Proposal to list methylnaltrexone bromide

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to list methylnaltrexone bromide (Relistor) 12 mg per 0.6 ml injection in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2018; funding would be subject to Special Authority criteria and HML restrictions.

Consultation closes at 5 pm on Wednesday, 22 November 2017 and responses can be emailed to andrew.oliver@pharmac.govt.nz.

What would the effect be?

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

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

The treatment is an injection administered once per day (every other day).

Who we think will be interested

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

About methylnaltrexone bromide (Relistor)

Methylnaltrexone bromide(external link) functions as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system. It is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient.

Methylnaltrexone bromide is administered as 12 mg per 0.6 ml subcutaneous (SC) injection given in the upper arm, abdomen or thigh. It is administered as a single dose on alternate days.

There would be two pack sizes listed on the Pharmaceutical Schedule, a single dose pack and a seven dose pack.

Why we’re proposing this

A funding application for methylnaltrexone bromide was reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) [PDF, 348 KB]. Funding was recommended in the community and DHB hospitals, subject to restrictions limiting its use to the treatment of opioid induced constipation in patients receiving palliative care when oral and rectal treatments are ineffective or unable to be tolerated.

Opioid induced constipation is a significant problem in patients receiving palliative care. The complications of constipation can be debilitating and cause additional pain and discomfort, which is contrary to the goals of palliative care. Methynaltrexone bromide SC injection is an effective and well tolerated alternative where rectal therapies that are currently available have failed or are not tolerated.

Details about our proposal

PHARMAC has entered into a provisional agreement with Link Pharmaceuticals Limited to list Relistor.

Methylnaltrexone bromide (Relistor) would 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) would 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:

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

Restricted

Initiation – Opioid induced constipation

Both:

To provide feedback

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 22 November 2017 to:

Andrew Oliver
Therapeutic Group Manager
PHARMAC

Email: andrew.oliver@pharmac.govt.nz

Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

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.