Decision to widen access to rituximab for treatment of membranous nephropathy

Medicines Decision

We're pleased to announce a decision to widen access to rituximab for the treatment of people with membranous nephropathy at high risk of end-stage kidney disease

What we’re doing

We're pleased to announce a decision to widen access to rituximab from 1 March 2021 for the treatment of people with membranous nephropathy at high risk of end-stage kidney disease despite  conservative measures.

We estimate that approximately 17 patients will benefit from this proposal each year.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 4 December 2020.

We thank all those who provided consultation feedback. Consultation is an important part of our process and, following consideration of the feedback received, we have made some changes to the Special Authority criteria we consulted on. More information about these changes can be found below.

Who we think will be most interested

  • People with membranous nephropathy and their whānau
  • Nephrologists and health professionals working in dialysis centres and transplant services
  • Hospital and community pharmacies, DHBs, pharmaceutical suppliers and wholesalers

Detail about this decision

Funded access to rituximab (Riximyo) will be amended in Section B of the Pharmaceutical Schedule from 1 March 2021 to include people with membranous nephropathy who continue to be at high risk of progression to end-stage kidney disease despite at least three months of prior treatment with conservative measures as follows (new criteria shown only):

Initial application – (Membranous nephropathy) only from a nephrologist or practitioner on the recommendation of a nephrologist. Approvals valid for 6 weeks for applications meeting the following criteria:

All of the following:

  1. Either
    1. Patient has biopsy-proven primary/idiopathic membranous nephropathy*; or
    2. Patient has PLA2R antibodies with no evidence of secondary cause, and an eGFR of >60ml/min/1.73m2; and
  2. Patient remains at high risk of progression to end-stage kidney disease despite more than 3 months of treatment with conservative measures (see Note); and
  3. The total rituximab dose would not exceed the equivalent of 375mg/m2 of body surface area per week for a total of 4 weeks.

 

Renewal – (Membranous nephropathy) only from a nephrologist or practitioner on the recommendation of a nephrologist. Approvals valid for 6 weeks for applications meeting the following criteria:

All of the following:

  1. Patient was previously treated with rituximab for membranous nephropathy*; and
  2. Either
    1. Treatment with rituximab was previously successful, but the condition has relapsed, and the patient now requires repeat treatment; or
    2. Patient achieved partial response to treatment and requires repeat treatment (see Note); and
  3. The total rituximab dose used would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

 

Notes:

  1. Indications marked with * are unapproved indications.
  2. High risk of progression to end-stage kidney disease defined as >5g/day proteinuria.
  3. Conservative measures include renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents unless contraindicated or the patient has experienced intolerable side effects.

Partial response defined as a reduction of proteinuria of at least 50% from baseline, and between 0.3 grams and 3.5 grams per 24 hours.

Similar restrictions will apply to Part II of Section H of the Pharmaceutical Schedule.

There are no proposed changes to other existing Special Authority criteria or hospital restrictions for rituximab (Riximyo).

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are set out below. 

THEME

PHARMAC COMMENT

Māori and Pasifika are over-represented in those experiencing end-stage kidney disease and widened access will contribute to improved health outcomes for these groups.

Supporting the reduction of health inequities, and improvement of health outcomes in Aotearoa New Zealand is a priority for us.

We understand that Māori and Pasifika experience poorer outcomes with membranous nephropathy and other relevant kidney conditions. We are pleased that widening access to rituximab is a step to improving this.

Special Authority criteria changes

 

Request to enable diagnosis based on anti-phospholipase A2 receptor (PLA2R) antibodies, no evidence of secondary causes and eGFR more than 60ml/min without the requirement for biopsy-proven disease.

These characteristics are highly predictive of tissue diagnosis, with no additional information gained by biopsy, which is invasive for patients.

Following consideration of the feedback received, the funding criteria  have been amended to enable diagnosis based on the presence of PLA2R antibodies in people without evidence of other secondary cause and an eGFR more than 60ml/min/1.73m2, removing the requirement to have a biopsy.

Request to enable repeat rituximab treatment at 6 months in people with partial remission (defined as reduction of proteinuria at least 50% from baseline and between 0.3 and 3.5g per 25 hours).

The funding criteria  have been amended to enable further rituximab treatment in people who achieve partial response to initial treatment.

Request to enable rituximab use in people with an eGFR of less than 40ml/min/1.73m2.

People with an eGFR of less than 40ml/min/1.73m2 at high risk of progression (defined as more than 5g/day proteinuria) would receive benefit from rituximab treatment.

The funding criteria have been amended to remove the requirement for a creatinine clearance (eGFR) of more than 40ml/min/1.73m2.

The proposed Special Authority criteria would not permit rituximab treatment for patients unable to trial all conservative measures for three months.

Some patients may be unable to trial all conservative measures due to clinical suitability (such as a contraindication). Request to enable these patients to access treatment.  

The funding criteria have been amended to enable that conservative measures be trialled for a minimum of three months unless contraindicated, or the patient has experienced intolerable side effects. 

A requirement to trial immunomodulators prior to rituximab treatment may be inappropriate for some patients if there is a need for a rapid effect.

We note the Special Authority criteria do not require prior trial of immunomodulators. 

People with membranous nephropathy need to have trialled three months of conservative measures unless those treatments are contraindicated or have been intolerable.

If these treatments are inappropriate due to urgency, a Special Authority waiver could be considered.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.