Western Australian Drug Evaluation Panel - WADEP

WA hospitals high-cost drug formulary

High-cost drugs approved (and not approved) for the WA hospitals formulary are listed below.

Where appropriate, high-cost drugs on the WA hospitals formulary are listed according to the same criteria as the PBS Schedule. If required, information about listing criteria on the PBS Schedule can be found by searching PBS Online (external site).

adalimumab (Crohn disease)

  • PBS: Authority required. Section 85. For the treatment of adult patients with severe refractory Crohn disease. Restrictive criteria for initial treatment, continuing treatment and interchangeability.
  • WA hospital formulary listing: Approved for the treatment of adult patients with severe refractory Crohn disease according to the same restrictions as the PBS.
  • Special requirements: In addition to the PBS criteria, an extension is approved to allow inclusion of patients demonstrating a decrease in CDAI score of ≥150 points, regardless of their total score following treatment.  This extension is likely to apply occasionally and is subject to use by individual approval on a case by case basis by a mechanism determined by each institution.  The recommended extension applies to:
  1. First continuing therapy after initial treatment
  2. Continuing subsidised treatment with adalimumab, by a gastroenterologist, of adults who:
    1. have a diagnosis of Crohn disease confirmed by endoscopy or radiological evaluation
    2. have demonstrated an adequate response to treatment with adalimumab where an adequate response to treatment is defined as a decrease in CDAI score of ≥150 points.

Continuing treatment in all cases will be limited to a maximum of 24 weeks of therapy.

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adalimumab (rheumatoid arthritis)

  • PBS: Section 85. Authority required. For the treatment of adult patients with severe active rheumatoid arthritis. Restrictive criteria for initial treatment, continuing treatment and interchangeability.
  • WA hospital formulary listing: Approved for severe active rheumatoid arthritis with the same restrictions as apply under the PBS. Interchangeable with other biological disease modifying anti-rheumatic drugs (bDMARDs) (etanercept, infliximab, abatacept and rituximab) but NOT anakinra.
  • Special requirements: Included with other other (bDMARDs) (etanercept, infliximab, abatacept and rituximab) under the interchangeability arrangements used by the PBS for the treatment of severe rheumatoid arthritis. Additional criteria for public hospital use to include the following:
  1. Treatment shall be supervised through specialist severe arthritis clinics.
  2. Treatment progress and outcomes shall be monitored, locally or via the proposed Australian Rheumatology Association Database (if ARA consent is obtained), and outcomes reported to WATAG.
  3. Arthritis patients already approved for and receiving treatment shall continue to receive such therapy while they satisfy the criteria for continuation or treatment as recommended by the PBS.
  4. These additional conditions apply only to adult hospital patients (> 18 years).
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alefacept (psoriasis)

  • PBS: Not listed.
  • WA hospital formulary listing: Not approved and not available.  Not recommended for treatment of severe psoriasis, as further evidence of clinical effectiveness and/or acceptable cost effectiveness is required.
  • Special requirements: Not applicable.
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anakinra (arthritis)

  • PBS: Authority required.  Treatment of adult patients with severe active rheumatoid arthritis.
  • WA hospital formulary listing: Anakinra is not approved for formulary use.  Hospital listing requires a formulary submission.
  • Special requirements: Not applicable.
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bortezomib (multiple myeloma)

  • PBS: Section 85, July 2007.  a) Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a WHO performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily.  b)  Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib.  c)  Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response.
  • WA hospital formulary listing: Approved under the same restrictions as the PBS for the salvage treatment of patients with multiple myeloma following failure of thalidomide.
  • Special requirements: As per the PBS listing.
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carmustine wafers (malignant glioma)

  • PBS: Section 85. Restricted benefit. For the treatemt of glioblastoma multiforme, suspected or confirmed, at the time of initial surgery. (Note - carmustine is not PBS-subsidised for use in conjunction with PBS-subsidised temozolomide.)
  • WA hospital formulary listing: Not approved and not available.
  • Special requirements: Not applicable.
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cetuximab (squamous cell cancers of head and neck)

