New Listings and Changes 1 June 2011

ADDITIONS

Additions - Items

8969C Calcium Folinate, Injection equivalent to 1000 mg folinic acid in 100 mL (Calcium Folinate Ebewe®)

The PBAC (March 2011 out of session) recommended the listing of a new higher strength of calcium folinate injection on a cost-minimisation basis with calcium folinate 100 mg in 10 mL. 

 

8986Y Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1 mL (Taxotere®)
8987B Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection®)
8988C Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent (Taxotere)
8989D Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4 mL (Taxotere®)
8990E Docetaxel, Solution concentrate for I.V. infusion 80 mg in 8 mL (DBL Docetaxel Concentrated Injection®)
8991F Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent (Taxotere®)
8992G Docetaxel, Solution concentrate for I.V. infusion 160 mg in 16 mL (DBL Docetaxel Concentrated Injection®)

The creation of the above new items is to align the PBS restriction of each brand with approved indications. It is anticipated that there will be no change in number of patients accessing these items.

 

8976K Phenoxymethylpenicillin, Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL (Phenoxymethyl penicillin AFT®)
5024K Phenoxymethylpenicillin, Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL (Phenoxymethyl penicillin AFT®) (Dental)
8977L Phenoxymethylpenicillin, Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (Phenoxymethyl penicillin AFT®)
5029Q Phenoxymethylpenicillin, Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL (Phenoxymethyl penicillin AFT®) (Dental)

The PBAC (March 2011) recommended listing of two new strengths of phenoxymethylpenicillin powder for oral liquid on the PBS on a cost-minimisation basis compared with phenoxymethylpenicillin 150 mg (as benzathine) per 5 ml.

 

8972F Risedronate Sodium, Tablet 35 mg (enteric coated) (Actonel EC®)
8973G Risedronate Sodium and Calcium Carbonate, Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium) (Actonel EC Combi®)
8974H Risedronate Sodium and Calcium Carbonate with Colecalciferol, Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g (equivalent to 1 g calcium) with colecalciferol 22 micrograms (Actonel EC Combi D®)

The PBAC recommended (March 2011) out of session the listing of the above new forms of risedronate sodium 35 mg tablet, (including the combination products) on a cost-minimisation basis with the PBS listed products containing risedronate sodium 35 mg and under the current listing conditions. The once weekly dose of risedronate sodium 35mg is currently subsidised for the treatment of patients with established osteoporosis meeting certain criteria. The new form will substitute for existing use of risedronate at an equivalent price.

 

8983T Saxagliptin, Tablet 5 mg (as hydrochloride) (Onglyza®)

The PBAC recommended (March 2010) the listing of saxagliptin as an authority required (streamlined) benefit for the treatment of Type 2 diabetes mellitus, in combination with metformin or a sulfonylurea, in a patient whose HbA1c is greater than 7 % despite treatment with either metformin or a sulfonylurea and where a combination of metformin and a sulfonylurea is contraindicated or not tolerated.  The listing was recommended on a cost-minimisation basis with sitagliptin with the equi-effective doses of saxagliptin 5 mg/day and sitagliptin 100 mg/day.

Saxagliptin will provide an alternative oral hypoglycaemic agent to currently PBS subsidised sitagliptin or the glitazones for the management of type two diabetes.

The PBAC recommended that the Safety Net 20 day rule should apply.

 

8984W Sirolimus, Tablet 0.5 mg (Rapamune®)

Sirolimus is currently subsidised for the prophylaxis of renal (kidney) allograft rejection.  The PBAC recommended listing (March 2011) of a new lower strength of sirolimus tablet on the PBS on a cost-minimisation basis compared with sirolimus 1 mg tablets. This is not newsworthy

The PBAC recommended the Safety Net 20 Day rule should apply.

 

8978M Telmisartan with Amlodipine, Tablet 40 mg-5 mg (as besylate) (Twynsta®)
8979N Telmisartan with Amlodipine, Tablet 40 mg-10 mg (as besylate) (Twynsta®)
8980P Telmisartan with Amlodipine, Tablet 80 mg-5 mg (as besylate) (Twynsta®)
8981Q Telmisartan with Amlodipine, Tablet 80 mg-10 mg (as besylate) (Twynsta®)

The PBAC recommended listing (March 2011) telmisartan with amlodipine (as besylate), tablets 40 mg-5 mg, 40 mg-10 mg, 80 mg-5 mg and 80 mg-10 mg on the PBS as a Restricted Benefit for treatment of hypertension in a patient who is not adequately controlled with either of the drugs in the combination., on a cost-minimisation basis compared with the corresponding strengths of the constituent components, telmisartan and amlodipine, given concomitantly.

