Carmustine implant with polifeprosan 20
7.7 mg (Gliadel®)
Orphan Australia Pty Ltd
Major submission
|
Anti cancer drug |
Extension of restricted benefit listing to include the treatment of recurrent glioblastoma multiforme in patients for whom surgical
resection is indicated. |
The PBAC rejected the submission because of uncertain clinical effectiveness. |
| Sponsor’s comment |
The sponsor will be considering its position regarding any future course of action. |
Dasatinib, tablets, 70 mg , 50 mg, 20 mg (Sprycel®)
Bristol-Myers Squibb Pharmaceutical Australia Pty Ltd
Major submission
|
Anti cancer drug |
Listing under the section 100 Special Authority Program for the treatment of acute
lymphoblastic leukaemia in adult patients expressing the Philadelphia chromosome or
transcript, bcr-abl tyrosine kinase, who are resistant or intolerant to imatinib mesylate.
|
The PBAC rejected the submission because of uncertain cost-effectiveness. |
| Sponsor’s comment |
The sponsor looks forward to working with the PBAC to resolve the issues that have
been identified.
|
Escitalopram, tablets, 10 mg and 20 mg, and 10 mg/mL oral solution (Lexapro®)
Lundbeck Australia Pty Ltd
Major submission
|
Anti depressant |
Restricted benefit listing for social anxiety disorder (social phobia) and generalised
anxiety disorder.
|
The PBAC rejected the submission because of uncertain cost-effectiveness. |
| Sponsor’s comment |
The sponsor looks forward to working with the PBAC to resolve the issues that have
been identified.
|
Etanercept injection set containing 4 vials pwd for inj 25 mg and 50 mg and 4 pre-filled
syringes solvent 1 mL (Enbrel®)
Wyeth Australia Pty Limited
Major submission
|
Psoriasis, Rheumatoid arthritis Ankylosing spondylitis and psoriatic arthritis |
Extension of listing for treatment of chronic severe plaque psoriasis. |
The PBAC rejected the submission because of uncertainty about the clinical evidence
and a high and uncertain cost effectiveness ratio.
|
| Sponsor’s comment |
Wyeth looks forward to working with the PBAC to address the issues raised by the Committee. |
Interferon beta-1b injection set of 1 vial pwd for inj 8,000,000 i.u. (250 mcg) and
solvent (Betaferon®)
Schering Pty Limited
Major submission
|
Treatment of multiple sclerosis |
Amendment of authority required criteria to allow patients diagnosed using the McDonald
Criteria to access treatment rather than the current Poser Criteria.
|
The PBAC rejected the submission because of uncertain clinical benefit and uncertain
cost effectiveness.
|
| Sponsor’s comment |
Bayer Schering Pharma will discuss this decision with the PBAC in order to clarify
and address the issues raised.
|
Lanthanum carbonate, chewable tablets, 500 mg, 750 mg and 1000 mg (Fosrenol®)
Orphan Australia Pty Ltd
Major submission
|
Management of phosphate levels in renal disease |
Authority required listing |
The PBAC rejected the submission because of a high and uncertain cost-effectiveness
ratio that primarily resulted from a lack of data to conclusively link treatment with
patient relevant outcomes.
|
| Sponsor’s comment |
The sponsor will be considering its position regarding any future course of action. |
Venlafaxine hydrochloride, capsules, 37.5 mg, 75 mg and 150 mg (Efexor-XR®)
Wyeth Australia Pty Ltd
Minor submission
|
Anti depressant |
Listing of a new pack size of 14 capsules per pack with no repeats as per the current
pack size.
|
The PBAC rejected the submission because there is already a mechanism available (ie
there is no compulsion to prescribe the maximum quantity) which allows for prescribing
of less than the maximum quantity of 28 capsules.
|
| Sponsor’s comment |
No comment |
