1-20 of 27 results for subject:Nivolumab
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To ask the Secretary of State for Health and Social Care, what steps his Department plans to take to ensure the continuation of Cancer Drugs Fund funding for patients needing adjuvant nivolumab in high risk resected malignant melanoma groups.
To ask the Secretary of State for Health and Social Care, what steps his Department plans to take to ensure the continuation of Cancer Drugs Fund funding for patients needing adjuvant nivolumab in high risk resected malignant melanoma groups.
The Cancer Drugs Fund (CDF) is now linked to the National Institute for Health and Clinical Excellence (NICE) technology appraisal programme.
In the case of nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease, this drug has been available to eligible National Health Service patients through the CDF in accordance with NICE’s recommendation in January 2019.
NICE is now reviewing this decision and published its draft recommendation in November 2020. NICE was unable to recommend nivolumab for routine funding in its draft guidance. However, this is not final guidance and a consultation on the draft recommendations closed on 25 November. NICE will has now considered the responses to the draft recommendation at the committee meeting on 5 January 2021 and expects to publish its final guidance in March 2021.
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the NICE draft guidance ID681 which recommends that nivolumab is not recommended for the adjuvant treatment of melanoma.
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the NICE draft guidance ID681 which recommends that nivolumab is not recommended for the adjuvant treatment of melanoma.
We have made no such assessment. The National Institute for Health and Care Excellence (NICE) is an independent body and it would not be appropriate for the Department to interfere in the development of NICE’s recommendations
While NICE was unable to recommend Nivolumab for routine funding in its draft recommendation of November 2020 (ID1681), this is not final guidance and a consultation on the draft recommendations closed on 25 November. NICE will now consider the responses to the draft recommendation and expects to publish its final guidance in March 2021.
To ask the Secretary of State for Health, what discussions his Department has had with NICE on that body's decision not to recommend nivolumab for treating relapsed or refractory classical Hodgkin lymphoma and the suitability of methods of appraisal used to assess blood cancer medicines which treat small patient populations.
To ask the Secretary of State for Health, what discussions his Department has had with NICE on that body's decision not to recommend nivolumab for treating relapsed or refractory classical Hodgkin lymphoma and the suitability of methods of appraisal used to assess blood cancer medicines which treat small patient populations.
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes it uses in the development of its guidance, which are developed through extensive engagement with stakeholders and periodically reviewed to ensure they remain appropriate. NICE has been able to recommend a number of drugs for the treatment of blood cancers for small patient populations through its technology appraisal programme.
NICE has not yet published final guidance on the use of nivolumab for the treatment of relapsed or refractory classical Hodgkin lymphoma and stakeholders had until 3 April to comment on NICE’s draft recommendations.
To ask the Secretary of State for Health, what assessment his Department has made of the clinical benefits of nivolumab for patients with relapsed or refractory classical Hodgkin lymphoma.
To ask the Secretary of State for Health, what assessment his Department has made of the clinical benefits of nivolumab for patients with relapsed or refractory classical Hodgkin lymphoma.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for providing robust, evidence based guidance for the National Health Service on the clinical and cost effectiveness of drugs and other treatments. NICE is currently appraising nivolumab for use in the treatment of relapsed or refractory classical Hodgkin lymphoma. NICE published its draft guidance for consultation on 14 March and stakeholders had until 3 April to comment. NICE currently expects to publish final guidance in July 2017.
To ask the Secretary of State for Health, what information his Department holds on delays in NICE providing its guidance on the Nivolumab drug; and whether any decisions have been made about the future funding of that drug.
To ask the Secretary of State for Health, what information his Department holds on delays in NICE providing its guidance on the Nivolumab drug; and whether any decisions have been made about the future funding of that drug.
The National Institute for Health and Care Excellence (NICE) makes information on the progress of ongoing technology appraisals available on its website, including explanations for any delays.
NICE has issued technology appraisal guidance recommending nivolumab (Opdivo) for a number of indications as follows:
- for treating advanced (unresectable or metastatic) melanoma in guidance published in February 2016;
- (in combination with ipilimumab) for treating advanced melanoma in guidance published in July 2016; and
- for previously treated advanced renal cell carcinoma in guidance published in November 2016.
NICE is also appraising nivolumab for a number of other indications, including lung cancers and head and neck cancer.
National Health Service commissioners are legally required to fund drugs and treatments recommended in NICE technology appraisal guidance within three months of the publication of final guidance. Under the new operating model for the Cancer Drugs Fund, NHS England will fund drugs recommended by NICE in draft technology appraisal guidance from the point of marketing authorisation.
