OUTPATIENT ONCOLOGY CARE IN FRANCE LEVERS AND BARRIERS FOR HOME CHEMOTHERAPY. Dr François Sarkozy Chairman

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OUTPATIET OCOLOGY CARE I FRACE LEVERS AD BARRIERS FOR HOME CHEMOTHERAPY Dr François Sarkozy Chairman AMGE- HH Market investigation Research results Results June May 206 206 Paris, st ovember 206

HOME HOSPITALISATIO (HH) FOR CHEMOTHERAPY IS OT THAT COMMO AD COCETRATED I A FEW FRECH CETRES OLY Today, HH is quite rare in any therapeutic areas. It only exists in isolated centres and represents ~% of total hospital care expenditure Availability varies throughout France (5 regions generating 50% of the business, discrepancies within regions) Centres rarely function on a for-profit basis With limited chemotherapy services Even if a range of services is available, activity tends to focus on complex dressings, intensive nursing / palliative care and enteral nutrition Chemotherapy comes in 2 th position When considering all hospital stays combined, chemotherapy at home barely represents 3% of HH services, and 0.7% of chemotherapy stays. Chemotherapy at home has a high regional concentration, with just 4 regions representing more than 80% of the French national total 3 of 25 authorised centres provide 40% of the national total (number of days): Santé Service, APHP, Centre Léon Bérard Recent signs of change on a national level and in certain regions: A shift towards outpatient treatment Ministerial budget granted to help cover some costs Commitment shown by certain Regional Health Agencies (ARS) AMGE- HH investigation Market Research results Results June June 206 206 2

The image part with relationship ID rid rid2 was not found in in the file. 4 REGIOS REPRESET 83 % OF THE HH FOR CHEMOTHERAPY ormandie Pays de la Loire - Bretagne Paris Centre Poitou-Charentes - Centre Limousin 2 2 2 8 2 2 2 ord Pas de Calais Val de Marne - Essonne Alsace-Lorraine Bourgogne Franche Comté Rhône-Alpes - Auvergne PACA Martinique AMGE- HH investigation results Board of Directors Midi-Pyrénées - Aquitaine Languedoc-Roussillon 3

DUE TO ITS PERCEIVED COMPLEXITY, HH IS OLY AVAILABLE FOR A FEW CHEMOTHERAPY DRUGS Organisation and operational procedures within HH centres are vastly different and dependent on Prescribing centres for the choice of products Each HH with specific organisation and procedures (use of Chemo software interface, private/ salaried nursing staff, in-house pharmacy or dependent on prescribing centre, etc.) The complexity of chemotherapy at home being perceived as high, suitability is limited to a few protocols to enable capitalisation on investment and expertise, and to ensure a regular flow of patients Hematologic malignancies are the most common forms of cancer benefiting from HH (50% of hospital stays) mostly using drugs on the list (Velcade, Vidaza and Mabcampath) Until now, HH has ensured that chemotherapy at home is provided with the same quality and safety conditions as for outpatient departments AMGE- HH investigation Market Research results Results June June 206 206 4

TODAY THERE ARE FOUR MAI HH ORGAIZATIOAL MODELS. Large multipurpose HHs collaborating with several prescribing centres Santé Service Ile de France APHP 2. HHs as part of a cancer centre, specialised in the management of cancer patients (chemotherapy at home, palliative care, transfusions) Léon Bérard (Lyon) Bagatelle (Bordeaux) 3. Multipurpose HHs organised into networks within their regions (same methods of working & protocols) ESCADEM network in Limousin - Organised on the impetus of a HEMATOLIM network and the regional health agency, - Based on 4 medium-sized HH centres Wide availability of drugs > 000 patients / year Flexibility of organisation HH's own in-house pharmacy & cytotoxic rehabilitation unit (CRU) Wide availability of drugs 600 patients / year In-house pharmacy & CRU shared w. centre Significant delegation of patient care 3 drugs < 00 patients/ year/ HH Standard protocols Disparate organisation Limited delegation of responsibility 4. Multipurpose medium-sized HHs offering limited chemotherapy services AMGE- HH investigation Market Research results Results June June 206 206-2 drugs < 50 patients/ year Limited delegation of responsibility 5

