Shots:
- What started as a father’s determination to find a better solution has grown into a widely reimbursed therapy. Along the way, strong clinical evidence, early physician support, and carefully designed payer pilots helped unlock nationwide coverage, reaching nearly 130 million lives across Blue Cross Blue Shield plans.
- In this conversation, Alon explains how Nerivio’s dual acute and preventive indications are transforming migraine care, shifting treatment toward earlier, more proactive disease management. By offering a safe, drug-free option, the therapy is expanding access for underserved groups such as pediatric patients, veterans, and women of childbearing age.
- PharmaShots welcomes Alon Ironi, CEO and Co-Founder of Theranica, for a compelling discussion on the rise of neuromodulation, the path from breakthrough innovation to nationwide reimbursement, and how drug-free therapies are reshaping the future of migraine management.
Saurabh: Reaching coverage for ~130 million lives with Blue Cross Blue Shield is a defining milestone. What were the critical inflection points that enabled Theranica to transition from innovation to nationwide reimbursed care?
Alon: It’s meaningful to see Nerivio reach this level of coverage because the journey started on a personal level. My daughter was diagnosed with migraine as a teenager, and I witnessed firsthand how limited the treatment experience could be — medications didn’t always work well enough, and the side effects could be difficult to manage. That experience underscored the need for an effective, drug-free option and ultimately set us on the path to developing Nerivio.
The first step was the creation of solid clinical data, combined with positive initial market acceptance by both healthcare providers and patients.
This set the stage for the second step – a Coverage with Evidence Development pilot by Highmark Blue Cross Blue Shield (BCBS), closely evaluating the clinical benefits of Nerivio, as well as its health economics advantages.
This was greatly enhanced by the expansion of the Nerivio indication to also include preventive treatment.
That led Highmark BCBS to be the first commercial Payor to place a positive coverage policy for Nerivio.
A year later, following dedicated work with the medical technology assessment of Anthem BCBS, combined with effective patient advocacy efforts, Anthem BCBS published its positive coverage policy for Nerivio, which served as a beacon for additional Payors.
Saurabh: With widespread adoption across Blue Cross Blue Shield plans, what does this signal about the evolving payer mindset toward neuromodulation and drug-free therapies?
Alon: It signals that the incredible, solid clinical database about Remote Electrical Neuromodulation (REN), combined with the strong field experience of hundreds of healthcare specialists and tens of thousands of patients gave the largest, mainstream healthcare systems and health insurance organizations the confidence to trust the science and the practical experience of REN. This widespread adoption effectively establishes REN as a new migraine standard of care, standing on par with leading pharmacological options. It proves that the industry now realizes migraine treatment is no longer limited to needles, pills, and chemical substances.
Saurabh: Achieving payer scale comparable to leading migraine drug classes is no small feat. What specific clinical or health economic data resonated most strongly with insurers?
Alon: It’s the persistent, repetitive high-efficacy results in a combination of rigorously designed, randomized, placebo-controlled, multi-center clinical trials on one hand, and real-world evidence studies with tens of thousands of patients on the other hand. This provided chief medical officers and policy makers in the most reputable health insurance companies the required confidence to add REN to their formularies.
Saurabh: Nerivio is cleared for both acute and preventive use. How does this dual indication redefine traditional migraine treatment pathways?
Alon: Studies in people living with migraine point out the importance of applying a preventive treatment regimen early in the evolution of the disease. They show that postponing the preventive element, utilizing only rescue (acute) treatment results with chronification of the disease patterns and degradation in the severity and duration of symptoms. Having a single, safe, drug-free, reliable therapy for both acute and preventive treatment sets the stage for a new standard of care of treating migraine, which has the potential of changing the course of the disease early in the life of people who live with it.
Saurabh: Do you see this milestone as validation of REN specifically, or as the beginning of a broader structural shift toward reimbursing evidence-based, non-pharmacological therapies?
Alon: While first and foremost it validates REN as a trusted treatment technology, it certainly has the potential of marking a wider transition in the medical approach towards chronic diseases in general, and Central Neural System (CNS) conditions in particular. The fact that certain endogenous neural mechanisms can be safely manipulated to heal the brain opens the door for a new breed of treatments that may play a central role in improving the quality of life for many millions of people.
Saurabh: How has national reimbursement changed the conversation between neurologists and patients when discussing first-line or adjunct migraine treatment options?
Alon: Absolutely. Neurologists, pain specialists, pediatricians and other healthcare specialists have great responsibility over the health of their patients. It’s important for them to offer and prescribe treatments that are safe and clinically effective, but also affordable and accessible to their patients. Knowing that a treatment is comfortably accessible nationwide gives them the confidence to utilize it for their patients.
Saurabh: For vulnerable populations, such as pediatric patients, veterans, and women of childbearing age; how does expanded access reshape real-world migraine management?
Alon: In a medical domain that has been based for decades mainly on chemical substances, these populations have been underserved, as most of the traditionally available treatments were not relevant for them. The fact that they now have evidence-based, effective treatment that is also affordably accessible is a long-awaited life-changing milestone for them.
Crucially, because REN is indicated for both acute treatment and prevention, it allows for a more proactive disease management strategy. For populations such as children and adolescents, this means they can begin treating the condition early in its development. By intervening at a younger age with a non-pharmacological preventative option, we can help these patients avoid the chronification and progression of migraine, fundamentally altering the trajectory of what is otherwise a debilitating chronic condition.
Saurabh: As neuromodulation gains traction across therapeutic areas, how does Theranica plan to sustain differentiation and category leadership?
Alon: Theranica continues to invest in advancing innovative electroceutical solutions across additional chronic conditions. Ongoing research and development will remain central to sustaining differentiation and leadership in this emerging category.
Saurabh: With REN becoming embedded in payer frameworks, do you anticipate future clinical guidelines reflecting neuromodulation as an earlier-line standard of care?
Alon: Certainly. Clinical guidelines are usually updated several years – sometimes even a decade – after new technologies are already widely adopted by the leading healthcare specialists, but they are important for the wider community of healthcare providers, mainly primary care physicians, pediatricians, and other specialties. We believe that upcoming guidelines of the American Headache Society on treating migraine in children and in pregnant women will reflect the wide adoption of REN as a tier-one treatment for these populations.
Saurabh: You’ve said the era of “only needles and pills” is becoming history. What does the migraine treatment landscape look like five years from now?
Alon: There are other medical devices under development for migraine by several innovative companies, and there are numerous innovative drug-free developments for other conditions as well. The medical world is finally catching up with the great advances made in neuroscience over the past two decades. As we better understand how the brain operates, and how the stimuli we are exposed to – including our thoughts and beliefs – influence micro-processes in our brain, new therapeutic pathways are being blazed, promising more effective ways to maintain and restore our health.
About the Author
Alon Ironi
CEO and Co-Founder, Theranica
Alon Ironi is the CEO and Co-Founder of Theranica, where he leads the company’s mission to transform neurological care through innovative neuromodulation technologies. A creative manager, technology innovator, and inventor, Alon brings together science, engineering, and human insight to build solutions that improve patients’ lives. As a passionate entrepreneur and serial leader of technology organizations, he is dedicated to translating breakthrough ideas into meaningful healthcare impact.
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