Adalimumab, injection 40 mg solution in 0.8 mL pre-filled pen, Humira Pen®,
Abbott Australasia Pty Ltd
Minor submission
|
Rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis |
Change the delivery system from a pre-filled syringe to a pre-filled pen. |
The PBAC recommended listing of a new delivery system of adalimumab for the same indications
as the currently listed product.
|
Amino acid formula with vitamins and minerals without phenylalanine, oral liquid,
87 ml x 30, and 174 mL x 30, PKU Cooler® 10 and 20,
Vitaflo Australia Pty Ltd
Minor submission
|
Nutrient for inborn error of metabolism |
List new pack sizes and change name of PKU Express Liquid to PKU Cooler and additional
pack sizes ie PKU Cooler 10 (87mL) and PKU Cooler 20 (174 mL).
|
The PBAC recommended listing of these new pack sizes on a cost neutral basis according
to the price of the currently listed PKU Express Liquid 130 mL x 30. The PBAC also
noted the name change from ‘PKU Express Liquid’ to ‘PKU Cooler’ for all three products,
on the basis of differentiating the liquid from the powder product.
|
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
130 mL liquid in foil pouch x 30 x 4 cartons, MSUD Express Cooler®,
Vitaflo Australia Pty Ltd
Minor submission
|
Nutrient for inborn error of metabolism |
Restricted benefit for maple syrup urine disease. |
The PBAC recommended listing as requested on a gram for gram of protein pricing basis,
at the new price agreed for products to treat maple syrup urine disease.
|
Amlodipine maleate, tablets, 5 mg and 10 mg, Amlo 5®, Amlo 10®,
Spirit Pharmaceuticals Pty Ltd
Minor submission
|
Blood pressure drug |
Listing as an unrestricted benefit. |
The PBAC recommended listing on a cost minimisation basis compared with amlodipine
besylate at comparable strengths (ie 5 mg of amlodipine base provided as the maleate
salt is equivalent to 5mg of amlodipine as the besylate salt. The PBAC considered
that these products should be “a” flagged to allow substitution to occur according
to current dispensing practice.
|
ANTICHOLINESTERASES
Donepezil hydrochloride, tablets, 5 mg, 10 mg, Aricept®, Pfizer Pty Ltd
Galantamine hydrochloride, prolonged release capsules 8 mg (base), 16 mg (base), 24
mg (base), Reminyl®, Janssen-Cilag Pty Ltd
Rivastigmine hydrogen tartrate, capsules, 1.5 mg (base), 3 mg (base), 4.5 mg (base),
6 mg (base), oral solution 2 mg (base) per mL, 120 mL, Exelon®, Novartis Pharmaceuticals
Minor submission
|
Alzheimer’s disease |
Request from Medicare Australia to add to the restriction wordings to ensure that
a baseline ADAS-Cog score is provided with the initial application if this measurement
is to be used to demonstrate improvement in cognitive function for continuing treatment.
|
The PBAC agreed to amend the restrictions by addition of the sentence “If an ADAS-Cog
score is not supplied with the initial application, this scale cannot be used for
the purposes of fulfilling the criteria for continued PBS supply” to address the problems
encountered with continuing treatment applications where the ADAS-cog score is not
provided with the application for initial treatment.
|
Apomorphine hydrochloride, injection, 20 mg in 2 mL, Apo-go®,
Mayne Pharma Limited
Minor submission
|
Parkinson’s disease |
Temporary replacement listing due to unavailability of currently listed product. |
The PBAC agreed to list this product at the price requested on the basis of clinical
need while the currently listed product is not available.
|
Apomorphine hydrochloride, solution for infusion, 5 mg per mL, pre-filled syringe,
10 mL, Apomine PFS®,
Mayne Pharma Limited
Minor submission
|
Parkinson’s disease |
Additional strength for patients who require higher dosages. |
The PBAC recommended listing this product at the price requested based on clinical
need, for patients who have higher dosage requirements.
|
Aprepitant, pack with 1 capsule 125 mg and 2 capsules 80 mg, Emend®,
Merck Sharp and Dohme (Australia) Pty Limited
Minor submission
|
Anti nausea drug |
To seek a change to the current restriction to allow authorisation of repeats for
subsequent chemotherapy cycles at the time of initial application.
