Mental health parity remains a challenge 10 years after landmark law

This week marks 10 years since the landmark bill, Mental Health Parity and Addiction Equity Act, was signed into law, signifying one of the single biggest achievements over the past decade in the fight to expand access to mental health and substance use disorder treatment services.

While some viewed the legislation at the time as the apex in a decades-long battle for equity in coverage for behavioral healthcare, advocates contend access to care for millions remains elusive.

“Unfortunately, we’re still not taking serious mental illness as seriously as we need to,” said John Snook, executive director for the Treatment Advocacy Center. “I think the realities around the costs that we incur are still not there when we’re talking about covering those costs on the front end.”

Chuck Ingoglia, senior vice president of policy and practice improvement for the National Council for Behavioral Health, said while the law is simple in its conceptualization that mental health and addiction treatment should be treated the same way as medical and surgical benefit, attempts to implement it has faced significant challenges.

At the heart of the problem has been a lack of consistency in the oversight and enforcement on the part of federal and state regulators to get insurers to comply with existing parity laws. Though enforcement largely falls on states, many of their laws are not robust, and varying their standards leave wide disparities.

Advocates feel much progress has been made in addressing and reducing some of the more obvious disparities in treatment. Some of those barriers to treatment have included placing stricter limits on the number of inpatient and outpatient mental health visits, separate prior authorization requirements than for medical care services, and separate deductibles and copays.

Angela Kimball, national director of advocacy and public policy for the National Alliance on Mental Illness, said many of these types of traditional barriers on mental health and substance use disorder treatment have been reduced or eliminated because of the Federal Parity Law. “What remained were much more subtle discriminatory practices,” Kimball said.

Many of the barriers that still exist come from what are known as insurer non-quantitative treatment limitations, which Kimball said have kept patients from realizing the true intent of the Federal Parity Law.

Such limits include differences in how health plans enact utilization management and how they define medical necessity, separate deductibles and co-pays for mental and medical healthcare, limited behavioral healthcare services offered within their provider networks, and lower reimbursement for behavioral healthcare providers, to name a few.

The impact of such limits on access to mental healthcare has been significant. Behavioral health patients are four times more likely to go out of network to get care, which raises the cost for such services, according to a 2017 report by actuarial firm Milliman. The report found out-of-network providers provided 32% of behavioral outpatient care in 2015 compared to 6% of medical/surgical care in the same setting.

In terms of reimbursement, the Milliman report found behavioral healthcare providers were paid on average more than 20% less than primary care services and 17% less than the average paid for specialist services.

Ingoglia said he has just begun to think about possible ways to improve the federal statute in order to address the gaps in access to mental healthcare and substance use disorder treatment caused by non-quantitative treatment limits.

But the focus over the years has been on improving state oversight and enforcement of parity laws, which many see as facilitators of mental healthcare and substance use disorder treatment coverage parity protections. Evidence has found states lack consistent definitions on what constitutes mental health and substance use disorders, how they are covered by insurance, and how much effort should be given toward enforcing compliance.

“We see disparities in terms of states in their willingness to actually try and enforce that intent,” Kimball said. Overall all but a handful of states have statutes in place that provide adequate protections for mental health and substance use disorder.

Such was the finding of a new report released this week by the organization ParityTrack, a group started by former U.S. Congressman and recognized mental health advocate Patrick Kennedy. The report tracked and examined parity laws in all 50 states and gave low marks for 43 while only giving high marks to one, Illinois.

In May Illinois passed legislation that has been touted as one of the toughest parity enforcement laws in the country, which expanded the type of health plans covered under parity requirements to include local, county, and school district health plans. All of those types of plans can opt out of compliance to the Federal Parity Law.

Paul Gionfriddo, president and CEO of Mental Health America, said the federal government had a role to play in helping to create a more uniformed expectation for parity compliance for all states.

“Even though the states really have the roles to regulate insurance historically, the federal government can establish certain boundaries,” Gionfriddo said. “The federal government’s guidance to the state is critically important in making sure that somebody who lives in Florida gets the same kind of care as somebody who lives in Illinois who gets the same kind of care as somebody who lives in Connecticut.”

Kimball said it would make sense if the federal government sent a consistent message on expectations for parity. But she felt the Trump administration’s final rule in August to expand access to short-term, limited duration insurance coverage sent the opposite message since those plans under the rule do not have to comply with the Federal Parity Law.

“Despite the gains that we’ve seen over the past 10 years, we’re also seeing a lot of attempts to take us back in time to when people were blatantly discriminated against,” Kimball said.

Pamela Greenberg, president and CEO of the Association for Behavioral Health and Wellness, which represents “payers that manage behavioral health insurance benefits,” agreed a more uniformed standard by which states assessed parity compliance would be helpful. She envisioned a standard by which states asked for the same type of documentation from insurers to prove their compliance.

Kate Berry, senior vice president of clinical affairs for the America’s Health Insurance Plans, said greater insurance compliance was just one part of achieving mental health parity and contended it also involved engagement with clinicians to provide care for mental illness and substance use disorder wherever it was needed.

She said work on that end has been seen in recent years as more providers have made efforts to integrates behavioral healthcare services within primary care settings, but more needed to be done.

Berry said criticism that has been levied at health insurers for not doing enough to comply with the intent of the parity law was misguided. “I don’t think there’s any evidence to say that that’s not happening,” Berry said.

In terms of the impact of nonquantitative treatment limits, Berry said AHIP has been consistent in calling for more clarification in the law, saying the guidance around them has been ambiguous and that it has created complexities.

“I see it as an area that because it’s ambiguous it creates confusion form everyone touched by the system.” Berry said.

Snook said ultimately, he saw healthcare providers as having a key role in the fight for parity by sharing their stories on the impact limitations of coverage have had on the health of their patients.

He said health insurers needed to reckon with the fact that lack of mental health parity was still a reality many Americans in need of mental health care face. “By not providing that level of coverage they’re not saving themselves any money and they’re really just hurting themselves,” Snook said.

http://www.modernhealthcare.com/article/20181005/NEWS/181009925

This automated indoor farm is growing so fast, it makes you think it might work

Bowery, which began distributing produce just under two years ago, is opening a new farm and ramping up its output by 30-fold.

[Photo: Bowery]

Around two years ago, the then 10-person team of Bowery, an indoor farming startup, started growing a small array of leafy greens out of what was once a shipbuilding yard in Kearny, New Jersey. Undeterred by the rather harsh post-industrial environment, the Bowery team was just looking for somewhere to set up that had a lot of space. After all, their farming system is more about the tech than it is the soil and the water and the things you might generally associate with farming. By growing produce in trays, stacked high in rooms whose temperature, lighting, and humidity is tightly controlled by a proprietary operating system, Bowery’s farming requires no soil, and instead delivers nutrients to its array of leafy greens via a hydroponic system that uses 95% less water than traditional agriculture.

Bowery certainly doesn’t look like a farm, but that, to CEO Irving Fain, is the point. “We’re excited about being able to move into these abandoned spaces in cities and create new jobs and industry,” he says. In Kearny, that’s exactly what Bowery is doing: On September 24, the startup officially unveiled its second, larger farm (the company does not disclose square footage) in a new building on the same industrial complex, which was built in 2017 as part of a larger revitalization effortin Kearny. In terms of output, the new farm is about 30 times more productive, and the startup has greatly diversified its crop output, adding bok choy, cilantro, and parsley to its original kale, spinach, and basil offerings. The startup is also expanding its distribution: It will continue selling through Whole Foods, as it already has been (at a price comparable to most of the retailer’s other greens) and also be featured on menus at Sweetgreen and Dig Inn throughout the Northeast.

