Not approved for use in SE London for treating cystic fibrosis homozygous for the F508del mutation as per NICE Technology appraisal guidance (see link below)
Specialist or hospital prescribing only.
The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital.
In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.
Treatment can be initiated in primary care after a recommendation from an appropriate specialist
Specialist initiation followed by maintenance prescribing in primary care
Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation