NEW YORK – The National Institute for Health and Care Excellence (NICE) is recommending Novartis' Kisqali (ribociclib) plus an aromatase inhibitor for certain patients with early-stage breast cancer within the National Health Service (NHS) England.
NICE said in a draft guidance Thursday that the combination of Kisqali and an aromatase inhibitor can be a treatment option for hormone receptor (HR)-positive, HER2-negative early-stage breast cancer patients who have responded to initial therapies, including surgery, but are at high risk for cancer recurrence. To be eligible for this treatment, patients must have lymph node-positive disease, with involvement of at least four axillary lymph nodes or have grade 3 tumors that are at least 5 cm in size and have spread to one to three axillary lymph nodes.
The institute estimated that up to 4,000 breast cancer patients may be eligible for this treatment, which will be available immediately with interim funding from the Cancer Drugs Fund.
NICE issued the draft recommendation after reviewing data from the Phase III NATALEE trial, which showed a statistically significant improvement in invasive disease-free survival when Kisqali was added to an aromatase inhibitor versus when patients received just an aromatase inhibitor. Based on data showing a 25 percent reduction in invasive disease-free survival for those in the Kisqali arm, the UK's Medicines and Healthcare Products Regulatory Agency approved this regimen in this setting in February.
However, the NATALEE trial showed no statistically significant difference in overall survival between Kisqali plus an aromatase inhibitor versus an aromatase inhibitor alone, NICE found. There was also uncertainty as to the clinical and cost-effectiveness of Kisqali plus an aromatase inhibitor when patients cannot receive Eli Lilly's Verzenio (abemaciclib) plus an endocrine treatment.
Currently, in England, early-stage HR-positive breast cancer patients at high risk of recurrence typically receive an aromatase inhibitor or Verzenio plus endocrine therapy.
Although NICE's independent appraisal committee determined that this regimen is a clinically and cost-effective treatment for this limited subset of breast cancer patients with lymph node-positive disease, it found the evidence lacking for the wider group of early-stage breast cancer patients at high risk of recurrence. As such, the committee has asked Novartis to provide more data on the treatment's impact on a wider population, which it hopes to discuss at a June meeting.
The list prices for Kisqali 200 mg tablets are £983.33 ($1,308.59) per 21-pack; £1,966.67 per 42-pack; and £2,950.00 per 63-pack. However, Novartis is providing Kisqali through a patient access scheme and making it available to NHS England at an undisclosed discount.
NICE already recommends Kisqali plus fulvestrant for metastatic breast cancer patients who have HR-positive HER2-negative disease after endocrine therapy.
Last year, the US Food and Drug Administration approved Kisqali with an aromatase inhibitor in the high-risk, early-stage breast cancer setting based on the NATALEE data, as did the European Medicines Agency's Committee for Medicinal Products for Human Use.