A new flare up over prescription drug costs is taking place in the UK. In a letter to the British Health Secretary, a coalition of cancer patients, physicians, and advocacy groups has asked the government to override patents on a Roche breast cancer treatment – and they have already lined up an unnamed drug maker to produce a lower-cost version of the medicine, known as Kadcyla, if the government agrees.
The request comes as patient access to the drug has grown more difficult. Last year, the National Institute for Health and Care Excellence, a government watchdog that measures cost effectiveness of drugs, recommended that Kadcyla not be covered due to the price. The coalition notes the Roche drug, which is known generically as TDM-1, costs about $155,000, or nearly four times the 2014 per capita income of $40,000 in the UK.
The decision riled patient groups in the UK. And their concern grew following recent cutbacks at the Cancer Drugs Fund, which is run by the National Health Service and pays for medicines considered too expensive under the usual coverage mechanism. As of next month, coverage is no longer extended to new Kadcyla patients.
And so, the coalition wants the government to issue a compulsory license that could be used to produce a cheaper version of Kadcyla. Countries can issue licenses so a copy of a patented medicine can be made without the consent of the drug maker that owns the patent. A World Trade Organization agreement says countries are free to determine grounds for granting a license.
The coalition members note that the purpose of a compulsory license is to widen access to medicines and that, by doing so, Roche would face competition and, presumably, the cost would drop.
“If the UK government begins a serious review of this petition, it instantly improves its short term bargaining position with Roche, and it begins to map out a future where cancer patients have a better chance to get the drugs they need,” said Manon Ress of Knowledge Ecology International, a coalition member, in a statement.
The pharmaceutical industry sees compulsory licenses as a threat to intellectual property and has sought the assistance of the US Trade Representative to discourage countries from issuing licenses. Earlier this year, PhRMA, the US industry trade group tried to persuade the US Trade Rep to take a more narrow view by arguing licenses should be “granted only when there is a true health emergency and as a measure of last resort.”
We asked the UK health ministry for comment and will update you accordingly.
The coalition, by the way, also suggested what it called “more ambitious strategies” to obtain access to a lower-cost version of the medicine. These include requiring Roche to disclose its know-how for manufacturing the medicine, sanctioning Roche for excessing pricing, and allowing for faster and smaller clinical trials to support developing of a cheaper version, among other things.
As for Roche, a spokeswoman wrote us that, “we understand the financial pressures the NHS is under, [but] patients in the UK should not be denied access to innovative and clinically effective medicines that are routinely available to patients in Europe.” There needs to be “a pragmatic, flexible and sustainable way of assessing cancer medicines” and that “access to these medicines will only be achieved with long-term reform.”
She adds that the drug maker will continue to hold talks with the NHS until Nov. 4, when the delistings on the Cancer Drugs Fund becomes official.Print This Post