Decision to fund treatments for multiple sclerosis, eye conditions, breast cancer and lung cancer

Thank you to those who took the time to give feedback. A summary of the main themes raised and our responses are below.

Special Authority for Subsidy

Initial application — (metastatic breast cancer) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Either:

1. Both:
   1. The individual has received an initial Special Authority approval for intravenous pertuzumab and trastuzumab for metastatic breast cancer; and
   2. Pertuzumab with trastuzumab to be administered subcutaneously at a maximum dose of 600 mg pertuzumab with 600 mg trastuzumab every three weeks (or equivalent); or
2. All of the following:
   1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. Either:
      1. Patient is chemotherapy treatment naïve; or
      2. Patient has not received prior treatment for their metastatic disease and has had a treatment free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
   3. The patient has good performance status (ECOG grade 0-1); and
   4. Loading dose of pertuzumab with trastuzumab to be administered subcutaneously at a maximum dose of 1200 mg pertuzumab with 600 mg trastuzumab, respectively; and
   5. Maintenance doses of pertuzumab with trastuzumab to be administered subcutaneously at a maximum dose of 600 mg pertuzumab with 600 mg trastuzumab every three weeks (or equivalent); and
   6. Pertuzumab with trastuzumab to be discontinued at disease progression.

Renewal — (metastatic breast cancer) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Either:

1. Both:
   1. The individual has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
   2. The cancer has not progressed at any time point during the previous 12 months whilst on pertuzumab and trastuzumab; or
2. All of the following:
   1. Individual has previously discontinued treatment with pertuzumab with trastuzumab for reasons other than severe toxicity or disease progression; and
   2. Individual has signs of disease progression; and
   3. Disease has not progressed during previous treatment with pertuzumab with trastuzumab.

Thank you to those who took the time to give feedback. A summary of the main themes raised in feedback and our responses to the feedback received are below.

Special Authority for Subsidy

Initial application — (diabetic macular oedema) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has centre involving diabetic macular oedema (DMO); and
2. Patient’s disease is nonresponsive to 4 doses of intravitreal bevacizumab when administered 4-6 weekly; and
3. Patient has reduced visual acuity between 6/9 – 6/36 with functional awareness of reduction in vision; and
4. Patient has DMO within central OCT (ocular coherence tomography) subfield > 350 micrometres; and
5. There is no centre-involving sub-retinal fibrosis or foveal atrophy; and
6. Patient has not previously been treated with aflibercept for longer than 3 months.

Renewal — (diabetic macular oedema) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. There is stability or two lines of Snellen visual acuity gain; and
2. There is structural improvement on OCT scan (with reduction in intra-retinal cysts, central retinal thickness, and sub-retinal fluid); and
3. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
4. There is no centre-involving sub-retinal fibrosis or foveal atrophy.

Initial application – (wet age related macular degeneration) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

1. Any of the following:
   1. Wet age-related macular degeneration (wet AMD); or
   2. Polypoidal choroidal vasculopathy; or
   3. Choroidal neovascular membrane from causes other than wet AMD; and
2. Either:
   1. The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or
   2. There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and
3. There is no structural damage to the central fovea of the treated eye; and
4. Patient has not previously been treated with ranibizumab or aflibercept for longer than 3 months.

Renewal criteria – (wet age related macular degeneration) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

1. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
2. There is no structural damage to the central fovea of the treated eye.

Special Authority for Subsidy

Initial application — (diabetic macular oedema) Only from an ophthalmologist from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has centre involving diabetic macular oedema (DMO); and
2. Patient’s disease is non responsive to 4 doses of intravitreal bevacizumab when administered 4-6 weekly; and
3. Patient has reduced visual acuity between 6/9 – 6/36 with functional awareness of reduction in vision; and
4. Patient has DMO within central OCT (ocular coherence tomography) subfield > 350 micrometers; and
5. There is no centre-involving sub-retinal fibrosis or foveal atrophy.; and
6. Patient has not previously been treated with faricimab for longer than 3 months.

