Persius/hicric huggingface dataset:
Loxapine inhalation for treating acute agitation and disturbed behaviours associated with schizophrenia and bipolar disorder (terminated appraisal)

# Background
The manufacturer (Alexza Pharmaceuticals) was invited to submit evidence for this single technology appraisal in January 2013.
In January 2013 the manufacturer informed NICE that they would not be making a submission for this appraisal. The manufacturer said that they have received the marketing authorisation for loxapine inhalation (Adusave) but that this restricts administration to adults with mild to moderate agitation associated with schizophrenia and bipolar disorder and to the hospital setting. The manufacturer stated that there is insufficient evidence available to develop the appropriate analytical model required to estimate cost effectiveness in line with NICE single technology appraisal procedures.
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 loxapine inhalation for treating mild to moderate agitation in adults with schizophrenia or bipolar disorder. If, after doing this, organisations still wish to consider loxapine inhalation for treating mild to moderate agitation in adults with schizophrenia or bipolar disorder, 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 where 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.
Core interventions in the treatment and management of schizophrenia in primary and secondary care (update). NICE clinical guideline 82 (2009).
The management of bipolar disorder in adults, children and adolescents in primary and secondary care. NICE clinical guideline 38 (2006).
Violence: The short-term management of disturbed/violent behaviour in in-patient psychiatric settings and emergency departments. NICE clinical guideline 25 (2005).
ISBN 978-1-4731-0147-0
Methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care (terminated appraisal)

# Background
The manufacturer of methylnaltrexone (TMC Pharma Services) was invited to submit evidence for the single technology appraisal of methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care.
In December 2012, TMC Pharma Services informed NICE that it would not be making an evidence submission for this appraisal. The manufacturer stated that it is holding the European marketing authorisation for methylnaltrexone on a temporary basis while the product owner finds a permanent European partner, but timelines for this are not currently known.
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 methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care. If, after doing this, organisations still wish to consider methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care, they should follow the advice set out in 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 where 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
Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults. NICE clinical guideline 140 (2012)
Prucalopride for the treatment of chronic constipation in women. NICE technology appraisal guidance 211 (2010)

## Under development
NICE is developing the following guidance (details available from the NICE website):
Lubiprostone for the treatment of opioid-induced constipation. NICE technology appraisal. Publication date to be confirmed.
Tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia (terminated appraisal)

# Background
The manufacturer of tadalafil (Lilly) was invited to submit evidence for this single technology appraisal in August 2012.
In September 2012, the manufacturer informed NICE that it would not be making an evidence submission for the appraisal of tadalafil for the treatment of benign prostatic hyperplasia. The manufacturer stated that there is insufficient evidence available to be able to undertake the appropriate analysis required to estimate the cost effectiveness of tadalafil within the defined treatment pathway outlined in Lower urinary tract symptoms: the management of lower urinary tract symptoms in men (NICE clinical guideline 97).
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 tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia. If, after doing this, organisations still wish to consider tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia, they should follow the advice set out in 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 where 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.
Lower urinary tract symptoms: the management of lower urinary tract symptoms in men. NICE clinical guideline 97 (2010).
Referral guidelines for suspected cancer in adults and children. NICE clinical guideline 27 (2005).
Laparoscopic prostatectomy for benign prostatic obstruction. NICE interventional procedure guidance 275 (2008).
Decitabine for the treatment of acute myeloid leukaemia (terminated appraisal)

# Background
The manufacturer of decitabine (Janssen) was invited to submit evidence for this single technology appraisal in September 2012.
The manufacturer informed NICE that it had decided not to provide an evidence submission because it could not provide adequate evidence to appraise the technology in accordance with the methods and reference case employed by NICE. The manufacturer stated that the single randomised controlled trial of decitabine in acute myeloid leukaemia did not provide enough data for certain outcomes (for example, low completion rates for patient-reported health outcomes) and that the trial's design (with a mixed treatment comparator) meant there were several potential subgroups with the potential for confounding. The manufacturer also said that it would be challenging to develop an economic model to meet the decision problem because the clinical outcomes would be complicated by subsequent rescue treatments. The manufacturer said that it would therefore not be able to address the clinical and cost effectiveness of decitabine in people with acute myeloid leukaemia.
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 decitabine for the treatment of acute myeloid leukaemia. If, after doing this, organisations still wish to consider decitabine for the treatment of acute myeloid leukaemia, they should follow the advice set out in 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.
Azacitidine for the treatment of myelodysplastic syndrome, chronic myelomonocytic leukaemia and acute myeloid leukaemia. NICE technology appraisal guidance 218 (2011).
Improving outcomes in haematological cancers. NICE cancer service guidance (2003).
Agomelatine for the treatment of major depressive episodes (terminated appraisal)

NICE is unable to recommend the use in the NHS of agomelatine for the treatment of major depressive episodes because no evidence submission was received from the manufacturer or sponsor of the technology.

