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Psoriasis: Enbrel®, Humira® and Stelara® (biological medicinal products)

Updated 01 July 2011

Guiding criteria for single reimbursement

Single reimbursement of Enbrel®, Humira® and Stelara® for the treatment of psoriasis is usually granted when the following criteria are satisfied and appear from the application:

  • the patient is an adult (above the age of 18) with moderate to severe chronic psoriasis (as defined by the Rule of Tens) and does not respond to, has contraindications to or is intolerant to (unacceptable adverse reactions) methotrexate and phototherapy in the form of narrow-spectrum UVB or PUVA and
  • in addition, if the patient has contraindications to methotrexate, the patient must have been found not to respond to or to be intolerant to (unacceptable adverse reactions) cyclosporine or acitretin before treatment with biological medicinal products is started.

The following applies to methotrexate

Lack of response to methotrexate is an unsatisfactory effect in patients treated for a period of at least three months at the highest tolerated dose (typically 15-25mg orally a week). If it is suspected that the medicine is not adequately absorbed or there are severe gastrointestinal reactions, subcutaneous injections should be attempted.

The following applies to phototherapy

Lack of response to narrow-spectrum UVB treatment is an unsatisfactory effect in patients treated for a period of 8-10 weeks three times a week. Patients that experience rapid recurrence after phototherapy and who need more than two treatment sessions a year are also defined as non-responsive patients.

Lack of response to PUVA treatment is an unsatisfactory effect in patients treated for a period of 8-10 weeks three times a week. Patients who need more than one treatment session a year or who have received more than 150-200 PUVA treatments are also defined as non-responsive patients.

The following applies to cyclosporine

Lack of response to cyclosporine is an unsatisfactory effect in patients treated with cyclosporine for a period of at least three months at the dose of 2.5-5 mg/kg/daily.

The following applies to acitretin

Lack of response to acitretin is an unsatisfactory effect in patients treated with actretin for a period of at least three months at a dose of 25-50mg daily.

Reimbursement is not granted if the injections are given in hospital or if the patient has been instructed in how to perform the injections at home under outpatient care. These patients are covered under the scheme for dispensing of free medicine to certain patients treated under outpatient care.

Psoriasis is considered to be severe when PASI, BSA or DLQI is more than 10 (the Rule of Tens).