DRUG PRICING IN ADRIATIC COUNTRIES IS REFERENCE PRICING THE BEST OPTION? CROATIAN EXPERIENCE

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1 CROATIA The Ministry of Health of the Republic of Croatia is a state administration body and the most of its activities the Ministry carries out through: The Croatian Health Insurance Fund - CHIF (Hrvatski zavod za zdravstveno osiguranje, HZZO) The CHIF (Fund) is a public institution with legal entity - rights, obligations and responsibilities defined by the law DRUG PRICING IN ADRIATIC COUNTRIES IS REFERENCE PRICING THE BEST OPTION? The framework of mandatory health insurance provides around 4.2 million insured persons (more than 99. %) and accordingly, the framework of additional health insurance provides around 2.5 million insured persons Pero Draganić, MD, PhD, Assist. Prof. ISPOR 19th Annual European Congress 29 October-2 November 216,Vienna, Austria 1

2 CHIF covers the health risk level of 8% within the mandatory health insurance That includes: -The right to primary health care, -Specialty consultative health care, -Hospital health care, -Use of drugs that are on the lists of CHIF and, use of health care abroad, dental-prosthetic assistance supplements and orthopedic and other devices. The rest of the cost of the services (2%) the insured persons are obliged to pay within a limited amount. The total costs of medicines consume about 22 % of the Croatian health care budget The drug consumption in the period is growing at a rate of 3-4% per year (DDD/TID and HRK). The financial average of the hospital drug consumption is 27 % of the total costs and it includes expensive drugs and orphan drugs The amount of OTC drugs covers about 1% of consumption CHIF covers 88 % of all the prescription drugs 2

3 The drugs are listed on the: - essential, - additional The drugs are listed on the: The essential medicines list in 215 has 375 drugs with their all pharmaceutical forms, These drugs are fully paid by CHIF The additional list has 79 drugs and their pharmaceutical forms For these drugs additional payment is required High cost medicines and orphan drugs are available through hospitals. The drugs come on the List of drugs through the expert council of the CHIF, the process is transparent CHIF updates these lists a couple of time per year accordingly, after each update, several more drugs are accounted for due to the need for them The main (drugs) payer is CHIF The private insurance companies offer some additional services, such as partial reimbursement of the hospital costs The pharmaceutical industry is involved in the risk-sharing policy through a special agreement with an existing version of the pay-back contracts for the expensive drugs 3

4 The proposal for marketing authorization of the drug to the basic or supplementary reimbursement list of the Fund and the amendment of the indications may be submitted by the MAH Budget impact analysis includes: Scientific evidence demonstrating the benefits of the drug in the indication: -Metha analysis on the efficacy and safety -Randomised Controlled Trials on the efficacy and safety -Can be attached to other types of studies, or a lower level of scientific evidence. -MAH shall produce a Budget Impact analysis The criteria for inclusion of drugs on basic or supplementary reimbursement list of the Fund: -The importance of the drug from the standpoint of public health, -Importance of therapeutic drug, -Relative therapeutic value of a drug, -Assessment of ethical aspects. Basic settings: The study should be made in accordance with the guidelines ISPOR (Mauskopf JA, et al. Principles of Good Practice for budget impact analysis: report of the ISPOR Task Force on good research practices-budget impact analysis. Value Health. 27 ; 1 (5): ). Source: The data used in the production of primary study should be the published Croatian data, and in the absence of the Croatian data other reported data and assessment experts should be used. All data must be referenced. Assumptions and input parameters: All assumption should be transparent, realistic, professional and science-based and referenced. Price: For all the calculations study used wholesale price of the drug. Also, the cost of drugs that are reported to the supplementary list of the Fund include the amount of charge borne by patients themselves. 4

5 Budget impact analysis includes: Scenario: When calculating the financial effect the Reference scenario and scenario that includes a new drug are compared. Modeling: should be conducted in accordance with the ISPOR guidelines (Weinstein MC, et al. Principles of Good Practice for decision analytic modeling and health-care evaluation: Report of the ISPOR Task Force on Good Research Practices-Modeling Studies. Value Health. 23 ; 6 (1): 9-17). Sensitivity analysis: Studies in the calculation need to use sensitivity analysis in the form of scenarios. It is necessary to change the model parameter values in order to test the robustness of the model and the reliability of conclusions under different assumptions. Validation of the model: The model must meet three types of validation: internal, external and parallel. With the study is necessary to submit evidence of the activities undertaken in connection all three types of validation. The Ordinance about the measures and the method of determining drug prices The basis for determining the comparative price of the drug is the price of the same drug (a drug of the same generic name and the same pharmaceutical form) in Italy, Slovenia and Czechia, and if necessary in Spain and in France. For this purpose, the average comparative drug prices are used Comparative price of the drug is calculated: - for Italy using the multiplication factor: for Slovenia used prices published on the website - for the Czechia used the multiplication factor:.86 - for Spain used the multiplication factor: for France using Vidal scales The price of the biological generic drugs should not exceed the level of 85% of the originator drug 5

6 Million HRK DDD/TID Total sale of drugs in Million HRK and in DDD/TSD The Ordinance about the measures and method of determining drug prices Comparative price of the drug is calculated: Italy -.685: Slovenia http : // ; Czechia -.86; Spain -.721; France - scales Vidal GDP per capita GDP US $ RATIO MF GDP*MF USA 51,48 EU 34,86 France 41, # Italy 33, ,85 Spain 3, ,48 Slovenia 23, # Czechia 2, ,17 Croatia 13,8 Source - Taking into account the GDP per capita and the multiplication factor, drugs in Croatia are more expensive than in the reference countries , 5, 4, 3, 2, 1, Year DDD/TID , , , , ,56 Year Million HRK

