NICE technology appraisals

Summary:

• Dabigatran etexilate is recommended as a treatment option for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation with one or more of the specified risk factors outlined in the guidance
• Treatment with dabigatran etexilate should only begin after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. For people who are taking warfarin, the potential risks and benefits of switching to dabigatran etexilate should be considered in light of their level of international normalised ratio control.

Summary:

• Prolonged-release exenatide in dual-therapy regimens (i.e. in combination with metformin or a sulphonylurea) and triple-therapy regimens (i.e. in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione), is recommended as a treatment option for people with type 2 diabetes who meet the specified criteria within the guidance
• Treatment with prolonged-release exenatide should only be continued if a beneficial metabolic response has been shown (as defined in the NICE recommendations).

Summary:

• Tocilizumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults who meet the specified criteria outlined in the guidance
• People currently receiving tocilizumab for the treatment of rheumatoid arthritis who do not meet the criteria should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Summary:

• Pharmalgen is recommended as an option for the treatment of IgE-mediated bee and wasp venom allergy in people who have had:
  • a severe systemic reaction to bee or wasp venom or
  • a moderate systemic reaction to bee or wasp venom and who have one or more of the following: a raised baseline serum tryptase, a high risk of future stings, or anxiety about future stings
• Treatment with Pharmalgen should be initiated and monitored in a specialist centre experienced in venom immunotherapy.

• Roflumilast is recommended only in the context of research as part of a clinical trial for adults with severe chronic obstructive pulmonary disease (defined as forced expiratory volume in 1 second [FEV₁] post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment
• Such research should be designed to generate robust evidence about the benefits of roflumilast as an add-on to long-acting muscarinic antagonists (LAMA) plus long-acting beta₂ agonists (LABA) plus inhaled corticosteroids (ICS), or LAMA plus LABA for people who are intolerant to ICS.

Summary:

• Rituximab is recommended as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated people, in combination with:
• cyclophosphamide, vincristine, and prednisolone
• cyclophosphamide, doxorubicin, vincristine, and prednisolone
• mitoxantrone, chlorambucil, and prednisolone
• cyclophosphamide, doxorubicin, etoposide, prednisolone, and interferon-α or
• chlorambucil.

Summary:

• The following treatments are not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy:
• Cetuximab monotherapy or combination chemotherapy
• Bevacizumab in combination with non-oxaliplatin (fluoropyrimidine-based) chemotherapy
• Panitumumab monotherapy
• People currently receiving the above therapies should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Summary:

• The criteria for using nilotinib, dasatinib, and high-dose imatinib are outlined in the technology appraisal
• People who are currently receiving dasatinib or high-dose imatinib for the treatment of CML should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

• NICE is unable to recommend the use in the NHS of panitumumab in combination with chemotherapy for the treatment of metastatic colorectal cancer because no evidence submission was received from the manufacturer or sponsor of the technology
• This appraisal relates to the treatment of wild-type KRAS metastatic corectal cancer for first-line treatment in combination with FOLFOX, and for second-line treatment in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

• Fulvestrant is not recommended, within its licensed indication, as an alternative to aromatase inhibitors for the treatment of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in post-menopausal women whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or who have disease progression on anti-oestrogen therapy
• Post-menopausal women currently receiving fulvestrant within its licensed indication as an alternative to aromatase inhibitors for the treatment of oestrogen-receptor-positive, locally advanced or metastatic breast cancer whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or who have disease progression on anti-oestrogen therapy, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

• Tocilizumab is recommended for the treatment of systemic juvenile idiopathic arthritis in children and young people aged 2 years and older whose disease has responded inadequately to non-steroidal anti-inflammatory drugs, systemic corticosteroids, and methotrexate if the manufacturer makes tocilizumab available with the discount agreed as part of the patient access scheme
• Tocilizumab is not recommended for the treatment of systemic juvenile idiopathic arthritis in children and young people aged 2 years and older whose disease continues to respond to methotrexate or who have not been treated with methotrexate.

• Ranibizumab is not recommended for the treatment of visual impairment due to diabetic macular oedema
• People currently receiving ranibizumab for the treatment of visual impairment due to diabetic macular oedema should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

• Ticagrelor in combination with low-dose aspirin is recommended for up to 12 months as a treatment option in adults with ACS, that is, people:
• with ST-segment-elevation myocardial infarction (STEMI) that cardiologists intend to treat with primary percutaneous coronary intervention or
• with non-ST-segment-elevation myocardial infarction (NSTEMI) or
• admitted to hospital with unstable angina defined as ST or T wave changes on electrocardiogram suggestive of ischaemia plus one of the characteristics defined in the guideline. Before ticagrelor is continued beyond the initial treatment, the diagnosis of unstable angina should first be confirmed, ideally by a cardiologist.

• Mifamurtide in combination with postoperative multi-agent chemotherapy is recommended within its licensed indication as an option for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection in children, adolescents, and young adults and when mifamurtide is made available at a reduced cost to the NHS under the patient access scheme.

• Abatacept in combination with methotrexate is not recommended for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate
• People currently receiving abatacept in combination with methotrexate, whose disease has responded inadequately to one or more conventional non-biological DMARDs including methotrexate, should have the option to continue treatment until they, and their clinicians, consider it appropriate to stop.

• Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if it is used as described for adalimumab and etanercept in NICE Technology Appraisal 143 and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme
• People currently taking golimumab who do not fulfil the criteria in Technology Appraisal 143 should have the option to continue treatment until they and their clinician consider it appropriate to stop.

• Retigabine is only recommended as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy, when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate, and topiramate has not provided an adequate response, or has not been tolerated.

• 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.

• Bivalirudin in combination with aspirin and clopidogrel is recommended for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

• Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following central retinal vein occlusion
• Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following branch retinal vein occlusion for people who meet the criteria specified in the guidance
• People currently receiving dexamethasone intravitreal implant for the treatment of macular oedema secondary to branch retinal vein occlusion who do not meet the criteria specified in the guidance should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

• Thalidomide in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma when high-dose chemotherapy with stem cell transplantation is considered inappropriate
• Bortezomib in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma:
  • if high-dose chemotherapy with stem cell transplantation is considered inappropriate and
  • the person is unable to tolerate or has contraindications to thalidomide.

• Erlotinib monotherapy is not recommended for maintenance treatment in people with locally advanced or metastatic non-small-cell lung cancer who have stable disease after platinum-based first-line chemotherapy
• People currently receiving erlotinib monotherapy for maintenance treatment of locally advanced or metastatic non-small-cell lung cancer who have stable disease after platinum-based first-line chemotherapy should have the option to continue treatment until they and their clinician consider it appropriate to stop.

• Rituximab maintenance therapy is recommended as an option for the treatment of people with follicular non-Hodgkin's lymphoma that has responded to first-line induction therapy with rituximab in combination with chemotherapy.

• Golimumab in combination with methotrexate is recommended as a treatment option for rheumatoid arthritis in adults whose rheumatoid arthritis has responded inadequately to disease-modifying anti?rheumatic drugs, if they meet the criteria outlined in the guidance
• of rheumatoid arthritis, healthcare professionals should take into account any physical, sensory or learning disabilities, communication difficulties, or disease characteristics that could adversely affect patient assessment and make any appropriate adjustments.

• NICE is unable to recommend the use in the NHS of golimumab for the treatment of methotrexate-naive rheumatoid arthritis because no evidence submission was received from the manufacturer or sponsor of the technology.