Proposed changes for rheumatology conditions (excluding rheumatoid arthritis)

Additions in bold, deletions in strikethrough:

Initial application — (ankylosing spondylitis) only from any rheumatologist relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for ankylosing spondylitis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for ankylosing spondylitis; or
2. All of the following:
   1. Patient has a confirmed diagnosis of ankylosing spondylitis present for more than six months; and
   2. Patient has low back pain and stiffness that is relieved by exercise but not by rest; and
   3. Patient has bilateral sacroiliitis demonstrated by radiologic imaging plain radiographs, CT or MRI scan; and
   4. Patient's ankylosing spondylitis Disease has not responded adequately to treatment with two or more non-steroidal anti-inflammatory drugs (NSAIDs) (unless contraindicated), in combination with anti-ulcer therapy if indicated, while patient was undergoing at least 3 months of a regular exercise regimen for ankylosing spondylitis; and
   5. Either:
      1. Patient has limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by the following Bath Ankylosing Spondylitis Metrology Index (BASMI) measures: a modified Schober's test of less than or equal to 4 cm and lumbar side flexion measurement of less than or equal to 10 cm (mean of left and right); or
      2. Patient has limitation of chest expansion by at least 2.5 cm below the following average normal values corrected for age and gender (see Notes); and
   6. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 6 on a 01010-point scale completed after 3-month exercise trial before ceasing any previous pharmacological treatment and not more than 1 month before the application.

Notes: The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment and The BASDAI measure must be no more than 1 month old at the time of initial application.
Average normal chest expansion corrected for age and gender:

18-24 years - Male: 7.0 cm; Female: 5.5 cm

25-34 years - Male: 7.5 cm; Female: 5.5 cm

35-44 years - Male: 6.5 cm; Female: 4.5 cm

45-54 years - Male: 6.0 cm; Female: 5.0 cm

55-64 years - Male: 5.5 cm; Female: 4.0 cm

65-74 years - Male: 4.0 cm; Female: 4.0 cm

75+ years - Male: 3.0 cm; Female: 2.5 cm

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Renewal — (ankylosing spondylitis) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following: Both:

1. Either:

1.1 Applicant is a rheumatologist; or

1.2 Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and

1. Following 12 weeks’ initial treatment and for subsequent renewals, Treatment has resulted in an improvement in BASDAI has improved from pre-treatment baseline of either by at least 4 or more points from pre-treatment baseline on a 10 point 10-point scale, or an improvement in BASDAI of by at least 50%, whichever is less; and
   
   2. Physician considers that the patient has benefited from treatment and that continued treatment is appropriate; and
2. 3. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Additions in bold, deletions in strikethrough:

Initial application — (ankylosing spondylitis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist any relevant practitioner. Approvals valid for 3 6 months for applications meeting the following criteria:

Both All of the following:

1. Patient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
2. Either:
   1. 2.1 The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. 2.2 Following 12 weeks of adalimumab and/or etanercept treatment, the pPatient has received insufficient benefit did not to meet the renewal criteria for adalimumab and/or etanercept for ankylosing spondylitis; and
3. Following initial induction doses, maximum dose 5mg/kg every 6-8 weeks.

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Renewal — (ankylosing spondylitis) only from any relevant practitioner a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following: Both:

1. Following 12 weeks of infliximab treatment, BASDAI has improved from pre-treatment baseline either by at least 4 or more points from pre-infliximab baseline on a 10 point 10-point scale, or by at least 50%, whichever is less; and
2. Physician considered that the patient has benefited from treatment and that continued treatment is appropriate; and
3. Infliximab is to be administered at doses no greater than Maximum dose 5mg/kg every 6-8 weeks.

Additions in bold, deletions in strikethrough:

Initial application — (ankylosing spondylitis – second-line biologic) only from a rheumatologist or any relevant pPractitioner on the recommendation of a rheumatologist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. The pPatient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. Following 12 weeks of adalimumab and/or etanercept treatment, the pPatient has received insufficient benefit to did not meet the renewal criteria for adalimumab and/or etanercept for ankylosing spondylitis.

