Proposal to widen access to febuxostat for prevention of tumour lysis syndrome

Medicines

Consultation Closed

We are seeking feedback on a proposal to widen access to febuxostat tablets.

What we’re proposing

We are seeking feedback on a proposal to widen access to febuxostat tablets from 1 February 2021 to include some patients at risk of tumour lysis syndrome (TLS).

Consultation closes at 4 pm on Monday 21 December 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that from 1 February 2021, funded access to febuxostat tablets would be widened to include patients at high risk of TLS who are intolerant of allopurinol.

We estimate that approximately 30 patients would benefit from this proposal each year.

Who we think will be 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

About febuxostat and tumour lysis syndrome

Febuxostat is a potent inhibitor of xanthine oxidase, which helps to reduce uric acid levels in the blood. Febuxostat tablets are taken orally, usually once per day.

Febuxostat is funded subject to Special Authority restrictions for the treatment of gout. However, it is also Medsafe approved for the prevention and treatment of hyperuricaemia (high uric acid levels) in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of TLS.

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.

TLS is rare, but most commonly occurs after cancer therapy for certain forms of leukaemia and lymphoma. The risk of TLS is divided into Low Risk (cancer therapy carries a less than 1% risk of TLS), Intermediate Risk (cancer therapy carries a 1-5% risk of TLS) and High Risk (cancer therapy carries a risk of TLS of greater than 5%).

Further details regarding the relative risk of TLS for different cancer types can be found here.(external link)

Prevention of TLS by reducing uric acid levels is routinely achieved with allopurinol, another inhibitor of xanthine oxidase that is funded without restrictions. However, there are a small number of patients who are intolerant of allopurinol and therefore require treatment with a different agent such as febuxostat to achieve a similar effect.

Why we’re proposing this

A funding application(external link) to widen access to febuxostat for the prevention of TLS in allopurinol-intolerant patients scheduled to receive a cancer therapy that carries an Intermediate or High Risk of TLS was reviewed by PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) in June 2020.

At this meeting PTAC recommended that febuxostat for TLS be funded with a high priority, based on the high health need of patients who develop TLS and the similar efficacy of allopurinol and febuxostat. [PDF, 191 KB]

Febuxostat is already funded for certain patients with gout and this proposed change would result in an amendment to the current Special Authority criteria to include patients who are allopurinol-intolerant and scheduled to receive a cancer therapy that is associated with an intermediate or high risk of TLS.

Details about our proposal

Funded access to febuxostat (Adenuric) would be amended 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 proposed changes to other existing Special Authority criteria or hospital restrictions for febuxostat.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4 pm on Monday 21 December 2020.

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.

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