Rule 8.1b gives children with cancer, treated in a paediatric setting, funded access to any medicine that could treat their cancer.
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Funding for children with cancer remains the same
Following public consultation, Pharmac – Te Pātaka Whaioranga is keeping Rule 8.1b. The rule allows for medicines to treat paediatric cancer in children with cancer to be automatically funded without Pharmac assessment.
We’ve heard very clearly from clinicians and the whānau of child and adolescent cancer patients that Rule 8.1b has a real impact on treatment and health outcomes.
All medicines currently being funded for child cancer patients under Rule 8.1b continue to be funded. The Rule 8.1b exception continues to apply to new paediatric cancer medicines where clinicians decide that these are the best option for their patients and the medicines are not already funded.
We'll be working closely with clinicians
A lot of emerging therapies have the potential to be expensive and we will work with clinicians on ways to manage these to ensure financial sustainability. In our experience, clinicians are very responsible stewards and the feedback we’ve received indicates they are keen to work with us to make improvements in a number of areas.
You spoke: We listened
Between November 2022 and March 2023 we publicly released a detailed discussion paper and invited submissions in response to 16 questions posed on our review of Rule 8.1b.
We received 86 feedback submissions from:
individuals
whānau with children or young people who are having or have had cancer treatment
clinicians and clinical networks
patient advocacy groups
a range of other health-related organisations.
Families described their experiences of having a child with cancer and, in some cases, dying from cancer. They spoke about the difference that Rule 8.1b had made to their child’s treatment. The overwhelming message from clinicians and clinical bodies was that Rule 8.1b was an essential part of the clinical pathway for treating child cancer.
“For a significant minority five-year survival is entirely dependent on access through 8.1b.”
“The numbers may be small but they are not insignificant, they are our Tamariki.”
“There is nothing more levelling than being on the children’s cancer ward. Every room holds its own heart-breaking story of a child’s struggle with cancer…..I can’t imagine how it would be if there was an inequality of access to medication…two families in the same cancer ward, one has a child on a better regime because they can pay for it…”
“With all that we have to face, not having to worry about being able to access the best treatment and medicines is one less thing to have to fight for.”
“For Māori and Pacific families, the rule makes a key difference to their experience. Time is the most precious resource for families at this time, and this preserves it and makes sure they don’t have to spend time advocating and fundraising.”
“[Rule 8.1b] is likely to be the determinative factor in the comparability of outcomes with our peer nations.”
“New Zealand can be justifiably proud of the paediatric cancer survival outcomes. It highlights world class survival rates for all children, irrespective of age, ethnicity, or where they live.”
“The consequence of not having rule 8.1b without a fit-for-purpose revised equivalent pathway would mean countless hours of burdensome applications, with delays in approvals beyond what may be clinically safe, the risk of inconsistent approvals and the potential reliance on decision makers without sufficient paediatric oncology expertise.”
Now that Pharmac has decided to keep Rule 8.1b, the next steps involve engaging with clinicians and patient groups to improve the way the Rule works. Specifically, we will look to:
improve governance and oversight of the decisions made under Rule 8.1b
work with clinicians to design a way to manage new and emerging therapies to ensure financial sustainability
consider options in our current budget to improve access to treatment for adolescent and young adults with a paediatric-type cancer regardless of where they are treated.
We’ve had really good feedback as a result of the review to date and there is clearly further work we need to do – for instance, working to improve access to medicines for adolescents and young adults.
Pharmac will present options for improvements to Rule 8.1b at a Board meeting later in 2024.
Questions and answers about rule 8.1b and the review
After taking over funding for hospital medicines, Pharmac intended to review Rule 8.1b to align with our usual assessment and decisions making processes. Pharmac began a review of Rule 8.1b in 2019, but this was put on hold due to the COVID-19 pandemic.
In 2021, a complaint was made to the Human Rights Commission that Rule 8.1b was inequitable because it prioritised children with cancer over children with other conditions. While that complaint ultimately did not progress, it raised valid questions about how Pharmac might improve access to funding for children and young people with other conditions.
In addition to considerations of equity, we wanted to understand whether there are any significant financial risks in the future because of new, expensive, cancer medicines being developed.
Normally all medicines go through a rigorous evaluation process before Pharmac decides whether to fund them. However, we make an exception for medicines to treat children with cancer. These can be funded without any evaluation from Pharmac, and this exception is known as Rule 8.1b. The Rule set up when Pharmac took over funding decisions for cancer medicines from District Health Boards in 2005.
Most medicines already funded
In practice, most medicines used for child cancer are listed on the Pharmaceutical Schedule and available to children and young people with cancer. Rule 8.1b means though that the small number of paediatric cancer medicines which are not on the Schedule can still be used by clinicians. This gives child cancer patients and their whānau access to treatments that are not yet publicly funded, in time for them to make a real difference to health outcomes, including the child’s survival.
Paediatric setting only
Rule 8.1b applies only to children who are treated in a paediatric setting - adolescents and young adults with cancer who are being treated in an adult setting are not eligible under Rule 8.1b. There are two specialist treatment centres for paediatric cancers in New Zealand, and a network of regional care centres (14 sites). The two specialist paediatric cancer services are Starship’s Blood and Cancer Centre in Auckland, and the Children’s Haematology Oncology Centre in Christchurch.
In 2020, 93 percent of medicines used to treat children with cancer were already listed on the Pharmaceutical Schedule. This means only 7 percent of paediatric medicines needed Rule 8.1b to be funded. However, this small proportion of cases accounts for half of the overall spend on all paediatric cancer medicines.
Up to 15 children each year
About 150 children are diagnosed with cancer each year, and up to 15 a year will need to access medicines under Rule 8.1b. The other children will be covered by the treatments already available. Most childhood cancers are diagnosed in children under the age of 5 years old, with the most common cancers being leukaemia, brain tumours, and lymphomas.
Paediatric cancer is less than 1% of cancers
Overall, in New Zealand each year around 27,000 people are diagnosed with cancer, meaning that children account for less than 1 percent of all cancers diagnosed annually. Expenditure on all paediatric cancer medicines currently accounts for less than 1 percent of the total budget for medicines and related products.
