ICER: Going Global

The US-based not-for-profit Institute for Clinical Effectiveness Review (ICER) has been making waves in the US in recent years by publishing value assessments of new drugs. Their views may only be advisory, but nevertheless payers are reportedly keen to use ICER reports as a further input into decisions on what to cover and how much to pay. Others are less so; the most recent pushback coming from the Pioneer Institute who have tabled some big questions that policy makers should be asking about ICERs work.

ICER has more than a passing resemblance to other agencies who also look at the value of drugs, in particular the National Institute for Health and Care Excellence (NICE) in the UK. Both agencies use cost per Quality Adjusted Life Years as one – but a key one – of the factors considered in coming to their view on a drug.

Now ICER has set up a working group to bring together the expertise of NICE – and other key health technology assessment (HTA) agencies – to develop new methods to guide value-based pricing of potential cures; a project called Valuing a Cure.

That these agencies are working together isn’t new – founder of ICER, Dr. Steven Pearson was a visiting fellow at NICE in the past and many staffers and others who work closely with HTA agencies routinely collaborate in the international work of ISPOR and HTAi - but the public announcement is a clear signal of the internationalization and desire for harmonization of HTA. The Commonwealth Fund and the National Institute for Care Management are funding the work.

That the collaborative is looking at value-based pricing of cures is also a signal that each agency is mindful of the particular issues that these bring. It’s hard to know for sure, for example, if a new treatment will be a cure for all potential patients at launch. It’s not just assessing value, but also managing affordability when cures are expensive – not necessarily in cost per QALY terms, they can be cheap in that sense – but may have a major budget impact.

ICER has said that the collaborative has the goal of ensuring that methods are tailored to cures. For ICER, the work will inform their 2019 update to their value assessment framework. Not said, but likely is that NICE will draw on the work as part of their promised scoping of a review of methods for their Technology Appraisal Programme in 2019/20, as part of the Voluntary Scheme for Branded Medicines Pricing and Access. For the HTA agencies, the hope is for consensus; that may be somewhat optimistic.

In what is arguably a trademark ICER approach, there is an open consultation on the work. ICER is asking for thoughts on some key questions, including:

• How should value-based prices for potential cures reflect substantial uncertainty regarding clinical safety and effectiveness due to limitations in study design, outcome measures, and the size and duration of clinical trials?
  • How should value-based prices for potential cures reflect uncertainty regarding inclusion of additional elements of value that may be important for potential cures, but which are not part of standard cost-effectiveness methods?
  • How should value-based prices for potential cures reflect extreme magnitudes of lifetime health gains and cost offsets that are far beyond those generated by traditional therapies?

The deadline for comments is February 20, 2019, so get those comments in!

Leela Barham is a freelance health economist and policy expert. She has published in peer-reviewed journals and presented at national and international conferences. She has provided advice to the Department of Health and Social Care on policy on pricing of branded medicines to inform the negotiation of a successor to the UK’s Pharmaceutical Price Regulation Scheme (PPRS) as well as worked with patient groups, the NHS, pharmaceutical companies and many others internationally on the economics of health care and pharmaceuticals.