New Listings and Changes 1 January 2011

New Listings and Changes 1 January 2011

Additions - Items

5461K Mesalazine, suppository (moulded), 1 g, 30 (Salofalk)

The PBAC (July 2010) recommended the listing on the PBS of mesalazine suppositories (Salofalk®) as a Restricted Benefit listing for the treatment of acute episodes of mild to moderate ulcerative proctitis on a cost minimisation basis with mesalazine suppositories (Pentasa®). The PBAC considered that the listing would provide an alternative mesalazine suppository formulation option for clinicians. 
Note: the supplier has notified the Department of an inability to supply this item from 1 January 2011.  Information will be posted on www.pbs.gov.au when this item becomes available.

Amlodipine with valsartan, tablets, 5 mg-320 mg (5459H) and 10 mg-320 mg (5460J) (Exforge 5/320 and Exforge 10/320)

The PBAC (July 2010) recommended the listing of two additional strengths of amlodipine with valsartan tablets 5 mg-320 mg and 10 mg-320 mg on a cost-minimisation basis compared with the corresponding strengths of the constituent components, amlodipine and valsartan given concomitantly.

5458G Quetiapine, tablet (modified release) 150 mg (as fumarate) (Seroquel XR)

The PBAC (November 2010) recommended out-of-session the listing of a new strength of quetiapine modified release tablets for the same indications as the existing PBS-listed quetiapine products, on a cost-minimisation basis with the currently listed quetiapine tablets.  The PBAC also took into account the July 2010 recommendation to remove the requirement that quetiapine be prescribed in combination with lithium or sodium valproate in the maintenance treatment of bipolar I disorder.  The PBAC noted that the new listing would increase dosing flexibility for patients and prescribers.

The PBAC recommended that this new strength of quetiapine tablets be available for prescribing by nurse practitioners in a shared care model arrangement, as was previously recommended for other strengths of quetiapine tablets.

5462L Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1mL (Taxotere)
5463M Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1mL (Taxotere) (Diff. Max. Qty)
5464N Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4mL (Taxotere)
(these products  have also been added to the Section 100 – Chemotherapy Pharmaceutical Access Program under the items 5854D, 5855E and 5856F respectively)

The PBAC recommended the listing of two strengths of a new presentation of docetaxel solution concentrate for intravenous infusion for the same indications as the currently PBS listed docetaxel products on a cost-minimisation basis with the corresponding strengths of docetaxel powder for I.V. infusion.  The PBAC noted that this new presentation of docetaxel had demonstrated bioequivalence with the existing docetaxel formulations to the satisfaction of the TGA.

Alterations – Restrictions

All Palliative Care items have been split into initial and continuing supply items.

