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Decisions on market authorization MA and reimbursement have different durations across countries because of health technology assessment HTA procedures and negotiations between manufacturers and national authorities. To overcome this delay, France has implemented a Temporary Authorization for Use ATU program that allows early access to drugs before MA, in order to treat patients with unmet medical needs. The objectives of our study were to establish the added therapeutic benefit ATB of ATUs for solid tumors and to investigate the correlations between three tools evaluating ATB and survival outcomes and drug costs. The latter score determines reimbursement and national market access. Thirty-five drugs in 39 indications were granted ATUs. All of them obtained MA and derived a clinical benefit to be reimbursed by the Social Security. Twenty-eight In conclusion, many patients were treated with innovations before MA thanks to ATU, although there are discrepancies between ATB scales, hence the importance of international collaboration in the evaluation of innovative therapies. Keywords: added therapeutic benefit; drug costs; early access program; health technology assessment; survival outcomes. Abstract Decisions on market authorization MA and reimbursement have different durations across countries because of health technology assessment HTA procedures and negotiations between manufacturers and national authorities. Publication types Research Support, Non-U. Substances Antineoplastic Agents.
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Decisions on market authorization MA and reimbursement have different durations across countries because of health technology assessment HTA procedures and negotiations between manufacturers and national authorities. To overcome this delay, France has implemented a Temporary Authorization for Use ATU program that allows early access to drugs before MA, in order to treat patients with unmet medical needs. The objectives of our study were to establish the added therapeutic benefit ATB of ATUs for solid tumors and to investigate the correlations between three tools evaluating ATB and survival outcomes and drug costs. The latter score determines reimbursement and national market access. Thirty-five drugs in 39 indications were granted ATUs. All of them obtained MA and derived a clinical benefit to be reimbursed by the Social Security. Twenty-eight In conclusion, many patients were treated with innovations before MA thanks to ATU, although there are discrepancies between ATB scales, hence the importance of international collaboration in the evaluation of innovative therapies. Keywords: added therapeutic benefit; drug costs; early access program; health technology assessment; survival outcomes. Abstract Decisions on market authorization MA and reimbursement have different durations across countries because of health technology assessment HTA procedures and negotiations between manufacturers and national authorities. Publication types Research Support, Non-U. Substances Antineoplastic Agents.
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