7 Million HRK DDD / TID DDD / TID The expenditure of drugs in DDD/TID and in HRK in the main groups of ATC classification in 211, 212, 213, 214 and C N A B M R H G L N C A J B R M G V The consumption in DDD/TID in all the ATC groups is within the average annual increase Spending in HRK, in all ATC groups is within the average annual increase, except within C group where the present decline in the amount of 2% over 5 years An increase of 3% is in L group over 5 years The order of the top 6 therapeutic groups in DDD/TID related to C9 N5 6 C8 B1 A1 4 C1 2 7

8 Million HRK DDD / TID The order of the top 7 therapeutic groups in Million HRK related to 215 The order of the top 1 drugs in DDD/TID related to L1 A1 N5 C9 L4 J1 C1 L1 29 % A1 34 % N5 5 % C9 18 % L4 1 % J1 26 % C1 4 % C9AA5 ramipril B1AC6 acetylsalicylic acid C8CA1 amlodipine N5BA1 diazepam C3CA1 furosemide C1AA5 atorvastatin A2BC2 pantoprazole N5BA12 alprazolam M1AE1 ibuprofen C9AA3 lisinopril 8

9 Million HRK Million HRK Million HRK The order of the top 9 drugs in Million HRK related to 215 R3AK6 salmeterol and fluticasone C1AA5 atorvastatin J1CR2 amoxicillin and enzyme inhibitor A2BC2 pantoprazole C9BA3 lisinopril and diuretics salmeterol and F. - 6% atorvastatin - 5 % amoxicillin ande.i. 15 % pantoprazole 46 % lisinopril and D. 4 % The expenditure in Million HRK on the third level of ATC system for group A - Drugs that act on the digestive system and metabolism (the categories and their average annual spending of more than 1 million) A1A - Insulins and Analogues A1B - Blood Glucose Lowering dr., Excl. Insulins A2B - Peptic Ulcer and GERD A16A - Other Alimentary products (Enzymes, Amino Acids) L1XC3 trastuzumab M1AE1 ibuprofen A1AD5 insulin aspart L1XC2 rituximab trastuzumab 47% ibuprofen 46% insulin,9% rituximab 25% 1 5 A2B Peptic Ulcer and GERD: % in HRK, and 26% in DDD/TID, 9

10 Million HRK DDD / TID The consumption of statins from 211 to 215 in DDD / TID The Expenditure in Million HRK at the third level of the ATC system in the group L1 - Antineoplastic agents (Cytostatics) 6. 5 L1X Other antineoplastic agents L1B Antimetabolites fluvastatin and others simvastatin rozuvastatin atorvastatin The decrease of the expenditure in HRK, in the C1 ATC group is at an annual rate of 8% The increase in the consumption in DDD/TID, in the C1 ATC group is at an annual rate of 5.4% L1X: 27% L1C Plant alkaloids and other natural products L1A Alkylating agents L1D Cytotoxic antibiotics and related substances Linear (L1X Other antineoplastic agents) L1X trastuzumab 8,8 rituximab 58,9 bevacizumab 49,2 nilotinib 39,1 imatinib 26,2 bortezomib 26, sunitinib 25,4 vemurafenib 17,5 dasatinib 15,1 erlotinib 14,7 1

11 Million HRK The Expenditure in Million HRK at the third level of the ATC system in the group L2 - Drugs for endocrine therapy, L3 - Immunostimulants, L4 - Immunosuppressants L4A: 1.6% L4A Immunosuppressants L3A Immunostimulants L2B Hormone antagonists and related agents L2A Hormones and related agents L4A Immunosuppressants - 1% adalimumab 54,1 infliximab 42,2 mikofenolic acid 29,8 etanercept 28,9 golimumab 18,7 tacrolimus 18,2 tocilizumab 17,6 ciklosporin 12,1 lenalidomid 7,9 ekulizumab 5,3 The total consumption of medicines in DDD / TID has grown at a rate of 3.8% annually in the period The total expenditure of medicines in HRK has grown at a rate of 3.6% annually in the period The hospital drug consumption in DDD / TID was, on average, 3.4% DDD/TID of total consumption and 28.1% to HRK of total spending in the period The consumption of the prescription medicines in DDD/TID was, on average, 92.1% DDD/TID of total consumption, and in HRK amounted to 92.6% of total spending in the period The consumption of the OTC medicines in DDD/TID was, on average, 7.9% DDD/TID of total consumption, and in HRK amounted to 7.4% of total spending in the period

12 CROATIA We can notice that in certain therapeutic groups of drugs significant savings in expenditure in HRK is achieved. These pharmacotherapeutic groups regarding the spending in HRK are among the top 2 groups. At the same time, the consumption of drugs in DDD/TID, in these groups was at a low or a higher increase in the observed period Higher decrease in expenditure in HRK was observed in groups C1, C9, A2, J1... In all these groups there are many generic parallels which resulted in a reduction in the expenditure. On the other hand, newer drugs like monoclonal antibodies, protein kinase inhibitors, TNF inhibitors... recorded a constant increase in expenditure in HRK, and therefore take an increasing share of the health budget for medicines Taking into account the GDP per capita and the multiplication factor we conclude that the drugs in Croatia are more expensive than in the reference countries Thank you for your attention For additional questions: pero.draganic@halmed.hr Agency for Medicinal Products and Medical Devices Ksaverska cesta 4, 1 Zagreb Telephone: Telefax: halmed@halmed.hr 12