Table 2

PBS subsidy of drugs marketed for depression, osteoporosis and overactive bladder marketed by sponsoring companies

CompanyDrug for condition
(brand)
PBS subsidy?(Y/N)PBAC decisions and rationale for restrictionsNotes
Depression
 ServierAgomelatine (Valdoxan)NoNovember 2010: uncertainty; inappropriate comparator
July 2011, March 2012: superior clinical effectiveness and safety over SSRIs not demonstrated
 AstraZenecaQuetiapine (Seroquel XR)*No for MDD, treatment-resistant depression or anxiety disordersNovember 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
 PfizerDesvenlafaxine (Pristiq)YesNovember 2008: cost minimisation† versus venlafaxine; no evidence of therapeutic advantage
Venlafaxine (Efexor-XR, Altven), sertraline (Zoloft), reboxetine (Edronax), doxepin (Sinequan)YesGeneral schedule‡ listings, major depressive disorder
Osteoporosis
 Amgen and GSKDenosumab (Prolia)YesJuly 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
 NovartisZoledronic acid (Aclasta)YesJuly 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)YesGeneral schedule‡
 ServierStrontium (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
 SanofiRisedronic acid (Actonel, Actonel Ec, Actonel Ec Combi, Actonel Ec Combi D)YesFebruary 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
 AstellasMirabegron (Betmiga)NoNA. No request made for PBS listing
 CSL and AstellasSolifenacin (Vesicare)NoJuly 2007: uncertain clinical benefit and cost-effectivenessFebruary 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.