Scottish Medicines Consortium Accepts Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients in Scotland with Newly Diagnosed Multiple Myeloma

Scottish Medicines Consortium Accepts Darzalex^®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients in Scotland with Newly Diagnosed Multiple Myeloma

• SMC recommends Darzalex^®▼ (daratumumab) in combination with VTd as an option for treating newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant ¹
• The decision was based on the phase III CASSIOPEIA study which showed that daratumumab and VTd was associated with a significant improvement in stringent complete response rates in patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplant ²   

High Wycombe, 18 January 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the Scottish Medicines Consortium’s (SMC) decision to accept daratumumab as a combination therapy with bortezomib, thalidomide and dexamethasone (VTd) for use by NHS Scotland for adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).¹

In making its recommendation, the SMC considered evidence from the Phase III, CASSIOPEIA study, which compared daratumumab and VTd (bortezomib, thalidomide and dexamethasone) to standard of care (VTd alone) in newly diagnosed multiple myeloma patients eligible for ASCT. The primary endpoint was the proportion of patients who achieved a stringent complete response (sCR) after consolidation. The daratumumab-VTd group achieved a statistically significant improvement in the sCR rate (28.9 vs 20.3, P=0.0010) post-consolidation (100 days post-ASCT) compared with the VTd group. In addition, the daratumumab-VTd arm also showed improvements in key secondary endpoints, including minimal residual disease (MRD) and progression-free survival (PFS) versus VTd alone. Patients in the daratumumab-VTd group showed an 18-month PFS rate of 93 per cent compared to 85 per cent for those in the VTd group.²

There are around 24,000 people living with multiple myeloma in the UK³ and around 457 new cases in Scotland every year.⁴ Multiple myeloma is usually an incurable blood cancer.⁵ Although treatment may result in remission, unfortunately patients will relapse as there is currently no cure.

“Today’s decision is hugely welcome as it provides transplant-eligible patients in Scotland with a new option that improves on the standard of care by giving valuable extra time and redefines treatment for those newly diagnosed with multiple myeloma,” commented Amanda Cunnington, Director of Health Economics, Market Access, Reimbursement (HEMAR) & Advocacy, Janssen-Cilag Limited. “Janssen is fully committed to delivering advances to meet the evolving needs of people living with this disease and in developing innovative solutions across the treatment continuum.”

The SMC decision represents a significant step forward in terms of its acceptance of MRD as a valid surrogate endpoint for PFS in people newly diagnosed with multiple myeloma. The SMC recognises that, in the absence of overall survival data from CASSIOPEIA which remains immature, the deeper responses of surrogate endpoints shown by daratumumab and VTd, for both primary and secondary endpoints, translates to longer remission and improved length and quality of life for those diagnosed with multiple myeloma.¹

Although the SMC advice is for the full licensed (intravenous) indication, because of recent changes to the SMC process, access has been extended to include the new subcutaneous (SC) formulation of daratumumab without the need for a separate abbreviated submission. This is good news for patients who will spend considerably less time in hospital, helping free up vital capacity in the healthcare system. 

Daratumumab SC formulation injection is already funded in NHS England and Wales, and in Northern Ireland, and available in Scotland through NHS Scotland Patient Access Scheme (PAS) arrangement.