Decision to fund mercaptopurine oral suspension

Medicines

Decision

We’re pleased to announce the approval of an agreement with Link Pharmaceuticals Limited for the listing of mercaptopurine (Allmercap) oral suspension 20 mg per ml.

What we’re doing

We’re pleased to announce the approval of an agreement with Link Pharmaceuticals Limited for the listing of mercaptopurine (Allmercap) oral suspension 20 mg per ml in Section B (Community) and Part II of Section H (DHB Hospital) of the Pharmaceutical Schedule from 1 June 2018.  Funding is subject to Special Authority criteria and DHB Hospital restrictions.

Mercaptopurine oral solution is a suitable formulation for young children who require low doses for the treatment of cancer, mainly acute lymphoblastic leukaemia (ALL).


Any changes to the original proposal?

This decision was subject to a consultation letter dated 5 April 2018. Having considered the consultation feedback, we have amended the restrictions so that both paediatric haematologists and paediatric oncologists can apply for Special Authorities.

We have also removed the restriction limiting use to ALL, meaning any patient that requires a total dose of less than one full 50 mg tablet per day will be eligible for the funding. This will allow patients with any other conditions treated by paediatric haematologists and paediatric oncologists to also access funded mercaptopurine oral suspension.


Who we think will be most interested

  • Health practitioners involved in the treatment of paediatric cancers
  • Parents and caregivers of young children who need mercaptopurine treatment requiring a total dose of less than one full 50 mg tablet per day
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers

Details about this decision

  • Mercaptopurine (Allmercap) oral suspension 20 mg per ml will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2018 as follows (prices ex-manufacturer, excl. GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Mercaptopurine  

Oral suspension 20 mg per ml

Allmercap

100 ml OP

$428.00

  • Mercaptopurine oral suspension will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy - Retail Pharmacy–Specialist

Initial application only from a paediatric haematologist or paediatric oncologist. Approvals valid for 12 months where the patient requires a total dose of less than one full 50 mg tablet per day.

Renewal only from a paediatric haematologist or paediatric oncologist. Approvals valid for 12 months where patient still requires a total dose of less than one full 50 mg tablet per day.

  • The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicines List; HML).
  • Mercaptopurine (Puri-nethol) 50 mg tablets would remain listed with the PCT – Retail Pharmacy-Specialist restriction.

Our response to what you told us

PHARMAC is grateful for the time people took to respond to the consultation. All consultation responses received by 20 April 2018 were considered in their entirety when making a decision.

Responses were generally supportive of this proposal to list mercaptopurine oral suspension. The table below summarises the main issues raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

Theme PHARMAC Comment
Paediatric oncologists also treat patients with ALL and should be able to apply for mercaptopurine oral liquid. The prescriber restriction has been amended to include paediatric oncologists.
The indication specification should include all children requiring mercaptopurine therapy, not just ALL. Mercaptopurine is also used to treat children with other diseases such as Langerhans Cell Histocytosis.

The Special Authority criteria has been amended to remove the ALL indication restriction so the criteria now include all patients treated by paediatric haematologist or paediatric oncologists requiring a total dose of less than one full 50 mg tablet per day.

Any other indications are beyond the scope of the clinical advice we have received to-date from the Cancer Treatments Subcommittee of PTAC (CaTSoP). PHARMAC would welcome a funding application for any other patient groups requiring mercaptopurine who may benefit form availability of a funded oral suspension.

A respondent noted that there is the occasional child who is unable to reliably take an alternating dose which is 50 mg on some days and less on other days. The wording of the Special Authority could be changed to less than or equal to 50 mg per day.  

We consider that if the patient requires any dose that equates to less than 50 mg on any given day they would meet the intent of the funding criteria and would be able to use the liquid every day.

As funding of the oral solution enables the same dose to be taken each day, we consider it unlikely that differential/alternating dosing would be required.

An initial approval for a 24 month period would remove the need for renewal. The majority of children requiring a dose of less than 50 mg per day will still require less than 50 mg per day at the end of their two years of therapy. We consider that given the young age of the likely patient group, the calculated dose may change over the 24 month period and they may no longer meet the intent of the restriction after 12 months. The Special Authority criteria is intended to target the significantly higher cost solution to those who will benefit most, which we consider are those requiring very small doses of mercaptopurine.
There should be consideration given to funding Allmercap for adult patients who are unable to use the tablet formulation. We have considered this feedback, however based on clinical advice from CaTSoP, and the potential doses required by larger individuals, we have decided not to change the restriction at this time. The Special Authority criteria is intended to target the significantly higher cost solution to those who will benefit most. 

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 66 00 50.