|
The PBAC recommended a change to the listing to allow repeats to be authorised to
cover all future cycles of chemotherapy on the basis of efficiency. As the first dose
of aprepitant is required one hour before chemotherapy for each cycle, this change
will ensure patients have access to treatment at the appropriate time for all cycles,
without having to obtain a further prescription.
|
Budesonide with eformoterol fumarate dihydrate, 100/6 and 200/6, Symbicort® turbuhaler,
AstraZeneca Pty Ltd
Major submission
|
Asthma drug |
For single maintenance and reliever therapy in patients who experience asthma symptoms
while receiving treatment with inhaled or oral corticosteroids or while receiving
treatment with a combination of an inhaled corticosteroid and a long acting beta-2
agonist.
|
The PBAC recommended amending the current listing as a restricted benefit to include
single maintenance and reliever therapy in patients who had frequent asthma symptoms
while taking oral or inhaled corticosteroids or a combination of an inhaled corticosteroid
and a long acting beta-2 agonist.
|
Budesonide with eformoterol fumarate dihydrate 400/12, Symbicort® turbuhaler,
AstraZeneca Pty Ltd
Minor submission
|
Asthma drug |
Consequential amendment to recommendation for lower strength of this product. |
Consequential to the recommendation to extend the current listings for Symbicort 100/6
and 200/6, the PBAC recommended that a NOTE precluding use of the 400/12 strength
as ‘maintenance and reliever’ therapy be added to the current restriction.
|
Calcipotriol, cream, 50 micrograms per g (0.005%), 30 g, Daivonex® ,
CSL Biotherapies Pty Ltd
Minor submission
|
Skin disorders |
Restricted benefit listing for chronic stable plaque type psoriasis vulgaris. |
The PBAC recommended listing on the basis of demonstrated equivalence to the currently
listed calcipotriol ointment and recognition of patient preference for the cream.
|
Cetuximab 2 mg/mL in 50 mL, Erbitux® ,
Alphapharm Pty Limited
Major submission
|
Anti-cancer drug |
Authority required for treatment in combination with radiotherapy of patients with
UICC Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx
in whom the use of cisplatin is either contraindicated or cannot be tolerated.
|
The PBAC recommended listing on the basis of acceptable cost-effectiveness against
radiotherapy alone. The Committee accepted that loco-regional control was a more relevant
end-point in head and neck cancers than in other cancers.
|
Ciprofloxacin ear drops, 3 mg per mL (0.3%),
5 mL, Ciloxan® ,
Alcon Laboratories (Australia) Pty Ltd
Minor submission
|
Antibiotic |
Request for a change to the restrction to align the age for treatment with the TGA
indication to read: “Treatment of chronic suppurative otitis media in an Aboriginal
and Torres Strait Islander person aged one month and older” The current restriction
reads “aged one year and older”.
|
The PBAC had no objection to the sponsor’s request to change the age restriction included
in the current listing from one year to one month, in line with the TGA registration.
|
Dasatinib tablets 70 mg, 50 mg , 20 mg Sprycel® ,
Bristol-Myers Squibb Pharmaceutical Australia Pty Ltd
Major submission
|
Anti cancer drug |
Section 100 Special Authority Program for the treatment of chronic myeloid leukaemia
in adult patients expressing the Philadelphia chromosome or transcript, bcr-abl tyrosine
kinase, who are resistant or intolerant to imatinib mesylate.
|
The PBAC recommended an authority required listing (exact mechanism to be determined)
for the treatment of all phases of chronic myeloid leukaemia (CML) in patients not
responding to imatinib because of resistance or intolerance, on a cost-effectiveness
basis against imatinib.
|
Diphtheria and Tetanus Vaccine, diluted for adult use, injection 0.5 mL in pre-filled
syringe, 5, ADT Booster® ,
CSL Limited
Minor submission
|
Vaccine |
Listing of a replacement ADT vaccine. |
The PBAC had no objection to the Secretariat amendment to the restriction recommended
for ADT Booster out of session in August 2006 because of changes approved by the TGA
to the draft product information following the meeting.
|
Etanercept, injection set containing 4 pre-filled syringes for injection 50 mg,
injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes
solvent 1 mL, (Enbrel® ),
Wyeth Australia Pty Ltd
Minor submission
|
Psoriatic arthritis and ankylosing spondylitis |
Inclusion of the 50 mg pre-filled syringe and 50 mg lyophilised vial for psoriatic
arthritis and ankylosing spondylitis.
