OBJECTIVES : Changing from a vial-based formulation to a pre-filled syringe (PFS) can be driven by desire to gain a competitive edge, to improve safety and accuracy, or to reduce wastage or a combination of these factors. The objective is to review the access requirements and pricing implications for the introduction of a novel PFS formulation of an existing drug to the market. The scope was the EU.

METHODS : A targeted literature review using Medline, Embase, and Cochrane and internal databases. This was supplemented by discussion with HTA bodies and experts providing further insight.

RESULTS : The procedure for launching a novel formulation of an existing drug displayed a degree of consistency between countries. The UK, Germany, and France typically do not require HTA for re-formulations (generally no claims made for added-value). If a premium price is desired, that added value should be demonstrated from outcomes in an RCT, as patient preference studies have little impact on payers. In Italy and Spain, in theory price could be re-negotiated as with a new launch. However, in practice an abridged procedure is accepted without the requirement for pricing discussions. The two key considerations are 1) is now an appropriate time to re-assess price? 2) will this new formulation open up a larger market and therefore impact on budgets? Sweden, Norway, and the Czech Republic are markets where timelines are relatively short.

CONCLUSIONS : The launch of a novel PFS formulation of an existing vial-based drug can typically follow an abridged procedure with price parity the likely outcome. However, price premium can be achieved if benefits demonstrated are in line with the unmet need.