Ibrance v Kisqali: Quicker Novartis Discount Helps Cut UK NICE’s Timeline
Executive Summary
It took NICE, England’s health technology appraisal body, 84 days to say yes to Novartis’ Kisqali and almost a year to recommend Pfizer’s Ibrance. Willingness to sacrifice on price could have had a big impact on timelines.
NICE, the health technology appraisal institute for England and Wales, has recommended two breast cancer drugs for use on the National Health Service: Pfizer’s Ibrance (palbociclib), and Novartis’ Kisqali (ribociclib). While NICE took just 84 days to say yes to Kisqali, it took the best part of a year for the institute to issue positive recommendations on Ibrance. The difference in timelines could be down to the companies’ willingness to compromise on price.
“We need NICE to work together with industry on a new process for evaluation where companies are encouraged to come forward with their best price much earlier in discussions. The current system is taking too long and prices still remain high,” – Paul Workman, Institute of Cancer Research
On Nov. 16, NICE published two pieces of final draft guidance, one for Novartis’ Kisqali, which received EU approval in August 2017 and the other for Pfizer’s Ibrance, approved in November 2016. Both are CDK4/6 inhibitors, a new class of drugs that mark “one of the most important breakthroughs for women with advanced breast cancer in the last two decades,” according to the Institute of Cancer Research.
NICE found that both drugs stalled the growth of cancer for an average of an extra 10 months and described them as promising. The institute indicated that the recommendations were largely down to a reduction in price. “Discounts to the price of both of these promising new drugs mean they can be recommended as options for people with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or secondary breast cancer, despite uncertainties about how long they extend overall survival,” it said in a statement. However, the speed with which the two companies offered their discounts could be reflected in the speed with which NICE agreed to recommend them.
Excluding any discounts, Kisqali costs £2,950 for a 63-tablet pack of 200mg tablets, while Ibrance costs £2,950 for a 21-capsule pack of 125mg capsules.
Kisqali became the first drug to be recommended by NICE within 90 days under new arrangements for appraising cancer drugs that were introduced along with reforms to the Cancer Drug Fund. Now, NICE can start to review drugs before marketing authorization, and as Novartis points out, the first appraisal committee meeting can take place even before an opinion from the European Medicines Agency’s scientific committee, the CHMP, has been issued. It took NICE just 84 days to make a positive recommendation.
But aside from the new process, Novartis says that “true collaboration” with the institute as soon as possible led to a NICE yes at the earliest possible opportunity. “We offered the NHS a good value option that addresses the needs of patients,” said the firm. Indeed, early on in the process Novartis offered NICE a confidential discount as part of the patient access scheme. According to the final appraisal document, it was unclear whether the progression free survival benefits of Kisqali would lead to a survival benefit. “But with the patient access scheme discount, ribociclib is a cost-effective use of NHS resources and it can be recommended,” said the final appraisal determination. It added that it was confident that cost-effectiveness estimates for the drug were in the range that the institute considers acceptable (between £20,000-£30,000 per quality adjusted life year.)
Meanwhile, Ibrance’ road to a positive recommendation was “long and drawn out,” according to Paul Workman, chief executive of the ICR. NICE held its first committee meeting in January 2017 and preliminary draft guidance followed in February. This stated that the cost of Ibrance was too high to justify its benefits, and in addition there were doubts about overall survival benefits. (Also see "Pfizer To Compromise On NICE Price For Ibrance?" - Scrip, 2 Feb, 2017.)
The appraisal was then paused while Pfizer put together an updated evidence package. It also provided the drug free of charge to all 800 eligible NHS patients until NICE and the Scottish Medicines Consortium concluded their appraisals (an SMC decision is expected later this year.) According to the final appraisal document, the discount that Pfizer offered helped bring the incremental cost-effective ratios for Ibrance “within the range considered a cost-effective use of NHS resources.”
Following the earlier negative recommendation, Pfizer commented that it had not initially offered a discount because meeting the £30,000 per QALY threshold would have meant a substantially lower price. “Under the current NICE methodology the monthly cost would have to be several hundred pounds per month (£293-£1,500), which is in the range of what chemotherapy was reimbursed at around 15 years ago,” said Pfizer in February. The company had previously warned that offering discounts was not a sustainable way to secure access to medicines. (Also see "Pfizer Laments Price Cut Needed To Secure Xalkori NICE Yes" - Scrip, 10 Nov, 2016.)
Pfizer has long criticized the NICE appraisal system for cancer medicines, and has highlighted its problems with appraising add-on therapies. The company told the Pink Sheet that it discussed these challenges with NICE during the Ibrance appraisal process. “We are pleased that, in the case of palbociclib, NICE showed flexibility in enabling discussions to continue, meaning that we could go back with additional data and revisions to our economic case. Moving forward, we all need to continue working together to find ways of streamlining the process further.”
The firm added that as cancer rates rise and advances in medicinal innovation are made, NICE’s evaluation process for “pioneering” cancer treatments needs to be reformed. Pfizer said that an analysis that it commissioned showed that “UK patients are prescribed up to 75% less new medicines by volume per capita in the first year of launch compared to those in France, Germany, Japan, Switzerland and the US.”.
In December 2015, Ibrance won a promising innovative medicine (PIM) designation from the UK regulator, the MHRA. A PIM designation is the first step in the MHRA’s early access to medicines scheme (EAMS), which aims to give patients access to promising and innovative medicines that have not yet been approved. The PIM does not appear to have had much impact in getting Ibrance to patients earlier, although, Pfizer notes that the institute quoted the PIM designation in its final decision when discussing the innovative nature of the drug. “We are pleased NICE has recognized the MHRA’s designation,” it said.
Meanwhile, the ICR’s Workman expressed frustration that NICE’s recommendation for Ibrance took so long, even though Pfizer had provided it for free. “We need NICE to work together with industry on a new process for evaluation where companies are encouraged to come forward with their best price much earlier in discussions. The current system is taking too long and prices still remain high,” he said.
From the editors of Scrip Regulatory Affairs.