Scottish Medicines Consortium Accepts DARZALEX®▼ (daratumumab) Subcutaneous Injection and IMBRUVICA® (ibrutinib) Combination Therapy for Treatment of Blood Cancers in Scotland

Scottish Medicines Consortium Accepts DARZALEX^®▼ (daratumumab) Subcutaneous Injection and IMBRUVICA^® (ibrutinib) Combination Therapy for Treatment of Blood Cancers in Scotland

• DARZALEX^®▼ (daratumumab) subcutaneous formulation injection approved for the treatment of relapsed and refractory multiple myeloma[i]^,[ii]
• IMBRUVICA^® (ibrutinib) in combination with rituximab is accepted for use in Waldenström’s macroglobulinemia[iii]

High Wycombe, 12 October 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the Scottish Medicines Consortium’s (SMC) decision to accept two of the Company’s treatments for rare and incurable blood cancers for use by NHS Scotland.

Daratumumab subcutaneous (SC) formulation injection is accepted by the SMC in two indications:

• as monotherapy as a fourth-line treatment option for adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.¹
• as a second-line treatment option in combination with bortezomib and dexamethasone, for adult patients with MM who have received at least one prior therapy.²

While NHS Scotland had provided early access to daratumumab SC due to the COVID-19 situation through a named patient programme, today’s decision ensures there will be continuity of access for these patients.

The SMC also accepted ibrutinib, in combination with rituximab, for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy.³ This decision means broader access for patients and clinicians who, for the past three years, had only been able to access ibrutinib via individual funding requests.

“We welcome today’s decision which marks a significant step in providing eligible blood cancer patients in Scotland with treatment options that may enhance clinical needs and lifestyles. This is particularly relevant currently as we work to support the NHS and protect their resources by minimising patients’ time in hospital,” commented Amanda Cunnington, Director of Health Economics, Market Access, Reimbursement (HEMAR) & Advocacy, Janssen-Cilag Limited. “Janssen is committed to gaining a better understanding of the evolving needs of people living with blood cancers, and the development of new innovative combinations and formulations to best meet those needs.”

There are around 24,000 people living with MM in the UK[iv] and around 457 new cases in Scotland every year.[v] Multiple myeloma is an incurable blood cancer that is often associated with time-intensive treatment regimens, which can be burdensome for patients and physicians.[vi] Daratumumab SC formulation injection demonstrates similar efficacy and fewer infusion-related reactions compared to IV administration.[vii]^,[viii] The SC formulation injection is administered as a fixed dose, which significantly reduces treatment time, from several hours to approximately three to five minutes, when compared to the IV formulation.^7,8

Around 400 people in the UK are diagnosed each year with WM, a rare and incurable blood cancer which damages the B-cells (a type of white blood cell) and affects twice as many men as women, mainly in those aged over 65.[ix]

The SMC issued guidance for daratumumab SC and ibrutinib based on a pragmatic review of clinical trial data for all three indications. The SMC’s decision for daratumumab SC for fourth- and second-line use in multiple myeloma was supported by data from the Phase 2 PLEIADES (MMY2040) and Phase 3 COLUMBA (MMY3012) studies.^1,2,[x]^,[xi] Results from the Phase 3, international, double-blind, randomised iNNOVATE trial in WM demonstrated significantly longer progression-free survival in patients receiving ibrutinib plus rituximab compared with placebo plus rituximab, as well as improvement in disease-related symptoms.[xii] The SMC considered that ibrutinib, the first treatment licensed for WM, would fulfil an unmet need in this condition, as efficacy of second line treatment is limited.

Today’s decision from the SMC applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement.

Daratumumab SC formulation injection is already funded in NHS England and Wales, and in Northern Ireland.

[i] Scottish Medicines Consortium. Daratumumab (Darzalex) subcutaneous injection as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma - SMC2304. Available at https://www.scottishmedicines.org.uk/medicines-advice.  Accessed October 2020

[ii] Scottish Medicines Consortium. Daratumumab (Darzalex) subcutaneous injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy - SMC2301. Available at https://www.scottishmedicines.org.uk/medicines-advice.  Accessed October 2020

[iii] Scottish Medicines Consortium. Ibrutinib (Imbruvica) in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia - SMC2259. Available at https://www.scottishmedicines.org.uk/medicines-advice.  Accessed October 2020

[iv] Myeloma UK, What is Myeloma? 2020. Available at: https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/ Last accessed: October 2020

[v] Cancer Research UK. Myeloma incidence by sex and UK country. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma/incidence#heading-Zero.  Last accessed October 2020.

[vi] National Health Service. Treatment: Multiple Myeloma. Available at: https://www.nhs.uk/conditions/multiple-myeloma/treatment/. Last accessed October 2020.

[vii] Mateos MV, Nahi H, Legiec W, et al. Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA. J Clin Oncol. 2019;37(Suppl.): abstract 8005.

[viii]Chari A, San-Miguel J, McCarthy H, et al. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy: Pleiades study update.  Blood. 2019;134(Suppl.1):abstract 3152.

[ix] Lymphoma Action. Lymphoplasmacytic lymphoma and Waldenström’s macroglobulinaemia. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/lymphoplasmacytic-lymphoma-and-waldenstroms-macroglobulinaemia Last accessed October 2020.

[x] Chari, A., Rodriguez‐Otero, P., McCarthy, H., et al., (2020), Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open‐label Phase II study. Br J Haematol. doi:10.1111/bjh.16980

[xi] Mateos MV, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. The Lancet Haematology. 2020;7(5):E370-E380

[xii] Dimopoulos, M et al. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia. N Engl J Med 2018; 378:2399-2410 DOI: 10.1056/NEJMoa1802917