The Latest NICE Cancer Drugs Funding Decisions

Peter Russell

July 06, 2018

Appraisal results for six cancer drugs have been published over the past week by the National Institute for Health and Care Excellence (NICE).

We round up the latest developments.

Padeliporfin

Draft guidance does not recommend padeliporfin (Tookad, Steba Biotech) for untreated low-risk prostate cancer in adults, NICE announced.

An appraisal committee found padeliporfin was not cost effective when compared with active monitoring, surgery or radiotherapy.

Clinical trial evidence showed that padeliporfin can slow disease progression, but its long-term effectiveness was unclear and there was no evidence to show how effective it was when compared with surgery or radiotherapy, NICE said.

Padeliporfin is a light-sensitive drug that is administered intravenously. Light via optical fibres inserted into the prostate activates the drug, which kills the cancer cells.

The draft guidance was put out to public consultation until later this month, with a re-appraisal due in August.

The ex-VAT cost of padeliporfin was £3761 per 183mg vial. The average cost of a course of treatment was £12,111 per patient. The appraisal committee decided that padeliporfin was not cost-effective when compared with active surveillance and radical therapies.

The Scottish Medicines Consortium (SMC) said it would decide whether padeliporfin should be accepted for use in Scotland in the fourth quarter of 2018.

Niraparib

NICE rejected niraparib (Zejula, Tesaro) for routine NHS use in the treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had responded to platinum-based chemotherapy.

It said niraparib appeared to be a promising treatment for a devastating condition with a poor prognosis but that there was a lack of available evidence to show whether it increased the time that patients lived and whether it was cost-effective.

However, NICE confirmed the drug's recommendation for use within England's Cancer Drugs Fund where it was available at a discount under a confidential commercial arrangement.

Target Ovarian Cancer said clinical trial data suggested that niraparib offered an additional 5.4 months of life for women without a BRCA mutation and an additional 15.5 months for women who have a BRCA1 or BRCA2 mutation. The charity said it hoped that by 2020, additional trial data would persuade NICE to recommend the drug for routine NHS use in England and Wales.

The full list price for niraparib is £4500 for a 58 capsule pack of 100mg capsules and £6750 for an 84 capsule pack of 100mg capsules. Dosage is initially 300 mg, taken orally each day.

A decision on whether to approve niraparib for routine NHS use in Scotland is due next month.

Crizotinib

The life-extending drug crizotinib (Xalkori, Pfizer) should be available via England's Cancer Drugs Fund for patients with ROS1-positive advanced non-small-cell lung cancer (NSCLC), NICE has said in a final appraisal.

ROS1-positive advanced NSCLC is a recently discovered type of NSCLC and this innovative drug has been shown to shrink tumours and delay progress of the disease in a small, single-arm trial.

However, crizotinib cannot be recommended for routine NHS use because of uncertainties in clinical evidence and on cost grounds, the regulator said.

The appraisal committee said that recording data from crizotinib's use on the Cancer Drugs Fund would help a future assessment of whether it should be available on the NHS.

Crizotinib was accepted for use by the SMC last month. The Roy Castle Lung Foundation said the move would bring "fresh options – and renewed hope – for patients".

Use of crizotinib is commonly 250mg, taken orally, twice daily. The list price of crizotinib is £4689 for 60 capsules. However, the drug is available for patients through the Cancer Drugs Fund at a confidentially agreed discount.

Nivolumab

Nivolumab (Opdivo, Bristol-Myers Squibb) was not recommended for routine NHS use in England by NICE for treating locally advanced unresectable or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.

An appraisal committee decided that a single trial had not compared the life-extending drug to other treatments and its effectiveness was unclear.

That lack of clinical data also ruled out its inclusion for the condition on the Cancer Drugs Fund, NICE said in final guidance.

Dosage is 3mg/kg by intravenous infusion every 2 weeks. The ex-VAT cost was £439 per 40mg vial or £1097 per 100mg vial. The manufacturer had offered a discount if the medication had been approved for NHS use.

The appraisal committee recognised that locally advanced unresectable or metastatic urothelial carcinoma had a substantial effect on quality of life, causing blood in the urine and increased frequency, urgency and pain associated with urination.

It said it was likely that nivolumab might extend the life of patients by at least 3 months and that it could prove to be an alternative to chemotherapies once more experience with the drug comes to hand.

Nivolumab was rejected for NHS use in Scotland because the SMC said "the submitting company did not present a sufficiently robust economic and clinical analysis".

Lenvatinib and sorafenib

Tyrosine kinase inhibitors lenvatinib (Lenvima, Eisai) and sorafenib (Nexavar, Bayer) have been recommended for routine NHS use in England to treat a rare type of thyroid cancer.

NICE said the drugs were the only treatment options available for progressive, locally advanced or metastatic differentiated thyroid cancer after surgery and radioactive iodine, and that the only other option was supportive care.

A final appraisal said clinical trial evidence showed that both drugs were effective at delaying progress of the disease.

However, they were not recommended for patients who have had tyrosine kinase inhibitors before, or who had to stop them early because they did not tolerate them.

Dosage of Lenvatinib is 24 mg a day; dosage of sorafenib is 400mg twice daily.

The cost of Lenvatinib is £1437 for 30 x 10 mg packs with 30 x 4mg packs. The cost of sorafenib is £3576.56 per 112 x 200mg pack. However, both drugs have been provided to the NHS under a confidential discount scheme.

Sorafenib is available through England's Cancer Drugs Fund for people with inoperable or metastatic papillary or follicular thyroid cancer that has not responded to radioactive iodine. Lenvatinib is available through a compassionate use programme for people who cannot tolerate sorafenib or whose disease has progressed while taking sorafenib.

Lenvatinib and sorafenib are available for routine NHS use in Scotland for this type of thyroid cancer.

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