OBJECTIVES

We are embarking upon an era of innovative new therapies e.g. CAR-T cell and gene therapies that offer transformational benefits for patients with severe unmet needs. However, their potentially curative benefits mean they can be cost-effective at very high per-patient prices and their affordability is a key payer challenge. This research aims to contextualise their affordability by comparing their budget impact to potential budget savings anticipated/experienced through the introduction of biosimilars, using the UK as a case study.

METHODS

List prices of the two currently licensed CAR-T cell therapies: tisagenlecleucel and axicabtagene ciloleucel were sourced from the relevant NICE guidance documents. The NHS England website was also screened to identify information on savings experienced through the use of biosimilar therapies on 07/06/2019.

RESULTS

In 2017, the UK NHS saved £200 million from the introduction and uptake of three biosimilar classes alone: infliximab, rituximab, and etanercept. In Autumn 2018, five Humira® biosimilars were launched, with expected savings of £300 million by 2021. Up to 200 patients a year are anticipated to be eligible for either tisagenlecleucel and axicabtagene ciloleucel in their currently licensed indications, with their list prices at £300,000 and £282,000 per patient, respectively. Cumulatively, the budget impact of treating all eligible patients with a CAR-T cell therapy comes up to £116 million/year.

CONCLUSIONS

The anticipated budget impact for currently available CAR-T cell therapies in their licensed indications (even based on their list prices and assuming no overlap of their indications, i.e. this is likely to represent a substantial overestimation of their net budget impact) is significantly outweighed by the potential budgetary savings that can be realized through utilisation of biosimilars. Affordability of transformational new therapy classes may be achievable by focusing on initiatives to encourage savings through biosimilars.