Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential impact of the rebate rates under the (a) voluntary and (b) statutory scheme for branded medicines on (i) the placement of clinical trials in the UK, (ii) the prioritisation of the UK as a launch market for new medicines and (iii) patient outcomes in the next five years.
Answered by Will Quince
The Government has assessed the link between volume-based rebate payments in our medicine pricing schemes and various kinds of investment in our impact assessment of recent updates to the statutory scheme for branded medicines pricing, which operates alongside the voluntary scheme for branded medicines pricing and access (VPAS).
The Government’s 2023 impact assessment of updates to the statutory scheme is available at the following link:
The Government is working to better understand the impacts the operation of the current VPAS on the United Kingdom life sciences industry. We are in direct conversations with pharmaceutical companies, including in the recent pre-negotiation workshops, as well as the Department for Science Innovation and Technology, and the Department for Business and Trade about the business environment for life sciences.
Controlling medicine spend is a key aim for both current and future schemes to improve patient outcomes by simplifying, streamlining and improving access, pricing, and uptake arrangements for cost effective medicines, and deliver faster adoption of the most clinically and cost-effective medicines.
With regard to the impact of price regulation on the placement of clinical trials in the UK and access to new medicines, the Government’s assessment is that price control schemes in general are more likely to impact decisions about the location of late-stage than early-stage trials, as the location of late-stage trials may be more influenced by commercial considerations about where to launch a new medicine. However, VPAS includes strong commercial incentives to launch new products in the form of freedom of list pricing and exemptions from payments for innovative medicines containing a new active substance. These incentives have contributed to VPAS driving significant improvements in patient access to clinically and cost-effective medicines, whilst ensuring sustainable and predictable spend growth for the National Health Service and industry during a period of economic uncertainty.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has had discussions with the Secretary of State for Science, Innovation and Technology on the Association of the British Pharmaceutical Industry proposals for a new Voluntary Scheme for Branded Medicines Pricing and Growth, including the proposals for (a) an investment facility, (b) to build a data recruitment centre and (c) a fund for a Medicines Equity Partnership.
Answered by Will Quince
The Department carefully considers all evidence in the public domain on matters relating to the growth and competitiveness of the United Kingdom life science sector, including the recent report by the Association of the British Pharmaceutical Industry.
The Department of Health and Social Care is in close discussions with Ministers from the Department for Science, Innovation and Technology and the Department for Business and Trade about the business environment for life sciences and its impact on investment.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what percentage of health technology appraisals conducted by NICE for therapies in combination have resulted in (a) termination, (b) a negative recommendation, (c) an optimised recommendation, (d) a positive recommendation or (e) a recommendation for use within the Cancer Drugs Fund or Innovative Medicines Fund.
Answered by Will Quince
Between 1 January 2017 and 31 December 2022, 20% of appraisals of combination therapies undertaken by the National Institute for Health and Care Excellence (NICE) were terminated due to the company not making an evidence submission to NICE.
Of the technologies appraised by NICE, 4% were not recommended, 31% were recommended for routine commissioning, 52% were optimised recommendations and 12% were recommended or optimised for use within the Cancer Drugs Fund.
No applications were recommended for the Innovative Medicines fund.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many and what proportion of health technology appraisals conducted by NICE for follow-on indications have resulted in (a) termination, (b) a negative recommendation, (c) an optimised recommendation, (d) a positive recommendation and (e) a recommendation for use within the (i) Cancer Drugs Fund and (ii) and Innovative Medicines Fund.
Answered by Will Quince
Between 1 January 2017 and 31 December 2022 31% of appraisals of licence extensions by the National Institute for Health and Care Excellence (NICE) were terminated due to the company not making an evidence submission to NICE. Of the licence extensions appraised by NICE 10% were not recommended, 37% were recommended for routine commissioning, 34% were optimised recommendations and 20% were recommended or optimised for use within the Cancer Drugs Fund. No applications were recommended for the Innovative Medicines fund.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what proportion of medicines appraised by NICE since 1 January 2017 were medicines that have already been appraised by NICE for another indication.
