PBAC Meeting Agenda
Agenda for the November 2013 PBAC Meeting
PDF Printable version of Meeting Agenda - November 2013 PBAC Meeting (PDF 56 KB)
The PBAC agenda primarily consists of applications relating to the new listing of a drug or vaccine on the PBS or the National Immunisation Program.
The PBAC agenda consists of the following:
1 Minutes of Previous Meeting
2 Chairman’s report (verbal)
3 Matters arising from the minutes
4 Matters arising/outstanding
5 New drug applications
6 Requests for changes to listings
7 Resubmissions
8 Pricing Matters
9 Matters relating to PBS review
10 Subcommittee and Working Party reports
11 Other business
12 Correspondence
13 Further information
14 Late papers
15 Tabled papers
Consumers will have the opportunity to provide comments on new drug submissions (item 5), changes to listings (item 6) and re-submissions (item 7). In many circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters.
- Closing date for consumer comments was 9 October 2013
Pharmaceutical benefits listed in the Schedule fall into three broad categories:
Unrestricted benefits – have no restrictions on their therapeutic uses;
Restricted benefits – can only be prescribed for specific therapeutic uses (noted as Restricted benefit);
and
Authority required benefits – Authority required benefits fall into two categories:
- Authority required benefits require prior approval from Medicare Australia or the DVA (noted as Authority required)
- Authority required (STREAMLINED) benefits do not require prior approval from Medicare Australia or the DVA but require the recording of a streamlined authority code (noted as Authority required (STREAMLINED)).
Submissions are categorised broadly as major or minor:
- Major: Submissions to list new medicines on the Schedule of Pharmaceutical Benefits or to make substantial changes to current listings are generally classified as major submissions. Major submissions require presentation of an economic evaluation.
- Minor: Submissions that relate to new forms of previously listed products and changes to the conditions of use e.g. change in maximum quantity/repeats or clarifying the wording of a restriction (while not altering the intended use) are considered to be minor submissions. Minor submissions do not usually require the presentation of an economic evaluation.
|
Submission type (new drug application, changes to listings, resubmissions) |
Drug Name, form(s), strength(s) and Sponsor (Drug name, form, strength, Trade name®, Sponsor)
|
Drug Type and Use (What is the drug used to treat?) |
Listing requested by Sponsor / Purpose of Submission (Includes type of listing requested (unrestricted, restricted benefit, authority required) and restriction wording. If restriction is lengthy it may be paraphrased |
|---|---|---|---|
|
Change to Listing (Major submission) |
ADALIMUMAB, 40 microgram/0.8 mL injection, 2 x 0.8 mL cartridges and 6 x 0.8 mL cartridges; 40 mg/0.8 mL injection, 2 x 0.8 mL syringes and 6 x 0.8 mL syringes Humira® AbbVie Pty Ltd |
Ulcerative colitis |
To request Authority Required listing for the treatment of adult patients with moderately to severely active ulcerative colitis. |
|
New Listing (Major submission) |
ALOGLIPTIN WITH METFORMIN, alogliptin 12.5mg + metformin 500mg, alogliptin 12.5mg + metformin 850mg, alogliptin 12.5mg + metformin 1000mg, tablet
Nesina Met®
Takeda Pharmaceuticals Australia Pty Ltd |
Type 2 Diabetes |
To request an Authority Required (STREAMLINED) listing for the treatment of type 2 diabetes in a patient whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, a thiazolidinedione or a glucagon-like peptide-1, despite treatment with metformin and where a combination of metformin and sulfonylurea is contraindicated or not tolerated. |
|
Change to Listing (Minor submission) |
AMINO ACID FORMULA WITHOUT PHENYLALANINE, 1 g tablet, 75
Phlexy-10®
Nutricia Australia Pty Ltd |
Medicinal food |
To advise the PBAC and Nutritional Products Working Party of a minor change to the nutritional information of Phlexy-10 tablets. |
|
Change to Listing (Major submission) |
ANTIRETROVIRAL THERAPY
Australasian Society for HIV Medicine (ASHM), National Association of People with HIV Australia (NAPWHA), Australian Federation of AIDS Organisations (AFAO) |
