New Listings and Changes 1 October 2011

ADDITIONS

Additions – Items

5430T Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent (Taxotere)
5433Y Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent (Taxotere)
5149B Docetaxel, Powder for I.V. infusion 20 mg with solvent (Docetaxel SUN)
5156J Docetaxel, Powder for I.V. infusion 80 mg with solvent (Docetaxel SUN)
5428Q Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1 mL (Taxotere, Oncotaxel 20)
5429R Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe, Docetaxel Sandoz)
5431W Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4 mL (Taxotere, Oncotaxel 80)
5432X Docetaxel, Solution concentrate for I.V. infusion 80 mg in 8 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe, Docetaxel Sandoz)

The PBAC (July 2011) recommended the listing of a new presentation of docetaxel under the same conditions as the currently listed products for the treatment of cancer. The note regarding bioequivalence currently associated with docetaxel’s listing will be amended to include this docetaxel presentation.

 

5442K Tobramycin, Solution for inhalation 300 mg in 5 mL (Tobi)

The PBAC (March 2011) recommended the listing of tobramycin solution for inhalation on the PBS with an Authority Required (STREAMLINED) listing for the management of proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis on the basis of acceptable cost effectiveness compared with placebo.

Cystic fibrosis is a genetic disorder which compromises mucous clearance from the lungs. Patients with cystic fibrosis therefore have a greater risk of developing chronic lung infections because bacterial infections persist within the mucous. To manage these infections, patients receive courses of antibiotics by injection or nebulisation. If chronically colonised with the organism Pseudomonas aeruginosa, patients may require multiple courses of antibiotics for the management of pulmonary exacerbations.

 

Alterations – Restriction

2310N  Oxaliplatin, Solution concentrate for I.V. infusion 200 mg in 40 mL (Eloxatin, SW)
8561N Meloxicam, Tablet 7.5 mg (Mobic, Movalis 7.5, Chem mart Meloxicam 7.5 mg, Terry White Chemists Meloxicam 7.5 mg, GenRx Meloxicam, Moxicam 7.5, Meloxicam-GA, Pharmacor Meloxicam 7.5, Meloxicam Ranbaxy, Meloxibell, Meloxicam Sandoz)
8887R Meloxicam, Capsule 7.5 mg (Mobic, Movalis 7.5)
8562P Meloxicam, Tablet 15 mg (Mobic, Movalis 15, Chem mart Meloxicam 15 mg, Terry White Chemists Meloxicam 15 mg, GenRx Meloxicam, Moxicam 15, Meloxicam-GA, Meloxicam Ranbaxy, Meloxibell, Pharmacor Meloxicam 15, Meloxicam Sandoz)
8888T Meloxicam, Capsule 15 mg (Mobic, Movalis 15)

The PBAC (March 2011) recommended amending the current NOTE for these products in relation to substitution between different forms or salts of products.

 

8074Y Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent (Taxotere)
8071T Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent (Taxotere)
5463M Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1 mL (Taxotere, Oncotaxel 20)
5486R Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe, Docetaxel Sandoz)
5464N Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4 mL (Taxotere, Oncotaxel 80)
5487T Docetaxel, Solution concentrate for I.V. infusion 80 mg in 8 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe, Docetaxel Sandoz)

These brands of docetaxel have different registered indications. The listings for these products are being amended to include the relevant indications for each given brand.

 

Alteration – Item Description

A minor amendment to the description of degarelix is being made to change the description “solvent, syringe and needles” to “injection set”.

From:  5455D Degarelix, Powder for injection 80 mg (as acetate) with solvent, syringe and needles (Firmagon 80mg)
To:  5455D Degarelix, Powder for injection 80 mg (as acetate), injection set (Firmagon 80mg)

From:  5456E Degarelix, Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2 (Firmagon 120mg)
To:  5456E Degarelix, Powder for injection 120 mg (as acetate), 2, injection set (Firmagon 120mg)

 

SECTION 100 – HIGHLY SPECIALISED DRUGS PROGRAM

Alterations – Restriction

The PBAC (March 2011) recommended amending the current NOTE for disodium pamidronate in relation to substitution between different forms or salts of products.

 

SECTION 100 – HUMAN GROWTH HORMONE

Alterations – Restriction

In September 2010, new “Guidelines for the Pharmaceutical Benefits Scheme Growth Hormone Program” took effect which are an amalgamation of the ‘Guidelines for the Availability of Human Growth Hormone (hGH) as a Pharmaceutical Benefit (July 2008)’ and the ‘Guidelines for the Availability of Human Growth Hormone (hGH) as a Pharmaceutical Benefit for the treatment of Prader-Willi Syndrome (February 2009)’.

The PBAC (July 2011) recommended amending the wording of the listing of somatropin to correctly reflect the current version of the Guidelines for the PBS Growth Hormone Program, noting that there are no longer separate guidelines for the availability of growth hormone for the treatment of Prader-Willi Syndrome. The PBAC further recommended amending the wording of the listing of somatropin to remove the description of Genotropin branded products.