product value through economic or quality of life benefits Bring scientific information to stakeholders sooner Enhance the practice of personalized medicine The Use of Patient Data to Improve Access to Medicines Conclusion There is a legal framework for introduction of patient registries Possibilities to establish new apporach for reimbursement of new (innovative and expensive drugs) Different types of Risk Sharing Agreements /Schemes Performance based RSS Payback models Restricted population Conditional reimbursement Implementation of new RB approach can accelerate patient acces to new drugs, develop partnership between authorities and industry Collection of valuable data for scientific purposes