Decision to fund unapproved medicines for various conditions

This agreement was the subject of a consultation letter dated 14 January 2013.

Details of the decision are provided on the following pages. In summary:

• The following pharmaceuticals will be listed in Section B and/or Part II of Section H of the Pharmaceutical Schedule from 1 April 2013:
  • Benzbromarone for gout
  • Diazoxide for hyperinsulinism
  • Para-amino salicylic acid and protionamide for tuberculosis infection
  • Paromomycin for cryptosporidium infection
  • Tetracycline and bismuth for helicobacter pylori infection
  • Stiripentol for Dravet syndrome
  • Nitazoxanide for protozoan infection
  • Pegaspargase (also known as pegylated asparaginase) for acute lymphoblastic leukaemia in combination with chemotherapy
• PHARMAC was made aware during consultation of the possibility of securing supply of an approved brand of rifaximin (a treatment for hepatic encephalopathy). As a consequence, PHARMAC has decided not to fund an unapproved brand of rifaximin at this time. In the meantime, clinicians can continue to make applications for funding of rifaximin via the Named Patient Pharmaceutical Assessment (NPPA) process.
• A number of minor changes to access criteria were made following consideration of consultation responses.
• The brand, strength and pack size of tetracycline to be funded has changed from the proposal consulted on following further consideration of the use of this medicine.

We would like to reiterate that PHARMAC’s funding of an unapproved medicine is not an endorsement of the medicine’s quality, safety or efficacy. Further, a practitioner prescribing an unapproved medicine is still obligated to comply with relevant legislation and regulations (including the Health and Disability Commissioner’s Code of Consumer Rights).

As with any pharmaceutical listed in the Pharmaceutical Schedule, funding will be provided if a prescriber choses to prescribe one of these medicines (providing any funding access criteria are met) but there is no obligation on practitioners to prescribe these medicines if they do not consider them appropriate for their patient.