Game changer Spravato first novel antidepressant in 30 years

Market launch press conference on Nov. 17, benefits to treatment-resistant depression patients

Inconvenient in-hospital administration and HCP monitoring, and financially burdening high price and non-reimbursement

Spravato Nasal Spray by Janssen Korea

For the first time in three decades, a novel antidepressant has been released in South Korea.

 

Although the drug would be able to provide new treatment opportunity to patients with severe depression through a new mechanism of action, the patients may face high barrier in convenience and pricing.

 

On Nov.

 

17, Janssen Korea convened a press conference for the launch of Spravato Nasal Spray (esketamine hydrochloride).

 

Spravato is used to treat patients with treatment-resistant depression (TRD), who do not appropriately respond on at least two or more antidepressants.

 

Not only is it the first new antidepressant to be launched in 30 years, but also it is a first option for TRD.

 

Spravato’s main substance esketamine controls the activity of the N-methyl-D-aspartate (NMDA) receptor—an ionotropic glutamate receptor—to improve synaptic transmission and treat the symptoms of depression.

 

Janssen has conducted about 28 studies and clinical trials to test the drug’s efficacy in patients with severe depression, whom do not respond to at least two or more antidepressants, and won the U.S.

 

Food and Drug Administration (FDA) approval in March last year.

 

The South Korean health authority green lit the drug in last June.

 

The biggest benefit of Spravato is a rapid reduction of depression symptoms.

 

While the effect of existing antidepressant options start demonstrating a few weeks after the administration, Spravato’s effect is apparent from the first day of administration.

 

President Lee Sang-yeol (Department of Psychiatry at Wonkwang University School of Medicine) of Korean College of Neuropsychopharmacology (KCNP) explained, “Since 2008, the demand for a novel mechanism of action to display treatment response or remission in a few hours or days was getting bigger.

 

And many of the specialists were most impressed with Spravato’s rapid reduction of symptoms.

 

In fact, many patients repeatedly commit suicide due to depression.

 

I think Spravato would be a big help for these patients.”

President Lee Sang-yeol of Korean College of Neuropsychopharmacology

Spravato is expected to contribute in raising the complete remission rate and lessening the residual symptoms with its new mechanism of action.

 

In a clinical trial, Spravato showed 52 percent of patients were in remission, and the Spravato group was 51 percent less likely to relapse compared to the reference group only using an oral drug.

 

Regardless of the significant benefit, the realistic barrier still exists.

 

The administration can be done only in hospital to prevent adverse reaction like dissociation.

 

Also it requires a healthcare provider’s monitoring for two hours after the administration.

 

The twice-weekly administration and monitoring at hospital would make patients rather inconvenient.

 

Even President Lee Sang-yeol agreed, “It would be difficult to use Spravato in clinics, as it requires the two-hour monitoring.

 

The drug would be used more frequently in tertiary hospitals with plenty of healthcare providers and emergency patients.” Also its non-reimbursed cost has to be entirely covered by patients.

 

Janssen Korea has not disclosed the official supply price in Korea, but the monthly cost can be estimated based on cases in foreign countries.

 

At a Spravato clinic in Canada, four doses in two weeks would cost approximately CAD 3,000 (approximately KRW 3.57 million).

 

Considering other oral antidepressants cost around a few hundred won and injection around 1,600 won, the patients would be heavily burdened to cover the cost of the nasal spray drug.

 

Although Janssen Korea is seeking for healthcare reimbursement on Spravato, the company is likely to face challenges.

 

It is highly questionable that the current reimbursement system in South Korea would appropriately recognize the drug’s value as other reference drugs’ prices are extremely low.

 

President Lee Sang-yeol stressed the high demand on the Spravato coverage and noted, “New drugs for other diseases can receive coverage regardless of the high price, but a novel psychopharmaceutical struggles to get coverage as they are compared to exceptionally low-priced drugs.

 

As there are tens of thousands of patients with depression in Korea, I desperately hope Spravato would get listed for reimbursement.”