Co-financing mechanisms Budget cap Pay back Risk-sharing instruments Reimbursement tax

Transcription

1 LINKING TODAY S DECISIONS WITH TOMORROW S POSSIBILITIES: HTA: LINKING TODAY S DECISIONS WITH TOMORROW S POSSIBILITIES: A PERSPECTIVE FROM POLAND, HUNGARY, GREECE AND SERBIA A PERSPECTIVE FROM POLAND Speakers: Poland - Karina Jahnz-Rozyk MD, PhD, President, ISPOR Poland Hungary - Imre Boncz MD, MSc, PhD, President, ISPOR Hungary Greece - Prof. Mary Geitona PhD, President, ISPOR Greece Moderator: Serbia - Dragana Atanasijevic MD, MSc, Vice President, ISPOR Serbia Karina Jahnz-Różyk Joanna Lis Polish economy strong on the European landscape F21 F211 GDP growth y/y (%) 5,1 1,8 3, 3,5 Inflation rate (%, average) 4,5 3,5 2, 2,3 Unemployment rate (%, end of year) 9,5 11,9 12,3 9,9 Consumption growth y/y (%) 6,3 2,1 2,1 3,4 Investments growth y/y (%) 8,2,4,4 6, Public debt (GDP %) 47, 49,8 54,7 54,4 Exchange rate PLN/GBP (period average) 4,42 4,86 4,76 4,52 Despite lowest drug prices in Europe, spend on pharmaceuticals is limited, with high patient s co-pay public spend on pharmaceuticals (USD/capita) private spend on pharmaceuticals Greece France % of European average price of pharmaceuticals Germany Poland Romania Czech Ireland Bulgaria Hungary Portugal Latvia France OECD average UK Portugal Italy Slovakia Ireland Denmark Hungary Germany Island Czech Republic Poland Political agenda is driven by the forthcoming Parliamentary elections in Autumn 211 HEALTHCARE PACKAGE 1-12 Acts in total Regulation of Drug Market Patients rights protection HCPs Specialization Healthcare services Additional insurances PHARMACEUTICAL PACKAGE Reimbursement Act Additional insurances Clinical Trials Act Pharmaceutical Law Registration Office Act The MAIN changes in the draft of Reimbursement Bill Co-financing mechanisms Budget cap Pay back Risk-sharing instruments Reimbursement tax Selected changes to the reimbursement rules and procedure New rules for drug availability criteria New reimbursement levels New rules on setting reimbursement limit Fixed margins and prices Q4/21 Q1/211 Q2/211 Q3/211 Q4/

2 Cost containment measures Buget cap, Payback, taxes : TODAY S DECISIONS WITH TOMORROW S CONSEQUENCES T1.3 / B11 - Poland 7 The total budget for reimbursement is established at the level of up to 17% of the amount allocated in the NHF annual plan for guaranteed benefits Pay back in proportion to excess of reimbursement budget above the fixed level of 17% of the NHF expenses, counted by algorithm Risk-sharing instruments may pertain to outcomes and financial based agreements Different from Italian concept, as it is not based on declared expenses for marketing, but on 3% of revenues from being covered by the reimbursement ( tax on revenues ) 8 New rules on setting pricing & reimbursement: TODAY S DECISIONS WITH TOMORROW S CONSEQUENCES New rules of establishing reimbursement levels -> Possible re-allocation of the products between reimbursement levels (higher co-payment) Elements that influence payer s decisions Economical analysis C New rules on setting reimbursement limit and limit groups -> jumbo groups Updating the role of HTA in pricing&reimbursement -> Price based on threshold analysis analiza racjonalizacyjna as a part of HTA Dossier B S M E 9 HTA decisions impact Decisions based on HTA can have: positive (payer perspective p and/or patient) or negative (payer and/or patient perspective) impact in various terms. Positive impact of HTA Allows for an informed decision making process Shows potential savings or additional spending Shows budget impact options Helpful in identifying subgroups which can be efficiently treated AHTAPol positive decisions: can improve patients access to new technologies help to optimize the funds allocation in the healthcare sector budget 2

