[Ip-health] NICE rebuffs Kadcyla as too expensive

Manon Ress manon.ress at keionline.org
Sat Aug 9 05:15:02 PDT 2014


NICE rebuffs Kadcyla as too expensive

Published on Friday, August 8, 2014

The U.K.'s NICE issued a final appraisal determination recommending against
Kadcyla trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat
HER2-positive, unresectable, locally advanced or metastatic breast cancer
in patients previously treated with the pharma's Herceptin trastuzumab and
a taxane -- Kadcyla's approved indication in the EU. In April draft
guidance, NICE said Kadcyla was too expensive. The committee said Roche
argued in response that NICE should take into account the 2014
Pharmaceutical Price Regulation Scheme (PPRS), under which industry
underwrites NHS expenditures above an annual limit in exchange for the
ability to set any price at launch. NICE said that terms of the 2014 PPRS
do not supersede the committee's role of evaluating the cost-effectiveness
of technologies (see BioCentury, Nov. 18, 2013).

NICE said Kadcyla is estimated to cost more than L90,000 ($151,416) per
patient at its full list price. Roche agreed to a patient access scheme
under which it would provide Kadcyla at an undisclosed discount. But even
with the discount, the committee said the most plausible incremental
cost-effectiveness ratio (ICER) for Kadcyla compared to Roche's Xeloda
capecitabine in combination with Tyverb lapatinib from GlaxoSmithKline plc
(LSE:GSK; NYSE:GSK) was L166,400 ($279,951) per quality-adjusted life year
(QALY) gained -- above the limit normally considered cost-effective. Roche
said it would have to discount Kadcyla by 60% to meet NICE's
cost-effectiveness threshold.

The Association of the British Pharmaceutical Industry (ABPI) sided with
NICE, stating that the 2014 PPRS "does not require NICE to accept whatever
price a company places on a new medicine."

Roche said it is considering its options, but added that Kadcyla's
rejection shows the U.K.'s current system "is not fit for purpose and in
need of a complete overhaul when it comes to reviewing cancer medicines."

Kadcyla -- a humanized mAb against HER2 linked to a DM1 cytotoxic agent
from ImmunoGen Inc. (NASDAQ:IMGN) -- is available in England through the
Cancer Drugs Fund, which is intended to give patients access to cancer
drugs that would not otherwise be available on the NHS. The cancer fund
currently has runway through 2016.

Manon Ress, Ph.D.
Knowledge Ecology International, KEI
manon.ress at keionline.org, tel.: +1 202 332 2670

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