1 First EFIC Symposium - Societal Impact of Pain Brussells 4-5 May 2010 Therapeutic strategies for the treatment of pain Paolo D. Siviero Economic Strategy and Pharmaceutical Policy Department Office for Pharmaceutical Policy Italian Medicines Agency -AIFA-
2 Prevalence of chronic pain by country 50% 40% 30% 20% 10% 0% 30% 27% 26% 23% 21% 19% 18% 18% 17% 17% 16% 16% 15% 13% 13% 11% Norway Poland Italy Belgium Austria Finland Sweden Netherlands Germany Israel Denmark Switzerland France Ireland UK Spain Source: Pain in Europe A Report
3 Opioid medicines: consumption in Europe UK GERMANY FRANCE GREECE SPAIN IRELAND ITALY AUSTRIA BELGIUM FINLAND - PORTUGAL Source: IMS Health data 2009 Standard units
4 Opioid medicines: expenditure in Europe 2008 UK GERMANY FRANCE GREECE SPAIN IRELAND ITALY AUSTRIA BELGIUM FINLAND PORTUGAL 700,0 600,0 500,0 400,0 300,0 200,0 100,0 0,0 Source: IMS Health data 2009 Million
5 Laws for pain therapy in Italy In Italy, in recent years, a series of rules have been approved to make the use of analgesic opioid medicines easier in pain therapy. The first step was taken with the law 12/2001. The main points of the law were: 1. new prescription pad for opioid medicine in triplice copy; 2. possibility of prescribing 2 opioid medicines or 2 different dosage of the same medicine for a therapy (maximum of 30 days); 3. home delivery of medicines included in the Annex III bis.
6 Law n 12/2001 Active substances included in the Annex III bis Opioids Cannabinoids * Buprenorphine Codeine Dihydrocodeine Phentanyl Hydrocodone Hydromorphone Methadone Morphine Oxycodone Oxymorphone Delta(9)-tetrahydrocannabinol Trans- Delta(9)- tetrahydrocannabinol *This medicines are not commercially available in Italy. Physicians who want to use these cannabinoids for their patients must apply for their import to Central Narcotics office of the Ministry of Health.
7 Ministerial Decree April 4th 2003 Simplification to the law 12/2001 prescription of active ingredients associations one of which included in the Annex III bis (atropine + morphine, paracetamol+ codeine; propyphenazone +codeine) Elimination of obligation by physician to: - write measures, dosages and route of administration on every copy - retain copy of prescription for six months
8 AIFA determination March 9th 2005 Abolition of Note AIFA number 3 for the association codeine/paracetamol Only Tramadol was subject to note AIFA number 3
9 Tramadol prescription Since October 2009 the note AIFA number 3 "medicines for the treatment of pain was abolished. The medicines, subjected to note 3, are therefore reimbursed by the national health service, without the limitations provided by the note.
10 Tramadol Variation date 27/10/2009 Product data before changes Type of price Public retail price for mutual recognition.(law 449/97 ART.36) included VAT and abolition of regressive markup (FINANZ.2003) Product data after changes Type of price Class NHS A Class NHS A NHS system Only for patient pathology affected NHS system AIFA note Note 3: Class A for pathology AIFA note Type of prescription RNR NOT REPEAT PRESCRIRTION ART.89 D.L.VO 219/06 Type of prescription Public retail price for mutual recognition.(law 449/97 ART.36) included VAT and abolition of regressive markup (FINANZ.2003) Reimbursed RNR NOT REPEAT PRESCRIRTION ART.89 D.L.VO 219/06
11 New law for pain therapy in Italy (1) A very important new law was adopted on March 9th 2010 in Italy, that considers pain as an integral and indispensable patient s therapeutic pattern and takes into consideration the respect, the dignity and integrity'' OF THE PERSON providing equal access to assistance and appropriateness to the specific needs of the sick.
12 New law for pain therapy in Italy (2) Main points: Assesment of pain and use of medicines in case history; Creation of a network for pain treatment and palliative care on a regional basis. It will facilitate the access both to palliative care and pain treatment; Simplification of the prescription for non injectable opioids; No more prescriptions on special pad for opioids but use of the National Service prescription pad.
