In Focus: From the lab to the clinic in New Zealand’s first CAR T-cell therapy clinical trial
Dr Nathaniel Dasyam is a postdoctoral researcher who has been working in the Malaghan Institute’s CAR T-cell therapy programme since 2019. Nathaniel is a self-described ‘Jack of all trades’ when it comes to his role within the programme..
Nathaniel works in the research team, where the CAR T-cells are designed, and supports both the GMP team, where the CAR T-cells are manufactured, and the clinical team, who administer the CAR T-cells to participants in the trial.
“It just so happened that the project I was working on previously at the Malaghan Institute, to test a therapeutic vaccine for melanoma, laid the groundwork for many of the processes that needed to be in place to manufacture CAR T-cells.”
This placed Nathaniel in an ideal position to help the CAR T-cell team develop methods needed to test CAR T-cells for the ENABLE clinical trial – a first of this kind for New Zealand. This was no mean feat given it involves developing a gene therapy in a highly regulated environment.
CAR T-cell therapy works by extracting a patient’s own immune cells and modifying them in the lab to identify and attack cancer cells once they have been returned to the patient. The ENABLE trial uses CAR T-cells to treat patients with certain types of relapsed and refractory B-cell non-Hodgkin lymphoma, who have exhausted other treatment options. Read more here: first-car-t-cell-therapy-clinical-trial
NZIER Community Pharmaceuticals Report 2022
NZIER has today released its 2022 Community Pharmaceuticals Report. This report looks at the overall trends in the Government-funded medicines budget for New Zealand in the 15-year period between 2006/07 and 2020/21.
We recommend reading the executive summary of the report as a starting point. Below are some key ideas which have come out of the report.
(1) The report identifies that there is a $332 million investment gap in medicines that are publicly funded and made available to patients through the public health system in New Zealand.
- This is the amount of additional investment that would be required on top of the current budget to have the same level of investment in medicines as existed in 2006/2007 in real terms (i.e. inflation and population adjusted).
- The additional investment is required because, despite some new investments being made, there have also been significant transfers of already existing medicines spending from other parts of the health system into the Combined Pharmaceutical Budget from 2012 onwards, which has hidden the fact that the core funding (community pharmaceutical expenditure) has been dropping [see Figure 2].
- As a result, when compared to the total Health budget which has grown by 1.0% in real terms over the 2006-2021 period, the community pharmaceuticals budget has decreased by 2.9% on an annual compound growth basis [see Table 1].
(2) One solution to this investment gap would be a corrective real terms adjustment of $332 million to maintain stability in pharmaceutical investment relative to other health and social investments [See Table 2].
- This corrective action approach was taken by the Government with the DHB deficits in Budget 2022. The Government has also taken a multi-year approach to funding the health system with a confirmed and committed $14.9 billion over the next four years. It is the first Budget ever to take that multi-year approach.
(3) Looking forward from 2022, the medicines budget received $191 million investment but only over a 2-year period ($72 million (2022/23)and $120 million (2023/24)), rather than a four-year period as for other parts of the system. This lack of funding commitment and stability was raised by the Treasury as the only major health budget issue in their Budget Economic & Fiscal Update (BEFU) for 2022.
- Other near-term issues include the need for the medicines budget to also include investment in COVID-19 vaccines and therapeutics going forward, which will put more pressure on an already stressed medicines budget situation.
Publicly funded community pharmaceuticals are a critical and valuable enabler for both New Zealanders' ability to self-manage health conditions and for the health system to function optimally. They, therefore, require protection from ongoing budget erosion. There also needs to be an alignment of the medicines budget appropriation to the broader health systems budget and planning cycles.
To read the full report, please click here
Help us Help you! Please join one of three CLL focus groups on 3rd or 10th of December on Zoom.
Help us help you!
We’re getting moving on some research to find out what CLL patients would like CLL Advocates NZ to do for them.
