'Disappointment' as NICE Rejects Ovarian Cancer Drug

Peter Russell

November 09, 2018

The ovarian cancer treatment drug olaparib will be rejected for routine NHS use in England and Wales, the National Institute for Health and Care Excellence (NICE) indicated this week, ending November 9th 2018.

There were also announcements on acute myeloid leukaemia and hepatocellular carcinoma.

Olaparib for Ovarian Cancer

The Institute of Cancer Research (ICR) said it was disappointed that olaparib (Lynparza, AstraZeneca) was not recommended for routine NHS use in England and Wales as a treatment option for adults with relapsed, platinum-sensitive ovarian, fallopian tube, and peritoneal cancer.

An appraisal committee acknowledged that clinical trials demonstrated that the PARP-inhibitor extended the time until cancer progressed compared with routine surveillance. Progression was 8.4 months with olaparib and 4.8 months with placebo.

The benefit was greater in the BRCA mutation-positive subgroup, for which NICE had already recommended olaparib as a third-line treatment.

However, in draft guidance, NICE said that olaparib, with a list price of £4635 per 28-day cycle, was too expensive to be considered a cost-effective option, and did not meet its end-of-life criteria.

Earlier this year, NICE recommended niraparib (Zejula, Tesaro) for this same indication for use on the Cancer Drugs Fund.

Prof Paul Workman, chief executive of the ICR, whose scientists first discovered how to target the drug at cancer's genetic weaknesses, said: "Today’s decision is a disappointing one for women with advanced ovarian cancer and their doctors.

"We would like to see olaparib available on the NHS for a broader group of women, to provide them with an important new treatment option."

Prof Workman added: "Olaparib is currently available on the NHS specifically for women with ovarian cancer who have inherited mutations in the BRCA genes, but studies have shown that another group of women who have responded well to platinum chemotherapy could also benefit from the drug. Unfortunately, today's decision means that these women will be unable to access olaparib.

"NICE’s decision today was a complicated one and cost was a major factor. Use of olaparib in women without BRCA mutations would be more clearly cost-effective if we could learn more about which women benefit and had a better test to pick them out for treatment."

Public consultation on the draft guidance closes on November 30th, with final guidance expected in April 2019.

Liposomal Cytarabine–Daunorubicin for Leukaemia

In final draft guidance, NICE recommended liposomal cytarabinedaunorubicin (Vyxeos, Jazz Pharmaceuticals) as an option for adults with acute myeloid leukaemia (AML).

An appraisal said that current treatment usually involved chemotherapy with standard daunorubicin and cytarabine. However, NICE said that patients prescribed the simultaneous combination of these two medications had better survival outcomes compared with those receiving the therapies separately.

Furthermore, liposomal cytarabine–daunorubicin met the regulator's criteria as an end-of-life treatment, and the committee concluded it was a cost-effective use of NHS resources. 

Liposomal cytarabine–daunorubicin is for adults who have untreated therapy-related AML or AML with myelodysplasia-related changes. Approximately 500 people would be eligible for this treatment each year in England.

The list price of the treatment is £4581 per 50ml vial, but the manufacturer has agreed a confidential discounted price.

Lenvatinib for Hepatocellular Carcinoma

NICE gave a positive response to lenvatinib (Lenvima, Eisai) as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults.

In a final appraisal, it said the recommendation for the tyrosine-kinase inhibitor applied only if patients had:

  • Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and

  • The manufacturer provided it according to a commercial arrangement

Advanced unresectable hepatocellular carcinoma is often diagnosed late in life, has a poor prognosis, and is a debilitating condition.

Usual treatment is with sorafenib (Nexavar, Bayer), but around a quarter of people stop taking it because they cannot tolerate its side effects.

NICE said that clinical trials showed that lenvatinib slowed disease progression and caused more tumours to shrink than sorafenib. Also, patients taking lenvatinib lived for about as long as those having sorafenib.

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