1. 2 Treaty establishing the European Community (EU-6) Signing Ceremony in Rome, Campidoglio - March 25, 1957 Welcome.

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Treaty establishing the European Community (EU-6)

Signing Ceremony in Rome, Campidoglio - March 25, 1957

Welcome

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AIFA – The Italian Medicines Agency

Governanance and maintenance

of the economic ceiling

Marketing Authorisation

Pharmacovigilance

Clinical trials

Independent research

DrugCommunication

Pricing & Reimbursemnt

GMP-GCP Inspections

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The key (common) issues • The assessment process: how safe and

effective a medicine is

• Pricing & Reimbursement: which patients will benefit most

• The transferability of the b/r assessment into in the real life

• Public funding of drug research for a better decision making process: an impossible task for National Agencies?

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Problems coming fromthe European MA Process

Source: J. Avorn, Circulation 2006

• Place in therapy of newly licensed drugs

• ATV (Added Therapeutic Value) assessment for new drugs

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Innovation and cost-effectivenessThe case of new anticancer drugs

• Poor predictivity of “responders”

• Patients with disease progression failures”) identifiable only at follow-up

• Reimbursement of innovative drugs as a function of their “real” effectiveness

Sharing Innovation – Risks - CostsSharing Innovation – Risks - Costs

National Registry of new anticancer drugsNational Registry of new anticancer drugs

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DrugFemale

N.Male

N.Total (F+M)

N. Total (F+M)

%

AVASTIN 77 99 176 11.1

ELOXATIN 221 290 511 32.2

EMEND 7 7 14 0.9

ERBITUX 149 203 352 22.2

FASLODEX 434 0 434 27.4

FOSCAN 0 2 2 0.1

GLIADEL 6 9 15 0.9

TARCEVA 24 37 61 3.8

ZEVALIN 12 9 21 1.3

Total 930 656 1586 100.0

Distribution of patients treatedby drug and gender

N. of Patients:   1586N. of Patients:   1586

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http://oss-sper-clin.agenziafarmaco.it/

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Ethics Committes in Italy:Ethics Committes in Italy: 309Ethics Committes in Italy:Ethics Committes in Italy: 309

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Clinical Trials Clinical Trials perper Phase PhaseClinical Trials Clinical Trials perper Phase Phase

Phase Nr. CTs %

Phase III 1.899 53.8Phase II 1.198 34.0Phase IV 306 8.7Bioeq / Biod 70 2.0Phase I 54 1.5Totale 3.158 100

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CTCTss perper Year Year andand Phase PhaseCTCTss perper Year Year andand Phase Phase

% % % % %

Nr. CTs Phase III Phase II Phase IVBioeq

/Bioav

Phase I

2000 560 61,6 27,5 7,9 2,1 0,92001 610 53,8 33,5 8,8 3,1 0,82002 565 52,4 36,4 7 2,3 22003 565 53,7 35,4 7,7 1,3 22004 607 53,2 35,1 8,1 2 1,5

2005 620 49.5 36.0 9,8 1,1 2.3

Total 3.158 54,5 33,9 8,1 2,1 1,5

Year

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Therapeutic branch CT %

Oncology 1,055 27.5 Cardiology/Vascular diseases 443 11.5 Immunology and infectious diseases 363 9.5 Neurology 311 8.1 Gastroenterology 272 7.1 Endocrinology 224 5.8 Respiratory system diseases 163 4.2 Nephrology/Urology 129 3.4 Hematology 128 3.3 Psychiatry/Psychology 108 2.8 Musculo-skeletal system diseases 105 2.7 Ophthalmology 98 2.6 Dermatology/Plastic surgery 85 2.2 Rheumatology 82 2.1 Gynecology and obstetrics 70 1.8 Genito-urinary system 66 1.7 Anesthesiology 55 1.4 Pharmacology/Toxicology 32 0.8 Pediatrics/Neonatology 23 0.6 Otolaryngology 14 0.4 Traumatology and emergency medicine 7 0.2 Odontology and maxillofacial surgery 6 0.2 Total 3,839 100.0

Clinical Trials per Therapeutic Classification

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The Italian Clinical Trials Registry

• The general sense and direction of research

• Which diseases are investigated by which drug(s) and strategy

• The degree of innovative research in real life

The key issues

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Independent Research

AREAs

• Orphan drugs and rare desease

• Head to head clinical trials

• Pharmacovigilance and appropriateness

Promoted and funded by AIFA

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Aims of the conference

To discussTo discussThe best way to implement evidence in

regulatory decisions

To considerTo considerLicensing, pricing, reimbursement and impact

on population health

To shareTo shareExperiences and points of view

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