Analgesics for the treatment of pain in Italy

Transcription

1 Societal Impact of Pain Brussels 3-4 May 2011 Analgesics for the treatment of pain in Italy Giovanni Tafuri, PharmD Pharmaceutical Policy Unit - Italian Medicines Agency (AIFA)

2 Legislation milestones of pain therapy in Italy (1) Law 39/1999: established citizens right to access palliative care and set up a programme for the creation of hospices in each Italian Region. Law 12/2001: aimed at a more effective treatment of pain in end-of-life care and in patients with serious chronic pain; home delivery of opioid analgesics. DM 4 April 2003: simplified medical prescription of opioid analgesics including combinations (e.g. atropine + morphine; codeine + paracetamol); Law 49/2006: distinction between potentially abusive substances and the related medicinal products.

3 Legislation milestones of pain therapy in Italy (2) DM 18 April 2007: extended the use of opioid analgesics to serious pain of various nature (e.g. in tumours, surgery, bone fractures etc.). Law 38/2010: further simplification of access to medications for treatment of pain and palliative care; inclusion of pain levels into patients case history; education of health care professionals; use of a simplified prescription form.

4 The old three-part opioid prescription form

5 The new simplified prescription form

6 Regulatory actions for analgesics March 2005: Previous restrictions for reimbursement to specific patient populations (mild to moderate pain in cancer or in degenerative diseases) for the combination codeine + paracetamol are abolished and it becomes fully reimbursed in pain treatment by the Italian National Health Service. October 2009: The same restrictions are abolished for tramadol.

7 Opioid availability in Western European countries Source: Cherny NI, Baselga J, de Conno F, Radbruch, L. Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative. Annals of Oncology (2010) 21:

8 NHS retail expenditure for pain treatment in Italy N H S s a le s ( x ) Italia - Spesa rimborsata per terapia del dolore: analisi del trend 1,7% 13,4% 4,5% spesa rimborsata per terapia del dolore 9,1% variazione rispetto all'anno precedente

9 D D D C o n s u m p tio n (x ) DDD consumption for pain treatment in Italy Italia - Consumi in DDD per terapia del dolore: analisi del trend (mercato rimborsato) ,4% 6,9% 1,2% consumi per terapia del dolore (mercato rimborsato) variazione rispetto all'anno precedente 4,1%

10 MORPHINE Italian NHS retail expenditure for opioid analgesics FENTANYL OXYCODONE PARAC./CODEINA TRAMADOL BUPRENORPHINE HYDROMORPHONE NHS expenditure ( x 1.000)

11 MORPHINE Retail (reimbursed) consumption of opioid analgesics in Italy FENTANYL OXYCODONE PARAC./CODEINA TRAMADOL BUPRENORPHINE HYDROMORPHONE DDD Consumption (x 1.000)

12 Retail Consumo consumption in SU per la in classe Standard N2A0 - Incidenza Units della for N2A0 ATC sul class totale mercato N2A0 1,00% 0,80% 0,60% 0,40% 0,20% 0,00% U K IR ELA N D G R EEC E G ER M A N Y A U S T R IA F R A N C E F IN LA N D B ELG IU M I TA LY S P A I N S ta n d a rd u n its % P O R TU G A L (stima)

13 P O R T U G A L G R E E C E 0,03 0,025 0,02 0,015 0,01 0,005 0 Retail ex factory sales for ATC class N2A0 Fatturato ex-factory classe N2A0: Incidenza della N2A0 sul totale mercato G E R M A N Y U K I R E LA N D A U S T R I A S P A I N B E LG I U M F I N LA N D F R A N C E I T A LY (stima) % ( )

14 GREECE 35% 30% 25% 20% 15% 10% 5% 0% Morphine: incidenza del fatturato rispetto al totale N2A0 FRANCE UK PORTUGAL GERMANY AUSTRIA ITALY BELGIUM IRELAND SPAIN FINLAND Morphine retail sales (% of N2A0) (stima)

15 GREECE 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Morphine: standard incidenza dei unit consumi retail consumption (SU) rispetto al totale (% of N2A0) PORTUGAL FRANCE BELGIUM GERMANY SPAIN UK AUSTRIA ITALY IRELA ND FINLA ND (stima)

16 ITALY 35% 30% 25% 20% 15% 10% 5% 0% Buprenorphine retail sales (% of N2A0) Buprenorphine: incidenza del fatturato rispetto al totale N2A0 PORTUGAL BELGIUM IRELAND SPAIN FINLAND UK AUSTRIA GERMANY (stima)

17 12% 10% 8% 6% 4% 2% 0% Buprenorphine: incidenza standard dei consumi unit (SU) retail rispetto consumption al totale N2A0 (% of N2A0) PORTUGAL SPAIN BELGIUM FINLAND GERMANY AUSTRIA UK ITALY IRELAND (stima)

18 80% 70% 60% 50% 40% 30% 20% 10% 0% Fentanyl: incidenza del fatturato rispetto al totale N2A0 S PA IN BELG IUM FRANCE PO RTUG AL G REECE AUS TRIA IRELA ND ITA LY FINLA ND UK Fentanyl retail sales (% of N2A0) (stima)

19 UK 25% 20% 15% 10% 5% 0% Fentanyl: standard incidenza dei unit consumi retail (SU) consumption rispetto al totale (% N2A0 of N2A0) S PA IN PO R TUG A L B ELG IUM A US TR IA G ER MA NY FR A NCE FINLA ND ITA LY IR ELA ND (stima)

20 SPAIN 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Oxycodone retail sales (% of N2A0) Oxycodone: incidenza del fatturato rispetto al totale N2A0 FINLAND GERMANY ITALY UK IRELAND FRANCE BELGIUM AUSTRIA (stima)

21 Oxycodone: standard incidenza unit dei consumi retail (SU) consumption rispetto al totale (% N2A0 of N2A0) 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% FINLAND ITALY GERMANY BELGIUM SPAIN FRANCE IRELAND UK AUSTRIA (stima)

22 DDD hospital consumption DDD Fentanyl Morphine Opioid combinations with paracetamol Tramadol Oxycodon

23 Hospital packages packages Fentanyl Morphine Opioid combinations with paracetamol Tramadol Oxycodon

24 NHS hospital expenditure NHS expenditure Fentanyl Morphine Opioid combinations with paracetamol Tramadol Oxycodon

25 Conclusions Opioid analgesics consumption in Italy remains lower than in some other EU countries. However, the importance of the adopted legislative and regulatory actions is confirmed by the increasing trends in expenditure and DDD consumption. Constant monitoring of the impact of the most recent legislation in the effort to align Italy with other EU countries for the treatment of pain.