The following are now “Authority required (STREAMLINED)” items effective 1 January 2011:
1007B Aciclovir, Tablet 200 mg, (Aciclovir 200, Acihexal, Acyclo-V 200, Chem mart Aciclovir, GenRx Aciclovir, Lovir, Ozvir, Terry White
Chemists Aciclovir, Zovirax 200 mg)
1003T Aciclovir, Tablet 200 mg, (Acihexal, Acyclo-V 200, GenRx Aciclovir, Lovir, Zovirax 200 mg)
1052J Aciclovir, Tablet 800 mg, (Aciclovir 800, Acihexal, Acyclo-V 800, GenRx Aciclovir, Zovirax 800 mg)
8234J Aciclovir, Tablet 800 mg, (Acihexal, Acyclo-V 800)
8808N Aprepitant, Pack containing 1 capsule 125 mg and 2 capsules 80 mg, (Emend)
8897G Famciclovir, Tablet 500 mg, (Famvir, Favic 500)
8896F Famciclovir, Tablet 500 mg, (Ezovir, Famvir, Favic 500)
2274Q Famciclovir, Tablet 250 mg, (APO-Famciclovir, Ezovir, Famciclovir Sandoz, Famvir, Favic 250)
8217L Famciclovir, Tablet 250 mg, (APO-Famciclovir, Ezovir, Famciclovir Sandoz, Famvir, Favic 250)
8002E Famciclovir, Tablet 250 mg, (APO-Famciclovir, Ezovir, Famciclovir Sandoz, Famvir, Favic 250)
8092X Famciclovir, Tablet 125 mg, (APO-Famciclovir, Ezovir, Famvir, Favic 125)
1757L Fluconazole, Solution for I.V. infusion 400 mg in 200 mL, (Baxter Healthcare Pty Ltd)
1474N Fluconazole, Solution for I.V. infusion 200 mg in 100 mL, (Baxter Healthcare Pty Ltd, Diflucan, Fluconazole-Claris, Fluconazole Hexal, Fluconazole Sandoz)
1473M Fluconazole, Solution for I.V. infusion 100 mg in 50 mL, (Diflucan, Fluconazole-Claris, Fluconazole Hexal)
1471K Fluconazole, Capsule 50 mg, (DBL Fluconazole, Diflucan, Dizole 50, Fluconazole Sandoz, Fluzole 50, Ozole)
1475P Fluconazole, Capsule 200 mg, (APO-Fluconazole, DBL Fluconazole, Diflucan, Dizole 200, Fluconazole Sandoz, Fluzole 200, Ozole)
1472L Fluconazole, Capsule 100 mg, (DBL Fluconazole, Diflucan, Dizole 100, Fluconazole Sandoz, Fluconazole Winthrop, Ozole)
8015W Gestrinone, Capsule 2.5 mg, (Dimetriose)
8873B Granisetron Hydrochloride, Tablet 2 mg (base), (Kytril)
8730L Granisetron Hydrochloride, Concentrated injection 3 mg (base) in 3 mL, (Granisetron Kabi, Kytril)
8196J Itraconazole, Capsule 100 mg, (Sporanox)
1573T Ketoconazole, Tablet 200 mg, (Nizoral)
1572R Ketoconazole, Tablet 200 mg, (Nizoral)
8413T Ondansetron, Wafer 8 mg, (Ondaz Zydis, Zofran Zydis)
8412R Ondansetron, Wafer 4 mg, (Ondaz Zydis, Zofran Zydis)
1595Y Ondansetron, Tablet 8 mg, (APO-Ondansetron, Ondaz, Onsetron 8, Zofran)
1594X Ondansetron, Tablet 4 mg, (APO-Ondansetron, Ondaz, Onsetron 4, Zofran)
8233H Ondansetron, Syrup 4 mg per 5 mL, 50 mL, (Zofran syrup 50 mL)
1597C Ondansetron, I.V. injection 8 mg in 4 mL, (Ondansetron-Claris, Ondaz, Onsetron, Pfizer Australia Pty Ltd, Zofran)
1596B Ondansetron, I.V. injection 4 mg in 2 mL, (Ondansetron-Claris, Ondaz, Onsetron, Pfizer Australia Pty Ltd, Zofran)
8134D Valaciclovir Hydrochloride, Tablet 500 mg (base), (Valtrex)
8133C Valaciclovir Hydrochloride, Tablet 500 mg (base), (Valtrex)
8064K Valaciclovir Hydrochloride, Tablet 500 mg (base), (Valtrex)

SECTION 100 – HIGHLY SPECIALISED DRUGS

Additions - Items

None

Alteration – restriction

9612X (priv) 5755X (pub) Infliximab, Powder for I.V. infusion 100mg (Remicade)

The PBAC (August 2010 Special Meeting) recommended a change to the dosage requirement for prednisolone in the restriction for infliximab for treatment of Crohn disease in paediatric patients to allow more suitable dosing for patients with low bodyweight.

The PBAC was concerned that the requested change might result in an increased starting dose for patients weighing greater than 40 kg and recommended a further amendment to address this issue, with the wording “1 mg per kg or 40 mg (whichever is the lesser)”.

Abacavir sulfate (Ziagen)
Abacavir sulfate with lamivudine (Kivexa)
Abacavir sulfate with lamivudine and zidovudine (Trizivir)
Atazanavir (Reyataz)
Darunavir (Prezista)
Didanosine (Videx EC)
Efavirenz  (Stocrin)
Emtricitabine (Emtriva)
Enfuvirtide (Fuzeon)
Etravirine (Intelence)
Fosamprenavir calcium (Telzir)
Indinavir sulfate (Crixivan)
Lamivudine (3TC)
Lamivudine with zidovudine (Combivir)
Lopinavir with ritonavir (Kaletra)
Maraviroc (Celsentri)
Nevirapine (Viramune)
Raltegravir potassium (Isentress)
Ritonavir (Norvir)
Saquinavir mesylate (Invirase)
Stavudine (Zerit)
Tenofovir (Viread)
Tenofovir with emtricitabine (Truvada)
Tenofovir with emtricitabine and efavirenz (Atripla)
Tipranavir (Aptivus)
Zidovudine (Retrovir)

The PBAC recommended (August 2010 Special Meeting) that for first-line PBS listed antiretroviral drugs that the viral load requirement should be deleted and the restriction be split into initial and continuation criteria.  The restriction wording for later-line therapies would also change to incorporate the phrase ‘in addition to optimised background therapy in combination with other antiretroviral agents’.