Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance he has provided to regulatory and health authorities on ensuring that the UK remains an attractive place to conduct clinical trials and supply human medicines.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The Department is working directly with the Medicines and Healthcare products Regulatory Agency, Health Research Authority, NHS England and NHS Improvement, the National Institute for Health Research and other partners across the health and life sciences sectors to ensure that the United Kingdom remains an attractive place to conduct clinical trials and supply human medicines.
The Medicines and Medical Devices Bill provides the UK the means to remain a world-leading regulator and an important market for medicines and medical devices and supports the delivery of the Life Sciences Industrial Strategy to make the UK a leading global hub for life sciences. The Bill makes clear the importance of ensuring the UK is an attractive place to bring new products to market and conduct clinical trials, specifying that before making any regulations under the Bill, the Secretary of State must consider this point.
We are determined to maintain the UK’s position as one of the best locations globally to run clinical trials.
Asked by: Crispin Blunt (Independent - Reigate)
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 implications for his policies on (a) improving access to innovative medicines and (b) fostering the life sciences sector of the National Institute for Health and Care Excellence health technology evaluation review.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) is reviewing its methods for the development of technology appraisal and highly specialised technology recommendations in line with the commitment in the 2019 voluntary scheme for branded medicines pricing and access. The scheme also states the Government’s expectations for the review as follows: ‘“The Department expects that any future changes to NICE methods and processes would respond to the new types of innovation coming to the market, be consistent with improving the health gain achieved by spending on new innovative medicines, and support faster adoption of the most clinically and cost effective medicines.”’
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will support the National Institute for Health and Care Excellence to undertake its methods and processes in a way that (a) enables the attractiveness of the UK as a place to conduct clinical trials or supply human medicines and (b) enables that organisation to fulfil its statutory duty to promote innovation.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) is reviewing its methods for the development of technology appraisal and highly specialised technology recommendations in line with the commitment in the 2019 voluntary scheme for branded medicines pricing and access. The scheme also states the Government’s expectations for the review as follows: ‘“The Department expects that any future changes to NICE methods and processes would respond to the new types of innovation coming to the market, be consistent with improving the health gain achieved by spending on new innovative medicines, and support faster adoption of the most clinically and cost effective medicines.”’
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the National Institute for Health and Care Excellence plans to publish the full outputs of the task and finish groups engaged in the development of its health technology evaluation review.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence has advised that it is considering the most appropriate way to publish the relevant information supporting the methods review work. Details will be released in due course.
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the reasons why the Cancer Drugs Fund has been underspent; and if he will make a statement.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The Government established the Cancer Drugs Fund (CDF) to ensure access for National Health Service patients in England to effective cancer drugs that would not otherwise have been available to them. New arrangements for the assessment and adoption of new cancer drugs were introduced in 2016 to help improve patient access to new cancer drugs and the CDF is now linked to the National Institute for Health and Care Excellence (NICE) technology appraisal programme.
Under the new arrangements, NICE now appraises all new cancer drugs, and NICE is able to recommend a drug for use through the CDF where there is too much uncertainty to be able to recommend routine use. All cancer drugs recommended by NICE are eligible for funding through the CDF from the point of NICE’s draft guidance.
Since it was reformed in July 2016, the CDF has had a fixed budget of £340 million. This will remain the same for 2020-21.
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he made of the effect of the (a) introduction of the ultra-orphan pathway by the Scottish Medicines Consortium and (b) additional factors and modifiers for orphan medicines and medicines that have evidence of achieving a substantial improvement in life expectancy and/or quality of life considered by the Scottish Medicines Consortium in relation to informing methods and processes at the National Institute for Health and Care Excellence.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) is responsible for the review of the methods it uses in the development of its technology appraisal and highly specialised technology recommendations in England. NICE has advised that additional factors and modifiers that may affect NICE’s decisions, including factors relevant to orphan medicines and medicines that substantially improve health and/or life expectancy, are being considered within its methods review. This review will give consideration to approaches in other health technology assessment bodies, including the devolved administrations.
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of establishing a new orphan medicines pathway at NICE to enable orphan medicines which do not qualify for the highly specialised technology evaluation programme to be appraised.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
There are no current plans to establish a further National Institute for Health and Care Excellence (NICE) assessment programme for orphan medicines. Where companies are willing to price their drugs fairly in a way that reflects the benefits they bring to patients, NICE has been able to recommend a number of orphan medicines for routine NHS funding through its technology appraisal programme. NICE is reviewing its methods for the development of technology appraisal and highly specialised technology recommendations, including the methods for the assessment of medicines licensed for rare diseases. The creation of an Innovative Medicines Fund will also build on the success of the Cancer Drugs Fund and support access to the most advanced medicines for patients with rare diseases.
