Quick Answer: Who Is Eligible for Spravato Treatment?
Adults dealing with treatment-resistant depression (TRD), who have not responded to at least two antidepressants, may have Spravato eligibility. The medication is not always limited to “severe” depression in patients, but is used when standard treatments fail.
Spravato requires a prescription from a licensed healthcare provider and is administered under supervision.
What Is Spravato and How Does It Work?
Many medications, when dealing with depression, target serotonin and other related neurotransmitters.
However, some patients experience what is called TRD. TRD is a diagnosis when either a patient has become accustomed to their antidepressant and it has lost its efficacy, or when medications fail to manage symptoms in a meaningful way.
What is the Spravato treatment?
Spravato (esketamine) is a prescription nasal spray different from traditional antidepressants. While most target serotonin and other neurotransmitters, Spravato works by targeting the glutamate system, which is often considered the primary excitatory neurotransmitter.
Due to its nasal spray application and targeting different pathways, symptom relief can happen within hours or days.
Often, Spravato is used alongside an oral antidepressant and administered in a clinical setting.
Is Spravato Only for Severe Depression?
Patients curious about their Spravato eligibility may wonder whether they need to have severe depression. This is a misconception.
Spravato’s focus is on treatment resistance, not symptom intensity. While some patients may have severe symptoms, they may not qualify for Spravato due to their antidepressant’s effectiveness.
Meanwhile, some patients with moderate depression may qualify if it turns out they are resistant to traditional antidepressants.
The clinical decision on Spravato depends on a TRD diagnosis and the patient’s eligibility.
Clinical decisions also depend on factors such as:
- History
- Response
- Risk factors
If a healthcare provider believes that any of these factors may not make the patient a good candidate, then they will most likely seek out alternative treatments instead.
What Is Treatment-Resistant Depression (TRD)?
Considering that being eligible for Spravato relies heavily on a TRD diagnosis, patients should clearly understand what TRD is and the treatment-resistant depression criteria.
The standard definition of TRD is a failure to respond to at least two antidepressants.
However, TRD does not have its own dedicated code in the ICD-10 or DSM-5 manual. Instead, clinicians will use the standard codes for Major Depressive Disorder and document treatment history as criteria.
This means that a patient who has tried each medication for an adequate dose (a therapeutic dose) and taken the medication for a sufficient duration (typically 6 to 8 weeks)
Those dealing with TRD suffer from impacts on quality of life that are more severe than those with standard depression. Because their symptoms are harder to treat and manage, the burden will often radiate out to health, work, and family.
Not only that, but TRD can result in a higher degree of impairment when compared to standard depression.
This includes suicidal thoughts and behaviors.
Criteria for Treatment-Resistant Depression
As noted above, the criteria for treatment-resistant depression include a lack of response to at least two other traditional antidepressants.
The criteria include:
Medication History
A patient must have been prescribed and tried at least two traditional antidepressants prior to receiving a TRD diagnosis.
This means the patient followed a proper therapeutic dosage for a sufficient duration (typically 6 to 8 weeks) for each medication they’ve been prescribed.
Lack of Sufficient Improvement
Despite properly following their medication’s recommended protocol, patients who are diagnosed with TRD have found that their symptoms continue to persist despite treatment.
When a clinician sees “minimal improvement”, the patient is still struggling with residual symptoms such as low energy, irritability, or sleep issues. However, this may mean the clinician augments the current prescription with a second medication instead of a drastic switch.
With no response to a medication, a clinician will typically see this as a signal to drastically change the protocol, such as switching antidepressant classes or including Spravato.
Clinical Evaluation
A diagnosis must be confirmed by a healthcare provider, who will determine a patient’s Spravato eligibility based on multiple factors, such as a TRD diagnosis, history, and risk factors.
Clinicians also typically rule out other conditions, such as pseudo-resistance. This occurs when a response was low simply because the dose was too low or the treatment duration was not sufficient.
Functional Impact
The functional impact of the depression, for a TRD diagnosis, must result in ongoing difficulty in daily life. These symptoms are typically severe and strongly inhibit a patient’s quality of life in many areas, such as work, health, family, and leisure.
Official Spravato Eligibility Criteria
Several factors must meet the Spravato treatment-resistant depression eligibility criteria.
Typically, a patient will fulfill the following criteria:
- Major Depressive Disorder (MDD) diagnosis
- TRD criteria met
- Take Spravato alongside an oral antidepressant
- Must be administered in a certified healthcare setting
- Patient must have been screened for contraindications:
- Certain medical conditions
- History of substance misuse (case-dependent)
Do You Have to Try Other Medications First?
Some patients, when researching treatment-resistant depression criteria, have asked, “Do you have to try other medications first?”
Yes, a patient is typically required to try other medications before being prescribed Spravato.
Step-therapy exists to help ensure:
- Safety
- Cost considerations
- Established treatment pathways
Some exceptions may exist in specific clinical situations and are determined by the clinician and patient.
This means a documented treatment history is vital for clinicians and patients, as a person’s history with antidepressant medications and other factors come into play so heavily when determining whether Spravato is a sound medical choice for a patient with TRD.
