Nevada passed a law last week instituting new reporting requirements for drug makers that manufacture insulin. Other states like New York and Maryland have also established requirements that pharmaceutical companies report price increases on certain drugs.
The law, S.B. 539, mandates that the Nevada Dept. of Health & Human Services make a list of prescription drugs that it deems “essential” to treat diabetes, along with the wholesale acquisition cost of each drug on the list. The department must also make a 2nd list, detailing the subset of drugs whose wholesale acquisition cost has increased as much or more than the medical care component of the consumer price index during the preceding calendar year or twice that during the preceding 2 years.
Manufacturers whose drugs are on the 1st list have to report to the department every year about things like the costs of procuring the drug and the profit earned by the manufacturer from the drug. The company must also disclose the total amount of financial assistance they provide through a patient assistance program, according to the FDA Law Blog.
Companies with drugs on the 2nd list have to report each factor that contributed to the spike in wholesale acquisition cost, as well as the percent increase attributable to each factor.
The law also has implications for sales representatives, pharmacy benefit managers and nonprofit organizations.
Manufacturers, PBMS or nonprofits that don’t meet the required reporting standards could be fined as much as $5,000 per day, the law states, and pharma sales reps that don’t submit timely reports could be fined as much as $500 per day.
The new Nevada law also mandates that the department create a report based on the information it receives and make it available to the public.
Nevada joins a growing number of states looking to reel in drug prices and it doesn’t appear that it will be the last – 30 states are combing through more than 150 bills that involve efforts to address drug price hikes.