Alexion gives NICE requested Soliris info ahead of July review

By Gareth Macdonald contact

- Last updated on GMT

Outside the NICE offices in London, UK
Outside the NICE offices in London, UK

Related tags: Monoclonal antibodies

Alexion says it has provided NICE with the R&D and manufacturing information it asked for ahead of the second assessment of its £3,150-a-vial rare blood disorder drug Soliris next month. 

NICE – the National Institute for Health and Care Excellence which governs the National Health Service’s use of drugs in England and Wales* - asked the drugmaker to explain the high cost of the monoclonal antibody in draft guidance issued in February.

At the time NICE CEO Andrew Dillon acknowledged that Soliris is an effective product that required considerable investment by Alexion but said that more information on its development and production was needed.

The drug price watchdog organisation was due to discuss Soliris in April, however, according to a an update published in April​ the meeting was put back until a then unspecified date to give reviewers more time to assess the monoclonal antibody (mAb).

Late July

This was confirmed by a NICE spokeswoman who told BioPharma-Reporter.com “The date for the committee meeting has been postponed and is yet to be confirmed for late July; a date for publication of the final guidance will be announced following the meeting​.”

She also told BioPharma-Reporter.com that: “The meeting has been postponed to enable new information to be considered by the committee​.”

The NICE spokeswoman did not confirm whether or not Alexion has submitted the information it requested, telling us that: “We can’t confirm any details until final publication​.”

Alexion spokeswoman Mitali Rajan told us that: “We have submitted our full response to the ECD within the requested timeframe and we remain committed to collaborating with NICE, to achieve a positive outcome on its review of Soliris for aHUS patients.”

Orphan drug

Soliris is used to treat for atypical Haemolytic Uraemic Syndrome (aHUS) which is a condition that affects over 200 people in England according to NICE.

At £3,150 per 30ml, NICE estimates that it would cost £340,000 ($567,000) to buy enough Soliris needed to treat one patient for a year. Other mAbs like Roche’s Avastin (bevacizumab) and AbbVie’s Humira (adalimumab) cost the NHS per patient, per year.

 *but not in Scotland, which was still part of the UK at time of publication.

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