NICE technology appraisals

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.

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).

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

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:

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.

1.1 Abatacept in combination with methotrexate is recommended as an option for treating rheumatoid arthritis in adults whose disease has responded inadequately to 2 conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, only if:

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:

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:

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:

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

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.

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).

Vinflunine is not recommended within its marketing authorisation for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract that has progressed after treatment with platinum-based chemotherapy.

NICE is unable to make a recommendation about the use in the NHS of decitabine for acute myeloid leukaemia because no evidence submission was received from the manufacturer of the technology.

Vemurafenib is recommended as an option for treating BRAF V600 mutation-positive unresectable or metastatic melanoma only if the manufacturer provides vemurafenib with the discount agreed in the patient access scheme.

Ipilimumab is recommended as an option for treating advanced (unresectable or metastatic) melanoma in people who have received prior therapy, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme.

Ivabradine is recommended as an option for treating chronic heart failure for people:

• with New York Heart Association (NYHA) class II to IV stable chronic heart failure with systolic dysfunction and
• who are in sinus rhythm with a heart rate of 75 beats per minute (bpm) or more
• and who are given ivabradine in combination with standard therapy including beta-blocker therapy, angiotensin-converting enzyme (ACE) inhibitors and aldosterone antagonists, or when beta-blocker therapy is contraindicated or not tolerated
and with a left ventricular ejection fraction of 35% or less.

Ivabradine should only be initiated after a stabilisation period of 4 weeks on optimised standard therapy with ACE inhibitors, beta-blockers and aldosterone antagonists.

Ivabradine should be initiated by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be carried out by a heart failure specialist, or in primary care by either a GP with a special interest in heart failure or a heart failure specialist nurse.

Mannitol dry powder for inhalation is recommended as an option for treating cystic fibrosis in adults:

• who cannot use rhDNase because of ineligibility, intolerance or inadequate response to rhDNase and
• whose lung function is rapidly declining (forced expiratory volume in 1 second [FEV1] decline greater than 2% annually) and
• for whom other osmotic agents are not considered appropriate.

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

Denosumab is recommended as an option for preventing skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from breast cancer and from solid tumours other than prostate if:

• bisphosphonates would otherwise be prescribed and
• the manufacturer provides denosumab with the discount agreed in the patient access scheme.

Denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from prostate cancer.

Adults with bone metastases from solid tumours currently receiving denosumab for the prevention of skeletal-related events that is not recommended according to 1.1 and 1.2 should be able to continue treatment until they and their clinician consider it appropriate to stop.

Alteplase is recommended within its marketing authorisation for treating acute ischaemic stroke in adults if:

• treatment is started as early as possible within 4.5 hours of onset of stroke symptoms, and
• intracranial haemorrhage has been excluded by appropriate imaging techniques.

Bevacizumab in combination with capecitabine is not recommended within its marketing authorisation for the first-line treatment of metastatic breast cancer, that is, when treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate, or when taxanes or anthracyclines have been used as part of adjuvant treatment within the past 12 months.

People currently receiving bevacizumab in combination with capecitabine 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 adalimumab for the treatment of moderate to severe ulcerative colitis because no evidence submission was received from the manufacturer or sponsor of the technology.

This appraisal relates to people whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.