J&J's Darzalex wins limited NICE approval for multiple myeloma

England's NICE has decided that Johnson & Johnson's multiple myeloma Darzalex can be funded as a fourth-line treatment through the Cancer Drug Fund.

While Johnson & Johnson’s multiple myeloma drug Darzalex has steadily won new approvals from the FDA, it continues to face obstacles in England.

The country’s drug cost watchdog has again rebuffed (PDF) Darzalex for routine use but has said it can be covered through the country’s Cancer Drug Fund as a fourth-line treatment.

The National Institute for Health and Care Excellence approved Darzalex use after three previous treatments and said the CFD arrangement would allow both J&J’s Janssen and NICE to further evaluate the drug’s clinical and cost effectiveness. It will be evaluated again in November 2020.

RELATED: J&J's multiple myeloma drug Darzalex gets cold shoulder from NICE

NHS England and Janssen lined out a commercial access agreement, which replaces the previous patient access scheme (PAS). Terms of the agreement, including the discounted price to NHS, are confidential. The guidance noted the list prices for the drug are £360 (about $500) for a 100 mg vial and £1,440 ($1,985) for the 400 mg vial. It figured a course of treatment would run up to £74,531 ($102,812) with administration costs.

NICE has not made it easier for Darzalex competitors. Last fall it shot down Takeda's Ninlaro in combination with Celgene’s Revlimid and chemo dexamethasone for myeloma patients who have received one or more previous therapies, deciding it didn’t meet all necessary criteria for inclusion in the watchdog’s Cancer Drugs Fund.

The situation has been much different for Darzalex in the U.S., where the FDA approved it for a fourth-line use two years ago. 

The drug, which competes with AbbVie and Bristol-Myers Squibb’s Empliciti as well as Takeda’s Ninlaro, has since picked up approvals for use earlier in treatment. Last November, it snagged a go-ahead in second-line use and the company recently released data that could help it win a coveted spot in first-line treatment.