Topotecan
Treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent therapy; small cell lung carcinoma after failure of first-line chemotherapy; and in combination with cisplatin for treatment of patients with histologically confirmed Stage IC-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy.
Decisions on record
- Meeting Jul 2020 Recommended Metastatic ovarian cancer
- Meeting Jul 2010 Not recommended Anti-cancer drug
Access path
- Jul 2010Not recommended
uncertain clinical benefit, high and uncertain incremental cost-effectiveness ratio, poorly defined restriction…
- Jul 2010Not recommended
uncertain clinical benefit, high and uncertain incremental cost-effectiveness ratio, poorly defined trial population…
- ↻ resubmittedJul 2020Recommended · restricted
Comparator changed: best supportive care → Hycamtin (topotecan)
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of a new form of topotecan, solution concentrate for I.V. infusion 4 mg in 4 mL (as hydrochloride), as an unrestricted benefit, on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy).PSD · Jul 2020
6.2 The PBAC noted that the TGA considered the new form of topotecan to be bioequivalent to the currently listed form of topotecan, Hycamtin.PSD · Jul 2020
5.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. Lung Foundation Australia described a range of benefits of listing a Topotecan Accord including a greater certainty of supply due to an alternative supplier as well as offering an effective alternative treatment for small cell lung cancer (SCLC) on the PBS.PSD · Jul 2020
5.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the Topotecan Accord submission, categorising it as one of the therapies of “highest priority for PBS listing” on the basis of improvements in overall survival and quality of life. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for Topotecan 2PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as Topotecan Accord is bioequivalent to Hycamtin with no expected improvement in efficacy or reduction in toxicity.
The PBAC noted that the results of the sensitivity analyses indicate that the model is most sensitive to variation in the assumptions used for calculating the utility values and the subgroup analyses assessing the effect of male gender and the presence of liver metastases. PBAC · 2010
Decision context
PopulationPatients with advanced metastatic ovarian cancer who have failed prior therapy including a platinum compound; also indicated for small cell lung cancer and cervical cancer as per TGA registration.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | Hycamtin (topotecan) | — | Cost-minimisation · Cost-minimisation |
| Jul 2010 | Not recommended | best supportive care | $15k–45k | RCT, Indirect comparison · OS |
| Jul 2010 | Not recommended | best supportive care | $15k–45k | RCT · OS |
Consumer voice
Lung Foundation Australia and the Medical Oncology Group of Australia both supported listing of Topotecan Accord, citing benefits including supply certainty, effective treatment for small cell lung cancer, improvements in overall survival and quality of life.
Lung Foundation Australia described a range of benefits of listing a Topotecan Accord including a greater certainty of supply due to an alternative supplier as well as offering an effective alternative treatment for small cell lung cancer (SCLC) on the PBS. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC specifies later-line treatment and platinum-failure requirement; TGA label permits first-line failure onwards without explicit platinum-prior criterion.