Treatment of previously untreated chronic lymphocytic
leukaemia in patients for whom full-dose fludarabine-
based therapy is unsuitable due to co-morbidities |
Treatment of previously untreated advanced follicular
lymphoma | Treatment of follicular lymphoma in
patients who did not respond or who progressed during
or up to six months after treatment with rituximab or a
rituximab-containing regimen
▶BY INTRAVENOUS INFUSION
▶Adult: (consult product literature or local protocols)
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For obinutuzumab contra-
indications, consult product literature.
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For full details on the cautions of
obinutuzumab, consult product literature.
▶Hepatitis B infection and reactivation Hepatitis B infection and
reactivation (including fatal cases) have been reported in
patients taking obinutuzumab. Patients with positive
hepatitis B serology should be referred to a liver specialist
for monitoring and initiation of antiviral therapy before
treatment initiation; treatment should not be initiated in
patients with evidence of current hepatitis B infection
until the infection has been adequately treated. Patients
should be closely monitored for clinical and laboratory
signs of active hepatitis B infection during treatment and
for up to a year following the last infusion (consult product
literature).
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Infusion
related side-effects have been reported; Patients should
receive premedication with paracetamol, an
antihistamine, and a corticosteroid before each dose—
consult product literature for details.
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NICE decisions
▶Obinutuzumab in combination with chlorambucil for
untreated chronic lymphocytic leukaemia (June 2015)
NICE TA343
Obinutuzumab (Gazyvaro ®), in combination with
chlorambucil, is an option for untreated chronic
lymphocytic leukaemia in patients who have comorbidities
that make full-dose fludarabine-based therapy unsuitable
for them, only if:
. bendamustine-based therapy is not suitable and
. the manufacturer provides obinutuzumab with the
discount agreed in the patient access scheme.
Patients currently receiving obinutuzumab that is not
recommended according to the above criteria should have
the option to continue treatment until they and their
clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta343
▶Obinutuzumab with bendamustine for treating follicular
lymphoma refractory to rituximab (August 2017) NICE TA472
Obinutuzumab (Gazyvaro ®) in combination with
bendamustine followed by obinutuzumab maintenance, is
recommended for use within the Cancer Drugs Fund as an
option for treating adults with follicular lymphoma that
did not respond or progressed during or up to six months
after treatment with rituximab or a rituximab-containing
regimen, only if the conditions in the managed access
agreement for obinutuzumab are followed.
www.nice.org.uk/guidance/ta472
▶Obinutuzumab for untreated advanced follicular lymphoma
(March 2018) NICE TA513
Obinutuzumab (Gazyvaro ®) is recommended as an option
for untreated advanced follicular lymphoma in adults (that
is, first as induction treatment with chemotherapy, then
alone as maintenance therapy), only if:
. the person has a Follicular Lymphoma International
Prognostic Index (FLIPI) score of 2 or more, and
. the manufacturer provides obinutuzumab with the
discount agreed in the patient access scheme.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
it appropriate to stop.
www.nice.org.uk/guidance/ta513
Scottish Medicines Consortium (SMC) decisions
SMC No. 1219/17
The Scottish Medicines Consortium has advised (March
2017) that obinutuzumab (Gazyvaro ®) is accepted for use
within NHS Scotland in combination with bendamustine
followed by obinutuzumab maintenance for the treatment
of patients with follicular lymphoma who did not respond
or who progressed during or up to six months after
treatment with rituximab or a rituximab-containing
regimen. This advice is contingent upon the continuing
availability of the Patient Access Scheme in NHS Scotland
or a list price that is equivalent or lower.
SMC No. SMC2015
The Scottish Medicines Consortium has advised
(September 2018) that obinutuzumab (Gazyvaro ®) is not
recommended for use within NHS Scotland in combination
with chemotherapy followed by obinutuzumab
maintenance therapy in patients achieving a response, for
the treatment of patients with previously untreated
advanced follicular lymphoma, as the economic case was
not demonstrated.
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