[Photo: Bowery]

For an indoor farming company, this type of speedy growth is now not unprecedented–AeroFarms, another New Jersey-based indoor farming company, is also rapidly expanding–but it is a sign that perhaps, the industry is beginning to iron out the kinks that initially called into question whether it was a model that was cut out for success. Balancing the development of new technology and the associated costs along with the pressures to actually produce significant quantities of edible vegetables often proved challenging and not financially viable. Stories like that of PodPonics, an indoor farming venture that had to fold when it couldn’t raise the capital necessary to scale, often tend to dominate the narrative around the model.

[Photo: Bowery]

But while Bowery is, as Fain says, focused on its mission of upping the local supply of fresh produce grown without pesticides, it’s taking a decidedly tech-centric approach to doing so–which may be fueling its success. Before launching its second farm, Bowery raised a round of $20 million in funding from Google Ventures and General Catalyst, among others, and brought in Brian Donato, who previously managed Amazon’s automated fulfillment centers, to help build it out as the SVP of operations.

In contrast to other indoor farming startups like FreshBox, which is less concerned with building its own tech system and more focused on using whatever systems will produce the greatest yield, Bowery is all about the tech. Its automated system that manages and controls the whole farm–called BoweryOS–is entirely proprietary. In the original farm, workers still help move trays of produce, and harvest the crops when their ready, but in the sprawling new facility, humans barely need to interact with the growing plants, because the system of sensors and cameras monitors the plants and controls how much water, light, and nutrients they receive.

[Photo: Bowery]

Unlike the original farm, where all the produce was grown in one room, the new facility has multiple growing rooms. “We can essentially create different climates room by room,” Fain says. This is especially beneficial for growing a broader range of greens: Crops like cilantro grow best in hot, dry climates, while kale and bok choy thrive in cooler, wetter environments, and Bowery can now create those different climates in its growing rooms. With the upgrades to the operating system, the “farmers” at the new Bowery farm walk around with tablets, mostly in the processing area, checking to ensure that the crops are growing according to plan, but mostly focusing on post-harvest work: quality control, sorting, and packaging.

In that way, Fain says, Bowery is trying to fulfill a tech-world promise of bringing a new type of job to areas, like Kearny, still reeling from the collapse of previous industry. “We don’t require a labor force that has experience in agriculture, or really any at all,” Fain says. “We can move into a new city and essentially hire anyone, and teach them how to read the system.” Bowery decided to open its second farm in the New York-New Jersey area because its first, smaller farm couldn’t tap as much into the local labor market as they wished. They’ve now grown the team from 10 people to over 60, and plan to keep expanding as the new farm continues to ramp up operations. And starting next year, Fain says, they’ll begin eying expansion to other cities.

https://www.fastcompany.com/90239250/bowerys-automated-indoor-farm-is-growing-fast

Why Texas hospitals’ urge to merge takes precedence

Health system M&As may be necessary as insurers with greater access to capital are expanding low-cost outpatient centers into Texas to capture patients.

The proposed merger of two giant Texas health systems illustrates the escalating pressure health insurance companies are bringing to bear on hospitals threatened by narrowing provider networks and a flood of new competition from health plan­–owned outpatient providers.

Dallas-based Baylor Scott & White Health and Houston-based Memorial Hermann Health System this week said they’ve signed a letter of intent to create a 68-hospital system that draws tens of thousands of patients from Oklahoma to the Gulf of Mexico.

And even as big as they are, the deal may be necessary as even larger companies with greater access to capital are expanding low-cost outpatient centers into Texas to capture patients, as fee-for-service medicine gives way to value-based models that emphasize population health outside of the inpatient hospital.

“These two health systems are concerned about increasing market concentration amongst insurers, as well as vertical integration between providers and between insurers and providers,” said Vivian Ho, an economics professor and the director of the Center for Health and Biosciences at Rice University’s Baker Institute for Public Policy in Houston. “They are aiming to preserve their negotiating power in the midst of a rapidly consolidating landscape.”

