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New Data Highlights the Value of SPRAVATO(TM) (esketamine) CIII Nasal Spray, the First New Antidepressant in Decades that Works Differently for Adults with Treatment-Resistant Depression (TRD)[1]

NEW ORLEANS, May 21, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson presented a new cost-efficiency analysis at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting (ISPOR 2019) that illustrates the value of SPRAVATO™ (esketamine) CIII nasal spray for treatment-resistant depression (TRD), for patients, U.S. payers, and society. The analysis showed that for people living with TRD, which is defined as having cycled through two or more oral antidepressant treatments in the same depressive episode without relief, SPRAVATO™ in conjunction with an oral antidepressant is a cost-efficient alternative to an oral antidepressant plus placebo.

Click to Tweet: #BREAKING: New cost-efficiency data presented at #ISPOR2019 highlights the value of SPRAVATO™ (esketamine) CIII nasal spray for patients, payers, and society. po.st/rdP8W5 See full PI including BOXED WARNINGS: po.st/JwU9cW 

TRD is a debilitating disease which has been reported in recent research to have an additional annual societal cost of $29 billion to $48 billion on top of the costs of major depressive disorder (MDD) in the U.S.2 "Given the profound emotional, functional, and economic burden of treatment-resistant depression, it was extremely important to comprehensively assess the economic value newly-approved SPRAVATO™ can bring to patients, payers, and society," said John Sheehan, Ph.D., M.B.A., R.Ph., Director, Real-World Value and Evidence at Janssen Scientific Affairs, LLC and co-author of the economic analysis. "We found that, because it can help more patients have a significant reduction in their depressive symptoms compared to an oral antidepressant plus placebo, SPRAVATO™ is a meaningful clinical and economic investment. People who no longer experience ongoing depressive symptoms pay less to manage their disease, reduce the cost to the overall healthcare system, and are able to get back to their lives."

The analysis utilized a cost-per-remitter model, consistent with parameters recommended by the Agency of Healthcare Research and Quality (AHRQ), to evaluate the costs associated with achieving and remaining in remission from TRD. Based on response, remission, and relapse rates from Phase 3 clinical trials, managing TRD with SPRAVATO™ in conjunction with an oral antidepressant was predicted to cost at least $20,000 less per patient in those achieving remission than patients receiving an oral antidepressant plus placebo. The goal of treatment for this recurrent disease is achieving and maintaining remission (defined as minimal or no depressive symptoms), as it improves functioning, reduces suicide risk, and leads to greater clinical stability.3 The cost savings per remitter increased by approximately threefold when also considering the loss of productivity. Similar cost-efficiency findings were seen across different types of payers in the U.S., including employer-sponsored insurance plans, Medicaid, the U.S. Department of Veterans Affairs (VA), and Integrated Delivery Networks (IDN).

With the approval of SPRAVATO™ comes a new way of treating adults with TRD that is unlike other treatment options in psychiatry. To ensure patients can access this important medicine, Janssen is working quickly to educate healthcare settings on the unique administration requirements. Payers have accelerated access reviews, and a growing number of insurance plans have started formally covering SPRAVATO™. It is expected that treatment with SPRAVATO™ will be broadly covered by insurance providers. 

Janssen also offers a comprehensive support program that helps patients get started on SPRAVATO™ and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible. Learn more at www.spravato.com/patient-support.

About the Study
Cost-Per-Remitter of Esketamine Nasal Spray Versus Standard of Care for Treatment-Resistant Depression (ISPOR 2019 Poster Number: PMH14)

To help determine the economic value of SPRAVATO™ plus an oral antidepressant compared to an oral antidepressant alone, a cost-per-remitter model analyzed:

  • SPRAVATO™ and oral antidepressant treatment outcomes (e.g., remission, response, and relapse rates) over a one-year period from two Phase 3 clinical trials;
  • Direct costs of SPRAVATO™ devices and administration; and
  • Indirect costs of lost productivity based on the National Health and Wellness Survey.

Separate analyses were conducted from the perspective of U.S. payers, including employer-sponsored insurance plans, Medicaid, the VA, and IDNs. Sensitivity analyses were also conducted to consider alternative inputs and parameter variations.

Analysis limitations include that SPRAVATO™ clinical trials included multinational populations, potential differences in adherence and persistence to treatment in controlled clinical versus real-world settings, an assumption that all patients follow a similar treatment path after relapse, and costs do not reflect commercial arrangements with payers or different rates of re-engagement in the labor force.  

