Persius/hicric huggingface dataset:
Alectinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (terminated appraisal)

NICE is unable to make a recommendation about the use in the NHS of alectinib for anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer previously treated with crizotinib because no evidence submission was received from Roche. We will review this decision if the company decides to make a submission.

# Background
Roche was invited to submit evidence for this single technology appraisal for alectinib in June 2016.
The company informed NICE that it would be difficult to demonstrate the cost effectiveness of alectinib in people who have had crizotinib. This is because the evidence base is a single arm, phase II clinical trial and the assessment of relative effectiveness would have to be based on naive indirect comparisons. Given this insufficient evidence and the availability of an alternative option, ceritinib, recently recommended by NICE, the company will not be submitting evidence for this appraisal.
The company stated that the evidence emerging from a trial directly comparing alectinib with crizotinib suggests that the value of alectinib to the NHS will be shown in people with untreated disease.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of alectinib for previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer. If, after doing this, organisations still wish to consider alectinib for previously treated ALK-positive advanced non-small-cell lung cancer, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when NICE guidance is unavailable.
NICE will review the position if the company decides that it wants to make a full submission.
ISBN: 978-1-4731-2418-9
Elotuzumab for previously treated multiple myeloma (terminated appraisal)

NICE was unable to make a recommendation about the use in the NHS of elotuzumab for previously treated multiple myeloma because no evidence submission was received from BristolMyers Squibb, but will review this decision if the company decides to make a submission.

# Background
BristolMyers Squibb was invited to submit evidence for this single technology appraisal for elotuzumab in December 2015.
Elotuzumab is used in combination with lenalidomide and dexamethasone. The ELOQUENT-2 clinical trial showed a favourable efficacy and safety profile of this regimen compared with lenalidomide plus dexamethasone.
The company was unable to show that the additional survival benefit or the improvements in quality of life associated with this combination were sufficient to warrant the increased cost to the NHS of funding all 3 drugs, as determined by the NICE cost-effectiveness threshold.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of elotuzumab for previously treated multiple myeloma. If, after doing this, organisations still wish to consider elotuzumab for previously treated multiple myeloma, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
ISBN: 978-1-4731-2420-2
Tenofovir alafenamide for treating chronic hepatitis B (terminated appraisal)

NICE was unable to make a recommendation about the use in the NHS of tenofovir alafenamide for treating chronic hepatitis B because no evidence submission was received from Gilead, but will review this decision if the company decides to make a submission.

# Background
Gilead was invited to submit evidence for this single technology appraisal for tenofovir alafenamide in May 2016.
Gilead has advised NICE that the particular population that would have the greatest need for tenofovir alafenamide cannot be differentiated from the broader population without additional data. Gilead therefore did not make a submission to NICE.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of tenofovir alafenamide for treating chronic hepatitis B. If, after doing this, organisations still wish to consider tenofovir alafenamide for treating chronic hepatitis B, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
ISBN: 978-1-4731-2421-9
Bevacizumab for treating EGFR mutation-positive non-small-cell lung cancer (terminated appraisal)

NICE was unable to make a recommendation about the use in the NHS of bevacizumab for treating epidermal growth factor receptor mutation-positive non-small-cell lung cancer because no evidence submission was received from Roche, but will review this decision if the company decides to make a submission.

# Background
Roche has informed NICE that it does not intend to pursue reimbursement for this indication and, as such, will not be making an evidence submission to NICE for this indication.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of bevacizumab for treating epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer. If, after doing this, organisations still wish to consider bevacizumab for treating EGFR mutation-positive non-small-cell lung cancer, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when NICE guidance is unavailable.
NICE will review the position at any point if the company decides that it wants to make a full submission.
ISBN: 978-1-4731-2422-6
Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy (terminated appraisal)

NICE was unable to make a recommendation about the use in the NHS of ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy because no evidence submission was received from Janssen-Cilag, but will review this decision if the company decides to make a submission.

# Background
Janssen-Cilag has informed NICE that they "...understand from the clinical community that there is no desire to use ibrutinib in combination with bendamustine and rituximab in relapsed or refractory chronic lymphocytic leukaemia (R/R CLL). Ibrutinib will only be used as monotherapy for the treatment of R/R CLL". As such, Janssen-Cilag will not be making an evidence submission to NICE for this indication.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy. If, after doing this, organisations still wish to consider ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when NICE guidance is unavailable.
NICE will review the position at any point if the company decides that it wants to make a full submission.
ISBN: 978-1-4731-2423-3
Eltrombopag for treating severe aplastic anaemia refractory to immunosuppressive therapy (terminated appraisal)

# Background
Novartis was invited to submit evidence for this single technology appraisal for eltrombopag in September 2015.
The company did not make an evidence submission because it was unable to develop robust clinical- or cost-effectiveness analyses. The marketing authorisation for eltrombopag for treating severe aplastic anaemia was based on 1 small (n=43), non-comparative, single-centre study. The primary endpoint (response rate) was measured at 3 months, and the relationship between this and long-term outcomes is unclear. All of these factors severely limited the ability of the company to construct a robust case for clinical or cost effectiveness.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of eltrombopag for severe aplastic anaemia refractory to immunosuppressive therapy. If, after doing this, organisations still wish to consider eltrombopag for severe aplastic anaemia refractory to immunosuppressive therapy, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
Copyright  National Institute for Health and Care Excellence 2016. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1654-2
Paclitaxel as albumin-bound nanoparticles with carboplatin for untreated non-small-cell lung cancer (terminated appraisal)