To be sure, in general, hospitals that decide to merge say they need to consolidate to gain influence against insurance companies like Humana, which is buying providers in Texas; and UnitedHealth Group, which owns Optum, and is gobbling up doctors and clinics and expanding its MedExpress brand urgent care centers across the country. Meanwhile, drugstore and retail clinic operator CVS Health is buying Aetna, and plans to develop more healthcare services beyond the 1,100 MinuteClinics that the pharmacy chain already owns.

All three of these health insurance companies are part of an escalating trend by health plans to form narrow network health plans designed to guide patients first to their own low-cost outpatient care centers before they would go to hospitals or other providers owned by Baylor or Memorial Hermann.

With Baylor and Memorial Hermann touting their established brand, Humana has gone so far as to rebrand all of the medical care provider operations it owns in Texas and Florida under the Conviva model, hoping to attract patients to both its clinics and its insurance offerings like Medicare Advantage plans for seniors.

“We are moving to an integrated model and are building a platform that will consolidate these brands in South Florida and Texas under a one payer-agnostic physician brand called Conviva,” Humana CEO Bruce Broussard told analysts on the company’s fourth-quarter earnings call in February of this year.

“Our strategy is for Conviva to provide local depth and drive both healthcare service and Medicare Advantage growth opportunities with greater member access and engagement in health over the long term,” Broussard said. “We believe this new, simplified structure will help us to continue to build trust throughout Florida and Texas markets, improving operations while continuing to make strategic investments in the business.”

To compete against the effort of insurers to package insurance and the provision of medical care, the two Texas health systems hope to make the combined system a “national model for integrated, consumer-centric, cost-effective care.” The merger of Baylor Scott & White with Memorial Hermann will cast a wide net with more than 1,100 medical care delivery sites; nearly 14,000 employed, independent and academic physicians; and two health plans the systems own. The two systems say they “record nearly 10 million patient encounters annually.”

“Together, we believe we will be able to accelerate our commitments to make care more consumer-centric; grow our capabilities to manage the health of populations; and bend the unsustainable healthcare cost curve in the state,” Memorial Hermann President and CEO Chuck Stokes said.

Analysts say any healthcare providers that hope to compete will need “size, scale, presence, and concentration,” says Kevin Holloran, Fitch Ratings senior director and leader of the firm’s not-for-profit hospital and healthcare group. “There is always the hoped-for economies of scale, and there is also typically an underlying need to have more touch-points should population health really take off,” Holloran said.

It also sets up a battle in Texas that is perhaps a more difficult market to compete in than other areas of the country because health insurance companies and medical care providers are fighting to divvy up a smaller percentage of paying patients.

Texas has the highest rate of uninsured Americans in the country with more than 17% of the state residents who were without coverage in 2017, according to the latest U.S. Census Bureau report on the uninsured, which was released last month.

Texas is the latest of the remaining 17 states that have yet to expand Medicaid under the Affordable Care Act. Of the 28 million Americans without coverage last year, 4.8 million of them were in Texas, the 2017 census figures show.

“Texas hospitals are facing a tougher financial situation than elsewhere, because the state did not elect a Medicaid expansion under the Affordable Care Act,” Rice University’s Ho said. “The absence of those funds, combined with the highest rate of uninsured patients in the nation, may have pushed Baylor and Memorial Hermann to consider this merger.”

https://www.healthleadersmedia.com/strategy/why-texas-hospitals-urge-merge-takes-precedence

Physical Therapy Noninferior to Surgery for Some Meniscal Tears

Physical therapy appears to be nearly as effective as early arthroscopic surgery for treating nonobstructive meniscal tears in middle-aged to older adults, a study has shown.

In a randomized controlled trial, patients with degenerative, nonobstructive meniscus tears assigned to a structured program of physical therapy (PT) had similar patient-reported knee function as patients who underwent arthroscopic partial meniscectomy (APM) during a 2-year period.

