CMS announces plan for NEW Alzheimer’s medications

CMS announces plan for NEW Alzheimer’s medications

by | Jun 5, 2023 | Health

Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure announced today how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. If the Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare.

“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” Brooks-LaSure said. “If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon.”

FDA Timeline

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product Leqembi on June 9, with a potential decision on traditional approval possible within weeks. Broader Medicare coverage would begin on the same day the FDA grants traditional approval. Under CMS’ current coverage policy, if FDA grants traditional approval to other drugs in this class they would also be eligible for broader coverage. Currently two drugs in this class have received accelerated approval from the FDA, but no product has received traditional approval.

Medicare Drug Inclusions

Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format. This method, and any others that may follow, will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA. Researchers will have access to the information to conduct studies, furthering knowledge of how these drugs can potentially help people. CMS is working with multiple organizations that are getting ready to open their own registries. More information will be released as they come on line.

Roll Out How’s

The approach is consistent with CMS’ National Coverage Determination. To get Medicare coverage people will need to 1) be enrolled in Medicare Part B, 2) be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease, and 3) have a qualified physician participating in a registry, including the options above, with an appropriate clinical team and follow up care. These criteria are in addition to any label requirements the FDA specifies.

Registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades. There is strong precedent for using registries to gather more information on a newly-approved treatment. For example, when the FDA granted traditional approval to the transcatheter aortic valve replacement (TAVR), CMS required the clinicians and hospitals to participate in a registry to track outcomes. Information gathered from that registry has since been used to further inform Medicare coverage determinations, and to help people and their clinicians make better decisions about whether TAVR is the best treatment for them.

Additional Information from CMS

Other registries for drugs that may slow the progression of Alzheimer’s disease may become available in the coming weeks and months. Information will be available at https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development as studies come on line.

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Alzheimer’s Disease Options Explored

Alzheimer’s Disease Options Explored

by | Mar 2, 2023 | Health

disease is a debilitating condition that affects millions of people worldwide. Despite years of research, there is still no cure for this disease. However, weighing new treatments for Alzheimer’s disease has several potential benefits that can help improve patient outcomes, reduce healthcare costs, increase research funding, improve understanding of the disease, and improve . In this article, we will explore each of these potential benefits in detail and discuss how weighing new treatments for Alzheimer’s disease is an important step in the fight against this debilitating condition.

Improved Patient Outcomes

Alzheimer’s disease is a progressive disorder that affects cognitive function, memory, and behavior. Currently available treatments only provide limited benefits and do not slow down the disease’s progression. However, new treatments that target the underlying mechanisms of the disease could provide more significant benefits. For instance, new drugs that reduce the production of amyloid plaques or tau protein tangles, which are the hallmark features of Alzheimer’s disease, could slow down the disease’s progression and improve cognitive function. Moreover, new treatments that target , oxidative stress, or neuronal damage could also improve patient outcomes. These new treatments have the potential to significantly improve the quality of life for individuals with Alzheimer’s disease, which is an important goal of healthcare.

Reduced Healthcare Costs

Alzheimer’s disease is a costly disease, both in terms of direct medical costs and indirect costs such as lost productivity and caregiver burden. In the United States, the annual cost of caring for individuals with Alzheimer’s disease and other dementias is estimated to be $305 billion. By 2050, this cost is projected to increase to $1.1 trillion. Developing more effective treatments that delay disease progression, reduce hospitalizations and long-term care, and improve quality of life could help reduce these costs significantly. For instance, new treatments that delay disease progression could reduce the need for hospitalization and long-term care, which are major contributors to healthcare costs. Moreover, improved quality of life for individuals with Alzheimer’s disease could reduce caregiver burden and improve productivity, which would have a positive impact on the economy.

Increased Research Funding

Despite years of research, the underlying mechanisms of Alzheimer’s disease are not fully understood. Moreover, most clinical trials of new treatments have failed to show significant benefits, leading to a decline in research funding. However, weighing new treatments for Alzheimer’s disease can help increase funding for research into the disease. New treatments that target the early stages of the disease, such as mild cognitive impairment, could lead to new discoveries and breakthroughs in treatment. Additionally, new treatments that involve personalized medicine, gene therapy, or stem cell therapy could also provide new avenues for research. Investing in research into new treatments for Alzheimer’s disease is critical for improving our understanding of the disease and developing more effective treatments.

