ARE ACCELERATED APPROVAL MECHANISMS A PREDICTOR TO EARLY ACCESS AND COVERAGE? A GLOBAL STUDY OF CANCER DRUGS
Author(s)
Tzouma V, Efthymiadou O, Mills M, Kanavos P
London School of Economics and Political Science, London, UK
Presentation Documents
OBJECTIVES: To explore the interrelationship between accelerated approval schemes for cancer drugs and national HTA processes across thirteen jurisdictions globally, by investigating the impact HTA and value assessment has on drugs approved through accelerated pathways. METHODS: RESULTS: Preliminary analysis indicates that market access for drugs authorised under an early access mechanism continues to rely heavily on HTA requirements. Additionally, HTA for these drugs does not necessarily lead to positive recommendations and may result in longer HTA review processes than drugs approved under standard MA. Moreover, some countries often resort to special funding arrangements to enable access to cancer drugs. CONCLUSIONS: Accelerated approval pathways do not guarantee coverage or early market access at population level and may result in delays in access. Alternative data sources and evidence to meet HTA requirements are important, including real world data generation or managed entry schemes, in order to enable access to new cancer therapies.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN253
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Oncology