  • PBS: Section 85, March 2007.  Authoritty required.  a) Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx for the week prior to radiotherapy, where cisplatin is contraindicated according to the TGA-approved Product Information;  b) Initial treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is not tolerated.  c) Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated.  Note:  A maximum lifetime supply for this indication is limited to a maximum of 8 treatments per site and to 10 treatments per site for patients in whom radiotherapy is interrupted.
  • WA hospital formulary listing: Recommended for listing for the treatment of patients with squamous cell cancers of the larynx, oropharynx or hypopharynx concurrent with radiation where chemotherapy with cisplatin is contraindicated or cannot be tolerated.
  • Special requirements: According to the PBS listing, there are no repeats for initial treatment and supply is limited to a lifetime maximum of 8 treatments per tumour site and to 10 treatments per tumour site for patients in whom radiotherapy is suspended. These limits are mandatory in WA public hospitals.
    Two conditions in addition to the PBS restrictions apply, requiring treatment with cetuximab to be:
  1. where cure or local control is probable and warranted, and
  2. where there is evidence that chemotherapy with cisplatin is contraindicated due to:
  1. renal impairment with creatinine clearance below 75 mL/minute
  2. significant neuropathy
  3. sensorineural deafness
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cinacalcet (hyper-parathyroidism)

  • PBS: Section 100 (initial treatment) and Section 85 (maintenance treatment), November 2007. Authority required. For the initial and continuing management, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyper-parathyroidism.
  • WA hospital formulary listing: Approved for the treatment of patients with chronic kidney disease on dialysis who have sustained secondary hyper-parathyroidism, according to the same restrictions for initiation and maintenance as the PBS.
  • Special requirements: Requirements for titration and monitoring as per the PBS.
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etanercept (rheumatoid arthritis)

  • PBS: Section 85. Authority required. For the treatment of adult patients with severe active rheumatoid arthritis. Restrictive criteria for initial treatment, continuing treatment and interchangeability.
  • WA hospital formulary listing: Approved for severe active rheumatoid arthritis with the same restrictions as apply under the PBS.  Interchangeable with other biological disease modifying anti-rheumatic drugs (bDMARDs) (adalimumab, infliximab, abatacept and rituximab) but NOT anakinra.
  • Special requirements: Included with other (bDMARDs) (adalimumab, infliximab, abatacept and rituximab) under the interchangeability arrangements used by the PBS for the treatment of severe rheumatoid arthritis.  Additional criteria for public hospital use to include the following:
  1. Treatment shall be supervised through specialist severe arthritis clinics.
  2. Treatment progress and outcomes shall be monitored, locally or via the proposed Australian Rheumatology Association Database (if ARA consent is obtained), and outcomes reported to WATAG.
  3. Arthritis patients already approved for and receiving treatment shall continue to receive such therapy while they satisfy the criteria for continuation or treatment as recommended by the PBS.
  4. These conditions only affect adult patients (> 18 years).
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everolimus (allograft rejection)

  • PBS: Section 100 (initial treatment) and Section 85 (maintenance treatment), March 2005.  Authority required.  Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for:
  1. prophylaxis of renal allograft rejection.  Management includes initiation, stabilisation and review, and maintenance of therapy as required; or
  2. prophylaxis of cardiac allograft rejection. Management includes initiation, stabilisation and review, and maintenance of therapy as required.
  • WA hospital formulary listing: Approved 13 April 2006.  Approved for use according to the PBS criteria with an extension to include use for prophylaxis of organ rejection in adults with renal dysfunction, chronic allograft rejection or intolerance of calcineurin inhibitor therapy after lung or heart-lung transplantation.
  • Special requirements: An extension of the PBS listing of everolimus is approved for the prophylaxis of organ rejection after lung or heart-transplantation in adults with, renal dysfunction, chronic allograft rejection, or intolerance of calcineurin inhibitor therapy.  Prescription restricted to specialised transplant units.
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gefitinib (non-small cell lung cancer)