To ask the Secretary of State for Health, when NICE plans to publish its guidance on the commissioning of Nivolumab for the treatment of breast cancer.
To ask the Secretary of State for Health, when NICE plans to publish its guidance on the commissioning of Nivolumab for the treatment of breast cancer.
The National Institute for Health and Care Excellence has not been asked to develop guidance on nivolumab (Opdivo) for the treatment of breast cancer.
Nivolumab is currently undergoing clinical trials on its potential use as a treatment for breast cancer, but does not currently have a marketing authorisation for use in this indication.
To ask the Secretary of State for Health, pursuant to the Answer of 27 June 2014 to Question 40281, on what date he expects NICE to publish the results of the consultation on the guidance on the use of nivolumab for the treatment of lung cancer.
To ask the Secretary of State for Health, pursuant to the Answer of 27 June 2014 to Question 40281, on what date he expects NICE to publish the results of the consultation on the guidance on the use of nivolumab for the treatment of lung cancer.
The National Institute for Health and Care Excellence (NICE) is currently carrying out two separate technology appraisals of nivolumab (Opdivo) for previously treated locally advanced or metastatic non-squamous non-small cell lung cancer and previously treated locally advanced or metastatic squamous non-small-cell lung cancer after prior chemotherapy in adults.
NICE is currently consulting on draft guidance for both appraisals and the closing date for comments is 4 November 2016. Subsequent timescales for guidance development are yet to be confirmed by NICE. NICE will publish comments received in response to the consultation and its responses alongside the next iteration of its draft guidance.
To ask the Secretary of State for Health, when he plans to make a decision on the drug Nivolumab becoming available under the Early Access to Medicines Scheme to treat patients with renal cell carcinoma.
To ask the Secretary of State for Health, when he plans to make a decision on the drug Nivolumab becoming available under the Early Access to Medicines Scheme to treat patients with renal cell carcinoma.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive scientific opinion concerning the use of nivolumab for renal cell carcinoma under the Early Access to Medicines Scheme on 11 February 2016. This scientific opinion has now lapsed as nivolumab has received its marketing authorisation for use in for renal cell carcinoma from the European Commission.
To ask the Secretary of State for Health, what assessment he has made of the effect of the time taken for NICE appraisal processes for the provision of Nivolumab on the treatment of NHS patients with non-small cell lung cancer; and if he will make a statement.
To ask the Secretary of State for Health, what assessment he has made of the effect of the time taken for NICE appraisal processes for the provision of Nivolumab on the treatment of NHS patients with non-small cell lung cancer; and if he will make a statement.
No such assessment has been made.
The National Institute for Health and Care Excellence (NICE) is currently carrying out technology appraisals of nivolumab for two lung cancer indications:
(i) Previously treated locally advanced or metastatic non-squamous non-small cell lung cancer. The expected publication date for this final guidance is September 2016.
(ii) Previously treated locally advanced or metastatic squamous non-small-cell lung cancer after prior chemotherapy in adults. The publication date for this final guidance is to be confirmed.
Commissioners are legally required to fund drugs and treatments recommended in NICE technology appraisal guidance within three months of its final guidance being issued. In the absence of guidance from NICE, it is for commissioners to make decisions on whether to fund new medicines based on an assessment of the available evidence.
From July 2016, the new arrangements for the Cancer Drugs Fund will ensure that the most promising and innovative medicines get to patients as quickly as possible. In particular, NICE will issue draft guidance on new cancer drugs or significant new licence indications before they have received marketing approval in the United Kingdom. Any drug that receives a positive draft recommendation would then be funded from the point of licence.
To ask the Secretary of State for Health, what plans he has to make (a) Nivolumab and (b) other immuno-oncology treatments for lung cancer available on the NHS.
To ask the Secretary of State for Health, what plans he has to make (a) Nivolumab and (b) other immuno-oncology treatments for lung cancer available on the NHS.
The National Institute for Health and Care Excellence (NICE) is currently carrying out technology appraisals of nivolumab for two lung cancer indications:
(i) previously treated locally advanced or metastatic non-squamous non-small cell lung cancer. The expected publication date for this final guidance is September 2016.
(ii) Previously treated locally advanced or metastatic squamous non-small-cell lung cancer after prior chemotherapy in adults. The publication date for this final guidance is to be confirmed.
The NICE is also appraising pembrolizumab for treating advanced or recurrent PD-L1 positive non-small cell lung cancer after progression with platinum-based chemotherapy [ID840]. The expected publication date for the final guidance on this appraisal is January 2017.