Human immunodeficiency virus (HIV) infection |
To request the removal of the CD4+ cell count restriction for initiation of first line anti-retroviral therapy (ART) in asymptomatic, ART naïve HIV positive patients. |
|
New Listing (Minor submission) |
ARGININE WITH CARBOHYDRATE, containing 5000 mg arginine oral liquid: powder for, 30 x 7.6 g sachets Arginine 5000® Vitaflo Australia Pty Ltd |
Medicinal food |
To request a Restricted benefit listing for urea cycle disorders for an additional strength of arginine with carbohydrate. |
|
New Listing (Major submission) |
AXITINIB, 1 mg and 5 mg, tablet Inlyta®
Pfizer Australia Pty Ltd |
Renal Cell Carcinoma (RCC) |
To request Authority Required listing for the treatment of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets certain criteria. |
|
Re-submission (Minor submission) |
BETAMETHASONE DIPROPIONATE + CALCIPOTRIOL, betamethasone (as dipropionate) 0.05% + calcipotriol 0.005% gel, 60 g
Daivobet®
Leo Pharma Pty Ltd |
Psoriasis of the scalp |
To request a Restricted benefit listing for a larger size (60g) for treatment of chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy. |
|
Change to Listing (Major submission) |
BEVACIZUMAB, 100 mg/4 mL and 400 mg/16 mL, injection, vial
Avastin®
Roche Products Pty Limited
|
Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer |
To request Section 100 (Efficient Funding of Chemotherapy) Authority Required (+/-STREAMLINED) listings for the treatment, in combination with paclitaxel and carboplatin, of a patient with previously untreated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who is at high risk of disease recurrence. |
|
New Listing (Minor submission) |
BIMATOPROST, 0.03% eye drops, preservative free, 30 x 0.4 mL unit doses
Lumigan® PF
Allergan Pty Ltd |
Glaucoma |
To request an Unrestricted benefit listing within the General Schedule and Optometrist Schedule of a preservative free, unit dose presentation of bimatoprost eye drops. |
|
Change to Listing (Major submission) |
BOTULINUM TOXIN TYPE A, 100 units, injection, 1 x 100 units vial
Botox®
Allergan Australia Pty Ltd |
Urinary Incontinence |
To request a Section 100 (Botulinum Toxin Program) Authority Required listing for the treatment of urinary incontinence due to idiopathic overactive bladder, in a patient who meets certain criteria. |
|
New Listing (Minor submission) |
CARBOHYDRATE, FAT, VITAMINS, MINERALS, TRACE ELEMENTS, LONG CHAIN POLYUNSATURATES (LCPs) ARACHIDONIC ACID (AA) AND DOCOSAHEXANOIC ACID (DHA), PROTEIN FREE FORMULA, oral liquid: powder for 21.5 g x 30 sachets, BaseCal 100® oral liquid: powder for 43 g x 30 sachets, BaseCal 200® Vitaflo Australia Pty Ltd |
Medicinal food |
To request a Restricted benefit listing for patients with proven inborn errors of protein metabolism who are unable to meet their requirements with permitted food and formulae. |
|
Re-submission (Minor submission) |
CARBOHYDRATE WITH DOCOSAHEXANOIC ACID, 200 mg, oral liquid: powder for, 4 g x 30 sachets DocOmega® Vitaflo Australia Pty Ltd |
Medicinal food |
To request a Restricted benefit listing for patients with peroxismal biogenesis disorders. |
|
Re-submission (Minor submission) |
CARBOHYDRATE WITH DOCOSAHEXANOIC ACID AND ARACHIDONIC ACID, carbohydrate with docosahexanoic acid 100 mg and arachidonic acid 200 mg, oral liquid: powder for, 4 g x 30 sachets KeyOmega® Vitaflo Australia Pty Ltd |
Medicinal food |
To request a Restricted benefit listing for patients with peroxisomal biogenesis disorders. |
|
Re-submission (Major submission) |
CETUXIMAB, 100 mg/20 mL and 500 mg/100 mL, injection, vial
Erbitux®
Merck Serono Australia Pty Ltd |
Metastatic colorectal cancer. |
Resubmission to request a Section 100 (Efficient Funding of Chemotherapy) listing for the treatment, in combination with 1st line chemotherapy, of a patient with previously untreated KRAS wild-type metastatic colorectal cancer. |
|
Review (Major submission) |
CINACALCET, 30mg, 60mg and 90mg, tablet
Senisipar®
Amgen Australia Pty Ltd
|
Secondary hyperparathyroidism in patients with end stage renal disease |
To provide the results of the EVOLVE trial and consider the impact of the results on the cost-effectiveness of cinacalcet in the treatment of secondary hyperparathyroidism in patients with end stage renal disease on dialysis and to update the clinical management algorithm based on Australian clinical practice. |
