Revolutionary Alzheimer’s Drug Leqembi Set to Receive Full FDA Approval

Published

10 months ago

July 8, 2023

Revolutionary Alzheimer’s Drug Leqembi Set to Receive Full FDA Approval

Medicare Coverage Expansion Expected to Benefit Millions

In a groundbreaking development, the US Food and Drug Administration (FDA) is poised to grant traditional approval to Leqembi, an Alzheimer’s drug that has demonstrated the ability to slow the progression of the devastating disease.

This historic decision, expected to be announced on Thursday, marks the first time a medication has been proven to have a positive impact on the memory-robbing effects of Alzheimer’s.

A Paradigm Shift: Leqembi’s Potential Impact

Once the FDA grants its approval, the Centers for Medicare and Medicaid Services (CMS) will also revise its coverage policy, expanding access to Leqembi for an estimated one million individuals suffering from early-stage Alzheimer’s.

Developed by Eisai and Biogen, Leqembi received accelerated approval in January based on evidence of its ability to clear amyloid plaque buildups in the brain, which are closely associated with the disease.

However, due to a prior coverage decision by CMS, the drug has been underutilized. With a price tag of $26,500 before insurance coverage, many individuals have been unable to afford it.

Medicare Coverage Expansion Expected to Benefit Millions

Joe Montminy, a 59-year-old diagnosed with younger-onset Alzheimer’s in his early 50s, expressed the frustration of having limited access to the treatment due to insurance coverage issues.

The expansion of coverage is of great significance to him and others in similar situations, as it provides hope for effective treatment options.

A New Era of Treatment

Leqembi’s approval is currently limited to individuals with early forms of Alzheimer’s, specifically those with mild cognitive impairment or mild dementia who have confirmed amyloid plaques in their brains.

Dr. Lawrence Honig, a neurology professor at Columbia University Irving Medical Center, estimates that this group represents about one-sixth of the more than six million Americans currently diagnosed with Alzheimer’s.

However, it’s important to note that individuals with more advanced stages of the disease may not experience the same benefits from the drug and could face increased safety risks.

Dr. Honig emphasizes that while Leqembi represents a significant breakthrough, it is not a cure. In an 18-month clinical trial, the drug showed a 27% reduction in cognitive decline and functional impairment.

Dr. Honig believes that these treatments are just the beginning of a new era in Alzheimer’s research, expressing optimism for the development of more efficacious therapies in the future.

Balancing Potential Benefits and Risks

Leqembi, like any medication, comes with potential side effects and requires regular brain imaging for monitoring purposes.

During the trial, approximately 13% of participants experienced brain swelling or bleeding, and certain groups, such as those with specific genetic factors or individuals on blood-thinning medications, may face higher risks.

Healthcare systems have been preparing for the anticipated increase in Leqembi usage. Dr. Georges Naasan, the medical director of the Division of Behavioral Neurology and Neuropsychology at Mount Sinai, acknowledges the complexities involved in the process but affirms that preparations have been underway to ensure a smooth transition. Infusion centers, such as Vivo Infusion, are gearing up to handle the potential surge of new patients.

Medicare Coverage Expansion and Potential Implications

CMS has announced plans to broaden coverage for Leqembi if it receives traditional FDA approval. However, there are certain qualifications attached to this expanded coverage.

Medicare will cover approved drugs when physicians and clinical teams participate in the collection of real-world evidence through a registry.

This approach aims to assess the effectiveness of the medication in broader community practice. CMS will facilitate a portal where providers can submit the collected evidence free of charge.

While CMS’s approach has been met with some concerns from patient groups and the pharmaceutical industry, who argue that it may create barriers to treatment, the expanded Medicare coverage of Leqembi and similar drugs that slow the progression of Alzheimer’s is expected to have a significant impact on healthcare spending.

An analysis by KFF (formerly the Kaiser Family Foundation) indicates that if 10% of the estimated 6.7 million older adults eligible for the drug opt to take Leqembi, with an annual list price of $26,500, it could result in a spending increase of $17.8 billion.

