Proposal to list mercaptopurine oral suspension
5 April 2018
What we’re proposing
PHARMAC is seeking feedback on a proposal to list mercaptopurine oral solution (Allmercap) 20 mg per ml from 1 June 2018, through a provisional agreement with Link Pharmaceuticals Limited.
Mercaptopurine oral solution is considered to be a more suitable formulation of mercaptopurine, compared with the currently funded tablet formulation, for young children who require low doses for the treatment of acute lymphoblastic leukaemia (ALL).
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Friday, 20 April 2018 to:
Senior Therapeutic Group Manager
What would the effect be?
Young children who require a dose of less than one full 50 mg mercaptopurine tablet per day for the treatment of their ALL would be eligible for treatment with the oral suspension.
Who we think will be interested
- Health practitioners involved in the treatment of paediatric cancers
- Parents and caregivers of young children with ALL
- Hospital and community pharmacists, DHBs, suppliers and wholesalers
About mercaptopurine oral suspension
Allmercap oral liquid suspension contains 20 mg per ml mercaptopurine and is supplied in a 100 ml bottle with a bottle adaptor and both a 1 ml and 5 ml graduated measuring syringe. Allmercap has a shelf-life once opened of 56 days.
Allmercap is indicated for the treatment of ALL in paediatric patients. More information can be found in the Medsafe datasheet.(external link)
Why we’re proposing this
Mercaptopurine is part of the standard treatment for ALL, which requires a long course of chemotherapy, but is highly curative, with the current five-year overall survival rate estimated at greater than 85%. The incidence of ALL peaks between 2 and 5 years, with >80% of childhood ALL diagnosed before 9 years of age.
Mercaptopurine 50 mg oral tablets are currently funded without restriction. However, the tablets may need to be divided and/or dissolved if part dosages are required in young children. Hospital pharmacists usually prepare these doses.
Listing of the oral suspension would provide accurate acceptable dosing without the risks associated with breaking and/or crushing tablets.
At its meeting in August 2017, the Cancer Treatments Subcommittee of PTAC (CaTSoP) recommended that mercaptopurine oral suspension be funded for children with ALL who require a dose of less than one full 50 mg tablet per day, with a high priority. The full CaTSoP minute regarding mercaptopurine oral solution is available here [PDF, 259 KB].
Details about our proposal
- Mercaptopurine oral suspension (Allmercap) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2018 at the following price and subsidy (ex-manufacturer, excluding GST):
Price and subsidy
Oral suspension 20 mg per ml
100 ml OP
- Allmercap would 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 haematologist. Approvals valid for 12 months for applications meeting the following criteria:
- Patient is a child with acute lymphoblastic leukaemia; and
- The patient requires a total dose of less than one full 50 mg tablet per day.
Renewal only from a haematologist. Approvals valid for 12 months where the child 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.
To provide feedback
Send us an email by 5pm on Friday 20 April 2018 to: firstname.lastname@example.org
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.
Last updated: 5 April 2018