Improved Understanding of the Disease

Weighing new treatments for Alzheimer’s disease can also lead to a better understanding of the underlying mechanisms of the disease. New imaging techniques such as positron emission tomography () and magnetic resonance imaging (MRI) can help identify the changes in the brain that occur during the disease’s progression. Moreover, new genetic studies can identify the risk factors and genetic variants associated with the disease. Such insights can inform the development of future treatments and potentially even a cure. Improved understanding of the disease is critical for developing more effective treatments and ultimately finding a cure for Alzheimer’s disease.

Improved Public

Alzheimer’s disease is a major public health issue, affecting millions of people around the world. Moreover, the disease has a significant impact on the individuals, families, and society as a whole. Caring for individuals with Alzheimer’s disease can be emotionally and financially draining for caregivers. Moreover, individuals with Alzheimer’s disease are at increased risk of falls, injuries, and other health problems. Developing new treatments for the disease can have a significant impact on public health, reducing the burden of the disease on individuals, families, and society as a whole. Moreover, new treatments could improve quality of life and reduce healthcare costs, which would have a positive impact on the economy.

Challenges in Developing New Treatments

Developing new treatments for Alzheimer’s disease is a complex and challenging process. The disease is multifactorial, with several underlying mechanisms involved. Moreover, the blood-brain barrier presents a significant challenge in delivering drugs to the brain. Additionally, Alzheimer’s disease is a chronic condition that requires long-term treatment, which can be costly and challenging for patients and caregivers. Furthermore, clinical trials of new treatments for Alzheimer’s disease have a high failure rate, which can be discouraging for researchers and investors.

Blood-Brain Barrier

The blood-brain barrier is a protective mechanism that prevents harmful substances from entering the brain. However, this mechanism also presents a challenge in delivering drugs to the brain. Many drugs that are effective in treating other diseases are unable to cross the blood-brain barrier, limiting their efficacy in treating Alzheimer’s disease. Researchers are exploring several strategies to overcome this challenge, including nanotechnology, gene therapy, and immune system modulation.

Clinical Trial Failures

Clinical trials of new treatments for Alzheimer’s disease have a high failure rate. Many drugs that show promise in preclinical studies fail to show significant benefits in clinical trials. This high failure rate is partly due to the complexity of the disease and the lack of understanding of its underlying mechanisms. However, it is also due to the limitations of current clinical trial designs, which may not be optimal for Alzheimer’s disease. To address this issue, researchers are exploring new trial designs, such as adaptive trials, that allow for flexibility and early efficacy assessments.

Promising New Treatments

Despite the challenges in developing new treatments for Alzheimer’s disease, several promising treatments are currently under investigation.

Biogen’s Aducanumab

Aducanumab is a monoclonal antibody that targets amyloid plaques, one of the hallmark features of Alzheimer’s disease. In clinical trials, aducanumab showed a significant reduction in amyloid plaques and a slowing of cognitive decline in patients with early-stage Alzheimer’s disease. In June 2021, the FDA approved aducanumab for the treatment of Alzheimer’s disease, making it the first drug to be approved for the disease in nearly 20 years.

Leuco-methylthioninium-bis(Hydromethanesulfonate) (LMTM)

LMTM is a drug that targets tau protein tangles, another hallmark feature of Alzheimer’s disease. In clinical trials, LMTM showed a significant reduction in tau protein tangles and a slowing of cognitive decline in patients with mild-to-moderate Alzheimer’s disease. However, subsequent trials did not show significant benefits, and further research is needed to determine the drug’s efficacy.

BAN2401

BAN2401 is a monoclonal antibody that targets amyloid plaques. In clinical trials, BAN2401 showed a significant reduction in amyloid plaques and a slowing of cognitive decline in patients with early-stage Alzheimer’s disease. Moreover, BAN2401 has shown potential in reducing the accumulation of amyloid plaques in the brain, which could have significant benefits in the long term. BAN2401 is currently in phase III clinical trials, and the results are eagerly awaited.

