When thinking about getting new pharmaceuticals to the market, many companies focus efforts on getting products through approval, and so tailor their market access strategy to meeting the regulators’ needs. However, for a successful market access, any company needs to have a strategy to meet the needs of the payers as well as the regulators.

Planning the strategy
Having a market access strategy fully in place at launch is vital to drive immediate sales as, according to McKinsey, around two-thirds of drugs do not meet their pre-launch sales expectations in the first year. Of those that don’t meet these pre-launch expectations, two-thirds are likely not to deliver to their full potential over the next two years, and these are sales lost that are unlikely to ever be regained.

Planning the market access strategy needs to begin as early as possible in the drug development lifecycle, as this allows companies to design clinical trials that can provide the data that both the payers and regulators need. It also makes sure that the data is ready in time for discussions with the payers, and that the outputs can be tailored to the needs in individual countries, as this is not a one size fits all approach.

The planning process also needs to take into account the needs right through to patent expiry, as payers can change payment models in response to changes in the market landscape, the threat of generics, and the entry into the market of new and innovative drugs.

Building the value story
The value story is an important part of the market access strategy. Understanding value and preparing a compelling value story needs an in-depth grasp of the size of the market, existing treatments and costs of care, unmet need, and what other companies have in their R&D pipelines, to truly understand best positioning for a new product not yet on the market. It is also important to look at how the payers work in different jurisdictions, for example what their decision-making criteria are, how the treatment is funded and how budgets are allocated. Forthcoming policy changes can also have a major impact on payer decision-making processes. This kind of landscape assessment also allows companies to understand the challenges which they have to circumnavigate, and the clinical and commercial opportunities.

By understanding the markets and generating the right types of evidence, companies can build a compelling value story to best support price and access negotiations with payers.

Making a success of market access
A winning market access strategy is needed for both clinical and commercial success, as the product must provide benefits to patients, and it must also provide a return on investment for the companies developing the drugs.

To achieve this, companies need to embrace market access strategy as an aim from the beginning, which requires understanding the needs of patients, focusing on payer perspectives, and providing pragmatic solutions that work in the real world.

To find out how we at Valid Insight can help optimise your market access strategy, contact us at discover@validinsight.com.