U.K. patient group demands government override Roche's Kadcyla patents

Roche ($RHHBY) has been facing pricing pushback for its breast cancer drug Kadcyla in the U.K., with the country's cost watchdog nixing the med last year and the last-ditch Cancer Drugs Fund recently rejecting it from its covered list. Now, patients are calling on Britain's health minister to take a radical step: Override the company's Kadcyla patents and open the door for lower-priced copies.

In a letter to U.K. Health Secretary Jeremy Hunt, the Coalition for Affordable T-DM1 asked the government to grant a compulsory license for Roche's patents on the drug, allowing other companies to manufacture or import cut-price biosimilar versions.

That would require other companies to develop biosimilars, and to speed the process along, the U.K. government could challenge Roche's test data or force the company to disclose its manufacturing processes for the drug, the group said. And if all else fails, the U.K. could fine Roche for excessive pricing, it added.

Compulsory licensing is allowed under British law in special circumstances, as it is in many countries, but the maneuver is uncommon even in the cash-strapped developing world. India forced Bayer to license its cancer drug Nexavar to a domestic generics maker several years ago, but has rejected subsequent requests; the country has, however, tossed out a series of Big Pharma patents.

The U.K. group's immediate aim would be persuading Roche to lower its price for Kadcyla. "These strategies will not directly address the current crisis in access ... for those patients who are now unable to get reimbursement for the drug," the letter stated. "However, any signal by the government that it will undertake one or more measures would likely change the reaction by Roche to longstanding requests to lower prices for (Kadcyla), and make it easier to obtain lower and more affordable prices in the near term."

But Roche is not caving to the pressure. The company says the U.K.'s reimbursement system is flawed. There should be a "pragmatic, flexible and sustainable" way to evaluate cancer drugs, the company told Reuters, and British patients should not be denied access to drugs available other places in Europe.

Roche has trod a rocky road with Kadcyla in the U.K. In August 2014, the country's cost-effectiveness gatekeeper, the National Institute for Health and Care Excellence (NICE) said that the drug was too expensive to cover even with a proposed discount, calling its £90,000 ($136,000)-per-patient price tag excessive. The move triggered backlash from patients in the U.K., with some asking NICE to work harder to resolve its pricing disputes with Roche.

Last month, the U.K.'s Cancer Drugs Fund, which is designed to cover treatments that NICE rejects, decided to stop paying for a slate of treatments, including Roche's Kadcyla. The move sparked the ire of Roche CEO Severin Schwan, who called the decision "stupid" and "completely arbitrary."

"It's stupid from a cost point of view," Schwan said at the time. "How the hell can you ignore all these benefits?" The treatment combines an antibody used in another Roche cancer drug, Herceptin, with a technology that delivers it directly to cancer cells, causing fewer side effects, Reuters notes.

The recent pushback also feeds into a growing debate over drug pricing, as payers, the public and lawmakers lobby against the rising price of branded meds. Things are heating up stateside, with politicians proposing government measures to lower prices and PBMs vowing to bring down sky-high costs with their own price-cutting measures. And NICE continues to reject certain cancer treatments if it determines their benefits do not outweigh the costs.

- here's the Coalition for Affordable T-DM1's letter (PDF)
- read the Reuters story

Special Reports: The top 15 pharma companies by 2014 revenue - Roche | Top 15 Drug Launch Superstars - Kadcyla - Roche/Genentech | Top 10 best-selling cancer drugs of 2013

Read more on