Tocilizumab for rheumatoid arthritis – use in DHB hospitals

Initiation —Rheumatoid Arthritis
Rheumatologist
Re-assessment required after 6 months

Either:

1. All of the following:

   1. The patient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and

   2. Either:

      1. The patient has experienced intolerable side effects from adalimumab and/or etanercept; or

      2. The patient has received insufficient benefit from at least a three-month trial of adalimumab and/or etanercept such that they do not meet the renewal criteria for rheumatoid arthritis; and

   3. The patient has been started on rituximab for rheumatoid arthritis in a DHB hospital in accordance with the HML rules; and

   4. Either:

      1. The patient has experienced intolerable side effects from rituximab; or

      2. At four months following the initial course of rituximab the patient has received insufficient benefit such that they do not meet the renewal criteria for rheumatoid arthritis; or

2. All of the following:

   1. Patient has had severe and active erosive rheumatoid arthritis for six months duration or longer; and

   2. Tocilizumab is to be used as monotherapy; and

   3. Either:

      1. Treatment with methotrexate is contraindicated; or

      2. Patient has tried and did not tolerate oral and/or parenteral methotrexate; and

   4. Either:

      1. Patient has tried and not responded to at least three months therapy at the maximum tolerated dose of cyclosporine alone or in combination with another agent; or

      2. Patient has tried and not responded to at least three months therapy at the maximum tolerated dose of leflunomide alone or in combination with another agent; and

       

   5. Either:

      1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 active, swollen, tender joints; or

      2. Patient has persistent symptoms of poorly controlled and active disease in at least four active joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and

   6. Either:

      1. Patient has a C-reactive protein level greater than 15 mg/L measured no more than one month prior to the date of this application; or

      2. C-reactive protein levels not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so for more than three months.

Continuation – Rheumatoid Arthritis
Rheumatologist
Re-assessment required after 6 months

Either:

1. Following 6 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. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.

• The price of tocilizumab, and the restrictions applying to tocilizumab for Adult-onset Still’s disease and systemic juvenile idiopathic arthritis, will remain unchanged.