OBJECTIVES:

In recent years, many pharmaceutical companies have increasingly focused on optimising clinical development programmes not only to the demands of the regulators, but also to health technology assessment (HTA) bodies (HTABs), and payers. Consequently, there has been an increase in scientific advice processes involving HTABs and regulatory bodies.

The objective of this study was to review scientific advice processes involving HTABs in the United Kingdom (UK), France, and Germany as well as the parallel EMA/EUnetHTA21 joint scientific consultation (JSC) process and evaluate similarities and differences between these.

METHODS:

A review of scientific advice processes in the UK, France, Germany and JSC was performed. Each advice process was evaluated in terms of regulatory agency participation and the following key attributes: years since introduction, timeline, fees, briefing book requirements, scientific topics for discussion, output, health economic assessment, language, meeting length, number of company attendees, external expert involvement, and patient involvement. The UK, France, Germany and JSC processes were contrasted to highlight differences and similarities.

RESULTS:

The scientific advice processes may be broadly categorised into five types: 1) single-country HTAB, 2) single-country HTAB and regulators,3) multi-country HTAB4) parallel JSC with HTAB and regulators, 5) regulators only.

The processes in the UK, France, Germany and the JSC process have similarities and differences in the characteristics. The most striking differences relate to the fees for engagement, the duration and outcomes of meetings, the scientific topics addressed and the extent of stakeholder involvement.

CONCLUSIONS:

Selecting an appropriate scientific advice process depends on the strategic objectives in the decision to obtain scientific advice and the specific regulatory and HTA complexities for the therapeutic area. The number of integrated scientific advice processes has increased in recent years. Manufacturers value the opportunity to test and optimise their clinical development plans to meet regulatory and HTABs requirements to facilitate reimbursement.