  • PBS: Section 85,  Authority required.  Initial PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where:
    1. disease progression has occurred following treatment with at least 1 chemotherapy agent; and
    2. there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material. The mutation(s) must be demonstrated by analysis of the DNA sequence of the EGFR gene.
  • WA hospital formulary listing: Not available. An application for use of gefitinib for second-line, post-failure of chemotherapy in non-small cell lung cancer was reviewed but suspended as a result of advice being issued by the US Food and Drug Administration (FDA).
  • Special requirements: A new submission is required for this drug to be considered for listing on the formularies of WA public hospitals.
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infliximab (ankylosing spondylitis)

  • PBS: Section 100. Authority required. For the treatment of adult patients with active ankylosing spondylitis.
  • WA hospital formulary listing: Approved for the treatment of ankylosing spondylitis according to the same restrictions as the PBS.
  • Special requirements: For use according to the PBS S100 listing criteria only.
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infliximab (Crohn disease)

  • PBS: Section 100. Authority required. For the treatment of adult patients with severe refractory Crohn disease. Restrictive criteria for initial treatment, continuing treatment and interchangeability with adalimumab.
  • WA hospital formulary listing: Approved for the treatment of adult patients with severe refractory Crohn disease according to the same restrictions as the PBS. Treatment of fistulising disease is not approved unless the patient satisfies the PBS criteria for severe active Crohn disease.
  • Special requirements: For use according to the PBS S100 listing criteria only.
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infliximab (plaque psoriasis)

  • PBS: Section 100, July 2006. Authority required. For the treatment of adult patients with severe chronic plaque psoriasis. Restrictive criteria for initial treatment and continuing treatment.
  • WA hospital formulary listing: Approved for the treatment of severe chronic plaque psoriasis according to the same restrictions as the PBS.
  • Special requirements: For use according to the PBS S100 listing criteria plus additional hospital criteria or alternative regimen as follows
  1. Application is by prospective approval on an individual patient basis by a process determined within each institution.
  2. Treatment must be undertaken by a qualified consultant dermatologist.
  3. Adult patients who have been diagnosed with severe chronic plaque psoriasis as defined by a psoriasis area and severity index (PASI) of at least 15 or severe psoriasis on the hands, face and/or feet and who have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
    (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
    (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
    (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
    (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks.
  4. Treatment is allowed in accordance with the registered Product Information Sheet, but is also approved according to the following alternative regimen (which uses less drug) at the discretion of the treating consultant:
    Alternative Regimen - Initial Treatment: One 3-5 mg/kg initial infusion followed by immunomodulation (eg methotrexate). (a) If patient responds appropriately (at least 75% improvement in symptoms) no further treatment until 8 weeks with disease progression despite maintenance therapy with immunomodulator. (b) If no response at 2 weeks give second 3-5 mg/kg infusion. (c) If no response at 6 weeks give third 3-5 mg/kg infusion.
    Alternative Regimen - Maintenance treatment: Continue immunomodulation and intermittent infliximab treatment if there is a disease flare, of 3-5 mg/kg infusion at minimum intervals of 8 weeks.
  5. Infliximab therapy should be reviewed and ceased if patients do not demonstrate a 75% reduction in psoriasis area and severity index (PASI) score at between 10 and 14 weeks after commencing infliximab therapy.
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infliximab (psoriatic arthritis)

  • PBS: Section 100. Authority required. Treatment of adult patients with severe active psoriatic arthritic according to specific criteria.
  • WA hospital formulary listing: Approved for the treatment of adult patients with severe active psoriatic arthritis according to the same criteria approved by the PBS S100.
  • Special requirements: PBS requirements apply to hospital use for the initiation, continuation, baseline monitoring and re-treatment of patients.
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infliximab (rheumatoid arthritis)

