[Ip-health] FiercePharma: U.K. patient group demands government override Roche's Kadcyla patents

Andrew S. Goldman andrew.goldman at keionline.org
Thu Oct 1 10:24:41 PDT 2015


October 1, 2015 | By Emily Wasserman

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

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

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

"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

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 [
Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

More information about the Ip-health mailing list