Decision to widen access to febuxostat for the prevention of tumour lysis syndrome

Decision

We're pleased to announce a decision to widen access to febuxostat tablets.

What we’re doing

We're pleased to announce a decision to widen access to febuxostat tablets from 1 February 2021 to include some people at risk of tumour lysis syndrome (TLS).

We estimate that approximately 35 people will benefit from this decision each year.

What does this mean for people?

This decision means that from 1 February 2021, people at risk of TLS who are intolerant of allopurinol will be eligible for funded access to febuxostat.  Febuxostat is currently funded through a Special Authority that can be applied for by any relevant practitioner. Applications for febuxostat for prevention of TLS can be applied for by a haematologist or oncologist.

TLS is a life-threatening condition that occurs when a large number of tumour cells die in a short period of time and release their contents into the blood stream. This can be toxic, resulting in kidney failure, heartbeat irregularities, seizures, neurological complications and potentially death.

Prevention of TLS by reducing uric acid levels is usually achieved with allopurinol, an inhibitor of xanthine oxidase that is funded without restrictions. However, there are a small number of people who are intolerant of allopurinol meaning that it can’t be used as a preventative treatment.

Febuxostat is another inhibitor of xanthine oxidase that can be taken orally, usually once per day.

Febuxostat is Medsafe approved for the prevention and treatment of high uric acid levels in adults undergoing chemotherapy for haematologic malignancies that carry an intermediate to high risk of TLS.(external link)

Febuxostat has similar efficacy to allopurinol and therefore can help with the prevention of TLS in people who are intolerant of allopurinol.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 7 December 2020.

There have been no changes as a result of the consultation feedback.

Who we think will be most interested

  • People with blood cancers and their whānau
  • Haematologists and oncologists
  • Hospital and community pharmacists
  • Other organisations with an interest in the treatment of cancer

Detail about this decision

Funded access to febuxostat (Adenuric) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2021 to include people who are scheduled to receive cancer therapy that carries an intermediate or high risk of TLS (new criteria shown only):

Initial application – (Tumour lysis syndrome) only from a haematologist or oncologist. Approvals valid for 6 weeks for applications meeting the following criteria:

Both:

  1. Patient is scheduled to receive cancer therapy carrying an intermediate or high risk of tumour lysis syndrome; and
  2. Patient has a documented history of allopurinol intolerance.

Renewal – (Tumour lysis syndrome) only from a haematologist or oncologist. Approvals valid for 6 weeks where the treatment remains appropriate and the patient is benefitting from treatment.

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

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback and our response to the feedback received are set out below.

Theme

Comment

Supportive:

  • Considered that the group of people unable to tolerate allopurinol when undergoing chemotherapy, whilst small, are difficult to adequately treat.
  • Considered this change to be a small positive action for a positive outcome.
  • Considered the proposed access criteria appropriate.

We are pleased to be widening access to febuxostat in a way that addresses a current unmet need

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.