ADDITIONS

Additions - Items

3408J Adrenaline, I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior)
3409K Adrenaline, I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)

Adrenaline intramuscular (I.M.) injection single dose syringe auto-injector (Anapen) listed as an authority required listing for anticipated emergency treatment of acute allergic reactions with anaphylaxis in patients who meet certain criteria on a cost minimisation basis with adrenaline I.M. injection single dose syringe auto-injector (EpiPen).  Anapen has a different mode of operation to EpiPen and therefore should not be prescribed to the same patient without training in their use. The PBS has listed both brands separately to ensure patients receive only one PBS subsidised product at any one time to avoid any potential confusion.

 

3401B Esomeprazole magnesium trihydrate, Tablet (enteric coated), equivalent to 40 mg esomeprazole (Nexium)

A new Authority Required restriction for esomeprazole 40mg, extends the PBS availability of esomeprazole 40 mg tablets to include treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, with a maximum quantity of 30 tablets and 5 repeats. These rare disorders cause excessive secretion of gastric (stomach) acid. They are difficult to cure but can be managed with medicines such as proton pump inhibitors (PPI) that reduce acid production in the stomach, and promote healing of ulcers in the stomach and small bowel.  The 20mg esomeprazole restricted benefit listing has also been altered to include this indication (see under alterations below).


3406G Glucose indicator—blood, Test strips, 50 (CareSens N)
3407H Glucose indicator—blood, Test strips, 50 (CareSens N) (Diff. Max. Rpts)

This is effectively the listing of a new brand where new item codes were required.

 

3402C Rosuvastatin, Tablet 5 mg (as calcium) (Crestor)
3403D Rosuvastatin, Tablet 10 mg (as calcium) (Crestor)
3404E Rosuvastatin, Tablet 20 mg (as calcium) (Crestor)
3405F Rosuvastatin, Tablet 40 mg (as calcium) (Crestor)

Rosuvastatin is included in the 12 month repeat prescription for chronic disease measure as a restricted benefit listing for use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements.

 

5260W Roxithromycin, Tablet 150 mg (APO-Roxithromycin, Biaxsig, Chem mart Roxithromycin, Roxar 150, Roxide, Roximycin, Roxithromycin-GA, Terry White Chemists Roxithromycin, Rulide) (Dental)
5261X Roxithromycin, Tablet 300 mg (APO-Roxithromycin, Biaxsig, Chem mart Roxithromycin, Roxar 300, Roxide, Roximycin, Roxithromycin-GA, Terry White Chemists Roxithromycin, Rulide) (Dental)
5259T Roxithromycin, Tablet for oral suspension 50 mg (Rulide D) (Dental)

Australian Dental Association has advised that there is a clinical need for roxithromycin tablets in the Dental Schedule.  Roxithromycin is listed as an unrestricted benefit in the Dental Schedule under the same conditions as the listing of roxithromycin in the General Schedule. Roxithromycin is an antibiotic used to treat upper respiratory tract and oral infections.

 

ALTERATIONS

Alterations — Restrictions

8697R Adrenaline, I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen Jr.)
8698T Adrenaline, I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen)

The Australasian Society of Clinical Immunology and Allergy (ASCIA) requested an amendment to the existing NOTE that would allow an increase in the maximum quantity (up to 2) of adrenaline auto-injector pens for patients aged 17 years and older in various circumstances. The NOTE has been changed to allow an increased maximum quantity of two pens to be prescribed for any patient at any one time so as to encompass all the groups considered by ASCIA to be at a high risk of anaphylaxis. 

 

9442Y Bevacizumab, Solution for I.V. infusion 100 mg in 4 mL (Avastin)
9443B Bevacizumab, Solution for I.V. infusion 400 mg in 16 mL (Avastin)

The restriction for bevacizumab has been modified by adding the statement “The maximum dose that will be approved is 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks”, noting that the sponsor has agreed to this change.  This change aligns the restriction with the current TGA approved Product Information dose recommendations for bevacizumab in combination with first-line chemotherapy, in patients with previously untreated metastatic colorectal cancer.  It also aligns the restriction with the economic data presented at the time PBAC recommended listing for this indication which assumed that patients would be treated with 5 mg per kg every two weeks (which is equivalent to 7.5 mg per kg every 3 weeks).  

