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Accelerate market access
Regulatory initiatives to accelerate market access – UK, Japan and USA edition

Accelerated pathways are emerging in individual countries that are designed to speed therapies through the approvals process and onto the market for patients who have unmet needs. Following on from our EU focus, in this post we look at the key schemes to date, that are in place in the UK, Japan and USA to […]

Market access strategy
Understanding payers’ real-world needs

All of the stakeholders involved in drug development and market access would like the right treatments to be available to the right patients, but in times of increasing austerity drug costs make this challenging. Payers need to see the value of a drug outside a clinical trial and in a real-world setting, in order to […]

Marker Access
Market access: are payers adversaries or partners to better patient outcomes?

For many years, the route to market access has been focused around completing clinical trials and meeting the safety and efficacy data needs of the regulators. This data is then used to persuade payers that the therapeutic is safe and works, and is therefore worth paying the price demanded. However, as budget cuts bite, competition […]

Market Access Strategy
Preparing your best market access strategy

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 […]

Drug launch excellence: Begin the value story early

Starting the market access plans as early as possible, even during the early stages of development, will improve a company’s chance of success at drug launch.