Proposal to widen access to rituximab for treatment of membranous nephropathy

Medicines

Consultation Closed

We are seeking feedback on a proposal to widen access to rituximab.

What we’re proposing

We are seeking feedback on a proposal to widen access to rituximab from 1 March 2021 for the treatment of membranous nephropathy in patients at high risk of progression to end-stage kidney disease despite conservative measures.

We particularly seek your feedback on the proposed funding criteria, including the definition of high risk of progression to end-stage kidney disease. More information about this is provided in the “To provide feedback” section below.

Consultation closes at 5 pm on Friday 18 December 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that from 1 March 2021, funded access to rituximab would be widened to include the treatment of people with membranous nephropathy who remain at high risk of end-stage kidney disease despite more than three months of prior treatment with conservative measures.

We estimate that approximately 16 patients would benefit from this proposal each year.

Who we think will be 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

About rituximab and membranous nephropathy

Rituximab is a monoclonal antibody agent currently funded for use in a variety of indications, including cancer, rheumatoid arthritis, autoimmune and haematological conditions (see: Section H: Rituximab(external link)).

Rituximab is registered with Medsafe for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and granulomatosis.

Rituximab is not registered for use in the other currently funded indications or for the proposed widening of funded access to include membranous nephropathy. This means that rituximab would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981 when used in these unapproved indications.

Membranous nephropathy is a kidney disorder that presents as an autoimmune disease in adults and is characterised by excessive protein excreted in the urine, low albumin, swelling and high cholesterol. Membranous nephropathy is typically diagnosed by taking a biopsy of the kidney, with treatment options dependent on the severity and progression of disease.

Initial treatment of membranous nephropathy is typically focused on conservative management including renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents. Many patients respond to conservative management; however, patients who experience insufficient response to conservative management are at risk of disease progression which can lead to end stage kidney disease, and kidney failure requiring kidney transplant or dialysis.

Why we’re proposing this

A funding application for widened access to rituximab for people with membranous nephropathy was reviewed by PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2020.(external link)

PTAC recommended that rituximab be funded with a high priority for the treatment of membranous nephropathy in people at high risk of progression to end stage kidney disease despite conservative measures [PDF, 509 KB].

This proposal is in line with PTAC’s recommendation.

Details about our proposal

Funded access to rituximab (Riximyo) would be amended in Section B and Part II of Section H 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. Patient has biopsy-proven primary/idiopathic membranous nephropathy*; and
  2. Patient remains at high risk** of progression to end-stage kidney disease despite more than 3 months of treatment with conservative measures***; 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. Treatment with rituximab was previously successful, but the condition has relapsed, and the patient now requires repeat treatment; 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: Indications marked with * are unapproved indications.

** high risk of progression to end-stage kidney disease defined as >5g/day proteinuria and a creatinine clearance (estimated glomerular filtrate rate (eGFR)) of ≥40ml/min/1.73m2.

*** conservative measures include renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents.

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

To provide feedback

Send us an email: consult@pharmac.govt.nz by Friday 18 December 2020.

We particularly seek your feedback on the proposed Special Authority criteria and hospital restrictions, including the definition of high risk of progression to end-stage kidney disease. This is currently defined as proteinuria of >5g/day and a creatinine clearance (estimated glomerular filtration rate (eGFR)) of ≥40ml/min/1.72m2. This definition reflects clinical advice and evidence that indicates that rituximab treatment is relatively ineffective in patients with membranous nephropathy that has already progressed to significant renal impairment (e.g. eGFR <40ml/min/1.72m2).

We seek feedback on whether there is evidence of benefit from rituximab in patients with membranous nephropathy and significant renal impairment (eGFR <40ml/min/1.72m2) and, if so, how many patients this would apply to in New Zealand.  

Your feedback may be shared

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