Funding for treatments

Approved medicines have been through the New Zealand regulatory process with Medsafe and are considered safe to prescribe, according to the conditions stated in the Medicine Data Sheet. Practitioners must consider both the risk and benefits of using the medication, before prescribing it.

Unapproved medicines include medicines that haven’t been through the Medsafe regulatory process, where approval has lapsed or been withdrawn, or medicines where the product available is different in some way to the product that was originally approved.

Under Section 25, practitioners can prescribe any medicine for a particular patient in their care, regardless of if the medicine is approved or not, or whether it is approved for a particular use.

Section 29 further allows any New Zealand company or pharmacy to legally obtain and supply an unapproved medicine to a patient when authorised by a prescriber, although reporting requirements apply. This requirement does not apply if a medical practitioner imports a medicine to treat a patient, but if a pharmacist imports the medicine on behalf of a medical practitioner, they must notify Medsafe. Patients must also be notified that the details about the supply of medicine, including their name, will be recorded by the supplier and sent to Medsafe. A section 29 notification is not required for ‘off-label’ use of medicines.

Clinical trials can be a way in which patients can access new or experimental treatments. Talk to patients about whether a clinical trial may be suitable for them. Breast Cancer Foundation NZ has a database of the clinical trials currently open in New Zealand and Australia. Visit the database.

Cost-sharing programmes help patients pay for non-PHARMAC funded medicines. These may offer free treatment doses, or a capped payment on the number of doses or overall cost. Once this cap is reached, often suppliers will then provide the medicine at no cost.

The Ministry of Health has stated that unfunded medicines cannot be administered in public hospitals, and so patients must pay for the administration of treatment, on top of the cost of medicines not covered under cost-sharing programmes.

Roche offers a Cost Share Programme for selected breast cancer treatments, such as Perjeta (for early HER2+ breast cancer) and Tecentriq (for advanced triple-negative breast cancer).

Find out more about the cost-sharing programme for Perjeta.

Find out more about the cost-sharing programme for Tecentriq.

The responsibility and liability of prescribing these medicines rests with the prescriber, including if the patient experiences any adverse events. For this reason, it’s recommended that a decision to prescribe any unapproved medicines is noted in the patient’s records, including the rationale for the prescription, and that the decision was discussed with the patient. A plan for monitoring treatment and adverse effects should be discussed and implemented.

If prescribing unapproved medicines to patients, practitioners should keep in mind that the patient has the right to be fully informed about the medicine, including a frank discussion on the standard of support for its use and any safety concerns. If requested, patients have the right to receive a written summary of this information. While informed consent can be verbal or written, written consent is required when the use of an unapproved medicine is considered experimental, as well as in the following situations:

• There is minimal evidence to support the medicine’s use.
• The evidence of the efficacy or safety of the medicine used in this manner is equivocal.
• Its use is part of a clinical trial.

Generally, if ‘off-label’ use is so common as to be regarded as usual practice, obtaining consent may not be needed, although this is at the practitioner’s discretion.

Prescribers are able to import medicines if a patient who has immigrated to New Zealand or spent time overseas requests a medication that they have been using while overseas, but which isn’t approved in New Zealand. Practitioners must still consider approved and subsidised alternatives and research the medicine themselves before obtaining it for the patient. A plan to monitor any side effects should be implemented.