Duvelisib (1) – Copiktra®
Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
Characteristics
| Start date | 01.02.2022 – Marketing authorisation: 19.05.2021 |
|---|---|
| Resolution | 21.07.2022 |
| INN | Duvelisib |
| Brand name | Copiktra® |
| Pharm. company | Secura Bio Limited |
| G-BA Procedure ID | D-785 |
| ATC code | L01EM04 Pi3K inhibitors (L01EM) |
| ICD-10 codes (AIS) | C91.10Chronic lymphocytic leukemia of B-cell type with failed remission, C91.11Chronic lymphocytic leukemia of B-cell type in remission |
| Alpha-ID codes (AIS) | I25521CLL (chronic lymphocytic leukemia), I31079CLL (chronic lymphocytic leukemia) in complete remission |
| DDD | 50 mg O |
| Therapeutic area | Oncological diseases Chronic lymphocytic leukemia (CLL) |
| Reason for procedure | Initial assessment |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Copiktra monotherapy is used for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) after at least two prior therapies. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with pretreated CLL who have not yet received a BTK-inhibitor and/or BCL2 inhibitor. | - ibrutinib or - venetoclax + rituximab or - chemoimmunotherapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) or bendamustine in combination with rituximab (BR) or chlorambucil in combination with rituximab (ClbR) (in each case only in the case of a long relapse-free interval and the absence of genetic risk factors). |
| b) | Adult patients with CLL with relapse or refractory status after prior therapy with at least one BTK inhibitor. | Venetoclax + Rituximab |
| c) | Adult patients with CLL with relapse or refractory status following prior therapy with at least one BCL2 inhibitor. | Ibrutinib |
| d) | Adult patients with CLL with relapse or refractory status following prior therapy with at least one BTK inhibitor and one BCL2 inhibitor. | Patient-specific therapy with selection of - Idelalisib in combination with rituximab, - Bendamustine in combination with rituximab, - Chlorambucil in combination with rituximab, and - Best Supportive Care (BSC). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DUO) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
- Clinical trials
- The pharmaceutical manufacturer submitted the randomised, open-label, actively controlled Phase III DUO trial, which compared duvelisib with ofatumumab in patients with CLL and small lymphocytic lymphoma (Small Lymphocytic Lymphoma [SLL]) whose disease is refractory following at least one prior course of treatment for benefit assessment.
a) Adult patients with previously treated CLL who have not yet received a BTK inhibitor and/or a BCL2 inhibitor
- An additional benefit is not proven.
b) Adult patients with CLL who have relapsed or become refractory following prior treatment with at least one BTK inhibitor
- An additional benefit is not proven.
c) Adult patients with CLL who have relapsed or are refractory following prior treatment with at least one BCL2 inhibitor
- An additional benefit is not proven.
d) Adult patients with CLL who have relapsed or are refractory following prior treatment with at least one BTK inhibitor and one BCL2 inhibitor
- An additional benefit is not proven.
- All patients in the control arm of the study were treated with ofatumumab.
- Ofatumumab does not currently have marketing authorisation for the treatment of CLL.
- The active ingredient does not constitute the appropriate comparator therapy for any of the patient groups mentioned.
- Consequently, there are no suitable data available for benefit assessment of duvelisib compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Duvelisib (2) | Copiktra® | Secura Bio Limited | Follicular lymphoma (FL), after ≥ 2 prior therapies | 380–5,170 | 100% additional benefit not proven | |
| Duvelisib (1) | Copiktra® | Secura Bio Limited | Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies | 550–2,060 | 100% additional benefit not proven |
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