LenvatinibARX-Lenvatinib
Advanced (unresectable) Barcelona Clinic Liver Cancer stage B or stage C hepatocellular carcinoma, first-line treatment.
Decisions on record
- Meeting Nov 2018 Recommended Hepatocellular carcinoma
- Meeting Jul 2018 Recommended Locally advanced or metastatic differentiated thyroid cancer
- Meeting Jul 2018 Deferred Hepatocellular carcinoma
- Meeting Mar 2018 Not recommended LENVATINIB is indicated for the treatment of: patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer. (in combination with everolimus) adult patients with advanced renal cell carcinoma whose disease has progressed following one prio
- Meeting Mar 2018 Not recommended Indication not stated
- Meeting Mar 2018 Not recommended Indication not stated
- Meeting Nov 2017 Not recommended Advanced renal cell carcinoma (RCC)
- Meeting Jul 2016 Recommended Thyroid cancer
2 earlier decisions
- Mar 2016 Not recommended Differentiated thyroid cancer
- Nov 2015 Deferred Stage III or IV differentiated thyroid cancer
Access path
- TGA registered · ARX-Lenvatinib
TGA label narrower than the PBS population
- Nov 2015Deferred
vs sorafenib and best supportive care (placebo)
- Mar 2016Not recommended
ICER too high, eligible population sub-optimally defined, restriction not robust, estimated patient numbers…
- ↻ resubmittedJul 2016Recommended
Comparator changed: best supportive care, sorafenib → best supportive care
- Nov 2017Not recommended
unclear clinical place in therapy given treatments currently available (nivolumab, axitinib), uncertain appropriate…
- Mar 2018Not recommended
clinical need and clinical place in therapy not adequately established, uncertain magnitude of clinical benefit…
- ↻ resubmittedJul 2018Recommended · restricted
Comparator changed: everolimus monotherapy (primary); nivolumab (secondary); cabozantinib…
- Jul 2018Recommended · restricted
Comparator changed: everolimus monotherapy (primary); nivolumab (secondary); cabozantinib…
- Nov 2018Recommended
Comparator changed: best supportive care → sorafenib
- PBS listing · Restricted
From the public summary
4.1 The PBAC reaffirmed its July 2018 advice that lenvatinib be listed on a cost- minimisation basis compared to sorafenib with the equi-effective doses based on the mean treatment durations and mean doses from Study 304.PSD · Nov 2018
4.2 The PBAC further recommended that it may be reasonable that the drug cost for lenvatinib be no more than 5% higher than the price of sorafenib using the previously recommended equi-effective doses reflecting its different safety profile.PSD · Nov 2018
6.19 The submission presented a cost-minimisation analysis for lenvatinib compared with sorafenib. The submission assumed that there were no differences in resource use between lenvatinib and sorafenib other than the use of the drugs themselves.PSD · Jul 2018
6.20 The submission based the equi-effective dose on the median lenvatinib daily dose and duration from Study 304. Treatment exposure for sorafenib was estimated from the median sorafenib daily dose in Study 304 and the median treatment duration from the PBS 10% Population Sample.PSD · Jul 2018
6.16 The submission described lenvatinib as non-inferior in terms of effectiveness compared with sorafenib. This was consistent with the non-inferiority result for OS.PSD · Jul 2018
The submission also described lenvatinib as superior in terms of OS based on subgroup analyses of the full-analysis set (FAS) in patients with baseline alpha- fetoprotein levels ≥ 200 ng/mL. The evaluators considered that this claim may not be supported given the post-hoc nature of the sub-group analysis. The pre-PBAC response stated that this analysis was pre-planned to adjust for other variables which may have impacted OS.PSD · Jul 2018
3.10 There were no consumer comments received for this item. Equi-effective dose and corresponding pricePSD · Nov 2018
3.13 At the July 2018 meeting, the PBAC considered that it is appropriate for the equi- effective doses to be based on the mean estimates of dose and duration from Study 304 as these estimates appropriately capture the range of doses and treatment durations, and reflect the range likely in clinical practice. The use of the medians will result in an underrepresentation of patients who remain on treatment for a relatively long duration.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as lenvatinib and sorafenib are cost-equivalent on an equi-effective dose basis.
The PBAC considered that a cost-minimisation analysis was reasonable when the mean treatment durations and mean doses of lenvatinib and sorafenib were used so that the treatment cost per patient was the same for both treatments. PBAC · 2018
Decision context
PopulationPatients with advanced (unresectable) Barcelona Clinic Liver Cancer stage B or stage C hepatocellular carcinoma, who are not suitable for transarterial chemoembolisation, have WHO performance status ≤2, are Child-Pugh class A, and have not received prior VEGF tyrosine kinase inhibitor therapy or have developed intolerance necessitating permanent withdrawal.
Risk sharingRisk-share arrangement including a financial cap in place for lenvatinib 4 mg (30 tablets). The PBAC further recommended that the drug cost for lenvatinib be no more than 5% higher than sorafenib using the previously recommended equi-effective doses.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Recommended | sorafenib | — | RCT · OS |
| Jul 2018 | Recommended · restricted | sorafenib | — | RCT · OS |
| Jul 2018 | Recommended · restricted | best supportive care | — | Other |
| Mar 2018 | Not recommended | everolimus monotherapy (primary); nivolumab (secondary); cabozantinib and axitinib (supplementary) | $45k–75k | RCT · OS |
| Nov 2017 | Not recommended | everolimus monotherapy | — | RCT · PFS |
| Jul 2016 | Recommended | best supportive care | $45k–75k | RCT · Other |
| Mar 2016 | Not recommended | best supportive care, sorafenib | $45k–75k | RCT · PFS |
| Nov 2015 | Deferred | sorafenib and best supportive care (placebo) | — | RCT · PFS |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to BCLC stage B/C, excludes prior VEGF-TKI, requires PS ≤2 and Child-Pugh A; TGA label has no such restrictions.