NICE issues draft “no” for MabThera use in rare autoimmune disease

In Regulation & Government by Tim PeplowLeave a Comment

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The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance which outlines how the committee “was minded not to recommend” Roche’s MabThera, also known as Rituxan and rituximab, for the treatment of a rare autoimmune disease.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is a rare inflammatory autoimmune disease that affects blood vessel walls, and around 1,200 people are diagnosed with the potentially fatal disease each year in England and Wales.

However, before NICE can further consider the use of MabThera in treating the disease, it wants clarification of certain data and evidence.

“Unfortunately, [NICE’s] independent committee was minded not to recommend rituximab for this condition because of gaps and uncertainties in the evidence submitted by the manufacturer,” said Professor Carole Longson, director of NICE’s health technology evaluation centre.

The draft guidance, however, is by no means the end of the road for rituximab in ANCA-associated vasculitis. “The next step is for the manufacturer to respond to the committee’s comments and submit further information as requested,” said Prof Longson. The further clarification requested centres around:

  • The definition of severe disease and the subgroup of people for whom avoiding treatment with cyclophosphamide is desirable;
  • Further data to show ritiximab’s benefits in the longer term;
  • A revised economic model which represents the management of severe ANCA-associated vasculitis in the UK, including current comparators and routine clinical practice.

See where Rituxan appears in the Top 10 Biggest Selling Orphan Drugs in 2018

Read more at PharmaTimes >

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