Dr Richard White, Commercial Director, and Dr Polly Field, Value Demonstration Leader, attended the Westminster Health Forum Keynote Seminar on Next steps for NICE, priorities for the pharmaceutical industry, and Accelerated Access Review. This was held on Thursday 14 January 2016 and Richard contributed the following article to the transcript of proceedings. The agenda for the seminar can be found here.
The Westminster Health Forum Keynote Seminar on Next steps for NICE, priorities for the pharmaceutical industry, and Accelerated Access Review, held on Thursday 14 January, showed that governments, healthcare providers, patient groups and industry must do more to work together to ensure patient access to new health interventions that address genuine unmet medical needs. An integrated HealthScience approach is required to combine the clinical and scientific aspects of health care with the economic, social, behavioural and political dimensions that determine the value of new interventions.
During the seminar, Professor Gillian Leng and Nicole Mather presented plans from NICE for the Cancer Drugs Fund and the Accelerated Access Review, and highlighted the increasing role that real-world evidence (RWE) will play in the evaluation of medicines in the future. In subsequent presentations, however, Professor Karl Claxton (University of York), Paul Catchpole (ABPI), Hannah Winter (Member, Patients Involved in NICE) and Julia Manning (2020health) suggested that the proposed plans are not optimal from the perspectives of health economists, industry and patient groups. From an industry perspective, Ray Ghouse (Boehringer Ingelheim) highlighted the difficulties in implementing NICE guidance at a local (CCG) level, because of the disconnect between long-term cost-effectiveness evaluations by NICE and the short-term, budget-based perspective of CCGs. James Roach (Wiltshire CCG) emphasized the need to focus on “benefits beyond the drug”, evaluating improvements at a healthcare pathway level and moving towards “multi-morbidity condition management”.
At a macro level, the need for a HealthScience approach is clear: to bring together different perspectives, enabling physicians, patient groups, payers, policy-makers and the healthcare industry to understand each other’s perceptions of value and evidence requirements. While each stakeholder has a different objective, from a public health perspective they have a common goal; to ensure that innovative, value-adding medicines and healthcare interventions achieve approval, reimbursement and patient access.
From a healthcare industry perspective, a HealthScience approach is particularly beneficial in health technology assessment (HTA) and in RWE study planning and communication. The proposed changes to the Cancer Drugs Fund would mean more evidence evaluations and a greater number of HTAs, which would have an impact on all stakeholders. RWE would be needed in an Accelerated Access process; however, based on experience of NICE decisions for coverage with evidence generation, there are concerns that the required evidence either has not been sufficiently robust or has not been developed at all. A collaborative integrated approach will be needed to ensure that RWE is developed, that it is robust enough to reduce initial uncertainty over a drug’s clinical effectiveness, and that it is communicated effectively in HTA submissions and peer-reviewed journal publications.
Oxford PharmaGenesis (www.pharmagenesis.com) has successfully implemented an integrated HealthScience approach in HTA, RWE and medical communications projects for 7 of the top 10 global pharmaceutical companies. Through working closely with clinical specialists, health economists, patient groups and policy experts, we help to develop robust, evidence-based HTA submissions and communications that demonstrate the value of new healthcare interventions. Our policy practice, the Oxford Health Policy Forum, has developed independent initiatives that have been endorsed by multiple top medical bodies, including the Heart Failure Association (heart failure initiative), the Royal College of Psychiatrists (schizophrenia initiative) and the European Brain Council (multiple sclerosis initiative).
