Despite unconventional support from President Donald Trump, Johnson & Johnson’s Spravato didn’t win broad backing at the U.S. Department of Veterans Affairs. Agency clinicians instead approved the depression spray’s use on a limited basis, requiring patients to try other options first.
A team of VA clinicians last week voted against putting the drug on the VA’s formulary, an agency spokeswoman said. Instead, the VA will require a process similar to prior authorizations for patients seeking treatment with the med. Aside from that limitation, the drug also carries strict administration requirements, such as a stipulation that doctors must monitor patients for two hours after dosing.
Spravato is an altered form of ketamine, which is used legally in anesthesia and illegally as a street drug. The med, also known as esketamine, won FDA approval earlier this year in patients who have tried and failed on at least two other depression medications.
“These evidence-based processes will ensure the medication is prioritized for use in veterans who have not previously responded to adequate trials of other available treatments for major depression,” a VA spokeswoman told FiercePharma.
A J&J representative said the company is "committed to working with public and private payers, including the U.S. Department of Veteran Affairs, to ensure access to Spravato for patients who need it."
"We firmly believe that people suffering from treatment-resistant depression, including our nation’s veterans, deserve the opportunity to benefit from this breakthrough medicine," she added.
The run-up to the VA vote generated considerable media attention, particularly after Trump praised the drug in a meeting this month with Veterans Affairs Secretary Robert Wilkie. Trump told Wilkie he believed J&J would be “generous” on pricing, and that the drug could lead to an “incredible” reduction in veteran suicides, Bloomberg reported. He also offered to negotiate the drug’s price.
Adding to the scrutiny was a recent report by the Guardian and the Center for Public Integrity that the VA hurried its review and potential implementation of the med based on interest from the president.
Reacting in a statement to those headlines, House Committee on Veterans' Affairs chairman Mark Takano said he's "incredibly alarmed by reporting today that suggests Spravato, a controversial new drug, is being rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits."
The drug’s price has also generated criticism. Spravato costs $4,720 to $6,785 before discounts for the first month, and up to $3,450 for additional months. Last week, cost watchdog ICER called the drug overpriced, saying the company would have to slash its price by 25% to 52% to make it cost-effective, while a J&J spokeswoman said the analysis “underestimates the proven short- and long-term benefits” of the drug.
Spravato won approval in March and is one of several new or upcoming launches J&J has touted as a potential blockbuster.