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Complex Authority Required highly specialised drugs (CAR HSD)

Complex Authority Required (CAR) drug means any of the following highly specialised drugs (HSD):

Funded drugs

The drugs funded under this program include:

  • adalimumab
  • abatacept
  • ambrisentan
  • azacitidine
  • bosentan monohydrate
  • eculizumab
  • eltrombopag
  • epoprostenol sodium
  • etanercept
  • iloprost trometamol
  • infliximab
  • lenalidomide
  • macitentan
  • omalizumab
  • rituximab
  • romiplostim
  • sildenafil citrate
  • tadalafil
  • tocilizumab.

Approvals

As written approval from Medicare Australia is required before prescribing these drugs there is no patient eligibility certification form to complete.

Dispensing of drugs

CAR prescriptions can be dispensed by either a public hospital pharmacy or a community pharmacy.

Special arrangements

For eculizumab (Soliris®)

From 1 December 2014, the drug eculizumab (Soliris®) is listed on the Pharmaceutical Benefits Scheme (PBS) as a section 100 only medicine (CAR HSD) for the treatment of atypical Haemolytic Uraemic Syndrome (aHUS).

In a departure from existing HSD program arrangements, this new listing enables eculizumab to be prescribed and administered to admitted patients receiving treatment at or from a public hospital.  This is a unique arrangement for eculizumab only.  

New record retention requirements also come into effect for eculizumab under this arrangement which require eligible medical practitioners prescribing eculizumab, or approved hospitals treating eligible patients with eculizumab as a pharmaceutical benefit, to keep a copy of any clinical records relating to that prescription for two years.

Additional details for prescribing eculizumab can be found on the Australian Department of Human Services website.

Primary Pulmonary and Pulmonary Arterial Hypertension

Additional details for prescribing Pulmonary Arterial Hypertension (PAH) drugs including the following list can be found on the Australian Department of Humas Services website. 

  • ambrisentan
  • bosentan monohydrate
  • epoprostenol sodium
  • iloprost trometamol
  • macitentan
  • sildenafil citrate
  • tadalafil

Who can prescribe

These drugs may only be prescribed by physicians associated with Pulmonary Arterial Hypertension (PAH) Designated Prescribing Centres. In South Australia these centres are:

  • Ashford Hospital and Ashford Specialist Centre
  • Flinders Medical Centre 
  • Lyell McEwin Hospital
  • Repatriation General Hospital 
  • Royal Adelaide Hospital 
  • The Queen Elizabeth Hospital 
  • The Women's and Children's Hospital. 

How to become a prescriber

Public Hospitals wishing to become Pulmonary Arterial Hypertension (PAH) Designated Prescribing Centres may lodge a submission (DOC 333KB) if they can satisfy specific requirements. These requirements include:

  • access to:
    • Heart lung transplant unit
    • PAH management services/clinic
    • Scleroderma management services/clinic
    • State/Territory health recognised cardiovascular centre.
  • experience and expertise in managing patients with PAH:
    • Current PAH management protocol
    • Experience in prescribing PAH therapies.
  • the availability of diagnostic services and expertise with procedures such as right heart catheterisation (RHC), echocardiography (Echo), pulmonary function testing (PFT) and six minute walk test protocol (6MWT).
  • outpatient pharmacy services and pharmacy expertise in managing Section 100 listed drugs and other highly specialised therapy.

For more information, refer to the Pulmonary arterial hypertension designated treatment centre criteria (PDF 77KB) fact sheet.

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