The UK’s National Institute for Health and Care Excellence (NICE) has backed Roche’s MabThera for use in a rare autoimmune disease.
The draft guidance overturns an earlier decision made by NICE which failed to recommend the use of MabThera (rituximab) for NHS use in England and Wales to treat anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis – an inflammation of the blood vessels.
It also comes against a series of negative NICE decisions for Roche, primarily involving its cancer drug Avastin (bevacizumab), which prompted the pharma company to challenge NICE’s process to evaluate the cost-effectiveness of medicines.
NICE’s initial decision to turn down MabThera in the vasculitis indication was due to “gaps and uncertainties” in the information provided by Roche, according to the body’s Health Technology Evaluation Centre director Prof Carole Longson.
This included the need for an improved economic model for MabThera’s use in severe ANCA-associated vasculitis, as well as greater clarity on what constitutes a severe disease in this indication, with ANCA-associated vasculitis an umbrella term for several related conditions that usually affect the lungs, kidneys, ears, nose or sinuses, sometimes leading to organ damage, bleeding or deafness.
NICE also requested details on what circumstances it is preferable to avoid treatment with current vasculitis therapy cyclophosphamide, which can have serious side effects, such as bone marrow suppression.
It appears Roche has managed to clarify things with NICE to some extent, although the draft guidance only recommends the drug if further treatment with cyclophosphamide would exceed the maximum cumulative cyclophosphamide dose.
Roche commented that it was pleased with the decision, although not raise concerns about the limitations of the recommendations.
“We are concerned that a small, but extremely important subgroup group of patients who cannot receive cyclophosphamide are not included within the NICE recommendation,” said the company.
“We know from clinical experts and patient groups that these patients have the highest unmet need for an effective alternative therapy. Patients who cannot receive cyclophosphamide include those patients wishing to start a family, as cyclophosphamide can severely affect a patient’s fertility. We will therefore endeavour to work with NICE and the clinical community to provide additional evidence for this very rare subgroup of patients.”
MabThera is already recommended by NICE in several other indications, including chronic lymphocytic leukaemia, non-Hodgkin lymphoma and rheumatoid arthritis.