UK5 Day2 France Presentation LONDRES CCO

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Information about UK5 Day2 France Presentation LONDRES CCO

Published on May 2, 2008

Author: Lassie


Slide1:  Defining a High Performance Cancer System: The French System Christine Lepage Laurent Borella Laurent Cals London 24 & 25 June 2007 Slide2:  1 The INCa’s policy to improve access to innovative cancer drugs Slide3:  One of the goals of the Cancer Plan: equal access to quality and innovation  a model = the drug Rise in global costs  challenge = control costs through best use Tous médicaments hôpital (AFSSAPS) Promoting equal access and best use of innovative drugs in France Slide4:  Equal access, guaranteed funding, including off-label use New systems of funding in 2004 for a specific list of expensive and innovative drugs  ”medicines“ decree of 24 August 2005 : General commitments: quality procedures, multidisciplinary consultations, respect of guidelines, obligatory participation in the Observatories Specific commitments for innovative drugs: compliance with the Marketing Authorisation or with best use guidelines defined by the INCa exceptionally, the prescriber can justify a prescription by making reference to studies from learned societies or from the international scientific literature Promoting equal access and best use of innovative drugs in France Slide5:  Best use guidelines The INCa, in collaboration with the AFSSAPS and the HAS, defines the protocols of off-label prescription: According to the scientific context at the time of writing Temporary and progressive according to available data and requests for, or changes to, Marketing Authorisations by the pharmaceutical laboratories Considering the possible directions to take in terms of clinical research or therapeutic strategy. Promoting equal access and best use of innovative drugs in France Slide6:  Knowledge, anticipation Updated databases of drug use:  regional and national  qualitative and quantitative Compare this information with epidemiological cancer data and with actions undertaken in the framework of the Cancer Plan Describe and quantify the penetration of innovation Impact of measures taken at the national, regional or local level concerning drugs Cost of treatment and its progression Drug Observatories: goals Slide7:  Regional and inter-regional observatories: 22 at the end of 2006 Slide8:  2 The cancer treatment authorisation procedure in France Slide9:  The Cancer Plan’s solution for access to cancer treatment Cancer treatments will not be concentrated in specialised centres but will be made available in all health establishments for part, or all, of the therapy However, the establishments will not be authorised to undertake cancer treatment unless they respect ”quality criteria“ and have a ”minimum activity threshold“ What will change … ”quality“:  What will change … ”quality“ All establishments are required to adhere to the obligatory quality conditions and the activity thresholds within a period of two years. Obligatory (INCa) : Diagnostic disclosure Multidisciplinary consultation Personalised care programme Adherence to guidelines Access to supportive care Access to clinical trials And participation in a network recognised by the INCa What will change … ”thresholds“, ”recommendations“:  What will change … ”thresholds“, ”recommendations“ The annual minimum activity thresholds have been established for different treatments, by organ or pathology where appropriate Opposable quality criteria (consent) and recommendations on the quality of each treatment, as well as quality assurance indicators, have been defined by the Institut National du Cancer The threshold decree:  The threshold decree Minimum annual activity thresholds which must be respected by health establishments: For external radiotherapy, per site with at least two machines: at least 600 patients per year For chemotherapy at least: 80 patients per year or 50 patients for outpatient treatment A minimum annual activity per cancer and per establishment for surgery:  A minimum annual activity per cancer and per establishment for surgery Breast cancers 30 per year Digestive cancers 30 per year Urological cancers 30 per year Thoracic cancers 30 per year Gynaecological cancers 20 per year ENT cancers 30 per year Slide15:  Adéquation niveau/options 2003 96,5% 92% 93% 3% 6% 6% 0,5% 2% 1% 78,5% 14,5% 65,7% 78% 14% 31,3% Slide16:  3 Breast Cancer Screening The most frequent cancer in women :  The most frequent cancer in women The number of new cases has almost doubled over the last 20 years 42,000 new cases estimated in France in 2000 Annual average rate of progression: +2.4% per year Main cause of death by cancer in women (11,000 deaths in 2003) Organised breast cancer screening:  Organised breast cancer screening Organised screening by mammography started between 1989 and 1991 National roll-out in March 2004 Aimed at women aged from 50 to 74 Examination proposed every 2 years Each mammography is systematically subject to a second expert reading by a radiologist The examination is free Coordinated by a local management structure Organised breast cancer screening:  Organised breast cancer screening Technical aspects: A mammography (2 per breast frontal and oblique) and a clinical examination Mammography done in private and public radiology practices 1st reading: the radiologists must have read at least 500 mammographies per year. 2nd reading: the radiologists must read at least 1500 radiographies per year Adherence to strict criteria Strict safety standards for equipment Regular checks by the AFSSAPS (French drug agency) Plan: to progressively change over to digital mammography Evaluation of the individual and organised screening programme:  Evaluation of the individual and organised screening programme Two systems of screening in France: Organised screening and individual screening Rate of screening: 72% The participation rate for women rose from 33.6% in 2003 to 40.2% in 2004 and 45.1% in the target population in 2005 A cancer rate of 6.6 for 1000 screened women. Among the screened cancers, 6.7% were detected by the second reader The cost of organising cancer screening was estimated at 70M€ in 2006 Slide21:  4 Colorectal Cancer Screening Colorectal cancer:  Colorectal cancer Colorectal cancer is frequent in Western countries Groups at risk are now starting to be identified as well as the characteristics of the adenoma-cancer sequence, permitting development of a screening strategy. A large consumption of vegetables reduces risk, whilst a sedentary lifestyle and high calorie intake increases risk of developing the cancer. It is now well established, in countries with a high risk, that the organisation of mass screening, based on a test for occult bleeding in the faeces, leads to a reduction in death by colorectal cancer. Colorectal cancer:  Colorectal cancer 3rd most frequent cancer in France 37,000 new cases estimated in France in 2000 Annual rate of progression: + 0.99% in men and + 0.83% in women 16,000 deaths in 2003 Colorectal cancer screening:  Colorectal cancer screening Progressive implementation of a national policy (planned for end of 2007) Organised screening every two years 50-74 years (age range recommended by the European Union) Test: look for occult bleeding in the faeces Choice of a limited number of laboratories Only 1 sort of test used Managed by the local management structures People at high or very high risk are subject to different procedures with a coloscopy done straight away Participation rate 42% (in 19 counties) Colorectal cancer screening Pilot programme in 4 counties:  Colorectal cancer screening Pilot programme in 4 counties First results in pilot programmes (Côte d’Or, Haut-Rhin, Ile-et-Vilaine, Saône-et-Loire) 621,449 people aged from 50 to 74 invited  324,389 tests done (52.2%)  9427 positive (2.9%)  7927 coloscopies (84.3%)   763 cancers 2623 adenoma (2.3 for 1000 screened) (8 for 1000 screened) Slide26:  52 avenue André Morizet ● 92513 Boulogne-Billancourt Cedex ● France Tél. +33 (0) 1 41 10 50 00 ● Fax +33 (0) 1 41 10 50 20

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