MDI market analysis and cost comparison in Hungary Róbert Tóth Ministry of Environment and Water Budapest, Hungary

Worldwide asthma 300 million affected individuals Cost of treated asthma seems high, the cost of not treated asthma correctly even higher Death from asthma /year

Proportion of population with asthma (%) Wales172 New-Zealand152.5 USA115 Czech Republic 82.5 Estonia 62 Uzbekistan 4 14 Hungary 32.5 Russian Federation Albania 2 11 Case fatality rate per 100,000 asthmatics

Survey in Hungary in 2000 cost of mild asthma 265 $/year cost of serious asthma 1002 $/year average cost of asthma 440 $/year in case of children cost is higher Total cost in Europe: 17.7 billion €/year 30 million patients

Inhaled medications for asthma ( 2-5  m is the optimal range) Pressurized metered-dose inhalers HFA suspension is better than CFC susp. Breath-actuated metered-dose inhalers Dry powder inhalers (turbuhaler, rotadisk) Soft mist inhalers Nebulized or „wet” aerosols

Chronology 1996: Ban of the use of CFCs in Art. 2 countries, essential use only In Hungary only 1 pharmaceutical company produced CFC MDIs (1995 Servier 51%) 1986: 333 t, 2002: 0.3 t CFCs Preparations in the past: –Taleum (Cromolyne sodium ) 1 mg / actuation CFC 11, CFC 12, CFC 114 –Taleum (Cromolyne sodium ) 5 mg / actuation CFC 11, CFC 12, CFC 114 –Paxirasol (Bromhexine ) 1,7 mg / actuation CFC 113, CFC 12, CFC 114 Prices were cheaper than of the imported MDIs. At present: Bioparox HFA

Prices in € in Hungary in 2006 NameType Original Price By family doctor By specialist Taleum 1 mg CFC MDI free Taleum 5 mg CFC MDI free BerodualHFA MDI FlixotideHFA MDI SpirivaInh. Cap Miflonide In. c. 400 mg

Regulation by the authorities 1st January, 1996: registration of new CFC MDIs ceased by National Institute of Pharmacy under the Health Ministry Registration reviewed every 5 years DPI since 1968 There is no CFC MDI in the Hungarian market Decision IX/19: National Transition Strategy 1998  Co- operation between health and environmental authorities Decision XII/2 Updated Trans. Strategy 2003 Declarations of non-essentiality of CFCs with specific active ingredients, finally in 2007: Sodium Cromoglycate

Declarations of non-essentiality by Hungary Category A: Salbutamol Terbutaline Fenoterol Category B: Beclomethasone Budesonide Fluticasone Category C: Sodium Cromoglycate Category D: Ipratropium Oxitropium Category E: Salmeterol Formoterol Category F: Combination products

There are around 100 medicines for respiratory diseases in the Hungarian market

Transition in the production from CFC MDIs to non-CFC products in Hungary Production only to domestic market Phasing-out of CFCs Active ingredients became obsolete Therapeutic advantages decreased → registration deleted Consortium of 10 big pharmaceutical company → Registration of products with HFA 134a

Prices in Hungary Bioparox nasal spray without prescription 400 dose HFA-134a 6.4 € ( )No subsidy

Prices in Hungary, inh. capsules Spiriva 30 pc Tiotropium& bromide (Boehr&I) 56 €5.6 €90% Miflonide 60 pc 200  g Budesonide Novartis Hungary 7.2 €1.3 €82% Miflonide 60 pc 400  g Budesonide Novartis Hungary 12 €1.4 €86% Brand name Active ingredient Price by by Specialist Subsidy Brand name Active ingredient Price by by Specialist Subsidy fam. doctor fam. doctor

Prices in Hungary, CFA MDIs Berodual 200 dose Ipratropium &bromide, Fenoterol (Boehr&I) 8.2 €0.82 €90% Ventolin 200 dose Salbutamol GSK Poland 3.3 €0.33 €90% Flixotide 120 dose Fluticasone GSK 250  g 40.4 €15.5 €62% Brand name Active ingredient Price by Specialist Subsidy Brand name Active ingredient Price by Specialist Subsidy by family doc. by family doc.