The full consultation response can be viewed here.
Commenting on ABPI’s consultation response, Paul Catchpole, Value and Access Director at the Association of the British Pharmaceutical Industry, ABPI, said:
“We are pleased to have the opportunity to submit a response to NICE’s VBA consultation, and we acknowledge the potential it brings to allow NICE to use a broader definition of value in order to reflect more fully the value that medicines bring to patients and society.
“Whilst the proposals set out in the consultation document provide a starting point, we are still far from the finish line. VBA is an opportunity for NICE to support the stated goals of improved adoption and diffusion of innovative medicines in the NHS, and ensure that NHS patients are amongst the first in the world to benefit from advances in medicine. If we are going to achieve more for patients, then a more radical reform of NICE methods and processes will be needed than is currently proposed in this consultation. We would like to see NICE approve more new innovative medicines in the context of the PPRS agreement to maximise benefits for patients and commissioners. A new mandate from government may be needed to achieve this. We do not want to see a situation where fewer new innovative medicines are being approved for NHS patients.
We need to see a new appraisal process that:
Is fit-for-purpose and responsive to the new medicines that are being developed by the pharmaceutical industry: The shape of the industry pipeline is changing dramatically and VBA needs to be able to appropriately and comprehensively value the new medicines that are being produced as a result of the changing pharmaceutical research and development model and the wide array of different types of new treatments which are already starting to become available.1
Embraces the opportunity to progress a more ambitious set of proposals for VBA: The new Pharmaceutical Price Regulation Scheme (PPRS) sees the pharmaceutical industry underwriting growth in the UK branded medicines bill over agreed levels for the next five years from 2014 – 2018. This includes explicit opportunities for NICE to adopt a more “pro-innovation” perspective in its decision making processes for technology appraisals of new medicines; rebalancing its approach to dealing with reasonable uncertainty in the evidence base for new medicines so that more NHS patients can benefit.
Does not make patients worse off than they were before: For example, the consultation proposes that existing end of life (EoL) criteria will be excluded from the NICE Methods Guide. Uncertainty regarding the way all the factors highlighted in the consultation will be aggregated raises concerns over the possibility that exclusion of the EoL criteria could result in a lower acceptance rate of life-extending, EoL treatments. This is unacceptable to the pharmaceutical industry and will, no doubt, be unacceptable to patients.
Provides clear framework to Appraisal Committees: An explicit decision making framework document should be provided to Appraisal Committees, after being reviewed and agreed by stakeholders to ensure consistency of approach across different Committees, to provide a greater degree of predictability and ensure that all relevant elements of value are considered. This should include allowing Appraisal Committees to approve medicines for use beyond any fixed upper threshold limit or to review specific additional evidence when this is deemed appropriate.
“In order to achieve these ambitions, there needs to be further engagement with the pharmaceutical industry and other key stakeholders before the methods for VBA are finalised and once there is more clarity from NICE on how VBA will work. Furthermore, once VBA is in place there should be a review of the arrangements once they have been applied in an agreed number of technology appraisals or after a defined period of time. The ABPI stands ready to work with the Government and NICE to support the progression of revised methods to VBA through further transparent and open dialogue.”
Notes to editor
1Increasingly, the new innovative medicines being developed by the industry are intended to treat smaller numbers of patients for rare diseases or indeed common diseases which are now often seen as a collection of rare diseases. 60% of over 5,600 active products in the global industry research pipeline are specialty medicines with oncology having the greatest number of medicines in the pipeline (IMS R&D Lifecycle database).
About the ABPI
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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