ANTI-PD1 DRUGS- ARE THE REIMBURSED INDICATIONS OF THE MARKETING AUTHORIZATION RESPECTED?
Author(s)
Therasse C1, Paubel P2, Cordonnier A1, Fusier I1
1AP-HP, AGEPS, Paris, France, 2General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP); Health Law Institute, INSERM UMR S 1145, Paris Descartes ; Faculté of pharmacy, Paris Descartes University, Sorbonne Paris Cité, Paris, France
OBJECTIVES In France, hospital drugs are reimbursed only for indications of the marketing authorization (MA) that have been assessed as having a medical interest. Off-label uses are also reimbursed if they are scientifically justified. The uses of anti-PD1 drugs (nivolumab, pembrolizumab) are closely monitored by the authorities due to the high treatment costs (€68,530-91,375 per patient per year) and the number of indications under development. In 2017, nivolumab was reimbursed in melanoma, non-small cell lung cancer (NSCLC) and renal carcinoma (RC) (2017/12) and pembrolizumab was reimbursed in melanoma (2017/01) and NSCLC (2017/05). The objectives of this study are to evaluate the costs and the distribution of the uses of anti-PD1 drugs (MA reimbursed; off-label) in the public hospitals of Paris (AP-HP). METHODS Analysis of data on anti-PD1 drugs available on e-PMSI (French Hospital National Database) since their first registrations for reimbursement: consumptions, costs, ICD10 diagnosis of the related hospital stays. RESULTS Anti-PD1 drugs were used in 15/37 hospitals of the AP-HP in 2017 (Jan-Nov) for a total cost of €25,059,345 (68% for nivolumab). According to ICD10 diagnosis, 6,531/7,680 hospital stays (85%) were associated with a reimbursed MA indication (1% for NSCLC and 16% in melanoma for pembrolizumab; 55% in NSCLC, 22% in melanoma and 5% in RC for nivolumab). The 5 most frequent ICD10 diagnosis associated with off-label uses were: other and unspecified malignant neoplasm of skin (16%); Hodgkin lymphoma (14%); secondary malignant neoplasm of other and unspecified sites (9%); secondary malignant neoplasm of respiratory and digestive organs (5%); malignant neoplasm of bladder, unspecified (5%). CONCLUSIONS It seems that the prescribers of the AP-HP have been properly made aware of the appropriate use of the anti-PD1 given that the prescriptions of these innovative and expensive drugs are made in the indications both authorized and reimbursed.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PCN207
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Organizational Practices, Real World Data & Information Systems
Topic Subcategory
Academic & Educational, Health & Insurance Records Systems, Prescribing Behavior, Reimbursement & Access Policy
Disease
Oncology
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