NICE technology appraisals

Ocriplasm is recommended as an option for treating vitreomacular traction in adults, only if:

• an epiretinal membrane is not present and
• they have a stage II full-thickness macular hole with a diameter of 400 micrometres or less and/or
• they have severe symptoms

1.1 Crizotinib is not recommended within its marketing authorisation, that is, for treating adults with previously treated anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer.

1.2 People currently receiving crizotinib that is not recommended according to 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Everolimus, in combination with exemestane, is not recommended within its marketing authorisation for treating menopausal women with advanced human epidermal growth factor receptor 2 (HER2) negative hormone-receptor-positive breast cancer that has recurred or progressed following treatment with non-steroidal aromatase inhibitor.

1.2 Women currently receiving everolimus for advanced breast cancer should be able to continue treatment until they and their clinician consider it appropriate to stop.

Aflibercept solution for injection is recommended as an option for treating wet age-related macular degeneration only if:

• it is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155 (re-issued in May 2012) and
• the manufacturer provides aflibercept solution for injection with the discount agreed in the patient access scheme.

1.2 People currently receiving aflibercept solution for injection whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Eltrombopag is recommended as an option for treating adults with chronic immune (idiopathic) thrombocytopenic purpura, within its marketing authorisation (that is, in adults who have had a splenectomy and whose condition is refractory to other treatments, or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated), only if:

• their condition is refractory to standard active treatments and rescue therapies, or
• they have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies and
• the manufacturer provides eltrombopag with the discount agreed in the patient access scheme.

• 1.2 People currently receiving eltrombopag whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

Aripiprazole is recommended as an option for treating moderate to severe manic episodes in adolescents with bipolar I disorder, within its marketing authorisation (that is, up to 12 weeks of treatment for moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 and older).

1.1 Pegloticase is not recommended within its marketing authorisation, that is, for treating severe debilitating tophaceous gout in adults who may also have erosive joint involvement and in whom xanthine oxidase inhibitors at the maximum medically appropriate dose have failed to normalise serum uric acid, or for whom these medicines are contraindicated.

1.2 People currently receiving pegloticase that is not recommended according to 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Mirabegron is recommended as an option for treating the symptoms of overactive bladder only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects.

1.2 People currently receiving mirabegron that is not recommended for them in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Ruxolitinib is not recommended within its marketing authorisation, that is, for the treatment of disease-related splenomegaly or symptoms in adults patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

1.2 People currently receiving ruxolitinib should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if it is used as described for dipeptidyl peptidase-4 (DPP-4) inhibitors in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87).

1.2 Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

1.3 Dapagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial.

1.4 People currently receiving dapagliflozin in a dual or triple therapy regimen that is not recommended for them in 1.1 or 1.3 should be able to continue treatment until they and their clinician consider it appropriate to stop.

Rivaroxban is recommended as an option for treating pulmonary embolism and preventing recurrent deep vein thrombosis and pulmonary embolism in adults.

NICE is unable to recommend the use in the NHS of loxapine inhalation for treating acute agitation and disturbed behaviours associated with schizophrenia and bipolar disorder because no evidence submission was received from the manufacturer of the technology.

Bevacizumab in combination with gemcitabine and carboplatin is not recommended within its marketing authorisation, that is, for treating people with the first recurrence of platinum-sensitive advanced ovarian cancer (including fallopian tube and primary peritoneal cancer) who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents.

People currently receiving bevacizumab in combination with gemcitabine and carboplatin for treating the first recurrence of platinum-sensitive advanced ovarian cancer should be able to continue treatment until they and their clinician consider it appropriate to stop.

Bevacizumab in combination with paclitaxel and carboplatin is not recommended for first-line treatment of advanced ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] stages IIIB, IIIC and IV epithelial ovarian, fallopian tube or primary peritoneal cancer).

People currently receiving bevacizumab for first-line treatment of advanced ovarian cancer should be able to continue treatment until they and their clinicians consider it appropriate to stop.