Renewal — (diabetic macular oedema) Only from an ophthalmologist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. There is stability or two lines of Snellen visual acuity gain; and
2. There is structural improvement on OCT scan (with reduction in intra-retinal cysts, central retinal thickness, and sub-retinal fluid); and
3. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
4. There is no centre-involving sub-retinal fibrosis or foveal atrophy.; and
5. After each consecutive 12 months treatment with (2nd line anti-VEGF agent), patient has retrialled with at least one injection of bevacizumab and had no response.

Initial application — (wet age-related macular degeneration) Only from an ophthalmologist from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

Either:

1. All of the following:
   1. Any of the following:
      1. Wet age-related macular degeneration (wet AMD); or
      2. Polypoidal choroidal vasculopathy; or
      3. Choroidal neovascular membrane from causes other than wet AMD; and
   2. Either:
      1. The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or
      2. There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and
   3. There is no structural damage to the central fovea of the treated eye; and
   4. Patient has not previously been treated with ranibizumab or faricimab for longer than 3 months; or
2. Either:
   1. Patient has current approval to use ranibizumab or faricimab for treatment of wAMD and was found to be intolerant to ranibizumab within 3 months; or
   2. Patient has previously* (*before June 2018) received treatment with ranibizumab for wAMD and disease was stable while on treatment.

Renewal — (wet age-related macular degeneration) Only from an ophthalmologist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Documented benefit must be demonstrated to continue; and
2. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
3. There is no structural damage to the central fovea of the treated eye.

Restricted

Initiation – Wet Age-Related Macular Degeneration

Ophthalmologist or nurse practitioner

Re-assessment required after 3 months

Either:

1. All of the following:
   1. Any of the following:
      1. Wet age-related macular degeneration (wet AMD); or
      2. Polypoidal choroidal vasculopathy; or
      3. Choroidal neovascular membrane from causes other than wet AMD; and
   2. Either:
      1. The patient has developed severe endophthalmitis or severe posterior uveitis following treatment with bevacizumab; or
      2. There is worsening of vision or failure of retina to dry despite three intraocular injections of bevacizumab four weeks apart; and
   3. There is no structural damage to the central fovea of the treated eye; and
   4. Patient has not previously been treated with aflibercept or faricimab for longer than 3 months; or
2. Patient has current approval to use aflibercept or faricimab for treatment of wAMD and was found to be intolerant to aflibercept within 3 months.

Continuation – Wet Age-Related Macular Degeneration

Ophthalmologist or nurse practitioner

Re-assessment required after 12 months

All of the following:

1. Documented benefit must be demonstrated to continue; and
2. Patient’s vision is 6/36 or better on the Snellen visual acuity score; and
3. There is no structural damage to the central fovea of the treated eye.

Thank you to those who took the time to give feedback. A summary of the main themes raised and our responses are below.

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Individual has locally advanced or metastatic, unresectable, non-squamous non-small cell lung cancer; and
2. Either:
   1. The individual has not received crizotinib; or
   2. Both:
      1. The individual has received an initial Special Authority approval for crizotinib and has discontinued crizotinib due to intolerance; and
      2. The cancer did not progress while the individual was on crizotinib; and
3. There is documentation confirming that the patient has a ROS1 rearrangement using an appropriate ROS1 test; and
4. Individual has ECOG performance score of 0-3; and
5. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Response to treatment has been determined by comparable radiological assessment following the most recent treatment period; and
2. No evidence of disease progression.

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient Individual has locally advanced or metastatic, unresectable, non-squamous non-small cell lung cancer; and
2. Either:
   1. The individual has not received entrectinib; or
   2. Both:
      1. The individual has received an initial Special Authority approval for entrectinib and has discontinued entrectinib due to intolerance; and
      2. The cancer did not progress while the individual was on entrectinib; and
3. There is documentation confirming that the patient has a ROS1 rearrangement using an appropriate ROS1 test; and
4. Patient Individual has ECOG performance score of 0-3; and
5. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Response to treatment has been determined by comparable radiological assessment following the most recent treatment period; and
2. No evidence of disease progression.

Thank you to those who took the time to give feedback. A summary of the main themes raised and our responses are below. 

Thank you to those who took the time to give feedback. A summary of the main themes raised and our responses are below. 