Commissioners are legally required to fund drugs and treatments recommended in the NICE technology appraisal guidance within three months of its final guidance being issued. In the absence of guidance from the NICE, it is for commissioners to make decisions on whether to fund new medicines based on an assessment of the available evidence.
To ask the Secretary of State for Health, if he will instruct officials of his Department to continue to work with the manufacturers of Nivolumab on ensuring that patients with non-squamous non-small cell lung cancer can access that drug through the NHS.
To ask the Secretary of State for Health, if he will instruct officials of his Department to continue to work with the manufacturers of Nivolumab on ensuring that patients with non-squamous non-small cell lung cancer can access that drug through the NHS.
The National Institute for Health and Care Excellence (NICE) is currently appraising nivolumab (Opdivo) for non-squamous non-small cell lung cancer.
As part of its appraisal, the NICE has considered a patient access scheme (PAS) proposal from the manufacturer Bristol-Myers Squibb which has been agreed by Ministers. Departmental officials are open to discussing any further proposals regarding the PAS with the company.
The NICE currently expects to publish its final guidance in September 2016.
In the absence of the NICE guidance, it is for commissioners to make funding decisions based on the available evidence.
To ask the Secretary of State for Health, what discussions he has had with the Royal College of Nursing on the use of nirolumab and ipilimumab to treat skin cancer.
To ask the Secretary of State for Health, what discussions he has had with the Royal College of Nursing on the use of nirolumab and ipilimumab to treat skin cancer.
We have had no such discussions.
Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) does not currently have a marketing authorisation in the United Kingdom for treating advanced or unresectable melanoma.
The National Institute for Health and Care Excellence (NICE) is currently appraising nivolumab in combination with ipilimumab for the treatment of advanced, unresectable melanoma. NICE currently expects to publish final guidance in September 2016.
In the absence of guidance from NICE, it is for commissioners to make decisions on whether to fund new medicines based on an assessment of the available evidence.
To ask the Secretary of State for Health, what information his Department holds on the effects of nivolumab on one year survival rates for lung cancer.
To ask the Secretary of State for Health, what information his Department holds on the effects of nivolumab on one year survival rates for lung cancer.
Nivolumab is currently marketed in the European Union under the brand name Opdivo.
The data available when Opdivo was licensed in 2015 indicated overall survival among patients given the product was around nine months, whereas among the patients given docetaxel, another cancer medicine, it was six months.
To ask the Secretary of State for Health, what estimate he made of the number of lung cancer patients in England who have accessed the immuno-oncology drug nivolumab via private healthcare providers or other private sources of funding in the last year; and when NICE will make its final decision...
To ask the Secretary of State for Health, what estimate he made of the number of lung cancer patients in England who have accessed the immuno-oncology drug nivolumab via private healthcare providers or other private sources of funding in the last year; and when NICE will make its final decision...
The Department does not hold the requested information concerning private healthcare or other private sources of funding.
The National Institute for Health and Care Excellence currently has two technology appraisals of nivolumab for lung cancer in development:
(i) Nivolumab for previously treated locally advanced or metastatic squamous non-small-cell lung cancer, with an anticipated publication date of May 2016.
(ii) Nivolumab for previously treated locally advanced or metastatic non-squamous non-small-cell lung cancer, with an anticipated publication date of September 2016.
To ask the Secretary of State for Health, if he will request that NICE work with the manufacturers of nivolumab to ensure patients with lung cancer can access that medicine at the earliest opportunity.
To ask the Secretary of State for Health, if he will request that NICE work with the manufacturers of nivolumab to ensure patients with lung cancer can access that medicine at the earliest opportunity.
No such assessment has been made. The National Institute for Health and Care Excellence (NICE) is currently appraising nivolumab (Opdivo) for squamous non-small cell lung cancer and has not yet issued its final guidance.
In developing its technology appraisal guidance, NICE works closely with stakeholders, including manufacturers. NICE’s consultation on its draft guidance closed on 19 January 2016.
In the absence of NICE guidance, it is for commissioners to make funding decisions based on the available evidence.
To ask the Secretary of State for Health, what assessment he has made of the effect of the negative interim NICE Appraisal Committee Decision on nivolumab for squamous non-small cell lung cancer on patients.
To ask the Secretary of State for Health, what assessment he has made of the effect of the negative interim NICE Appraisal Committee Decision on nivolumab for squamous non-small cell lung cancer on patients.