Other Promising Treatments

Several other treatments are also under investigation, including:

  • GV-971, a drug derived from seaweed that targets gut bacteria
  • Amylyx Pharmaceuticals’ AMX0035, a combination therapy that targets neuroinflammation and neuronal damage
  • Gene therapies that target genetic risk factors for Alzheimer’s disease, such as apolipoprotein E (APOE)

While these treatments are still in the early stages of investigation, they hold promise for the future of Alzheimer’s disease treatment.

Conclusion

Alzheimer’s disease is a devastating condition that affects millions of people worldwide. Despite the significant amount of research that has been done in the field, there is still no cure for this disease. However, weighing new treatments for Alzheimer’s disease has several potential benefits, including improved patient outcomes, reduced healthcare costs, increased research funding, improved understanding of the disease, and improved public health. New treatments that target the underlying mechanisms of the disease could provide more significant benefits than currently available treatments. While there are challenges in developing new treatments for Alzheimer’s disease, promising new treatments are currently under investigation, and the future is looking brighter for individuals affected by this devastating condition.

It is important to continue investing in research into new treatments for Alzheimer’s disease. The disease has a significant impact on public health, and developing new treatments could reduce the burden of the disease on individuals, families, and society as a whole. Moreover, new treatments could improve quality of life and reduce healthcare costs, which would have a positive impact on the economy. We must continue to support researchers and healthcare providers in their efforts to develop more effective treatments for Alzheimer’s disease.  

 

Your Attitude and Quality of Life

Your Attitude and Quality of Life

by | Mar 1, 2023 | Psychology

Is the quality of your life really impacted by your attitude? And what do the professionals say about it? Yes, cultivating an attitude of gratitude can have numerous benefits for both physical and mental , and can be worth the effort. In today’s fast-paced and stressful world, it’s easy to get caught up in negativity and forget to appreciate the good things in life. But taking a few minutes each day to cultivate an attitude of gratitude can make a significant difference in your overall .

How does an attitude of gratitude impact quality of life?

  1. Better mental health: A positive attitude is associated with lower rates of , anxiety, and stress. Optimistic individuals tend to have better coping skills, resilience, and a more positive self-image. When you focus on the positive aspects of life, you’re less likely to get bogged down by negative thoughts and emotions.
  2. Improved physical health: Positive attitudes have been linked to better physical health outcomes, including lower rates of , lower blood pressure, and a stronger immune system. Individuals with positive attitudes may also be more likely to engage in healthy behaviors such as and eating a healthy . When you feel good about yourself and your life, you’re more motivated to take care of your body.
  3. Better relationships: Positive attitudes can lead to more positive interactions with others and stronger social connections. Optimistic individuals tend to be more outgoing, friendly, and empathetic, which can lead to better interpersonal relationships and social support. When you appreciate the people in your life and express gratitude for their presence, you’re more likely to foster positive relationships.
  4. Improved overall well-being: A positive attitude can lead to a greater sense of purpose, meaning, and satisfaction in life. Positive individuals tend to be more resilient in the face of challenges and have a greater sense of overall well-being. When you focus on the good things in your life and appreciate what you have, you’re less likely to feel overwhelmed by difficulties and more likely to find joy in everyday moments.

How can you cultivate an attitude of gratitude?

Cultivating an attitude of gratitude does not have to be a major effort – it can be as simple as taking a few minutes each day to reflect on the good things in life, keeping a gratitude journal, or expressing thanks to others. The more that gratitude becomes a habit or routine, the easier it may be to maintain an overall positive outlook on life. Here are some practical ways to cultivate an attitude of gratitude:

  1. Keep a gratitude journal: Write down three things you’re grateful for each day. This can be as simple as a good cup of coffee, a sunny day, or a phone call from a friend. By focusing on the positive aspects of your life, you’re training your brain to look for the good.
  2. Express gratitude to others: Take time to thank the people in your life who make a difference. This can be as simple as a thank-you note or a heartfelt conversation. When you express gratitude to others, you’re not only cultivating an attitude of gratitude in yourself but also spreading positivity to those around you.
  3. Practice mindfulness: Take a few minutes each day to sit quietly and focus on your breath. As you breathe in and out, think about the things in your life that you’re grateful for.