Answered by Will Quince
Between 1 January 2017 and 31 December 2022, the National Institute for Health and Care Excellence published technology appraisal guidance on 156 new active substances in their first indication and 120 on extensions to marketing authorisations that added a significant new therapeutic indication.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether policies to improve patient access to combination therapies will be considered by his Department in upcoming negotiations for the 2024 Voluntary Scheme for Branded Medicines Pricing and Access.
Answered by Will Quince
The Department is considering how a successor to the voluntary scheme for branded medicines pricing and access should operate from 2024 onwards and will work with industry to agree a mutually beneficial successor that that supports better patient outcomes, ensuring the sustainability of National Health Service spend on branded medicines and enables a strong United Kingdom life sciences industry.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many commercial agreements NHS England has agreed with manufacturers of medicines that allow, support or result in non-uniform pricing by medicine.
Answered by Will Quince
Since 2020 NHS England has agreed 24 commercial agreements that have resulted in non-uniform pricing by medicine, via either the Cancer Drugs Fund or through bespoke commercial deals to support routine commissioning.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment his Department has made of the impact of the NHS continuing to adopt uniform pricing by medicine on patient access to innovative medicines.
Answered by Will Quince
No assessment has been made. NHS England set out their commercial approach to new medicines in the Commercial Framework published in February 2021. The framework sets out, in line with commitments made under the Voluntary scheme for branded medicines pricing and access (VPAS), that the National Health Service can reach complex confidential commercial arrangements with companies that bring new medicines to the market which offer greater levels of health gain relative to cost. The commercial framework allows the flexibility to create different commercial approaches where the importance of the medicine warrants it.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will work with the National Institute of Health and Care Excellence to establish or adapt frameworks which support combination therapies to be assessed and accessed more readily in the UK, as part of NICE's iterative approach.
Answered by Will Quince
The Department wants patients to benefit from access to effective new treatments at a price that represents value and is fair to all parties. The National Institute for Health and Care Excellence (NICE) has been able to recommend over 95% of the combination therapies on which it published technology appraisal guidance between 2017 and 2022. NICE is developing a modular approach to its methods and process updates and potential topics will be considered by NICE taking into account all relevant factors.
NHS England’s Commercial Framework for New Medicines recognises that realising the full potential health benefits from combination drug therapies can be challenging given the requirement for commercial confidentiality and the need to maintain competition.
Alongside NICE, NHS England has been supporting the Association of the British Pharmaceutical Industry (ABPI) efforts to find solutions to enable companies to engage with one another where health-improving combination therapies face challenges coming to market.
In the United Kingdom, the Competition and Markets Authority represents the sole competent authority, and the commercial aspects of bringing combination therapies to the market must be compliant with relevant legislation.
There are currently no plans to establish a task and finish group.
Asked by: Chris Green (Conservative - Bolton West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make it his policy to establish an independently-led task and finish group to consult on and suggest innovative solutions for overcoming pricing, cost effectiveness and legal challenges around patient access to combination therapy treatments in oncology.
Answered by Will Quince
The Department wants patients to benefit from access to effective new treatments at a price that represents value and is fair to all parties. The National Institute for Health and Care Excellence (NICE) has been able to recommend over 95% of the combination therapies on which it published technology appraisal guidance between 2017 and 2022. NICE is developing a modular approach to its methods and process updates and potential topics will be considered by NICE taking into account all relevant factors.
NHS England’s Commercial Framework for New Medicines recognises that realising the full potential health benefits from combination drug therapies can be challenging given the requirement for commercial confidentiality and the need to maintain competition.
Alongside NICE, NHS England has been supporting the Association of the British Pharmaceutical Industry (ABPI) efforts to find solutions to enable companies to engage with one another where health-improving combination therapies face challenges coming to market.
In the United Kingdom, the Competition and Markets Authority represents the sole competent authority, and the commercial aspects of bringing combination therapies to the market must be compliant with relevant legislation.
There are currently no plans to establish a task and finish group.