Appendix C. Detail on criteria for audit of the use of etanercept and efalizumab for the treatment of adults with psoriasis

Appendix C. Detail on criteria for audit of the use of etanercept and efalizumab for the treatment of adults with psoriasis

Possible objectives for an audit

An audit could be carried out to ensure that efalizumab and etanercept are used appropriately in the treatment of adults with plaque psoriasis.

Possible patients to be included in the audit

An audit could be carried out on all adults seen for plaque psoriasis in a reasonable period for audit, for example, 6 months.

An alternative could be to find patients for whom efalizumab or etanercept has been prescribed as treatment for plaque psoriasis, and use the measures below to ensure that the drugs have been prescribed appropriately.

Measures that could be used as a basis for an audit

The measures that could be used in an audit of etanercept and efalizumab for the treatment of plaque psoriasis are as follows.

Criterion

Standard

Exception

Definition of terms

1. An adult with plaque psoriasis is prescribed etanercept, within its licensed indications, at a dose not exceeding 25 mg twice weekly only when both of the following criteria are met

a. The disease is severe and

b. The psoriasis has failed to respond to standard systemic therapies, or the person is intolerant to, or has a contraindication to, these treatments

100% of adults who are prescribed etanercept for plaque psoriasis

None

'Severe' psoriasis means a total Psoriasis Area Severity Index (PASI) ≥ 10 and a Dermatology Life Quality Index (DLQI) > 10.

Clinicians will need to agree locally on how to define 'failed to respond to' and 'intolerance to' standard systemic therapies, for audit purposes.

'Standard systemic therapies' include ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation).

(As a guide for designing the audit, see the British Association of Dermatologists Guidelines for use of biological interventions in psoriasis for more detail related to definitions.)

See the summaries of product characteristics for contraindications to standard systemic therapies in routine use

2. A person with plaque psoriasis is prescribed efalizumab, within its licensed indications, only when all of the following criteria are met

a. The disease is severe and

b. The psoriasis has failed to respond to standard systemic therapies or the person is intolerant to, or has a contraindication to, these treatments and

a. The psoriasis has failed to respond to etanercept or the person is intolerant to, or has a contraindication to etanercept

100% of adults who are prescribed efalizumab for plaque psoriasis

A person had begun a course of treatment with efalizumab at the date of publication of this guidance and has opted to continue to receive treatment until the person and his or her clinicians consider it is appropriate to stop

'Responded to treatment with etanercept' is defined as a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI 12 weeks from when treatment started.

See the SPC for contraindications to etanercept.

Clinicians will need to agree locally on how to document the patient's option of continuing to receive efalizumab until it is considered appropriate to stop

3. The response to etanercept or efalizumab is assessed at 12 weeks of treatment using the PASI and DLQI

100% of the people for whom etanercept or efalizumab has been prescribed for severe psoriasis and who have been on the drug for at least 12 weeks

None

Assessment is to determine the response to treatment for either etanercept or efalizumab. See above for the definition of response to treatment.

Clinicians will need to agree locally to how assessment of response to treatment is documented, for audit purposes

4. The prescription of etanercept or efalizumab is discontinued at 12 weeks unless the psoriasis has responded adequately to treatment

100% of the people for whom etanercept or efalizumab has been prescribed for severe psoriasis and who have been on the drug for at least 12 weeks

None

See above for relevant definitions

5. Further treatment is prescribed for people whose psoriasis does not adequately respond at 12 weeks

0% of people for whom etanercept or efalizumab has been prescribed and whose psoriasis has not responded adequately

None

See above for relevant definitions

6. The use of etanercept and efalizumab for psoriasis is initiated and supervised only by a specialist physician experienced in the diagnosis and treatment of psoriasis

100% of the people for whom etanercept or efalizumab has been prescribed for severe psoriasis

If a person has both psoriasis and psoriatic arthritis, his or her treatment is managed by collaboration between a rheumatologist and a dermatologist

Clinicians will need to agree locally on what constitutes initiation and supervision of the use of etanercept and efalizumab for psoriasis and what constitutes collaboration between a rheumatologist and a dermatologist, for audit purposes

Calculation of compliance

Compliance (%) with each measure described in the table above is calculated as follows.

Number of patients whose care is consistent with the criterionplus number of patients who meet any exception listed

x 100

Number of patients to whom the measure applies

Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.