“Recent legislative proposals, including US Senate Bill S.2543, US House of Representatives Bill HR 3, and various Trump Administration proposals and plans, have advanced some form of international reference pricing (IRP) to lower drug prices. As its name suggests, IRP seeks to benchmark US drug prices to prices of similar or comparable drugs in other counties. Some proposals would have the federal government develop a reference price index based on prices paid by a select group of high-income countries, and then restrict prices to a narrow range of the index.
[..] American drug pricing policy rewards large capital investments and risks the biomedical industry undertakes in bringing innovations to the market by allowing companies to charge temporary monopoly prices. Because most Americans have insurance and face a fraction of the monopoly price, demand is greater than it would otherwise be in a market without insurance. Consequently, insurers pay for drugs at monopoly prices, a practice that fuels industry profits and raises premiums to employers and out-of-pocket costs to patients. Health plans, especially public ones, would want patients who might benefit from a drug to receive it, subject to budget constraints. Therefore, in principle, they should aggressively negotiate a lower price that still maintains appropriate incentives for manufacturers to innovate. However, the private health insurance market in the US is heavily regulated in ways that limit the full power of such negotiations, such as through imposition of requirements that all drugs in a protected class be covered, even though not all drugs within a class show similar value. Public health insurers, like Medicare, are sometimes expressly prohibited from negotiating prices, and, in the Part D outpatient drug benefit, Medicare has ceded this role to private managed care organizations.
[..] most public-funded health care systems worldwide engage in rigorous negotiations, often supported by transparent value assessment processes. Their prices, which the US plans to reference, are a product of these processes. The US’s fundamental challenge has been the lack of political will to formally address drug pricing using any form of national value assessment that explicitly considers drugs’ relative costs and benefits, and informs prices accordingly. Cost-effectiveness analysis, one of the methodological tools of value assessments, is effectively prohibited for major federal payers and evaluators under the Affordable Care Act. The US Congress does not allow the Centers for Medicare and Medicaid Services (CMS) to consider explicitly any value assessment inclusive of costs and prices to determine coverage for drugs or services.
The IRP proposals are misguided as they do not address these central limitations of US statutes – the barriers to systematic use of value assessment and negotiation in drug pricing. They are also “lazy” as they rely on the results from international value assessment processes rather than adopting evaluation practices in the US to align prices with value.
[..] It is also naïve to think that observed low prices in other countries would remain low (or even transparent) once the US implements IRP. This is especially true under the most-favored-nations model, which targets only one country’s price for any particular drug as the reference (i.e., the OECD country with the lowest price for that drug — as long as the country has a GDP per capita of at least 60 percent of the US level). [..] Unfettered IRP will lead to increases in market prices for the countries referenced, which may align with the goal of having other countries pay a bigger share of pharmaceutical development expenditures. More importantly, it should be expected that the referenced countries will resist this price creep in their own country by hiding their negotiated prices, while letting list prices equate to those of US prices. The real losers of such an outcome would be lower-income countries that do not have the resources and expertise to implement their own value assessment practices and must rely on negotiated prices from other counties. We believe it is highly dubious that IRP, in the long-run, would reduce US drug prices and, more importantly, reduce patient out-of-pocket burden.
[..] The latest bills and proposals that promote IRP fail to learn from the experience of public purchasers, such as the Veterans Administration (VA) and Medicaid, that often achieve lower prices through negotiation and best-price rules. For example, the federal supply schedule drug prices, or the prices available to the “Big Four” (VA, Department of Defense, Public Health Service, and Coast Guard), often resemble prices in European counties. The Veterans Administration contracting mechanism often beats Big Four prices, although it comes with access restrictions.”
Full post, Basu A, Neumann PJ and Sullivan S. Health Affairs Blog, 2020.12.2