Proposed changes for plaque psoriasis

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.

---

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

Additions in bold, deletions in strikethrough:

Initial application — (plaque psoriasis) only from a dermatologist or any relevant practitioner on the recommendation of a dermatologist any relevant practitioner.

Approvals valid for 3 4 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient had an initial Special Authority approval for adalimumab, etanercept or secukinumab for severe chronic plaque psoriasis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab, etanercept or secukinumab; or
      2. The pPatient has received insufficient benefit from adalimumab, etanercept or secukinumab to meet the renewal criteria for adalimumab, etanercept or secukinumab 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 from 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 received insufficient benefit (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 following cessation of each prior treatment course of stopping that treatment; and
   4. The most recent PASI or DLQI assessment is within 1 month before the application.

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.

---

Renewal — (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. Following each prior infliximab 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-infliximab 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 infliximab treatment course 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-infliximab treatment course baseline values; or
         2. Following each prior infliximab 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-infliximab treatment baseline value; or
   3. Both:
      1. Patient had 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. The pPatient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to the pre-infliximab baseline DLQI prior to commencing infliximab; and
2. Infliximab to be administered at doses no greater than Maximum dose 5mg/kg every 8 weeks.

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.