Lenalidomide | Capsule 5 mg | Oral | Cipla Lenalidomide | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalide | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Dr.Reddy's | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Sandoz | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide-Teva | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Revlimid | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| Capsule 10 mg | Oral | Cipla Lenalidomide | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalide | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Dr.Reddy's | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Sandoz | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide-Teva | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Revlimid | C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| Capsule 15 mg | Oral | Cipla Lenalidomide | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalide | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Dr.Reddy's | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Sandoz | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide-Teva | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Revlimid | C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| Capsule 25 mg | Oral | Cipla Lenalidomide | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalide | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Dr.Reddy's | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide Sandoz | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Lenalidomide-Teva | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
| | | Revlimid | C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 | | See Schedule 2 | See Schedule 2 |
Lenalidomide | C13782 | | Relapsed and/or refractory multiple myeloma
Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone
Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND
Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing. | Compliance with Authority Required procedures |
| C13785 | | Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have been treated with lenalidomide or bortezomib for this condition; AND
The treatment must not exceed a total of 4 cycles under this restriction.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), 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 - the percentage of plasma cells; 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 stated/declared. 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 held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13786 | | Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have been treated with lenalidomide or bortezomib for this condition; AND
The treatment must not exceed a total of 4 cycles under this restriction.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), 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 - the percentage of plasma cells; 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 stated/declared. 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 held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13787 | | Multiple myeloma
Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) 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 in 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. | Compliance with Authority Required procedures |
| C13791 | | Multiple myeloma
Initial treatment with lenalidomide monotherapy in newly diagnosed disease
The treatment must be as monotherapy; AND
The condition must be confirmed by a histological diagnosis; AND
Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND
Patient must not have progressive disease following autologous stem cell transplant (ASCT).
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) the date the autologous stem cell transplant was performed; and
(3) nomination of which disease activity parameters will be used to assess progression.
To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) 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 - the percentage of plasma cells; 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 progression, 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 stated/declared. 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 held in the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13801 | | Myelodysplastic syndrome
Continuing treatment
Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND
Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND
Patient must not have progressive disease; AND
The condition must not have progressed to acute myeloid leukaemia.
The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.
The following evidence of response must be provided at each application:
(i) a haemoglobin level taken within the last 4 weeks; and
(ii) the date of the last transfusion; and
(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;
All reports must be documented in the patient's medical records.
For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13803 | | Multiple myeloma
Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) 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.
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 in 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 via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and
(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and
(4) details of the basis of the diagnosis of progressive disease or failure to respond; and
(5) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), 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 - the percentage of plasma cells; 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 stated/declared. 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 held in the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13804 | | Multiple myeloma
Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as monotherapy.
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 in 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. | Compliance with Authority Required procedures |
| C13805 | | Multiple myeloma
Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease
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 form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone. | Compliance with Authority Required procedures |
| C13810 | | Myelodysplastic syndrome
Initial treatment
The treatment must be limited to a maximum duration of 16 weeks; AND
Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
Patient must be red blood cell transfusion dependent.
Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.
Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:
1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR
2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR
4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR
5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR
7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
Classification of a patient as red blood cell transfusion dependent requires that:
(i) the patient has been transfused within the last 8 weeks; and
(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and
(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and
(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and
(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.
All the reports must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13811 | | Multiple myeloma
Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles)
Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
The treatment must not exceed a total of 4 cycles under this restriction. | Compliance with Authority Required procedures |
| C13812 | | Multiple myeloma
Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation
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
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and
(2) confirmation of ineligibility for prior stem cell transplant; and
(3) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), 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 - the percentage of plasma cells; 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 stated/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 held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13813 | | Multiple myeloma
Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles)
Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
The treatment must not exceed a total of 2 cycles under this restriction. | Compliance with Authority Required procedures |