|
New Listing (Major submission) |
CLOBETASOL PROPIONATE, 500 microgram per mL shampoo for topical application, 125 mL
Clobex®
Galderma Australia Pty Ltd |
Moderate to severe scalp psoriasis |
To request a Restricted benefit listing for the treatment of adults with moderate to severe scalp psoriasis who are not adequately controlled with either a vitamin D analogue or potent corticosteroid mono-therapy. |
|
New Listing (Major submission) |
CRIZOTINIB, 200 mg and 250 mg, capsule
Xalkori®
Pfizer Australia Pty Ltd
|
Non-small cell lung cancer (NSCLC) |
To request Authority Required listing for treatment of a patient with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC) who has disease progression following at least one platinum-based chemotherapy. |
|
Change to Listing (Major submission) |
DENOSUMAB, 120 mg/1.7 mL, injection, vial
Xgeva®
Amgen Australia Pty Ltd |
Giant cell tumour of bone |
To request an Authority Required (STREAMLINED) listing for the treatment of giant cell tumour of bone in adult and skeletally mature adolescent patients. |
|
New Listing (Major submission) |
DOLUTEGRAVIR, 50 mg, tablet
Tivicay®
ViiV Healthcare Pty Ltd |
Human immunodeficiency virus (HIV) infection |
To request Section 100 (Highly Specialised Drugs Program) Authority Required (+/-STREAMLINED) listing for the treatment of HIV infection in combination with other anti-retrovirals, in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease. |
|
Change to Listing (Minor submission) |
DOXYCYCLINE,
doxycycline 100 mg capsule, modified release, 7 capsules
doxycycline 100 mg capsule, modified release, 21 capsules doxycycline 50 mg capsule, modified release, 25 capsules Mayne Pharma Doxycycline® / Doryx® Mayne Pharma International Pty Ltd |
Bacterial infection |
To request the inclusion of a ‘Note’ on the PBS listings for doxycycline tablets and capsules stating that doxycycline tablet and capsule forms are equivalent for the purposes of substitution. |
|
Re-submission (Major submission) |
ERIBULIN MESILATE, 1 mg/2 mL, injection, vial
Halaven®
Eisai Australia Pty Ltd |
Breast cancer |
Resubmission to request Section 100 (Efficient Funding of Chemotherapy) Authority Required (+/-STREAMLINED) listings for the treatment of a patient with locally advanced or metastatic breast cancer who has progressed after a least two chemotherapeutic regimens for advanced disease. |
|
New Listing (Minor submission) |
ESOMEPRAZOLE MAGNESIUM, 20mg and 40mg modified release capsules
Noxicid®
Alphapharm Pty Limited |
Acid related disorders
|
To request listing of a new salt and form of esomeprazole (esomeprazole magnesium capsules) under the same conditions as the currently listed esomeprazole magnesium trihydrate tablets (Nexium®) with inclusion of a brand equivalence indicator between the two forms. |
|
Re-submission (Major submission) |
EXENATIDE, 2 mg, power for injection, vial
Bydureon®
Bristol-Myers Squibb Australia Pty Ltd |
Type 2 diabetes
|
Resubmission to request an Authority Required (STREAMLINED) listing for the treatment of Type 2 diabetes as: 1) Dual combination therapy with metformin or a sulfonylurea; and 2) Triple combination therapy with metformin and a sulfonylurea; in a patient who meets certain criteria. |
|
New Listing (Major submission) |
EZETIMIBE AND ROSUVASTATIN, ezetimibe 10 mg + rosuvastatin 5 mg; ezetimibe 10 mg + rosuvastatin 10 mg; ezetimibe 10 mg + rosuvastatin 20 mg; ezetimibe 10 mg + rosuvastatin 40 mg, tablet Rosuzet® Composite Pack Merck Sharp and Dohme Australia Pty Ltd |
High cholesterol |
To request an Authority Required (STREAMLINED) listing for the treatment of hypercholesterolemia, in a patient who meets certain criteria. |
|
Re-submission (Major submission) |
FERRIC CARBOXYMALTOSE, 500 mg/10 mL, injection, vial
Ferinject® Vifor Pharma Pty Ltd |
Iron deficiency anaemia |
Resubmission to request PBS listing as an unrestricted benefit for the treatment of iron deficiency anaemia. |
|
New Listing (Minor submission) |
GLUCOSE INDICATOR BLOOD Glucose indicator blood strip: diagnostic, 100 diagnostic strips, (with 100 lancets per pack) GoodLife Blood Glucose Test Strip® JNS Biomedical Pty Ltd |
