1 Recommendations

1.1

Crovalimab is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria in people 12 years and over who weigh 40 kg or more. It is recommended for people who:

  • have haemolysis with clinical symptoms indicating high disease activity

  • are clinically stable after having a complement component 5 inhibitor for at least the past 6 months.

    Crovalimab is only recommended if the company provides it according to the commercial arrangement.

1.2

If people with the condition and their healthcare professional consider crovalimab to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account.

Why these recommendations were made

Usual treatment for paroxysmal nocturnal haemoglobinuria is eculizumab or ravulizumab. Eculizumab biosimilars are also available, but very few people have them in clinical practice, so they have not been included as comparators. Crovalimab works in a similar way to eculizumab and ravulizumab, and would be offered to the same population.

Clinical trial evidence shows that crovalimab works as well as eculizumab. Crovalimab has not been directly compared with ravulizumab in a clinical trial, but indirect comparisons suggest that it is likely to be as effective.

When switching from eculizumab or ravulizumab to crovalimab, some people can experience adverse events called type 3 immune complex reactions. But, these events usually do not last long and so are not included in the economic model.

A cost comparison suggests crovalimab has lower costs than eculizumab or ravulizumab. So crovalimab is recommended.

For all evidence see the committee papers. For more information on NICE's evaluation of ravulizumab, see the committee discussion section in NICE's technology appraisal guidance on ravulizumab for treating paroxysmal nocturnal haemoglobinuria.