LONDON, Nov 27 (APM) - NICE on Thursday said the National Health Service should fund Alexion’s highly expensive Soliris (eculizumab) in the orphan indication of haemolytic uraemic syndrome (aHUS) but has introduced measures to ensure its use is in line with clinical and cost-effective best practice.
NICE's thinking that state funding should be available for the 340,000 pounds (430,000 euros) per patient per year agent was put out for consultation in September (APMMA 39592) and today’s positive second draft will now become binding on the NHS in January unless it faces an appeal - a very unlikely event.
NICE’s ‘yes’ includes a number of stipulations designed to ensure use of the drug is properly targeted - primarily in terms of making sure treatment was stopped when that was indicated and correct dosage is maintained during treatment. These are:
:: Coordination of eculizumab use through an expert centre.
:: Monitoring systems to record the number of people with a diagnosis of aHUS and the number who have eculizumab, and the dose and duration of treatment.
:: A national protocol for starting and stopping eculizumab for clinical reasons.
:: A research programme with robust methods to evaluate when stopping treatment or dose adjustment might occur.
This is NICE’s first assessment for an expensive drug for a very rare disease after it took over the role from the Advisory Group for National Specialised Services.
ns\nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
