Astra’s Tagrisso Gets U.K. Backing After Price Agreement

  • 300 lung cancer patients in England, Wales will be eligible
  • NICE issued draft recommendation against Merck’s Keytruda

AstraZeneca Plc, the U.K.’s second-largest drugmaker, won the endorsement of the country’s health-cost regulator for use of its Tagrisso medicine, while a competing lung-cancer drug from Merck & Co. was rejected as not being cost-effective.

Tagrisso will be paid for through the 340 million-pound ($435 million) Cancer Drugs Fund, which covers the latest therapies while information is collected on how well they work in practice. It’s the first new cancer treatment to be introduced into the state-run National Health Service through such an agreement, according to a statement from the National Institute for Health and Care Excellence Tuesday.

Under the fund’s new rules, cancer drugs that receive a draft positive NICE recommendation are immediately eligible for temporary funding. After NICE reviewers said in May that the long-term benefits of Tagrisso were unclear, AstraZeneca provided updated evidence from studies. AstraZeneca also agreed to provide upcoming trial results and an undisclosed discount on the drug’s list price of 4,722.30 pounds a month, prompting NICE to back the use of Tagrisso in some patients with an aggressive form of lung cancer, according to the regulator.

“The new process is getting drugs to patients much faster,” said Lisa Anson, U.K. president at AstraZeneca, in an interview. “It’s one of the fastest development programs that’s ever been seen in pharmaceuticals, in three years. We want, and the NHS wants, to get this drug to the patients, and put in place this interim funding to support it.”

Price Contention

Only one in 10 lung cancer patients in the U.K. survives five years or more after diagnosis, creating a demand for new treatments for people who don’t respond to conventional treatments like radiation and chemotherapy.

The price of such treatments has become a bone of contention between NICE and drugmakers, with the health-cost regulator Tuesday also issuing draft guidance that doesn’t recommend Merck’s Keytruda. While Merck had offered an undisclosed discount on the list price, the drug still isn’t cost-effective and shouldn’t be included in the Cancer Drugs Fund, NICE said in a statement. Earlier in the year, NICE also rejected Bristol-Myers Squibb Co.’s Opdivo for lung-cancer patients.

Tagrisso, a once-daily tablet, is approved for use in people with advanced non-small cell lung cancer and a genetic mutation known as T790M. About 3 percent to 5 percent of patients have this mutation at diagnosis. Lung cancer is the world’s most deadly tumor, and non-small cell lung cancer is the most common form of the disease. NICE backed Tagrisso for patients who have failed first-line treatment. About 300 patients a year in England and Wales will be eligible to receive it, NICE said.

Tagrisso has been approved in Europe since February. In the future, the goal is that the lag time between approval and NHS coverage will shrink, Anson said. “Going forward, this type of deal, we would hope, would happen more in line with the initial approval time-frame,” she said. “That’s the intention.”

AstraZeneca plans to return to NICE with long-term data on Tagrisso to secure its routine use in the U.K. public health system. That data could be available in two years, Anson said.

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