UK regulators do not back Roche’s breast cancer drug

pharmafile | May 20, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing NICE, Perjeta, Roche, breast cancer, recommendation 

The National Institute for Health and Care Excellence (Nice) has provisionally turned down Swiss drugmaker Roche’s (VTX: ROG) breast cancer drug Perjeta (pertuzumab) saying it is unsure of long term benefits. 

The regulator said there was a lack of long-term evidence comparing pertuzumab with other treatments used before breast cancer surgery. There was evidence that adding pertuzumab to trastuzumab and docetaxel was more successful at getting rid of cancer in the breast and lymph nodes before surgery but it was very uncertain about the extent to which this would reduce the risk of the disease recurring and result in longer survival. 

Sir Andrew Dillon, Nice chief executive, said: “In order to be able to recommend pertuzumab as an addition to trastuzumab and chemotherapy, the committee needed to have more evidence of its long-term clinical benefits, particularly its impact on overall survival. On the basis of the evidence presented, the committee was very unsure about the extent of these benefits.” 

Pertuzumab is licensed for use in combination with trastuzumab (Herceptin) and docetaxel (a type of chemotherapy) before breast cancer surgery to shrink the cancer so that it becomes operable.
The draft guidance looks at pertuzumab used in this way to treat HER2-positive breast cancer that is locally advanced, inflammatory, or early-stage and at high risk of coming back.

Over 50,000 women and around 340 men are diagnosed with breast cancer each year in the UK with about 10-15% of these characterised as HER2-positive breast cancer. 

Richard Erwin, general manager, Roche UK, said:  “It is a real concern for cancer patients that Perjeta, the neoadjuvant treatment, may not be available for patients in the UK when its clinical efficacy has been proven and it is within the cost effectiveness range for this indication. This again demonstrates why we are concerned that Nice’s methodology does not work for some medicines and therapy areas. We need to create a more sustainable and flexible approval system that makes the assessment of cancer medicines as streamlined as possible.”  

Pertuzumab costs £2,395 per 420 mg vial. The total cost of treatment with pertuzumab ranges from £7,185 to £16,765. 

Anjali Shukla

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