Health
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Hospital Circular 01/2003

Date Issued: 8 January 2003

Publication: 01/2003

Distribution: Public Hospitals

Subject: Highly Specialised Drugs Program

Purpose: To advise hospitals involved of changes to the Highly Specialised Drugs Program, effective 1 February 2003.


We have had recent advice from the Commonwealth of changes to the Highly Specialised Drugs Program, effective 1 February 2003.

1. ADD DRUG

Pegfilgrastim (Neulasta)

6363X Injection 6 mg in 0.6 mL single pre-filled syringe 1 $1,925.00

For use in patients undergoing induction and consolidation therapy for acute myeloid leukaemia;
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in:

Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned;

Patients receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned;

Patients receiving chemotherapy for myeloma who have had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned.

2. ADD ITEM

Mycophenolate mofetil (CellCept)

6364Y Powder for oral suspension 1 g per 5 mL, 165 mL 1 $244.51

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 of therapy as required;
  2. Prophylaxis of cardiac allograft rejection. Management includes initiation, stabilisation and review of therapy as required.

3. PRICE DECREASE

Disodium pamidronate (Pamisol & Aredia)

6286W Concentrated injection 15 mg in 5 mL 1 $56.89
6290C Injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL 1 $227.57
6287X Concentrated injection 30 mg in 10 mL 1 $113.79
6279L Injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL 1 $227.57
6288Y Concentrated injection 60 mg in 10 mL 1 $227.57
6289B Concentrated injection 90 mg in 10 mL 1 $341.36
6223M Injection set containing 1 vial powder for I.V. infusion 90 mg and 1 ampoule solvent 10 mL 1 $341.36

4. AMEND RESTRICTION

Baclofen (Lioresal Intrathecal)

6284R Intrathecal injection 10 mg in 5 mL 1 $140.00
6285T Intrathecal injection 10 mg in 20 mL 1 $140.00
Change from:

Patients with severe chronic spasticity due to multiple sclerosis or spinal cord injury or disease where oral antispastic agents have failed or have caused unacceptable side effects.

Change to:

Severe chronic spasticity, where oral antispastic agents have failed or have caused unacceptable side effects, in patients with chronic spasticity:

  1. of cerebral origin; or
  2. due to multiple sclerosis; or
  3. due to spinal cord injury; or
  4. due to spinal cord disease.

Cyclosporin (Neoral & Cysporin)

6232B Capsule 10 mg 60 $37.20
6352H Capsule 25 mg 30 $45.01
6111P Capsule 25 mg 50 $75.02
6353J Capsule 50 mg 30 $90.00
6112Q Capsule 50 mg 50 $150.00
6354K Capsule 100 mg 30 $180.00
6114T Capsule 100 mg 50 $300.00
6125J Oral liquid 100 mg per mL, 50 mL 1 $315.79
Change from:

For use by organ or tissue transplant recipients;

Treatment by dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate;

Treatment by dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life;

Treatment by nephrologists of nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired;

Treatment by rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate.

Change to:

Management of rejection in patients following organ or tissue transplantation, under the supervision and direction of a transplant unit. Management includes initiation, stabilisation and review of therapy as required;

Management (which includes initiation, stabilisation and review of therapy) by

  1. dermatologists or clinical immunologists of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate;
  2. dermatologists of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life;
  3. nephrologists of patients with nephrotic syndrome in patients in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired;
  4. rheumatologists or clinical immunologists of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate.

Darbepoetin alfa (Aranesp)

6320P Injection 10 micrograms in 0.4 mL pre-filled syringe 4 $187.41
6321Q Injection 20 micrograms in 0.5 mL pre-filled syringe 4 $352.96
6322R Injection 30 micrograms in 0.3 mL pre-filled syringe 4 $482.87
6323T Injection 40 micrograms in 0.4 mL pre-filled syringe 4 $586.10
6324W Injection 50 micrograms in 0.5 mL pre-filled syringe 4 $724.62
6325X Injection 60 micrograms in 0.3 mL pre-filled syringe 4 $850.87
6326Y Injection 100 micrograms in 0.5 mL pre-filled syringe 4 $1,379.21
Change from:

For the treatment of anaemia requiring transfusion, associated with chronic renal failure.

