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To better understand local clinical and payer insight, biopharma need to engage with stakeholders early to see how they perceive current unmet needs, as well as perception of key clinical, policy and economic drivers. Insight can be collected from a variety of stakeholders – including patients, physicians, payers and policymakers; and can be collected via advisory boards, one-on-one interviews or secondary research.

Objectives for biopharma in engaging pre-launch with the NHS

Strict rules around governance will impact any pre-launch activity. Clause 3.3 of the PMCPA guidance outlines that engagement with NHS decision makers is allowed when there is a need for them to receive advanced information about new medicines that may significantly affect their future expenditure. Gaining an understanding of what is happening in the future, the likely budget impact, and the impact to services and pathways will be important for local NHS bodies. Post-launch the quicker local NHS organisations can agree on how a drug should be used appropriately within a treatment pathway, the sooner patients will benefit and outcomes will be improved.

Investment is important, as often hidden challenges in the system can act as barriers to new drug technology uptake. These barriers could include existing rigid services, apathy, or unwillingness to change and budgetary pressures.  As a biopharma company you want to identify these pathway challenges as early as possible and have a collaborative solution ready to go at launch, rather than losing the first 12-18 months finding your way and working out what added value services to develop and provide. Having this planning and preparation time will maximize the probability of a solution resonating with the NHS at an appropriate and flexible resource level.

Early Stakeholder EngagementWhy does biopharma often wait so long to engage with the NHS?

Considering the relatively sizeable investment that biopharma puts into sales and marketing, it is perhaps surprising that companies wait so long to engage – often with relatively small market access teams and unrealistic expectations of how quickly change can be implemented in the NHS.

This can be because many biopharma organisations solely view market access in terms of pre-launch and formulary acceptance. There is room for biopharma to understand how good market access strategies can make a real difference when mobilized early and at numerous points in a treatment’s life cycle. Investment decisions are still largely made based on the impact of a treatment’s market share as opposed to its potential impact on supporting the effective management of a relevant treatment pathway. If biopharma sticks to this narrow definition, it will be an ongoing challenge for it to be a catalyst for change when delivering healthcare.

Bridging the gap: Outcomes must play a central role

A significant current challenge for biopharma is the disconnect between data captured within clinical trials and outcome data demanded by local payers.

There is often a gap between the evidence gathered in Phase III trials that have been constructed at a global level, and the evidential requirements of payers at a local level.  Payers will often demand for outcome data that biopharma trials were never powered to demonstrate. Clinical sectors of biopharma companies must work alongside commercial teams to help shape a new approach to clinical trial design in Phase III. There is definitely a need for mindset shift, and Phase III trials must start to demonstrate more of the outcomes that payers are interested in.

There are a number of ways to bridge this gap. When we talk about access in biopharma, we often talk about getting a drug positioned and funded as part of a formulary decision – a consensus on how that should be used in a local healthcare environment. But if biopharma doesn’t have the outcomes data at launch that is required to drive formulary, it must start to consider the kind of resources it can deploy. In a local health economy, if the requirement is for the data points to support formulary approval and they don’t exist in the clinical data, pushing the formulary process through in a binary way based on the data available can present the risk of being rejected.  Rather than risk not gaining access, biopharma can open up discussions with stakeholders to see how it can provide resources to capture outcomes that would influence a positive formulary decision. This may be assisting cohorts of patients and tracking them through use of the product in a defined way, with a 6-12 month timeline for example, followed by a re-evaluation of that localized data to support a local formulary application.

In summary, the market access landscape in the UK has changed.  The processes and capabilities that biopharma needs to employ have evolved, and the early development and implementation of an integrated market access solution – based on local clinical and payer insight – is now essential. The move towards localization in the UK requires biopharma companies to clearly define their market access journey starting at a Global/European level, and ending with enduring local market success. This in turn requires investment in the right capability mix with associated flexibility along the journey – something that biopharma can enjoy by partnering with organizations that have proven capability, and a comprehensive market access solution mix.


** To learn more about early engagement with stakeholders, view a recording from our recent webinar

Topics in this blog post: Biopharma, Commercialization, EU, Market Access, NHS