The findings “are consistent with current consensus that APM should not be the first treatment in middle-aged and older patients with meniscal tears,” the investigators write.

Victor A. van de Graaf, MD, from the Department of Orthopedic Surgery, Joint Research, OLVG Oosterpark Hospital, Amsterdam, the Netherlands, and colleagues published their findings online October 2 in JAMA.

The authors of an accompanying editorial agree that the findings provide additional support for a structured, nonoperative treatment approach to managing this knee condition. They caution, however, that changing clinical practice may require the various professionals involved in meniscus tear management to develop mutually agreeable evidence-based treatment guidelines. These include orthopedic surgeons, physiatrists, physical therapists, professional organizations, and insurance companies.

To evaluate the relative effectiveness of PT and APM in this study, the investigators enrolled 321 patients aged 45 to 70 years with degenerative meniscus tears without knee locking, instability, or severe osteoarthritis. Of these, they randomly assigned 159 to receive APM within 4 weeks and 162 to receive a PT exercise protocol developed by a knee-specialized physical therapist. The PT protocol consisted of 16 half-hour sessions over the course of 8 weeks, beginning within 2 weeks of randomization. Surgery patients were only referred to PT if they did not recover as anticipated, and PT patients that did not attain the desired outcomes could extend their PT or elect APM.

The primary outcome measure was patient-reported knee function on the Subjective Knee Form of the International Knee Documentation Committee assessed from baseline and over the course of 24 months, with a noninferiority threshold of 8 points. The threshold was adopted from an earlier study that estimated the noninferiority margin from a more heterogeneous meniscus injury population “[b]ecause a minimal clinically important difference…for the [International Knee Documentation Committee] has not been defined in a population consisting only of patients with meniscal tears,” according to the investigators.

During the 2-year follow-up, mean knee function scores improved by 26.2 points (from 44.8 points to 71.5 points) in the APM group and by 20.4 points (from 46.5 points to 67.7 points) in the PT group. The between-group difference in the primary mixed model analysis of the overall effect was 3.6 points (97.5% confidence interval [CI], −∞ to 6.5) in favor of APM, which met the noninferiority criteria.

Although the between-group differences at 3 months and 6 months also showed noninferiority of PT, the effects at 12 and 24 months did not, according to the authors. “Longer follow-up will provide more details on the effect of time on the between-group differences,” they write.

Additional, exploratory outcomes included knee pain during weight bearing, general health, activity level, and osteoarthritis severity. The mixed-model analysis of the overall effects found a between-group difference of 5.9 mm (95% CI, 1.4-10.3; P = .01) in favor of APM for knee pain during weight bearing, 1.3 points (95% CI, −0.2 to 2.7; P = .08) in favor of APM for general health, no significant difference (0.04 points [95% CI, −0.3 to 0.2; P = .73) for activity level, and no significant difference for osteoarthritis progression (0.10 points more progression in the APM group; 95% CI, −0.05 to 0.26; P = .18).

Of the patients randomly assigned to PT, 29% underwent delayed APM, “demonstrating that not all patients initially treated with PT were satisfied with their results,” the authors write. “The post-hoc exploratory findings on effect modification could guide future research on the characteristics of individuals who may be less likely to respond to PT to improve their treatment options and functional outcome.”

On the basis of the study results, the authors state that PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.

The authors of the accompanying editorial, Laith Jazrawi, MD, Heather T. Gold, PhD, and Joseph D. Zuckerman, MD, from the Department of Orthopedic Surgery at New York University School of Medicine, New York City, question whether limitations posed by the study design compromise the relevance of the findings.

“The trial used a noninferiority trial design, which is appropriate because PT may have other advantages over APM, such as lower cost, noninvasive nature, and fewer adverse effects such as surgical complications. However, the choice of the noninferiority threshold, or margin, was suboptimal,” they write, explaining that the threshold was estimated based on a “very different” patient group (older man age, multiple surgical procedure types) and shorter follow-up (preoperative and postoperative International Knee Documentation Committee score after 12 months vs 24 months).