Change to:

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100g/L, associated with chronic renal failure, defined as a glomerular filtration rate of less than 60mL/min, where treatment is initiated by, or follows consultation by the prescriber with, a nephrologist.

Note: With the amended indication for darbepoetin from 1 February 2003 it is proposed that patients prior to this period be eligible to continue to receive subsidised treatment irrespective of whether they meet the definitions of renal failure or anaemia or the requirement of involvement by a nephrologist.

Epoetin alfa (Eprex)

6251B Injection 1,000 units in 0.5 mL pre-filled syringe 6 $147.00
6204M Injection 2,000 units in 0.5 mL pre-filled syringe 6 $272.00
6205N Injection 3,000 units in 0.3 mL pre-filled syringe 6 $351.00
6206P Injection 4,000 units in 0.4 mL pre-filled syringe 6 $447.00
6302Q Injection 5,000 units in 0.5 mL pre-filled syringe 6 $556.50
6303R Injection 6,000 units in 0.6 mL pre-filled syringe 6 $660.60
6304T Injection 7,000 units in 0.7 mL pre-filled syringe 6 $756.00
6305W Injection 8,000 units in 0.8 mL pre-filled syringe 6 $856.80
6306X Injection 9,000 units in 0.9 mL pre-filled syringe 6 $953.10
6207Q Injection 10,000 units in 1 mL pre-filled syringe 6 $1,037.00
6339P Injection 40,000 units in 1 mL pre-filled syringe 1 $660.00
Change from:

For the treatment of anaemia requiring transfusion, associated with chronic renal failure.

Change to:

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100g/L, associated with chronic renal failure, defined as a glomerular filtration rate of less than 60mL/min, where treatment is initiated by, or follows consultation by the prescriber with, a nephrologist.

Note: With the amended indication for epoetin from 1 February 2003 it is proposed that patients prior to this period be eligible to continue to receive subsidised treatment irrespective of whether they meet the definitions of renal failure or anaemia or the requirement of involvement by a nephrologist.

Mycophenolate mofetil (Cellcept)

6208R Capsule 250 mg 300 $555.70
6209T Tablet 500 mg 150 $555.70
Change from:

Prophylaxis of renal allograft rejection;
Prophylaxis of cardiac allograft rejection.

Change to:

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 of therapy as required;
  2. Prophylaxis of cardiac allograft rejection. Management includes initiation, stabilisation and review of therapy as required.

Tacrolimus (Prograf)

6328C Capsule 500 micrograms 100 $184.80
6216E Capsule 1 mg 100 $369.60
6217F Capsule 5 mg 50 $924.00
Change from:

For the prevention and treatment of rejection in liver transplant recipients;
For the prevention and treatment of rejection in renal transplant recipients.

Change to:

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for:

  1. Prophylaxis and treatment of liver allograft rejection. Management includes initiation, stabilisation and review of therapy as required;
  2. Prophylaxis and treatment of renal allograft rejection. Management includes initiation, stabilisation and review of therapy as required.

5. AMEND PACK SIZE

Valaciclovir hydrochloride (Valtrex)

6280M Tablet 500 mg (base) 100 $483.63 Valtrex GK

6. DELETE

Epoetin alfa (Eprex)

6304T Injection 7,000 units in 0.7 mL pre-filled syringe 6 $756.00
6306X Injection 9,000 units in 0.9 mL pre-filled syringe 6 $953.10

This item is being discontinued by manufacturer.

Changes notified by hospital circular will be updated in the Guidelines on the Commonwealth/State Highly Specialised Drugs Program Guidelines website and the claim form amended.

Noreen Dowd
Director, Programs Branch
Metropolitan Health and Aged Care Services