Proposal to widen funded access to lenalidomide for multiple myeloma

A decision has been made

Read the notification of PHARMAC's decision – published 11 March 2020

Access to lenalidomide (Revlimid) would be amended in Section B of the Pharmaceutical Schedule from 1 April 2020 to include people with newly diagnosed multiple myeloma who have undergone auto-SCT as follows (deletions in strikethrough, additions in bold):

Special Authority for Subsidy

Special Authority for Subsidy
Initial application – (Relapsed/refractory disease) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient has relapsed or refractory multiple myeloma with progressive disease; and
2. Patient has not previously been treated with lenalidomide; and
3. Either
   1. Lenalidomide to be used as third line* treatment for multiple myeloma; or
   2. Both:
      1. Lenalidomide to be used as second line treatment for multiple myeloma; and
      2. The patient has experienced severe (grade 3 or higher), dose limiting, peripheral neuropathy with either bortezomib or thalidomide that precludes further treatment with either of these treatments; and
4. Lenalidomide to be administered at a maximum dose of 25 mg/day in combination with dexamethasone.

Renewal – (Relapsed/refractory disease) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

Both:

1. No evidence of disease progression; and
2. The treatment remains appropriate and patient is benefitting from treatment.

Initial application – (Maintenance following first-line autologous SCT) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient has newly diagnosed symptomatic multiple myeloma and has undergone first-line treatment that included an autologous stem cell transplantation; and
2. Patient has at least a stable disease response in the first 100 days after transplantation; and
3. Lenalidomide maintenance is to be commenced within 4 months of transplantation; and
4. The patient has ECOG performance score of 0-1; and
5. Lenalidomide to be administered at a maximum dose of 15 mg/day.

Renewal – (Maintenance following first line autologous SCT) only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria.

Both:

1. No evidence of disease progression; and
2. The treatment remains appropriate and patient is benefitting from treatment.

Note: Indication marked with * is an unapproved indication. A line of treatment is considered to comprise either: a) a known therapeutic chemotherapy regimen and supportive treatments or b) a transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments. Prescriptions must be written by a registered prescriber in the lenalidomide risk management programme operated by the supplier.

Equivalent changes to the restrictions for lenalidomide (Revlimid) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).