Sodium Phenylbutyrate

Red

Brand Name(s):Ammonaps

Indication:Urea cycle disorders – long-term treatment

Rationale:4

Considered:Dec-07

Review Date:Oct-20

Comments:
Tocilizumab for the treatment of rheumatoid arthritis (rapid review of technology appraisal guidance 198)
NICE technology appraisal guidance 247

This guidance replaces NICE technology appraisal guidance 198 issued in August 2010.
Tocilizumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults if:
the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and it is used as described for tumour necrosis factor (TNF) inhibitor treatments in Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (NICE technology appraisal guidance 130), specifically the recommendations on disease activity and choice of treatment or the disease has responded inadequately to DMARDs and a TNF inhibitor and the person cannot receive rituximab because of a contraindication to rituximab, or because rituximab is withdrawn because of an adverse event, and tocilizumab is used as described for TNF inhibitor treatments in Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (NICE technology appraisal guidance 195), specifically the recommendations on disease activity or the disease has responded inadequately to one or more TNF inhibitor treatments and to rituximab and the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme.

People currently receiving tocilizumab for the treatment of rheumatoid arthritis who do not meet the criteria in 1.1 should have the option to continuetreatment until they and their clinicians consider it appropriate to stop.
Issued: February 2012

…………………………
Tocilizumab for the treatment of systemic juvenile idiopathic arthritis
Guidance

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 (NSAIDs), 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.

Children and young people currently receiving tocilizumab for the treatment of systemic juvenile idiopathic arthritis who do not meet the criteria in 1.1 should have the option to continue treatment until it is considered appropriate to stop.

This decision should be made jointly by the clinicians, and the child or young person and/or their parents or carers.

NICE technology appraisal guidance 238 December 2011
…………………………

– A case of fatal anaphylaxis has been reported in a patient treated with tocilizumab (RoActemra)
– Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving tocilizumab, both during and following its administration
– Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with RoActemra
– If prophylaxis or any other serious hypersensitivity/infusion reaction occurs,
– administration of tocilizumab should be stopped immediately
– appropriate medical management should be initiated, and
– tocilizumab should be permanently discontinued

European Medicines Agency (EMA)
Roche: Dear healthcare professional letter 02/12/2010
…………………………