Based on information as of 5/5/2017
What is Radicava?
In clinical trials, some people given Radicava showed significantly less decline in 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 patients with ALS.1,2
What will Radicava do for people with ALS? How meaningful of a treatment is it?
Although Radicava is not a cure, it may be an important advance in helping people live with the disease. Because people with ALS experience varying rates of progression, slowing the decline of that loss of function is important. Depending on a person’s level of function when they begin treatment, the impact Radicava demonstrated in clinical trials could translate into potentially helping people preserve function longer.1
What is the recommended dose of Radicava?
Radicava is administered via intravenous infusion. According to the Prescribing Information, Radicava is administered in 28-day cycles by intravenous infusion. It takes 60 minutes to receive each 60 mg dose.1
For the initial cycle, the treatment is infused for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused for 10 days within a 14-day period, followed by a two-week drug-free period.1
What data formed the basis for the FDA approval?
Study MCI186-19 was the pivotal Phase 3 study that evaluated the efficacy and safety of Radicava compared with placebo in 137 people with ALS. In the study, after a 12-week pre-observation period, eligible patients were randomized 1:1 to receive Radicava 60 mg intravenously for 60 minutes or placebo during a six-month double-blind placebo-controlled phase. The primary endpoint for the study was change in the ALSFRS-R score from baseline to six months.1
Were there any issues with safety?
The most common adverse reactions that occurred in more than 10 percent of patients, and were greater than placebo, were bruising (contusion), trouble walking (gait disturbance), headache, inflammation of the skin (eczema) and rash (contact dermatitis).1
- Hypersensitivity reactions have occurred in patients receiving Radicava and can occur after administration.
- Patients should be monitored carefully, since these reactions may occur. If hypersensitivity reactions occur, discontinue Radicava, receive treatment per standard of care, and monitor until symptoms and signs resolve. Notify your physician immediately.
Accessing Radicava Treatment
What company will be manufacturing and distributing Radicava?
Mitsubishi Tanabe Pharma American (‘MT Pharma,’ or MTPA), based in Jersey City, N.J., has been established to commercialize approved pharmaceutical products of Mitsubishi Tanabe Pharma Corporation (based in Osaka, Japan) in the U.S. market.
How can I get Radicava?
Based on current information, it is anticipated Radicava will be available in the U.S. by August 2017; however, MTPA has outlined several steps you can take now to be able to access Radicava when it becomes available:
- Like other FDA-approved medications, Radicava requires a prescription from your health care professional. Talk to him/her to determine if Radicava is an appropriate treatment for you. If it is, they will provide you with a prescription.
- Go to www.Radicava.com to provide your email address, which will enable you to receive updates on availability from MTPA.
- As soon as you receive a prescription, contact Searchlight Support by calling 844-SRCHLGT (844-772-4548). Searchlight Support can assist you with personal case management, reimbursement support, and once you start treatment, 24/7 product support. Some people with ALS who receive prescriptions for Radicava may be eligible to receive additional assistance from MTPA. MTPA will be able to discuss what assistance is available.
Why is Radicava not available immediately after FDA approval?
Although MTPA is taking multiple steps to accelerate importing Radicava to the U.S., there are certain portions of the complex supply chain that could not be done prior to approval. For example, FDA approval of the manufacturing facility and certain required customs clearances.
MTPA is working to import the medicine into the U.S. as quickly as possible. In addition to manufacturing hundreds of thousands of IV bags ahead of FDA approval, and taking steps to prepare logistics ahead of time, their plan is to air-ship Radicava to further accelerate the supply of the medicine from Japan, where it is manufactured.
How does the Searchlight Support program work?
Searchlight Support is a program developed by MTPA designed to help people with ALS, who have been prescribed Radicava, access the medicine and support people once they are taking the medicine. As soon as a patient receives a Radicava prescription and opts in to participate in the program, Searchlight Support will initiate:
- Case Management: Every person who opts in will have access to a dedicated, personal case manager who will help them investigate and secure coverage through their insurance. The Case Manager will assist the person with ALS through the process.
- Bridge Program: MTPA created a program in which eligible patients may receive Radicava at no charge from MTPA while their insurance is making a coverage determination. MTPA has established the eligibility requirements.
- Clinical Educator Support: Under Searchlight Support, patients who sign up can ask a clinical educator questions about ALS, Radicava, or MTPA support programs. These clinical educators will be available to answer product or insurance-related questions day or night.
For more information, call 1-844-SRCHLGT or 1-844-772-4548. Patients prescribed Radicava should check eligibility requirements for each aspect of MTPA’s patient assistance program as restrictions apply.
How much will Radicava cost me?
The drug’s list price is $1K per infusion, $11K per dosage cycle, which amounts to $146K per year. This does not take into account coverage from insurance or Medicare/Medicaid. The company also says it will offer co-pay assistance for commercially insured patients. For more information please contact MT Pharma at www.mt-pharma-america.com or call at 844-772-4548.
What can I do if I don’t have insurance?
MTPA has created a program that provides Radicava at no charge if you do not have insurance and meet income and certain other requirements. The program is available to eligible patients without insurance. MTPA has established the eligibility requirements.
What happens while I’m waiting for Searchlight Support to confirm my insurance?
MTPA has developed a program in which eligible patients may receive Radicava at no charge from MTPA while insurance is making a coverage determination. MTPA has established the eligibility requirements.
Can I get Radicava before August?
There is currently no Radicava available in the U.S. As soon as it arrives in the U.S. and is delivered to treatment centers and/or health care provider offices, patients will have access. Based on current information, we expect Radicava to be available in August.
Do I need to travel to an ALS Center?
Radicava is given to patients through an IV, and your insurance coverage may determine whether it is administered at an outpatient center, in your home, or another appropriate venue. MTPA will ship Radicava to approved centers for infusion and to specialty pharmacies that can deliver it to patients who will receive treatments in their homes.
Can Searchlight Support help with my transportation?
When you are first prescribed Radicava and opt in to Searchlight Support, your case manager can help you identify transportation options in your area.
What if I have clinical questions about Radicava?
Under Searchlight Support, patients who sign up can ask a clinical educator questions about ALS, Radicava, or MTPA support programs. These clinical educators will be available to answer product or insurance-related questions day or night.
Can I take Radicava while on Riluzole?
You should always check with your physician, but MT Pharma stated that 90% of the patients involved in its J-19 clinical trial were on Riluzole during the trial, and there is not a contra-indication.
1Radicava™ U.S. Prescribing Information.
2Simon, 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.
To view the press release, visit alstexas.org/radicava.