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to paragraph 3.21 of the 2019 voluntary scheme for branded medicines pricing and access, when NICE will review the process and methods for the highly specialised technology evaluation programme; and what methodology will be used in that review.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) has now initiated the review of its technology appraisal and highly specialised technologies methods in line with the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. Further information about the process and timescale for the review is available on the NICE website at the following link:
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 26 February 2020 to Question 18743 on Medical Treatments: Innovation, if he will include provisions on improving access to medicine for rare diseases as part of the innovative medicines fund.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Detailed proposals for the new Innovative Medicines Fund are in development and will be consulted on in due course. The Fund will build on the success of the reformed Cancer Drugs Fund so that doctors can use the most advanced, life-saving treatments for conditions such as autoimmune disease or cancer, or for children with other rare diseases.
Asked by: Crispin Blunt (Independent - Reigate)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, which medicinal products were made available on the NHS with a managed access agreement in (a) 2018-19 and (b) 2019 to date.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) has recommended 11 topics for access via a Managed Access Agreement (MAA) in 2019/20 to date. In 2018/19, 12 topics were recommended via an MAA.
These topics are listed in the following table.
NICE ref | Drug | Indication | Managed access start date |
| |
2018/19 |
| ||||
TA522 | Pembrolizumab | locally advanced or metastatic urothelial cancer where cisplatin is unsuitable | 27 April 2018 |
| |
TA529 | Crizotinib | ROS1-positive advanced non-small-cell lung cancer | 31 May 2018 |
| |
TA528 | Niraparib | platinum-sensitive ovarian cancer after second response to chemotherapy | 1 June 2018 |
| |
TA540 | Pembrolizumab | Relapsed or refractory classical Hodgkin lymphoma | 25 July 2018 |
| |
TA554 | Tisagenlecleucel | relapsed or refractory B-cell acute lymphoblastic leukaemia | 16 November 2018 |
| |
TA553 | Pembrolizumab | adjuvant treatment of resected melanoma with high risk of recurrence | 19 November 2018 |
| |
TA557 | Pembrolizumab (with pemetrexed and platinum chemotherapy) | untreated metastatic non-squamous NSCLC | 21 November 2018 |
| |
TA558 | Nivolumab | adjuvant treatment of resected stage III and IV melanoma | 30 November 2018 |
| |
TA559 | Axicabtagene ciloleucel | diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma after 2 or more systemic therapies | 7 December 2018 |
| |
TA567 | Tisagenlecleucel | relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies | 1 February 2019 |
| |
TA573 | Daratumumab with bortezomib | Multiple myeloma | 12 March 2019 |
| |
TA578 | Durvalumab | NSCLC | 28 March 2019 |
| |
2019/2020 |
| ||||
TA579 | Abemaciclib with fulvestrant | HER2-negative breast cancer after endocrine therapy | 2 April 2019 | ||
TA581 | Nivolumab with ipilimumab | untreated advanced renal cell carcinoma | 5 April 2019 | ||
TA592 | Cemiplimab | cutaneous squamous cell carcinoma | 2 July 2019 | ||
TA588 | Nusinersen | Spinal Muscular Atrophy | 3 July 2019 | ||
TA593 | Ribociclib | in combination with fulvestrant for treating advanced hormone-receptor positive, HER2-negative breast cancer | 17 July 2019 | ||
TA598 | Olaparib | maintenance treatment of newly diagnosed BRCA-mutated advanced ovarian, fallopian tube or peritoneal cancer, after response to first-line platinum-based chemotherapy | 26 July 2019 | ||
TA600 | Pembrolizumab with carboplatin and paclitaxel | Metastatic squamous NSCLC | 8 August 2019 | ||
TA611 | Rucaparib | maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer | 11 October 2019 | ||
TA619 | Palbociclib in combination with fulvestrant | advanced, HR+ HER2- breast cancer after endocrine therapy | 28 November 2019 | ||
TA620 | Olaparib | maintenance treatment of BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube and peritoneal cancer, after response to platinum-based chemotherapy | 29 November 2019 | ||
HST12 | Cerliponase alfa | neuronal ceroid lipofuscinosis type 2 | 5 November 2019 | ||