|
The PBAC recommended out of session the listing of the 50 mg pre-filled syringe and
50 mg lyophilised vial for psoriatic arthritis and ankylosing spondylitis. The PBAC
noted the sponsor did not request the listing of the 25 mg pre-filled syringe on the
PBS for these conditions because the pre-filled syringe would not be suitable for
the majority of the potential population.
|
Ezetimibe, tablet 10 mg, Ezetrol® ,
Merck Sharp & Dohme (Australia) Pty Ltd
Minor submission
|
Cholesterol lowering drug |
Add to the listing the following after conditions (1) and (2), following a request
from Medicare Australia to clarify the intent of the restriction.
“The cholesterol level after 3 months of treatment with a statin and the dose of the
statin must be provided at the time of application. The cholesterol level results
provided must be no more than 2 months old at the time of application”.
|
The PBAC had no objection to the Secretariat amending the restriction to repeat the
phrase
“The cholesterol level after 3 months of treatment with a statin and the dose of the
statin must be provided at the time of application. The cholesterol level results
provided must be no more than 2 months old at the time of application” immediately
after conditions (1) and (2) in the restriction.
|
Ezetimibe with Simvastatin, tablets, 10 mg – 40 mg and 10 mg – 80 mg, Vytorin® ,
Merck Sharp & Dohme (Australia) Pty Ltd
Minor submission
|
Cholesterol lowering drug |
Add to the listing the following after conditions (1) and (2), following a request
from Medicare Australia to clarify the intent of the restriction.
“The cholesterol level after 3 months of treatment with a statin and the dose of the
statin must be provided at the time of application. The cholesterol level results
provided must be no more than 2 months old at the time of application”.
|
The PBAC had no objection to the Secretariat amending the restriction to repeat the
phrase
“The cholesterol level after 3 months of treatment with a statin and the dose of the
statin must be provided at the time of application. The cholesterol level results
provided must be no more than 2 months old at the time of application” immediately
after conditions (1) and (2) in the restriction.
|
Fluticasone propionate with salmeterol xinafoate, oral presssurised inhalation 250
mcg-25 mcg (base) per dose,120, CFC-free formulation, Seretide MDI 250/25®, & powder
for oral inhalation in breath actuated device 500 mcg-50 mcg (base) per dose,60, Seretide
Accuhaler 500/50® ,
GlaxoSmithKline Australia Pty Ltd
Major submission
|
Asthma and Chronic Obstructive Pulmonary Disease (COPD) |
Restricted benefit for the long-term maintenance treatment of chronic obstructive
pulmonary disease (COPD) in patients with a history of repeated exacerbations.
|
The PBAC recommended a restricted benefit listing on a cost-minimisation basis with
the equi-effective doses being fluticasone 500 mcg/salmeterol 50 mcg inhaled twice
daily being equivalent to tiotropium bromide monohydrate 18 mcg inhaled once daily
in the treatment of COPD. The recommended restriction reflects the wording of the
TGA registered indication.
|
Glucose Indicator, blood electrode strips, Accu-Chek® Performa, Roche Diagnostics
Australia Pty Ltd
Minor submission
|
Testing strips for use by diabetics |
Listing of test strips for a self-monitoring blood glucose system. |
The PBAC recommended the listing of an additional brand of blood glucose test strips. |
Glucose Indicator, blood reagent strips, Betachek G5® ,
National Diagnostic Products (Australia) Pty Ltd
Minor submission
|
Testing strips for use by diabetics |
Listing of test strips for a self-monitoring blood glucose system |
The PBAC recommended the listing of an additional brand of blood glucose test strips. |
Glucose Indicator, blood reagent strips, Glucoboy Blood Glucose Test Strip® 50, Diabetes
Association of Australia
Minor submission
|
Testing strips for use by diabetics |
Listing of test strips for a self-monitoring blood glucose system |
The PBAC recommended out of session the listing of an additional brand of blood glucose
test strips.
|
Hydroxocobalamin, injection, 1 mg in 1 mL, (Goldshield Hydroxocobalamin® ),
Mayne Pharma Limited
Minor submission
|
Vitamin B12 deficiency |
Restricted benefit listing for the treatment of pernicious anaemia, other proven Vitamin
B12 deficiencies and for prophylaxis after gastrectomy.
