New Listings and Changes 1 May 2010

 

ADDITIONS

Additions — Items

9339M Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids, Compound powder 400 g (EleCare LCP)

9340N Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids, Compound powder 400 g (EleCare LCP) (Diff. Restriction)

EleCare-LCP contains ingredients in similar proportional amounts as the currently PBS-listed EleCare formula, with the exception of two additional supplements: C. Cohnii oil and M. Alpina oils.  EleCare is clinically documented to be hypoallergenic (Sicherer et al, 2001), virtually eliminating the potential for an allergic reaction and is clinically shown to support growth when used as primary source of nutrition. 

The PBAC noted the advice of the Nutritional Products Working Party that EleCare LCP should be made available for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae, severe intolerance (not infant colic) to cows’ milk protein, and severe intestinal malabsorption including short bowel syndrome in patients who meet certain criteria, and recommended that the product be listed on a cost-minimisation basis with Neocate LCP.  

 

9307W Carmellose sodium with glycerin, Eye drops 5 mg-9 mg per mL (0.5%-0.9%), single dose units 0.4 mL, 30 (Optive)

5561Q Carmellose sodium with glycerin, Eye drops 5 mg-9 mg per mL (0.5%-0.9%), single dose units 0.4 mL, 30 (Optive) (Optometrical) 

The PBAC recommended carmellose sodium with glycerin single unit eye drops be listed on the PBS Authority Required (streamlined) for severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops. The PBAC also recommended listing in the Optometric Schedule.  

 

9341P Dasatinib, Tablet 100 mg (Sprycel)

9342Q Dasatinib, Tablet 100 mg (Sprycel) (Diff. Max. Rpts)

9343R Dasatinib, Tablet 100 mg (Sprycel) (Diff. Restriction) 

The PBAC recommended out of session an Authority required listing of a new 100 mg strength as an addition to the currently listed 20 mg, 50 mg and 70 mg strengths for dasatinib following approval by the TGA. Dasatinib is currently listed on the PBS for treatment of specific forms of acute and chronic leukaemia. The availability of the 100 mg tablet is expected to reduce the pill burden (1 x 100 mg instead of 2 x 50 mg) for patients on this medicine.  

 

9332E Interferon beta-1a, Solution for injection 132 micrograms in 1.5 mL multidose cartridge (Rebif 44)

The PBAC recommended the Authority required listing of a new multi-dose cartridge presentation of interferon beta-1a for relapsing-remitting multiple sclerosis, at the same price and with the same restriction as the existing PBS listed product Rebif 44®.  The sponsor has undertaken to provide the required electromechanical autoinjector and consumables to patients at no cost.  Due to the different presentation, this multi-dose product will have a different maximum quantity and repeats to the Rebif 44® presentation.  

 

9335H Lacosamide, Tablet 100 mg (Vimpat)

9334G Lacosamide, Tablets 100 mg, 14 (Vimpat)

9337K Lacosamide, Tablet 150 mg (Vimpat)

9336J Lacosamide, Tablets 150 mg, 14 (Vimpat)

9338L Lacosamide, Tablet 200 mg (Vimpat)

9333F Lacosamide, Tablet 50 mg (Vimpat) 

The PBAC recommended the listing of lacosamide on a cost-effectiveness basis as an authority required benefit for intractable epilepsy. Therapy must be initiated by a neurologist in a patient who has failed at least one first line therapy and two second line therapies.  A streamlined authority was not considered suitable for use in this last-line setting. 

Epilepsy is a common neurological condition, characterised by recurrent, unprovoked seizures, and produces significant morbidity in the general community.  For many patients, existing antiepileptic drugs are either ineffective or produce unacceptable side-effects.  Lacosamide would provide an additional therapeutic option in the management of intractable epilepsy (epilepsy not adequately controlled by medication). 

 

9345W Levodopa with carbidopa and entacapone, Tablet 125 mg-31.25 mg-200 mg (Stalevo125/31.25/200mg)

9344T Levodopa with carbidopa and entacapone, Tablet 75 mg-18.75 mg-200 mg (Stalevo 75/18.75/200mg)

The PBAC recommended the Authority required (STREAMLINED) listing of two new strengths of levodopa with carbidopa and entacapone for Parkinson disease, in accordance with the combination guidelines, on a cost-minimisation basis compared with the equivalent doses of the constituent components.

 

3489P Methoxyflurane, Liquid for inhalation 999.9 mg per g, 3 mL (with inhaler) (Penthrox) (Doctor's Bag) (Available as an emergency treatment drug only)

The PBAC recommended listing of methoxyflurane in the PBS Doctor's Bag Item List on the basis of acceptable cost effectiveness. Methoxyflurane (inhalation) provides an alternative rapid onset, portable and non-narcotic analgesic for use by doctors and nurses in the emergency community-based settings. Methoxyflurane is a self administered inhalation that is suitable for use in sporting injuries, minor fractures and other trauma where patients remain conscious and are supervised by a doctor or nurse. 

 

9350D Zoledronic acid, Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL (Aclasta) (Diff.Restriction)

Zoledronic acid for Paget disease is being listed with a separate (new) item code.  This new item code allows for separate monitoring of use for this indication. 

 

ALTERATIONS

Alterations — Restrictions

8798C Levodopa with carbidopa and entacapone, Tablet 100 mg-25 mg-200 mg (Stalevo 100/25/200mg)

8799D Levodopa with carbidopa and entacapone, Tablet 150 mg-37.5 mg-200 mg (Stalevo 150/37.5/200mg)

9292C Levodopa with carbidopa and entacapone, Tablet 200 mg-50 mg-200 mg (Stalevo 200/50/200mg)

8797B Levodopa with carbidopa and entacapone, Tablet 50 mg-12.5 mg-200 mg (Stalevo 50/12.5/200mg) 

The restriction for these items remains unchanged, however the “streamlined” code number has changed.