NICE’s new methods: putting innovation first, but at what cost?

Deciding when a new drug merits funding and when it does not—often to the displeasure of clinicians and patients alike—is an unenviable task. In England and Wales, it falls largely on the National Institute for Health and Care Excellence (NICE), whose recommendations shape the NHS’s adoption of new technologies.

Traditionally, NICE has based its binding recommendations primarily, though not exclusively, on cost effectiveness: the amount of health a technology generates per pound spent compared with current practice. Under this approach, technologies that have not reliably demonstrated their clinical effectiveness will generally be rejected—for example, amantadine (Lysovir/Symmetrel) for the treatment of influenza.¹⁴ Also rejected are technologies considered insufficiently cost effective, a point generally defined by NICE as £20 000-£30 000 per quality adjusted life year (QALY).1 In 2016, NICE rejected the cystic fibrosis drug lumacaftor-ivacaftor (Orkambi) on the grounds that its likely clinical benefits did not justify its cost of £200 000-£350 000 per QALY.2

This approach to priority setting is not without its critics.3 But it is generally accepted as sound because it gives due weight to the interests of all patients—both those who will benefit from access to a new technology and those whose health will be adversely affected by the reallocation of resources from which they were benefiting.4 In recent years, however, NICE’s emphasis on cost effectiveness has come into conflict with the drive to secure access to innovative health technologies, the benefits of which are often both costly and uncertain.5 NICE’s rejection of lumacaftor-ivacaftor, for example, was later disregarded by the NHS, which, in the …