IdelalisibZYDELIG (100 mg and 150 mg idelalisib) tablets
Refractory follicular B-cell non-Hodgkin's lymphoma in patients refractory to both rituximab and an alkylating agent, as monotherapy.
Decisions on record
- Meeting Aug 2016 Recommended Chronic lymphocytic leukaemia and small lymphocytic lymphoma no PSD
- Meeting Jul 2016 Recommended Chronic lymphocytic leukaemia and small lymphocytic lymphoma
- Meeting Jul 2016 Recommended Follicular Lymphoma
- Meeting Mar 2016 Deferred Follicular lymphoma
- Meeting Mar 2016 Deferred Chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
- Meeting Nov 2015 Deferred Follicular lymphoma
- Meeting Nov 2015 Deferred Chronic lymphocytic leukaemia
- Meeting Mar 2015 Not recommended chronic lymphocytic leukaemia
1 earlier decision
- Mar 2015 Not recommended Non-Hodgkin's lymphoma
Access path
- TGA registered · ZYDELIG (100 mg and 150 mg idelalisib) tablets
TGA label narrower than the PBS population
- Mar 2015Not recommended
Comparator changed: rituximab monotherapy and/or best supportive care (for patients truly…
- Mar 2015Not recommended
Comparator changed: rituximab monotherapy and/or best supportive care (for patients truly…
- Nov 2015Not recommended
Immature overall survival data, concerns regarding RPSFT methodology and confidence intervals, uncertainty in OS hazard…
- Nov 2015Deferred
Evidence: Single-arm → RCT
- Mar 2016Deferred
Comparator changed: best supportive care → rituximab monotherapy (best supportive care)
- Mar 2016Deferred
Comparator changed: best supportive care → rituximab monotherapy (best supportive care)
- Jul 2016Recommended · restricted
- Jul 2016Recommended · restricted
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the Authority Required listing of idelalisib in combination with rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL). The PBAC was satisfied that idelalisib provides, for some patients, a significant improvement in efficacy over best supportive care.PSD · Jul 2016
5.2 The PBAC acknowledged that the safety signals observed in the Phase 3 trials, resulting in the March 2016 submission deferral, were not identified in a re-analysis of the clinical trials that have been considered by the PBAC in the support of the proposed listing.PSD · Jul 2016
6.31 The resubmission presented a cost-utility analysis, based on the results of Trial 312-0116. A comparison between the model presented in the resubmission and the previous submission is summarised in Table 7.PSD · Nov 2015
1 Latimer N. Survival analysis for economic evaluations alongside clinical trials – extrapolation with patient-level data: inconsistencies, limitations and a practical guide. Med Decis Making. 2013 Aug;33(6):743-54 13PSD · Nov 2015
6.23 The resubmission described idelalisib plus rituximab as having superior comparative 11PSD · Nov 2015
6.24 This superior comparative effectiveness claim might be reasonably supported: the PBAC considered that placebo plus rituximab might be a reasonable proxy for best supportive care in this patient group for overall survival (Item 7.8, March 2015 PBAC) idelalisib plus rituximab showed superior progression free survival and overall survival benefits compared to placebo plus rituximab, using the ITT analysis.PSD · Nov 2015
4.2 The PBAC noted and welcomed the input from an organisation (1) via the Consumer Comments facility on the PBS website. The comment reiterated the lack of treatment options for patients with follicular lymphoma and highlighted the importance of providing another therapeutic option for these patients. 2PSD · Jul 2016
6.52 The resubmission proposed a '''''''% discount on the dispensed price for maximum quantity (DPMQ) price. 19PSD · Nov 2015
Cost-effectiveness
ICER value not stated in public summary document; document notes PBAC 'maintained that the ICER remained high' but no numeric value provided.
The PBAC maintained that the ICER remained high but considered this acceptable for this patient population for whom there are few treatment options. PBAC · 2016
Decision context
PopulationPatients with follicular B-cell non-Hodgkin's lymphoma that is refractory to both rituximab and an alkylating agent, as monotherapy.
Risk sharingRisk sharing arrangement with financial cap recommended; cap based on utilisation estimates in March 2016 submission; utilisation to be reviewed 3 years after listing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended · restricted | best supportive care | — | RCT · OS |
| Jul 2016 | Recommended · restricted | best supportive care | — | Single-arm · PFS |
| Mar 2016 | Deferred | rituximab monotherapy (best supportive care) | $45k–75k | RCT · OS |
| Mar 2016 | Deferred | best supportive care | $45k–75k | RCT · PFS |
| Nov 2015 | Not recommended | best supportive care | — | RCT · PFS |
| Nov 2015 | Deferred | best supportive care | — | Single-arm · PFS |
| Mar 2015 | Not recommended | rituximab monotherapy and/or best supportive care (for patients truly unable to tolerate chemo-immunotherapy); chemo-imm | — | RCT · PFS |
| Mar 2015 | Not recommended | best supportive care | — | Single-arm · ORR |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| Genome-wide microarray testing for multiple myeloma and chronic lymphocytic leukaemia | del(17p) and other chromosomal abnormalities | supported | 2019 |
| 17p deletion testing by FISH for CLL/SLL | 17p deletion (del(17p)) | supported | 2019 |
| 17p deletion testing (FISH) for CLL/SLL | 17p deletion (del(17p)) | supported | 2020 |
Consumer voice
One consumer organisation highlighted the lack of treatment options for patients with follicular lymphoma and emphasised the importance of providing another therapeutic option for these patients.
The comment reiterated the lack of treatment options for patients with follicular lymphoma and highlighted the importance of providing another therapeutic option for these patients. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to rituximab AND alkylating agent refractoriness; TGA label requires only two prior systemic therapies without specifying drug classes.