“Given that the current randomized trial showed only a 5.8-point difference before and after surgery in the intention-to-treat, unadjusted analysis, the threshold deserves careful scrutiny and probably should have been lower to be more confident about noninferiority,” the editorialists suggest. This limitation notwithstanding, they do agree that the findings provide further support for a structured nonoperative treatment approach for meniscal tears in the setting of degenerative OA. Further, they write, “[o]rthopedic surgeons should recognize the value of this nonoperative approach and incorporate it into their treatment approach with the expectation that many patients will be treated successfully.”

The editorialists also agree with the need for evidence-based guidelines developed by a multidisciplinary consortium. “The guidelines should be focused on the best interests of the patients, rather than the clinicians, therapists, and other groups or entities who may gain from the different treatments for degenerative meniscal tears,” they write.

This study was funded by the Netherlands Organization for Health Research and Development, Zilverenkruis Health Insurance, and the Foundation of Medical Research of the OLVG, Amsterdam. Several study authors disclose multiple financial relationships with several pharmaceutical, biomedical, and research organizations. For the full list of disclosures, please see the journal website. Gold serves as the president of the Society for Medical Decision Making. The remaining editorialists have disclosed no relevant financial relationships.

JAMA. Published online October 2, 2018. Article full text, Editorial extract

https://www.medscape.com/viewarticle/902999#vp_1

Most Physicians Disenchanted With Their Profession

Seven out of 10 physicians would not recommend their profession to their children or other family members, and more than half are thinking about retiring within the next 5 years, including one-third of those under the age of 50, according to a new national survey by The Doctors Company, a physician-owned medical malpractice insurer.

The survey of more than 3400 US physicians uncovered a “complex picture” of the attitudes of physicians nationwide toward the important issues facing the industry, with physicians reporting feeling disenchanted with the practice of medicine, the authors note in their report.

While the rate of change within practice models may have slowed in recent years, many physicians view the adoption of electronic health records (EHRs) and new reimbursement models as compromising the traditional doctor-patient relationship and the ability to provide quality patient care, the authors say.

Yet the survey also shows that physicians have not wavered in their advocacy for preserving the doctor-patient relationship and providing high-quality care.

Among the key findings from the Future of Healthcare survey:

* More than half of physicians (54%) plan to retire within the next 5 years because of pressure from declining reimbursement, increased administrative burden, and industry consolidation. The average age of men who took the survey was 62; for women, it was 55. Male physicians are more likely to retire than female physicians. Women are more likely to report that they are primary care physicians (PCPs) and men are much more likely to report being surgical specialists, so the burdens leading doctors to retire may be felt less on the PCP level, the authors say.

* More than half of physicians (54%) believe EHRs have had a negative impact on physician-patient relationships. “Doctors are concerned that EHRs are burdensome and distracting during patient interaction. One doctor suggested that the software causes major frustration to patients and physicians alike,” the authors report.

* Nearly two-thirds (61%) of physicians believe EHRs are having a negative impact on efficiency and productivity. “Many comments suggest that doctors are frustrated with the functionality, reliability, and lack of interoperability within their EHRs,” the authors note.

* More than 40% of doctors think value-based care will have a negative impact on the physician-patient relationship. “Many doctors worry that pay-for-performance reimbursement doesn’t take into account the nuances of the doctor-patient relationship and puts a focus on population-level data instead of individual outcomes,” the authors say. Along this same line, 63% of the physicians surveyed said they believe value-based care and reimbursement will have a negative impact on their earnings.

* Almost two-thirds (62%) of doctors say they don’t plan to change practice models, perhaps indicating that the pace of practice change seen in recent years may have run its course, the authors say.

