Decision to fund modified-release nitrofurantoin capsules

Decision

PHARMAC is pleased to announce a decision to fund a new modified-release formulation of nitrofurantoin for the treatment of uncomplicated urinary tract infections.

What we're doing

Te Arai BioFarma Limited’s Macrobid brand of nitrofurantoin modified-release 100 mg capsules will be funded from 1 March 2021. 

This decision resulted from PHARMAC’s annual tender process.

Nitrofurantoin standard-release 50 mg and 100 mg tablets are currently funded and usually are taken four times a day. The new modified-release formulation of nitrofurantoin only needs to be taken twice a day, meaning that treatment is more convenient for people and it is likely that more people will complete their course of treatment. We anticipate this is likely to lead to reduction in treatment failures and it will provide a more suitable treatment option for uncomplicated urinary tract infection.

We estimate that approximately 50,000 people will benefit from the listing of nitrofurantoin modified-release capsules in the first year of funding.

Background to the decision

In November 2015, the Anti-Infective Subcommittee of PTAC recommended that nitrofurantoin modified-release capsules be funded with high priority.

More information, including links to the Subcommittee record, can be found in the Application Tracker: Nitrofurantoin, modified release capsules(external link).

In August 2019, PHARMAC issued a consultation on the draft 2019/20 Invitation to Tender (ITT), which included nitrofurantoin modified-release. Consultation responders requested PHARMAC consider tendering the 100 mg strength.

In October 2020 PHARMAC awarded the 2019/20 ITT tender for nitrofurantoin modified-release 100 mg capsules to Macrobid supplied by Te Arai BioFarma Limited.

Who we think will be most interested

  • People who have urinary tract infections and their whānau
  • Pharmacists and pharmacy staff
  • Primary care prescribers (including general practitioners, nurse practitioners and pharmacist prescribers)
  • Infectious disease specialists and clinical microbiologists
  • Obstetricians and Gynaecologists
  • Urologists
  • Pharmaceutical suppliers and wholesalers

Details about this decision

Nitrofurantoin modified-release 100 mg capsules will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 March 2021 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical and presentation

Brand

Pack Size

Subsidy and price (ex-man., ex. GST)

Nitrofurantoin cap modified-release 100 mg

Macrobid

100

$86.40

Macrobid will have Sole Subsidised Supply status and Hospital Supply Status from 1 September 2021 until 30 June 2023. This means that Macrobid will be the only funded brand of nitrofurantoin modified-release 100 mg capsules during this time.

Things to be aware of

The funding of nitrofurantoin standard-release 50 mg and 100 mg tablets is not changed by this decision and they will continue to be funded and available.

It is important that prescribers and pharmacists are aware the bottle artwork for Macrobid does not specify that the product is modified-release; therefore, extra caution is recommended when prescribing and dispensing either presentation of nitrofurantoin.

Macrobid has recently received Medsafe approval for supply in New Zealand.(external link)

A datasheet with prescribing information is expected to be available on Medsafe’s website prior to 1 March 2021.

Questions about this decision?

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 660 050.