J&J's multiple myeloma med Darzalex gets cold shoulder from NICE

England's price watchdog has declined to cover J&J's Darzalex for multiple myeloma.

There are big expectations for big sales over time for Johnson & Johnson multiple myeloma drug Darzalex: nearly $5 billion by 2022. But England's drug price watchdog is making it hard on J&J to realize its potential there.

In draft guidance issued today, the National Institute for Health and Care Excellence essentially decided that advisers couldn’t determine how effective the drug would be in treating patients who have failed on other treatments based on the evidence they had seen. Therefore, NICE said it couldn’t arrive at a determination on the drug’s cost effectiveness and that means they are not recommending its use as a monotherapy against multiple myeloma.

NICE pointed out that the drug came with a list price of £74,531 ($92,149) for the average patients when administrative costs were thrown in, and £68,862 ($85,140) when they were excluded.

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The news was not well received by Janssen, which said it is clear reforms are needed in the way NICE reviews new meds.

"This decision is extremely disappointing and highlights that little has changed in the way that medicines are assessed in the UK," Jennifer Lee, director of health economics, market access and reimbursement (HEMAR) and advocacy at Janssen UK, said in a statement. "We recognise that NICE is struggling to evaluate breakthrough treatments, such as daratumumab, which receive early approval. Our primary concern is for UK patients to receive the same, timely access to our medicines as patients across Western Europe."

The price watchdog made clear that patients already taking the drug may continue “without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.”

It has also given J&J’s Janssen unit, and the public, until April 7 to make a more persuasive case, and it is in this time period that negotiations for lower prices often take place that result in a reversal of a decision.

While big things have been predicted for the drug, so far the pathway has not been easy for J&J. When it was approved in 2015, the drug was given a fourth-line use, setting it behind its closest competitors, Celgene's Pomalyst and Amgen's Kyprolis, in the treatment sequence.  

But that changed last fall when the FDA approved Darzalex in combination with the chemo drug dexamethasone and either Celgene’s Revlimid or Takeda’s Velcade—for patients who had received just one prior therapy. That approval broadened its target population considerably, and it’ll bring in patients who tend to stay on therapy for longer periods of time, giving Darzalex two routes to sales growth.

There has also been a lot of speculation as to whether Janssen’s first-in-class anti-CD38 drug will displace Pomalyst, Kyprolis and other drugs such as Takeda's Ninlaro, Bristol-Myers Squibb/AbbVie's Empliciti and Novartis' Farydak in the increasingly crowded multiple myeloma market. EvaluatePharma, for one, has suggested it will.

Editor's Note: The story was updated with a statement from Janssen.

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