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

The same changes to the restrictions for ticagrelor (Brilinta) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

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.

The same changes to the restrictions for budesonide capsules (Entocort CIR) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

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.

The same changes to the restrictions for etanercept (Enbrel) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Special Authority for Subsidy

Initial application only from a haematologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; and
2. Either

2.1 A classification of risk of intermediate-2 or high-risk myelofibrosis according to either the International Prognostic Scoring System (IPSS), Dynamic International Prognostic Scoring System (DIPSS), or the Age-Adjusted DIPSS; and or
2.2 Both

2.2.1 A classification of risk of intermediate-1 myelofibrosis according to either the International Prognostic Scoring System (IPSS), Dynamic International Prognostic Scoring System (DIPSS), or the Age-Adjusted DIPSS; and
2.2.2 Patient has severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; and  

3. A maximum dose of 20 mg twice daily is to be given.

Renewal only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. The treatment remains appropriate and the patient is benefiting from treatment; and
2. A maximum dose of 20 mg twice daily is to be given.

The same changes to the restrictions for ruxolitnib (Jakavi) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).