This figure surpasses the total spending on the top 10 Part B drugs administered in doctors’ offices in 2021. Higher Medicare Part B premiums for all enrollees may be a consequence of the increased spending. Nevertheless,

References:

https://edition.cnn.com/2023/07/06/health/leqembi-alzheimers-fda-approval-medicare/index.html

Post Views: 131

Alpha-Gal Syndrome: The Hidden Threat Triggered by Tick Bites Could Impact Thousands

Published

10 months ago

July 28, 2023

Nurse Vicky

Alpha-Gal Syndrome: The Hidden Threat Triggered by Tick Bites Could Impact Thousands

Tick-borne illnesses are not uncommon, but a little-known and potentially life-threatening food allergy called Alpha-Gal Syndrome (AGS) is causing concern among health authorities. The Centers for Disease Control and Prevention (CDC) issued a warning, shedding light on this mysterious condition that could be affecting hundreds of thousands of Americans. AGS, also known as the “red-meat allergy” or the “tick bite meat allergy,” has been linked to the bite of the Lone Star tick, predominantly found in Southeastern and Eastern states.

alpha-gal syndrome

Unmasking the Alpha-Gal Syndrome

When the Lone Star tick bites, it injects a sugar molecule called alpha-gal into the body, which leads to allergies against certain types of red meat and mammal-derived products. This includes popular foods like pork, beef, rabbit, lamb, cheese, milk, dairy products, and even gelatin. Astonishingly, individuals with AGS can experience serious allergy symptoms within a few hours of consuming such foods.

The Alarming Lack of Awareness

Despite the rising number of suspected cases, AGS remains largely unfamiliar to many medical professionals. The CDC’s epidemiologist, Dr. Johanna Salzer, reveals that their survey showed almost half of physicians had never heard of the syndrome, while another third lacked confidence in diagnosing or managing patients with AGS. This knowledge gap contributes to the underreporting of cases, and the actual number of affected individuals could be as high as 450,000.

alpha-gal syndrome

The Spectrum of Reactions

AGS does not manifest consistently among individuals. Some may only experience mild gastrointestinal symptoms, while others can suffer from severe anaphylactic reactions. The perplexing nature of this condition makes it challenging for both patients and healthcare providers to pinpoint the exact triggers and tailor appropriate management.

Untangling the Lone Star Tick’s Trail

The geographic distribution of AGS aligns closely with the habitats of the Lone Star tick. The South, Midwest, and Mid-Atlantic regions are hotspots for this syndrome. However, there have been clusters of cases in unexpected areas like Minnesota and Wisconsin, indicating the potential involvement of other tick species or unidentified pockets of the Lone Star tick population.

alpha-gal syndrome

Promoting Prevention and Awareness

To protect against tick bites and the subsequent risks of AGS, experts recommend using EPA-approved insect repellents, wearing long-sleeved clothing, and avoiding grassy and wooded areas. Regular tick checks and thorough showers after outdoor activities can also be effective preventive measures.

alpha-gal syndrome

The Critical Need for Timely Diagnosis and Management

AGS patients often face a lengthy journey to obtain a proper diagnosis, taking an average of seven years to identify the condition accurately. Access to allergists can also be a barrier for many individuals seeking appropriate treatment. While there is currently no cure for AGS, healthcare providers can assist in managing symptoms and mitigating severe reactions through measures like Epi-Pens.

Conclusion

Alpha-Gal Syndrome poses a significant health risk, lurking in the shadows of tick bites, yet remaining unnoticed by many healthcare providers. Raising awareness about AGS is crucial to safeguarding public health and ensuring timely diagnosis and management. With increased knowledge and preventive measures, individuals can protect themselves from this potentially life-threatening “red-meat allergy” and its hidden triggers.

Sources: https://www.foxnews.com/health/mysterious-illness-triggered-tick-bite-affect-thousands-many-doctors-unaware

Post Views: 132

Selena Gomez’s Heartfelt Olive Branch to Francia Raisa

Published

10 months ago

July 27, 2023

Nurse Vicky

Selena Gomez’s Heartfelt Olive Branch to Francia Raisa

Selena Gomez Reaches Out on Francia’s Birthday Amidst Past Tensions

In a surprising turn of events, Selena Gomez, the renowned singer, and actress, seems to be making amends with her former friend and organ donor, Francia Raisa, on the occasion of Francia’s birthday.

The two had experienced a falling out recently, but Selena’s heartfelt message on social media suggests a possible reconciliation.

The post, shared on Selena’s social media accounts, features an endearing throwback picture of the duo, radiating joy and camaraderie. Selena captioned the photo with a touching message, “Happiest of birthdays to this special human being. No matter where life takes us, I love you.

Raisa: From Organ Donor to Estranged Friend

The apparent rift between Selena Gomez and Francia Raisa came to light when Francia publicly acknowledged the breakdown of their friendship.

selena gomez's heartfelt olive branch to francia raisa

This revelation had left fans and followers perplexed, as the two had been close for many years, with Francia even going to great lengths to support Selena in her health struggles.