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Renewal — (ankylosing spondylitis – second-line biologic) only from any relevant practitioner a rheumatologist or medical practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following Both:

1. Following 12 weeks initial treatment of secukinumab treatment, BASDAI has improved from the pre-secukinumab baseline either by at least 4 points on a 10 point10-point scale, or by at least 50%, whichever is less; and
2. Physician considers that the patient has benefitted from treatment and that continued treatment is appropriate; and
3. Secukinumab to be administered at doses no greater than Maximum dose 300 mg monthly.

Additions in bold, deletions in strikethrough:

Initial application — (arthritis - oligoarticular course juvenile idiopathic arthritis) only from a named specialist or rheumatologist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for oligoarticular course juvenile idiopathic arthritis (JIA); and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for oligoarticular course JIA; or
2. All of the following:
   1. To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   2. Patient has had oligoarticular course JIA for 6 months duration or longer; and
   3. 3Any of the followingEither:
      1. 1 At least 2 active joints with pain, tenderness or a limited range of motion, pain, or tenderness after a 3-month trial of methotrexate (at the maximum tolerated dose), unless contraindicated; or
      2. 2 Moderate or high disease activity (cJADAS10 score greater than 1.5) with poor prognostic features after a 3-month trial of methotrexate (at the maximum tolerated dose), unless contraindicated.; or
      3. 3 High disease activity (cJADAS10 score greater than 4) after a 6-month trial of methotrexate.

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Renewal — (arthritis - oligoarticular course juvenile idiopathic arthritis) from any relevant practitioner. only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
2. Either
   1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
   2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Additions in bold, deletions in strikethrough:

Initial application — (arthritis - polyarticular course juvenile idiopathic arthritis) only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for polyarticular course juvenile idiopathic arthritis (JIA); and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for polyarticular course JIA; or
2. All of the following:
   1. To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   2. Patient has had polyarticular course JIA for 6 months duration or longer; and
   3. Any of the following:
3. Any of the following:
   1. 2.3.1 2.1 At least 5 active joints and at least 3 joints with pain, tenderness or a limited range of motion, pain, or tenderness after a 3-month trial of methotrexate at the maximum tolerated dose , unless contraindicated; or
   2. 2.3.2 2.2 Moderate or high disease activity (cJADAS10 score of at least 2.5) after a 3-month trial of methotrexate at the maximum tolerated dose, unless contraindicated; or
   3. 2.3.3 2.3 Low disease activity (cJADAS10 score between 1.1 and 2.5) after a 6-month trial of methotrexate.

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Renewal — (arthritis - polyarticular course juvenile idiopathic arthritis) from any relevant practitioner only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
2. Either:
   1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
   2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Additions in bold, deletions in strikethrough:

Initial application — (arthritis – psoriatic arthritis) only from a rheumatologist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab or secukinumab for psoriatic arthritis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab or secukinumab; or
      2. The pPatient has received insufficient benefit from adalimumab or secukinumab to meet the renewal criteria for adalimumab or secukinumab for psoriatic arthritis; or
2. All of the following:
   1. Patient has had severe active psoriatic arthritis for six months duration or longer; and
   2. Patient has tried and not responded to received insufficient benefit from at least three 3 months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose unless contraindicated; and
   3. Patient tried and not responded to received insufficient benefit from at least three 3 months of sulfasalazine at a dose of at least 2 g per day or leflunomide at a dose of up to 20 mg daily (or maximum tolerated doses) unless contraindicated; and
   4.  Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen, tender joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
   5. Any of the following:
      1. 1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
         2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour measured within one month before the application; or
         3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than three months.

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Renewal - (arthritis – psoriatic arthritis) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist.

Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following Both:
Either:

• Applicant is a rheumatologist; or
• Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and

1. Either:

• Following 3 to 4 months' initial treatment, the patient has 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
• The patient demonstrates at At least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior etanercept treatment in the opinion of the treating physician; and

1. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Additions in bold, deletions in strikethrough:

Initial application — (arthritis - psoriatic arthritis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist any relevant practitioner.

Approvals valid for 4 6 months for applications meeting the following criteria:

Both All of the following:

1. The pPatient has had an initial Special Authority approval for adalimumab, and/or etanercept, and/or secukinumab for psoriatic arthritis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from adalimumab and/or etanercept and/or secukinumab; or
   2. Following 3-4 months' initial treatment with adalimumab and/or etanercept and/or secukinumab, the pPatient has received insufficient benefit did not to meet the renewal criteria for adalimumab, and/or etanercept and/or secukinumab for psoriatic arthritis; and
3. Following initial induction doses, maximum dose 5mg/kg every 8 weeks.

