National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 6 of 2018) (Cth)

PB 6 of 2018

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Acting Assistant Secretary, Private Health Insurance and Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated 25 January 2018

NATASHA PLOENGES

Acting Assistant Secretary

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1).

(2)This Instrument may also be cited as PB 6 of 2018.

Commencement

This Instrument commences on 1 February 2018.

Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

Schedule 1, entry for Abacavir with Lamivudine

insert as the first entry in the columns in the order indicated:

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg Oral Abacavir/Lamivudine GH 600/300 GQ EMP C4527 C4528 60 5 D

Schedule 1, entry for Clozapine in the form Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Clozaril 25”: NV substitute: GO

Schedule 1, entry for Clozapine in the form Tablet 100 mg

omit from the column headed “Responsible Person” for the brand “Clozaril 100”: NV substitute: GO

Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; and Capsule 10 mg

(a)omit from the column headed “Circumstances”: C4090 C4091

(b)omit from the column headed “Circumstances”: C6750 C6751

(c)insert in the column headed “Circumstances” in numerical order: C7380 C7381 C7383 C7404

Schedule 1, entry for Lenalidomide in each of the forms: Capsule 15 mg; and Capsule 25 mg

omit from the column headed “Circumstances”: C4090 C4091 C6750 C6751 substitute: C7380 C7381 C7383 C7404

Schedule 1, after entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL

insert:

Ocrelizumab Solution concentrate for I.V. infusion 300 mg in 10 mL Injection Ocrevus RO EMP C7386 C7398 C7411 C7412 2 0 D

Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg

omit from the column headed “Circumstances”: C5101 C5102 substitute: C7391 C7407

Schedule 1, after entry for Raltegravir in the form Tablet 400 mg (as potassium)

insert:

Tablet 600 mg (as potassium) Oral Isentress HD MK EMP C4454 C4512 120 5 D

Schedule 3, entry for Lenalidomide

(a)omit:

C4090
Where the patient is receiving treatment at/from a private or public hospital

Multiple myeloma
Initial PBS subsidised treatment
The condition must be confirmed by a histological diagnosis,
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone,
Patient must have progressive disease after at least one prior therapy,
Patient must have undergone or be ineligible for a primary stem cell transplant,
Patient must have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide based therapy for progressive disease,
Patient must not be receiving concomitant PBS subsidised bortezomib.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24 hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Thalidomide treatment failure is defined as:
(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment.
Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living.
Toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug related seizures, serious Grade 3 or 4 drug related dermatological reactions, such as Stevens Johnson Syndrome, or other Grade 3 or 4 toxicity.
Failure to achieve at least a minimal response after 8 or more weeks of thalidomide based therapy for progressive disease is defined as:
(1) less than a 25% reduction in serum or urine M protein; or
(2) in oligo secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels.
If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) duration of thalidomide and daily dose prescribed; and
(4) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence Jones proteinuria the results of 24 hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

Patients receiving lenalidomide under the PBS listing must be registered in the i access risk management program.
Compliance with modified Authority Required procedures

C4091
Where the patient is receiving treatment at/from a private or public hospital

Multiple myeloma
Continuing PBS subsidised treatment
Patient must have previously received an authority prescription for lenalidomide,
Patient must not have progressive disease,
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24 hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

Patients receiving lenalidomide under the PBS listing must be registered in the access risk management program.
Compliance with modified Authority Required procedures

(b)omit:

C6750
Where the patient is receiving treatment at/from a private or public hospital

Multiple myeloma
Initial treatment
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
Patient must be ineligible for a primary stem cell transplantation; AND
Patient must not be receiving PBS subsidised bortezomib for this condition; AND
The treatment must be in combination with dexamethasone.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and ineligibility for prior stem cell transplant; and nomination of which disease activity parameters will be used to assess response; and
(3) a signed patient acknowledgement.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence Jones proteinuria the results of 24 hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
Compliance with modified Authority Required procedures

C6751
Where the patient is receiving treatment at/from a private or public hospital

Multiple myeloma
Continuing treatment
Patient must have previously been authorised with a PBS prescription with this drug for the condition; AND
Patient must not have demonstrated progressive disease; AND
Patient must not be receiving PBS subsidised bortezomib for this condition; AND
The treatment must be in combination with dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24 hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Patients receiving this drug under the PBS listing must be registered in the i access risk management program.
Compliance with modified Authority Required procedures

(c)insert in numerical order after existing text:

C7380
Multiple myeloma

Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.

Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
Compliance with Authority Required procedures

C7381
Multiple myeloma

Initial treatment
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
Patient must be ineligible for a primary stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
The treatment must be in combination with dexamethasone.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and ineligibility for prior stem cell transplant; and nomination of which disease activity parameters will be used to assess response; and
(3) a signed patient acknowledgement.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.
Compliance with Written Authority Required procedures

C7383
Multiple myeloma

Continuing treatment
Patient must have previously been authorised with a PBS prescription with this drug for the condition; AND
Patient must not have demonstrated progressive disease; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
The treatment must be in combination with dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.
Compliance with Authority Required procedures

C7404
Multiple myeloma

Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and
(3) a signed patient acknowledgment.
To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.
Compliance with Written Authority Required procedures

Schedule 3, after entry for Nevirapine

insert:

Ocrelizumab C7386
Multiple sclerosis

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Must be treated by a neurologist.
Compliance with Authority Required procedures - Streamlined Authority Code 7386

C7398
Multiple sclerosis

Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
Compliance with Authority Required procedures

C7411
Multiple sclerosis

Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 7411

C7412
Multiple sclerosis

Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Must be treated by a neurologist.
Compliance with Authority Required procedures

Schedule 3, entry for Pomalidomide

substitute:

Pomalidomide C7391
Multiple myeloma

Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease; AND
The treatment must be in combination with dexamethasone; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.
Compliance with Authority Required procedures

C7407
Multiple myeloma

Initial treatment
The treatment must be in combination with dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide; AND
Patient must have experienced treatment failure with bortezomib; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma pomalidomide Authority Application Supporting Information form; and
(3) reports demonstrating the patient has failed treatment with lenalidomide and bortezomib.

Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.
Compliance with Written Authority Required procedures

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Citations

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 6 of 2018) (Cth)

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C7380	Multiple myeloma Continuing PBS-subsidised treatment Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND The treatment must be as monotherapy; OR The treatment must be in combination with dexamethasone; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues. Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.	Compliance with Authority Required procedures
C7381	Multiple myeloma Initial treatment The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must be ineligible for a primary stem cell transplantation; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND The treatment must be in combination with dexamethasone. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and ineligibility for prior stem cell transplant; and nomination of which disease activity parameters will be used to assess response; and (3) a signed patient acknowledgement. To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.	Compliance with Written Authority Required procedures
C7383	Multiple myeloma Continuing treatment Patient must have previously been authorised with a PBS prescription with this drug for the condition; AND Patient must not have demonstrated progressive disease; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND The treatment must be in combination with dexamethasone. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program.	Compliance with Authority Required procedures
C7404	Multiple myeloma Initial PBS-subsidised treatment The condition must be confirmed by a histological diagnosis; AND The treatment must be as monotherapy; OR The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a primary stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and (3) a signed patient acknowledgment. To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided. Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program.	Compliance with Written Authority Required procedures

Ocrelizumab	C7386	Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 7386
C7398	Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures
C7411	Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 7411
C7412	Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist.	Compliance with Authority Required procedures