Development of a reimbursement submission for the Pharmaceutical Benefits Advisory Committee (PBAC), Medical Services Advisory Committee (MSAC) or both in the case of a co-dependent technology, and the prerequisite application for consideration by the PICO Advisory Sub-committee (PASC) is a crucial step in any market access strategy.
Planning and project management of the submission process is important to ensure that the rate-limiting steps, such as obtaining real-world clinical evidence, are incorporated.
Review cycles should be scheduled early to avoid the need for rework, especially changes in economic model variables which subsequently impact the outputs, budget impact models and the write-ups of both.
Adequate time to contemplate the implications and interpretations of models is essential.
A submission that receives a positive recommendation for subsidy will, however only provide a seat at the negotiating table. What happens at the table depends on the effectiveness of the overall market access strategy.
New Zealand (NZ) PHARMAC submissions should not be considered as ‘mini-me’ versions of an Australian submission. Although the NZ system is less prescriptive with regards to Guidelines and data presentation (with peer-reviewed publications most important), the focus is on the impact of a new product at the patient level and, in particular for the different ethnic groups that constitute NZ society.
Technical writing example 1: Wlodarczyk J, Kemp D, Leadbitter S. 2015
Technical writing example 2: Tran G, Hack SP, Kerr A, et al. 2013