Real World Evidence
Designing studies to show real-world value

There is a gap between scientific knowledge and daily medical practice. Although there may be major science breakthroughs, this does not directly translate into new treatments available to patients. New products from research and development can only be translated into medical practice if they are reimbursed by payers. In pharmaceuticals and biotech, there are two […]

Real-world patient data
Generating insights with real-world patient data

Generation of real-world data is on the increase, from smartphones and social media to medical records and clinical trials. This wealth of data has a huge amount of potential, but in order to make the most of it, life science companies need to focus on generating the right kind of insights from the megabytes of […]

Access Strategy
NICE and the role of scientific advice in shaping access strategy

Seeking advice from a health technology assessment (HTA) body, whether alone or in combination with a regulatory body, can help companies to focus on the payer perspective at an early stage of clinical development, and shape the therapy development and access strategy based on the feedback. By ensuring that the clinical trials include the types […]

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 […]

accelerate market access
EU regulatory initiatives can accelerate market access to new medicines

The drug development process is a long one – depending on the specific therapeutic and disease, it can take up to 15 years for a product to be ready for market access. Once a drug is submitted to the European Medicines Agency (EMA) for marketing authorisation, the agency aims to issue an opinion within 210 […]

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 […]