Biosimilars Access
How can biosimilars support patient access?

Uncertainties about interchangeability still surround biosimilars. Despite regulatory changes that aid the approval process and the promise of affordability, the use of these drugs has been met with mixed reactions – some experts see the value of having alternatives while others question the quality and immunogenicity of biosimilars. In addition, discussions around cost are raising […]

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 […]

Understanding payer strategies to control prices

Pricing therapeutics is challenging. Price too low, and the pharmaceutical business model is not sustainable as R&D costs are high and few products deliver significant sales volumes. Price too high and health technology assessment (HTA) bodies will not list the drugs, payer strategies will delay reimbursement and funding, and the media and public will hit back. […]

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 […]

Drug affordability
The EU evaluates affordability and availability of medicines

Drug prices are rising across the European Union, and in economically-difficult times this is having an impact on drug affordability and accessibility. The European Union health ministers have met to discuss the impact of the situation, and make decisions that could change the way that drugs are priced across the region. These conclusions were published […]

Speeding drugs to market using adaptive pathways

For parents of children with serious disorders where there is no approved treatment, or physicians who have tried everything for their patients with terminal diseases, the wait for approval of innovative drugs is a long one. The European Medicines Agency’s adaptive pathways pilot project aims to allow patients and their physicians to access life-changing or […]

Valid Insight
Standardising evidence generation: EUnetHTA’s HTA core model

EUnetHTA is a network of health technology assessment (HTA) bodies across Europe. This cross-border group aims to standardise evidence generation, and support decision-making by working together, in order to add value to the HTA process at regional, national and European levels. This will be achieved through the best use of resources, and by sharing knowledge […]

Patient Data
New sources of patient data to support product value

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 […]

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 […]