In summary, an attitude of gratitude can have numerous benefits for physical and mental health, and can be worth the effort. Whether through daily reflections or other practices, cultivating gratitude can help to promote a more positive outlook on life and may contribute to improved overall well-being.

What are the True Impacts of Sleep

What are the True Impacts of Sleep

by | Mar 1, 2023 | Wellness

As a general rule, we all know that we feel better after a good night’s and worse when we don’t. If so, why? A person’s and happiness are directly tied to the amount and quality of sleep they get each night. Some of the many positive effects of sleep on health are listed here.

Physical Health Benefits of Sleep

Restoring and revitalizing the body physically is a primary function of sleep. During your sleep, your body repairs damaged tissues, creates new cells, and secretes growth hormones. Lack of sleep can lead to negative physical health outcomes.

Metabolic Syndrome: Sleep deprivation has been associated with metabolic syndrome, a cluster of conditions that includes high blood sugar, , excess abdominal fat, and abnormal cholesterol or triglyceride levels. Metabolic syndrome increases the risk of developing type 2 and .

Type 2 Diabetes: A lack of sleep can also affect insulin sensitivity, leading to impaired glucose tolerance and an increased risk of developing type 2 diabetes.

Cardiovascular Disease: Sleep deprivation has been linked to an increased risk of developing cardiovascular disease, including hypertension, stroke, and heart attack.

Immune Function: Sleep is essential for optimal immune function, including the production of cytokines, which help fight infection and . Sleep deprivation can impair the immune system, making it more challenging for the body to fight off infections and illnesses.

Mental Health Benefits of Sleep

Sleep is also crucial for maintaining sound mental health. Irritability, mood fluctuations, and inability to focus are all symptoms of sleep deprivation. In addition to raising the likelihood of developing both sadness and anxiety, chronic sleep loss has been shown to make these conditions more likely to manifest.

Cognitive Function: In order to think clearly, remember information, and come up with original solutions, you need a good night’s sleep. Certain mental operations can be hindered by sleep deprivation, which in turn can decrease productivity and performance.

Emotional Control: Sleep aids in emotional regulation by providing time and space for processing and coping with feelings. Low sleep quality has been linked to increased emotional reactivity and a diminished ability to cope with stress.

The Importance of Good Sleep Habits

Healthy sleep is crucial to your overall health and happiness. Those who get enough sleep report feeling revitalized, re-energized, and mentally sharp. But, not getting enough shut-eye might make you feel drained and listless.

For best health and happiness, it is crucial to prioritize excellent sleep habits including:

1. Stick to a regular sleep schedule.

Going to bed and waking up at the same time each day can help regulate your body’s internal clock, making it easier to fall asleep and wake up naturally.

2. Make your bedroom a relaxing place to unwind.

Creating a peaceful sleep environment with a comfortable bed, appropriate temperature, and minimal distractions can help promote restful sleep.

3. Avoid screen time in the hours before bed.

The blue light emitted from screens can interfere with the body’s natural production of melatonin, a hormone that regulates sleep and wakefulness. Avoiding screens for at least an hour before bed can help promote better sleep quality.

Conclusion

All things considered, sleep is crucial to a person’s in terms of their physical health, mental health, cognitive function, emotional control, and general sense of happiness. Lack of sleep can lead to negative outcomes in all of these areas.

To ensure optimal health and well-being, it is important to prioritize good sleep habits and seek professional medical advice if you are experiencing ongoing sleep problems or chronic sleep deprivation. If you are struggling to get enough quality sleep, consult with your healthcare provider, who can help identify any underlying medical conditions that may be affecting your sleep and provide treatment options.

In addition to seeking medical advice, there are many things you can do to improve your sleep hygiene, including establishing a relaxing bedtime routine, avoiding caffeine and alcohol before bed, and getting regular . Meditation and relaxation techniques, such as deep breathing exercises, can also help promote better sleep.

It’s important to note that while everyone’s sleep needs are different, most adults require between seven and nine hours of sleep per night to function optimally. Children and teenagers require even more sleep, with newborns requiring up to 17 hours of sleep per day.

In conclusion, the impact of sleep on health is significant, and quality sleep is essential for physical and mental well-being. By prioritizing good sleep hygiene and seeking professional medical advice when needed, you can improve your sleep and enjoy the many health benefits that come with it.

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