# Background
The manufacturer of agomelatine (Servier) has informed NICE that it would not be making an evidence submission for the appraisal of agomelatine for the treatment of major depressive episodes. Servier drew attention to the fact that NICE guidelines for England and Wales recommend generic selective serotonin reuptake inhibitors (SSRIs) as first-line treatment followed by a different SSRI or a better tolerated newer-generation agent as second-line treatment. The manufacturer noted that the majority of the clinical trial evidence for agomelatine was as a first-line treatment and furthermore was not against the full range of comparators in the scope. The manufacturer stated that this precluded the development of an economic case that would address the NICE decision problem and maintain the requisite level of certainty.
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 agomelatine for the treatment of major depressive episodes in adults. If, after doing this, organisations still wish to consider the use of agomelatine for the treatment of major depressive episodes in adults, they should follow the advice set out in 'Good practice guidance on managing the introduction of new healthcare interventions and links to NICE technology appraisal guidance' (www.dh.gov.uk/en/DH_064983), which outlines the approach that should be adopted in circumstances where 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 website (www.nice.org.uk)

## Published
Common mental health disorders. NICE clinical guideline 123 (2011). Available from www.nice.org.uk/guidance/CG123
Depression with chronic physical health problems. NICE clinical guideline 91 (2009). Available from www.nice.org.uk/guidance/CG91
Depression in adults (update). NICE clinical guideline 90 (2009). Available from www.nice.org.uk/guidance/CG90
Vagus nerve stimulation for treatment-resistant depression. NICE interventional procedure guidance 330 (2009). Available from www.nice.org.uk/guidance/IPG330
Transcranial magnetic stimulation for severe depression. NICE interventional procedure guidance 242 (2007). Available from www.nice.org.uk/guidance/IPG242
Bipolar disorder. NICE clinical guideline 38 (2006). Available from www.nice.org.uk/guidance/CG38
Depression in children and young people. NICE clinical guideline 28 (2005). Available from www.nice.org.uk/guidance/CG28
Bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab (terminated appraisal)

# Background
The manufacturer of bendamustine (Napp Pharmaceuticals) was invited to submit evidence for this single technology appraisal (STA) in May 2010.
In June 2010, the manufacturer informed NICE that it would not be making an evidence submission because it was unable to identify relevant sources of clinical evidence suitable for a NICE appraisal in people with rituximab-refractory disease. The manufacturer indicated that further research was ongoing but data would not be available in a time frame that would allow NICE to produce timely guidance.
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 bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen. If, after doing this, organisations still wish to consider the use of bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen, they should follow the advice set out in '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 where 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 website.

## Published
Rituximab for the treatment of relapsed or refractory stage III or IV follicular non-Hodgkin's lymphoma (review of technology appraisal guidance 37). NICE technology appraisal guidance 137 (2008).
Rituximab for the first-line maintenance treatment of follicular non-Hodgkin's lymphoma. NICE technology appraisal guidance 226 (2011).
Rituximab for the first-line treatment of stage III-IV follicular lymphoma: (review of NICE technology appraisal guidance 110). NICE technology appraisal guidance 243 (2012).
Temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma (terminated appraisal)

# Background
The manufacturer of temsirolimus (Wyeth) was invited to submit evidence for this single technology appraisal (STA) in November 2009.
In January 2010, the manufacturer informed NICE that it would not be making an evidence submission. The manufacturer subsequently confirmed this in August 2010. Given the rarity of the condition, the complex clinical management of mantle cell lymphoma and the large number of comparator regimens used in the single randomised clinical trial, the manufacturer did not believe that an adequate assessment of the clinical and cost effectiveness of temsirolimus would be possible.
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 temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma. If, after doing this, organisations still wish to consider the use of temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma, they should follow the advice set out in '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 where 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
There is no related NICE guidance.
Bevacizumab for the treatment of non-small-cell lung cancer (terminated appraisal)