Please help us with this by joining one of three focus groups on Zoom to help us understand what issues are of greatest concern and interest to you and how we can help with them.
The sessions will be very friendly, café-style discussions with groups of 6 – 8 people and a professional facilitator, and you’ll be able to join by one simple click on an email we’ll send you. The groups will be held on :
- Saturday 3rd December 10:00am – 11:30am
- Saturday 3rd December 1:30pm – 3:00pm
- Saturday 10th December 10:00am – 11:30am
We have limited resources so we’re very keen to start the year with a fresh agenda focused on what really matters to patients and their whanau.
Please contact Melanie (our admin assistant) on clladvocates@outlook.co.nz with any questions, and to let us know if you can join one of these groups.
The information we gather from these sessions will be strictly confidential to CLL Advocates NZ and you would not need to show your full name online if you prefer.
Please help us to help you!
Pharmac is proposing to fund Ibrutinib!!!
I’m very pleased to advise that Pharmac has today asked for feedback (Follow this link) on a proposal to fund ibrutinib for New Zealanders with CLL. At last!
It’s seven years since Janssen (the supplier) first applied to Pharmac for funding for ibrutinib for patients with relapsed or refractory CLL.
CLLANZ as a patient advocacy group, and our founder the late Dr Neil Graham in particular, have battled hard over the last few years to highlight the desperate need for this treatment. I’m only sorry that Neil did not live to hear this news.
While it’s great that Pharmac is finally moving on this, it is disappointing that they’ve significantly narrowed the criteria first sought for this treatment. These were to fund it as an alternative to venetoclax-containing regimens, and for previously untreated CLL patients for whom chemoimmunotherapy is inappropriate, and notably those with 17p deletion, and TP53 and unmutated IgVH.
However the Pharmac proposal now up for consultation is to fund ibrutinib for relapsed/refractory CLL patients only after they’ve had venetoclax, or for patients where venetoclax is intolerable. So it’s not available as an alternative to venetoclax, an option clinicians have been calling for urgently for some time. Importantly, it also means it won’t be funded for patients who are currently self-funding ibrutinib, or patients receiving it on a compassionate access programme or on a clinical trial. This seems unreasonable and unfair, and we want to seek clarity from Pharmac on what will happen with these patient groups for whom treatment with ibrutinib remains a high priority.
Pharmac is inviting feedback on their proposal until 4pm on Thursday, 29 September. CLLANZ will be providing feedback and we strongly encourage you as patients and whanau to email Pharmac with your own feedback on this to: consult@pharmac.govt.nz. But we feel that it would be more effective to have a coordinated response from CLLANZ friends and supporters on this and propose to come back to you with some guidance, once we have had time to absorb the detail of the proposal and its ramifications.
Let’s not detract from the fact that today’s development is undoubtedly great news, and I’m sure we will all want to support the proposal. But we might also wish to comment on the eligibility restrictions. It may be, with sufficient encouragement and evidence from the CLL community, that Pharmac will consider extending funding of ibrutinib for all relapsed/refractory CLL patients and ideally, as a first line treatment, finally putting us in step with the rest of the world.
As you may be aware, following the highly critical report by the independent Pharmac Review Panel, Pharmac has undertaken to be more open to patient voices, and we want to take this opportunity to be heard!
With best wishes
Dr Gillian Corbett (On behalf of CLLANZ Trustees)
World CLL day
It is World CLL Day today which is held on the first day of Blood Cancer Awareness Month.
On World CLL Day we also wish to send a message of THANKS to those with healthy immunities for considering our community and showing understanding. During the COVID-19 pandemic many people experienced isolation, fear and the difficulty of keeping safe – an insight into the life of a CLL patient.
https://www.wclld.org/about-world-cll-day/
Rachel Smalley: 1,000 kiwis will die while Pharmac takes eight months to make a decision
OPINION: How long does it take you to make a decision about whether or not to buy something?
You’ve got all the information in front of you. You know it’s a good product. It works. You need it. And you’ve got the money to buy it. So how long will it take?
