Posted on May 13, 2016
As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding the right resources to help us make informed decisions that suit our needs. Building a successful commercialisation strategy for a new medicine is no different and requires a plan that must include the right resources and knowledge.
Introducing a novel treatment into Australia requires the sponsor to align with governance factors that shape the local pharmaceutical industry. An in-depth understanding of the current regulatory and reimbursement environment is critical for success. As such, planning for product launch should begin with the development of a cohesive strategy that occurs long before the submission of a regulatory registration dossier or government reimbursement application.
Consequently, resourcing and investing in accurate market insight advice specific to the Australian market can be invaluable. Government authorities are demanding more data than ever before, so coordinating relevant activities in the lead-up to launch cannot be underestimated. Market insight advice can formulate valuable assessments that will ensure any key gaps in various inputs are identified and filled which is critical to strategic decision-making. Market Insight professionals are similar to a knowledgeable party planner who meticulously researches and plans to bring the most useful and relevant resources together to set the scene and create a successful event.
Of course, it does not stop there, optimising a planned strategy also requires timely and appropriate execution. There is no point in the DJ arriving three days before the party, just as it can be fruitless to attempt a cost-effectiveness analysis with incomplete data or an unconfirmed indication. At the same time, it is also wise to show up a little early to scope the scene and identify where information is missing. As the demand for detailed clinical and economic evidence increases, a timely market access strategy allows a sponsor to paint a clear picture of the new treatment’s value offering to decision-makers at the earliest feasible point, having addressed any previously identified shortcomings in the acquired data.
Capturing clinical data that encapsulates the needs of both a regulatory and PBAC application is a worthwhile consideration prior to the drafting of a TGA/PBAC parallel process submission. Each individual TGA and PBAC application should be well structured and complement the other to form a compliant, comprehensive and cohesive submission for the proposed product. The timing of these types of submissions requires effective pre-planning and communication, a process that is significantly strengthened by synergy between the Market Access and Regulatory Services experts involved.
Just as a party host should be checking in to make sure that hot food is continuously available for guests, for commercialisation, inputs should be checked for accuracy and completeness. As a medicine gets closer to launch, marketing strategy development, pricing considerations, and cost effectiveness modelling help support reimbursement goals. When accessed through a single source such as Commercial Eyes, coaction is assured between the experts working within these distinct workflows, helping to harmonise and strengthen each of the applications required to achieve the optimal launch of a medicine on the Australian market.
Early implementation of a well-conceived strategy, specific to the needs of the product, will benefit both registration and reimbursement applications. As with any successful event, a commercialisation strategy must be well planned and properly executed to achieve optimal results. Engaging Commercial Eyes opens a specialised avenue to multiple experts in all areas of Market Insights, Market Access, and Regulatory Services. As a unified team, we can offer an integrated approach to any product launch and help you effectively manage the entry of your new drug into the Australian marketplace.
This article is co-written by our Market Access team and Matthew Douglas from our Market Insights team