NICE Expands Chemotherapy Options with Rituximab

The National Institute for Health and Clinical Excellence says that it will recommend rituximab in combination with several chemotherapy regimens as first-line treatments for people with advanced follicular lymphoma.

Current NICE guidance recommends rituximab in combination with cyclophosphamide, vincristine and prednisolone (CVP) for this patient group.

In final draft guidance issued Dec. 1, the agency, which makes cost- and clinical-effectiveness decisions for England and Wales, said that rituximab (MabThera, Roche) could also be used in combination with chlorambucil or the following chemotherapy regimens:

– Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).

– Mitoxantrone, chlorambucil, and prednisolone (MCP).

– Cyclophosphamide, doxorubicin, etoposide, prednisolone, and interferon-alpha (CHVPi).

All recommended regimens are authorized in Europe, are commonly used in the United Kingdom, and have been evaluated with and without rituximab in open-label clinical trials in patients with stage III and IV follicular lymphoma. For all, addition of rituximab was shown to correspond with a significant survival benefit compared with the chemotherapy-alone groups.

Having a range of chemotherapy options available is important, NICE said, due to differences in patients’ fitness as they age. Chlorambucil is seen as an option mainly for older patients, or patients with a lower performance status.

Rituximab is a genetically engineered chimeric monoclonal antibody that targets cells bearing the CD20 surface marker. For follicular lymphoma, dosage is 375 mg/m² body surface area for up to eight cycles, administered on day 1 of the chemotherapy cycle. Each 10-mL (100-mg) vial costs £174.63, or £873.15 for 500 mL.

Current NICE guidance also recommends rituximab monotherapy as a maintenance treatment immediately following first-line treatment with rituximab-containing chemotherapy regimens. While most patients presenting with advanced follicular lymphoma are treatment-naive, rituximab plus chemotherapy is also recommended by NICE for relapsed or refractory advanced follicular lymphoma.

The NICE reviewers found all of the rituximab-plus-chemotherapy regimens to be well within NICE’s cost-effectiveness parameters, with an estimated incremental cost effectiveness ratio of £7,720 per quality-adjusted life year for rituximab plus CVP; £10,800 per QALY gained for rituximab plus CHOP; and £9,320 per QALY gained for rituximab plus MCP. For CHVPi, the cost-effectiveness estimates remained uncertain. However, the agency felt it was unlikely that estimates would exceed its "threshold range" of between £20,000 and £30,000 per QALY.

The National Institute for Health and Clinical Excellence says that it will recommend rituximab in combination with several chemotherapy regimens as first-line treatments for people with advanced follicular lymphoma.

Current NICE guidance recommends rituximab in combination with cyclophosphamide, vincristine and prednisolone (CVP) for this patient group.

In final draft guidance issued Dec. 1, the agency, which makes cost- and clinical-effectiveness decisions for England and Wales, said that rituximab (MabThera, Roche) could also be used in combination with chlorambucil or the following chemotherapy regimens:

– Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).

– Mitoxantrone, chlorambucil, and prednisolone (MCP).

– Cyclophosphamide, doxorubicin, etoposide, prednisolone, and interferon-alpha (CHVPi).

All recommended regimens are authorized in Europe, are commonly used in the United Kingdom, and have been evaluated with and without rituximab in open-label clinical trials in patients with stage III and IV follicular lymphoma. For all, addition of rituximab was shown to correspond with a significant survival benefit compared with the chemotherapy-alone groups.

Having a range of chemotherapy options available is important, NICE said, due to differences in patients’ fitness as they age. Chlorambucil is seen as an option mainly for older patients, or patients with a lower performance status.

Rituximab is a genetically engineered chimeric monoclonal antibody that targets cells bearing the CD20 surface marker. For follicular lymphoma, dosage is 375 mg/m² body surface area for up to eight cycles, administered on day 1 of the chemotherapy cycle. Each 10-mL (100-mg) vial costs £174.63, or £873.15 for 500 mL.

Current NICE guidance also recommends rituximab monotherapy as a maintenance treatment immediately following first-line treatment with rituximab-containing chemotherapy regimens. While most patients presenting with advanced follicular lymphoma are treatment-naive, rituximab plus chemotherapy is also recommended by NICE for relapsed or refractory advanced follicular lymphoma.

The NICE reviewers found all of the rituximab-plus-chemotherapy regimens to be well within NICE’s cost-effectiveness parameters, with an estimated incremental cost effectiveness ratio of £7,720 per quality-adjusted life year for rituximab plus CVP; £10,800 per QALY gained for rituximab plus CHOP; and £9,320 per QALY gained for rituximab plus MCP. For CHVPi, the cost-effectiveness estimates remained uncertain. However, the agency felt it was unlikely that estimates would exceed its "threshold range" of between £20,000 and £30,000 per QALY.

The National Institute for Health and Clinical Excellence says that it will recommend rituximab in combination with several chemotherapy regimens as first-line treatments for people with advanced follicular lymphoma.

Current NICE guidance recommends rituximab in combination with cyclophosphamide, vincristine and prednisolone (CVP) for this patient group.

In final draft guidance issued Dec. 1, the agency, which makes cost- and clinical-effectiveness decisions for England and Wales, said that rituximab (MabThera, Roche) could also be used in combination with chlorambucil or the following chemotherapy regimens:

– Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).

– Mitoxantrone, chlorambucil, and prednisolone (MCP).

– Cyclophosphamide, doxorubicin, etoposide, prednisolone, and interferon-alpha (CHVPi).

All recommended regimens are authorized in Europe, are commonly used in the United Kingdom, and have been evaluated with and without rituximab in open-label clinical trials in patients with stage III and IV follicular lymphoma. For all, addition of rituximab was shown to correspond with a significant survival benefit compared with the chemotherapy-alone groups.

Having a range of chemotherapy options available is important, NICE said, due to differences in patients’ fitness as they age. Chlorambucil is seen as an option mainly for older patients, or patients with a lower performance status.

Rituximab is a genetically engineered chimeric monoclonal antibody that targets cells bearing the CD20 surface marker. For follicular lymphoma, dosage is 375 mg/m² body surface area for up to eight cycles, administered on day 1 of the chemotherapy cycle. Each 10-mL (100-mg) vial costs £174.63, or £873.15 for 500 mL.

Current NICE guidance also recommends rituximab monotherapy as a maintenance treatment immediately following first-line treatment with rituximab-containing chemotherapy regimens. While most patients presenting with advanced follicular lymphoma are treatment-naive, rituximab plus chemotherapy is also recommended by NICE for relapsed or refractory advanced follicular lymphoma.

The NICE reviewers found all of the rituximab-plus-chemotherapy regimens to be well within NICE’s cost-effectiveness parameters, with an estimated incremental cost effectiveness ratio of £7,720 per quality-adjusted life year for rituximab plus CVP; £10,800 per QALY gained for rituximab plus CHOP; and £9,320 per QALY gained for rituximab plus MCP. For CHVPi, the cost-effectiveness estimates remained uncertain. However, the agency felt it was unlikely that estimates would exceed its "threshold range" of between £20,000 and £30,000 per QALY.