New Listings and Changes 1 March 2011

ADDITIONS

Additions - Items

5488W Bortezomib, Powder for injection 3.5 mg
5489X Bortezomib, Powder for injection 3.5 mg

Bortezomib is currently available for patients with multiple myeloma when disease progresses following treatment with certain medicines and who are not eligible for primary stem cell transplant. The PBAC (August 2010) recommended an extension to the current Authority Required listing of bortezomib for patients who have progressive disease and have previously been treated with PBS‐subsidised bortezomib. Patients must have experienced at least a partial response to the most recent course of PBS‐subsidised bortezomib therapy.

Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. These cells are part of the immune system which helps protect the body from infections and other harmful substances. In time, myeloma cells collect in the bone marrow of long bones and form tumours called a plasmacytoma. Common clinical symptoms of this disease include bone pain, anaemia, renal damage and increased susceptibility to infections.

Around 80 patients who experience further episodes of multiple myeloma and who are able to have bortezomib retreatment are expected to benefit from the extension to the listing of bortezomib.

 

5484P Amino Acid Formula with Vitamins and Minerals without Lysine and low in Tryptophan, Sachets 25 g, 30 (GA express®)

The PBAC (November 2010) recommended the listing of GA Express® on the PBS as a Restricted Benefit for the treatment of glutaric aciduria type 1 in persons aged 3 years and over.

Glutaric aciduria type 1 is a rare inborn error of amino acid metabolism caused by the deficiency of the mitochondrial enzyme glutaryl CoA dehydrogenase and characterised by the build up of glutaric acid resulting in severe progressive brain damage in infants and young children.  The estimated prevalence of the disease is 1 in every 100,000 newborns.

GA Express will provide an alternative therapy for glutaric aciduria Type 1 disease.

 

5483N Amino Acid Formula with Vitamins and Minerals without Phenylalanine, Oral gel 85 g, 30 (PKU squeezie®)

The PBAC (November 2010) recommended the listing of PKU Squeezie® on the PBS as a Restricted Benefit for phenylketonuria (PKU).

PKU is a rare inherited disorder with deficiency of the enzyme phenylalanine hydroxylase, therefore the body cannot breakdown the amino acid, phenylalanine, which is in protein.  The biochemical consequences of this deficiency are accumulation of phenylalanine and its metabolites in the blood, and a relative deficiency of tyrosine.  A high level of phenylalanine is thought to be the main cause of neurotoxicity in PKU.  Treatment involves a very low protein diet, accompanied by a phenylalanine free protein substitute.  

PKU Squeezie® would provide a ready-prepared phenylalanine-free protein substitute.

 

5482M Arginine with Carbohydrate, Sachets 4 g containing 2 g arginine, 30 (Arginine 2000 Amino Acid Supplement®)

The PBAC (November 2010) recommended the listing of the higher dose Arginine 2000 Amino Acid Supplement® on the PBS as a Restricted Benefit for urea cycle disorders.

Urea cycle disorders (UCD) can occur at any age from neonatal phase to childhood or adulthood.  A low protein diet is required in UCD to reduce the accumulation of waste nitrogen in the form of glutamine and alanine, and reduce the load on the urea cycle.  The level of protein restriction will vary depending on the clinical condition of the patient, although it is necessary to meet minimal protein requirements.

The listing of Arginine 2000 Amino Acid Supplement® provides prescribers with an alternative, higher dose form that will be more convenient for older and heavier patients. Around 20 patients are expected to benefit from the listing of this product.

 

5481L Citrulline with Carbohydrate, Sachets 4 g containing 1 g citrulline, 30 (Citrulline 1000 Amino Acid Supplement®)

The PBAC (November 2010) recommended listing Citrulline Amino Acid Supplement on the PBS as a Restricted Benefit for urea cycle disorders in order to prevent low plasma arginine or citrulline levels.

Urea cycle disorders (UCD) can occur at any age from neonatal phase to childhood or adulthood.  A low protein diet is required in UCD to reduce the accumulation of waste nitrogen in the form of glutamine and alanine, and reduce the load on the urea cycle.  The level of protein restriction will vary depending on the clinical condition of the patient, although it is necessary to meet minimal protein requirements.

