Proposed changes to etanercept access criteria

Changes that would be made to the eligibility criteria with 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. The pPatient has had an initial Special Authority approval for adalimumab and/or tocilizumab for adult-onset Still's disease AOSD; or and
   2. The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the HML rules; and
   3. 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.

Changes that would be made to the eligibility criteria with 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. 2. 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
   
   3 Physician considers that the patient has benefited from treatment and that continued treatment is appropriate; and
2. 4. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Changes that would be made to the eligibility criteria with 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:
   
   2.1 To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   2.2 Patient has had polyarticular course JIA for 6 months duration or longer; and
   
   Any of the following:
   Any of the following:
   1. 2.3.1 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 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 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

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.

Changes that would be made to the eligibility criteria with 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:
         2.1  To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
         2.2  Patient has had oligoarticular course JIA for 6 months duration or longer; and
   2. 3Any of the followingEither:
      1. 3.1 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. 3.2 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
         1. 1. 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.

Changes that would be made to the eligibility criteria with 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:
2. The pPatient has had an initial Special Authority approval for adalimumab or secukinumab for psoriatic arthritis; and
3. 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
4. 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. 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.

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:

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

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 etanercept treatment in the opinion of the treating physician; and
2. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (pyoderma gangrenosum*) only from any relevant practitioner a dermatologist. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

All of the following: Both:

1. Patient has pyoderma gangrenosum*; and
   
   Patient has received insufficient benefit from three 3 months of conventional therapy including a minimum of three 3 pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response. Where conventional pharmaceuticals are contraindicated, a 3 month trial has occurred of those that are not contraindicated; and
2. A mMaximum of 8 doses every 4 months.

Note: Indications marked with * are unapproved indications.

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Renewal — (pyoderma gangrenosum) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has shown clinical improvement; and
2. Patient continues to require treatment; and
3. A maximum of 8 doses.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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

Either:

1. Both:
   1. The p Patient has had an initial Special Authority approval for adalimumab for rheumatoid arthritis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects; or
      2. The pPatient has received insufficient benefit to meet the renewal criteria for rheumatoid arthritis; or
2. All of the following:
   1. Patient has had rheumatoid arthritis (either confirmed by radiology radiologic imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
   2. Treatment is to be use as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   3. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate at a maximum tolerated dose (unless contraindicated); and
   4. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate (at maximum tolerated doses unless contraindicated); and
   5. Either:
      1. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate in combination with the maximum tolerated dose of ciclosporin, unless contraindicated; or
      2. Patient has tried and not responded to received insufficient benefit from at least 3 three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with methotrexate, unless contraindicated; and
   6. Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least 4 four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip.

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Renewal — (Arthritis - rheumatoid) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both: All of the following:

1. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
2. Either:
   1. Following 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. On subsequent reapplications, 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
3. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (severe chronic Plaque psoriasis) only from a dermatologist or any relevant practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for severe chronic plaque psoriasis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from etanercept to meet the renewal criteria for severe chronic plaque psoriasis; or
2. All of the following:
   1. Any of the following:
      1. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 10 where lesions have been present for at least 6 months from the time of initial diagnosis; or
      2. Patient has severe chronic plaque psoriasis of the face, or palm of a hand, or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; or
      3. Patient has severe chronic localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months form the time of initial diagnosis, and with a Dermatology Life Quality Index (DLQI) score greater than 10; and
   2. Patient has tried, but had an inadequate response (see Note) to received insufficient benefit from (see Note), or has experienced intolerable side effects from, at least three 3 of the following at maximum tolerated doses (unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
   3. A PASI assessment or Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than within 1 month of stopping following cessation of each prior treatment course that treatment,; and
   4. The most recent PASI or DLQI assessment is no more than within 1 month old at the time of before the

Note: "Inadequate response Insufficient benefit " is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 10, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand, foot, genital or flexural areas at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and for the face, palm of a hand or sole of a foot the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, aAs assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.

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Renewal — (severe chronic Plaque psoriasis) from any relevant practitioner. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Any of the following:
   1. Both:
      1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
      2. Either:
         1. Following each prior etanercept treatment course the pPatient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-treatment baseline value; or
         2. Following each prior etanercept treatment course the pPatient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, when compared with the pre-treatment baseline value; or
   2. Both:
      1. Patient had severe chronic plaque psoriasis of the face, or palm of a hand, or sole of a foot at the start of treatment; and
      2. Either:
         1. Following each prior etanercept treatment course the pPatient has a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-treatment course baseline values; or
         2. Following each prior etanercept treatment course the pPatient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
   3. Both:
      1. Patient has severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
      2. Either:
         1. The pPatient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
         2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to the pre-treatment baseline DLQI prior to commencing etanercept; and
2. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Note: A treatment course is defined as a minimum of 12 weeks etanercept treatment

Changes that would be made to the eligibility criteria with 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
3. 5. Any of the following:
   1. 5.1 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. 5.2 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. 5.3 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. Either:
   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. 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. Etanercept to be administered at doses no greater than Maximum dose 50 mg dose every 7 days.