NICE does a U-turn on J&J’s Zytiga for pre-chemo after drugmaker offers cost-cutting deal – FiercePharma

7 months ago Comments Off on NICE does a U-turn on J&J’s Zytiga for pre-chemo after drugmaker offers cost-cutting deal – FiercePharma

The U.K.’s National Institute for Health and Care Excellence (NICE) has been soft-shoeing around Johnson & Johnson’s ($JNJ) Zytiga for awhile now. The cost-effectiveness watchdogs had said they’d like to recommend the prostate cancer drug as a pre-chemo treatment, but that Zytiga was just too expensive. Now NICE is changing its tune, agreeing to fund the med as long as J&J delivers some discounts.

In final guidance, NICE said it would back Zytiga for men with metastatic prostate cancer (mCRPC) that’s relapsed after hormone treatment. Zytiga’s list price will be reduced to £2,300 for 120 tablets from £2,930. After 10 months of treatment, Janssen will provide the drug at no cost.

NICE based its decision on new data from Janssen, which showed that 14% of patients in the U.S. who took Zytiga stayed on treatment for more than four years. That, along with discounts, was enough to sway the cost watchdog.

NICE Director Carole Longson

“I am very pleased that the new evidence submitted has meant we are able to recommend (Zytiga). There are few treatments available for patients at this stage of prostate cancer so this is very good news,” NICE Director Carole Longson said in a statement.

NICE and J&J have a contentious past when it comes to Zytiga. The cost gatekeeper gave a thumbs-down to the med for pre-chemo use back in 2014. At the time, NICE CEO Sir Andrew Dillon blamed the body’s decision on J&J. The drug’s benefits did not justify its high price tag, Dillon said. And J&J didn’t seem willing to make any big concessions to change NICE’s mind.

“We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend (Zytiga) for use in this way,” Dillon said at the time.

Now, NICE’s “long overdue but welcome decision means that patients in England will finally be able to access this innovative cancer medicine routinely,” Janssen U.K. and Ireland Managing Director Mark Hicken said in a statement. “We have worked tirelessly for several years to ensure (Zytiga),a UK-discovered medicine, which demonstrates long term survival and quality of life benefits for patients, is made widely available for men who cannot have or do not want chemotherapy and are delighted that this is now possible for them.”

NICE’s thumbs-up comes at a critical moment for Zytiga, which has been facing rivalry from Astellas and Medivation’s ($MDVN) prostate cancer med Xtandi. In December, NICE backed Xtandi for pre-chemo settings, raising another hurdle to Zytiga as it tries to defend its market share. Both drugs are approved for pre-chemo treatment in the EU.

Even though Zytiga has the first-to-market advantage, some analysts think it’s only a matter of time before Xtandi overtakes its competitor. Xtandi is more convenient, as patients can take the pill on its own. Zytiga must be taken with prednisone. And Xtandi is already seeing a strong uptake in post-chemo patients, suggesting some hot competition in the pre-chemo setting.

“Strong adoption of Xtandi among oncologists as the preferred agent in the post-chemo setting, in our opinion, speaks to the preference for Xtandi’s advantage that goes beyond lack of steroid co-administration and sets up potentially an even stronger launch following pre-chemo approval,” Leerink Partners analyst Howard Liang said in a note to clients last year.

– here’s NICE’s statement
– read J&J’s release

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NICE Zytiga snub is ‘plainly illogical,’ critic says
New data positions Astellas prostate cancer med Xtandi to grab market share from J&J’s Zytiga

NICE does a U-turn on J&J’s Zytiga for pre-chemo after drugmaker offers cost-cutting deal – FiercePharma