Treatment-resistant depression (TDR), a subset of Major Depressive Disorder (MDD), is characterized by a lack of response to two first-line therapeutic options even with proper adherence to the medication. Depression affects millions of people worldwide, and the traditional method of therapy typically involves oral antidepressants such as serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs). Nearly 30% of patients diagnosed with MDD fall into the category of TDR, with only a few viable treatments proven to relieve symptoms. One such therapy is Spravato, an intranasal esketamine spray administered alongside an oral antidepressant.
Esketamine is a derivative of ketamine, which is often used as an anesthetic. Although chemically related to ketamine, esketamine is different in composition as the S-enantiomer of racemic ketamine. The intranasal administration of Spravato allows for a faster antidepressant effect compared to traditional oral routes, which often require weeks or months to show improvements. Studies have shown an increased remission rate for esketamine; 72% within the first two months and nearly 88% within the first eight months, compared to oral therapies. Trials in 24 countries have demonstrated effective results, proving significantly higher remission rates with Spravato in conjunction with oral antidepressants.
Spravato is classified as a Schedule III drug and is only available through a restricted distribution program known as SPRAVATO REMS (Risk Evaluation and Mitigation Strategy). REMS ensures that the benefits of therapies outweigh the risks, managing potential adverse outcomes such as sedation or dissociation from abuse or misuse. Due to these restrictions, Spravato must be administered under the supervision of a healthcare provider at a certified Spravato Treatment Center, rather than self-administered at home.
Affordability is addressed through the SPRAVATO withMe Savings Program, which allows patients to pay as little as $10 per treatment, with an annual benefit cap of $8,150 applicable to co-pays, deductibles, and co-insurance. While this program doesn’t cover treatment observation costs, the SPRAVATO withME Observation Rebate Program provides additional support. Patients can explore $0 Spravato sessions, with a maximum benefit of $500 per year, by meeting with a Spravato withMe Care Navigator and being monitored for two hours post-administration. Spravato may also be covered through commercial insurance and some government programs. For those without insurance, the Johnson & Johnson Patient Assistance Foundation (JJPAF) offers free prescription medication for eligible patients.
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