 

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)
8826M Brimonidine tartrate with timolol maleate, Eye drops 2 mg-5 mg (base) per mL (0.2%-0.5%), 5 mL (Combigan)
5535H Brimonidine tartrate with timolol maleate, Eye drops 2 mg-5 mg (base) per mL (0.2%-0.5%), 5 mL (Combigan) (Optometrical)
8567X Dorzolamide hydrochloride with timolol maleate, Eye drops 20 mg (base)-5 mg (base) per mL (2%-0.5%), 5 mL (Cosopt)
5542Q Dorzolamide hydrochloride with timolol maleate, Eye drops 20 mg (base)-5 mg (base) per mL (2%-0.5%), 5 mL (Cosopt) (Optometrical)
9057Q Travoprost with timolol maleate, Eye drops 40 micrograms-5 mg (base) per mL (0.004%-0.5%), 2.5 mL (Duotrav)
5555J Travoprost with timolol maleate, Eye drops 40 micrograms-5 mg (base) per mL (0.004%-0.5%), 2.5 mL (Duotrav) (Optometrical)
8895E Latanoprost with timolol maleate, Eye drops 50 micrograms-5 mg (base) per mL (0.005%-0.5%), 2.5 mL (Xalacom)
5553G Latanoprost with timolol maleate, Eye drops 50 micrograms-5 mg (base) per mL (0.005%-0.5%), 2.5 mL (Xalacom) (Optometrical)

A change has been made to the restriction wording of “elevated intra-ocular pressure in a patient with open angle glaucoma/ocular hypertension not adequately controlled with monotherapy” to be applied to all restricted benefit listings of the currently subsidised combination eye drops containing an alpha-agonist (brimonidine) with timolol, a carbonic anhydrase inhibitor (dorzolamide) with timolol or a prostaglandin/prostamide analogue (bimatoprost, latanoprost, travoprost) with timolol.  The PBAC considered that the use of a combination product in a patient whose elevated intraocular pressure due to open angle glaucoma or ocular hypertension is not adequately controlled on monotherapy is consistent with current guidelines which no longer recommend timolol as the first-line therapy for all patients.

 

8606Y Bisoprolol fumarate, Tablet 10 mg (Bicor, Bisoprolol Sandoz, Bispro 10)
8604W Bisoprolol fumarate, Tablet 2.5 mg (Bicor, Bisoprolol Sandoz, Bispro 2.5)
8605X Bisoprolol fumarate, Tablet 5 mg (Bicor, Bisoprolol Sandoz, Bispro 5)
8255L Carvedilol, Tablet 3.125 mg (Chem mart Carvedilol 3.125 mg, Dilasig 3.125, Dilatrend 3.125, GenRx Carvedilol, GN-Carvedilol, Kredex, Terry White Chemists Carvedilol 3.125 mg, Vedilol 3.125)
8256M Carvedilol, Tablet 6.25 mg (Carvedilol generichealth, Carvedilol Sandoz, Chem mart Carvedilol 6.25 mg, Dicarz, Dilasig 6.25, Dilatrend 6.25, GenRx Carvedilol, GN-Carvedilol, Kredex, Terry White Chemists Carvedilol 6.25 mg, Vedilol 6.25)
8257N Carvedilol, Tablet 12.5 mg (Carvedilol generichealth, Carvedilol Sandoz, Chem mart Carvedilol 12.5 mg, Dicarz, Dilasig 12.5, Dilatrend 12.5, GenRx Carvedilol, GN-Carvedilol, Kredex, Terry White Chemists Carvedilol 12.5 mg, Vedilol 12.5)
8258P Carvedilol, Tablet 25 mg (Carvedilol generichealth, Carvedilol Sandoz, Chem mart Carvedilol 25 mg, Dicarz, Dilasig 25, Dilatrend 25, GenRx Carvedilol, GN-Carvedilol, Kredex, Terry White Chemists Carvedilol 25 mg, Vedilol 25)
8732N Metoprolol succinate, Tablet 23.75 mg (controlled release) (Toprol-XL 23.75)
8733P Metoprolol succinate, Tablet 47.5 mg (controlled release) (Toprol-XL 47.5)
8734Q Metoprolol succinate, Tablet 95 mg (controlled release) (Toprol-XL 95)
8735R Metoprolol succinate, Tablet 190 mg (controlled release) (Toprol-XL 190)

 

The current restriction has been amended to read as follows:

Authority required (STREAMLINED)

Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an ACE-inhibitor or angiotensin II antagonist, if tolerated.

The PBAC reaffirmed its November 2009 recommendation to amend the restrictions for all beta-blockers which are PBS listed for heart failure to include the use of angiotensin II antagonists (as well as ACE-inhibitors) in the restriction for consistency with the recommendation for nebivolol at the November 2009 meeting.  The PBAC considered that current evidence supported the use of angiotensin II antagonists in heart failure and that in clinical practice ACE-inhibitors and angiotensin II antagonists are used interchangeably.

