New Listings & Changes to PBS 1 August 2009

 

ADDITIONS

Additions – Items

9453M  Arsenic trioxide, Injection concentrate 10 mg in 10 mL (Phenasen^®)

From 1 August 2009 arsenic trioxide will be listed on the PBS  for the treatment of relapsed acute promyelocytic leukaemia (APL) on the basis of high clinical need and uncertain but acceptable cost-effectiveness compared with all-trans retinoic acid (ATRA) and intensive chemotherapy.

 Acute promyelocytic leukaemia is a form of acute myeloid leukaemia (AML) and accounts for about 10% of acute AML diagnoses. The disease is usually associated with a specific chromosomal translocation between the long arms of chromosomes 15 and 17, referred to as t(15:17). The resulting fusion protein (PML-RARα) is thought to block myeloid cell differentiation and myeloid cells accumulate at the promyelocytic stage. The standard treatment of APL involves the combined use of anthracycline chemotherapy together with all-trans retinoic acid (ATRA).

The availability of arsenic will provide a PBS-subsidised treatment for patients with APL who have either failed to respond to or have relapsed following treatment with standard first-line therapy.

A public summary document is available;
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-arsenic-trioxide-march09 

 

9464D  Bimatoprost with timolol maleate, Eye drops 300 micrograms-5 mg (base) per mL (0.03%-0.5%), 3 mL (Ganfort 0.3/5)
5558M  Bimatoprost with timolol maleate, Eye drops 300 micrograms-5 mg (base) per mL (0.03%-0.5%), 3 mL (Ganfort 0.3/5) (Optometrical)

Bimatoprost with timolol maleate will be listed on the PBS for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension. It was recommended on a cost-minimisation basis compared with its constituent components, bimatoprost 0.03% and timolol maleate 0.5% eye drops given concomitantly.

This fixed combination product provides a therapeutic alternative to two mono-therapies of the respective components. Administration of a single product avoids the problem of ‘wash out’ where the first administered drug is physically ‘washed out’ of the eye by the second drug.

As bimatoprost with timolol maleate is listed on a cost minimisation basis there is no expected additional cost to the PBS.

A public summary document is available;
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-bimatoprost-march09 

 

9455P  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel)
9456Q  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Max. Rpts)
9457R  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.)
9458T  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.) (Diff. Max. Rpts)
9459W Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.)
9460X  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.) (Diff. Max. Rpts)
9461Y  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.)
9462B  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel) (Diff. Restr.) (Diff. Max. Rpts)

Etanercept 50 mg in 1 ml single use pre-filled pen (auto-injector) will be listed on the PBS for all the currently listed PBS indications, where 50 mg doses are recommended, with the same maximum quantities and repeats which are available for the other 50 mg products.

This is an alternative formulation to one already available on the PBS and is the same price.

 

9463C  Gemcitabine hydrochloride, Solution concentrate for I.V. infusion 500 mg (base) in 50 mL (Gemcitabine Ebewe)

An additional strength  of the solution concentrate for I.V infusion will be listed on the PBS in addition to the existing 200 mg in 20 mL and 1,000 mg in 100 mL volumes listed on the PBS.

 

9474P  Glucose, I.V. infusion 69.5 mmol (anhydrous) per 250 mL (5%), 250 mL (BR)
9444C  Glucose, I.V. infusion 139 mmol (anhydrous) per 500 mL (5%), 500 mL (BR, PK)
5005K  Glucose, I.V. infusion 139 mmol (anhydrous) per 500 mL (5%), 500 mL (BR, PK) (Dental)
9445D  Glucose, I.V. infusion 278 mmol (anhydrous) per 500 mL (10%), 500 mL (PK)

The PBAC (March 2009) recommended the listing of two new pack sizes of glucose 5% intravenous infusion on the PBS and the addition of 10%, 500ml.

 

9471L  Glucose indicator—blood, Electrode strips, 50 (MyGlucoHealth)
9472M  Glucose indicator—blood, Electrode strips, 50 (MyGlucoHealth) (Diff. Max. Rpts)

The PBAC (July 2009) recommended out of session the listing of an additional brand of test strips.

 

9446E  High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, Powder 300 g (KetoCal)

On the advice of the Nutritional Products Working Party (NPWP) this formula will be listed on the PBS as a Restricted Benefit for patients with intractable seizures requiring treatment with a ketogenic diet, glucose transport protein defects and pyruvate dehydrogenase deficiency on the basis of acceptable cost-effectiveness.  The PBAC noted the advice of the NPWP that the ketogenic diet was complex and has a number of safety concerns and for these reasons, Ketocal should only be used under the strict supervision of an expert medical team including a dietician, metabolic physician and/or neurologist.

