Proposed changes to the Mabthera access criteria

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (arthritis - rheumatoid arthritis - TNF inhibitors contraindicated) only from a rheumatologist or any relevant Ppractitioner on the recommendation of a rheumatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:                                                                            

1. Treatment with a Tumour Necrosis Factor alpha inhibitor is contraindicated; and
2. Patient has had severe and active erosive rheumatoid arthritis (either confirmed by radiology radiologic imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
3. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose, unless contraindicated; and
4. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate (at maximum tolerated doses), unless contraindicated; and
5. Any of the following Either:
   1. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate in combination with the maximum tolerated dose of ciclosporin, unless contraindicated; or
   2. Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with intramuscular gold; or
      
      5.3 Patient has tried and Disease has not responded to at least 3three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with oral or parenteral methotrexate, unless contraindicated; and
6. Either:
   1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 swollen, tender joints; or
   2. Patient has persistent symptoms of poorly controlled and active disease in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder, or hip; and
7. Either:
   1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
   2. C-reactive protein levels CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than 3three months; and
      
      8 Either:
      8.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
      8.2 Patient is contraindicated to both m Methotrexate and leflunomide are contraindicated, requiring use of rituximab monotherapy to be used; and
8. 9 Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (arthritis - rheumatoid arthritis - prior TNF inhibitor use) only from a rheumatologist or any relevant Ppractitioner on the recommendation of a rheumatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1 Both:

1. 1.1 The pPatient has had an initial community Special Authority approval for at least one of etanercept and/or adalimumab for rheumatoid arthritis; and
2. 1.2 Either:
   1. 1.2.1 The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. 1.2.2 Following at least a four4 month trial of adalimumab and/or etanercept, the patient did not meet the renewal criteria for adalimumab and/or etanercept for rheumatoid arthritis were not met; and
      
      2 Either:
      2.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
      2.2 Patient is contraindicated to both m Methotrexate and leflunomide are contraindicated, requiring rituximab monotherapy to be used.; and
3. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Renewal — (arthritis - rheumatoid arthritis – retreatment in ‘partial responders'’ for people who have experienced a partial response to rituximab) only from a rheumatologist or any relevant Ppractitioner on the recommendation of a rheumatologist. Approvals valid for 4 months 12 months for applications meeting the following criteria:

All of the following:

1. Any of the following:
   1. At 4 months fFollowing the initial course of rituximab infusions the patient had experienced between a 30% and 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. At 4 months fFollowing the second course of rituximab infusions the patient had experienced 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
   3. At 4 months fFollowing the third and subsequent courses of rituximab infusions, the patient demonstrates experienced 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; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
   3. Either:
   3.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   3.2 Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy. to be used.; and
3. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Renewal — (arthritis - rheumatoid arthritis – retreatment in for people who experience a response ‘responders’ to rituximab) only from a rheumatologist or any relevant Ppractitioner on the recommendation of a rheumatologist. Approvals valid for 4 months 12 months for applications meeting the following criteria:

All of the following:

1. Either:
   1. At 4 months fFollowing the initial course of rituximab infusions the patient had experienced 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. At 4 months fFollowing the second and subsequent courses of rituximab infusions, the patient demonstrates experienced 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; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
   
   3 Either:
   3.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
   3.2 Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
3. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.