How Is Spravato Different from Traditional Antidepressants?
How is Spravato different from antidepressants?
Traditional antidepressants and Spravato differ in several major ways.
While traditional antidepressants typically work with neurotransmitters such as serotonin, norepinephrine, and dopamine, Spravato works with glutamate and its receptors. This neurotransmitter is considered the primary excitatory neurotransmitter, with over 90% of the synaptic connections in your brain using glutamate to send signals.
This means faster effectiveness, often seeing results in a matter of hours or days, versus weeks.
Meanwhile, many antidepressants are taken orally and can be personally administered at home. Spravato is a nasal spray, which is administered in a clinical setting due to necessary observations.
Spravato is only used when other medications have been used but are not effective in the treatment of depression symptoms.
How Is Spravato Administered?
How is Spravato administered?
It is given as a nasal spray and is administered in a certified medical facility. Licensed clinicians supervise dosing sessions, including a careful observation period after use due to possible side effects.
The medication is typically administered with the following frequency:
Induction phase: Lasts from weeks 1 to 4. This initial phase means the medication is administered twice per week, resulting in 8 total sessions.
Optimization phase: This lasts from weeks 5-8. The frequency is reduced to once per week, with the goal of testing whether initial progress holds with fewer visits while the brain continues to remodel neural pathways.
Maintenance phase: Week 9 and beyond. During the maintenance phase, a patient’s dosing frequency is typically every one to two weeks, though some stable patients may move to every three or four weeks.
What to Expect During Spravato Treatment
The Spravato treatment experience involves the following:
- The patient is prepared, and their vitals are checked.
- A patient is given a nasal spray device that they administer themselves as the provider watches.
- Once the medication is administered, the patient stays in a comfortable, quiet room for at least two hours.
- Most people feel the effects within 15 minutes. Some patients experience side effects, such as disassociation, sleepiness, or mild changes in light and sound perception.
- After the two hours, the patient receives a final assessment to ensure vitals are normal and side effects are minimal.
- Patients may not drive themselves home after an appointment.
Over time, a patient may see gradual progress as the medication works in conjunction with traditional antidepressants. This makes it extremely important to stay consistent with treatments.
Potential Side Effects and Safety Considerations
Spravato side effects may include:
- Dizziness
- Nausea
- Dissociation
However, most effects are temporary.
Safety Considerations
Under the Spravato REMS protocol, the following conditions must be met:
- Only dispensed and administered in healthcare settings
- A healthcare provider and patient must be officially enrolled in the program
- The medication must be self-administered under the direct observation of a healthcare professional
- Patients must be observed at the clinic for at least 120 minutes before being discharged.
- Every treatment session is documented and reported back to a REMS administrator.
Cost of Spravato and Insurance Considerations
While a patient’s Spravato cost can vary dramatically due to insurance coverage and the specific treatment phase, it is considered expensive.
Per session, it can cost over $1,200, with the induction phase costing upwards of $9,600, if not more.
The medication is typically expensive due to the specialized administration that must take place and the fact that it’s a newer therapy.
Plus, insurance will often require a prior authorization and proof of TRD to cover Spravato treatments.
This makes Spravato’s affordability tough for many patients.
Options to Help Make Spravato More Affordable
Those looking for help with Spravato costs may benefit from alternative payment options. Considering the financial barriers, alternative savings options are significant in the fight against TRD.
Some assistance options include:
Manufacturer programs: Offered by the manufacturers to help offset the costs that patients incur with various brand-name prescriptions.
Insurance support: Some insurance coverage plans will provide adequate coverage of the costs of Spravato.
Nonprofit resources: Financial assistance and aid may be available to help patients afford prescription medications.
For those looking to make the most of patient assistance programs, which provide access to medications at reasonable costs, Prescription Hope may be a powerful benefit.
Prescription Hope simplifies the enrollment process for patient assistance programs, supports access to prescribed medication, and manages renewals.
Please note that all information provided in this article is not a substitute for medical advice, and should be viewed as for informational purposes only.
When to Talk to Your Doctor About Spravato
If multiple antidepressants haven’t worked, you feel that your persistent depression symptoms are affecting your daily life, and you have an interest in alternative treatment options, then Spravato may be a useful medication to explore.
All patients must receive a professional evaluation to determine whether the medication may be right for them.
Important Things Patients Should Keep in Mind
Remember, Spravato is not a first-line treatment. It is only administered once a patient is determined to have TRD and has met other clinical criteria.
Administration of Spravato requires supervision by professional healthcare providers in a clinical setting and commitment from the patient.
Patients must follow their provider’s guidance closely.
Finale Thoughts: Understanding If Spravato Is Right for You
Patients interested in taking Spravato must talk to their healthcare provider and determine whether they meet the Spravato eligibility requirements. This eligibility may depend on treatment history and other factors.
Spravato eligibility requires determining that traditional antidepressants do not manage their symptoms effectively.
Talk to your healthcare provider and ask questions about whether Spravato may be a possible treatment pathway for you.
If accessing newer treatments like Spravato is financially challenging, exploring patient assistance programs may help make these options more accessible.