Special Authority for Subsidy

Initial application — (chronic lymphocytic leukaemia) only from a haematologist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. The patient has progressive Binet stage A, B or C CD20+ chronic lymphocytic leukaemia requiring treatment; and
2. The patient is obinutuzumab treatment naive; and
3. The patient is not eligible for full dose FCR due to comorbidities with a score > 6 on the Cumulative Illness Rating Scale (CIRS) or reduced renal function (creatinine clearance < 70mL/min); and
4. Patient has adequate neutrophil and platelet counts* unless the cytopenias are a consequence of marrow infiltration by CLL; and
5. Patient has good performance status; and
6. Obinutuzumab to be administered at a maximum cumulative dose of 8,000 mg and in combination with chlorambucil for a maximum of 6 cycles.

Notes: Chronic lymphocytic leukaemia includes small lymphocytic lymphoma. Comorbidity refers only to illness/impairment other than CLL induced illness/impairment in the patient. 'Good performance status' means ECOG score of 0-1, however, in patients temporarily debilitated by their CLL disease symptoms a higher ECOG (2 or 3) is acceptable where treatment with obinutuzumab is expected to improve symptoms and improve ECOG score to < 2.

* Neutrophil greater than or equal to 1.5 × 10⁹/L and platelets greater than or equal to 75 × 10⁹/L.

Initial application — (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

1. Either:
   1. Patient has follicular lymphoma; or
   2. Patient has marginal zone lymphoma; and
2. Patient is refractory to or has relapsed within 12 months of a rituximab containing combined chemo-immunotherapy regimen*; and
3. Patient has an ECOG performance status of 0-2; and
4. Patient has been previously treated with no more than four chemotherapy regimens; and
5. Obinutuzumab to be administered at a maximum dose of 1000 mg for a maximum of 6 cycles in combination with chemotherapy*.

Note: * includes unapproved indications

Renewal — (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 24 months for applications meeting the following criteria:

All of the following:

1. Patient has no evidence of disease progression following obinutuzumab induction therapy; and
2. Obinutuzumab to be administered at a maximum of 1000 mg every 2 months for a maximum of 2 years; and
3. Obinutuzumab to be discontinued at disease progression.

Special Authority for Subsidy

Initial application — (rheumatoid arthritis - TNF inhibitors contraindicated) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Treatment with a Tumour Necrosis Factor alpha inhibitor is contraindicated; and
2. Patient has had severe and active erosive rheumatoid arthritis (either confirmed by radiology imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
3. Patient has tried and not responded to at least three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose; and
4. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate (at maximum tolerated doses); and
5. Any of the following:
   1. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with the maximum tolerated dose of ciclosporin; or
   2. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with intramuscular gold; or
   3. Patient has tried and not responded to at least three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with oral or parenteral methotrexate; and
6. Either:
   1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 swollen, tender joints; or
   2. Patient has persistent symptoms of poorly controlled and active disease in at least four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
7. Either:
   1. Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or
   2. C-reactive protein levels not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months; and
8. Either:
   1. Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   2. Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
9. Maximum of two 1,000 mg infusions of rituximab given two weeks apart.

Initial application — (rheumatoid arthritis - prior TNF inhibitor use) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Both:
   1. The patient has had an initial community Special Authority approval for at least one of etanercept and/or adalimumab for rheumatoid arthritis; and
   2. Either:
      1. The patient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
      2. Following at least a four month trial of adalimumab and/or etanercept, the patient did not meet the renewal criteria for adalimumab and/or etanercept for rheumatoid arthritis; and
2. Either:
   1. Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   2. Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
3. Maximum of two 1,000 mg infusions of rituximab given two weeks apart.

Renewal — (rheumatoid arthritis - re-treatment in 'partial responders' to rituximab) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Any of the following:
   1. At 4 months following the initial course of rituximab infusions the patient had between a 30% and 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. At 4 months following the second course of rituximab infusions the patient had at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   3. At 4 months following the third and subsequent courses of rituximab infusions, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
3. Either:
   1. Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   2. Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
4. Maximum of two 1,000 mg infusions of rituximab given two weeks apart.

Renewal — (rheumatoid arthritis - re-treatment in 'responders' to rituximab) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Either:
   1. At 4 months following the initial course of rituximab infusions the patient had at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. At 4 months following the second and subsequent courses of rituximab infusions, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
3. Either:
   1. Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   2. Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
4. Maximum of two 1,000 mg infusions of rituximab given two weeks apart.