# Background
The manufacturer of bevacizumab (Roche Products) was invited to submit evidence for this single technology appraisal in April 2007.
In June 2007, the manufacturer informed NICE that it would not be launching or promoting bevacizumab for the lung cancer indication and as a result it would not be making an evidence submission for this appraisal.
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 bevacizumab in addition to platinum-based chemotherapy for the first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small-cell lung cancer. If, after doing this, organisations still wish to consider the use of bevacizumab in addition to platinum-based chemotherapy for the first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small-cell lung cancer, they should follow the advice set out in '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 where 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 website.
Pemetrexed for the treatment of malignant pleural mesothelioma. NICE technology appraisal guidance 135 (2008).
Pemetrexed for the treatment of non-small-cell lung cancer. NICE technology appraisal guidance 124 (2007).
Lung cancer: the diagnosis and treatment of lung cancer. NICE clinical guideline 24 (2005). 
Erlotinib for the treatment of non-small-cell lung cancer. NICE technology appraisal guidance 162 (2008).
Carmustine implants for the treatment of recurrent glioblastoma multiforme (terminated appraisal)

# Background
The manufacturer of carmustine implants (Archimedes Pharma UK) was invited to submit evidence for this single technology appraisal in May 2007.
NICE did not receive a submission from the manufacturer that followed the specification for manufacturer or sponsor submissions of evidence for single technology appraisal and NICE's methodological reference case.
In July 2007, the manufacturer sent a 'submission statement' to NICE. In this statement the manufacturer expressed the view that following the publication of 'Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma' (NICE technology appraisal guidance 121) most patients will have received previous treatment with carmustine implants before they undergo subsequent surgery for recurrent glioblastoma. However, the manufacturer stated that all of the available data are from recurrent glioblastoma patients who have not previously received treatment with carmustine implants. Therefore the data do not reflect current clinical practice and it would not be possible to draw valid conclusions on cost effectiveness. The manufacturer also commented that only a small number of patients would undergo subsequent surgery for recurrent glioblastoma in England and Wales each year.
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 carmustine implants as an adjunct to surgery in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated. If, after doing this, organisations still wish to consider the use of carmustine implants for the treatment of recurrent glioblastoma multiforme, they should follow the advice set out in '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 where 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 website.
Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma. NICE technology appraisal guidance 121 (2007).
Improving outcomes for people with brain and other CNS tumours. NICE cancer service guidance (2006).
Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer). NICE technology appraisal guidance 23 (2001).
Auditory brain stem implants

# Guidance
Current evidence on the safety and efficacy of auditory brain stem implants appears adequate to support the use of this procedure by surgical teams experienced in this technique, provided that normal arrangements are in place for consent, audit and clinical governance.# The procedure

# Indications
This procedure is used to treat total deafness in both ears caused by damage to the vestibulocochlear nerve as a result of tumours or surgery.
In people with vestibulocochlear nerve damage, hearing is not improved by hearing aids or cochlear implants.

# Outline of the procedure
The cochlear nucleus lies in the brain stem and is responsible for processing sound signals carried from the ear through the vestibulocochlear nerve. Auditory brain stem implants are electrodes placed in the cochlear nucleus.
Removal of vestibulocochlear nerve tumours and placement of auditory brain stem implants are often done at the same time. An incision is made in the skin on the side of the head and some of the bone behind the ear is removed. This exposes the tumour so that it can be removed and also allows access to the brain stem beneath it. The electrodes can then be implanted into the cochlear nucleus. The brain stem may sometimes be approached through the back of the head. People with auditory brain stem implants wear an external receiver and speech processor. This device converts sounds into electrical signals, which are then sent to the implant.

# Efficacy
The evidence was limited to case series data. One study reported that 85% (75/88) of patients received auditory sensations when their implants were activated. In another study, some hearing was reported in 94% (51/54) of patients. For more details, refer to the Sources of evidence section.
One Specialist Advisor commented that results were unpredictable.

# Safety
The main complications reported in the identified studies were: cerebrospinal fluid leak 3% (2/61); meningitis 2% (1/61); and pulmonary embolism 2% (1/54). A study of 61 patients reported no severe or serious non-auditory sensations. Tingling in various parts of the body was reported to be 'not uncommon' in a study of 88 patients. For more details, refer to the Sources of evidence section.
The Specialist Advisors listed the potential adverse effects of the procedure as death, damage to lower cranial nerves, intracranial haematoma/brainstem stroke, meningitis, and implant-related infection.

# Other comments
This procedure is suitable for a small proportion of patients who have complete hearing loss for whom no alternative treatment would restore hearing. In the UK, this procedure has been performed on only a small number of patients in a limited number of hospitals.
Long-term data are needed for this procedure.# Further information

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the overview to this guidance.

# Information for patients
NICE has produced information on this procedure for patients and carers. It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.