13 OMS Analgesic Scale If pain hold over or increase If pain hold over or increase 2 Weak opioids with or without adjuvant 1 No opioid medicines- NSAIDs with or without adjuvant 3 Strong opioids with or without adjuvant
14 Total consumption and expenditure for pain therapy in Italy Expenditure Consumption in DDD Source: IMS Health data
15 Consumption according to OMS Analgesic Scale NSAIDs + COX-2 +PARACETAMOL WEAK OPIOID STRONG OPIOID NSAIDs + COX-2 +PARACETAMOL WEAK OPIOID STRONG OPIOID Source: IMS Health data
16 No opioids- NSAIDs with or without adjuvant: Consumption Consumption in DDD/1.000 Ab/ die for pain therapy MOLECULE ACECLOFENAC 0,92 0,82 0,89 0,83 DICLOFENAC 3,33 3,44 3,65 3,60 IBUPROFEN 0,60 0,64 0,84 0,84 INDOMETACIN 0,10 0,09 0,08 0,06 KETOPROFEN 1,98 1,99 2,19 2,31 KETOROLAC 0,25 0,16 0,15 0,14 NAPROXEN 0,55 0,59 0,54 0,54 NIMESULIDE 4,54 3,96 3,85 3,64 PARACETAMOL 0,05 0,10 0,21 0,30 TOTAL 12,32 11,79 12,4 12,26 Source: IMS Health data
17 No opioids- NSAIDs with or without adjuvant: Consumption 5 4, ,5 3 2,5 2 1,5 1 0,5 ACECLOFENAC DICLOFENAC IBUPROFEN INDOMETACIN KETOPROFEN KETOROLAC NAPROXEN 0 NIMESULIDE PARACETAMOL Source: IMS Health data 2009 DDD/1000/ ab die
18 No opioids- NSAIDs with or without adjuvant: expenditure MOLECULE Reimbursed expenditure by NHS for pain therapy ( x 1.000) ACECLOFENAC DICLOFENAC IBUPROFEN INDOMETACIN KETOPROFEN KETOROLAC NAPROXEN NIMESULIDE PARACETAMOL TOTAL Source: IMS Health data
19 No opioids- NSAIDs with or without adjuvant: expenditure 2008 ACECLOFENAC DICLOFENAC IBUPROFEN INDOMETACIN KETOPROFEN KETOROLAC NAPROXEN NIMESULIDE PARACETAMOL Million Source: IMS Health data
20 Weak opioids with or without adjuvant: consumption and expenditure Expenditure Codeine Tramadol Total Consumption* Codeine 0,45 0,38 0,4 0,29 Tramadol DDD/1000 ab/die 0,48 0,55 0,56 0,57 * Consumption is expressed in DDD Source: IMSHealth data
21 Weak opioids with or without adjuvant: consumption and expenditure * Consumption is expressed in DDD Consumption Expenditure Source: IMSHealth data
22 Strong opioids with or without adjuvant: consumption , ,30 0,25 0,20 0,15 0,10 0, BUPRENORPHINE FENTANYL HYDROMORPHONE METHADONE MORPHINE OXYCODONE DIHYDROCODEINE Source: IMS Health data 2009 DDD/1000 ab/die
23 Strong opioids with or without adjuvant: expenditure BUPRENORPHINE FENTANYL 0 HYDROMORPHONE METHADONE MORPHINE OXYCODONE DIHYDROCODEINE Source: IMS Health data 2009 Million
26 Adjuvant medicines: consumption and expenditure Source: IMS Health data CONSUMPTION IN DDD EXPENDITURE
27 Neuropatic pain: consumption and expenditure 0,70 0,60 0,50 0,40 0,30 0,20 0, Expenditure in million PREGABALIN GABAPENTIN GABAPENTIN PREGABALIN Consumption in DDD/1000/ab die GABAPENTIN PREGABALIN
28 PRIALT: an orphan drug for pain therapy (1) PRIALT is indicated to manage severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatments, such as systemic analgesics, adjunctive therapies, or IT morphine. Since the number of patients that required intrathecal terapy was very low, the disease was considered "rare", and Prialt in July, 2001 was designated an orphan medicine
29 PRIALT: an orphan drug for pain therapy (2) On 21 February 2005 the European Commission granted authorization to Marketing for Prialt, which is valid throughout the European Union This authorization was renewed for 5 more years In Italy Prialt granted authorization (AIFA 7/5/2007) and was on sale since 9/7/2007
30 Prialt: consumption and expenditure Consumption Expenditure Source: Traceability hospital data
31 Prescription of strong opioids in EU Oral morphine remains the drug of choice for moderate or severe cancer pain and an important indicator of progress in cancer pain management, according to international guidelines We analyzed the trend in morphine and other strong opioids consumption in Europe Annals of Oncology 20: ,2009
