The American College of Physicians (ACP) issued a policy statement to help contain the cost of prescription drugs. The position paper was published online March 28 in the Annals of Internal Medicine.
Among the ACP’s recommendations is a call for transparency in the pricing, cost and comparative value of all pharmaceutical products, including disclosure of research and development costs that contribute to a given drug’s pricing.
The organization also wants to see more approaches developed to address the escalating costs of prescription drugs, such as giving Medicare and other publicly funded programs greater flexibility to negotiate volume discounts on prescription drug prices and pursue bulk-purchasing agreements. Another approach the ACP suggested would be the development of a process to permit the reimportation of certain drugs manufactured here in this country, as long as the safety of the reimported drug’s source can be ascertained. A third suggested approach would be to create policies or programs designed to increase competition for brand-name and generic “sole-source” drugs.
The ACP opposes extending market or data exclusivity periods beyond current exclusivities granted to most types of prescription drugs. At the same time, the organization supports “robust” oversight and enforcement of restrictions on practices drug manufacturers use to prevent or delay competition, such as product-hopping (i.e., making insignificant tweaks to a product’s formulation just before a generic version is set to enter the market), evergreening (i.e., seeking extra patents on variations of the original drug, such as new forms of release, new dosages and new combinations) and pay-for-delay (where manufacturers of branded drugs offer patent settlements that pay generic companies not to bring their products to market).
The ACP also supports exploring new approaches that would encourage value-based decision making—options such as value frameworks, bundled payments and indication-specific pricing, as well as evidence-based benefit designs that include “explicit consideration of the pricing, cost, value and comparative effectiveness of prescription medications included in a health plan’s benefit package.”
Further, the organization said payers that use tiered or restrictive formularies should ensure that enrollees’ cost sharing for specialty drugs is not so high that it creates a substantial barrier to accessing needed drugs.
A final recommendation by the ACP is for biosimilar drug policies that not only help patients distinguish originator products from their biosimilar counterparts, but also ensure the safe use of biosimilar products.