In some rare urea cycle disorders such as ornithine transcarbamoylase (OTC) deficiency (OTC), carbamylphosphate synthase (CPS) deficiency and N-acetylglutamate synthase (NAGS) deficiency, citrulline supplementation may be required to meet arginine requirements.   Citrulline is rapidly converted to arginine in the body.  Citrulline amino acid supplement would provide an additional source of arginine amino acid supplementation in these various rare UCDs.

 

5470X Ondansetron, Tablet (orally disintegrating) 4 mg (Ondansetron ODT-DRLA®)
5471Y Ondansetron, Tablet (orally disintegrating) 8 mg (Ondansetron ODT-DRLA®)
5472B Ondansetron, Tablet (orally disintegrating) 4 mg (Ondansetron ODT-DRLA®)
5473C Ondansetron, Tablet (orally disintegrating) 8 mg (Ondansetron ODT-DRLA®)

The PBAC (November 2010) recommended the listing of the new dose form of ondansetron, oral dispersible tablets on the PBS under the same circumstances as the currently listed ondansetron wafers and with a note that bioequivalence has been demonstrated between the two forms of ondansetron.

Ondansetron is subsidised for the control of chemotherapy or radiotherapy induced nausea that occurs within 48hours of treatment.

 

5477G Cephazolin, Powder for injection 500 mg
5478H Cephazolin, Powder for injection 1 g
5479J Cephazolin, Powder for injection 2 g

These are new cephazolin items are specifically for the indication of cellulitis and do not include a note that allows prescribing by a nurse practitioner.

 

5485Q Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe®)
5486R Docetaxel, Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe®)
5487T Docetaxel, Solution concentrate for I.V. infusion 80 mg in 8 mL (DBL Docetaxel Concentrated Injection, Docetaxel Ebewe®)

The PBAC (November 2010) recommended the listing of docetaxel in a different volume vials 20mg in 2ml and 80mg in 8mls for intravenous infusion for the same indications as the currently PBS-listed docetaxel products on a cost-minimisation basis with the corresponding vials of docetaxel powder for I.V. infusion.

 

Alterations – Restrictions

8094B Bicalutamide, Tablet 50 mg (APO-Bicalutamide, Bicalutamide-GA, Bicalutamide Ranbaxy, Calutex, Cosamide, Cosudex)
Minor restriction wording change from “agonist” to “analogue”.

 

1256D Cephazolin, Powder for injection 500 mg (Hospira Pty Limited)
1257E Cephazolin, Powder for injection 1 g (Cefazolin Sandoz, Cephazolin Alphapharm, Hospira Pty Limited, Kefzol)
9326W Cephazolin, Powder for injection 2 g (Cefazolin Sandoz, Cephazolin Alphapharm)

The PBS restriction for cephazolin previously included infections where there is bacteriological evidence, septacaemia and cellulitis. The indication of cellulitis has been removed from these items and listed under separate items as above. The PBAC (November 2010) recommended that cephazolin for bacterial infection and septicaemia be made available for prescribing by nurse practitioners.

 

9157Y Cinacalcet, Tablet 30 mg (as hydrochloride) (Sensipar®)
9158B Cinacalcet, Tablet 60 mg (as hydrochloride) (Sensipar®)
9159C Cinacalcet, Tablet 90 mg (as hydrochloride) (Sensipar®)

Includes the addition of a Note (as follows) to allow nurse prescribing under a shared care model.
“For prescribing by nurse practitioners where care of a patient is shared between a nurse practitioner and medical practitioner in a formalized arrangement with an agreed management plan.”

 

1208N Ciprofloxacin, Tablet 250 mg (effective 20 January 2011)
1209P Ciprofloxacin, Tablet 500 mg (effective 20 January 2011)
1210Q Ciprofloxacin, Tablet 750 mg (effective 20 January 2011)

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).

 

9166K Erlotinib, Tablet 25 mg (as hydrochloride) (Tarceva®)
9167L Erlotinib, Tablet 100 mg (as hydrochloride) (Tarceva®)
9168M Erlotinib, Tablet 150 mg (as hydrochloride) (Tarceva®)

This alteration removes the grandfather clause that allowed patients who received erlotinib through the patient access program in 2008 to be eligible for PBS subsidized erlotinib. The other indications in the restriction remain unchanged.

 

1417N Flutamide, Tablet 250 mg (Eulexin®, Flutamin®)
8131Y Nilutamide, Tablet 150 mg (Anandron®)
Minor restriction wording change from “agonist” to “analogue”.

 

Alterations – Notes and restrictions

8694N Pioglitazone, Tablet 15 mg (as hydrochloride) (Actos®)
8695P Pioglitazone, Tablet 30 mg (as hydrochloride) (Actos®)
8696Q Pioglitazone, Tablet 45 mg (as hydrochloride) (Actos®)
8689H Rosiglitazone, Tablet 4 mg (as maleate) (Avandia®)
8690J Rosiglitazone, Tablet 8 mg (as maleate) (Avandia®)
9059T Rosiglitazone with Metformin, Tablet containing 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride (Avandamet®)
9060W Rosiglitazone with Metformin, Tablet containing 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride (Avandamet®)
9061X Rosiglitazone with Metformin, Tablet containing 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride (Avandamet®)
9062Y Rosiglitazone with Metformin, Tablet containing 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride (Avandamet)
9180E Sitagliptin, Tablet 25 mg (as phosphate monohydrate) (Januvia®)
9181F Sitagliptin, Tablet 50 mg (as phosphate monohydrate) (Januvia®)
9182G Sitagliptin, Tablet 100 mg (as phosphate monohydrate) (Januvia®)
9449H Sitagliptin with Metformin, Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride (Janumet®)
9450J Sitagliptin with Metformin, Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride (Janumet®)
9451K Sitagliptin with Metformin, Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride (Janumet®)
3415R Vildagliptin, Tablet 50 mg (Galvus®)

The above oral anti-diabetic drugs have notes added that outline in which circumstances they are not subsidised eg monotherapy and triple oral combinations.

9425C Adalimumab, Injection 40 mg in 0.8 mL pre‐filled syringe (Humira®)
9426D Adalimumab, Injection 40 mg in 0.8 mL pre‐filled pen (Humira®)
9427E Adalimumab, Injection 40 mg in 0.8 mL pre‐filled syringe (Humira®)
9428F Adalimumab, Injection 40 mg in 0.8 mL pre‐filled pen (Humira®)
9037P Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre‐filled syringes solvent 1 mL (Enbrel®)
9429G Etanercept, Injection set containing 4 vials powder for injection 25 mg and 4 pre‐filled syringes solvent 1 mL (Enbrel®)
9091L Etanercept, Injections 50 mg in 1 mL single use pre‐filled syringes, 4 (Enbrel®)
9431J Etanercept, Injections 50 mg in 1 mL single use pre‐filled syringes, 4 (Enbrel®)
9461Y Etanercept, Injection 50 mg in 1 mL single use auto‐injector, 4 (Enbrel®)
9462B Etanercept, Injection 50 mg in 1 mL single use auto‐injector, 4 (Enbrel®)
9304Q Ustekinumab, Injection 45 mg in 0.5 mL (Stelara®)
9305R Ustekinumab, Injection 45 mg in 0.5 mL (Stelara®)

Section 100

5758C Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Public)
9617E Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Private)

Changes to the restriction for the above bDMARD items for chronic plaque psoriasis relate to the removal of the grandfather clause.

Alteration ─ Restriction and Note

3423E Exenatide, Injection solution 5 micrograms per dose in pre‐filled pen, 60 doses (Byetta 5 microgram)
3424F Exenatide, Injection solution 10 micrograms per dose in pre‐filled pen, 60 doses (Byetta 10 microgram)

SECTION 100 – HIGHLY SPECIALISED DRUGS

Alteration – restriction

5758C Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Public)
9617E Infliximab, Powder for I.V. infusion 100 mg (Remicade®) (Private)

See above in alteration to notes and restrictions for items restricted to chronic plaque psoriasis.

 

Sources:
Recommendations from PBAC short minutes.  The drug background comes from the “Clinical place for the proposed therapy” section of the PBAC long minutes (when available).