32 Morphine prescription in Europe UK FRANCE GERMANY SPAIN AUSTRIA ITALY BELGIUM PORTUGAL IRELAND FINLAND GREECE Source: IMS Health data
33 Oxicodone prescription in Europe 2006 UK FRANCE SPAIN GERMANY IRELAND ITALY BELGIUM FINLAND AUSTRIA GREECE PORTUGAL Source: IMS Health data
34 Buprenorphine prescription in Europe UK FRANCE SPAIN GERMANY IRELAND ITALY BELGIUM FINLAND AUSTRIA GREECE PORTUGAL Source: IMS Health data
35 Fentanyl prescription in Europe GERMANY SPAIN 0 FRANCE UK ITALY BELGIUM AUSTRIA GREECE IRELAND FINLAND PORTUGAL Source: IMS Health data
36 What is next? Only one (opioid) product intended for submission this year to the EMA for the treatment of chronic pain. There were two scientific advice requests in 2009 on products for the treatment of chronic pain and two in However, these do not appear to have been translated into eligibility / rapporteurship requests for the centralised procedure yet.
37 Discussion In Europe the trend in morphine consumption increased significantly only in UK, whereas remained steady in other countries; After the launch into the market of new molecules, such as oxicodone, buprenorphine and fentanyl, we show in all European countries an increase in consumption, especially for oxicodone. It is unclear if this is appropriate but is definitely not in accordance with international guidelines.
38 Social Impact of Pain Absenteeism from work due to pain causes losses of 34 billion euros per year to the European economy; Most available studies present in literature, show that chronic pain such as arthritis has a significant impact on occupational performance in the workplace and contributes to decrease productivity, reduce rates of employment, personal and societal economic cost; Sources: Impact and social cost of chronic pain; Care 3, 2009 Work.2010;35(3): J Manag Care Pharm Feb;16(1 Suppl B):S9-13.
39 Social Impact of Pain Despite the extensive utilization of narcotic analgesics, pain is often uncontrolled; Inappropriate use of narcotic analgesics leads to uncontrolled pain management, dependance, and may lead to patient deaths, creating a tremendous cost burden on the health care system. The impact of opioid dependence on employers, managed care, and society is significant; Sources: Impact and social cost of chronic pain; Care 3, 2009 Work.2010;35(3): J Manag Care Pharm Feb;16(1 Suppl B):S9-13.
40 The Italian perspective: cost releted to pain In Italy, pain therapy pharmeceutical expenditure is extimated to cost more than 200 million euros; Annual pharmaceutical expenditure for opioid medicine is over 50 million euros of which over 30 million euros is hospital expenditure; Cost-benefit analysis comparing the cost data resulting from absence from work and the need for medicalcare leads to the conclusion that treated patients cost to the society much less than the untreated patients. Sources: J Manag Care Pharm Feb;16(1 Suppl B):S9-13.
41 The Italian persective: open questions The difference between acute and chronic pain is recognised in Italy; In Italy the use of analgesic medicine for the treatment of pain is lower than in other EU countries but there is a desire to bring Italy in line with the rest of the world; Often it may be thought that the prolonged somministration of opioid medicines can cause opiate addiction as drug habit.
42 Conclusion Italian NHS has begun a process for the simplification of procedures to facilitate the access to medicines for the treatment of pain. AIFA may reassess the distinction beetween acute and chronic pain, and the class of reimbursement for such medicines.
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