1.1 Ranibizumab is recommended as an option for treating visual impairment caused by macular oedema:

• following central retinal vein occlusion or
• following branch retinal vein occlusion only if treatment with laser photocoagulation has not been beneficial, or when laser photocoagulation is not suitable because of the extent of macular haemorrhage and
• only if the manufacturer provides ranibizumab with the discount agreed in the patient access scheme revised in the context of NICE technology appraisal guidance 274.

• 1.2 People currently receiving ranibizumab whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Pirfenidone is recommended as an option for treating idiopathic pulmonary fibrosis only if:

• the person has a forced vital capacity (FVC) between 50% and 80% predicted and

• the manufacturer provides pirfenidone with the discount agreed in the patient access scheme.

• Treatment with pirfenidone that is recommended according to 1.1 should be discontinued if there is evidence of disease progression (a decline in per cent predicted FVC of 10% or more within any 12 month period).

  People currently receiving pirfenidone that is not recommended according to 1.1 should have the option to continue treatment until they and their clinician consider it appropriate to stop.

NICE is unable to recommend the use in the NHS of canakinumab for treating gouty arthritis attacks and reducing the frequency of subsequent attacks because no evidence submission was received from the manufacturer of the technology.

1.1 Abatacept in combination with methotrexate is recommended as an option for treating rheumatoid arthritis in adults whose disease has responded inadequately to conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, only if:

• it is used in accordance with the recommendations for other biological DMARDs in Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (NICE technology appraisal guidance 130) and
• the manufacturer provides abatacept with the discount agreed in the patient access scheme.

• 1.2 People currently receiving abatacept whose disease does not meet the criteria in section 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

1.1 Percutaneous verteboplasty, and percutaneous balloon kyphoplasty without stenting, are recommended as options for treating osteoporotic vertebral compression fractures only in people:

• who have severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management and
• in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging.

1.1 Omalizumab is recommended as an option for treating severe persistent confirmed allergic IgE-mediated asthma an add-on to optimised standard therapy in people aged 6 years and older:

• who need continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year), and
• only if the manufacturer makes omalizumab available with the discount agreed in the patient access scheme.

  1.2 Optimised standard therapy is defined as a full trial of and, if tolerated, documented compliance with inhaled high-dose corticosteroids, long-acting beta2 agonists, leukotriene receptor antagonists, theophyllines, oral corticosteroids, and smoking cessation if clinically appropriate.

  1.3 People currently receiving omalizumab whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

NICE is unable to recommend the use in the NHS of methylnaltrexone for treating opioid-induced bowel dysfunction in people with advanced illness receiving palliative care because no evidence submission was received from the manufacturer of the technology.

1.1 Tobramycin dry powder for inhalation (DPI) is recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis only if:

• nebulised tobramycin is considered an appropriate treatment, that is, when colistimethate sodium is contraindicated, is not tolerated or has not produced an adequate clinical response and
• the manufacturer provides tobramycin DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS.

• Colistimethate sodium DPI is recommended as an option for treating chronic pulmonary infection caused by P.aeruginosa in people with cystic fibrosis only if:

• they would clinically benefit from continued colistimethate sodium but do not tolerate it in its nebulised form and thus tobramycin therapy would otherwise be considered and
• the manufacturer provides colistimethate sodium DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS.

• 1.2 People currently using tobramycin DPI or colistimethate sodium DPI that is not recommended according to 1.1 or 1.2 should be able to continue treatment until they and their clinician consider it appropriate to stop. For children and young people this decision should be made jointly by the clinician, the child or young person and their parents or carers.

Apixaban is recommended as an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with nonvalvular atrial fibrillation with 1 or more risk factors such as:

• prior stroke or transient ischaemic attack
• age 75 years or older
• hypertension
• diabetes mellitus
• symptomatic heart failure.

The decision about whether to start treatment with apixaban should be made after an informed discussion between the clinician and the person about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate and rivaroxaban. For people who are taking warfarin, the potential risks and benefits of switching to apixaban should be considered in light of their level of international normalised ratio (INR) control.

Ranibizumab is recommended as an option for treating visual impairment due to diabetic macular oedema only if:

• the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and
• the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012).

NICE is unable to recommend the use in the NHS of tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia because no evidence submission was received from the manufacturer of the technology.