Pharmaceutical Schedule – Paediatric Oncology Funding Policy (Rule 8.1b)

Purpose

This policy describes the application of Rule 8.1b of the Pharmaceutical Schedule.

Rule 8.1b provides an exception pathway that enables access to publicly funded cancer medicines outside of Pharmac's usual funding assessment and decision-making processes.

This policy confirms the existing operation of Rule 8.1b for children receiving treatment in paediatric oncology and haematology services, and establishes an additional access pathway for adolescents and young adults (AYA) with paediatric-origin cancers.

8.1b Paediatric Oncology: An Unlisted pharmaceutical or a Hospital Pharmaceutical outside of any relevant Restrictions may be Given (and will be eligible to receive a Subsidy) in accordance with Pharmac’s Rule 8.1b Policy.

Scope

Rule 8.1b of the Pharmaceutical Schedule applies through two pathways:

Pathway One: Children receiving cancer treatment in paediatric oncology/haematology services

This policy does not change the existing operation of Rule 8.1b. Children receiving treatment for cancer within New Zealand's two recognised paediatric oncology and haematology services remain eligible for access to funded cancer medicines under Rule 8.1b in accordance with existing arrangements.

Pathway Two: Adolescents and young adults with paediatric-origin cancers

In addition to the existing pathway for children, access to funded cancer medicines under Rule 8.1b may be available for adolescents and young adults (AYA) with paediatric-origin cancers.

To be eligible, all three of the following criteria must be met:

Criterion 1: Paediatric-origin cancer

The patient has a cancer included on Pharmac's defined list of paediatric-origin cancers (refer Appendix One).

Criterion 2: Paediatric-based treatment protocol

The patient is being treated using a paediatric-based treatment protocol.

This requirement applies regardless of whether treatment is delivered within a paediatric or adult haematology/oncology service.

Criterion 3: Eligibility for AYA cancer services

The patient is eligible for AYA cancer services under the Health New Zealand Tier 3 Service Specification.(external link)

Clinical Oversight

Eligibility under the AYA pathway should be determined through established clinical governance processes, including multidisciplinary team or multidisciplinary meeting (MDT/MDM) review, where appropriate. Where MDT/MDM review occurs, it should support:

• confirmation of a paediatric-origin cancer
• use of a paediatric-based treatment protocol
• eligibility under the AYA cancer service framework.

Application of Health New Zealand AYA Service Eligibility

Eligibility for AYA cancer services is determined in accordance with the Health New Zealand Tier 3 Service Specification.

Where a patient is accepted into AYA cancer services under the flexibility provisions of the Tier 3 Service Specification, eligibility under Rule 8.1b may be considered, provided all other requirements of this policy are met.

Notification requirements

Use of medicines under Rule 8.1b must be notified to Pharmac through completion and submission of the approved Rule 8.1b Cancer Treatment Notification Form by the treating clinician, pharmacist, or authorised delegate.

Notification requirements apply to:

• children receiving funded cancer medicines in paediatric oncology/haematology services
• adolescents and young adults accessing funded cancer medicines through the AYA pathway.

The current notification form is available on Pharmac's website.

Information collected through the notification process may be used by Pharmac for monitoring, forecasting, implementation, and policy review purposes.

Submission of a notification form does not constitute a request for approval and does not affect eligibility for access under Rule 8.1b.

Review and publication 

This policy will be reviewed every three years, or more frequently if required. Pharmac may review and amend this policy following clinical advice, changes to AYA service eligibility settings, emerging treatment approaches, or operational experience with the policy. Any review will follow Pharmac's standard process for the review and development of organisational policy.

Appendix One – Defined paediatric-origin cancers

This list applies only to Pathway Two (Adolescents and Young Adults with Paediatric-Origin Cancers) and does not affect access under Pathway One for children receiving treatment within paediatric oncology/haematology services.

This list is intended to provide clear clinical boundaries for access to funded cancer medicines for AYA, and to support consistent application of the Pharmaceutical Schedule Rule 8.1b Policy across paediatric and adult cancer services.

For the purposes of the AYA pathway, paediatric-origin cancers are:

• acute lymphoblastic leukaemia
• osteosarcoma
• Ewings sarcoma and related bone sarcomas
• neuroblastoma and ganglioneuroblastoma
• ependymoma and choroid plexus tumours
• intracranial and intraspinal embryonal tumours, including:
  • medulloblastoma
• rhabdomyosarcoma
• hepatoblastoma
• nephroblastoma and other non-epithelial renal tumours
• other rare paediatric‑origin solid tumours where:
  • tumour biology is consistent with paediatric disease
  • treatment using a paediatric protocol is recommended by an MDT/MDM.

Tumour types considered out of scope

The following cancers are not considered paediatric-origin cancers for the purposes of Pathway Two of this policy:

• acute myeloid leukaemia
• lymphomas
• adult‑type solid tumours commonly seen in the AYA age group (e.g. melanoma, colorectal cancer).