Janssen has expressed concerns at NICE's decision not to recommend Darzalex® (daratumumab) monotherapy for treatment of relapsed and refractory multiple myeloma in adults (after therapy including a proteasome inhibitor (PI) and an immunomodulatory agent and whose disease has progressed on the last therapy).
If the NICE Appraisal Consultation Document becomes final, patients who have failed nearly all existing treatment options will remain unable to access an innovative and much needed treatment for this incurable form of blood cancer on the NHS. The treatment is already reimbursed in several European countries.
Daratumumab was designated breakthrough status by the US Food & Drug Administration (FDA) and granted a license on Phase 2 trial data - a process reserved for medicines expected to be of major public health interest because of their therapeutic innovation - following accelerated assessment by the European Medicines Agency (EMA).
Janssen says that despite assurances from Government and the ambition set out in the Accelerated Access Review to make the UK a world-leader in healthcare innovation with an NHS that ‘embraces the new drugs and technologies that patients need,’ this is not matched in reality.
Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK, said: “This decision is extremely disappointing and highlights that little has changed in the way that medicines are assessed in the UK.
"We recognise that NICE is struggling to evaluate breakthrough treatments, such as daratumumab, which receive early approval. NICE must work within defined parameters set by Government, which present real challenges in assessing innovative treatments like daratumumab. It is clear that key reforms are needed to the way NICE reviews such treatments if patients are to be given faster access to the medicines they need. Our primary concern is for UK patients to receive the same, timely access to our medicines as patients across Western Europe," added Ms Lee.
The closing date for comments on the NICE Appraisal Consultation Document on daratumumab is 7 April 2017.