Diabetes |
Request to list a new form of blood glucose test strips. |
|
New Listing (Major submission) |
GLYCOPYRRONIUM BROMIDE, 50 microgram, powder for inhalation
Seebri® Breezhaler® Novartis Pharmaceuticals Australia Pty Ltd |
Chronic Obstructive Pulmonary Disease (COPD). |
To request a Restricted benefit listing for the maintenance treatment of chronic obstructive pulmonary disease (COPD). |
|
Change to listing (Minor submission) |
HOMATROPINE HYDROBROMIDE, 2% eye drops, 15 mL
Isopto Homatropine®
Optometrists Association Australia |
Anterior uveitis |
Request for homatropine to be included on the optometric section of the PBS under the same conditions that it is currently listed for prescribing by medical practitioners and nurse practitioners. |
|
Re-submission (Major submission) |
INFLIXIMAB, 100 mg, injection, vial
Remicade®
Janssen-Cilag Pty Ltd |
Ulcerative Colitis |
Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required listing for the treatment of acute, severe ulcerative colitis, not responding to IV corticosteroids, in a patient aged 6 years or older who meets certain criteria. |
|
Re-submission (Major submission) |
INGENOL MEBUTATE, Gel, 0.15mg per g (0.015%), 3 x0.47g
Picato®
LEO Pharma Pty Ltd |
Skin cancer |
Resubmission to request listing as Restricted benefit for field therapy for the treatment of solar keratoses of the face and scalp in patients who have previously diagnosed squamous cell carcinoma. |
|
New listing (Minor submission) |
METFORMIN HYDROCHLORIDE, 750 mg tablet, modified release, 60 tablets
Diabex XR®
Alphapharm Pty Ltd |
Diabetes |
Requests to list an additional strength of metformin modified release tablet as an Unrestricted benefit. |
|
New Listing (Major submission) |
METFORMIN XR AND SAXAGLIPTIN, metformin XR 500 mg + saxagliptin 5 mg; metformin XR 1000 mg + saxagliptin 5 mg and metformin XR 1000 mg + saxagliptin 2.5 mg, tablet, modified release
Kombiglyze XR®
Bristol Myers Squibb Australia Pty Ltd
|
Type 2 diabetes |
To request an Authority Required (STREAMLINED) listing for the treatment of type 2 diabetes in a patient whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, a thiazolidinedione or a glucagon-like peptide-1, despite treatment with metformin and where a combination of metformin and sulfonylurea is contraindicated or not tolerated. |
|
New Listing (Major submission) |
METFORMIN XR AND SITAGLIPTIN, metformin XR 1000 mg + sitagliptin 50 mg and metformin XR 1000 mg + sitagliptin 100 mg, tablet, modified release
Janumet XR®
Merck Sharp and Dohme Australia Pty Ltd |
Type 2 diabetes |
To request an Authority Required (STREAMLINED) listing for the treatment of type 2 diabetes in a patient whose HbA1c is greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor, a thiazolidinedione or a glucagon-like peptide-1, despite treatment with metformin and where a combination of metformin and sulfonylurea is contraindicated or not tolerated. |
|
New Listing (Major submission) |
MULTICOMPONENT MENINGOCOCCAL GROUP B VACCINE, 0.5mL, injection, prefilled syringe
Bexsero®
Novartis Vaccines and Diagnostics Pty Ltd |
Meningococcal B disease |
To request the inclusion on the National Immunisation Program (NIP) Schedule for prevention of Meningococcal B disease in infants and adolescents. |
|
Change to Listing (Minor submission) |
NARATRIPTAN, 2.5 mg tablet, 2
Naramig®
Aspen Pharmacare Australia Pty Ltd |
Migraine |
Requests to amend the current Authority Required listing of naratriptan to Authority Required (STREAMLINED). |
|
Re-submission (Major submission) |
PANITUMUMAB, 100 mg/5 mL and 400 mg/20 mL, injection, vial
Vectibix®
Amgen Australia Pty Ltd
|
Metastatic colorectal cancer |
Resubmission to request Section 100 (Efficient Funding of Chemotherapy) Authority Required (+/-STREAMLINED) listings for the treatment of KRAS wild-type metastatic colorectal cancer in patients who have failed first-line chemotherapy. |
|
Re-submission (Major submission) |
PLERIXAFOR, 24 mg/1.2 mL, injection, vial
Mozobil®
Sanofi-Aventis Australia Pty Ltd
|
Multiple myeloma or lymphoma |
Resubmission for a Section 100 (Highly Specialised Drugs Program) Authority Required (+/-STREAMLINED) listing for use in combination with G-CSF, in patients with multiple myeloma or lymphoma requiring an autologous stem cell transplant (ASCT) who meet certain criteria. |
