Post sponsored by NewzEngine.com

Source: Pharmac

What we’re proposing

PHARMAC is seeking your feedback on the proposal to change the Special Authority criteria for bortezomib.

Following PHARMAC’s 2018/19 Invitation to Tender, PHARMAC is proposing to widen funded access to bortezomib by amending the Special Authority criteria that apply to bortezomib. This proposal would allow bortezomib to be used without further restriction for the treatment of multiple myeloma and amyloid light-chain (AL) amyloidosis.  

PHARMAC has not yet made a decision on which brand of bortezomib will be funded as a result of the tender. The widening access proposal is dependent on the outcome of the tender, which means that the timing of the access changes, and which brand of bortezomib would be funded at the time, is still to be determined.

PHARMAC is seeking your feedback only on the proposal to change the Special Authority criteria for bortezomib.

Consultation closes at 4pm, Wednesday 6 November 2019 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

For patients and prescribers

The proposed change to the Special Authority criteria would result in increased flexibility in the funding of bortezomib for people with multiple myeloma or AL amyloidosis. Funded bortezomib could be used at any time and the number of treatment cycles would no longer be limited. The main expected effect of the proposal is to permit bortezomib re-treatment in those people who had a favourable response to fist-line therapy.

For DHBs

The proposed change to the Special Authority criteria would likely increase the number of funded subcutaneous bortezomib injections a DHB provides. We anticipate that up to 40% (120 people) of the 300 people who currently use bortezomib annually in New Zealand could benefit from bortezomib re-treatment. As part of this consultation, we seek feedback on the number of patients who would use bortezomib as re-treatment and the likely duration of re-treatment if funded. 

Who we think will be interested

  • People who have multiple myeloma and AL amyloidosis and their whānau
  • Leukaemia & Blood Cancer New Zealand
  • Haematologists/oncologists
  • Hospital pharmacies
  • DHB infusion service providers
  • Other organisations with an interest in cancer treatment

About bortezomib 

Bortezomib is a cytotoxic agent that is mainly used in the treatment of multiple myeloma. It is a subcutaneous injection that is primarily administered by a medical professional in outpatient services.

Bortezomib is currently funded subject to Special Authority criteria for patients with multiple myeloma or systemic AL amyloidosis as first-line therapy. A small number of patients are eligible to use bortezomib as a second-line therapy if they have relapsed or refractory multiple myeloma and have not previously received bortezomib.


Why we’re proposing this

PHARMAC has historically received clinical advice in support of widening access to bortezomib.

The full history of the proposal, including minutes of the clinical reviews, can be found here(external link).

We now have a potential opportunity to widen the access criteria for bortezomib in conjunction with awarding a tender for bortezomib. The widening access would be dependent on the outcome of the tender, which means that the timing of the access changes, and which brand of bortezomib would be funded at the time, is still to be determined.

This proposal would mean that bortezomib would be funded for patients with multiple myeloma or AL amyloidosis without further restrictions. Another similar treatment, thalidomide, is already funded for this patient group without restrictions, so this proposal would allow greater flexibility in how these agents are used to target a patient’s disease.

Details about our proposal

The current Special Authority criteria for bortezomib inj 3.5 mg vial (shown below in strikethrough) would be replaced by the following new Special Authority criteria:

Initial application — (multiple myeloma/amyloidosis)

Applications only from a relevant specialist or any other medical practitioner on the recommendation of a relevant specialist. Approvals valid without further renewal unless notified where the treatment remains appropriate and the patient is benefiting from treatment.

Either:

  1. The patient has symptomatic multiple myeloma; or
  2. The patient has symptomatic systemic AL amyloidosis*

Note: Indications marked with * are unapproved indications.

If the proposal is progressed, PHARMAC would work with the Ministry of Health to ensure those who have an existing or recently expired approval for bortezomib are transitioned to an approval that would be valid without further renewal.

The existing criteria, shown below in strikethrough, would be deleted.

  1. Initial application — (Treatment naive multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

Both:

    1 Either:

        1.1 The patient has treatment-naive symptomatic multiple myeloma; or

        1.2 The patient has treatment-naive symptomatic systemic AL amyloidosis *; and

    2 Maximum of 9 treatment cycles.

Note: Indications marked with * are unapproved indications.

  1. Initial application — (Relapsed/refractory multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

All of the following:

    1 Either:

        1.1 The patient has relapsed or refractory multiple myeloma; or

        1.2 The patient has relapsed or refractory systemic AL amyloidosis *; and

    2 The patient has received only one prior front line chemotherapy for multiple myeloma or amyloidosis; and

    3 The patient has not had prior publicly funded treatment with bortezomib; and

    4 Maximum of 4 treatment cycles.

Note: Indications marked with * are unapproved indications.

  1. Renewal — (Relapsed/refractory multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

Both:

    1 The patient’s disease obtained at least a partial response from treatment with bortezomib at the completion of cycle 4; and

    2 Maximum of 4 further treatment cycles (making a total maximum of 8 consecutive treatment cycles).

Notes: Responding relapsed/refractory multiple myeloma patients should receive no more than 2 additional cycles of treatment

beyond the cycle at which a confirmed complete response was first achieved. A line of therapy 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.

Refer to datasheet for recommended dosage and number of doses of bortezomib per treatment cycle.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm, Wednesday 6 November 2019.

We particularly seek your feedback on…

  1. The total duration or total number of cycles of bortezomib patients would likely receive over the course of their disease, noting the possibility of dose-related peripheral neuropathy.  
  2. Whether bortezomib would preferentially be used as a monotherapy or in combination with either thalidomide or lenalidomide.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Last updated: 22 October 2019

MIL OSI