BortezomibBortezom
Multiple myeloma. Listing of two new solution for injection forms (2.5 mg/mL and 3.5 mg/1.4 mL) under the Section 100 Efficient Funding of Chemotherapy Program.
Decisions on record
- Meeting Mar 2022 Recommended Multiple myeloma
- Meeting Jul 2021 Recommended Multiple myeloma
- Meeting Jul 2021 Recommended Multiple myeloma
- Meeting Mar 2018 Noted Multiple myeloma no PSD
- Meeting Mar 2016 Recommended Multiple myeloma
- Meeting Mar 2012 Recommended Anti-cancer drug for multiple myeloma.
- Meeting Jul 2011 Recommended Multiple myeloma
- Meeting Mar 2011 Deferred Multiple myeloma
6 earlier decisions
- Mar 2010 Not recommended Treat multiple myeloma in patients ineligible for transplant
- Jul 2009 Recommended Anti-cancer drug
- Jul 2009 Recommended Anti-cancer drug
- Jul 2008 Recommended Multiple myeloma no PSD
- Jul 2007 Recommended Multiple myeloma
- Nov 2006 Not recommended Treatment of multiple myeloma patients who have received at least one prior therapy and who have progressive disease.
Access path
- TGA registered · Bortezom
TGA label equal than the PBS population
- Mar 2006Not recommended
uncertain clinical benefit over the mix of comparators, uncertain and high cost effectiveness ratio, doubts about…
- Mar 2006Not recommended
uncertain clinical benefit over the mix of comparators, uncertain and high cost-effectiveness ratio, doubts about…
- Nov 2006Not recommended
unacceptable cost effectiveness, uncertain cost offsets claimed for stem cell transplantation, uncertainty about…
- Nov 2006Not recommended
unacceptable cost effectiveness, uncertain cost offsets claimed for stem cell transplantation, uncertainty about…
- ↻ resubmittedJul 2007Recommended · restricted
Comparator changed: mixture of salvage treatments including autologous and allogeneic…
- Jul 2007Recommended · restricted
Comparator changed: mixture of salvage treatments including autologous and allogeneic…
- Jul 2009Recommended · restricted
Comparator changed: mixture of salvage treatments (IV chemotherapy, high dose…
- Mar 2010Recommended · restricted
Comparator changed: thalidomide, melphalan and prednisone (MPT) → thalidomide in…
- Mar 2010Recommended · restricted
Comparator changed: thalidomide, melphalan and prednisone (MPT) → thalidomide in…
- Mar 2011Recommended
Comparator changed: thalidomide in combination with melphalan and prednisone → thalidomide
- Jul 2011Recommended · restricted
- Mar 2012Recommended
- Mar 2012Recommended
- Mar 2016Recommended · restricted
Evidence: RCT → Cost-minimisation
- Jul 2021Recommended · restricted
Listing: Authority Required → Restricted
- Jul 2021Recommended · restricted
Listing: Authority Required → Restricted
- Mar 2022Recommended · restricted
- Mar 2022Recommended · restricted
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the Section 100 Efficient Funding of Chemotherapy (EFC) Program listing of two new forms of bortezomib (Bortezomib Ever Pharma®)PSD · Mar 2022
2.5 mg/mL and 3.5 mg/1.4 mL solutions for injection under the same circumstances as the currently listed brands of bortezomib.PSD · Mar 2022
6.4 As a minor submission, there was no economic comparison presented.PSD · Mar 2016
5.2 The PBAC noted and welcomed the input from individuals (9), via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with bortezomib including increased life expectancy and the ability to return to work and caring responsibilities. Many commented that injection site pain is a common side effect.PSD · Mar 2022
5.2 The PBAC noted and welcomed the input from individuals (9), via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with bortezomib including increased life expectancy and the ability to return to work and caring responsibilities. Many commented that injection site pain is a common side effect.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC noted recommendation was on cost-minimisation basis with nil cost to Government.
The proposed listing is not expected to result in any net financial changes to the PBS. PSD · 2021
Decision context
PopulationPatients with multiple myeloma requiring bortezomib therapy, eligible for treatment via intravenous or subcutaneous administration.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | bortezomib 1 mg, 3 mg and 3.5 mg powder for injection | — | Cost-minimisation · Cost-minimisation |
| Mar 2022 | Recommended · restricted | bortezomib 1 mg, 3 mg and 3.5 mg powder for injection | — | Cost-minimisation · Cost-minimisation |
| Jul 2021 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2021 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Recommended · restricted | — | — | Cost-minimisation |
| Mar 2012 | Recommended | thalidomide | — | RCT · VGPR, OS |
| Mar 2012 | Recommended | thalidomide | — | RCT · VGPR |
| Jul 2011 | Recommended · restricted | — | — | — |
| Mar 2011 | Recommended | thalidomide | $15k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Mar 2010 | Recommended · restricted | thalidomide in combination with melphalan and prednisone (MPT) | $15k–45k | Meta-analysis · OS |
| Mar 2010 | Recommended · restricted | thalidomide in combination with melphalan and prednisone | $15k–45k | Meta-analysis · OS |
| Jul 2009 | Recommended · restricted | thalidomide, melphalan and prednisone (MPT) | — | RCT | Meta-analysis · OS | PFS |
| Jul 2007 | Recommended · restricted | mixture of salvage treatments | $45k–75k | RCT |
| Jul 2007 | Recommended · restricted | mixture of salvage treatments (IV chemotherapy, high dose therapy/autologous stem cell transplant, mini-allogeneic trans | $45k–75k | RCT |
| Nov 2006 | Not recommended | mixture of salvage treatments, including autologous and allogeneic stem cell transplant and standard chemotherapy regime | $45k–75k | RCT |
| Nov 2006 | Not recommended | mixture of salvage treatments including autologous and allogeneic stem cell transplant and standard chemotherapy regimen | $45k–75k | RCT |
| Mar 2006 | Not recommended | mixture of salvage treatments, including autologous and allogeneic stem cell transplant and standard chemotherapy regime | $45k–75k | RCT · OS, PFS |
| Mar 2006 | Not recommended | mixture of salvage treatments including autologous and allogeneic stem cell transplant and standard chemotherapy regimen | $45k–105k | RCT · PFS |
Consumer voice
Nine individuals submitted comments describing benefits of bortezomib treatment including increased life expectancy and ability to return to work and caring responsibilities, while noting injection site pain as a common side effect and emphasizing that the advantages outweigh disadvantages.
The comments described a range of benefits of treatment with bortezomib including increased life expectancy and the ability to return to work and caring responsibilities. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC indication cover multiple myeloma patients requiring bortezomib therapy; PBAC specifies administration routes already within standard practice.