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High cost medicine reviews

The Statewide Formulary for High Cost Medicines aims to ensure that eligible patients will have equal opportunity to receive a high cost medicine based upon their clinical condition rather than where they live or what hospital they attend. 

All public hospitals must comply with the SA Health Statewide Formulary for High Cost Medicines policy (PDF 281KB) to enhance equity of access within the South Australian public health system. 

Application process

Formulary applications for high cost medicines should be forwarded to your hospital Drug & Therapeutics Committee. The application should be signed by the Chair of the committee and then forwarded to South Australian Medicines Evaluation Panel (SAMEP) for review. Further information on submitting a formulary application, see the Information for clinicians on submitting a formulary application for a High Cost Medicine (PDF 1377KB) is provided on the following form. SAMEP will then undergo a systematic process of evaluating the medicine for safety, clinical efficacy and cost-effectiveness. SAMEP will consult with specialist clinicians and seek additional external expertise if required.

If you are require a high cost medicine for a single use, please refer to the Individual patient use (IPU) of high cost medicines page.

Further information

For further information on Statewide Formulary for High Cost Medicines, contact the South Australian Medicines Evaluation Panel.

Completed reviews

The following medicine reviews have been completed by South Australian Medicines Evaluation Panel: 

Anagrelide

Indication: Third-line option for treatment of essential thrombocythaemia, in patients who fail treatment with hydroxyurea (HU) due to intolerance or lack of efficacy, and who are contraindicated to, or failed second-line therapy.

SAMEP recommendations: Anagrelide recommendations (PDF 1535KB)

Outcome: Listed on the high cost medicines formulary

Checklist form for patient eligibility: Anagrelide eligibility checklist form (DOC 488KB)

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Arsenic trioxide

Indication: For the induction of remission and consolidation in patients with newly diagnosed acute promyelocytic leukemia (APL) whose APL is characterised by the presence of the t(15:17) translocation of PML/RAR-alpha gene expression

Outcome: Available via streamlined IPU

Checklist form for patient eligibility: Arsenic trioxide streamlined individual patient use (IOU) request (DOCX 197KB)

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Alemtuzumab

Indication: B-cell Chronic Lymphocytic Leukaemia (B-CLL)

SAMEP recommendations: Alemtuzumab rapid review (PDF 1314KB)

Outcome: Not listed on formulary

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Bendamustine

Indication: Treatment of relapsed or refractory
non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukaemia (CLL)

SAMEP recommendations: Bendamustine recommendations (PDF 1524KB)

Outcome: No further IPU approvals recommended for specified patient population

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Bevacizumab

Indication: Recurrent glioblastoma multiforme

SAMEP recommendations: Bevacizumab (PDF 1416KB)

Outcome: Not listed on high cost medicines formulary (no further IPU approvals recommended)  

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Botulinum toxin type A

Indication: Treatment of focal spasticity

SAMEP recommendations: Botulinum toxin type A evaluation summary (PDF 1454KB)

Outcome: Listed on High Cost Medicines formulary

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Defibrotide

Indication: Treatment or prophylaxis of veno-occlusive disease

SAMEP recommendations: Defibrotide rapid review (PDF 1285KB)

Outcome: No further IPUs recommended

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Fampridine

Indication: Symptomatic improvement of walking ability in adult patients with multiple sclerosis

SAMEP recommendations: Fampridine evaluation summary (PDF 1388KB)

Outcome: Not listed on formulary

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Infliximab

Acute severe colitis refractory to intravenous corticosteroids

SAMEP recommendations: SAMEP review completed prior to PBS listing for ulcerative colitis. Contact SAMEP for a copy of the review.

Outcome: Listed on High Cost Medicines formulary

Checklist form for patient eligibilityInfliximab: Pharmacy checklist form (DOC 478 KB)

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hidradenitis suppurativa

SAMEP recommendations: Contact SAMEP for a copy of the review

Outcome: Not listed on the high cost medicines formulary

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Ipilimumab induced, steroid-refractory, colitis

SAMEP recommendations: both an oncologist and a gastroenterologist must be involved in the decision to prescribe infliximab. A clinical pathway has been drafted by SAMEP to guide prescribing; but is not mandatory given there is very limited evidence to support the use of infliximab for this indication. Contact SAMEP for a copy of the draft pathway.

