New Listings and Changes 1 April 2011

ADDITIONS

Additions - Items

8961P  Adalimumab,  Injection 40 mg in 0.8 mL pre‐filled syringe, 6 (Humira®)
8962Q  Adalimumab, Injection 40 mg in 0.8 mL pre‐filled pen, 6 (Humira®)
8963R  Adalimumab,  Injection 40 mg in 0.8 mL pre‐filled syringe (Humira®)
8964T  Adalimumab,  Injection 40 mg in 0.8 mL pre‐filled syringe (Humira®) (Diff. Max. Rpts)
8965W Adalimumab, Injection 40 mg in 0.8 mL pre‐filled pen (Humira®)
8966X  Adalimumab,  Injection 40 mg in 0.8 mL pre‐filled pen (Humira®) (Diff. Max. Rpts)

The PBAC (November 2010) recommended an extension to the listing of adalimumab for the treatment of complex refractory fistulising Crohn disease.

Adalimumab is given as an alternative treatment to infliximab, which requires an intravenous infusion. As adalimumab is administered as a subcutaneous injection, it will benefit patients and doctors who have limited access to infusion centres.

 

8954G Adapalene with Benzoyl Peroxide, Gel 1 mg‐25 mg per g (0.1%‐2.5%), 30 g (Epiduo®)
8955H Adapalene with Benzoyl Peroxide, Gel 1 mg‐25 mg per g (0.1%‐2.5%), 30 g (Epiduo®)

The PBAC (November 2010) recommended the listing of adapalene with benzoyl peroxide on the PBS with a Restricted Benefit listing for acute treatment of severe acne vulgaris in combination with an oral antibiotic, and maintenance treatment of severe acne vulgaris.

Acne vulgaris is a condition characterised by increased sebum production, hypercornification of the pilosebaceous duct and overgrowth of Propionbacterium acnes which can manifest as either noninflammatory lesions (open or closed comedones) and/or inflammatory lesions (pustules, red papules, nodules and cysts) predominantly presenting on the face, neck, chest, shoulders and upper back areas. 

Adapalene with benzoyl peroxide offers a PBS-subsidised topically applied alternative for people with severe uncontrolled acne.

 

8952E Olanzapine, Wafer 15 mg (Zyprexa Zydis®)
8953F Olanzapine, Wafer 20 mg (Zyprexa Zydis®)

The PBAC (November 2010) recommended the listing of two higher strength wafers of olanzapine (15 mg and 20 mg) on the PBS for the treatment of schizophrenia and maintenance treatment of bipolar I disorder under the same listing conditions as the currently PBS-listed tablets and wafers. 

The higher strengths of olanzapine wafers will allow a higher dose to be given during the acute phase of psychiatric disorders.

 

5480K Valaciclovir, Tablet 500 mg (as hydrochloride) (APO‐Valaciclovir, Chem mart Valaciclovir, Terry White Chemists Valaciclovir, Vaclovir, Valaciclovir GA, Valaciclovir RBX, Valaciclovir SZ, Valnir, Valtrex, Zelitrex®)

The current restriction is for both episodic treatment or suppressive therapy of recurrent genital herpes. The restriction will be amended to have separate item codes for episodic treatment (8134D) and suppressive therapy (5480K).

 

5474D Vildagliptin with Metformin, Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride (Galvumet 50/500®)
5475E Vildagliptin with Metformin, Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride (Galvumet 50/850®)
5476F Vildagliptin with Metformin, Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride (Galvumet 50/1000®)

The PBAC (November 2010) recommended the listing of vildagliptin with metformin fixed dose combination tablets 50mg-500 mg, 50 mg-850 mg and 50 mg-1000 mg on the PBS with an Authority Required (STREAMLINED) listing in accordance with the combination guidelines.

Vildagliptin with metformin will provide an alternative treatment option for adults with type 2 diabetes.

 

9388D Zonisamide, Capsule 25 mg (Zonegran®)
9389E Zonisamide, Capsule 50 mg (Zonegran®)
9390F Zonisamide, Capsule 100 mg (Zonegran®)

The PBAC (November 2007) recommended the listing of zonisamide for the treatment of partial epileptic seizures on a cost-minimisation basis compared with lamotrigine. 

The listing of zonisamide will provide an alternative treatment option for patients suffering from partial epileptic seizures.

 

Alterations – Notes and Restrictions

1208N Ciprofloxacin, Tablet 250 mg (C-Flox 250, Cifran, Ciprofloxacin-DRLA, Ciprofloxacin Sandoz, Ciprol 250, Ciproxin 250, GenRx Ciprofloxacin, Profloxin®)
1209P Ciprofloxacin, Tablet 500 mg (Ascent Pharmaceuticals Limited, C-Flox 500, Cifran, Ciprofloxacin 500, Ciprofloxacin-BW, Ciprofloxacin-DRLA, Ciprofloxacin‐GA, Ciprofloxacin Sandoz, Ciprol 500, Ciproxin 500, GenRx Ciprofloxacin®)
1210Q Ciprofloxacin, Tablet 750 mg (Ascent Pharmaceuticals Limited, C-Flox 750, Cifran, Ciprofloxacin 750, Ciprofloxacin-BW, Ciprofloxacin-DRLA, Ciprofloxacin‐GA, Ciprofloxacin Sandoz, Ciprol 750, Ciproxin 750, GenRx Ciprofloxacin®).