No such assessment has been made. The National Institute for Health and Care Excellence (NICE) is currently appraising nivolumab (Opdivo) for squamous non-small cell lung cancer and has not yet issued its final guidance.
In developing its technology appraisal guidance, NICE works closely with stakeholders, including manufacturers. NICE’s consultation on its draft guidance closed on 19 January 2016.
In the absence of NICE guidance, it is for commissioners to make funding decisions based on the available evidence.
To ask the Secretary of State for Health, how many patients are receiving nivolumab for locally advanced or metastatic squamous non-small cell lung cancer in (a) England and (b) Strangford; and when NICE plans to complete its appraisal of that drug.
To ask the Secretary of State for Health, how many patients are receiving nivolumab for locally advanced or metastatic squamous non-small cell lung cancer in (a) England and (b) Strangford; and when NICE plans to complete its appraisal of that drug.
NHS England has advised that it understands that the manufacturer of nivolumab (Opdivo), Bristol-Myers Squibb, received 73 registrations for nivolumab for locally advanced or metastatic squamous non-small cell lung cancer through the Early Access to Medicines Scheme before the scientific opinion expired in July 2015. A geographical breakdown of this figure is not available.
NHS England does not currently fund nivolumab for metastatic squamous non-small cell lung cancer and has advised that its funding position will be determined by the National Institute for Health and Care Excellence’s final technology appraisal guidance which is expected in May 2016. Further information is available at:
To ask the Secretary of State for Health, what plans he has to ensure early access for the immuno-oncology treatment nivolumab for both lung cancer and melanoma.
To ask the Secretary of State for Health, what plans he has to ensure early access for the immuno-oncology treatment nivolumab for both lung cancer and melanoma.
Nivolumab (Opdivo) received a positive scientific opinion under the early access to medicines scheme for melanoma in May 2015 and for lung cancer in June 2015. Nivolumab was subsequently licensed for the treatment of advanced (unresectable or metastatic) melanoma in June 2015 and for locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in July 2015.
The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance on the use of nivolumab for the treatment of:
- advanced, unresectable, metastatic melanoma - final guidance expected in May 2016;
- non-small-cell, squamous, metastatic lung cancer (after chemotherapy) - final guidance expected in May 2016; and
- untreated, advanced, unresectable, metastatic melanoma (with ipilimumab) - final guidance expected September 2016.
Commissioners are legally required to fund drugs and treatments recommended in NICE technology appraisal guidance within three months of its final guidance being issued. In the absence of guidance from NICE, it is for commissioners to make decisions on whether to fund new medicines based on an assessment of the available evidence.
We take the issue of ensuring rapid access to innovative therapies very seriously, which is why we have launched an independent Accelerated Access Review to make recommendations to Government on speeding up access for National Health Service patients to innovative and cost effective new medicines, diagnostics, medical technologies and digital products. The review published its interim report on 27 October 2015 and its full report and recommendations are expected in spring 2016.
To ask the Secretary of State for Health, if he will take steps to ensure NHS melanoma patients are able to access nivolumab before its appraisal by NICE.
To ask the Secretary of State for Health, if he will take steps to ensure NHS melanoma patients are able to access nivolumab before its appraisal by NICE.
The National Institute for Health and Care Excellence (NICE) is currently appraising nivolumab for Melanoma (advanced, unresectable, metastatic) - [ID845], and the anticipated publication date for its final guidance is May 2016. Further information is available on NICE’s website at:
www.nice.org.uk/guidance/indevelopment/gid-tag515
In the absence of NICE guidance, funding decisions for individual treatments should be made by the relevant National Health Service commissioner, based on an assessment of the available evidence. Commissioners are also required to have processes in place for the consideration of exceptional funding requests.
NHS England is responsible for commissioning chemotherapy in England and has advised that it will not usually develop a commissioning policy on treatments which are undergoing NICE appraisal. Nivolumab is undergoing assessment and is not yet routinely funded for patients.
To ask the Secretary of State for Health, what estimate he has made of the number of lung cancer patients who would benefit from the immunotherapy nivolumab; and if he will make a statement.
To ask the Secretary of State for Health, what estimate he has made of the number of lung cancer patients who would benefit from the immunotherapy nivolumab; and if he will make a statement.
NHS England has advised that it is not currently possible to estimate the numbers of patients in England who will be suitable for treatment, as the licence for nivolumab has been split into two distinct sub-groups (squamous and non-squamous non-small cell lung cancer) and the latter has yet to receive a marketing authorisation.