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Renewal — (arthritis - psoriatic arthritis) only from any relevant practitioner a rheumatologist or Practitioner on the recommendation of a rheumatologist.

Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Following 3 to 4 months' initial treatment, the patient has 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. The patient demonstrates at At least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior infliximab treatment in the opinion of the treating physician; and
2. Infliximab to be administered at doses no greater than Maximum dose 5 mg/kg every 8 weeks.

Additions in bold, deletions in strikethrough:

Initial application — (arthritis - psoriatic arthritis) only from a rheumatologist or any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab, etanercept or infliximab for psoriatic arthritis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab, etanercept or infliximab; or
      2. The pPatient has received insufficient benefit from adalimumab, etanercept or infliximab to meet the renewal criteria for adalimumab, etanercept or infliximab for psoriatic arthritis; or
2. All of the following:
   1. Patient has had severe active psoriatic arthritis for six 6 months duration or longer; and
   2. The pPatient has tried and not responded to received insufficient benefit from at least three 3 months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose unless contraindicated; and
   3. The pPatient has tried and not responded to received insufficient benefit from at least three 3 months of sulfasalazine at a dose of at least 2 g per day or leflunomide at a dose of up to 20 mg daily (or maximum tolerated doses) unless contraindicated; and
   4. Either:
      1. The pPatient has persistent symptoms of poorly controlled and active disease in at least 15 swollen, tender joints; or
      2. The pPatient has persistent symptoms of poorly controlled and active disease in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
   5. Any of the following:
      1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
      2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour no more than measured within one month before the application; or
      3. ESR and CRP not measured as patient the is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than three 3

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Renewal — (arthritis - psoriatic arthritis) only from any relevant practitioner a dermatologist or medical practitioner on the recommendation of a dermatologist.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Following 3 to 4 months' initial treatment, the patient has 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. The patient demonstrates At least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior secukinumab treatment in the opinion of the treating physician; and
2. Secukinumab to be administered at doses no greater than Maximum dose 300 mg monthly.

Additions in bold, deletions in strikethrough:

Initial application — (severe Behcet's disease) from any relevant practitioner. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

All of the following:

1. The pPatient has severe Behcet's disease which is significantly impacting the patient’s their quality of life (see Notes); and
2. Either:
   1. The pPatient has severe ocular, neurological and/or vasculitic symptoms and has not responded adequately to received insufficient benefit from one 1 or more treatment(s) appropriate for the particular symptom(s) (see Notes); or
   2. The pPatient has severe gastrointestinal, rheumatologic and/or mucocutaneous symptoms and has not responded adequately to received insufficient benefit from 2 two or more treatments appropriate for the particular symptom(s) (see Notes); and
3. Following initial loading doses, maximum dose 5mg/kg every 8 weeks.
4. The patient is experiencing significant loss of quality of life.

Notes: Behcet’s disease diagnosed according to the International Study Group for Behcet’s Disease. Lancet 1990;335(8697):1078-80. Quality of life measured using an appropriate quality of life scale such as that published in Gilworth et al J Rheumatol. 2004;31:931-7. Treatments appropriate for the particular symptoms are those that are considered standard conventional treatments for these symptoms, for example intravenous/oral steroids and other immunosuppressants for ocular symptoms; azathioprine, steroids, thalidomide, interferon alpha and ciclosporin for mucocutaneous symptoms; and colchicine, steroids and methotrexate for rheumatological symptoms.

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Renewal — (severe Behcet's disease) from any relevant practitioner.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Patient has had a good clinical response to initial treatment with measurably improved quality of life; and
2. Infliximab to be administered at doses no greater than 5 mg/kg every 8 weeks.

Additions in bold, deletions in strikethrough:

Initial application — (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for without further renewal unless notified 12 months for applications meeting the following criteria.

All of the following:

1. Patient has confirmed antisynthetase syndrome; and
2. 2. Patient has severe, immediately life- or organ-threatening disease, including interstitial lung disease; and
3. 3. Either:
   1. 1 Treatment with at least 3 immunosuppressants (oral corticosteroids, cyclophosphamide, methotrexate, mycophenolate, ciclosporin, azathioprine) has not be been ineffective at controlling active disease; or
   2. 2 Rapid treatment is required due to for life threatening complications.; and
4. 4. Maximum of four two 1,0001000 mg infusions of rituximab every 6 months.