What if I said that every week that passes where you don’t make a decision, 26 New Zealanders will die? What then? Do you think you could focus or add some urgency to that decision?
I’m pretty sure you could.
Why is it, then, that the same level of urgency doesn’t apply to Government – and in particular, to Pharmac, our drug-buying agency?
World_CLL_Day_September_2022
CLL Advocates June Newsletter
24 June 2022
Our Thoughts at Matariki
Mānawatia a Matariki
We feel it’s appropriate on this special day to remember and celebrate the life of the founder of CLLANZ, Dr Neil Graham. Neil was a very generous, energetic, and compassionate human being who gave his time freely to help improve the lives of New Zealanders living with CLL. His work helped create a ‘community’ of CLL patients, through his personal engagement with patients, creation of the ongoing private CLL Advocates Facebook Group, and production of the first dedicated CLL Patient Booklet for New Zealanders. With a relentless focus on advocating for access to CLL treatments, Neil also raised the profile and understanding of CLL among politicians, Pharmac officials and other policy decision makers. He played a vital role in gaining funding for venetoclax.
Looking to the future, as is also appropriate on this day, the fight for better treatments goes on. In particular, after all these years of waiting, we’d like to see funding for ibrutinib for patients in need of it. But at this stage there’s no sign of any progress on that. While we welcome the release (finally!) of the Pharmac Review Panel report, we’re not greatly confident that it will lead to real change in the nature, speed, and transparency of Pharmac’s decision-making processes. After a three-month delay, releasing the report on the day Prime Minister Ardern met President Joe Biden suggests the Government may not have wanted it to get much attention! We have noted a change in Pharmac’s language but are keen to see some meaningful change in their processes.
We’re very pleased to say that CLLANZ Trustee Dr Gillian Corbett (see her bio Dr Gillian Corbett) has agreed to take on the role of Medical Director of CLLANZ.
You can contact her at: trustees@clladvocates.nz
Gillian will be able to lead or advise on our advocacy activities, but we are still looking for help to progress the priorities we outlined in our last newsletter. Please do get in touch with us if you can help in any way.
We hope you’re having a happy Matariki with family and friends, and we send our warmest thoughts and wishes to Neil Graham’s family and our thanks for all he did for New Zealanders living with CLL.
CLLANZ Trustees
Pharmac Report - Final Review
The Pharmac report has been released.
Dr Andrew Little has advised that:
“The panel found Pharmac’s model has delivered significant benefits, but to achieve its purpose these benefits need to be shared more equitably across our communities, especially for Māori and Pacific peoples,” Andrew Little said.
“As a result of this Review, Pharmac will have a much greater focus on improving the health of Māori, Pacific peoples, disabled people and other groups who do not yet share equitably in the benefits Pharmac provides.
“Pharmac has confirmed to me that it accepts the Panel’s findings. Pharmac is committed to making the needed strategic and operational changes, and already has work underway to do this.
“The panel made 33 recommendations and the government agrees in principle with most of them. There is a small number of recommendations where the government takes a different view, for example where the health reforms will address the underlying issues now or in the future,”
What are your thoughts on the review?
Here is the link for the Pharmac Review. Pharmac Review - Final Report
This is the Executive summary: Pharmac-Review-Executive-Summary.pdf
International COVID-19 Blood Cancer Coalition (ICBCC) - Patient Impact Statement and Recommendations
Protecting immunocompromised blood cancer patients during the COVID-19 pandemic
The coalition has prepared a Joint Patient Impact Statement for use in different countries to aid when advocating for the provision of anti-COVID-19 treatment and care for immunocompromised or immunosuppressed (IC/IS) blood cancer patients.
The Statement has to date been endorsed by networks and national organisations of the global patient advocacy community as well as renowned medical societies and representatives from the global clinical community .
There is a total of 71 endorsers to date including CLL Advocates NZ, Dr Gillian Corbett.