About Treatment-Resistant Depression (TRD)
TRD is a devastating and highly debilitating disease that places an ongoing emotional, functional, and economic burden on the individual, their loved ones, and society.2 Approximately one-third of adults in the U.S. with major depressive disorder (MDD) may suffer from TRD, defined as MDD that has not responded adequately to at least two different antidepressants of adequate dose and duration in the current episode.3,5

ABOUT SPRAVATO™
The U.S. FDA granted Breakthrough Therapy designation for SPRAVATO™ for treatment-resistant depression. Janssen is also investigating the medicine for a second indication, major depressive disorder with imminent risk for suicide.4 Janssen is currently conducting Phase 3 clinical studies for this second indication.

IMPORTANT SAFETY INFORMATION5

WHAT IS SPRAVATO™?
SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.

SPRAVATO™ is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO™ is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO™ is safe and effective in children.

What is the most important information I should know about SPRAVATO?

SPRAVATO can cause serious side effects, including:

  • Sedation and dissociation. SPRAVATO™ may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
    • Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
    • Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO™. Your healthcare provider will decide when you are ready to leave the healthcare setting.
  • Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO™ treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO™.
    • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO™ is only available through a restricted program called the SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO™ can only be administered at healthcare settings certified in the SPRAVATO™ REMS Program and to patients enrolled in the program.
  • Increased risk of suicidal thoughts or actions. SPRAVATO™ may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions?

    • Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
    • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
  • Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: 
    • attempts to commit suicide
    • worsening depression
    • thoughts about suicide or dying
    • other unusual changes in behavior or mood

SPRAVATO is not for use in children.

Do not take SPRAVATO if you:

  • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
  • have an abnormal connection between your veins and arteries (arteriovenous malformation)
  • have a history of bleeding in the brain
  • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO™.

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO™.

Before you take SPRAVATO, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart or brain problems, including:
    • high blood pressure (hypertension)
    • slow or fast heartbeats that cause shortness of breath, chest pain, light headedness, or fainting
    • history of heart attack
    • history of stroke
    • heart valve disease or heart failure
    • history of brain injury or any condition where there is increased pressure in the brain
  • have liver problems.
  • have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true).
  • are pregnant or plan to become pregnant. SPRAVATO™ may harm your baby. You should not take SPRAVATO™ if you are pregnant.
    • Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO™.
    • If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO™.
    • There is a pregnancy registry for women who are exposed to SPRAVATO™ during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO™ and their baby. If you become pregnant during treatment with SPRAVATO™, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
  • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO™.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO™ with certain medicine may cause side effects. Especially tell your healthcare provider if you take Central Nervous System (CNS) depressants, psychostimulants, or Monoamine oxidase inhibitors (MAOIs) medicines.

How will I take SPRAVATO?

  • You will take SPRAVATO™ nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO™ nasal spray device.
  • Your healthcare provider will tell you how much SPRAVATO™ you will take and when you will take it.
  • Follow your SPRAVATO™ treatment schedule exactly as your healthcare provider tells you to.
  • During and after each use of the SPRAVATO™ nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  • You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO™.
  • If you miss a SPRAVATO™ treatment, your healthcare provider may change your dose and treatment schedule.
  • Some people taking SPRAVATO™ get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO™ and not drink liquids at least 30 minutes before taking SPRAVATO™.
  • If you take a nasal corticosteroid or nasal decongestant medicine, take these medicines at least 1 hour before taking SPRAVATO™. 

What should I avoid while taking SPRAVATO?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO™. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO?" 

What are the possible side effects of SPRAVATO?
SPRAVATO may cause serious side effects including:

  • See "What is the most important information I should know about SPRAVATO?"
  • Increased blood pressure. SPRAVATO™ can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO™ and for at least 2 hours after you take SPRAVATO™. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO™.
  • Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
  • Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.

The most common side effects of SPRAVATO when used along with an antidepressant taken by mouth include: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.

If these common side effects occur, they usually happen right after taking SPRAVATO™ and go away the same day.

These are not all the possible side effects of SPRAVATO™.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

Please see full Prescribing Information including Boxed WARNINGS, and Medication Guide for SPRAVATO™ and discuss any questions you may have with your healthcare provider.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Pharmaceuticals, Inc. and Janssen Scientific Affairs, LLC are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of SPRAVATO™ (esketamine) CIII nasal spray. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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1 Duman RS. F1000Research. 2018;7:F1000.
2 Mrazek D et al. Psychiatr Serv. 2014 Aug 1;65(8):977-987.
3 Rush AJ et al. Am J Psychiatry. 2006;163:1905-1917.
4 Johnson & Johnson Press Release. Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide. Available at: https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide. Accessed May 20, 2019.
5 SPRAVATO™ [Prescribing Information]. Titusville, N.J., Janssen Pharmaceuticals, Inc.

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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson