Independent US institute to investigate drug pricing

The debate over the cost of new medicinal products will soon have a new voice, in the form of a non-profit group that has just been granted more than $5 million to investigate the issue.

The Institute for Clinical and Economic Review (ICER) says it intends to produce reports on new drugs that reach the market "that have the potential to significantly change patient care and health system budgets."

The pledge will put many new cancer drugs into scope, many with annual costs of $100,000 or more, along with new therapies for hepatitis C virus (HCV), Novartis' just-approved heart failure therapy Entresto (sacubitril/valsartan) and new cholesterol-lowering antibodies from Sanofi/Regeneron and Amgen.

ICER's approach is analogous to that used by healthy technology assessment (HTA) authorities such as the UK's National Institute of Health and Care Excellence (NICE), with the organisation launching its review process after a new drug is approved by the US Food and Drug Administration (FDA).

The organisation clearly has no executive power but says its independent reviews will be used by payers and policymakers to gauge whether the price of new medicines is fair.

One payer - pharmacy benefits manager Express Scripts - has already voiced its support for the programme, which is backed by the Laura and John Arnold Foundation.

The initiative "will make a huge difference by providing what is sorely needed: an independent, trusted source of information about new drugs," commented the PBM's chief executive Steve Miller.

Express Scripts has been a vocal critic of the pricing of some new drugs - including HCV therapies from Gilead Sciences and AbbVie - and has been a key player in the recent trend towards PBMs offering exclusive positions on formularies in return for discounts.

That manoeuvre has come into criticism from some doctors, who argue that it interferes with clinical choice. However, Express Scripts maintains something must be done to curb pricing given that last year more than half a million Americans had medication costs in excess of $50,000 a year, a rise of 63% on 2013.

"I believe many payers and policy makers will find this information of critical importance as they evaluate the new drugs," continued Miller. "We look forward to using it to help us improve the ability of patients to get access to new, innovative drugs at a price the system can afford."

ICER says it will release its first two reports in September and publish between 15 and 20 in the first two years of the programme. The first reports will cover Entresto and the cholesterol antibodies - Sanofi/Regeneron's Praluent (alirocumab) and Amgen's Repatha (evolocumab).

Repatha has just been approved in Europe, its first market, but neither of the antibodies is yet available in the US.

"With drug prices soaring to new highs amid questions about their true value to patients, insurers, providers, patients, policy makers - and manufacturers themselves - need a trustworthy, independent source for evaluating the value of new drugs and a transparent, objective basis for price negotiations and coverage decisions," said ICER in a statement.