  • PBS: Section 100. Authority required. For the treatment of adult patients with severe active rheumatoid arthritis. Restrictive criteria for initial treatment, continuing treatment and interchangeability.
  • RPBS:  Authority required.  Initial and continuing treatment, in combination with methotrexate, of specific accepted war-caused or service-related disability of refractory rheumatoid arthritis, and meeting the stated RPBS requirements.
  • WA hospital formulary listing: Approved for severe active rheumatoid arthritis with the same restrictions as apply under the PBS. Interchangeable with other biological disease modifying anti-rheumatic drugs (bDMARDs) (adalimumab, etanercept, abatacept and rituximab) but NOT anakinra.
  • Special requirements: Included with other (bDMARDs) (adalimumab, etanercept and rituximab) under the interchangeability arrangements used by the PBS for the treatment of severe rheumatoid arthritis. Additional criteria for public hospital use to include the following:
  1. Treatment shall be supervised through specialist severe arthritis clinic.
  2. Treatment progress and outcomes shall be monitored, locally or via the proposed Australian Rheumatology Association Database (if ARA consent is obtained), and outcomes reported to WATAG.
  3. Arthritis patients already approved for and receiving treatment shall continue to receive such therapy while they satisfy the criteria for continuation or treatment as recommended by the PBS.
  4. These conditions only affect adult patients greater than 18 years of age.
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lapatinib (metastatic breast cancer)

  • PBS: Section 85. Authority required. For treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer (equivalent to Stage IIIC or Stage IV) who has received prior therapy with an anthracycline and a taxane, each for at least 3 cycles, and whose disease has progressed despite treatment with trastuzumab for metastatic disease. Restrictive criteria apply for initial and continuing treatment.
  • WA hospital formulary listing: Approved for listing January 2008 subject to PBS criteria.
  • Special requirements: Listed at WA public hospitals according to the same criteria as the PBS.
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methylphenidate - osmotic release oral system (ADHD)

  • PBS: Section 85. Authority required. For the treatment of attention deficit hyperactivity disorder (ADHD) in a patient aged 6 to 18 years inclusive, who has demonstrated a response to immediate release methylphenidate hydrochloride with no emergence of serious adverse events, and who requires continuous coverage over 12 hours. Restricted to use by consultant paediatrician or child psychiatrist.
  • WA hospital formulary listing: Approved for listing November 2008 subject to PBS criteria.
  • Special requirements: In addition to the PBS criteria, for hospital use the prescription of OROS methylphenidate is restricted to use by a consultant paediatrician or child psychiatrist who is also authorised stimulant prescriber. The use of OROS methylphenidate is reserved for third-line treatment after immediate-release methylphenidate or dexamphetamine (first-line) and long-acting (LA) methylphenidate (second-line). Requirements that patients be diagnosed with ADHD according to recognised criteria e.g. ICD-10 or DSM-IV prevail. Prescription of OROS methylphenidate must also be in accordance with the Stimulant Regulatory Guidelines or as otherwise authorised in writing by the Chief Executive Officer of Health.
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omalizimuab (severe persistent allergic asthma)

