Industry Trend Analysis - NICE Rejection Will Not Setback Darzalex' Growth - MAY 2017


BMI View: If the UK's National Institute of Health and Care Excellence reject s the approval of Janssen Biotech (Johnson & Johnson ' s) Darzalex (daratumumab) in the UK, this will be a hit to the company ' s global expansion plan of this product. In comparison to the recent second-line US approval to treat patients with multiple myeloma (MM), this possible NICE rejection will not prevent Darzalex's revenue growth. Darzalex will outcompete most of the competitors in the MM therapy area, except for Celgene ' s Revlimid (lenalidomide), which will remain the dominant player until its patent runs out in 2026.

Janssen Biotech ( Johnson & Johnson) is concerned that the UK's National Institute for Health and Care Excellence (NICE) has not recommended Darzalex (daratumumab) monotherapy for treatment of relapsed and refractory multiple myeloma (r/r MM) in adults, after receiving therapy, which includes a proteasome inhibitor and an immunomodulatory agent and whose disease has progressed on the last therapy. Should the NICE appraisal consultation document (ACD) become final, patients who have failed nearly all existing treatment options, will remain unable to access daratumumab for this incurable form of blood cancer on the NHS, whilst it is already reimbursed in several European countries. The closing date for comments on the NICE ACD on daratumumab is April 7 2017.

Daratumumab was designated breakthrough status by the FDA and granted a licence on Phase II trial data following accelerated assessment by the EMA. Efficacy data from a Phase II study and a Phase I/II study support the use of daratumumab as monotherapy in r/r MM patients. Findings from a combined efficacy analysis of these two trials demonstrated that after a mean follow-up of 20.7 months, the estimated median overall survival for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20.1 months (95% confidence interval, 17 not estimable), with 65% surviving up to 12 months, whereas current treatment options have shown around an average survival of five to nine months. The overall response rate for the combined analysis was 31%, and 83% of patients achieved stable disease or better. The most common adverse events (AEs) in the Phase II trial, which occurred in more than 20% of patients, were fatigue, anaemia, nausea, thrombocytopenia, back pain, neutropenia and cough. The most common AEs in the Phase I/II trial were fatigue, allergic rhinitis, and pyrexia (fever).

Revlimid To Remain Dominant Player In MM Market
Estimated Product Revenue (USDmn)
Source: Bloomberg, BMI

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