Outcome: Maximum of two doses, provisionally available for 12 months via IPU request to hospital DTC, with clinical outcomes to be collected and reviewed to determine effectiveness. For review in 12 months.

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Omalizumab

Indication: Severe idiopathic urticaria

SAMEP recommendations: Omalizumab recommendations (PDF 1499KB)

Outcome: Not listed on the high cost medicines formulary (No further IPUs recommended for specified patient population)

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Palivizumab

Indication: Prevention of serious lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) in infants at high risk of RSV disease

SAMEP recommendations: Palivizumab for prevention of RSV evaluation summary  (PDF 1470KB)

Outcome: Not listed on the SA High Cost Medicines formulary

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Plerixafor

Indication: For use in combination with chemotherapy and GCSF to mobilise haematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma or multiple myeloma who are poor/failed mobilisers

SAMEP recommendations: Contact SAMEP for a copy of the algorithm or review

Outcome: Listed on High Cost Medicine formulary in compliance with PBS criteria only.

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Rituximab

ANCA-associated vasculitis

Sub types include:

  • Granulomatosis with polyangiitis (Wegener’s granulomatosis)
  • Microscopic polyangiitis
  • Churg-Strauss syndrome

SAMEP recommendations: Rituximab in AAV evaluation summary (PDF 1833KB), recommendations (June 2016) pending.

Outcome: Listed on High Cost Medicines formulary

Checklist form for patient eligibilityRituximab in AAV: patient eligibility form (PDF 468KB)

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Immune thrombocytopenia

Immune thrombocytopenia (ITP) refractory to best practice first line therapy (multiple courses of steroids, including dexamethasone and prednisolone, and intravenous immunoglobulin), meeting the following criteria:

  • Disease duration is < 1 year
  • Patient has not previously been treated with rituximab for ITP.
  • Patient has failed first line therapy, defined in the patient eligibility criteria.

SAMEP recommendations: Contact SAMEP for a copy of the algorithm or review

Outcome: Listed on High Cost Medicines formulary

Checklist form for patient eligibilityRituximab in ITP: patient eligibility form (PDF 178KB)

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Immune thrombocytopenia

Immune thrombocytopenia (ITP) refractory to best practice first line therapy (multiple courses of steroids, including dexamethasone and prednisolone, and intravenous immunoglobulin), meeting the following criteria:

  • Disease duration is < 1 year
  • Patient has not previously been treated with rituximab for ITP.
  • Patient has failed first line therapy, defined in the patient eligibility criteria.

SAMEP recommendations: Contact SAMEP for a copy of the algorithm or review

Outcome: Listed on High Cost Medicines formulary

Checklist form for patient eligibility: Rituximab in ITP: patient eligibility form (PDF 178KB)

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Autoimmune haemolytic anaemia

SAMEP recommendation: Summary document pending

Outcome: Listed on High Cost Medicines formulary in accordance with approved clinical pathway (PDF 177KB)

Checklist form for patient eligibility: Rituximab in autoimmune haemolytic anaemiaL Patient eligibility (DOC 526KB)

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Refractory inflammatory myositis

SAMEP recommendations: Rituximab in IMM evaluation summary (PDF 1425KB)

Outcome: Listed on High Cost Medicines formulary

Checklist for patient eligibility: Rituximab in inflammatory myositis: checklist form (DOC 478KB)

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Trastuzumab emtansine

Indication: HER2-positive metastatic breast cancer

SAMEP recommendation: Contact SAMEP for further information on the rapid review

Outcome: Not listed on formulary. No further IPU requests to be funded by SA Health.

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Medicines under review

The following medicines are currently being reviewed by the South Australian Medicines Evaluation Panel

Generic name Indication Date submission received Status
Tenofovir disoproxil fumerate + emtricitabine Pre-exposure prophylaxis of HIV December 2015 Review in progress
Adalimumab Hidradenitis suppurativa 12 June 2015 review suspended – awaiting outcome of upcoming PBAC review
Intravenous posaconazole Treatment and prophylaxis of invasive fungal infections 4 May 2015 Awaiting feedback from haematology
Rituximab Immune thrombocytopenia SAMEP- initiated Review in progress

 

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