Decision to fund methylnaltrexone in palliative care

Medicines

Decision

What we’re doing

We’re pleased to announce the approval of an agreement with Link Pharmaceuticals Limited for the listing of methylnaltrexone bromide (Relistor) 12 mg per 0.6 ml injection in Section B (Community) and Part II of Section H (Hospital) of the Pharmaceutical Schedule from 1 January 2018.  Funding is subject to Special Authority criteria and DHB Hospital restrictions.

Any changes to the original proposal?

This was the subject of a consultation letter dated 8 November 2017. No changes have been made to the proposal.

Who we think will be most interested

This decision will be of interest to

  • Community, hospital and hospice prescribers, particularly palliative care clinicians, oncologists, pain specialists, and general practitioners.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.
  • Consumer advocacy groups.

What will the effect of this decision be?

From 1 January 2018 methylnaltrexone bromide will be funded in the community and DHB hospitals for patients receiving palliative care, who have opioid induced constipation, and for whom oral and rectal treatments for opioid constipation are ineffective or unable to be tolerated.

Any relevant practitioner will be able to apply for Special Authority approval for patients who meet the criteria.

Two pack sizes will be listed; a single dose pack and a seven dose pack.

Detail of this decision

Methylnaltrexone bromide (Relistor) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2018 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Methylnaltrexone bromide

Inj 12 mg per 0.6 ml

Relistor

1

$36.00

Methylnaltrexone bromide

Inj 12 mg per 0.6 ml

Relistor

7

$246.00

Methylnaltrexone bromide (Relistor) will be listed in Section B subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application - (Opioid induced constipation) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Both:

  1. The patient is receiving palliative care; and
  2. Either:

2.1.  Oral and rectal treatments for opioid induced constipation are ineffective; or
2.2.  Oral and rectal treatments for opioid induced constipation are unable to be tolerated.

Methylnaltrexone bromide (Relistor) will be listed in Part II Section H subject to the following restrictions:

Restricted

Initiation – Opioid induced constipation

Both:

  1. The patient is receiving palliative care; and
  2. Either:

2.1.  Oral and rectal treatments for opioid induced constipation are ineffective; or
2.2.  Oral and rectal treatments for opioid induced constipation are unable to be tolerated.

Our response to what you told us

We’re very grateful for the time people took to respond to this consultation. All consultation responses received by 22 November 2017 were considered in their entirety when making the decision. The table below summarises the main themes raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

If you have any questions, 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 66 00 50.

Theme

PHARMAC Comment

Respondents supported the proposal to fund methylnaltrexone bromide for opioid induced constipation in palliative care for patients who either do not tolerate or do not respond to conventional laxative treatment.

Noted.

Some respondents suggested methylnaltrexone bromide should be made available outside the palliative care setting.

PHARMAC notes that methylnaltrexone is only indicated for use in palliative care. PHARMAC has not received any funding applications for use outside the palliative care setting.

Some respondents suggested removing the Special Authority criteria from macrogol (another treatment for constipation).

PHARMAC is considering a proposal to widen access to macrogol.

Some respondents considered that there is a risk that some prescribers could assume methylnaltrexone bromide can reverse opioid overdose, and recommended that the packaging should contain a warning that methylnaltrexone only works on the gastrointestinal system and will not be effective for life threatening overdose.

PHARMAC notes that such usage would be both outside the registered indications and the funding restrictions.

PHARMAC will share this feedback with Medsafe, the agency responsible for regulating the safety of medicines and their labelling.

Some respondents were supportive of both a single dose pack and a seven dose pack being funded.  They considered this should help minimise wastage.

Noted.