McKINNEY, Texas--(BUSINESS WIRE)--Soleo Health, an innovative national provider of complex specialty pharmacy and infusion services, announced today it provided real-world data to Mitsubishi Tanabe Pharma America, Inc. (MTPA) relating to the use of RADICAVA® (edaravone) in amyotrophic lateral sclerosis (ALS) patients, through a collaborative data services agreement.
Soleo Health provided home infusion services for patients receiving RADICAVA intravenously since the medicine became available in the U.S. in August 2017 for the treatment of ALS.
Soleo Health utilized its SoleMetrics® proprietary clinical outcomes program to collect data over time to gather intelligent outcomes throughout the patients’ journeys while they were under the care of Soleo Health clinicians. SoleMetrics has the distinct ability to collect disease-specific, drug-specific and de-identified patient-specific data for patients under its clinical care, providing real-world data for prescribers, manufacturers, payors and health systems.
MTPA selected Soleo Health to leverage its SoleMetrics program and availability of this exclusive data. To obtain real-world data on the use of RADICAVA, Soleo Health shared previously collected information from 163 patients receiving treatment for at least three months. A retrospective analysis of the database was compiled by MTPA to better understand the average change in physical function, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R) score.
“Our collaboration with MTPA is just one example of the capabilities that SoleMetrics brings to drug manufacturers and the specialty pharmacy industry. The real-world evidence we collect offers distinct insights into the patients’ journeys that we believe can be valuable to all stakeholders with whom we engage, and is truly unique to our organization. We are finding that SoleMetrics is helping to further set Soleo Health apart in the marketplace amongst patients, physicians, providers and manufacturer companies alike. Most importantly, we are providing a critical service that we hope will improve the care we provide every day by applying and sharing the clinical and economic value of our data through SoleMetrics,” explained Drew Walk, Soleo Health’s chief executive officer.
Barbara Prosser, Soleo Health’s vice president, health outcomes and research, added: “Our clinical capabilities are the hallmark of how Soleo Health cares for its patients. The importance of clinical data for patient monitoring allows Soleo Health to establish best practices and deliver positive reporting outcomes. SoleMetrics affords us the ability to provide optimal care consistently while helping to improve the quality of life for the patients entrusted in our care.”
About Soleo Health
McKinney, Texas-based Soleo Health is an innovative national provider of complex specialty pharmacy and infusion services, administered in the home or at alternate sites of care. Soleo Health’s interdisciplinary team, comprised of experienced clinical pharmacists and registered nurses, utilizes a consistent patient management process, which leads to quantifiable clinical and economic value while improving patients’ experience.
Soleo Health operates 20 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states, and is accredited by The Joint Commission. For more information, visit www.soleohealth.com or connect with Soleo Health on Facebook, Twitter and LinkedIn.
About RADICAVA® (edaravone)
The U.S. Food and Drug Administration approved RADICAVA® (edaravone) on May 5, 2017, as a treatment for amyotrophic lateral sclerosis (ALS).1 In a pivotal trial, people given RADICAVA experienced a 33 percent slower rate of decline in the loss of physical function, compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in people with ALS.2,3
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.
IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:
- have asthma.
- are allergic to other medicines.
- are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of RADICAVA?
- RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
- Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
- RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
- Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
- Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.
The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com.
RADICAVA is a registered trademark of Mitsubishi Tanabe Pharma America, Inc.
1 |
RADICAVA® U.S. Prescribing Information. August 2018. |
|
2 |
Simon, N. G., Turner, M. R., Vucic, S., Al-Chalabi, A., Shefner, J., Lomen-Hoerth, C., & Kiernan, M. C. (2014). Quantifying Disease Progression in Amyotrophic Lateral Sclerosis. Annals of Neurology, 76(5), 643-657. http://dx.doi.org/10.1002/ana.24273. |
|
3 |
The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group (2017). Safety and efficacy of edaravone in well-defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurology. 16(7), 505-512. |
