National Institute for Health and Clinical Excellence (NICE)
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Draft guidance gives green light to more treatment options for advanced follicular lymphoma
New draft guidance recommends rituximab (MabThera, Roche products) in combination with a wide range of chemotherapy treatments for people with symptomatic stage III and IV follicular lymphoma. The independent appraisal committee at NICE found that rituximab in combination with CVP, CHOP, MCP and CHVPi chemotherapy regimens is both clinically and cost-effective as a first-line treatment.
NICE has previously recommended rituximab in combination with CVP for this indication: this review of that appraisal now provisionally adds three other chemotherapy plus rituximab options.
In line with the technology appraisals process this draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS. Final guidance is expected in January 2012.
Around 1869 people in England and Wales have follicular lymphoma, and the majority of people present with advanced stage disease (III - IV). Advanced follicular lymphoma is not curable and so the aim of disease management is to both increase life expectancy and health-related quality of life.
Commenting on NICE's draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The independent appraisal committee carefully considered all the evidence on rituximab's clinical and cost effectiveness. Four good quality randomized trials indicate that adding rituximab to CVP, CHOP, MCP and CHVPi can help patients live longer and improve their overall response to this disease, when compared with chemotherapy alone.
"Committee members also heard evidence that patients require different treatment combinations depending on their age and overall health. Some people are not fit enough to receive rituximab plus CVP, the most common form of treatment, and so other treatment options might be useful for them.
"In addition, the economic analyses demonstrate that adding rituximab to the chemotherapy regimens is good value for money. The independent advisory committee concluded that the cost of rituximab in relation to how well it works in combination with CVP, CHOP, MCP and CHVPi is an effective use of NHS resources. This draft guidance is now open for consultation, and we welcome any feedback on our proposed recommendations."
This technology appraisal is a review of NICE technology appraisal 110, issued in September 2006. The previous guidance recommends the use of rituximab plus CVP as an option for first-line induction therapy for symptomatic stage III-IV follicular lymphoma. However in 2008 the marketing authorisation was revised to allow the use of a wider range of chemotherapy regimens, which is the subject of this guidance review.
Notes to Editors
About the guidance
1. The appraisal consultation document (ACD) will be available from Monday 5 September 2011 at http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12982. Consultation will take place between 5 - 26 September 2011.
2. NICE is developing guidance on rituximab in combination with cyclophosphamide, vincristine and prednisolone (CVP), cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP), mitoxantrone, chlorambucil and prednisolone (MCP), and cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-α (CHVPi) as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated patients.
3. Non-Hodgkin's lymphoma is a cancer of the lymphatic tissue, causing enlargement of the lymph nodes and generalised symptoms. The lymphatic system produces, stores and delivers lymphocytes, which are cells that fight infection. Follicular lymphoma is a type of low grade or indolent non-Hodgkin's lymphoma that develops slowly, and often without symptoms, for many years. It affects B-cell lymphocytes, so is classified as a B-cell non-Hodgkin's lymphoma.
4. Rituximab (MabThera, Roche Products) is a genetically engineered chimeric (mouse/human) monoclonal antibody that depletes the B-cells by targeting cells bearing the CD20 surface marker.
5. The recommended dose of rituximab in combination with chemotherapy for induction treatment of previously untreated patients with follicular lymphoma is 375 mg/m2 body surface area, per cycle, for up to 8 cycles, administered on day 1 of the chemotherapy cycle.
6. The cost of one 10-ml (100-mg) vial is £174.63 and one 50-ml (500-mg) vial is £873.15 (excluding VAT; ‘British National Formulary' BNF edition 61). For a person with an average body surface area of 1.85 m2, and assuming vial wastage, the average cost per cycle of rituximab is £1222 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.
7. The Assessment Group calculated an ICER of £7720 per QALY gained for rituximab plus CVP, £10,800 per QALY gained for rituximab plus CHOP and £9320 per QALY gained for rituximab plus MCP. The Committee accepted the manufacturer's ICER for rituximab plus CHVPi (£9200) per QALY gained.
8. The Committee did not accept that these analyses fully reflect how rituximab is used in clinical practice and the ICERs increase when it is assumed that rituximab first-line maintenance treatment is provided and if there is a loss of efficacy when rituximab is used as a re-treatment. However, the Committee was persuaded that this uncertainty was not such that it increased the ICERs to above the threshold range (£20,000-£30,000) that would normally be considered cost-effective.
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