Enfortumab VedotinPadcev
Recommended OncologyAuthority RequiredFirst-line line 💬 consumer voice
First-line treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer in patients who have not previously received systemic therapy for this condition.
3
Submissions
1 resub
2022–24
On the record
$75k–95k
ICER range
1 sourced ICER · 2023
—
Cost basis
Decisions on record
- Meeting Nov 2024 Recommended Locally advanced or metastatic urothelial cancer
- Meeting Nov 2022 Deferred Locally advanced or metastatic urothelial cancer post-chemotherapy
- Meeting Mar 2022 Not recommended Urothelial cancer
Access path
- TGA registered · Padcev
TGA label narrower than the PBS population
- Mar 2022Not recommended
vs docetaxel or paclitaxel
- ↻ resubmittedFeb 2023Recommended · restricted
- Nov 2024Recommended · restricted
Comparator changed: docetaxel or paclitaxel → platinum-based chemotherapy with…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing of enfortumab vedotin in combination with pembrolizumab (EV+PEM) for the first line treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer (la/mUC). The PBAC is satisfied that EV+PEM provides, for some patients, a significant improvement in efficacy over platinum based chemotherapy with gemcitabine (Plat+Gem).PSD · Nov 2024
34 Mathew Thomas V, Jo Y, Tripathi N, et al. Treatment Patterns and Attrition With Lines of Therapy for Advanced Urothelial Carcinoma in the US. JAMA Netw Open. 2024;7(5): e249417. doi:10.1001/ jamanetworkopen.2024. 941 45PSD · Nov 2024
Economic analysis
6.33 The submission presented a modelled economic evaluation of EV+PEM compared with Plat+Gem for the treatment of patients with la/mUC. Comparative effectiveness, safety and time on treatment data were derived from the key randomised trial – EV- 302. Consistent with the claim of superior effectiveness and superior safety, the economic evaluation was a cost-effectiveness / cost-utility analysis.PSD · Nov 2024
Table 9: Summary of model structure, key inputs and rationale Component Description Justification/comments Enfortumab vedotin + Pembrolizumab vs Australian clinical practice involves the use of Platinum chemotherapy + Gemcitabine avelumab in the maintenance setting (post- platinum therapy). The model inputs were derived Treatments from EV-302 with some use of avelumab captured in this trial (see paragraph 6.8). This was reasonable.PSD · Nov 2024
Clinical claim
superior to Plat+Gem in terms of effectiveness and superior in terms of safety Source: Table 1-1, p28 of the submission.PSD · Nov 2024
6.28 The submission described EV+PEM as superior in terms of effectiveness and safety compared with Plat+Gem in patients with previously untreated la/mUC.PSD · Nov 2024
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (11), health care professionals (4) and organisations (3) via the Consumer Comments facility on the PBS website. The input from individuals who have used this medicine for their own health along with input from their partners or family members described benefits of EV+PEM treatment including reductions in tumour size and cancer-related symptoms along with improvements in quality of life.PSD · Nov 2024
Consistent with the input from Rare Cancers Australia, the input described the advantages of such therapy as patients living longer with improvements in quality of life which would be highly beneficial to the patient and their supporting carer/family.PSD · Nov 2024
Cost-effectiveness
ICER not stated in the provided PSD text.
ICER uncertain
Decision context
PopulationPatients with previously untreated locally advanced or metastatic urothelial cancer with WHO performance status of 0, 1, or 2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | platinum-based chemotherapy with gemcitabine (Plat+Gem) | — | RCT · OS |
| Feb 2023 | Recommended · restricted | docetaxel or paclitaxel | $75k–95k | RCT · OS |
| Mar 2022 | Not recommended | docetaxel or paclitaxel | — | RCT · OS |
Clinical evidence
Consumer voice
Individuals and their families reported benefits including tumour size reduction and improved quality of life, alongside side effects such as diarrhoea, fatigue, and neuropathy. Healthcare professionals and cancer advocacy organisations highlighted major survival benefits, unmet treatment needs for ineligible patients, and the significant impact of the disease on mental health and carers.
The input from individuals who have used this medicine for their own health along with input from their partners or family members described benefits of EV+PEM treatment including reductions in tumour size and cancer-related symptoms along with improvements in quality of life. Consumer comments · PSD
quality of lifesurvival benefitside effectsunmet needaccess barrierstreatment burden on family
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status 0–2; TGA label has no performance status limitation.