Reclassification of hepatitis C treatment

In 2023, glecaprevir and pibrentasvir in combination (trade name: Maviret®) were reclassified from prescription-only to an exemption from prescription when managed by nurses and pharmacists under certain conditions.

This reclassification reduces barriers to access to hepatitis C treatment, particularly for vulnerable people. It allows nurses and pharmacists working within their scopes of practice to treat hepatitis C in the community.

This reclassification enables a novel collaborative nurse-pharmacist model. In most cases, the pharmacist dispenses the medication, working with the nurse to ensure supply is appropriate and/or referring people as needed.

The classifications of these two medicines are:

Prescription Medicine

• Glecaprevir; except when supplied in combination with pibrentasvir in a manufacturer’s original pack that has received consent from the Minister of Health or Director General for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council.
• Pibrentasvir; except when supplied in combination with glecaprevir in a manufacturer’s original pack that has received consent from the Minister of Health or Director General for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council.
  
  

This means that the combination medicine containing both ingredients (Maviret) does not need a prescription to be supplied to the patient when all of the conditions below are met:

1. the nurse or pharmacist must meet the requirements of their registration bodies.
   
   a. Nurses need to apply for authorisation from the Nursing Council and show they meet these requirements, as outlined on the Nursing Council website. See: Hepatitis-C-Medication-Supply page. The Public Register shows which nurses have this endorsement, see: https://nursingcouncil.org.nz/Public/NCNZ/Public_Register.aspx
   
   b. Pharmacists do not need to be authorised, but need to hold evidence that they meet their requirements, as outlined on the Pharmacy Council website.
   
   
2. This reclassification is only for treating chronic hepatitis C – Maviret cannot be used without a prescription in a new acute infection.
   
   
3. Only people who meet the clinical and eligibility criteria (as outlined in the training programme including the flowchart models in the Models of Supply section) can be supplied the medicine without a prescription.
   
   
4. Only a medicine that is registered in New Zealand can be provided, and it needs to be provided in the manufacturer’s approved pack.
   
   

Note: Maviret is fully funded when supplied through a credentialled nurse and credentialled pharmacist when dispensed from an AbbVie Care Pharmacy. The patient needs to meet the clinical and eligibility criteria, and be eligible for funded treatment in New Zealand.

New Zealand’s hepatitis C programme is delivered by four regional services. Talk to your Regional Hepatitis C Manager for further information about regional support to provide hepatitis C testing and treatment services.

These requirements include successful completion of two courses:

1. Chronic Hepatitis C training available from the Goodfellow Unit, providing general information on hepatitis C, and
2. Hepatitis C Implementing Non-Prescription Supply Through Nurses and Pharmacists. This is available from the Goodfellow Unit, providing specific information on how to implement this reclassification.  

These trainings have been endorsed by the Pharmacy Council of New Zealand and the Nursing Council of New Zealand. Each course takes about an hour (depending on underlying knowledge) and includes a test on completion. A 100% mark needs to be achieved to pass. Multiple attempts at the tests are possible. When each course is successfully completed (100% pass is required on the test), download a certificate for evidence. These two certificates will need to be submitted to the Nursing Council (nurses) or held as evidence of successful completion (pharmacists).

Please see the Models of Supply showing the Nurse-led collaborative model with the pharmacist, the Pharmacist-led collaborative model with the nurse, and the Nurse direct supply, outreach model for a small number of nurses. A copy of the referral criteria for the Nurse-led and Pharmacist-led collaborative models has also been included.

A very small number of nurses can do this. See Standard Operating Procedures for more information.

This is a document expected to be completed by the pharmacist and kept as a record of the clinical interaction. This document is to be used with the collaborative Nurse-led or Pharmacist-led models. It does not need to be used for replenishing supplies for the Nurse Direct Supply, Outreach, as the clinical responsibility for the supply is entirely with the nurse in these cases.