 

5421H  Hypromellose, Oral gel 20 mg per g, 100 g (Aquae Gel) (Palliative Care)
5422J  Hypromellose, Oral gel 20 mg per g, 100 g (Aquae Gel) (Palliative Care) (Diff. Max. Rpts)

Hypromellose oral gel will be added to the Palliative Care section for palliative care patients where dry mouth is a symptom.

The listing is intended to provide a more viscous version of currently listed Aquae^® (carmellose sodium) mouth spray and so provide a longer duration of relief.

This medication will substitute for other PBS listed medications.

 

9454N  Oxybutynin, Transdermal patches 36 mg (releasing approximately 3.9 mg per 24 hours), 8 (Oxytrol)

Oxybutynin transdermal patches will be listed on the PBS for treatment of urge urinary incontinence or urgency due to detrusor instability in a patient who cannot tolerate or swallow oral oxybutynin, on the basis of acceptable cost effectiveness over placebo.

Transdermal oxybutynin represents a treatment option for patients with urge urinary incontinence or urgency, in patients who are unable to tolerate the oral dose form.

A public summary document is available;
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-oxybutynin-march09

 

9447F  Praziquantel, Tablet 600 mg (Biltricide)

Praziquantel tablets will be listed on the PBS for the treatment of schistosoma infections due to various types of blood fluke as a streamlined authority on the basis of acceptable cost-effectiveness. The PBAC noted that the submission was in response to a Government initiative to address the health care needs of refugee and humanitarian entrants to Australia.

Schistosomes (also known as Blood fluke) are one of the major human helminth parasites endemic in 74 developing countries, threatening 650 million people and causing severe morbidity especially in children under the age of 14 (WHO, 2008). It is due to a trematode of the genus Schistosoma, of which 5 species are the principal causes of the human disease, i.e S. mansoni, S. haematobium, S. japonicum, S. mekongi and S. intercalatum.

Life cycle:

 

9465E  Rivaroxaban, Tablet 10 mg (Xarelto)
9468H  Rivaroxaban, Tablet 10 mg (Xarelto) (Diff. Max. Rpts)
9466F  Rivaroxaban, Tablet 10 mg, 15 (Xarelto)
9469J  Rivaroxaban, Tablet 10 mg, 15 (Xarelto) (Diff. Max. Rpts)
9467G  Rivaroxaban, Tablet 10 mg, 30 (Xarelto)

Rivaroxaban tablet 10 mg for the prevention of venous thromboembolism in patients undergoing total replacement of the hip or knee will be listed on the PBS, on the basis of uncertain but overall acceptable cost-effectiveness compared with enoxaparin. 

Rivaroxaban will provide an oral alternative to the currently available injectable anti-thrombotic drugs used to prevent venous thromboembolism (VTE) in patients who have undergone major orthopaedic surgery of the lower limb (total hip or knee replacement).

A public summary document is available;
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-rivaroxaban-march09

 

9449H  Sitagliptin with metformin hydrochloride, Tablet 50 mg (as phosphate monohydrate)-500 mg (Janumet)
9450J  Sitagliptin with metformin hydrochloride, Tablet 50 mg (as phosphate monohydrate)-850 mg (Janumet)
9451K  Sitagliptin with metformin hydrochloride, Tablet 50 mg (as phosphate monohydrate)-1000 mg (Janumet)

Sitagliptin with metformin will be listed on the PBS for the treatment of in type 2 diabetes mellitus, on a cost-minimisation basis compared with the individual components, sitagliptin and metformin.

This medication will substitute for other PBS listed medications.

 

9473N  Sodium chloride, I.V. infusion 38.5 mmol per 250 mL (0.9%), 250 mL (BR)
9392H  Sodium chloride, I.V. infusion 77 mmol per 500 mL (0.9%), 500 mL (BR, PK)
5021G  Sodium chloride, I.V. infusion 77 mmol per 500 mL (0.9%), 500 mL (BR, PK) (Dental)

Two pack new sizes of sodium chloride 0.9% intravenous infusion will be listed on the PBS.

Sodium chloride 0.9% intravenous infusion is indicated for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. It may also be used as a solvent for intravenously administered drugs where compatibility has been established.

