NICE Reverses View On Perjeta In Breast Cancer After Roche's Price Cut
Executive Summary
The UK's HTA NICE says it is now backing Roche's Perjeta (pertuzumab) to treat a certain form of breast cancer on the publicly funded NHS after Roche offered a price discount.
In its latest success in getting price concessions from drug makers, the National Institute for Health and Care Excellence (NICE) says it is now backing Perjeta (pertuzumab) to treat a certain form of breast cancer on the National Health Service in England and Wales after vendor Roche offered a confidential discount.
The HTA's decision endorsing the drug's use in combination with Herceptin (trastuzumab) and the chemotherapy docetaxel as an option before surgery in patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer to shrink the cancer so that it becomes operable, is a reversal of a rejection issued in May when NICE listed a number of reasons not to back Perjeta, including an inadequate data package from Roche; concerns around the use of pathological complete response as a substitute for overall survival outcomes; and the drug not being a cost-effective use of public funds. (Also see "Outdated System Preventing Breast Cancer Patients Getting Access To Early Treatment In England, Says Roche" - Scrip, 20 May, 2016.)
Datamonitor Healthcare analyst Zachary McLellan said NICE's volte face in recommending Perjeta reflects the fact the Perjeta/Herceptin combination has demonstrated strong efficacy in HER2+ breast cancer patients.
"The largest barrier to the combination’s uptake, especially in cost-conservative markets such as the UK, has been its high price. NICE had previously issued draft guidance that did not recommend Perjeta in combination with Herceptin and chemotherapy in the neoadjuvant setting, citing the need for more long-term efficacy data in light of the associated economic burden of this regimen. In fact, Roche advised in September of this year that it was engaged in price negotiations with the National Health Service in an effort to ensure the combinations reimbursement," McLellan noted.
McLellan told Scrip that NICE's recommendation might also reflect positive final survival data from the pivotal Phase II NeoSphere trial where updated five-year survival rates of patients receiving the Perjeta/Herceptin and docetaxel combination surpassed those of patients receiving Herceptin and docetaxel only, Perjeta and Herceptin only, and Perjeta and docetaxel only. "However, the updated data were likely insufficient for a positive recommendation without the discount," the analyst said.
NICE said that before the confidential price discount is applied, the cost of Pertuzumab is £2,395 per 420 mg vial, excluding VAT. No indication was given of the scale of the discount offered by Roche.
Pertuzumab is a recombinant monoclonal antibody which targets human epidermal growth factor receptor 2 (HER2)-positive breast tumors. It interrupts the activation of the HER2 intracellular signalling pathway, leading to cell growth arrest and apoptosis. It is administered by intravenous infusion.
"This was not simply about price – the medicine in this setting met the cost effectiveness threshold. This was about NICE accepting that one of the clinical trial endpoints; pathological complete response (pCR), was more likely than not to have an association with longer-term survival." – Roche Statement
Roche in a statement said it was "delighted" with NICE's change of heart and described it as good news for over 1,800 women per year in England and Wales who have the aggressive form of breast cancer.
"This was not simply about price – the medicine in this setting met the cost effectiveness threshold. This was about NICE accepting that one of the clinical trial endpoints; pathological complete response (pCR), was more likely than not to have an association with longer term survival," the company said. As part of its submission, NICE heard from a patient whose response to treatment with Perjeta was described by her clinician as "spectacular", the statement added.
Roche, the world's top manufacturer of cancer therapies, has previously criticized NICE's refusal to recommend Perjeta and other innovative cancer drugs, saying the HTA system in England and Wales is not fit for purpose when it comes to such therapies.
Roche's tone was more conciliatory after NICE's latest pronouncement on Perjeta.
"This positive decision is particularly welcome as, until recently, no new medicines for breast cancer patients had been approved in the last nine years. Over the last month, however, we have seen some positive progress with three breast cancer medicines approved in three weeks," Roche said – those being Eisai Co. Ltd. 's Halaven (eribulin) for treating locally advanced or metastatic breast cancer after two or more chemotherapy regimens; Novartis AG's Afinitor (everolimus) with exemestane for treating advanced breast cancer after endocrine therapy and now Perjeta for the neoadjuvant treatment of HER2-positive breast cancer.
Urging that the momentum be maintained, Roche said it hoped NICE would soon change its mind on breast therapy Kadcyla (trastuzumab emtansine). NICE on Dec. 16 last year confirmed its earlier stance to reject the therapy despite the Swiss company's offer of a price discount. The cost-effectiveness agency issued similar guidance in 2014. (Also see "Frustrated Roche Hopes NICE Will Eventually Back Kadcyla" - Scrip, 16 Dec, 2015.)
“NICE will be meeting to decide on the future of Kadcyla in the metastatic setting in two weeks’ time. We very much hope for another positive decision to ensure breast cancer patients in England and Wales have long-term access to this treatment option,” Roche said.