3 Possible negative impact of HTA ISPOR CHAPTER FORUMS HTA: LINKING TODAY S DECISIONS WITH TOMORROW S POSSIBILITIES: A PERSPECTIVE FROM POLAND, HUNGARY, GREECE AND SERBIA Tuesday, 6 November, 21, Paris Can restrict access to new, innovative therapies for patients Sometimes the one available treatment option doesn t fit all patients (e.g. due to safety profile, identified markers etc.) Can discriminate some patients in terms of equal access to treatment AHTAPol negative decisions (e.g. oncology examples): can significantly restrict or block patients access to new technologies don t allow for further negotiations with the payer (e.g. risk-sharing schemes or price negotiations) can block in long time perspective the possibility to introduce new therapeutic option HTA: Today s decisions, tomorrow s possibilities the Hungarian perspective Dr. Imre BONCZ associate professor (University of Pécs) president (ISPOR Hungary Regional Chapter) Topics of the presentation Introduction of HTA into coverage decisions Health demands and supply Fiscal approach or value based purchasing Introduction of HTA and health-economics into pharmaceutical coverage decisions in Hungary From 1st May 24 (EU accession) Legal regulation Institutional background Financial background Procedure Professional human resource Principles for reimbursement of pharmaceuticals Clinical efficacy Affordability Accountabiliy, Predictbility Publicness, Transparence of interest sphere Equity, Need-based dapproach Health-economics (cost-effectiveness) Factors influencing the coverage decisions of pharmaceuticals health insurance reimbursement Budget impact Lobby Lack of transparency Political and economic networks Health-economics (cost-effectiveness) 3

4 Standardized death rates, all ages, all causes per 1. % of population aged 65+ years Hungary OLD-EU-15 NEW-EU-12 Hungary OLD-EU-15 NEW-EU SDR all causes, all ages, per % of population aged 65+ year Balancing between future health demands and service supply Budget impact of cost-effective and not-cost effective medical technologies 12 DEMAND CE strategy not CE strategy 1 Unmet demands 1 Unmet demands CE strategy not CE strategy Health gain on a long run Budget impact on the current budget Deficit of health insurance fund in Hungary between Actual expenditures of the Hungarian drugbudget ( ) UF Billion HU EXPENDITURES DEFICIT REVENUES Billion HUF (plan) 4

5 Deficit of the Hungarian drug-budget (planned-actual)/actual Summary Many countries facing growing health demands 4% 3% 32,1% 36,6% 3,4% Searching for the right answer Percent (%) 21,5% 2% 1% 7,% 3,4% 2,8% % 22,1% 21,% 16,1% 16,2% 13,5% 11,7%,% Sometimes budget impact defeats cost-effectiveness Simple fiscal approach or increased role of HTA / HE -1% ,1% ,4% % Thank you for your kind attention! Dr. Imre BONCZ, MD,MSc,PhD,Habil University of Pécs Institute of Health Insurance imre.boncz@etk.pte.hu HTA: Linking Today s Decisions with Tomorrow s Possibilities: The Greek Perspective Greece ISPOR Chapter Mary Geitona, MSc, Ph.D As. Professor University of Peloponnese The Socio-economic Environment of Greece Compulsory social insurance coverage based on occupation Universal and free access to health care NHS: the major provider of health care (inpatient care) and the social insurance funds polyclinics (outpatient care) Greece is under IMF rescue and inspection to reduce public expenses and mainly health care and pharmaceutical spending Annual Growth Rate of -2.5 % Inflation Rate of 5.2 % Unemployment Rate of 2 % Health expenditures Total health care spending: 9.6 % of GDP Health Expenditure Annual Growth Rate: 6.9 % Private Health Expenditure: 4+ % of total healthcare spending Pharmaceutical Expenditures: 2.2% 2% GDP or 22.7% of total health spending Public spending: 76% of total pharmaceutical expenditures Public spending on pharmaceuticals: 28% of public health expenditures Hospital debts over 6 billion euros: about 1/2 of total NHS hospital spending 5