This medication will substitute for other PBS listed medications.

 

9448G  Soy lecithin, Eye spray 10 mg per mL (1%), 10 mL (tearsagain)
5545W  Soy lecithin, Eye spray 10 mg per mL (1%), 10 mL (tearsagain) (Diff. Restriction)

Soy lecithin liposomal eye spray will be listed on the PBS for the treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.  It was recommended on a cost-minimisation basis compared to single dose unit lubricant eye drops.

Soy lecithin eye spray will replace currently listed products.

 

9452L  Voriconazole, Powder for oral suspension 40 mg per mL, 70 mL (Vfend)

Voriconazole suspension will be listed on the PBS for the treatment of invasive aspergillosis in immunocompromised patients, serious fungal infections caused by Scedosporium species or Fusarium species, serious Candida infections and other serious invasive mycosis.

This is an additional formulation which can be used by children and people having difficulty swallowing.

 

ALTERATIONS

Alterations — Restrictions

8358X  Clopidogrel hydrogen sulfate, Tablet 75 mg (base) (Iscover, Plavix)

There will be an extension to the listing of clopidogrel on the PBS to include use following cardiac stent insertion in combination with aspirin.  The PBAC considered that there is evidence that this is best clinical practice and noted that any increase in use is likely to be minimal following this listing.

A public summary document is available;
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-clopidogrel-march09 

 

8456C  Quetiapine fumarate, Tablet 25 mg (base) (Seroquel)
8457D  Quetiapine fumarate, Tablet 100 mg (base) (Seroquel)
8458E  Quetiapine fumarate, Tablet 200 mg (base) (Seroquel)
8580N  Quetiapine fumarate, Tablet 300 mg (base) (Seroquel)

There will be an extension to the listing of quetiapine fumarate to include the maintenance treatment of bipolar I disorder, in combination with lithium or sodium valproate on the basis of cost-minimisation with olanzapine.

This medication will substitute for other PBS listed medications.

 

SECTION 100 - HIGHLY SPECIALISED DRUGS PROGRAM

ADDITIONS

Additions — Items

9640J  Apomorphine hydrochloride, Injection 50 mg in 5 mL (APO-go)

A new strength of apomorphine injection 50 mg in 5 ml will be listed on the PBS.  There will be no cost implications for the PBS.

 

9641K  Etanercept, Injection 50 mg in 1 mL single use injection pen, 4 (Enbrel)
Refer to above s85 listing. Etanercept is listed on s100 for juvenile chronic arthritis.

Etanercept 50 mg in 1 ml single use pre-filled pen (auto-injector) will be listed on the PBS for all the currently listed PBS indications, where 50 mg doses are recommended, with the same maximum quantities and repeats which are available for the other 50 mg products.

This product will substitute for other 50mg products.

 

ALTERATIONS

Alterations — Restrictions and Notes

The following changes to bosentan epoprostenol and iloprost arise from the need for consistency across the restriction wording and will not impact cost to the PBS.

6477X  Epoprostenol sodium, Powder for I.V. infusion 500 micrograms (base) with diluent (Flolan)
6478Y  Epoprostenol sodium, Powder for I.V. infusion 1.5 mg (base) with diluent (Flolan)

The PBS restriction will be amended for epoprostenol in primary pulmonary hypertension (PPH) for WHO Class III patients be amended to limit availability to PPH WHO Class III patients who have failed to respond to a prior PBS-subsidised therapy.

The first-line listing for patients with PPH Class IV remains.

 

6456T  Iloprost trometamol, Solution for inhalation 20 micrograms (base) in 2 mL (Ventavis)

The PBS restriction for iloprost will be amended to limit availability to second-line use following oral therapy in patients with PPH WHO Class III or PAH Class III secondary to connective tissue disease.

 

6429J  Bosentan monohydrate, Tablet 62.5 mg (base) (Tracleer)
6430K  Bosentan monohydrate, Tablet 125 mg (base) (Tracleer)
9605M  Sildenafil citrate, Tablet 20 mg (base) (Revatio)
9622K  Sitaxentan sodium, Tablet 100 mg (Thelin)

The note at the beginning of each item has been amended for consistency across the group of drugs for pulmonary hypertension.  This note details the drug specific indications and  interchangeability rules.  This is a flow-on effect of the changes to the listings for epoprostenol and iloprost. Grandfather clauses have been removed for bosentan and sitaxentan.