NICE rebuffs J&J's Darzalex price for newly diagnosed myeloma but leaves negotiation door open

Darzalex Faspro
Darzalex Faspro is a fixed-dose, under-the-skin version and has a list price of £4,320 (about $5,920) per 1,800-mg vial. (Johnson & Johnson)

As a four-drug regimen containing Johnson & Johnson’s Darzalex gains traction in the U.S. for newly diagnosed multiple myeloma, a cost-effectiveness watchdog across the pond figures the therapy might be too expensive to deserve reimbursement.

In a draft guidance Thursday, the National Institute for Health and Care Excellence (NICE) declined to back National Health Service (NHS) coverage of Darzalex’s use on top of Takeda’s Velcade, immunomodulator thalidomide and corticosteroid dexamethasone (VTd) for patients with untreated multiple myeloma who are eligible for stem cell transplant.

The regimen’s long-term benefits were unclear, NICE said. Plus, J&J’s economic model didn’t incorporate Bristol Myers Squibb’s Revlimid as a maintenance therapy after transplant, they noted in the draft document (PDF).

Darzalex has shown in clinical trials that it can improve on the efficacy of standard-of-care VTd in newly diagnosed transplant-eligible myeloma patients. In the phase 3 Cassiopeia trial, the Darazlex-VTd combo reduced the risk of death by 48% over VTd alone after a median follow-up of 29.2 months, according to a NICE summary. The trial has another analysis with longer, 44.5 months of follow-up, but that set of data was confidential. NICE suggests that the duration of the Darzalex regimen’s treatment effect is “highly uncertain.”

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The Darazlex regimen involves an induction phase before transplant and a short consolidation phase after transplant. But NICE reviewers noted that maintenance treatment with Revlimid has recently become standard for front-line myeloma post-transplant. J&J’s economic model included the costs of Revlimid but not the benefits, because no clinical data is available evaluating Revlimid maintenance after Darzalex consolidation therapy.

Darzalex’s list price is £4,320 (about $5,920) per 1,800-mg vial of the fixed-dose, under-the-skin version, known as Darzalex Faspro. The original intravenous infusion carries a list price of £360 per 100-mg vial, and £1,440 per 400-mg vial. Like all other companies that wish to have their drugs listed on NHS, J&J offered a confidential discount. NICE obviously doesn’t think the price cut is enough.

NICE has opened the evaluation to comments until Sept. 17 and plans to hold another appraisal committee meeting on Nov. 4, with a goal to publish a final decision by Jan. 12, 2022.

RELATED: EHA: Johnson & Johnson, nearing Sanofi showdown, bolsters Darzalex's myeloma lead with 'unprecedented' survival data

A combination of Darazlex with Velcade and dexamethasone is already covered via the more onerous Cancer Drugs Fund for multiple myeloma patients who have had one previous treatment. Darzalex monotherapy is also recommended for use under the Fund for patients who have tried three previous therapies.

NICE also has a project open for Darzalex’s combination with Amgen’s Kyprolis and dexamethasone for previously treated myeloma.