Back in 2017, when Selena Gomez faced a severe health crisis due to her battle with lupus, Francia Raisa proved to be a true friend by selflessly donating one of her kidneys to save Selena’s life. This act of courage and kindness further strengthened their bond at that time.

The Taylor Swift Interview Incident

However, the delicate friendship took a hit when Selena Gomez made a remark in an interview, stating that the only person she was genuinely close to in Hollywood was Taylor Swift.

This comment didn’t sit well with Francia, given the history they shared and the significant sacrifice she had made for Selena. As a result, Francia unfollowed Selena on social media, indicating her hurt and disappointment.

selena gomez's heartfelt olive branch to francia raisa

A Birthday Post as an Olive Branch

Selena’s recent birthday message to Francia has caught the attention of fans and media alike, with many speculating whether this is an attempt to mend fences between the two. Could this be the olive branch that initiates the healing process and leads to a reconciliation?

The heartfelt post is likely to stir emotions and curiosity among their supporters. While some are hopeful for a reunion, others wonder if Francia will respond positively to Selena’s gesture.

What’s Next for Selena and Francia?

As the news of Selena Gomez’s birthday wishes for Francia Raisa spreads like wildfire, people are eager to witness how this situation unfolds. Will Francia reciprocate the gesture and signal a fresh start for their friendship?

For now, the ball is in Francia’s court, and fans will have to stay tuned to see if the birthday post truly “moves the needle” and paves the way for a renewed bond between the former friends.

Conclusion

In the world of Hollywood, friendships and relationships can often be complex and fragile. Selena Gomez and Francia Raisa’s journey from close friends to estranged companions has been a rollercoaster of emotions.

With Selena’s heartfelt birthday message, there’s a glimmer of hope that they might find a way back to each other’s lives.

As fans and well-wishers, we can only hope that this sweet gesture marks the beginning of a new chapter for Selena Gomez and Francia Raisa—a chapter of forgiveness, understanding, and lasting friendship.

Source: https://www.tmz.com/2023/07/26/selena-gomez-francia-raisa-happy-birthday-organ-donor-former-friend/

Post Views: 100

Understanding PTSD and Mental Health Implications Five Years After the Carr Fire

Published

10 months ago

July 21, 2023

Nurse Vicky

Unseen Scars: Understanding PTSD and Mental Health Implications Five Years After the Carr Fire

SHASTA COUNTY, Calif. — Half a decade ago, the Carr Fire engulfed Shasta County, California, leaving an unforgettable scar on the landscape and residents’ lives.

Although new neighborhoods have arisen from the ashes, the psychological wounds linger, often manifesting as anxiety and fear triggered by smoke or the sound of emergency vehicles.

Living in the Aftermath: Personal Perspectives

Among the countless families impacted, Todd Buck’s experience encapsulates the ongoing struggle. After losing their home to the Carr Fire, Buck and his family now find any hint of smoke raises their anxiety levels significantly.

Buck reflects, “Every time we see smoke, the anxiety level goes up. Some are affected more, my wife is really affected by it. I am as well.”

This anxiety is also familiar to Spencer Baker’s family who faced the devastating loss of their home shortly after moving to Shasta County. Baker acknowledges the nerve-racking reality, wondering, “It was devastating…what do you do?”

Unveiling the PTSD Aftermath: Insights from a Mental Health Professional

Peggy Alena Marie Farver, a licensed marriage and family therapist specializing in Post Traumatic Stress Disorder (PTSD), continues to aid clients grappling with PTSD symptoms stemming from the Carr Fire.

She notices a spike in anxiety levels, especially during certain times of the year. Farver states, “People, especially during this time of year, find an increase in anxiety. The symptoms don’t just disappear. It was just so intense. So traumatic.”

Baker’s family, living on a popular route for fire crews, regularly face the tension triggered by sirens and smoke. It’s this lingering fear that exemplifies the deep impact of the Carr Fire on residents.

PTSD Symptoms and Coping Mechanisms

Farver elucidates that PTSD symptoms often include fear of recurrence and strong physical reactions to triggers such as smoke or a red sunset.

She stresses the importance of acknowledging these feelings, finding an appropriate coping mechanism, and absolving oneself of any guilt.

Farver’s expertise in art therapy lends itself to powerful interventions, fostering effective coping skills to practice for life.

Looking Ahead: Healing and Hope Post Carr Fire

Buck, despite his ordeal, sees a silver lining. He credits the Carr Fire for fostering a closer community. Buck concludes, “That’s what keeps us going and as I said, it’s a process and we’re going to keep at it and every day is a new day.”