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[Lani]

Reuters Health Information
Call for Britain to Over-Ride Patents on Roche Cancer Drug
By Ben Hirschler
October 02, 2015


LONDON (Reuters) - A group of patients and campaigners has called on Britain's health minister to over-ride patents protecting Roche's expensive breast cancer drug Kadcyla (ado-trastuzumab emtansine, T-DM1) to allow for the import or manufacture of cut-price copies.

The move shows the growing pricing pressure on drug companies on both sides of the Atlantic, especially in the field of cancer where new treatments can cost well over $100,000.

In a letter to Health Secretary Jeremy Hunt on Thursday, the Coalition for Affordable T-DM1 said the government should grant a compulsory licence for patents covering Kadcyla, or T-DM1, allowing other companies to supply biosimilar versions.

It said UK and European law contained provisions for this and one company had already indicated a willingness to make the drug in Britain, if a compulsory licence was issued. (http://bit.ly/1MJrG3O)

While Kadcyla can add about six months to the lives of some women with breast cancer, Britain's cost watchdog the National Institute for Health and Care Excellence (NICE) says its price of 90,000 pounds ($136,000) per patient is excessive.

The Swiss drugmaker contends the cost is actually less than this because the drug is typically given for shorter periods than NICE assumes.

In response to the coalition's letter, Roche said there needed to be a "pragmatic, flexible and sustainable" way of assessing cancer drugs and British patients should not be denied access to medicines routinely available elsewhere in Europe.

The British health ministry said Hunt would respond to the letter in due course.

As well as being rejected by NICE, from next month Kadcyla will also not be covered by the Cancer Drugs Fund - set up to pay for drugs turned down by NICE - prompting Roche Chief Executive Severin Schwan recently to call Britain's drug system "stupid".

Issuing a compulsory licence would put Britain on a collision course with the pharmaceuticals industry, something the government is unlikely to want given its desire to encourage life sciences.

In the past, compulsory licences have been used by some developing countries, most notably India, which stunned the industry in 2012 by overriding a valid patent on Bayer's cancer drug Nexavar.

Kadcyla is one of a number of targeted therapies that are revolutionising cancer care. Other promising new approaches include a range of drugs to help the immune system fight cancer, which also carry a high price.