Proposed changes to the secukinumab access criteria

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

Either:

1. All of the following:
   1. Any of the following:
      1. Patient has "whole body" plaque psoriasis with a 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 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 localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months from the time of initial diagnosis, and with a DLQI score greater than 10; and
   2. Patient has received insufficient benefit (see Note) or has experienced intolerable side effects from at least 3 of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
   3. A PASI assessment or DLQI assessment has been completed for the most recent prior treatment course, within 1 month of stopping that treatment; and
   4. The most recent PASI or DQLI assessment is within 1 month before the application; or
2. All of the following:
   1. Patient has had a Special Authority approval for adalimumab, etanercept, or infliximab, for plaque psoriasis; and
   2. Either:
      1. Patient has experienced intolerable side effects; or
      2. Patient has received insufficient benefit to meet the renewal criteria for plaque psoriasis; and
3. A PASI assessment or DLQI assessment has been completed for the most recent prior treatment within 1 month of stopping that treatment; and
4. The most recent PASI or DQLI assessment is within 1 month before the application.

Note: A treatment course is defined as a minimum of 12 weeks of treatment. "Insufficient benefit" is defined as: for whole body plaque psoriasis, a PASI score of greater than 10; for plaque psoriasis of the face, hand, foot, genital or flexural areas, at least 2 of the 3 PASI symptom sub scores 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. As assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment

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

Renewal — (severe chronic plaque psoriasis – first and second-line biologic) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Both:
      1. Patient’s PASI score has reduced by 75% or more (PASI 75) as compared to pre-secukinumab baseline PASI prior to commencing secukinumab; and
      2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to pre-secukinumab baseline DLQI prior to commencing secukinumab; or
   2. Both:
      1. Patient had severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
      2. Either:
         1. Patient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-secukinumab treatment baseline value; or
         2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to pre-secukinumab baseline DLQI prior to commencing secukinumab; and
2. Secukinumab to be administered at a Maximum dose of 300 mg monthly.

Changes that would be made to the eligibility criteria with 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.

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
2. Secukinumab to be administered at doses no greater than Maximum dose 300 mg monthly.

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 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

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.