Latest draft guidance extends use of follicular lymphoma drug
In new draft guidance the healthcare guidance body NICE recommends rituximab (MabThera, Roche products) as an option when used in combination with a wide range of chemotherapy treatments for people with advanced follicular lymphoma.
Evidence shows adding rituximab to chemotherapy treatments CVP1, CHOP2, MCP3, and CHVPi4, helps people to live longer and improves their quality of life, compared with chemotherapy alone. It is also good value for money for the NHS. In addition, the committee considered the use of rituximab plus chlorambucil for advanced follicular lymphoma, and concluded that it is an appropriate use of NHS resources.
Follicular lymphoma is a cancer of the lymphatic tissue, which causes enlargement of the lymph nodes and generalised symptoms. The lymphatic system produces, stores and delivers lymphocytes, which are cells that fight infection. 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.
In line with the technology appraisals process, consultees now have the opportunity to appeal against this latest draft guidance (the Final Appraisal Determination). If no appeals are received, NICE expects to publish its final guidance for the NHS in January 2012.
Commenting on NICE's draft recommendation, Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: “We are very pleased to be able to recommend rituximab in combination with chemotherapy treatments CVP, CHOP, MCP, CHVPi or chlorambucil, in today's draft guidance. The committee heard from patient experts that rituximab treatment improves their quality of life. We also know a range of choice and availability of treatments has a positive effect on patients and their families.
“At the second committee meeting, members heard from the clinical specialist that some older people are not fit enough to receive the most common types of chemotherapy. For that reason, the committee decided to also recommend rituximab in combination with chlorambucil in the latest draft guidance, to give clinicians wider treatment options for their patients.”
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 for rituximab was revised to allow the use of a wider range of chemotherapy regimens, which is the subject of this guidance review. This review now provisionally adds four other chemotherapy plus rituximab options for patients.
Notes to Editors
About the guidance
1. The final appraisal determination (FAD) will be available from Thursday 1 December 2011. Consultees have until Thursday 15 December to appeal this draft guidance.
2. NICE is developing guidance on rituximab in combination with CVP, CHOP, MCP, CHVPi or chlorambucil as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated patients.
3. 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 £1222.41 (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.
8. The committee agreed that the manufacturer's comparison of rituximab plus CHVPi versus CHVPi alone would need to inform the decision-making for the addition of rituximab to CHVPi. The committee did not accept that the analyses fully reflected how rituximab was used in clinical practice and the ICERs increased when it was assumed that rituximab first-line treatment was provided and if there was a loss of efficacy when rituximab was 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.
9. The Committee also concluded that for the group of patients likely to receive rituximab plus chlorambucil in the NHS, it is an appropriate use of NHS resources.
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
3. NICE produces standards for patient care:
- quality standards -these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.
4. NICEprovides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
1. cyclophosphamide, vincristine and prednisolone (CVP)
2. cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)
3. mitoxantrone, chlorambucil and prednisolone (MCP)
4. cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-α (CHVPi)
This page was last updated: 29 November 2011