* Three quarters (75%) of solo practitioners plan to stay independent. “Private practices are increasingly being acquired by health systems that want to better control the continuum of care, and some medical groups are merging to create larger practices to drive efficiency, cost savings, and better technology,” the authors note. “Nonetheless, three quarters of the solo practitioners who took this survey told us they don’t expect to be a part of that industry shift, but rather expect to remain independent. While many are staying put in their current practice model, physicians expressed concern about how industry changes will impact the future of individual and small group practices.”

* Physicians have mixed views on accountable care organizations, with 43% saying they do not plan to participate and 57% saying they plan to participate, are undecided, or need more information.

* Physicians also have mixed feelings about clinically integrated networks (CINs): 38% do not plan to participate in a CIN and 37% are either undecided or need more information about participating in a CIN.

* Physicians are also split on independent physician associations: 30% plan to participate, 36% do not plan to participate, and 34% are either undecided or need more information.

* More than half (56%) of physicians don’t plan to participate in patient-centered medical homes, 15% plan to participate, and 29% are undecided or need more information.

The survey included physicians in a range of medical specialties from 49 states and the District of Columbia who are insured by The Doctors Company.

The report was created in partnership with Modern Healthcare Custom Media and is available online.

https://www.medscape.com/viewarticle/903051

Cadila Healthcare gets final approval from USFDA for Exemestane tablets

Zydus Cadila has received an approval from the USFDA to market Exemestane tablets (US RLD, AROMASW tablets), 25 mg, the company said in a statement to the exchanges on Friday.

The company will produce these tablets in its formulations manufacturing facility at SEZ, Ahmedabad. “The estimated sales of Exemestane tablets are $68.6mn,” said Cadila in a press note.

“These tablets are belongs to the group of medicines called aromatase inhibitor used in women after menopause for the treatment of early breast cancer (cancer that has not spread outside the breast) in women who have cancer that needs the female hormone estrogen to grow have had other treatments for breast cancer for 2-3 years and are switching to Exemestane to complete five years in a row of hormonal therapy,” the company said. These tablets are also used in the treatment of advanced breast cancer after treatment with other therapies.

The group now has 220 approvals and has so far filed over 330 ANDAs, since the commencement of the filing process in FY04, the company added.

https://www.marketscreener.com/CADILA-HEALTHCARE-LTD-34067618/news/Cadila-Healthcare-receives-final-approval-from-USFDA-for-Exemestane-tablets-27381631/

VALNEVA: FDA Approval of Accelerated IXIARO Vaccination Schedule

Valneva SE (“Valneva” or “the Company”), a commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today that the U.S. Food and Drug Administration (FDA) has approved an alternate IXIARO immunization schedule of two doses administered seven days apart for adult travelers aged 18-65 years old. This accelerated schedule comes in addition to the previously approved schedule.

IXIARO is the only Japanese encephalitis (JE) vaccine licensed and available in the United States (U.S.). The vaccine was approved with a two-dose primary immunization with the two vaccinations administered 28 days apart. The newly-approved accelerated vaccination schedule allows rapid immunization in adults with the two doses given seven days apart. This rapid schedule has already been approved and is used in Europe and Canada.

Franck Grimaud, Valneva`s Chief Business Officer, commented, “Many people make their travel plans at the last minute, so being able to receive IXIARO`s two shots within seven days makes it easier for travelers, ultimately enhancing the value proposition of our product. The U.S. is IXIARO`s largest market and we expect that this new schedule will encourage more U.S. travelers to seek prevention against this devastating disease.”

The FDA`s revised schedule follows previous approvals by Health Canada and the European Medicines Agency, who authorized accelerated IXIARO vaccination schedules for adult travelers in March 2018 and April 2015, respectively.

https://www.marketscreener.com/VALNEVA-54466/news/VALNEVA-Announces-FDA-Approval-of-Accelerated-IXIARO-Vaccination-Schedule-27381634/