  • PBS: Not listed.
  • WA hospital formulary listing: Approved for listing May 2008 subject to restrictions described below.
  • Special requirements: Omalizumab is available for use in a highly targeted population of adult or adolescent patients with severe persistent allergic asthma, subject to the following restrictions:
  1. All requests for use must be via an individual patient approval to the relevant hospital Drug and Therapeutics Committee.
  2. The patients must meet all of the following criteria for use:
    1. Age ≥12 years of age.
    2. Severe, persistent asthma in spite of optimised therapy. Must have trialled concurrently and as a minimum:
      1. High dose inhaled corticosteroid, and
      2. Long acting beta agonist, and
      3. Prednisolone ³10 mg/day, and
      4. Other medications if clinically appropriate, including montelukast, theophyliine, cromoglycate and antichoingerics.
    3. Allergic asthma confirmed via appropriate testing and history of typical symptoms.
    4. Other causes of severe asthma have been fully explored including correct drug usage, compliance and non-allergic triggers.
    5. Frequent severe asthma exacerbations where the person has had at least two hospital admissions for severe asthma in the past year.
    6. Chance of mortality or severe morbidity from asthma is high and the patient:
      1. Has had at least one episode necessitating assisted ventilation despite optimal therapy, or
      2. Has had at least one admission to ICU for severe asthma, or
      3. Requires such high levels of corticosteroids to be of significant risk to ongoing health.
    7. Other systemic immunosuppressive drugs (eg. methotrexate, gold, cyclosporin) have been trialled or in the view of the treating clinician pose an unacceptable health risk.
    8. The person has stopped smoking.
  3. Treatment must be initiated by a physician experienced in the management of severe persistent asthma.
  4. Marked improvement in asthma control must be demonstrated within six months of Omalizumab therapy, or treatment must be ceased.  The following criteria must be met to continue therapy:
    1. Decrease in daily oral steroid of at least 25% at 4 months.
    2. Total oral steroid use must be less than 10mg/day at 12 months and following a program of progressive reduction of corticosteroids to nil unless adrenal suppression exists.
    3. Greater than 25% improvement in symptoms, rescue medication use, frequency of clinically significant and severe exacerbations or emergency visits/admissions to hospital at 4 months and maintained or better at 8 months.
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pemetrexed disodium (mesothelioma)

  • PBS: Section 85, November 2007.  Authority required.  For the treatment of patients with mesothelioma in combination with cisplatin.
  • WA hospital formulary listing: Initially approved October 2005.  Approved according to the PBS criteria for the treatment of malignant pleural mesothelioma in combination with cisplatin.
  • Special requirements: Approved for treatment in patients with performance status 0 to 1 and no other significant co-morbidities. Doses greater than 500 mg per metre squared body surface area (BSA) will not be approved. The patient's BSA must be provided. No applications for increased maximum quantities for the 500 mg vial will be authorised.
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pemetrexed disodium (non-small cell lung cancer)

  • PBS: Section 85.  Authority required.  Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy.
  • WA hospital formulary listing: Approved according to the same restrictions as the PBS for treatment of patients with locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy.
  • Special requirements: Available after prior platinum based chemotherapy with paclitaxel or docetaxel is either contraindicated, or where tolerance has developed, or where treatment was unsuccessful, or is likely to result in adverse clinical consequences.
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posaconazole (fungal infections)

  • PBS:
  1. The treatment of specified fungal infections in patients intolerant to, or with disease refractory to, alternative therapy.
  2. Prophylaxis of invasive fungal infections, including both yeasts and moulds, in a patient who is at high risk of developing these infections, as defined for neutropaenia and graft versus host disease (GVHD).
  • WA hospital formulary listing: Approved for:
  1. The treatment of specified fungal infections in patients intolerant to, or with disease refractory to, alternative therapy.
  2. Prophylaxis of invasive fungal infections, including both yeasts and moulds, in a patient who is at high risk of developing these infections, as defined for neutropaenia and graft versus host disease (GVHD).
  • Special requirements: Specified fungal infections include invasive aspergillosis, fusariosis, zygomycosis, coccidiodomycosis, chromoblastomycosis, and mycetoma. Available for both in-patients and out-patients on prescription or recommendation of an infectious diseases physician or clinical microbiologist only.
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pregabalin (neuropathic pain)

  • PBS: Not listed.
  • RPBS:  For the treatment of refractory neuropathic pain not controlled by other drugs.
  • WA hospital formulary listing: Approved for the treatment of refractory neuropathic pain not controlled by other drugs according to neuropathic pain treatment algorithm.
  • Special requirements: See WATAG Advisory note December 2007.  For treatment according to approved treatment algorithm.
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risperidone long acting injectable (schizophrenia)