|
The PBAC recommended listing at the price requested on the basis of providing an alternative
to the currently listed product which is in short supply.
|
Ibandronic acid, tablet, 150 mg, Bonviva® ,
Roche Products Pty Limited
Major submission
|
Osteoporosis |
Authority required for treatment as the sole PBS-subsidised anti-resorptive agent
for established post-menopausal osteoporosis in patients with fracture due to minimal
trauma.
|
The PBAC recommended listing on a cost-minimisation basis with alendronate for the
treatment of established osteoporosis, with the equi-effective doses being ibandronic
acid 150 mg/month and alendronate 70 mg/week.
|
Infliximab, powder for I.V. infusion, 100 mg, Remicade® , Schering-Plough Pty Ltd
Major submission
|
Crohn’s disease |
Section 100 Authority required listing for the treatment of moderate to severe Crohn’s
disease in patients who have failed an adequate trial of conventional therapy.
|
The PBAC recommended the listing of infliximab for the treatment of patients with
severe Crohn’s disease (Crohn’s Disease Activity Index ? 300) or patients with an
ileostomy or colectomy due to Crohn’s disease on the basis of a high but acceptable
cost-effectiveness ratio compared to placebo. Acceptable cost-effectiveness was demonstrated
at a dose of 5 mg/kg infliximab for three doses (weeks 0, 2 and 6) and when continuation
of treatment beyond three doses was determined by remission (CDAI ? 150) at approximately
12 weeks from the commencement of treatment.
|
Influenza Vaccine, injection 0.25 mL, Vaxigrip Junior® , Sanofi Pasteur Pty Ltd
Minor submission
|
Vaccine |
Listing of a smaller syringe size of 0.25 mL as a restricted benefit for infants and
children 6-35 months
|
The PBAC recommended listing as a restricted benefit on the basis of the dosage requirement
for eligible children up to 35 months of age.
|
Insulin Glargine, pre-filled disposable device, 100 units per mL, 3 mL, 5, Lantus
SoloStar® , Sanofi Aventis Australia Pty Ltd
Minor submission
|
Diabetes |
New presentation of existing product. |
The PBAC recommended out of session the listing of a new presentation of the cartridge
formulation which involved the irreversible integration of the existing 3 mL cartridge
into a fully disposable injection system.
|
Insulin glulisine (human analogue) 100 unit per mL, 3 mL, 5,Apidra® ,
Sanofi-Aventis Australia Pty Ltd
Major submission
|
Diabetes |
Unrestricted benefit. |
The PBAC recommended listing as an unrestricted benefit on a cost-minimisation basis
against insulin lispro, with the equi-effective doses being 1 unit of insulin glulisine
and 1 unit of insulin lispro.
|
Lanreotide Acetate, injection 30 mg, Somatuline LA® ; 60 mg, 90 mg and 120 mg (base)
in single dose pre-filled syringe, Somatuline Autogel® , Ipsen Pty Ltd
Minor submission
|
Peptide analogue used in the treatment of acromegaly and carcinoid syndrome |
Replace the words “Patients with a histologically confirmed diagnosis of a functional
carcinoid tumour” with “Functional carcinoid tumour causing intractable symptoms”.
Replace the words “where surgery and radiotherapy are contraindicated” with “if the
patient is unfit or unwilling to undergo surgery and where radiotherapy is contraindicated”.
(for Somatuline Autogel only)
|
The PBAC had no objection the secretariat’s suggested change to the restriction wording
for Somatuline Autogel for the treatment of carcinoid tumour on the basis that, according
to expert opinion, it is often not possible to confirm diagnosis histologically due
to the location of the tumour.
The PBAC also recommended a change to the listing of lanreotide for the treatment
of acromegaly to bring it into line with the recommended change for octreotide in
this condition.
|
Leflunomide tablets, 10 mg and 20 mg, Arabloc® , Arava® ,
Sanofi-Aventis Australia Pty Ltd
Major submission
|
Psoriatic arthritis and rheumatoid arthritis |
Authority required for initiation by consultant physicians for the treatment of active
psoriatic arthritis in patients for whom other disease modifying anti-rheumatic drugs
(including methotrexate) are inappropriate or ineffective; ongoing leflunomide therapy
for active psoriatic arthritis in patients for whom other disease modifying anti-rheumatic
drugs (including methotrexate) are inappropriate and/or ineffective.
