Table 2.
PBS subsidy of drugs marketed for depression, osteoporosis and overactive bladder marketed by sponsoring companies
| Company | Drug for condition (brand) |
PBS subsidy?(Y/N) | PBAC decisions and rationale for restrictions | Notes |
| Depression | ||||
| Servier | Agomelatine (Valdoxan) | No | November 2010: uncertainty; inappropriate comparator July 2011, March 2012: superior clinical effectiveness and safety over SSRIs not demonstrated |
|
| AstraZeneca | Quetiapine (Seroquel XR)* | No for MDD, treatment-resistant depression or anxiety disorders | November 2011: inadequate clinical evidence to support superiority July 2013: non-inferior comparative safety and effectiveness not established |
Quetiapine is PBS-funded for schizophrenia; acute mania and bipolar disorder |
| Pfizer | Desvenlafaxine (Pristiq) | Yes | November 2008: cost minimisation† versus venlafaxine; no evidence of therapeutic advantage | |
| Venlafaxine (Efexor-XR, Altven), sertraline (Zoloft), reboxetine (Edronax), doxepin (Sinequan) | Yes | General schedule‡ listings, major depressive disorder | ||
| Osteoporosis | ||||
| Amgen and GSK | Denosumab (Prolia) | Yes | July 2010: cost-minimisation† versus zoledronic acid November 2011: streamlined authority§, postmenopausal osteoporosis, age 70+, BMD T-score ≤−2.5; cost-minimisation versus alendronate July 2013: superiority versus zoledronic acid rejected; non-inferiority accepted |
2009: co-commercialised by Amgen and GSK; Dec 2015: Amgen reacquires all marketing rights in Australia |
| Novartis | Zoledronic acid (Aclasta) | Yes | July 2008: authority required¶ cost-minimisation versus alendronate; November 2008: listing extended: women aged 70+; BMD T-score≤−3.0 November 2009: extended to men July 2011: 3-year limit removed; listing changed to streamlined authority |
|
| Oestradiol/norethisterone (Estalis Continuous) | Yes | General schedule‡ | ||
| Servier | Strontium (Protos) | No (previously subsidised) | July 2015: restricted to severe established osteoporosis, patients unable to use other drugs, without cardiovascular contraindications August 2016: delisted due to cardiac risks |
|
| Sanofi | Risedronic acid (Actonel, Actonel Ec, Actonel Ec Combi, Actonel Ec Combi D) | Yes | February 2001: postmenopausal osteoporosis; minimal fracture trauma; cost-minimisation versus alendronate December 2001— extended to corticosteroid-induced osteoporosis March 2013: extended to patients aged 70+BMD T-score≤−2.5 |
December 2014: Sanofi transfers marketing rights to Actavis |
| Overactive bladder | ||||
| Astellas | Mirabegron (Betmiga) | No | NA. No request made for PBS listing | |
| CSL and Astellas | Solifenacin (Vesicare) | No | July 2007: uncertain clinical benefit and cost-effectiveness | February 2011—October 2014: marketed by CSL October 2014: Astellas regains marketing rights |
*Immediate release quetiapine products are not indicated for MDD or general anxiety disorder, only Seroquel XR.
†Cost-minimisation: product is considered non-inferior in safety and efficacy to listed comparator; no higher pricing allowed.
‡General schedule: no prior authority required.
§Streamlined authority: no prior approval required, but a streamlined authority code is required on the prescription; if quantities and/or repeats exceed specified levels, treated as authority required.
¶Authority required: telephone or written approval required from Department of Health prior to prescribing.
BMD, bone mineral density; GSK, GlaxoSmithKline; MDD, major depressive disorder; NA, not applicable; PBAC, Pharmaceutical Benefits Advisory Committee; PBS, Pharmaceutical Benefits Scheme; SSRI, selective serotonin reuptake inhibitor.