Proposal to fund adalimumab and etanercept for the treatment of pyoderma gangrenosum

Special Authority:

Initial application – only from a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following;

1. Patient has pyoderma gangrenosum*; and
2. Patient has received three months of conventional therapy including a minimum of three pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response; and
   
   Either;
   
   
3. Patient is commenced on adalimumab at 40mg per week on alternate weeks up to a maximum of 3 x 40mg doses:  or
4. Patient is commenced on etanercept at 50mg per week up to a maximum of 3 x 50 mg doses.

Renewal – only from a dermatologist or a Practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following;

1. Either:
   1.  The applicant is a dermatologist: or
   2. The applicant is a Practitioner and confirms that a dermatologist has provided a letter, email or fax of recommendation; and
2. Patient has shown clinical improvement; and
3. Patient continues to require treatment; and
   Either;
4. Patient is commenced on adalimumab at 40mg per week on alternate weeks up to a maximum of 3 x 40mg doses:
   or
5. Patient is commenced on etanercept at 50mg per week up to a maximum of 3 x 50 mg doses.

* Note: Indications marked with * are Unapproved Indications (refer to Section A: General Rules, Part I (Interpretations and Definitions) and Part IV (Miscellaneous Provisions) rule 4.6).

• From 1 June 2014 the restrictions for etanercept and adalimumab in Part II of Section H (hospital) of the Pharmaceutical Schedule would be amended to include the indication of pyoderma gangrenosum as follows:

Initiation  – pyoderma gangrenosum

Dermatologist

Re-assessment required after 4 months

All of the following;

1. Patient has pyoderma gangrenosum*; and
2. Patient has received three months of conventional therapy including a minimum of three pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response; and
   Either;
3. Patient is commenced on adalimumab at 40mg per week on alternative weeks up to a maximum of 3 x 40mg dose:  or
4. Patient is commenced on etanercept at 50mg per week up to a maximum of 3 x 50 mg dose.

Continuation– pyoderma gangrenosum

Re-assessment required after 4 months

Dermatologist

All of the following;

1. Patient has shown clinical improvement; and
2. Patient continues to require treatment; and
   Either;
3. Patient is commenced on adalimumab at 40mg per week on alternative weeks up to a maximum of 3 x 40mg doses:  or
4. Patient is commenced on etanercept at 50mg per week up to a maximum of 3 x 50 mg doses.

* Note: Indications marked with * are Unapproved Indications (refer to Section A: General Rules, Part I (Interpretations and Definitions) and Part IV (Miscellaneous Provisions) rule 4.6)