|
The PBAC recommended listing in severe active psoriatic arthritis on a cost-effectiveness
basis compared to placebo for patients who have not responded to DMARD treatment and
on the basis of clinical need.
|
Letrozole tablet, 2.5 mg, Femara®
Novartis Pharmaceuticals Australia Pty Limited
Major submission
|
Anti cancer drug |
To remove note restricting use in early breast cancer to a duration of 5 years. |
The PBAC recommended the listing of letrozole for extended adjuvant treatment of early
breast cancer after treatment with tamoxifen on the basis of high but acceptable cost-effectiveness
compared to placebo (for no extension of hormonal treatment). The total duration of
treatment in early breast cancer with letrozole should not exceed 5 years, and treatment
should commence within 6 months of ceasing tamoxifen.
|
Levonorgestrel intrauterine drug delivery system 52 mg (20 mcg/24 hrs), Mirena®
Schering Pty Limited
Major submission
|
Hormone therapy |
Restricted benefit listing for treatment of idiopathic menorrhagia when oral medical
therapies for menorrhagia have been ineffective or are contraindicated.
|
The PBAC recommended listing as a restricted benefit as requested on a cost-minimisation
basis compared to hysterectomy and on the basis that over a five year period, overall
savings would result for cases where hysterectomy had not been undertaken during that
time period.
|
Macrogol 3350, sachets containing powder for solution 13.125 g with electrolytes,
30, Movicol®
Norgine Pty Limited
Major submission
|
Laxative |
Restricted benefit for paraplegic and quadriplegic patients and others with severe
neurogenic impairment of bowel function not responding to other oral therapies.
|
The PBAC recommended listing as requested. The PBAC recognised that access to macrogol
3350 by this patient group would meet an important clinical need, and that superiority
over other oral therapies had been demonstrated in other conditions impairing bowel
function sufficient to justify the price advantage for macrogol 3350 over these other
oral therapies.
|
Meningococcal Group C, conjugate vaccine, Meningitec® ,
Wyeth Australia Pty Ltd
Minor submission
|
Meningitis |
Inclusion on the National Immunisation Program of a new presentation. |
The PBAC recommended out of session the listing of a new pre-filled syringe on the
National Immunisation Program (NIP). The single dose vial presentation is no longer
being manufactured and will be replaced globally by a pre-filled syringe.
|
Monovalent Human Rotavirus oral vaccine, oral, 1mL (reconstituted), Rotarix® , GlaxoSmithKline
Pty Ltd
Minor submission
|
Rotavirus gastroenteritis |
Removal of reference to strain in the National Immunisation Schedule. |
The PBAC agreed to change the recommended restriction for Rotarix® by removing the
referral to strain G1P[8].
|
Montelukast sodium chewable tablets, 4 mg (base) 5 mg (base), Singulair® ,
Merck Sharp and Dohme (Australia) Pty Limited
Minor submission
|
Asthma drug |
A minor amendment to the listing to change “episodic” to “intermittent” for consistency
with National Asthma Council Australia 2006 Asthma Management Handbook.
|
The PBAC had no objection to the request by the sponsor to change the wording of the
restriction for the current PBS listing to maintain consistency with the recently
updated Asthma Management Handbook (2006). The term ‘episodic’ is to be replaced with
‘intermittent’.
|
Octreotide acetate injection 50 mcg, 100 mcg, 500 mcg, Sandostatin® ; 10 mg, 20 mg,
30 mg, Sandostatin LAR® ; Novartis Pharmaceuticals Australia Pty Ltd
Minor submission
|
Peptide analogue used in the treatment of acromegaly and carcinoid syndrome |
Change wording in listing as a section 100 Highly Specialised Drug from “where surgery
and radiotherapy are contraindicated” to “where patients are unfit or unwilling to
undergo surgery or radiotherapy”
Replace the words “Patients with a histologically confirmed diagnosis of a functional
carcinoid tumour” with “Functional carcinoid tumour causing intractable symptoms”.
|
The PBAC recommended a change to the listing of octreotide for the treatment of acromegaly
to bring it into line with the TGA registered indication for patients unfit or unwilling
to undergo surgery.