The Prime Minister approved the urgent amendment to the listing of ciprofloxacin on 19 January 2011 for a two month period from January to March 2011 for the treatment of severe skin infections associated with exposure to flood waters. This was in response to the substantial floods experienced in Queensland and other flood affected states (i.e Victoria, New South Wales and Tasmania). From 1 April 2011, the indication for the treatment of severe skin infections will be removed from the PBS listings.

 

8134D Valaciclovir, Tablet 500 mg (as hydrochloride) (APO-Valaciclovir, Chem mart Valaciclovir, Terry White Chemists, Valaciclovir, Vaclovir, Valaciclovir GA, Valaciclovir RBX, Valaciclovir Sandoz, Valaciclovir SZ, Valnir, Valtrex, Zelitrex®).

The current restriction is for both episodic treatment or suppressive therapy of recurrent genital herpes. The restriction will be amended to have separate item codes for episodic treatment (8134D) and suppressive therapy (5480K).

 

SECTION 100 – HIGHLY SPECIALISED DRUGS

Additions - Items

9692D Filgrastim, Injection 300 micrograms in 0.5 mL single use pre‐filled syringe (Nivestim®) (Public)
9693E Filgrastim, Injection 300 micrograms in 0.5 mL single use pre‐filled syringe (Nivestim®) (Private)
9694F Filgrastim, Injection 480 micrograms in 0.5 mL single use pre‐filled syringe (Nivestim®) (Public)
9695G Filgrastim, Injection 480 micrograms in 0.5 mL single use pre‐filled syringe (Nivestim®) (Private)

The PBAC (November 2010) recommended the listing of these filgrastim products under the same conditions as the existing listing for filgrastrim.

Filgrastim is used to reduce the duration and clinical sequelae of neutropenia in patients undergoing chemotherapy or receiving bone marrow transplants. It is also used to stimulate the release of stem cells in the blood for subsequent stem cell collection and transplantation.

 

9696H Romiplostim, Powder for injection 375 micrograms (250 micrograms in 0.5 mL when reconstituted) (Nplate®) (Public)
9697J Romiplostim, Powder for injection 375 micrograms (250 micrograms in 0.5 mL when reconstituted) (Nplate®) (Private)
9698K Romiplostim, Powder for injection 625 micrograms (500 micrograms in 1 mL when reconstituted) (Nplate®) (Public)
9699L Romiplostim, Powder for injection 625 micrograms (500 micrograms in 1 mL when reconstituted) (Nplate®) (Private)

The PBAC (March 2010) recommended the listing of romiplostim as a pharmaceutical benefit under section 100 (Highly Specialised Drug) Public and Private Hospital Authority Required for treatment of adult patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP).

ITP is an autoimmune disorder characterised by persistently low platelet counts (thrombocytopenia) and cutaneous and mucosal bleeding. Bleeding can range from mild (bruising and purpura) to severe (intracranial or gastrointestinal haemorrhage) and can sometimes result in death. The major therapeutic goal for ITP is to increase platelet count to a safe level while minimising treatment-related toxicity.

Romiplostim is a peptibody that stimulates platelet production for long-term treatment of adult chronic ITP patients.

 

Alterations ─ Notes and Restrictions

9654D Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Public)
9674E Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Private)

The PBAC (November 2010) recommended an extension to the listing of adalimumab for the treatment of complex refractory fistulising Crohn disease. As such, the restriction for the current listing for this indication, infliximab, has been revised to permit patients to swap between adalimumab and infliximab.

 

5618Q  Bosentan Monohydrate, Tablet 62.5 mg (base) (Tracleer®) (Public)
6429J   Bosentan Monohydrate, Tablet 62.5 mg (base) (Tracleer®) (Private)
5619R  Bosentan Monohydrate, Tablet 125 mg (base) (Tracleer®) (Public)
6430K  Bosentan Monohydrate, Tablet 125 mg (base) (Tracleer®) (Private)
5731P Epoprostenol, Powder for I.V. infusion 500 micrograms (base) with diluent (Flolan®) (Public)
6477X Epoprostenol, Powder for I.V. infusion 500 micrograms (base) with diluent (Flolan®) (Private)
5732Q Epoprostenol, Powder for I.V. infusion 1.5 mg (base) with diluent (Flolan®) (Public)
6478Y Epoprostenol, Powder for I.V. infusion 1.5 mg (base) with diluent (Flolan®) (Private)
5751Q Iloprost, Solution for inhalation 20 micrograms (base) in 2 mL (Ventavis®) (Public)
6456T Iloprost, Solution for inhalation 20 micrograms (base) in 2 mL (Ventavis®) (Private)
9547L Sildenafil, Tablet 20 mg (base) (Revatio®) (Public)
9605M Sildenafil, Tablet 20 mg (base) (Revatio®) (Private)
5607D Ambrisentan, Tablet 5 mg (Volibris®) (Public)
5608E Ambrisentan, Tablet 10 mg (Volibris®) (Public)
9648T Ambrisentan, Tablet 5 mg (Volibris®) (Private)
9649W Ambrisentan, Tablet 10 mg (Volibris®) (Private)

Amend note to remove references to sitaxentan (an alternative therapy) in the restrictions of these drugs as sitaxentan is being deleted from the PBS due to its withdrawal from the Australian market. A grandfather restriction for ambrisentan only will also be deleted.