The key to effective market access is the demonstration of product value over and above that of the existing alternatives. In this age of increasing healthcare costs and diminishing budgets, payers need to be convinced of both a new product’s potential to improve outcomes and its value in managing the burden on healthcare systems. Rather than being regarded as one more cost to be managed, market access presents an opportunity for industry to secure payers’ endorsements of their products – by identifying, creating and communicating product value.
Early and sufficient investment is paramount to success – investing too little or too late in a market access strategy can deny a product’s successful integration into the marketplace. Taking the payers’ perspective early on in the product development life cycle is vital. Timely consideration of how payers perceive value in terms of product cost versus clinical benefits, and how the product will fit into or change the current treatment algorithm to the benefit of patients, healthcare providers, and payers are all factors that help to improve and refine evidence-generation strategies.
Early and iterative cost effectiveness analysis (CEA) can help frame price levels that will most likely deliver cost-effective outcomes, and assist manufacturers in identifying or generating the additional evidence necessary to reduce uncertainty in the clinical or economic value of a product. A sound pricing and market access strategy requires understanding both of this uncertainty and the evidence needed to optimise clinical, economic and patient-reported quality-of-life data early in the development life cycle. Indeed, the strongest health economics arguments are constructed by factoring in the payer’s perspective from the start of trial design through to the iterative refinement of pricing and market access strategies.
A proactive approach of building relationships with payers, so as to incorporate their perspectives early, will pay dividends. Directly exploring the payer’s perspective may be challenging for the industry in some markets, but with good primary research it is possible to ‘put oneself in the payer’s shoes’ and to make informed assumptions. A payer’s interests or objectives may often differ from what industry might assume, and this can present opportunities. For example, a payer’s concern may be assumed to be overall budget impact, but, in reality, a reduction in spend this calendar year may be a higher priority, and so the optimised strategy could be that of free initiation.
Payers and sponsors alike want to grant patients access to good medicines
Evidence generation strategies can also be improved by understanding payer preferences and objections early in product development. Payers often challenge on price because there is a lack of evidence for a product’s benefits over existing options and uncertainty about whether the product will improve outcomes in the real world. One means of pre-empting such objections is by supplementing clinical trial data, or generating additional information on outcomes for existing treatments, with real-world data sets and their translation into real-world evidence.
Such real-world evidence is commonly used to develop risk algorithms and disease progression models, and can also be used to inform the economic and humanistic burden of illness and patient pathways and to augment segmentation of the market or patient population. So long as any uncertainty is characterised and communicated properly, real-world evidence can play a significant role not only in a market access strategy, but also in providing evidence for submissions and directing further evidence generation.
Any strategy that is designed to address payers’ current concerns and considerations should also be constructed in the context of future or pending changes in reimbursement, particularly around innovative and orphan products. In the UK, for instance, NICE now regulates access to the Cancer Drugs Fund, and products will need to meet NICE thresholds in order to be reimbursed. Likewise, in France, economic evaluation is used increasingly to justify the price of both innovative products and those with moderate improvements over existing technologies, ie an ASMR of 3. Combined with the demanding – and often less familiar – requirements of the GBA and IQWIG in Germany and other agencies in Europe, these changes make early understanding of the payer environment critical to building a strategy to meet these demands.
Amid all the pressures of bringing a product to market, how immediate negotiations with payers will affect future negotiations must not be neglected. Long-term market success requires relationships built upon trust and understanding – industry must be honest about the benefits of a product to enable payers to more accurately assess its impact on patients. While not every product brought to market will be a breakthrough this can be communicated to payers while also achieving a strong reimbursement position.
Our ‘bottom line’ is that payers and sponsors alike want to grant patients access to good medicines, and by treating payers as partners early in development more favourable outcomes for all are possible.
James Eaton is senior principal, health economics and Catherine Beecher is divisional principal, pricing and market access, ICON Commercialisation & Outcomes