6 Cost - containment Measures for Pharmaceuticals - Drugs Pricing All efforts to contain healthcare expenditure are mostly focusing on the pharmaceuticals prices control. Price control on pharmaceuticals has been successful Price control on the share of pharmaceuticals on total health spending has been NOT successful. Co-payments reaching (25%) have not a significant impact on controlling expenditures due to the low prices of pharmaceuticals. No intensives for changing physicians prescribing behaviour (ie generic substitution) This situation has resulted in: Continuous rise of drugs expenditures driven by the increasing volume of prescribed drugs. Example: Between 1991 and 26 spending on pharmaceuticals by the largest social health insurance fund (IKA) increased dramatically by 285%, despite a 58% decrease in the relative price of drugs (Lambrelli and O Donnell 21). The inconsistency in the trends between prices and expenditure is explained by the absence of control over prescription, the lack of control over drug mix and drug quantities prescribed Recent pricing measures The new pricing bulletin published in September 21 with significant mistakes introduced: Drug prices cuts of about 4,9 products Drug prices increase of about 1,4 products Drug prices stability of about 6 products The average aggregate price reduction was approximately 21%. Due the many mistakes found, a revised issue is expected This situation appears to result in long delays in many new products. Other Cost - containment Measures Positive Reimbursement list The effort to control prescribing through the positive list has also failed and additionally: a) has restricted patients access to new and more effective drugs, given that new and more expensive products have been excluded from the list. b) In October 21, a shortage of 38 prescribed drugs has been announced by the National Organization for Medicines (EOF) (i.e Madopar for the Parkinson s Disease with a 3% decrease in the company s sales. c) Parallel trade and exports are increasing (in October 21 EOF has prohibited temporarily the exportation of certain 4 drugs from the Greek market (i.e Madopar included) The criteria for inclusion on the past positive list The product: should be marketed in 3 countries market authorisation should have been granted in Greece drug s average daily treatment cost related with a relative reference pharmacoeconomic criteria for the new drugs!!!!!!! New criteria for setting the reimbursement list and for setting the reimbursement prices by EOF (October 21) Drugs will be classified in ATC4 groupings Computation of a class daily cost of treatment based on the daily doses The average daily cost of treatment for the entire cluster including branded and generic products, All products included in the list will be reimbursed at a reference social security reimbursement price The social security reimbursement price will be the product of the cluster reference daily cost to the number of daily doses considered Cost-effectiveness criteria are not taken under consideration 6

7 Rational Measures Sickness Funds Efforts to Control Pharmaceutical Expenditures 1. Introduction of Electronic prescribing system Recent findings from piloting performance in 21 In the social fund for employees in the private sector (IKA), in 28 numerous physicians have been found to prescribe 4, - 7,5 prescriptions costing up to 2, Euros per month. 2. Changing of physicians prescription patterns, generic substitution Rational Measures Sickness Funds Efforts to Control Diagnostic tests Expenditures 1. Introduction of Electronic registries data bases Recent findings of piloting performance in 21 In the social fund for civil servants (OPAD) 5% reduction in the number of lab- diagnostic examinations per capita between 29 and 21 Rationalizing NHS Hospitals Expenditure Hospital debts accounting for about 6 billion Euros The government delays in arranging debts payment to medical device suppliers (MDS) MDS deny to provide material / equipment to the NHS hospitals Recent announcements: NHS hospitals are pressed by IMF guidelines to cut their expenses at least by 2% Introduction of drug tenders, formularies, generic substitution and the realisation of an integrated IT system intra and across hospitals. Rationalizing Health Resources Allocation (HRA) in Greece??????? Past experience has shown: HRA based on the MAX investment with unknown /never assessed Benefits Current experience presents: HRA based on the MIN investment with unknown Benefits since HTA remains out of any consideration Future: Government s expectations will not be fulfilled due to its short term targeting and the continuing denial of value based prices and practices Investment in HTA offers long term results related to improvements in health care access and outcomes Unfortunately: HTA seems to be out of any discussion for another time in Greece HTA: LINKING TODAY S DECISIONS WITH TOMORROW S POSSIBILITIES: A PERSPECTIVE FROM POLAND, HUNGARY, GREECE AND SERBIA Thank you Q&A Session 7