  • PBS: Section 85.  Authority required.  For the treatment of schizophrenia.
  • WA hospital formulary listing: Approved with restrictions for the treatment of schizophrenia when a depot atypical neuroleptic is required.
  • Special requirements:
  1. Initial Treatment (4 months only)
    This long acting injectable medication is indicated in patients with schizophrenia who have documented significant adverse consequences resulting from significant non-compliance* following treatment with oral antipsychotic drugs AND in whom a reasonable trial of depot "typical" drugs such as zuclopenthixol or flupenthixol has been associated with unacceptable objective side-effects.
    *Defined as non-compliance of sufficient degree to cause re-hospitalisation or dangerous behaviour to self or others.
  2. Continuing Treatment
    Continuation after 4 months is conditional on achievement of clinical benefit and absence of extrapyramidal side-effects. If no clinical improvement is demonstrable after 4 months, drug should be ceased.
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rituximab (diffuse large B-cell lymphoma)

  • PBS: Section 85. Authority required. For treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.
  • WA hospital formulary listing: Approved for the treatment of patients of all ages with DLBCL according to the PBS criteria.
  • Special requirements: Use of rituximab in public hospitals for the above indications is subject to the same restrictions as under the PBS.  Repeated courses of treatment are prohibited following failed therapy.
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rituximab (relapsed or refractory B-cell non-Hodgkin's lymphoma)

  • PBS: Section 85.  Authority required. a)  Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma;  b)  Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma.
  • WA hospital formulary listing: Approved for the treatment of a) relapse or refractory, low-grade B-cell non-Hodgkin's lymphoma; and b) relapse or refractory, follicular B-cell non-Hodgkin's lymphoma.
  • Special requirements: Use of rituximab for the above indications is subject to the same restrictions as under the PBS, plus additional initiation and continuation criteria for public hospital use.
  1. Initial Treatment:  patients must have an ECOG or equivalent performance status of 0 - 2 (fair to good), and not have a diagnosis of chronic lymphocytic leukaemia
  2. Continuing Treatment:  patients must exhibit a response to therapy during the previous cycle; hence rituximab must be withdrawn in patients who have failed to respond to the drug during the previous cycle, and not re-used in that patient again.

Repeated courses of treatment are prohibited following failed therapy.
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rituximab (follicular, B-cell non-Hodgkin’s lymphoma)

  • PBS: Section 85.  Authority required.  For the treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.
  • WA hospital formulary listing: Approved according to PBS S85 criteria for the treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin’s lymphoma, in combination with chemotherapy.
  • Special requirements: Subject to annual review and reporting of expenditure and data on mortality benefits.
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rituximab (rheumatoid arthritis)

  • PBS: Section 100.  Authority required.  For the treatment of adult patients with severe active rheumatoid arthritis.  Restrictive criteria apply for initial treatment, continuing treatment and interchangeability.
  • WA hospital formulary listing: Approved according to PBS S100 criteria.  Approved for severe active rheumatoid arthritis with the same restrictions as apply under the PBS.  Interchangeable with other TNF-alpha inhibitors (adalimumab, etanercept and infliximab), but NOT anakinra or abatacept.
  • Special requirements: For use according to the PBS S100 listing criteria.  Included with the TNF-alpha inhibitors (adalimumab, etanercept and infliximab) under the interchangeability arrangements used by the PBS for the treatment of severe rheumatoid arthritis.
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trastuzumab (early breast cancer)

  • PBS: Section 100.  Authority required.  For treatment of HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery.  Restrictive criteria apply for initial and continuing treatment.
  • WA hospital formulary listing: Approved according to PBS S100 criteria.
  • Special requirements: The total duration of treatment (initial plus continuing) is 52 weeks.  HER2 positivity must be demonstrated by in situ hybridisation (ISH).  Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.  Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to commencing treatment and then at 3 monthly intervals during treatment.
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