DECISIO CRITERIA FOR HH MIGHT VARY FROM CETRE TO CETRE WITH COMMO FEATURES Saturation of outpatient departments Specific features and skills of the HH in question Drug profile (toxicity, stability, reconstitution) Feedback on experience from the prescribing centre and trust vis a vis the HH organization Operational methods & communication between departments and HH Patient profiles & selection Economic factors AMGE- HH investigation Market Research results Results June June 206 206 6

The image part with relationship ID rid rid2 was not found in in the file. LEVERS AD BARRIERS FOR THE USE OF HH... Levers encouraging the development of HH Barriers/ concerns which may be significant Saturation of outpatient departments Encouragement from regional health agencies (ARS) Strength of conviction by a charismatic coordinator & vision of certain prescribers Reputation of HH (proximity, experience, qualifications in oncology, team/ trained nurses) Clear procedures and interfaces Seen as a solution that is suited to certain drugs and patient profiles (older patients living a long way from prescribing centres) Drug knowledge (experience) and usage limitations Economic factors (cost of drugs) Potential loss of business & resource subsidies Fear of additional, unpaid workload for the prescribing centre (e.g. in the absence of oncohaematological expertise within the HH) Coordination Difficulty in involving GPs/ Familiy Doctors Response to cases of adverse reaction Lack of well defined interfaces (prescription software, etc.) and faith in HH In some regions, services are already available (e.g. Franche Comté) in terms of local outpatient care (specific network public hospitals) AMGE- HH investigation Market Research results Results Board Board of Directors of Directors 7

HH RECOMMEDATIO FOR A EW PROTOCOL DEPEDS O THE PLAYERS IVOLVED AD SOME SPECIFIC CRITERIA... 4 key players are involved in the decision process Prescribing centre: the prescriber and the hospital pharmacist HH: the treatment director / coordinating physician and the pharmacist The decision to offer a new HH protocol lies within the hands of the prescribing centre (physician and pharmacist - feasibility of cooperation with the HH) Drugs that have already been used in outpatient care for at least to 3 years and meet certain criteria (toxicity, stability, administration, chemo go-ahead) Patient selection depends on a wide range of criteria included in French national health authority - AAES - recommendations Patient distance from hospital is the main Environment criterion Availability of the family doctor may be a key condition in some HHs, but Protocol complexity and management of adverse reactions Significant investment for a small number of patients, Economic criteria may be included when drugs are expensive and not included on the drug list In the case of very high costs, discussions may be undertaken with regional health agencies / French national health services AMGE- HH investigation Market Research results Results June June 206 206 8

...DRUGS MUST BE SUITED TO HH. Drug's toxicity profile, analysed by both the hospital pharmacist and the HH pharmacist Drug toxicity (administration between injections) Interaction with other medicines 2. Reconstitution (for HHs with a cytotoxicity rehabilitation unit) and stability of the drug (when the drug is prepared and sent out by the hospital's in-house pharmacy) Ideal: 48 hrs. Usually: 24 hrs. Exceptional but manageable: 6 hrs. Conditions for transportation 3. Administration, under the stewardship of the HH treatment director (coordinating physician) Procedures for basic chemo go-aheads Administration duration, with specific rules depending on HHs (option of using private nursing staff): 2 hrs. on average Basic administration method with a preference for either subcutaneous administration or a central venous catheter (CVC) Preliminary identification of potential discrepancies / errors / risks for the patient, and behaviours to adopt AMGE- HH investigation Market Research results Results June June 206 206 9

I A EVIROMET THAT IS FAVOURABLE TO THE DEVELOPMET OF OUTPATIET CARE, HHS EED TO BE MORE PROFESSIOAL AD SPECIALISED Support from Authorities A significant development potential Additional 4 M budget envelope for drugs A shift towards outpatient treatment Elimination of authorisation requests for beds Recent increase in fixed price groups (GHT - especially in chemotherapy) Inclusion of HH in regional health agency treatment plans Increasing number of patients Patient willingness Evolution in treatments: increasingly fragmented and more prolonged, with simplified administration methods that suit HH. HH requires high professional standards to meet expectations Interfaced information systems between HH and prescribers (chemo software) Professionalisation of those involved in HH to reassure prescribing physicians - Medicalisation of teams (onco-hematological expertise) Chemo go-ahead and adverse reaction management - Training for nurses Investment in cytotoxicity rehabilitation units / in-house pharmacies - Optimisation lever for logistics as long as a certain number of services are performed AMGE- HH investigation Market Research results Results June June 206 206 0

The image part with relationship ID rid4 was not found in the file. Patient Training May 206.