New Listings and Changes 1 August 2011

ADDITIONS

Additions - Items

8975J Desmopressin Acetate, Wafer 240 micrograms (base) (Minirin Melt)

The PBAC (March 2011) recommended the listing of a new higher strength desmopressin wafer for patients with nocturnal enuresis who are prescribed maximum dose of 240 micrograms at night.  This listing will benefit patients who require higher doses.

 

5270J Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1 mL (Taxotere, Oncotaxel20)
5272L Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4 mL (Taxotere, Oncotaxel80)
5271K Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent (Taxotere)
5273M Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent (Taxotere)

The PBAC (November 2010) 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 was a new presentation of docetaxel which had been demonstrated to be bioequivalent to the existing docetaxel formulations to the satisfaction of the TGA.

 

5490Y Dutasteride with Tamsulosin, Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms (Duodart 500ug/400ug)

The PBAC (November 2010) recommended the listing of dutasteride with tamsulosin for the treatment of patients with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) on a cost minimisation basis.

Benign prostatic hyperplasia is a condition common in older men.  This progressive condition is associated with worsening lower urinary tract symptoms such as hesitant and interrupted weak stream, urgency, leaking or dribbling and a sense of incomplete voiding leading to more frequent urination, especially at night.  The condition may eventually require surgery.

The combination product provides an alternative to taking dutasteride and an alpha blocker as separate medicines. People taking dutasteride (Avodart) and an alpha-blocker will be able to take the combination medicine and save the out-of-pocket expenditure of a copayment.

 

5277R Fentanyl, Transdermal patch 2.55 mg (releasing approximately 25 micrograms per hour) (Denpax)
5278T Fentanyl, Transdermal patch 5.10 mg (releasing approximately 50 micrograms per hour) (Denpax)
5279W Fentanyl, Transdermal patch 7.65 mg (releasing approximately 75 micrograms per hour) (Denpax)
5280X Fentanyl, Transdermal patch 10.20 mg (releasing approximately 100 micrograms per hour) (Denpax)

The PBAC (March 2011) recommended listing a new brand of fentanyl patches on the PBS as a Restricted Benefit for the treatment of chronic severe disabling pain not responding to non-narcotic analgesics on a cost-minimisation basis with Durogesic® brand of fentanyl patches.  The TGA considers that these patches are bioequivalent to the alternative brand Durogesic as they have the same rate of release.

A separate PBS item number is required for Denpax as the patch reservoirs contain differing total amounts of drug to Durogesic.  The PBAC recommended that NOTES indicating that the two brands are equivalent for the purposes of substitution be included in the listing, with wording consistent with the recommendation made for Item 4.2 – Bioequivalence NOTE review.

The PBAC recommended the Safety Net 20 Day Rule should apply.  These items are suitable for nurse practitioner prescribers with collaborative care arrangements.

 

5449T Leflunomide, Tablet 10 mg (Arava, Arabloc)
5450W Leflunomide, Tablet 20 mg (Arava, Arabloc)

Leflunomide is already listed on the PBS as a 10 mg tablet (item 8374R) and 20 mg tablet (item 8375T) for the indications active rheumatoid arthritis and active psoriatic arthritis. New items 5449T and 5450W are being added to the PBS to allow the addition of two brands (Lunava and APO-Leflunamide) that do not have an indication for active psoriatic arthritis in their product information.

 

5263B Methylprednisolone, Powder for injection 40 mg (as sodium succinate) (Methylpred)
5264C Methylprednisolone, Powder for injection 1 g (as sodium succinate) (Methylpred)

The PBAC (March 2011) recommended listing of a new presentation of methylprednisolone powder for injection (without diluent) on the PBS on a cost-minimisation basis compared with methylprednisolone powder for injection with diluent

The PBAC recommended that methylprednisolone is suitable for inclusion in the PBS medicines for prescribing by nurse practitioners within collaborative arrangements.

 

Section 100 – Highly Specialised Drugs Program

Additions - Items

5829T Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim)(Public)
5830W Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim)(Private)

The PBAC recommends listing of a new brand of filgrastim (November 2010) on the PBS.  The TGA Delegate proposed to register these filgrastim products as similar biological medicines being of “comparable safety and efficacy”. Therefore, the PBAC recommended that all filgrastim brands be listed under the same PBS restrictions.  However, these products are not substitutable by the dispensing pharmacist.

Filgrastim is used to support the production of white blood cells and is commonly used as supportive therapy for patients undergoing treatment with chemotherapy.

 

Section 100 – Human Growth Hormone Program

6310D Somatropin (Recombinant human growth hormone) , Injection 10 mg (30 i.u.) vial with diluent (with preservative) (Zomacton)

The PBAC (March 2011) recommended the listing of a new higher strength of Zomacton (somatropin) on a cost-minimisation basis with the 4 mg strength of Zomacton, under the current human growth hormone section 100 listing conditions.