The PBAC had no objection the secretariat’s suggested change to the restriction wording
for octreotide for the treatment of carcinoid tumour and VIPoma on the basis that,
according to expert opinion, it is often not possible to confirm diagnosis histologically
due to the location of the tumour.
|
Olanzapine, tablets, 2.5 mg, 5 mg, 7.5 mg, 10 mg, Zyprexa® ,
Eli Lilly Australia Pty Ltd
Minor submission
|
Antipsychotic drug |
Change of pack size to coincide with the wafer presentations. |
The PBAC agreed to the sponsor’s request to harmonise the packaging of Zyprexa and
Zyprexa Zydis by changing the Zyprexa pack size from 30 to 28.
|
Olmesartan medoxomil with hydrochlorothiazide tablets, 20 mg-12.5 mg, 40 mg-12.5 mg,
40 mg-25 mg, Olmetec Plus® ,
Schering-Plough Pty Limited
Major submission
|
High blood pressure |
Restricted benefit listing for hypertension in patients who are not adequately controlled
with either hydrochlorothiazide or olmesartan monotherapy.
|
The PBAC recommended listing on a cost-minimisation basis compared with the corresponding
strengths of the hydrochlorothiazide and olmesartan medoxomil components given concomitantly.
|
Pentavalent Human-Bovine Rotavirus oral vaccine, oral, 2mL, RotaTeq® ,
CSL Limited
Minor submission
|
Rotavirus gastroenteritis |
Removal of reference to strain in the National Immunisation Schedule. |
The PBAC agreed to change the recommended restriction for RotaTeq® by removing referral
to strains.
|
Perindopril arginine with Indapamide hemihydrate, tablet, 5mg-1.25mg,
Coversyl Plus® ,
Servier Laboratories Pty Ltd
Minor submission
|
High blood pressure |
Restricted benefit listing of a new perindopril with indapamide combination product
containing perindopril arginine.
|
The PBAC recommended out of session the listing of a new salt of perindopril in combination
with indapamide with the same restriction, maximum quantity, repeats and price as
the current perindopril erbumine combination product. The PBAC noted both the old
and new products will be “a” flagged as interchangeable.
|
Phenoxybenzamine capsule,10 mg, Dibenyline® , Goldshield Healthcare (Australia) Pty
Ltd
Minor submission
|
Phaeo-chromocytoma |
Temporary restricted benefit for phaechromocytoma and neurogenic urinary retention. |
The PBAC noted advice from the sponsor of the difficulty in sourcing phenoxybenzamine
and considered that it was clinically necessary to retain this drug on the PBS as
it is the only drug subsidised for the treatment of phaeochromocytoma. The PBAC therefore
recommended listing of a new pack size on the PBS.
|
Ramipril tablet, 10 mg Tritace® ,
Sanofi-Aventis Pty Ltd
Minor submission
|
Cardiovascular disease |
Listing as an unrestricted benefit. |
The PBAC recommended listing as requested on a cost minimisation basis compared with
ramipril capsule 10 mg and on the basis of demonstrated bioequivalence to the currently
listed 10 mg capsule. The PBAC considered that these products should be “a” flagged
to allow substitution to occur according to current dispensing practice.
|
Ramipril with felodipine tablets 2.5mg-2.5mg and 5 mg-5 mg, Triasyn® ,
Sanofi-Aventis Australia Pty Ltd
Major submission
|
High blood pressure |
Restricted Benefit listing for the treatment of hypertension in patients who are not
adequately controlled with either ramipril or felodipine monotherapy.
|
The PBAC recommended listing on a cost-minimisation basis compared with the corresponding
strengths of the ramipril and felodipine components given concomitantly.
|
Ranibizumab 1.8 mg/0.3 mL and 3.0 mg/0.3 mL solution for intravitreal injection (Lucentis® )
Novartis Pharmaceuticals Australia Pty Limited
Major submission
|
Age Related Macular Degeneration |
Authority Required for initial treatment of active neovascular (wet) age-related macular
degeneration and continuing treatment of neovascular (wet) age-related macular degeneration
(AMD), in patients previously treated with ranibizumab with evidence of continued
disease activity as defined by a loss of 5 letters of visual acuity (ETDRS or one
Snellen line equivalent) and or/or evidence of leakage of fluid, haemorrhage or lesion
growth.
|
The PBAC recommended listing for the treatment of subfoveal choroidal neovascularisation
(CNV) due to age related macular degeneration on a cost-effectiveness basis against
verteporfin with PDT in predominantly classic disease, and against placebo in minimally
classic or occult disease. Listing was recommended on the basis of acceptable cost-effectiveness.
|
Risedronate sodium 35 mg tablets x 4, 5 mg x 28 and Risedronate sodium 30 mg with
calcium carbonate 1.25 g. Actonel® and Actonel Combi®
Sanofi-Aventis Australia Pty Ltd
Major submission
|
Osteoporosis |
Authority required listing for the prevention of first fracture in patients aged ?
