CIRS Agenda_2015.indd

HTA and Market Access Programme Research

Stakeholder Survey: Early Scientific Advice

There is rising pressure for companies to adjust their drug development plans to accommodate both regulatory and HTA requirements for commercial success. One approach to address this need is to obtain early scientific advice from HTA agencies. This approach is increasingly used by companies to improve the understanding of the needs of HTA agencies/payers and to ensure both an effective and efficient development programme. However, the variability in the processes used by HTA organisations in different countries and the methodologies for making HTA decisions to which they apply result in a complex and challenging environment that leads to difficulty for companies seeking to identify the optimal pathway to obtain HTA advice.

With the aim of aligning the advice procedures and expected technical requirements, joint regulatory and HTA agency advice, as well as advice from multiple HTA agencies are now available through a number of recently established initiatives. The question for industry is “from whom, when and on what topics should we seek advice?” Furthermore, in order to improve the process and to facilitate shared learnings for all stakeholders participating in early dialogues, it is important to understand the outcome measures or performance markers of a successful scientific advice experience in order to ensure the efficient use of resource and optimal outcomes from these interactions.

At a CIRS Workshop in January 2008, participants recommended two opportunities for shared scientific advice: A pilot scheme in which the scientific advice given by EMA would be open to observers from HTA and a panel of experts that could be convened from industry and HTA agencies that could work together (in a similar manner to ICH) and provide guidance on the principles and criteria needed to demonstrate the value of innovative medicines to patients and healthcare systems.

With this groundwork, CIRS has been working on a series of research projects that address the topic of efficient use of early HTA scientific advice. CIRS conducted a stakeholder perception survey in 2009 to investigate which stages of development regulatory bodies and HTA agencies tend to give scientific advice to companies developing new medicines and if and when it might be possible to coordinate that advice to avoid giving conflicting guidance for the development of the same dossier. The outcome of the survey was discussed at the 2009 CIRS Workshop to address the related issues of overlap in activities between licensing and reimbursement and the potential for mismatch of outcomes. A full report of this Workshop can be found at http://cirsci.org/sites/default/files/September%202009%20WS%20Report.pdf

Since 2011, as part of the annual CIRS HTA Industry Metrics project, data on scientific advice meetings and their impact on development have been collected for individual products from participating pharmaceutical companies. Key elements measured are the type of advice provider, timing, scope, and consistency of advice between different stakeholders and the reasons companies may not be compliant with the advice given. The outcome of the CIRS Industry Metrics project provides a baseline against which changes in companies’ approaches to HTA interactions can be assessed along with the potential to identify the impact of HTA scientific advice on market access when the products roll out to local jurisdictions.

In 2015, a focused survey will be undertaken by CIRS with participating members to explore the current perceptions and experiences of industry when seeking HTA scientific advice. A technical Forum will be held in December 2015 for member companies to address the key learnings and implication of the survey and to discuss in particular the optimal pathway(s) for early HTA advice and their potential to improve the process of bringing a new medicine to market.