Accelerated Approval and Access Schemes: A mapping of policies across the globe and the impact of accelerated approval on the HTA of new oncology medicines


May 2017 – July 2018

Accelerated Approval and Access Schemes

Accelerated approval pathways have been established by the FDA in the USA, the EMA in the EU, and other regulatory agencies in Canada, Japan and Brazil, among others, and aim to enable faster access to the market and the patient community of medicines that hold significant promise from a therapeutic standpoint in early stage clinical development.

A global survey and a comprehensive literature review were undertaken to identify, map and analyse current policies and practices of early regulatory approval of new drugs and of national early and/or accelerated access schemes from an international and comparative perspective and explore their implications for coverage and access.  

Drugs that are of major interest for public health or that constitute therapeutic innovations may be subject to these accelerated approval procedures; cancer treatments are key among them. While regulatory standards appear to have been relaxed to accommodate faster access to market for innovative medicines, it is unclear what impact these practices are having on coverage and reimbursement decisions and what impact standard health technology assessment processes are having on these.

For this project, the Medical Technology Research Group conducted an impact analysis using a validated methodological framework to research the interrelationship between accelerated approval schemes for oncology drugs and national HTA processes. The team analysed whether oncology drugs benefitting from these schemes are indeed benefitting from faster access to reimbursement decisions and whether the criteria used in conventional HTA processes are the same or differ and, if the latter, how and what impact this is having on coverage recommendations.


Outputs 

Are Accelerated Approval Mechanisms a Predictor to Early Access and Coverage? A Global Study of Cancer Drugs
October 2017

Authors: Victoria Tzouma, Olina Efthymiadou, Mackenzie Mills & Panos Kanavos

A report exploring variation and interrelationships between HTA processes and accelerated approval schemes for cancer drugs across thirteen countries (Australia, Brazil, England, Canada, France, Germany, Italy, Japan, the Netherlands, Scotland, Sweden, Spain and USA).

View the poster presentation for ISPOR.


Early Access to Medicines Pathways – Results of a Global Survey
October 2017 

Authors: Mackenzie Mills, Olina Efthymiadou, Victoria Tzouma, Federico Grimaccia & Panos Kanavos

A report on the findings from two survey tools developed to identify, map, and differentiate early access pathways across 25 countries.


Impact

Pink Sheet - Pharma intelligence - "Do Accelerated Approval Pathways Mean Earlier Patient Access?"
November 2017

Registration required for access to the full article.


Read also

AstraZeneca - "Are Accelerated Approval Mechanisms a Predictor to Early Access?"
8 November 2017

An article about the project on the AstraZeneca website , written by Panos Kanavos.


ISPOR Annual European Congress - "Does Accelerated Approval Deliver Accelerated Access?"
8 November 2017

The handout for the symposium at the ISPOR 20th Annual European Congress.

Client: AstraZeneca

Team members: Panos Kanavos, Victoria Tzouma, Olina Efthymiadou, Mackenzie Mills & Colin Flannelly