MIL OSI – Source: Pharmac – Press Release/Statement
Headline: Proposal for sole supply of erythropoietin
Section B
Initial application – (chronic renal failure) from a relevant any Specialist. Approvals valid for 2 years for applications meeting the following criteria:
Both:
1. Both:
1.1 patient in chronic renal failure; and
1.2 Haemoglobin ≤ 100 g/L; and
2. Any of the following:
2.1 Both:
2.1.1 patient is not diabetic; and
2.1.2 glomerular filtration rate ≤ 30 ml/min; or
2.2 Both:
2.2.1 patient is diabetic; and
2.2.2 glomerular filtration rate ≤ 45 ml/min; or
2.3 patient is on haemodialysis or peritoneal dialysis.
Note
Erythropoietin beta/alphaalfa is indicated in the treatment of anaemia associated with chronic renal failure (CRF) where no cause for anaemia other than CRF is detected and there is adequate monitoring of iron stores and iron replacement therapy.
The Cockroft-Gault Formula may be used to estimate glomerular filtration rate (GFR) in persons 18 years and over:
GFR (ml/min) (male) = (140 – age) x Ideal Body Weight (kg) / 814 x serum creatinine (mmol/l)
GFR (ml/min) (female) = Estimated GFR (male) x 0.85
Initial application – (myelodysplasia) from any Specialist. Approvals valid for 2 months for applications meeting the following criteria:
All of the following:
1. Patient has a confirmed diagnosis of myelodysplasia (MDS);
2. Has had symptomatic anaemia with haemoglobin <100g/L and is red cell transfusion-dependent*;
3. Patient has very low or low risk MDS based on the WHO classification based prognostic scoring system for myelodysplastic syndrome (WPSS);
4. Other causes of anaemia such as B12 and folate deficiency have been excluded;
5. Patient has a serum erythropoietin level of <500 IU/mL; and
6. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.
*Transfusion dependence is defined as a transfusion requirement of at least 4 units of red cells per month over a period of 4 months.
Renewal – (chronic renal failure) from a relevant any Specialist. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.
Note
Erythropoietin beta/alphaalfa is indicated in the treatment of anaemia associated with chronic renal failure (CRF) where no cause for anaemia other than CRF is detected and there is adequate monitoring of iron stores and iron replacement therapy.
The Cockroft-Gault Formula may be used to estimate glomerular filtration rate (GFR) in persons 18 years and over:
GFR (ml/min) (male) = (140 – age) x Ideal Body Weight (kg) / 814 x serum creatinine (mmol/l)
GFR (ml/min) (female) = Estimated GFR (male) x 0.85
Renewal application – (myelodysplasia) from any Specialist. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
1. The patient’s transfusion requirement continues to be reduced with erythropoietin treatment;
2. Transformation to acute myeloid leukaemia has not occurred; and
3. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.
Part II of Section H
Restricted (chronic renal failure)
Both:
1 Both:
1.1 Patient in chronic renal failure; and
1.2 Haemoglobin ≤ 100g/L; and
2 Any of the following:
2.1 Both:
2.1.1 Patient is not diabetic; and
2.1.2 Glomerular filtration rate ≤ 30ml/min; or
2.2 Both:
2.2.1 Patient is diabetic; and
2.2.2 Glomerular filtration rate ≤ 45ml/min; or
2.3 Patient is on haemodialysis or peritoneal dialysis.
Initiation (myelodysplasia)
Re-assessment required after 2 months
All of the following:
1. Patient has a confirmed diagnosis of myelodysplasia (MDS);
2. Has had symptomatic anaemia with haemoglobin <100g/L and is red cell transfusion-dependent*;
3. Patient has very low or low risk MDS based on the WHO classification based prognostic scoring system for myelodysplastic syndrome (WPSS);
4. Other causes of anaemia such as B12 and folate deficiency have been excluded;
5. Patient has a serum erythropoietin level of <500 IU/mL; and
6. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.
*Transfusion dependence is defined as a transfusion requirement of at least 4 units of red cells per month over a period of 4 months.
Continuation (myelodysplasia)
Re-assessment required after 12 months
All of the following:
1. The patient’s transfusion requirement continues to be reduced with erythropoietin treatment;
2. Transformation to acute myeloid leukaemia has not occurred; and
3. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.
Restricted (all other indications)
Haematologist
For use in patients where blood transfusion is not a viable treatment alternative.
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