|
Re-submission (Minor submission) |
QUETIAPINE 50mg, 150mg, 200mg, and 300mg, tablet, modified release
Seroquel XR®
AstraZeneca
|
Major depressive disorder |
Resubmission for an Authority Required listing for the treatment of recurrent major depressive disorder in patients who have not responded to two other antidepressants. Initiation of treatment is limited to psychiatrists only. |
|
Re-submission (Major submission) |
RANIBIZUMAB, 2.3 mg/0.23 mL, injection, vial
Lucentis®
Novartis Pharmaceuticals Australia Pty Ltd |
Diabetic macular oedema |
Resubmission to request an Authority Required listing for the treatment, by an ophthalmologist, of visual impairment due to diabetic macular oedema as diagnosed by fluorescein angiography. |
|
Re-submission (Major submission) |
RANIBIZUMAB, 2.3 mg/0.23 mL, injection, vial
Lucentis®
Novartis Pharmaceuticals Australia Pty Ltd |
Macular oedema secondary to retinal vein occlusion. |
Resubmission to request an Authority Required listing for the treatment, by an ophthalmologist, of visual impairment due to macular oedema secondary to retinal vein occlusion. |
|
Re-submission (Major submission) |
SORAFENIB, 200mg, tablet
Nexavar®
Bayer Australia Limited |
Renal cell carcinoma (RCC) |
Resubmission to request an Authority Required listing for the treatment, as the sole PBS-subsidised therapy, of Stage IV (advanced) clear cell renal carcinoma in patients who meet certain criteria. |
|
Re-submission (Major submission) |
TAPENTADOL HYDROCHLORIDE, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg, tablet, sustained release
Palexia® SR
BioCSL (Australia) Pty Ltd |
Chronic, severe, disabling pain |
Resubmission to request a Restricted benefit listing for the treatment of chronic, severe, disabling pain not responding to non-narcotic analgesics. |
|
Change to Listing (Minor submission) |
TEMOZOLOMIDE, 180 mg capsule, 5
Temodal®
Merck, Sharp & Dohme (Australia) Pty Ltd |
Glioblastoma multiforme |
Request to extend the Authority Required listing of temozolomide 180 mg on the PBS to include patients with newly diagnosed glioblastoma multiforme concomitant with radiotherapy. |
|
Re-submission (Major submission) |
TOBRAMYCIN, 28 mg, powder for inhalation, capsule
TOBI®PODHALER®
Novartis Pharmaceuticals Australia Pty Ltd |
Cystic Fibrosis |
Resubmission to request an Authority Required (STREAMLINED) listing for the treatment of Pseudomonas aeruginosa infection in a patient aged 6 years or older with cystic fibrosis. |
|
Change to Listing (Major submission) |
TOCILIZUMAB, 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, injection, vial
Actemra®
Roche Products Pty Limited |
Juvenile idiopathic arthritis (JIA)
|
To request a Section 100 (Highly Specialised Drugs Program) listing for the treatment of active polyarticular course juvenile idiopathic arthritis (JIA) in: 1) a patient under 18 years or age and; 2) a patient aged 18 years or older who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; who meets certain criteria. |
|
New Listing (Minor submission) |
TRIGLYCERIDES MEDIUM CHAIN, formula oral liquid 250 mL x 18 tetrapak
BetaQuik®
Vitaflo Australia Pty Ltd
|
Medicinal food |
To request a Restricted benefit listing for: - patients requiring a medium chain triglycerides (MCT) diet such as the ketogenic treatment of intractable childhood epilepsy, cerebrospinal fluid glucose transporter deficiency (GLUT-1) and pyruvate dehydrogenase deficiency (PDHD); - other disorders requiring MCT based diets including chylous ascites, chylothorax, hyperlipoporteinaemia type 1, long chain fatty acid oxidation disorders, fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis and gastrointestinal disorders |
|
New Listing (Minor submission) |
TRIGLYCERIDES LONG CHAIN, formula oral liquid 250 ml x 18 tetrapak
CarbZero®
Vitaflo Australia Pty Ltd |
Medicinal food |
To request a Restricted benefit listing for patients requiring a long chain triglycerides (LCT) supplement for dietary management with the ketogenic diet for intractable childhood epilepsy, glucose transporter protein (GLUT-1) deficiency and pyruvate dehydrogenase deficiency (PDHD). |
