Mezghani Bassem -Tunisia Mezghani... · Mezghani Bassem -Tunisia Lead Group Log Drug Approval -...
Transcript of Mezghani Bassem -Tunisia Mezghani... · Mezghani Bassem -Tunisia Lead Group Log Drug Approval -...
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
• Tunisian Health System: Social Welfare with a Public insurance for all
citizens including Indigent persons.
(± Additional private insurance)
• Choice: Public Hospital/Private Clinics (Indigents Public H)
• National Drug Administration
Registration for definitive Approval: one or several diseases / uses
Case by case Approval: Drugs with no current Registration
Approval with restrictions to a person, in a specific use and limited
duration
• National Research Ethics Committee: Approval for drugs use in Clinical
Trials ( & National Drug Administration)
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
• Salah Azaiz Cancer Institute Tunis –Tunisia
Annually: ≈80 newly diagnosed; ≈140 received Pacli-Carbo CT (All)
Pharmacy:
► Drugs with Registration and Approval: “Efficient” System (!! Drugs
availability in the National Central Pharmacy – Number of Providers;
Imported/local Made)
► Drugs with no current Registration or with Registration but no
Approval for the planned use
1) Practionners: Specific applications to the National Drug
Administration for a case by case Approval: If accepted
2) Pharmacy: Drug is bought from the National Central
Pharmacy
3) Drug administration
4) Social Welfare reimbursement (Indigent persons: Hospital)
► Drugs – Clinical Trials
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Drug Approval -disease
Approval -use Procurement Availability Hospital Pharmacy
Paclitaxel Ovarian Cancer
• First line adjuvant
• Metastatic disease
• Local• Imported
Out of stock Events: Rare
Short delay++
No protocolsamendments
Carboplatin • OvarianCancer
• Others
All Imported
Gemcitabine OthersOvarianCancer
Imported
Docetaxel OthersOvarianCancer
• Local• Imported
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Drug Approval - disease Approval -use
Procurement Availability
Cisplatin • Ovarian Cancer• Others
All Imported
Doxorubicin • Ovarian Cancer• Others
All Imported
Topotecan
Pegylated LiposomalDoxorubicin
Albumin-BoundPaclitaxel
Trabectedin
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Drug Approval - disease Approval -use
Procurement Availability
Bevacizumab • Others• Ovarian Cancer
Imported
Pazopanib • Others• Ovarian Cancer
Imported
Olaparib
Niraparib
Rucaparib
Erlotinib
Pemetrexed • Others• Ovarian Cancer
Imported
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Regimen / Drug Approval Procurement Availability
BleomycinEtoposideCisplatin
ChoriocarcinomaEmbryonal Carcinoma
Imported
VincristinActinomycinCyclophosphamide
• Ovarian Cancer• Others
Imported
Ifosfamide • Ovarian Cancer• Others
Imported
FluorouracilOxaliplatin
• Others• Ovarian Cancer for
FU
Imported
Rare Ovarian Tumors
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Survey
• January 2018
• Medical Oncologists: Hospital / Private Clinics
• 15 Questions
Drugs availability
Complying with Updated Guidelines and Standard of Care
Use of Unregistered Drugs
Use of regimens inspired by the design of Current Clinical Trials
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
1) Availabilty of Paclitaxel and Carboplatin : Frequency of out of Stock events thatled at least to to an administration delay or require a protocol amendment
13%
60%
20%
7%
Never
Rarely (<5/years)
Sometimes (5-10/year)
Frequently (>10/year)
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
2) 3 weekly Paclitaxel and Carboplatin Regimen in an adjuvant use : Number of cycles?
14%
14%
72%
6 cycles All stages
6-8 cycles All stages
3-6 cycles for stage I FIGOand 6 cycles for others
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
3) Dose-dense Paclitaxel + 3 weekly Carboplatin regimen in an adjuvant use (GOG262, ICON 8 Design)
43%
43%
14%
Never
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
4) Dose-dense Paclitaxel + weekly Carboplatin AUC 2 regimen in an adjuvant use (MITO 7, ICON 8 Design)
85%
15%
Never
Rarely
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
5) 3 weekly Carboplatin regimen in an adjuvant use in Stage I FIGO if chemotherapy isappropriate
64%
36%Never
Rarely
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
6) 3 weekly Carboplatin regimen in an adjuvant use in Eldery >70 Stage III/IV FIGO
69%
31%
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
7) Weekly Paclitaxel 60mg/m2 + Carboplatin AUC 2 regimen in an adjuvant use in Eldery >70 Stage III/IV FIGO (EWOC 1 Design)
31%
54%
15%
Never
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
8) Bevacizumab + Paclitaxel-Carboplatin regimen in an adjuvant use in case of Residualdisease or Stage IV FIGO (ICON 7 Design)
42%
50%
8%
Never
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
9) Maintenance Therapy with weekly Paclitaxel regimen following adjuvant chemotherapy
77%
15%
8%
Never
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
10) Maintenance Therapy with 4 weekly Paclitaxel regimen following adjuvant chemotherapy
92%
8%
Never
Rarely
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
11) Maintenance Therapy with Bevacizumab following adjuvant chemotherapy + Bevacizumab
73%
18%
9%
Never
Rarely
Frequently
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
12) Bevacizumab Addition to Chemotherapy in patients with Platinum ResistantOvarian Cancer (AURELIA Design)
50%50%Never
Rarely
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
13) Platinum Sensitive Recurrences: Therapeutic protocols?
73%
9%
18%
CT 3 +_ Surgery
CT 6 +_ Surgery
CT until Progression
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
14) Platinum Sensitive Recurrences: Chemotherapy Regimens?
91%
9%
Paclitaxel- Carboplatin
Gemcitabin - Platinumbased
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
15) Platinum Sensitive Recurrences: Bevacizumab use + Chemotherapy?
55%
45% Never
Rarely
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Medical Therapies in Ovarian Cancer
The Arabic Perspectives
Mezghani Bassem -Tunisia
Lead Group Log
Conclusion
• Daily Practice
All patients ⸧ Indigents receive conventional CT adequately (Rare
delays Rare Out of Stock events)
Limited access to innovative drugs Limited Financial
resources (Tunisian Health System)
• National Drug Administration Registration/Specific Approval
• Clinical Trials National Research Ethics Committee & National Drug
Administration Approval for drugs use in Clinical Trials