NICE Backed Arrowhead’s Plozasiran Eight Days After UK Authorisation, as a Cost Match for 57 to 114 People in England
Arrowhead Pharmaceuticals said on 27 October that NICE has recommended Redemplo (plozasiran) for adults with genetically confirmed familial chylomicronaemia syndrome when diet and conventional triglyceride-lowering treatment have not worked well enough, under a commercial arrangement with an undisclosed price. The guidance covers England and Wales, and Scotland decides through the Scottish Medicines Consortium. The MHRA authorised the siRNA drug on 19 October through its International Recognition Procedure, relying on the European Commission’s June approval. NICE ran the appraisal as a standard technology appraisal after the topic failed two criteria for its highly specialised route, and the external assessment group reviewed it as a cost comparison.
A cost comparison means Arrowhead accepted a price no higher than a treatment NICE already recommends, and in return announced NHS funding eight days after authorisation. Volanesorsen has been funded under NICE’s 2020 guidance and olezarsen has been appraised for the same patients, so in a population this small the APOC3 drugs now compete under a shared price ceiling.
- Sobi and volanesorsen: the contest is now dosing and eligibility. Plozasiran is injected every three months against monthly for olezarsen, and its recommendation does not carry the high pancreatitis-risk condition NICE attached to volanesorsen in 2020. With price capped by the comparison, those two differences will decide what specialist lipid services prescribe.
- NHS England: the FCS price becomes a reference for severe hypertriglyceridaemia. Arrowhead plans a US filing in severe hypertriglyceridaemia before the end of 2026, after SHASTA-3 and SHASTA-4 cut triglycerides by about 80% in roughly 750 patients, and Sobi won a CHMP opinion for olezarsen in that indication on 16 October. A price set by cost comparison for an ultra-rare group becomes the opening reference when the same drugs seek funding for far more patients.
- Signposts: Scotland, the committee papers and the next filings. Watch for the Scottish Medicines Consortium decision, NICE’s committee papers, which should show the comparator plozasiran was matched against, and when Arrowhead and Sobi file severe hypertriglyceridaemia in the UK.
Read the original source (Arrowhead Pharmaceuticals) →
Read the appraisal record and final scope (NICE) →
Read the UK authorisation (MHRA) →
Read the PALISADE results and EU approval (Arrowhead Pharmaceuticals) →
Read the SHASTA-3 and SHASTA-4 results (Arrowhead Pharmaceuticals) →
Read the olezarsen CHMP opinion (Sobi) →
