Proposed regulations on drug price disclosures in advertisements.
This is the latest proposal in a series of newly proposed congressional bills and FDA regulations that require pharmaceutical companies to disclose their prices in drug advertising, says Edward J. Buthusiem, managing director, Berkeley Research Group, a global consulting firm.
“The new regulation would require pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) of a drug or biologic for a typical month of therapy in televised direct-to-consumer advertisements,” says Jeremy Schafer, PharmD, MBA, senior vice president of director-payer access solutions at Precision for Value, a pharmaceutical consulting firm. “The regulation would impact any drugs or biologics eligible for payment under Medicare or Medicaid—essentially nearly all pharmaceuticals and biologics—with the exception of those with a WAC below $35 per month.”
“HHS Secretary Alex Azar has stated that the intended goal of the new regulation is to reduce the price to consumers of prescription drugs and biologics,” Schafer says. “Increasing price transparency by educating consumers on the cost of drugs so they can make informed decisions is part of the justification for this rule.”
Ahead of this regulation, Buthusiem says pharmacists should be prepared to articulate answers to pricing questions and fill in gaps that advertisements miss. “In a typical in-person interaction, a pharmacist will be the first point of contact and needs to have a deep understanding of the various details, regulations, and plans to provide accurate information to patients,” he says.
Along these lines, Schafer says pharmacists should be aware that patients may ask them about the cost of a drug they saw on TV and what, if any, portion of that the patient may be responsible for. Pharmacists may also be asked if there are less costly alternatives, so pharmacists should be aware of alternatives, whether the therapy and its alternatives may be appropriate, and what the cost may be.
The comment period ended in December, so the rule, as written or modified, could go into effect at any time this year.
Karen Appold is a medical writer in Lehigh Valley, PA.