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
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 All cancer drugs recommended by NICE are eligible for funding through the CDF from the point of NICE’s draft guidance.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
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
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
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
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
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 | ||
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 effect of the NHS Commercial Framework on access to medicines through managed access agreements.
Answered by Jo Churchill
NHS England and NHS Improvement has advised that the Commercial Framework for new medicines remains in draft at this time with publication expected in spring 2020. The Commercial Framework is designed to complement the processes and methods of the National Institute for Health and Care Excellence’s technology appraisal programme which provides direction on when managed access agreements may be appropriate. The framework will promote the opportunities that currently exist and clarify NHS England and NHS Improvement’s involvement within the existing arrangements rather than advising on new opportunities for managed access agreements.
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 Cancer Drugs Fund expenditure cap is for (a) 2019-20 and (b) 2020-21.
Answered by Jo Churchill
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, pursuant to the Answer of 26 February 2020 to Question 18744 on Medical Treatments: Innovation,whether he plans to hold a public consultation on his proposals for an innovative medicines fund.
Answered by Jo Churchill
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, what steps Public Health England plans to take to assess the effectiveness of the HPV vaccination programme.
Answered by Jo Churchill
Public Health England (PHE) is conducting surveillance activities to monitor the effectiveness of the National Human Papillomavirus (HPV) Vaccination Programme. The current HPV vaccine protects against two high-risk HPV types, HPV16 and HPV18 which cause around 80% of cervical cancers in the United Kingdom and two low-risk HPV types, HPV6 and HPV11 which cause most genital warts.
Surveillance conducted among young sexually active women in England has compared changes in the number of women who have a HPV infection over time since the introduction of the HPV vaccination.