VA Adds Radicava to its National Formulary for ALS Patients

VA Adds Radicava to its National Formulary for ALS Patients

The U.S. Department of Veterans Affairs (VA) has added Radicava (edaravone) to its national formulary (VANF), making it possible for veterans with amyotrophic lateral sclerosis (ALS) to access treatment within the VA’s healthcare system, according to Mitsubishi Tanabe Pharma America (MTPA).

The VANF is a list of drugs and supplies that are covered under the VA’s comprehensive medical care program. All products must be made available across the VA system so that veterans can access high-quality, best-value pharmaceutical therapies in a standardized way.

The VANF criteria follows the U.S. Food and Drug Administration’s approved labeling. All VA requests will be determined at the national level by a single team of experts, enabling cross-system consistency.

“The VA’s decision to offer broad coverage is a significant step to help veterans living with ALS,” Tom Larson, chief commercial officer of MTPA, said in a press release. “Veterans sacrificed for our country through their service, and we are pleased the VA has taken this important step for the ALS community.”

In clinical trials, people given Radicava experienced a 33 percent slower rate of decline in the loss of physical function when compared to placebo, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) – a tool for monitoring the progression of disability in ALS.

Radicava was approved by the FDA on May 5, 2017, as a new treatment option for patients with ALS. MTPA announced in October 2017 that Radicava was available for purchase in the United States, bringing new hope to many patients.

Now, Radicava is also available for U.S. veterans.

“It is a great source of hope to not only see the FDA approve Radicava, but to also have the VA rapidly approve it for use in veterans,” said retired U.S. Navy Lt. Commander Matt Bellina, who was diagnosed with ALS. “This signals a great effort to uphold the sacred obligation to care for all of us who served.”

Estimates point to 5,000 to 6,000 Americans who are diagnosed with ALS every year. According to the ALS Association, a new report from experts convened by the Institute of Medicine agrees with prior conclusions that U.S. military veterans appear to have an increased risk of developing ALS.

Factors that might increase the risk of ALS in veterans include exposure to lead, pesticides or other environmental contacts, like use of tobacco, alcohol, or extreme physical activity. However, the expert committee called for new studies to further investigate the connection between ALS and military service, to examine which aspects of the military lifestyle might be more strongly associated with the disease.

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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  1. Charlie says:

    ‘Dr. Warren Bell, a family physician from British Columbia and founding president of the Canadian Association of Physicians for the Environment, said he is concerned about the long-term health effects of exposure to low levels of glyphosate.

    “Glyphosate residues have been found in California wine, in menstrual pads, in German beer, in the urine of 99.6 per cent of Germans tested,” he told CBC Nova Scotia last year.

    Once glyphosate is in a person’s body, he said, there is evidence to suggest it could mimic a naturally occurring amino acid, called glycine, and prevent proteins in the body from working properly…”

    The key word is in the last paragraph. It is ‘proteins.’
    How often do we hear that word in ALS research…?

  2. Charlie says:

    Perhaps researchers could divert a little attention from identifying ever more rogue genes, to looking at what in the environment and everyday foodstuffs might be making those proteins and genes go rogue in the first place.

  3. Dan Montgomery says:

    For over a year the doctors back at the VA in Palestine, Texas gave me one missed diagnosis after another. I became very angry and frustrated. I nearly stopped breathing. I lost strength and weight (50+ pounds). I gave my Texas ranch away last January 2016, my piece of heaven on earth that I had worked so hard for and I could not stop crying. Then I drifted out west and had been running a sleepless run, searching for the answer but losing my exits one by one.

    After multiple emergency room visits and seeing dozens more doctors it took one doctor on March 15, 2016 about 10 minutes to figure out why I had been suffering (ALS). The VA say they are just now thinking about Radicava treatments for me since I am a 100% disabled American veteran.

    Today I was denied Ravicava. They said my ALS is too advanced. My medical coverage comes thru the VA. I am a 100% disabled veteran. The VA is obligated to pay 100% of all my medical treatments. But today they said no to the only new FDA approved treatment for ALS in 20 years. No hope for me now. They thanked me for my service and sent me home to die.

    Everyday something reminds me of my service to our country. Today I was reminded of the firefight that was so intense that the 2nd squad had to pull back but one Marine was left behind. That is when my squad ran towards the fight. As the sound of bullets whistled thru the air I lifted the body of PFC Craig Ward out of the mud and carried him on my back. We carried him for over a click to a safe area where a chopper picked him up. As the chopper rose into the sky to take Craig back home to his mother in Missouri I stared up into Heaven and begin to pray. I then shouted out to my squad that no soldier, no brother will ever be left behind.

    Today I was left behind. Today I feel alone. But I have hope and I know that if my brothers hear my cry for help that they will come. They will lift me up onto their backs, carry me to the chopper that will lift me to Heaven and take me back home.

    • Teresa says:

      I am so sorry Dan. This breaks my heart! My partner is getting weekly IVs of glutathione which is another potent antioxidant, (like Radicava) at a wellness clinic. No prescription required and a fraction of the cost. God bless you. May you find Grace and relief soon. With Love, Teresa.

  4. Jody Jameson-Theye says:

    My husband too has been denied Ravicava also by the VA and commercial insurance. He has served in the military and has been deemed 100% disabled by the VA. Our physician has made many appeals with no avail and I have taken to the Department of Insurance. The ALS association along with Searchlight have not been supportive. The treatment should be decided by the patient and their physician not by restrictions placed by health insurance companies and the VA as not medically necessary based on each ALS patient’s capacity to benefit from the treatment. I am sure the cost of the drug is playing a factor with insurance companies.

  5. You should at least give some credit to the contagious for a cure and als new now who have met with the fda and were instrumental in right to try and again this week will attempt to get fda regulations changed. They are taking a different path and all will benefit if they succeed.

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