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Source: Pharmac

Details about the decision

From 1 March 2020, two brands of rituximab will be funded for use in different clinical indications. Each product will have separate Special Authority funding criteria. Prescribers and hospital pharmacists will need to work together to manage the transition in their hospital. PHARMAC will provide information and resources about biosimilar rituximab to support the change.

Summary of funding of rituximab

Rituximab brand

From 1 March 2020

From 1 December 2020

Riximyo (biosimilar)

For new and existing patients for all currently funded indications except for rheumatoid arthritis

For new funded indications

For all current and new funded indications, except for rheumatoid arthritis

Mabthera

For new and existing patients with rheumatoid arthritis

For renewals (but not for initials) for existing patients for all currently funded indications but not for new funded indications

For rheumatoid arthritis only

Most patients currently on treatment with rituximab will not be impacted by this proposal. Patients can continue to receive their current brand of rituximab until their treatment course is complete, if this is before 1 December 2020.

Patients who have started on Mabthera and require treatment after 1 December 2020, for any indication except rheumatoid arthritis, will need to transition to biosimilar rituximab (Riximyo). Given the 9-month transition period we expect that this would only be a very small number of current patients. This change will be carefully supported by the treating clinician, working with the patient and family/caregivers. PHARMAC will communicate with relevant clinicians, pharmacies, support services and DHB services regarding the change process.

Patients with rheumatoid arthritis will continue to receive the Mabthera brand of rituximab. Legal patents on the use of Mabthera for the treatment of rheumatoid arthritis prevent the use of other brands for this condition at this time.

If a patient is unable to use the new brand of rituximab for a clinical reason, and it is safe to consider further treatment with rituximab, PHARMAC will consider a Named Patient Pharmaceutical Assessment (NPPA) application from a clinician to use the Mabthera brand of rituximab for an individual patient.

New listing for Riximyo

From 1 March 2020, Riximyo will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical

Formulation

Brand

Pack size

Price & Subsidy

Rituximab (Riximyo)

Inj 100 mg per 10 ml vial

Riximyo

2

$275.33

Rituximab (Riximyo)

Inj 500 mg per 50 ml vial

Riximyo

1

$688.20

Rituximab (Riximyo)

Inj 1 mg for ECP

Baxter

1 mg

$1.38

Rituximab (Riximyo) will be listed as a PCT only-Specialist pharmaceutical in Section B of the Pharmaceutical Schedule. A confidential rebate applies to all presentations of Riximyo, which reduces the net price to the funder. 

Changes to listing for Mabthera

From 1 March 2020, the Pharmaceutical Schedule listing for the Mabthera brand of rituximab will be amended to specify the brand at the chemical level as follows (additions in bold):

Chemical

Formulation

Brand

Pack size

Price & Subsidy

Rituximab
(Mabthera)

Inj 100 mg per 10 ml vial

Mabthera

2

$1,075.50

Rituximab
(Mabthera)

Inj 500 mg per 50 ml vial

Mabthera

1

$2,688.30

Rituximab
(Mabthera)

Inj 1 mg for ECP

Baxter

1 mg

$5.64

To claim a subsidy, the correct brand will need to be used for the correct indication. PHARMAC will take steps to ensure that indication specificity/exclusivity is also applied to rituximab procured via Contract Manufacturers.

Special Authority and hospital restriction changes

Changes for Riximyo

The Special Authority criteria and hospital indication restrictions will be amended from 1 March 2020 to widen access to 7 new or amended indications for the Riximyo brand.

For full details of the changes to the Special Authority criteria please refer to the consultation letter.

Following consultation, we have made some changes to the original proposed criteria for anti-NMDA receptor encephalitis and severe chronic inflammatory demyelinating neuropathy. Changes are outlined below (changes to the original proposal in bold and strikethrough):

Special Authority for Subsidy

Initial application – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following

  1. Patient has severe chronic inflammatory demyelinating polyneuropathy (CIPD); and
  2. Either

2.1   Treatment with at least 3 immunosuppressants (oral and intravenous steroids, cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or
Both

2.1.1   Treatment with steroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling active disease; and

2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or

2.2   Rapid treatment is required due to life threatening complications; and

  1. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Renewal – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

  1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function compared to baseline; and
  2. The patient has not received rituximab in the previous 6 months; and
  3. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Initial application – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following

  1. Patient has severe anti-NMDA receptor autoimmune encephalitis; and
  2. Either

2.1   Treatment with at least 3 immunosuppressants (oral and intravenous steroids, cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease;
Both

2.1.1   Treatment with steroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling active disease; and

2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or

2.2   Rapid treatment is required due to life threatening complications; and

  1. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Renewal – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or any medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

  1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function; and
  2. The patient has not received rituximab in the previous 6 months; and
  3. The patient has experienced a relapse and now requires further treatment; and
  4. One of the following dose regimens is to be used: 375 mg/m2 of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

The same restrictions for the Riximyo brand of rituximab will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

 

Changes for Mabthera

From 1 March 2020, the current Special Authority criteria for Mabthera will change. Mabthera will only be funded for patients already on treatment (no new patients) for all funded indications excluding rheumatoid arthritis. Initial applications will be removed from the Special Authority application form. Mabthera will not be funded for the new/amended indications outlined above for the Riximyo brand.

From 1 December 2020, the Special Authority criteria for Mabthera will be amended to only include the currently funded rheumatoid arthritis uses.

The same restrictions for the Mabthera brand of rituximab will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

Support for the changes

PHARMAC staff will work with health care professionals and consumer organisations to provide information on biosimilar rituximab.  This is likely to include education sessions for clinical DHB staff and patient information on rituximab.  PHARMAC staff will work with DHB staff in the development of these resources.

Information will also be available during the transition period for prescribers and pharmacists on PHARMAC’s website.

Last updated: 5 December 2019

MIL OSI