PRO data
Curbing non-adherence with PRO data
  • September 23, 2016
  • Valid Insight

On average, it is estimated that over 50% of patients eventually abandon their treatment. Patient-reported outcomes (PROs) could facilitate efforts to reduce these figures. Defined as any data coming directly from patients about how they feel or function in relation to a health condition or its treatment – with no clinician interpretation to remove the […]

Biosimilars Access
How can biosimilars support patient access?
  • September 14, 2016
  • Valid Insight

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
  • August 31, 2016
  • Valid Insight

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
  • August 3, 2016
  • Valid Insight

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
  • July 26, 2016
  • Valid Insight

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
  • July 19, 2016
  • Valid Insight

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
  • July 5, 2016
  • Valid Insight

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
  • June 28, 2016
  • Valid Insight

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
  • June 22, 2016
  • Valid Insight

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
  • June 8, 2016
  • Valid Insight

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 […]