New Listings and Changes 1 February 2011

ADDITIONS

Additions - Items

3414Q Nicotine, Transdermal patch, releasing approximately 21 mg per 24 hours (Nicotinell Step 1Patch®)
5465P  Nicotine, Transdermal patch, releasing approximately 21 mg per 24 hours (Nicabate P®)

The PBAC (March 2010) recommended the listing of nicotine transdermal patches on the PBS as an Authority required listing as an aid to cessation of smoking in patients who have entered or are entering a comprehensive support and counselling program in the context of a public health priority area, noting that reduction of chronic disease caused by smoking is one of the key focuses of the national health taskforce on prevention.

Smoking is Australia’s largest preventable cause of death and disease.

Over three million people, i.e. around 18% of Australians, aged 14 years and over still smoke at least weekly. ¹

The listing of nicotine transdermal patches on the PBS will assist around 300,000 people in their attempts to quit smoking.

 

5469W Varenicline, Tablet, 1mg (as tartrate) (Champix®)

The PBAC (November 2009) recommended the listing of varenicline tartrate tablets on the PBS be extended to make available a second 12 week course for patients who have successfully completed an initial 12 week course of varenicline, but require a further 12 week course to aid in maintaining abstinence, and who are enrolled in a comprehensive support and counselling program, on the basis of an acceptable cost effectiveness ratio.

Providing a further three months of varenicline therapy to those patients who successfully complete the first course of this drug will help around 70,000 people to continue their abstinence from smoking.

 

5468T Dutasteride, Capsule, 500micrograms (Avodart®)

The PBAC (November 2009) recommended the listing of dutasteride on the PBS as an Authority Required (streamlined) benefit for the treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia, where treatment is initiated by a urologist, on the basis of acceptable cost effectiveness compared with alfa-antagonist alone.

The listing of dutasteride will benefit around 130,000 Australian men who experience lower urinary tract symptoms due to an enlarged prostate.

 

5466Q Amino Acid Synthetic Formula supplemented with Long Chain Polyunsaturated Fatty Acids and Medium Chain Triglycerides, compound powder, 400g (Neocate LCP+MCT®)
5467R Amino Acid Synthetic Formula supplemented with Long Chain Polyunsaturated Fatty Acids and Medium Chain Triglycerides, compound powder, 400g (Neocate LCP+MCT®)(Diff Max. Rpts)

The PBAC (July 2010) recommended the listing on the PBS of Neocate LCP + MCT® as an Authority Required benefit for use in a child meeting certain criteria with either combined intolerance (not infant colic) to cow’s milk protein, soy protein and protein hydrolysate formulas, severe intolerance (not infant colic) to cow’s milk protein, or severe intestinal malabsorption including short bowel syndrome. 

Food protein allergy affects approximately 6 – 8 % of infants under 3 years of age and up to 1 in 5 are estimated to be intolerant to extensively hydrolysed formula and require an amino acid formula.

A majority of infants with cows’ milk allergy or multiple food protein intolerance do not require medium chain triglycerides (MCTs) as their major source of fat.  In such patients, products with highly reduced allergenicity based on extensively hydrolysed protein or amino acid mixtures, irrespective of MCT content, are indicated (e.g. Neocate LCP).  However, a subset of these patients who may also have gastrointestinal disease and/or fat malabsorption may benefit from the inclusion of medium chain triglycerides.  Neocate LCP + MCT® provides a treatment option for these patients.

Neocate LCP + MCT®is a hypoallergenic infant formula specifically produced using free amino acids as its protein source so as to cause no allergic reactions. It is indicated for cows’ milk protein allergy and multiple food allergy and has been formulated with an increase in medium chain triglycerides as its fat source.

 

Alterations – Restrictions

9198D Nicotine, Transdermal patch, releasing approximately 15 mg per 16 hours (Nicorette Patch®)

The PBAC (July 2010) recommended out-of-session an extension to the listing of nicotine patches (Nicorette Patch®)on the PBS under the listing conditions recommended for this product at the March 2010 PBAC meeting.

 

Alteration ─ Restriction and Note

9129L Varenicline, Tablet 1 mg (as tartrate) (Champix).

Alterations to the existing note for this item have been made to be consistent with the new varenicline item listed for extending treatment for an additional 12 weeks in eligible patients.

 

SECTION 100 – HIGHLY SPECIALISED DRUGS

Additions - Items

9597D Azacitidine, Powder for injection, 100mg (Vidaza®) (Public)
9598E Azacitidine, Powder for injection, 100mg (Vidaza®) (Public Diff Max.Rpts)
6100C Azacitidine, Powder for injection, 100mg (Vidaza®) ( Private)
6138C Azacitidine, Powder for injection, 100mg (Vidaza®) (Private Diff Max.Rpts)

The PBAC (September 2009 extraordinary meeting) recommended the listing of azacitidine on the PBS as a Section 100 listing for the treatment of myelodysplastic syndrome (MDS) in patients who meet certain criteria.

The myelodysplastic syndromes (MDS) are a group of disorders of haematopoiesis (formation of blood cells) in the blood cell forming tissue in bone marrow. They include refractory anaemia, chronic myelomonocytic leukaemia (CMML), and acute myeloid leukaemia (AML).  The incidence of MDS is highest among older persons, with the median age of diagnosis being in the range of 65 to 70 years.  Within Australia, there were 972 cases of MDS (4.6 per 100,000 head of population) reported in 2004.  However, MDS is generally under-diagnosed and underreported since patients presenting with early stages of disease may fail to be fully investigated for other abnormalities of the bone marrow.

There are currently no curative options available for patients with MDS although a small percentage of younger and fitter patients may achieve long-term disease control through allogeneic transplantation.  All patients will receive best supportive care (BSC) consisting of red blood cell (RBC) and platelet transfusions, antibiotics, drugs to support production of blood cells and iron chelating therapy.  Active therapies such as azacitadine are considered in patients at higher risk of having MDS affected cells transforming to leukaemia cells.

 

9690B Trastuzumab, powder for I.V. infusion, 60 mg (Herceptin®) (Public)
9691C Trastuzumab, powder for I.V. infusion, 60 mg (Herceptin®) (Private)

The PBAC (July 2010) recommended out-of-session the listing of the new lower strength of trastuzumab for the treatment of HER2 positive early breast cancer on a cost-minimisation basis with trastuzumab 150 mg.

 

SECTION 100 – PBS GROWTH HORMONE PROGRAM

Additions – Items

6311E Somatropin, Solution for injection, 10mg (30iu) in 1.5ml cartridge (with preservative) (Omnitrope®)

The PBAC recommended listing of a new strength of an existing product and presentation of somatropin at the same price as the currently listed product.

Growth hormone (somatropin) is subsidised by the Australian Government through Pharmaceutical Benefits Scheme (PBS) special arrangements made under Section 100 of the National Health Act 1953.

Omnitrope is intended for the long term treatment of children (above three years of age) with growth disturbance due to insufficient secretion of pituitary growth hormone, growth disturbance associated with gonadal dysgenesis (Turner Syndrome) and growth disturbance associated with chronic renal insufficiency.

The PBS Growth Hormone Program treats around 1,700 children and adolescents.  Expenditure is around $25 million a year. The program is administered by the Department of Health and Ageing with advice from the Growth Hormone Advisory Committee, a panel of paediatric endocrinologists. 

 

1 Source: Australia: the healthiest country by 2020. Technical Report 2 “Tobacco control in Australia: Making smoking history”, p1. Accessed at: http://www.preventativehealth.org.au/internet/preventativehealth/publishing.nsf/Content/home-1