70 years with a bone mineral density (BMD) T-score ? -3.0 as determined by appropriate
diagnostic tests.
|
The PBAC recommended extending the current listing to allow subsidised use in the
primary treatment of osteoporosis on a cost-minimisation basis compared with alendronate.
The equi-effective doses are risedronate 35 mg weekly and alendronate 70 mg weekly.
|
Rituximab solution for I.V. infusion 500 mg in 50 mL vials, Mabthera®
Roche Products Pty Limited
Major submission
|
Monoclonal antibody for use in lymphoma and rheumatoid arthritis |
Section 100 Highly Specialised Drug listing for severe active rheumatoid arthritis
(RA) in patients who have received prior treatment with a tumour necrosis factor antagonist
(antiTNF).
|
The PBAC recommended listing in combination with methotrexate, on a cost-minimisation
basis as compared to etanercept and adalimumab for patients who have failed to demonstrate
a response to at least one TNF inhibitor. The equi-effective doses are rituximab 1000
mg on Days 1 and 15 being equivalent to etanercept 25 mg twice weekly and adalimumab
40 mg once every second week.
|
Somatropin recombinant human growth hormone, solution for injection, 10 mg (30iu)
in 2mL cartridge, Nutropin AQ®,
Ipsen Pty Ltd
Minor submission
|
Human Growth Hormone |
Listing of a new brand |
The PBAC recommended out of session listing a new brand of somatropin under the Section
100 Human Growth Hormone Program.
|
Thyrotropin alfa-rch, kit containing 2 vials of powder for I.M. injection 1.1 mg,
Thyrogen®,
Genzyme Australasia Pty Ltd
Major submission
|
Thyroid disease |
Authority required listing for use in adult post-thyroidectomy patients, without known
metastatic disease who are/will be maintained on hormone suppression therapy, in the
ablation of thyroid remnant tissue with radioactive iodine. PBS-subsidised use is
limited to once per lifetime.
|
The PBAC recommended listing to prepare for radio-iodine ablation on the basis of
acceptable cost-effectiveness compared to withdrawing thyroid hormone therapy and
thus inducing a longer period of hypothyroidism of 4-6 weeks prior to ablation.
|
Tiagabine hydrochloride monohydrate, tablet 2.5 mg, Gabitril®,
Mayne Pharma Ltd
Minor submission
|
Anti-epileptic drug |
Addition of a lower strength tablet. |
The PBAC recommended the listing of a lower strength of tiagabine hydrochloride with
the same restriction as the currently listed products.
|
Tipranavir,soft capsules, 250 mg, Aptivus®
Boehringer Ingelheim Pty Ltd
Major submission
|
HIV-AIDS |
Section 100 Highly Specialised Drug. Treatment, in combination with other antiretroviral
agents, and co-administered with 200 mg ritonavir twice daily, of HIV infection in
antiretroviral experienced adults with a) evidence of HIV replication and/or b) CD4
cell counts of less than 500 per cubic millimetre. Patients must have failed previous
treatment with, or have resistance to, 3 different antiretroviral regimens, including
regimens with at least 1 non-nucleoside reverse transcriptase inhibitor, 1 nucleoside
reverse transcriptase inhibitor, and 2 protease inhibitors.
`
|
The PBAC considered that tipranavir offers a clinical advantage in the high risk salvage
patient group for whom subsidy is sought and recommended listing on a cost-effectiveness
basis over the comparator.
|
Topiramate tablets, 25 mg and 50 mg, Topamax®
Janssen-Cilag Pty Ltd
Major submission
|
Anti-epileptic and migraine prophylaxis |
Authority Required listing for migraine prophylaxis in adults who are experiencing
an average of 3 or more migraines per month for a period of at least six months and
meet certain criteria.
|
The PBAC recommended listing on the basis of acceptable cost-effectiveness compared
to placebo for migraine prophylaxis in patients unable to take a beta-blocker and/or
pizotifen.
|
