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The National Institute for Health and Care Excellence (NICE) has published its Final Appraisal Document for MSD’s letermovir [ID1153] which is subject to appeal, with final guidance expected to be published 31st July 2019.

Letermovir is recommended, within its marketing authorisation, as an option for preventing cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) in adults who are seropositive for CMV.

Letermovir is recommended as an option for suitable patients only if MSD provides it according to the commercial arrangement reached with NICE.

HSCT can be a life-saving treatment for a range of different diseases including certain cancers such as leukaemia and lymphoma. However, a typical HSCT regimen can weaken the immune system, allowing for the reactivation of CMV in infected individuals.

Approximately 50-80% of adults in the UK are thought to be infected with CMV – a common member of the herpes family of viruses – and, once infected, it often persists in the body in an inactive or latent state, typically causing no symptoms.

For CMV infected patients undergoing an allogeneic HSCT (where the transplanted stem cells originate from a donor), it is reported that up to 50% experience CMV reactivation due to their compromised immunity, placing them at an increased risk of serious complications and potentially increased mortality.

Letermovir is a member of a new class of drugs called non-nucleoside CMV inhibitors. Taken orally, it works by inhibiting the ability of the CMV virus to replicate within the body.

The NICE decision means that specialist doctors in England, Wales and Northern Ireland may soon have the funding option of initiating this preventative therapy in appropriate patients.

The NICE recommendation was based on data from a Phase 3 clinical trial that included 565 patients who received stem cell transplants. Results from this study were published in the New England Journal of Medicine.

The Scottish Medicines Consortium recently concluded its own appraisal of the clinical and cost-effectiveness of letermovir, accepting it for suitable use within NHS Scotland in March 2019.

Prof. Karl Peggs, Clinical and Scientific Director of the Sir Naim Dangoor Centre for Cellular Therapy, UCLH, said: “Cytomegalovirus remains a major clinical challenge following allogeneic transplantation, and current treatment strategies remain both toxic and burdensome to patients. Any new therapy that can reduce this burden is clearly welcomed by both physicians and patients, and the agreement from NICE to make letermovir available to NHS patients is major step forward in this regard.”

Dr Robert Danby, Consultant Haematologist, Oxford University Hospitals NHS Foundation Trust and Anthony Nolan, who advised the committee, said: “This decision marks the biggest advance we’ve seen for a number of years in preventing CMV reactivation post allogeneic haematopoietic stem cell transplantation. It’s fantastic news for patients and has the potential to have a big impact on quality of life.”

Henny Braund, Chief Executive of Anthony Nolan, which manages a register of over 700,000 potential stem cell donors, said: “I am delighted that NICE have accepted the use of letermovir, in what is an important step forward. This decision may subsequently allow stem cell transplant patients in England, Wales and Northern Ireland access to a treatment which could significantly improve their quality of life.”