Advocates urge action after NICE rejects Voranigo for England’s NHS
Public comment period opens for new IDH-mutant brain tumor therapy
In a setback for brain tumor patients, England’s National Health Service (NHS) has been advised not to routinely cover the new cancer therapy Voranigo (vorasidenib).
The National Institute for Health and Care Excellence (NICE) issued a draft recommendation against funding the treatment, which is approved for certain forms of glioma, citing concerns that the drug’s benefits don’t justify its high cost.
NICE specifically reviewed Voranigo for patients 12 and older with astrocytoma or oligodendroglioma tumors carrying IDH1 or IDH2 mutations, typically given after surgery. The agency’s draft guidance states the evidence does not currently prove the medication offers “value for money” for the NHS. This decision, however, is not final, and patient advocates are already pushing back.
The draft decision rejecting the medication for this indication does not affect its use in other contexts, nor does it affect patients with these tumors who were already taking the drug.
“[Voranigo] is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations. This is because the available evidence does not suggest that [Voranigo] is value for money in this population,” the draft guidance states.
Advocacy and public comment period
NICE’s recommendation was met with disappointment from The Brain Tumour Charity, but advocates stressed that this guidance is not yet final. There will now be a period for public comment until Nov. 4, after which NICE’s evaluation committee will reassess the data before issuing its final verdict. When there’s strong community interest in a new treatment, it’s not unusual for NICE to reverse course following an initial negative evaluation.
The Brain Tumour Charity is currently running a survey and collecting messages to share with NICE as part of the public comment process. A news story from the organization states: “There is a vital opportunity for further evidence and community insight to help shape the final decision. That’s why we need to hear from you. By sharing your views, experiences or reflections — whether through our short survey or by sending us a message — you can help ensure the voices of those affected are at the heart of the process.”
Gliomas like astrocytoma and oligodendroglioma are cancers that develop due to the uncontrolled growth of brain cells. Often, these cancers harbor mutations in the IDH enzyme, which contributes to abnormal cell growth. Voranigo, developed by Servier, is designed to inhibit these mutant enzymes, thereby slowing cancer growth.
A Phase 3 trial called INDIGO (NCT04164901) tested Voranigo against a placebo in more than 300 people with IDH-mutant glioma, and results showed patients given the therapy went significantly longer without the disease progressing. Based on these findings, the therapy was recently approved for IDH-mutant glioma in the European Union. This followed similar authorizations in the U.S., Canada, and other countries worldwide.
Voranigo has also been approved for IDH-mutant glioma in the U.K. However, just because a medicine is approved doesn’t mean insurance will cover the cost of treatment, and NICE has say over which treatments will be covered by England’s publicly funded NHS.
According to the draft guidance, NICE’s main concern is that the clinical trial data indicated Voranigo can delay disease progression, but there’s no data proving the therapy can help patients live longer. The agency also raised questions about the therapy’s impact on patients’ quality of life. Given these and other uncertainties, NICE said it’s not possible to make a reliable assessment about whether the benefits of Voranigo are worth the cost of the therapy. As such, the agency recommended against the NHS covering it.
The Brain Tumour Charity argued against NICE’s interpretation, saying that since Voranigo can delay disease progression, patients may have reduced need for other treatments such as chemotherapy and radiation, which could help patients preserve a better quality of life for longer.
“While we recognise the purpose behind the UK’s specific regulatory arrangements, it is more than disappointing to see how decisions like these — even in draft — create yet another barrier to accessing new treatments for patients whose access to promising advances has been minimal and unmet need painfully high,” said Michele Afif, the charity’s CEO. “The Brain Tumour Charity continues to campaign for a regulatory system that is flexible, responsive to the unique challenges people diagnosed with a brain tumour face every day and open to reviewing decisions so that they can access promising new treatments without further delays.”
About the Author
