The UK’s drug pricing regulator the National Institute for Health and Care Excellence (Nice) has decided not to recommend Kyowa Kirin’s Poteligeo (mogamulizumab) for routine use in the National Health Service (NHS) in England and Wales.

Poteligeo is a humanised monoclonal antibody drug indicated for mycosis fungoides and Sézary syndrome, two types of rare non-Hodgkin lymphoma of the skin, cutaneous T cell lymphoma, after at least one systemic treatment.

NICE’s decision was based on the determination by a committee that the clinical evidence for Poteligeo in mycosis fungoides or Sézary syndrome is uncertain. This is because the application was based on a clinical trial that compared Poteligeo with vorionstat, which is neither approved nor used in the UK. In addition, NICE decided indirect comparisons with therapies used in the NHS were also uncertain.

NICE also considered whether Poteligeo could be recommended as a life-extending treatment at the end of life. However, the watchdog was concerned about the discrepancies between median overall survival results from Health Episode Statistics (HES) database analysis and in the company’s clinical trial. AS a result, the regulator determined it could not deem Poteligeo to be a life-extending treatment at the end of life for cutaneous T cell lymphoma.

The regulator also determined that the drug was not cost-effective, and therefore not a good use of NHS resources.

NICE decided that for this drug an acceptable incremental cost-effectiveness ratio (ICER) was between £20,000 and £30,000 per quality-adjusted life year (QALY). However, it determined that Kyowa Kirin’s base-case ICER for Poteligeo was £31,030 per QALY when an agreed commercial pricing arrangement was taken into account. NICE then determined that this cost was more likely to be £33,043 per QALY based on HES data and up to £80,555 per QALY based on clinical trial data presented by Kyowa Kirin.

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Cancer drugs can be recommended under the Cancer Drugs Fund to allow the drug to be used in the NHS while additional data is collected. But in this case, NICE deemed that the collection of further data was “unlikely to address the clinical uncertainty because of the limitations in the trial design”.

Kyowa Kirin northern cluster general manager responsible for the UK market Richard Johnson commented: “We are disappointed that, despite feedback from the patient and clinical community together with extensive evidence provided, the appraisal committee’s decision is negative.

“Kyowa Kirin remains committed to supporting adults with mycosis fungoides and Sézary syndrome. The company will do all it can to ensure people with these debilitating haematological malignancies and eligible for these treatments have access to mogamulizumab.”

UK-based Charity Lymphoma Action’s director of operations and external affairs Stephen Scowcroft said: “We are deeply disappointed by this decision and the effect it will have on people living with these rare and debilitating haematological cancers.

“We know that there is a real need for effective treatments for people living with mycosis fungoides and Sézary syndrome as there are currently limited treatment options and this can have a significant impact on a person’s quality of life, daily function and social interactions.

“We believe patients should have access to the best care and there continues to be a need for effective treatments for people living with mycosis fungoides and Sézary syndrome.

“We call on the relevant stakeholders, NICE and the company, to continue to discuss the options and to work with the patient community to find a resolution.”

Other March NICE decisions

Early March has been a busy period for NICE. On 3 March, NICE recommended Eli Lilly’s Olumiant (baricitinb) for routine NHS use to treat moderate to severe atopic dermatitis in adults who have not responded to at least one systemic immunosuppressant.

This decision is based on clinical trial results that showed the drug “reduces the severity and symptoms of atopic dermatitis compared with placebo”. Although NICE noted that Olumiant was not directly compared to standard of care dupilumab, it has a role to play in treating patients who have to discontinue dupilumab treatment because of side effects.

NICE determined that the most likely cost-effectiveness estimates for Olumiant were an acceptable use of NHS resources. NICE and Eli Lilly had come to an undisclosed commercial arrangement for the price of Olumiant.

Also on the 3 March, the regulator recommended Celgene’s Revlimid (lenalidomide) for routine NHS use. NICE’s recommendation is for newly diagnosed multiple myeloma patients who have undergone an autologous stem cell transplant.

NICE made this decision because there is no maintenance treatment for these patients and clinical results suggested Revlimid extended both survival and time before disease progression. Revlimid was also deemed cost-effective and a good use of NHS resources by NICE.