# Background
Celgene was invited to submit evidence for this single technology appraisal for paclitaxel as albuminbound nanoparticles in September 2015.
The company stated that it does not intend to launch paclitaxel as albuminbound nanoparticles with carboplatin for untreated nonsmallcell lung cancer when potentially curative surgery or radiation therapy or both are unsuitable, in the UK.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of paclitaxel as albuminbound nanoparticles with carboplatin for adults with untreated nonsmallcell lung cancer when potentially curative surgery or radiation therapy or both are unsuitable. If, after doing this, organisations still wish to consider paclitaxel as albuminbound nanoparticles with carboplatin for untreated nonsmallcell lung cancer, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
Copyright  National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and notforprofit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1510-1
Ruxolitinib for treating polycythaemia vera (terminated appraisal)

# Background
Novartis Pharmaceuticals was invited to submit evidence for this single technology appraisal for ruxolitinib in March 2015.
The company informed NICE that the data used to support the marketing authorisation for ruxolitinib for treating polycythaemia vera were from a trial that only included people with splenomegaly. However, the marketing authorisation includes those with and without splenomegaly. The company stated that a trial comparing ruxolitinib with best supportive care is ongoing and includes people without splenomegaly. In addition this trial would capture the quality of life and resource data needed to better characterise the disease and the effect of ruxolitinib. The company explained that without data from this ongoing trial it would not be possible to develop a submission that would meet the standards necessary to ensure a proper appraisal.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of ruxolitinib for treating polycythaemia vera that is resistant to hydroxycarbamide or for people who cannot tolerate hydroxycarbamide. If, after doing this, organisations still wish to consider ruxolitinib for treating polycythaemia vera that is resistant to hydroxycarbamide or for people who cannot tolerate hydroxycarbamide, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
Copyright  National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1451-7
Bevacizumab for treating relapsed, platinumresistant epithelial ovarian, fallopian tube or primary peritoneal cancer (terminated appraisal)

# Background
Roche Products was invited to submit evidence for this single technology appraisal for bevacizumab in March 2015.
Roche conceded that it would not be possible to demonstrate the cost effectiveness of bevacizumab for relapsed, platinumresistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Bevacizumab cannot be given special consideration as a treatment used at the end of life because the total population eligible for treatment across all its licensed indications is too large.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of bevacizumab for relapsed, platinumresistant epithelial ovarian, fallopian tube or primary peritoneal cancer. If, after doing this, organisations still wish to consider bevacizumab for relapsed, platinumresistant epithelial ovarian, fallopian tube or primary peritoneal cancer, they should follow the advice on rational local decisionmaking in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
Copyright  National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and notforprofit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1401-2
Cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of antiplatelet therapy (terminated appraisal)

# Background
The Medicines Company was invited to submit evidence for this single technology appraisal for cangrelor in October 2014.
The company informed NICE that it would not be providing an evidence submission because there was insufficient data to develop the appropriate costeffectiveness assessment of cangrelor for the population covered in the marketing authorisation, that is, adult patients with coronary artery disease undergoing percutaneous coronary intervention who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the manufacturer did not make an evidence submission when considering whether or not to recommend local use of cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of antiplatelet therapy. If, after doing this, organisations still wish to consider cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of antiplatelet therapy, they should follow the advice set out in NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable. NICE will review the position at any point if the manufacturer indicates that it wishes to make a full submission.
Copyright  National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and notforprofit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1341-1
Regorafenib for metastatic colorectal cancer after treatment for metastatic disease (terminated appraisal)

# Background
Bayer was invited to submit evidence for this single technology appraisal for regorafenib in May 2013. The appraisal was suspended shortly afterwards because the company explained that there was no evidence base on which to compare regorafenib for metastatic colorectal cancer with standard care in the UK. However, the company expected that an ongoing trial would provide these data, and that the trial was expected to complete in 2014.
The company has now reviewed the baseline characteristics of the people recruited to that trial. It considered that the number of people in the trial who have had care equivalent to standard care in the UK is too small to form the basis of a submission for this appraisal.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of regorafenib for metastatic colorectal cancer after treatment for metastatic disease. If, after doing this, organisations still wish to consider regorafenib for metastatic colorectal cancer after treatment for metastatic disease, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the company indicates that it wishes to make a full submission.
Copyright
 National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-1023-6
Canakinumab for treating systemic juvenile idiopathic arthritis (terminated appraisal)

# Background
The manufacturer of canakinumab (Novartis) was invited to submit evidence for this single technology appraisal in November 2013.
The manufacturer informed NICE that it had decided not to provide an evidence submission because it does not believe that sufficient data are available to inform a robust health technology assessment of canakinumab for the patients with systemic juvenile idiopathic arthritis who are likely to be considered for treatment in UK clinical practice.
NICE has therefore terminated this single technology appraisal.# Information
NHS organisations should take into account the reasons why the manufacturer did not make an evidence submission when considering whether or not to recommend local use of canakinumab for treating systemic juvenile idiopathic arthritis. If, after doing this, organisations still wish to consider canakinumab for treating systemic juvenile idiopathic arthritis, they should follow the advice set out in the Department of Health's Good practice guidance on managing the introduction of new healthcare interventions and links to NICE technology appraisal guidance, which outlines the approach that should be adopted in circumstances in which NICE guidance is unavailable.
NICE will review the position at any point if the manufacturer indicates that it wishes to make a full submission.

# Related NICE guidance
For information about NICE guidance that has been issued or is in development, see the NICE website.

## Published
Tocilizumab for the treatment of systemic juvenile idiopathic arthritis. NICE technology appraisal guidance 238 (2011).
Copyright  National Institute for Health and Care Excellence 2013. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
ISBN: 978-1-4731-0373-3