RamucirumabCyramza
Treatment of patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy, in combination with paclitaxel.
Decisions on record
- Meeting Jul 2022 Noted Gastric or gastro-oesophageal junction adenocarcinoma no PSD
- Meeting Jul 2019 Not recommended Advanced metastatic gastric or gastro- oesophageal junction adenocarcinoma
- Meeting Mar 2018 Recommended Advanced gastric or gastro-oesophageal junction adenocarcinomas
Access path
- TGA registered · Cyramza
TGA label narrower than the PBS population
- Mar 2018Recommended · restricted
vs paclitaxel monotherapy
- Jul 2019Not recommended
unacceptably high ICER at $105,000-$200,000/QALY (PBAC considered acceptable range $40,000-$45,000/QALY), modest…
From the public summary
5.1 The PBAC did not recommend a change to the basis of its March 2018 recommendation for ramucirumab in combination with paclitaxel (RAM+PAC) for the treatment of patients with gastric or gastro-oesophageal junction adenocarcinoma.PSD · Jul 2019
5.2 The PBAC recalled that in March 2018 it recommended RAM+PAC for the treatment of G/GEJ adenocarcinoma on the basis that a substantial price reduction of around ''''''% would be required for RAM+PAC to be cost-effective against PAC in the proposed PBS population (see paragraph 3.2).PSD · Jul 2019
4.3 The minor resubmission presented a revised base case ICER of $45,000/QALY - $75,000/QALY gained. To achieve this ICER, the following changes were made to the model: a revised price that was around '''''% lower than the price requested in the previous submission (see Table 1); updates to the public and private Efficient Funding of Chemotherapy dispensing fees; and equal rates of post-progression hospitalisation in the two treatment arms, of 3.1% …PSD · Jul 2019
4.4 The minor resubmission requested that the PBAC reconsider the post-progression hospitalisation rate in cancer patients to be greater than zero on the basis of the follow-up period hospitalisation rates from the key clinical trial, RAINBOW, as well as other publications citing hospitalisation rates and costs in cancer patients.PSD · Jul 2019
6.32 The submission claimed that RAM+PAC was superior in terms of effectiveness and non-inferior (stated as “comparable”) in terms of safety, compared with PBO+PAC.PSD · Mar 2018
6.33 The clinical claim presented in the submission for the effectiveness of RAM+PAC was a 2.3 month gain in median OS, which corresponded to a 19% reduced risk of death over a median duration of follow-up of approximately 9 months.PSD · Mar 2018
4.2 The Medical Oncology Group of Australia (MOGA) expressed its support for the RAM+PAC resubmission. The PBAC noted that the MOGA presented the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for 3PSD · Jul 2019
6.65 No risk sharing arrangements have been presented in the submission. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2018
Cost-effectiveness
Decision context
PopulationAdult patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy, ECOG performance status 0 or 1, treated in combination with paclitaxel
Why it was knocked back
- unacceptably high ICER at $105,000-$200,000/QALY (PBAC considered acceptable range $40,000-$45,000/QALY), modest clinical benefit, significant toxicity
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Not recommended | paclitaxel | $105k–200k | RCT · OS |
| Mar 2018 | Recommended · restricted | paclitaxel monotherapy | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RAINBOW | Ph 3 | 665 | Overall Survival Time (OS) | completed |
Consumer voice
The Medical Oncology Group of Australia expressed support for the ramucirumab plus paclitaxel resubmission, presenting ESMO-MCBS scores that indicated limited clinical benefit compared to paclitaxel alone.
The Medical Oncology Group of Australia (MOGA) expressed its support for the RAM+PAC resubmission. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds ECOG performance status 0-1 restriction and specifies second-line setting not explicitly stated in TGA label.