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Another Controversial High Price Med: NICE Rejects Roche (RHHBY)'s New $152,850 Breast Cancer Drug

8/8/2014 5:54:23 AM

Another Controversial High Price Med: National Institute for Clinical Excellence Rejects Roche's New $152,850 Breast Cancer Drug Another Controversial High Price Med: NICE Rejects Roche's New $152,850 Breast Cancer Drug

August 8, 2014
By Mark Terry, Breaking News Staff

Britain’s state-run health service declined to reimburse for a breast cancer drug, citing that it was too expensive, even after a discount. The drug, Kadcyla, manufactured by Roche (RHHBY), is used to treat HER2 positive breast cancer that has metastasized and can’t be treated with surgery and doesn’t respond to other treatments.

Kadcyla was approved in Europe in November 2013 and costs approximately $152,800 per patient over the length of a 14-1/2-month course of treatment. The National Institute for Health and Care Excellence (NICE) stated that the drug was too costly to add to the National Health Service’s (NHS) budget for routine funding. Roche spokeswoman Claudia Schmitt in an email statement noted that they would have to discount Kadcyla by 60 percent to meet NICE’s cost-effectiveness threshold, which she said was “simply not achievable.”

This case is yet another example of problems facing government agencies in reimbursing for expensive drugs, such as the recent story about Questcor Pharmaceuticals’ Acthar medication, with a price tag of $41,763 per prescription.
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It also highlights a potentially problematic situation regarding charities and foundations created to help patients with co-pays for expensive medications that are not fully covered by insurers or government agencies. One example is the Cancer Drugs Fund, created in 2010 to help pay for drugs that are too costly for NHS approval. In the four years since the creation of the fund, the largest beneficiary has been Roche. In the case of Kadcyla, Roche has already received approximately £600 million from the fund since its inception.

In the U.S., the Office of Inspector General (OIG) has stated that when these patient assistance programs (PAPs) are structured properly, they can be very effective in helping patients afford expensive drug treatments. However, there are concerns that if a charity’s scope is so narrow that it directs the patients toward specific drugs and their specific manufacturers, then they may violate anti-kickback legislation.

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