The PBAC noted that PBS listing was unlikely to increase utilisation in the market, rather, it would provide an additional treatment choice to the currently listed angiotensin-II receptor antagonist with calcium channel blocker combination products.

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

The PBAC recommended the Safety Net 20 Day rule should apply.

 

Alterations – Alterations – Notes

8741C Adalimumab, Injection 40 mg in 0.8 mL single use pre-filled syringe
9100Y Adalimumab, Injection 40 mg in 0.8 mL single use pre-filled syringe

8638P Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
9090K Etanercept, Injection 50 mg in 1 mL single use pre-filled syringe, 4
9460X Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4

3428K Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe
3429L Golimumab, Injection 50 mg in 0.5 mL single use pre-filled pen

The restriction Notes for the above bDMARD’s used in the treatment of severe rheumatoid arthritis have been amended so that both the total 6-month trial of DMARD therapy immediately prior to an initial application for bDMARD therapy; and the time-period that patients can cease therapy with a bDMARD before being required to requalify for treatment under the Initial 1 treatment restriction have a trial period or time period of 2years for consistency.

 

Alterations – Restrictions and Notes

8737W Adalimumab, Injection 40 mg in 0.8 mL single use pre-filled syringe
9099X Adalimumab, Injection 40 mg in 0.8 mL single use pre-filled syringe
3425G Certolizumab Pegol, Injection 200 mg in 1 mL single use pre-filled syringe
8637N Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
9089J Etanercept, Injection 50 mg in 1 mL single use pre-filled syringe, 4
9459W Etanercept, Injection 50 mg in 1 mL single use auto-injector, 4
3426H Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe
3427J Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe

The Restriction and Notes for the above bDMARD’s used in the treatment of severe rheumatoid arthritis have been amended to clarify: 1) the full 6-month trial of DMARD therapy immediately prior to an initial application for bDMARD therapy; and 2) the time-period that patients can cease therapy with a bDMARD before being required to requalify for treatment under the Initial 1 treatment restriction be set at 2 years for consistency.

 

5463M Docetaxel, Solution concentrate for I.V. infusion 20 mg in 1 mL
5486R Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL
8071T Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent
5464N Docetaxel, Solution concentrate for I.V. infusion 80 mg in 4 mL
5487T Docetaxel, Solution concentrate for I.V. infusion 80 mg in 8 mL
8074Y Docetaxel, Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
8967Y Docetaxel, Solution concentrate for I.V. infusion 160 mg in 16 mL

Amendment of restrictions to align PBS restriction of each brand with approved indications. There will be no change in number of patients accessing these items.

 

SECTION 100 – HIGHLY SPECIALISED DRUGS

Additions – Items

9747B Sirolimus, Tablet 0.5 mg (Rapamune®) (Public)
9748C Sirolimus, Tablet 0.5 mg (Rapamune®) (Private)

Sirolimus is currently subsidised for the prophylaxis of renal (kidney) allograft rejection.  The PBAC recommended listing (March 2011) of a new lower strength of sirolimus tablet on the PBS on a cost-minimisation basis compared with sirolimus 1 mg tablets.

 

Alterations – Additions – Restrictions and Notes

5605B Abatacept, Powder for I.V. infusion 250 mg (Orencia) (Public)
9621J Abatacept, Powder for I.V. infusion 250 mg (Orencia) (Private)

5757B Infliximab, Powder for I.V. infusion 100 mg (Remicade) (Public)
6397Q Infliximab, Powder for I.V. infusion 100 mg (Remicade) (Private)

9544H Rituximab, Solution for I.V. infusion 500 mg in 50 mL (Mabthera) (Public)
9611W Rituximab, Solution for I.V. infusion 500 mg in 50 mL (Mabthera) (Private)

9657G Tocilizumab, Concentrate for injection 80 mg in 4 mL (Actemra) (Public)
9671B Tocilizumab, Concentrate for injection 80 mg in 4 mL (Actemra) (Private)
9658H Tocilizumab, Concentrate for injection 200 mg in 10 mL (Actemra) (Public)
9672C Tocilizumab, Concentrate for injection 200 mg in 10 mL (Actemra) (Private)
9659J Tocilizumab, Concentrate for injection 400 mg in 20 mL (Actemra) (Public)
9673D Tocilizumab, Concentrate for injection 400 mg in 20 mL (Actemra) (Private)

The Restriction and Notes for the above bDMARD’s used in the treatment of severe rheumatoid arthritis have been amended to clarify 1) the full 6-month trial of DMARD therapy immediately prior to an initial application for bDMARD therapy; and 2) the time-period that patients can cease therapy with a bDMARD before being required to requalify for treatment under the Initial 1 treatment restriction be set at 2 years for consistency.