Real-world data is a vital part of market access today, and there are a variety of different sources of patient data to work with ranging from observational data collected from claims databases and patient records, through to some of the outputs from registries and monitoring platforms linked to accelerated approval processes. Data direct from patients […]
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 […]
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 […]
Austerity has been the buzzword for governments around the globe, as economies fight deficits and economic downturns. The combination of austerity, along with the aging population and the rising cost of therapeutics, means that healthcare is one of the areas particularly hit by the financial challenges. In order to ensure that the right patients can […]
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 […]
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 […]
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 […]
Since the completion of the human genome project in 2003, researchers at the 1000 Genomes Project have sequenced over 2500 human genomes from 26 groups of people around the world; the genome of a human from around 430,000 years ago has been sequenced; and the UK plans to sequence 100,000 human genomes from NHS patients. […]
While there are challenges to be overcome, the opportunities of social media to generate useful insights that could improve drug development, disease diagnosis and treatment, are enormous and are only likely to grow.
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.