Oral semi-solid 109 g, 36 (PKU Lophlex Sensation 20)

Oral

PKU Lophlex Sensation 20

SB

MP NP

C4295

3

5

1

Amoxycillin/ Clavulanic Acid 500/125 generichealth

GQ

PDP

C1836 C1837

10

0

10

Amoxycillin/ Clavulanic Acid 500/125 generichealth

GQ

MP NP MW

C1836 C1837

10

1

10

Azithromycin-GA

UA

MP NP

C1405 C1838 C1839

P1838 P1839

2

0

2

Azithromycin-GA

UA

MP NP

C1405 C1838 C1839

P1405

2

2

2

Pharmacor Candesartan 4

CR

MP NP

30

5

30

Pharmacor Candesartan 8

CR

MP NP

30

5

30

Pharmacor Candesartan 16

CR

MP NP

30

5

30

Pharmacor Candesartan 32

CR

MP NP

30

5

30

Taxotere

SW

MP

C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239

See Note 3

See
Note 3

1

D(100)

Doxycycline Sandoz

HX

MP NP

C1346 C1851 C1852

25

5

25

Famciclovir SCP 250

CR

MP NP

C3622 C3623

P3622

21

0

21

Famciclovir SCP 250

CR

MP NP

C3622 C3623

P3623

56

5

56

Aldiq

QA

MP

C4229

1

1

1

Iron Polymaltose Complex

Injection 100 mg (iron) in 2 mL

Injection

Ferrosig

SI

MP NP

5

0

5

MP NP

P4302

5

5

5

Ferrum H

AS

MP NP

5

0

5

MP NP

P4302

5

5

5

T Lukast

AF

MP NP

C2617

28

5

28

T Lukast

AF

MP NP

C2618 C3217

28

5

28

Omeprazole Winthrop

WA

MP NP

C4074 C4075 C4089 C4152

P4074

30

1

30

Omeprazole Winthrop

WA

MP NP

C4074 C4075 C4089 C4152

P4075 P4089 P4152

30

5

30

Perindopril generichealth

GQ

MP NP

30

5

30

Quinapril generichealth

GQ

MP NP

30

5

30

Rabeprazole Actavis 20

UA

MP NP

C1177 C1337 C1533

P1177

30

2

30

Rabeprazole Actavis 20

UA

MP NP

C1177 C1337 C1533

P1337 P1533

30

5

30

Ramipril generichealth

GQ

MP NP

30

5

30

Trandolapril generichealth

GQ

MP NP

28

5

28

Dornase Alfa

C4288 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Patient must have a forced vital capacity (FVC) greater than 40% predicted for age, gender and weight;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 5 years of age or older

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation

Prior to dornase alfa therapy, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease

Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily

FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy

To be eligible for continued PBS-subsidised treatment with dornase alfa following 3 months of initial treatment:

(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient

Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use

Other aspects of treatment, such as physiotherapy, must be continued

Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy, then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4288

C4290 

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Patient must have a forced vital capacity (FVC) greater than 40% predicted for age, gender and weight;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease)
Patient must be 5 years of age or older

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation

Prior to dornase alfa therapy, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease

Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily

FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy

To be eligible for continued PBS-subsidised treatment with dornase alfa following 3 months of initial treatment:

(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient

Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use

Other aspects of treatment, such as physiotherapy, must be continued

Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy, then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)

Compliance with Written or Telephone Authority Required procedures

C4291 

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Continuing treatment

Patient must have initiated treatment with dornase alfa at an age of less than 5 years;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be 5 years of age or older

Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures

C4296 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Continuing treatment

Patient must have initiated treatment with dornase alfa at an age of less than 5 years;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be 5 years of age or older

Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4296

C4297 

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Patient must have initiated treatment with dornase alfa prior to 1 November 2009;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be less than 5 years of age

Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures

C4298 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Patient must have initiated treatment with dornase alfa prior to 1 November 2009;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be less than 5 years of age

Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4298

C4300 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy;
Patient must be less than 5 years of age

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4300

C4301

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy
Patient must be less than 5 years of age

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals

Compliance with Written or Telephone Authority Required procedures

C1578

Patients with intractable seizures requiring treatment with a ketogenic diet

C1579

Glucose transport protein defects

C1580

Pyruvate dehydrogenase deficiency

C4289

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency

KetoCal 4:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist

Iron Polymaltose Complex

P4302

Iron deficiency anaemia

Patient must be undergoing chronic haemodialysis
 

Compliance with Authority Required procedures - Streamlined Authority Code 4302

Iron Sucrose

C4292

Iron deficiency anaemia

Patient must be undergoing chronic haemodialysis;
The treatment must be in combination with an erythropoiesis stimulating agent;
Patient must have had a documented hypersensitivity reaction to iron polymaltose;
Patient must be a person in whom continued intravenous iron therapy is appropriate

Compliance with Authority Required procedures - Streamlined Authority Code 4292

Mannitol

C4293 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Patient must have initiated treatment with mannitol prior to 1 August 2012;
Patient must have undergone a comprehensive assessment involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, which documents agreement that mannitol treatment is continuing to produce a worthwhile benefit;
Patient must be 6 years of age or older

Further reassessments are to be undertaken and documented every 6 months. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4293

C4294 

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Patient must have initiated treatment with mannitol prior to 1 August 2012;
Patient must have undergone a comprehensive assessment involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, which documents agreement that mannitol treatment is continuing to produce a worthwhile benefit;
Patient must be 6 years of age or older

Further reassessments are to be undertaken and documented every 6 months. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use

Compliance with Written or Telephone Authority Required procedures

C4299 

Where the patient is receiving treatment at/from a public hospital

Cystic fibrosis

Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information mannitol initiation dose assessment, prior to mannitol therapy. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
Patient must have a forced expiratory volume in 1 second (FEV1) greater than 30% predicted for age, gender and height;
Patient must be intolerant or inadequately responsive to dornase alfa;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 6 years of age or older

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation

Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease

Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily

FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy

To be eligible for continued PBS-subsidised treatment with mannitol following 3 months of initial treatment:

(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient

Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that mannitol treatment is continuing to produce worthwhile benefits. Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use

Other aspects of treatment, such as physiotherapy, must be continued

Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4299

C4303

Where the patient is receiving treatment at/from a private hospital

Cystic fibrosis

Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information mannitol initiation dose assessment, prior to mannitol therapy. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
Patient must have a forced expiratory volume in 1 second (FEV1) greater than 30% predicted for age, gender and height;
Patient must be intolerant or inadequately responsive to dornase alfa;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 6 years of age or older

Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit

The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation

Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease

Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily

FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy

To be eligible for continued PBS-subsidised treatment with mannitol following 3 months of initial treatment:

(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient

Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that mannitol treatment is continuing to produce worthwhile benefits. Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use

Other aspects of treatment, such as physiotherapy, must be continued

Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)

Compliance with Written or Telephone Authority Required procedures

C4304

Schizophrenia

Compliance with Authority Required procedures - Streamlined Authority Code 4304