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Renewal — (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in inflammatory markers, muscle strength, and pulmonary function; and
2. The patient has not received rituximab in the previous 6 months.; and
3. Maximum of two cycles of 2 × 1,000mg infusions of rituximab given two weeks apart

Additions in bold, deletions in strikethrough:

Initial application — (Stills disease - adult-onset Stills disease (AOSD)) only from a rheumatologist any relevant practitioner.

Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1.1 Either:
   1. 1.1.1 The pPatient has had an initial Special Authority approval for adalimumab and/or tocilizumab for adult-onset Still's disease AOSD; or and
      
      1.1.2  The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the HML rules; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab and/or tocilizumab; or
      2. The pPatient has received insufficient benefit to meet the renewal criteria from at least a three3-month trial of adalimumab and/or tocilizumab such that they do not meet the renewal criteria for AOSD; or
2. All of the following:
   1. Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19:424-430); and
   2. Patient has tried and not responded to received insufficient benefit from at least 6 months of glucocorticosteroids at a dose of at least 5 mg/kg prednisone-equivalents, non-steroidal anti-inflammatory drugs NSAIDs and methotrexate, unless contraindicated; and
   3. Patient has persistent symptoms of disabling poorly controlled and active disease.

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Renewal — (adult-onset Still's disease) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Applicant is a rheumatologist; or
   2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
2. The patient has a sustained improvement in inflammatory markers and functional status.

Additions in bold, deletions in strikethrough:

Initial application — (treatment refractory systemic lupus erythematosus (SLE)*) only from a rheumatologist, nephrologist or any relevant Ppractitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid without further renewal unless notified for 7 months for applications meeting the following criteria:

All of the following:

1. The pPatient has severe, immediately life- or organ-threatening SLE*; and
2. The disease condition has been proved refractory to treatment with corticosteroids at a dose of at least 1 mg/kg unless contraindicated; and
3. The disease condition has relapsed following prior treatment for at least 6 months with maximal tolerated doses of azathioprine, mycophenolate mofetil, and high dose cyclophosphamide, or cyclophosphamide is contraindicated; and
4. Initial treatment Mmaximum of four 1000 mg infusions of rituximab; and
5. Treatment for relapse following initial partial response to rituximab up to a maximum of two 1000 mg infusions every 6 months.

Note: Indications marked with * are unapproved indications.

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Renewal — (treatment refractory systemic lupus erythematosus (SLE)*) only from a rheumatologist, nephrologist, or Practitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s SLE* achieved at least a partial response was achieved from to the previous round of prior rituximab treatment; and
2. The disease has subsequently relapsed.; and
3. Maximum of two 1000 mg infusions of rituximab

Note: Indications marked with * are unapproved indications.

Additions in bold, deletions in strikethrough:

Initial application — (undifferentiated spondyloarthritis*) only from a rheumatologist any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has undifferentiated peripheral spondyloarthritis* with active peripheral joint arthritis in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder, or hip; and
2. Patient has tried and not responded to received insufficient benefit from at least three 3 months of oral or parenteral each of methotrexate, sulfasalazine, and leflunomide at a dose of at least 20 mg weekly or a maximum tolerated doses, unless contraindicated; and
3. Patient has tried and not responded to at least three months of sulfasalazine at a dose of at least 2 g per day (or maximum tolerated dose); and
4. Patient has tried and not responded to at least three months of leflunomide at a dose of up to 20 mg daily (or maximum tolerated dose); and
5. 5. Any of the following:
   1. 1 Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
   2. 2 Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour measured no more than within one month prior to the date of this before the application; or
   3. 3 ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than three months.

Note: Indications marked with * are unapproved indications.

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Renewal — (undifferentiated spondyloarthritis*) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following Both:

1. Either:

1.1 Applicant is a rheumatologist; or

1.2 Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with etanercept treatment; and

1. 2 Either:
   1. 2.1 Following 3 to 4 months’ initial treatment, the patient has experienced 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. 2.2 The pPatient demonstrates has experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior etanercept treatment in the opinion of the treating physician; and
2. 3. Etanercept to be administered at doses no greater than Maximum dose 50 mg dose every 7 days.