Decision for funding in the blood, alimentary and immunosuppressant therapy areas

Special Authority for Subsidy

Initial application – (thrombosis prevention post neurological stenting) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria.

Both:

1. Patient has had a neurological stenting procedure* in the last 60 days; and
2. Either

2.1  Patient has demonstrated clopidogrel resistance using the P2Y12 (VerifyNow) assay and requires antiplatelet treatment with ticagrelor; or

2.2  Clopidogrel resistance has been demonstrated by the occurrence of a new cerebral ischemic event.

Renewal – (thrombosis prevention post neurological stenting) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria.

Both:

1. Patient is continuing to benefit from treatment; and
2. Treatment continues to be clinically appropriate.

Note: Indications marked with * are unapproved indications

Special Authority for Subsidy

Initial application – (non-cirrhotic autoimmune hepatitis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has autoimmune hepatitis*; and
2. Patient does not have cirrhosis; and
3. Any of the following:

3.1 Diabetes; or

3.2 Cushingoid habitus; or

3.3 Osteoporosis where there is significant risk of fracture; or

3.4 Severe acne following treatment with conventional corticosteroid therapy; or

3.5 History of severe psychiatric problems associated with corticosteroid treatment; or

3.6 History of major mental illness (such as bipolar affective disorder) where the risk of conventional corticosteroid treatment causing relapse is considered to be high; or

3.7 Relapse during pregnancy (where conventional corticosteroids are considered to be contraindicated).

3.8 Adolescents with poor linear growth (where conventional corticosteroid use may limit further growth) 

Note: Indications marked with * are unapproved indications

Renewal – (non-cirrhotic autoimmune hepatitis) from any relevant practitioner. Approvals valid for 6 months where the treatment remains appropriate and the patient is benefitting from the treatment.

Special Authority for Subsidy

Initial application — (undifferentiated peripheral spondyloarthritis) only from a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has undifferentiated peripheral spondyloarthritis* with active peripheral joint arthritis in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
2. Patient has tried and not responded to at least three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose; and
3. Patient has tried and not responded to at least three months of sulfasalazine at a dose of at least 2 g per day (or maximum tolerated dose); and
4. Patient has tried and not responded to at least three months of leflunomide at a dose of up to 20 mg daily (or maximum tolerated dose); and

5. Any of the following:

   5.1 Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or

   5.2 Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour measured no more than one month prior to the date of this application; or

   5.3 ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

Note: Indications marked with * are unapproved indications

Renewal — (undifferentiated peripheral spondyloarthritis) only from a rheumatologist or medical practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Either:

1.1 Applicant is a rheumatologist; or

1.2 Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with etanercept treatment; and

2. Either:

2.1 Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or

2.2 The patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior etanercept treatment in the opinion of the treating physician; and

3. Etanercept to be administered at doses no greater than 50 mg dose every 7 days.