 

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)
9415M Nab paclitaxel, Powder for I.V. injection 100 mg (base) (Abraxane)
3026G Paclitaxel, Solution concentrate for I.V. infusion 30 mg in 5 mL (Anzatax, Paclitaxel Actavis, Plaxel, Taxol, Paclitaxel Ebewe)
8018B Paclitaxel, Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Anzatax, Paclitaxel Actavis, Paclitaxel Ebewe, Plaxel, Taxol)
3017T Paclitaxel, Solution concentrate for I.V. infusion 150 mg in 25 mL (Anzatax, Paclitaxel Actavis, Paclitaxel Ebewe, Plaxel)
8360B Paclitaxel, Solution concentrate for I.V. infusion 300 mg in 50 mL (Anzatax, Paclitaxel Actavis, Paclitaxel Ebewe, Plaxel, Taxol)

The current restrictions for the use of taxanes (docetaxel, nab paclitaxel and paclitaxel) for use in advanced breast cancer have been changed by removing the requirement to have had prior therapy that includes an anthracycline. The adjuvant treatment setting for breast cancer is changing and that it is now possible to receive adjuvant chemotherapy without an anthracycline, for example, docetaxel and cyclophosphamide combination (TC).  
The outcome of prior anthracycline versus no prior anthracycline was unlikely to be different and that is was unlikely that this would lead to an increase use of taxanes on the PBS.

 

8600P Esomeprazole magnesium trihydrate, Tablet (enteric coated), equivalent to 20 mg esomeprazole (Nexium)

The current listing for esomeprazole 20mg tablets has been amended for “maintenance of healed gastro-oesophageal reflux disease” to include scleroderma of the oesophagus and pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. This is consistent with other PPI restrictions currently listed on the PBS.

 

9148L Lapatinib, Tablet 250 mg (as ditosylate monohydrate) (Tykerb)

 

The current requirement of prior treatment with an anthracycline in order to receive PBS subsidised lapatinib, for patients with HER2 positive breast cancer who have not received an anthracycline in the adjuvant or metastatic setting and which is not due to intolerance has been reviewed removing of the requirement for 3 cycles of an anthracycline which was in line with the changing treatment protocols for breast cancer.

 

8694N Pioglitazone hydrochloride, Tablet 15 mg (base) (Actos)
8695P Pioglitazone hydrochloride, Tablet 30 mg (base) (Actos)
8696Q Pioglitazone hydrochloride, Tablet 45 mg (base) (Actos)
8689H Rosiglitazone maleate, Tablet 4 mg (base) (Avandia)
8690J Rosiglitazone maleate, Tablet 8 mg (base) (Avandia)
9059T Rosiglitazone maleate with metformin hydrochloride, Tablet 2 mg (base)-500 mg (Avandamet)
9060W Rosiglitazone maleate with metformin hydrochloride, Tablet 2 mg (base)-1 g (Avandamet)
9061X Rosiglitazone maleate with metformin hydrochloride, Tablet 4 mg (base)-500 mg (Avandamet)
9062Y Rosiglitazone maleate with metformin hydrochloride, Tablet 4 mg (base)-1 g (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 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)

The restriction wording for all currently PBS subsidised dipeptidyl peptidase 4 inhibitors (gliptins) and thiazolidinediones (glitazones) has been modified to allow patients to switch between agents in these two classes without having to requalify with respect to glycosylated haemoglobin levels (HbA1c).  Although the evidence to support switches from a gliptin to a glitazone, and vice versa, is limited, it is considered unreasonable to require a loss of diabetic control prior to switching.

Section 100

Alteration – restriction and note

9624M Natalizumab, Solution concentrate for I.V. infusion 300 mg in 15 mL (Tysabri)

The PBAC (August 2009) recommended amending the listing for natalizumab when the new payment arrangements for the S100 Highly Specialised Drugs Program in public hospitals are effective to allow for an Authority Required (Streamlined) listing of natalizumab in public hospitals. The PBAC recommended in August 2009 a maximum quantity of one and 11 repeats for consistency with the provision for one year’s supply currently permitted for HSD items.  At the November 2009 meeting, PBAC recommended that the number of repeats be changed (reduced) to five, noting that natalizumab may cause serious adverse effects and patients should be reviewed regularly as to whether natalizumab remains efficacious in preventing continuing progression of disability.