PRRT and the NHS England Cancer Drugs Fund

cost cutting vs life cutting?
cost cutting vs life cutting?

As of 4 Nov 15, PRRT was delisted from the NHS England Cancer Drugs Fund. Appeals were made but were rejected, despite the glowing results from the NETTER-1 trial.  Although a replacement system is now in place, PRRT remains barred from routine NHS use.

Please see the following post for the very latest on PRRT worldwide – CLICK HERE

I was extremely disappointed to learn of the decision to remove PRRT (Lutetium or Yttrium) from the Cancer Drugs Fund (CDF) as reported by the NET Patient Foundation. You can read the detail of the decision here: CDF Statement.  PRRT has regularly been described by NET specialists and patients as the “magic bullet” due to its potential to shrink or kill tumours.

This is the second Neuroendocrine Cancer treatment to be withdrawn this year, after the earlier decision on Everolimus (Afinitor) in April . In fact, the recent cuts to the CDF were described in the media as a “massacre” as the list was reduced by two-thirds.  You can see the current CDF list by clicking here.

The timing of these cuts is extraordinary and when you look at the output from recent trial reports presented at the Europetwo-thirdsCongress (ECC) for both Neuroendocrine Cancer related drugs recently cut:

Everolimus

The RADIANT-4 trial said that Everolimus had a significant effect in non-functional NETs which are very difficult to treat.  This is particularly important for Lung NETs as no treatment currently exists.  The RADIANT-2 trial had already proven the efficacy of the drug for advanced carcinoid (in conjunction with Octreotide) and the RADIANT-3 trial proved good data for treatment with advanced functional pNETs.  Read the report here.

PRRT – 177Lu-DOTATATE

The ECC also reported a significant finding from the NETTER-1 trial.  Treatment with the novel peptide receptor radionuclide therapy (PRRT) Lutathera significantly increased progression-free survival (PFS) over Octreotide LAR (Sandostatin) in patients with advanced midgut NETs.  It shows a PFS that has never been shown before in this type of cancer adding that this was significant because these patients have a real unmet medical need.

Lutathera is a 177Lu-DOTATATE PRRT that targets somatostatin receptors, which are overexpressed in about 80% of NETs, to deliver cytotoxic radiation directly to the tumor – See more by clicking here.

To fully understand the background to the problem, you need to understand both PRRT and the Cancer Drugs Fund and a quick primer on both follows.

What is PRRT?

For those who are not entirely sure what PRRT is, here’s a quick primer from The Society of Nuclear Medicine and Molecular Imaging:

Peptide receptor radionuclide therapy (PRRT) is a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine carcinoma or NETs (neuroendocrine tumors). PRRT is also currently being investigated as a treatment for prostate and pancreatic tumors.

In PRRT, a cell-targeting protein (or peptide) called octreotide is combined with a small amount of radioactive material, or radionuclide, creating a special type of radiopharmaceutical called a radiopeptide. When injected into the patient’s bloodstream, this radiopeptide travels to and binds to neuroendocrine tumor cells, delivering a high dose of radiation to the cancer.

The cells in most neuroendocrine tumors have an abundance (called an overexpression) of a specific type of surface receptor—a protein that extends from the cell’s surface—that binds to a hormone in the body called somatostatin. Octreotide is a laboratory-made version of this hormone that binds to somatostatin receptors on neuroendocrine tumors. In PRRT, octreotide is combined with a therapeutic dose of the radionuclides. Yttrium 90 (Y-90) and Lutetium 177 (Lu-177) are the most commonly used radionuclides.  

What conditions are treated with PRRT?

PRRT may be used to treat NETs, including carcinoids, islet cell carcinoma of the pancreas, small cell carcinoma of the lung, pheochromocytoma (a rare tumor that forms in the adrenal glands), gastro-enteropancreatic (stomach, intestines and pancreas) neuroendocrine tumors, and rare thyroid cancers that are unresponsive to treatment with radioiodine.

PRRT is an option for patients:
• who have advanced and/or progressive neuroendocrine tumours
• who are not candidates for surgery
• whose symptoms do not respond to other medical therapies.

The main goals of PRRT are to provide symptom relief, to stop or slow tumor progression and to improve overall survival.

These video’s on Nuclear Medicine are by Professor Val Lewington – the UK’s most experienced person on PRRT.  I was at this presentation and she is absolutely amazing. It’s slightly dated but still very current.  This presentation also covers Octreotide and Gallium 68 scans under the heading of Nuclear Medicine – if you are still unsure about PRRT or Nuclear Medicine in general, these videos are definitely worth a watch.

The Role of Nuclear Medicine in NETs

Q&A Sessions

This is also a great source of information maintained by NET Patients in the USA.  Click here

What was the Cancer Drugs Fund?

The Cancer Drugs Fund was money the UK Government has set aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE) and aren’t available within the NHS in England. This may be because the drugs haven’t been looked at yet. Or it may be because NICE have said that they don’t work well enough or are not cost-effective. This was introduced as a ‘political statement’ by the then Conservative/Liberal Democrat coalition government in 2010/11.  The aim of the fund is to make it easier for people to get as much treatment as possible.

The Cancer Drugs Fund was for people who live in England. The governments of Scotland, Wales and Northern Ireland decide on how they spend money on health and so far haven’t decided to have a similar programme.

Worth noting that on 1 April 2013, NHS England took on responsibility for the operational management of the Cancer Drugs Fund (CDF). The NHS spends approximately £1.3 billion annually on the provision of cancer drugs within routine commissioning. The CDF was established as an additional funding source to this.

There was a national list of drugs available through the fund – you may have heard this called the priority list. If you met the conditions for a drug that was on the list, you should have been able to have it on the NHS if you live in England. The Fund would also have considered applications on behalf of individual patients for other drugs that are not on the list.  However, under the new system, Individual funding requests (IFRs) relating to cancer drugs will no longer be considered via the CDF process.  All IFRs relating to cancer drugs will now be considered using NHS England’s single, national IFR system, which was updated in January 2016.

The new system came info force on 29 July 2016 and you can read more if you click this link

Summary

Although the decision is shocking to most, it was not totally unexpected as the Government and NHS have been hinting for sometime that the costs of the fund need to be reined in.  In any case if was only ever a temporary arrangement until a another model could be put into place.  There is a political element as the fund was set up by David Cameron with healthcare experts suggesting that it made no sense as a response to rising drug prices.  Moreover, by topping up the fund, the same experts claimed this was making the manufacturers the real beneficiaries of the fund as they have been able to sell their drugs to the NHS at prices that are unaffordable (and therefore unsustainable) for the NHS.

UK NET patients who have advanced and/or progressive neuroendocrine tumours which cannot be removed by surgery and whose symptoms do not respond to other medical therapies, still need help.

Ironically, the UK seems to be intent on cutting provision of the treatment (at least for NHS patients) as the US is trying very hard to formally introduce it.  This is a disgraceful situation and advanced Neuroendocrine Cancer patients and those who may need this treatment in the future are being terribly let down.

I will keep this blog ‘live’ in order to add information as things progress.

Thanks for reading

Ronny
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