FOR PROFIT MEDICINE
Prostate cancer patients face financial toxicity: Who is affected and how do they cope?
New insights into financial impact on patients with advanced prostate cancer in The Journal of Urology®
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July 7, 2023 – Fifty percent of patients with metastatic prostate cancer experience some level of financial hardship due to their treatment, according to a study in the August issue of The Journal of Urology®, an Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer.
"Our findings help in understanding the rates of and risk factors for financial toxicity among patients with advanced prostate cancer, along with the coping mechanisms, including the impact on personal spending, experienced by those reporting higher levels of financial toxicity," comments senior author Stephen A. Boorjian, MD, of Mayo Clinic, Rochester, Minn.
"Our most significant finding may be that patients experience financial toxicity despite their ability to remain compliant with treatment," says lead author Daniel D. Joyce, MD. "Simply asking patients whether they are following their suggested treatments is not sufficient to screen for financial toxicity."
New data on financial toxicity rates, risk factors, and coping strategies
The researchers administered a validated questionnaire concerning financial toxicity to all patients seen at their advanced prostate cancer clinic over a three-month period. Financial toxicity – which has been defined as "the harm to patients that results from treatment costs" – has become recognized as important patient-centered outcome. Previous reports suggest that up to half of cancer survivors are affected by financial toxicity, which has been linked to increased rates of adverse treatment outcomes.
Drs. Joyce and Boorjian and colleagues assessed the rate of financial toxicity and the related patient characteristics and coping strategies among patients being treated for metastatic prostate cancer. The analysis included responses from 281 patients, median age 69 years.
Based on the study questionnaire, 79 patients were classified as having high financial toxicity. Overall, 54% of patients said they experienced at least some level of financial hardship related to their cancer treatment. The impact was "more profound" among patients with high financial toxicity, with 89% percent reporting financial hardship.
Patients may make 'profound personal sacrifices' to remain compliant with prostate cancer treatments
Several patient characteristics were associated with higher or lower risks of financial toxicity. Older patients had lower financial toxicity, as each additional year of age was associated with a 25% reduction in risk. For patients who were married (or had a non-married partner), financial toxicity risk was nearly four times lower than for those who were unmarried, widowed, or divorced. Not surprisingly, income was a significant factor: risk of financial toxicity was nine times lower for patients with annual incomes of $100,000, compared to incomes under $20,000.
Patients experiencing high financial toxicity coped in varied ways. They were more likely to decrease spending on basic goods and leisure activities, to use their savings to pay for medical care, to delay filling prescriptions, and to borrow money to pay for their care. "Notably, very few patients reported only partially filling medications or stopping medications altogether due to cost," the researchers write.
More than half of patients with high financial toxicity reported difficulty paying bills – and patients in this group were more likely to have delays in starting cancer treatment. Patients with high financial toxicity were also more likely to use financial assistance programs: 32%, compared to 12% of those with low financial toxicity. "Patients are often unable to meet the high treatment initiation costs without some type of financial assistance program or subsidy," the researchers write.
Dr. Joyce comments: "Some patients may be making profound personal sacrifices in order remain adherent with their prostate cancer treatment, which may have a significant impact on the quality of life that we hope to prolong with these treatments. Conversations about these issues are even more crucial given the observed improvement in financial toxicity among patients in our study who were able to access financial assistance programs."
The researchers highlight the need to identify factors that may mitigate the financial impact of treatments for metastatic prostate cancer. They conclude: "Such data are crucial to understand how to include financial toxicity in shared decision-making and to guide future interventions designed to reduce financial toxicity in this population."
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About The Journal of Urology®
The Official Journal of the American Urological Association (AUA), and the most widely read and highly cited journal in the field, The Journal of Urology® brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology. This premier journal presents investigative studies on critical areas of research and practice, survey articles providing brief editorial comments on the best and most important urology literature worldwide and practice-oriented reports on significant clinical observations. The Journal of Urology® covers the wide scope of urology, including pediatric urology, urologic cancers, renal transplantation, male infertility, urinary tract stones, female urology and neurourology.
About the American Urological Association
Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 23,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health care policy. To learn more about the AUA visit: www.auanet.org
About Wolters Kluwer
Wolters Kluwer (EURONEXT: WKL) is a global leader in professional information, software solutions, and services for the healthcare, tax and accounting, financial and corporate compliance, legal and regulatory, and corporate performance and ESG sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.
Wolters Kluwer reported 2022 annual revenues of €5.5 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 20,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.
For more information, visit www.wolterskluwer.com, follow us on LinkedIn, Twitter, Facebook, and YouTube.
JOURNAL
The Journal of Urology
ARTICLE PUBLICATION DATE
1-Aug-2023
Expanding Medicaid improved
care without crowding out other patients
Sharp rise in clinic visits that included high-value preventive care for heart, brain and bone risks was seen in states that opted to allow all low-income adults to get covered
People with low incomes who live in states that expanded Medicaid got more of the kind of health care that can keep them healthier in the long run, compared with similar people in non-expansion states, a new study finds.
They also received more health care overall, specifically clinic visits. But they didn’t crowd out patients covered by Medicare or private insurance such as from an employer, the study finds. Those groups continued to have clinic visits and receive preventive care at the same rate as before Medicaid expanded.
The findings, made using detailed health care data from two groups of states that made different decisions about expanding coverage under the Affordable Care Act, are published in BMC Health Services Research by a team from the University of Michigan and the University of California Los Angeles.
“Expanding Medicaid not only expanded low-income adults’ overall access to health care, but it also specifically expanded access to preventive care that could pay off down the road in better health,” says Aaron Parzuchowski, M.D., M.P.H., M.S., who led the study while he was a National Clinician Scholar at the U-M Institute for Healthcare Policy and Innovation and the VA Ann Arbor Healthcare System. “At the same time, concerns that other patients would receive less care, or more hurried care with less focus on prevention, did not pan out.”
To qualify for Medicaid coverage in an expansion state, a single adult can have an income no higher than about $20,000.
Three of the five states in the study that hadn’t expanded Medicaid at the time of the analysis – Virginia, North Carolina and Georgia – have now done so. But the other two – Florida and Texas – and eight other states still have not. About 3.5 million adults could qualify for coverage if those 10 states expanded the program.
In addition, more than 1.5 million adults and children have lost Medicaid coverage in recent months across the country during the “unwinding” of pandemic-era provisions; most for administrative reasons rather than due to increased income.
Parzuchowski, who is now a lecturer in internal medicine at Michigan Medicine, U-M’s academic medical center, worked with the UCLA team led by John Mafi, M.D., as well as A. Mark Fendrick, M.D., director of U-M’s Center for Value Based Insurance Design.
In addition to overall trends in care, their study zeroes in on what experts refer to as “high value” care – medications and other treatments that can help prevent or delay costly health problems in adults with clogged heart arteries, heart failure, diabetes, depression or osteoporosis.
The team used data from the National Ambulatory Medical Care Survey, run by the Centers for Disease Control and Prevention, to look at the insurance coverage, health conditions and medical care of 143 million adults living in high-population states from 2012 to 2015. They focused on adults’ visits to physician offices and clinics, excluding federally funded ‘safety net’ clinics.
Medicaid expansion became law in 2014 in eight of the states studied (Arizona, California, Illinois, Massachusetts, New Jersey, New York, Ohio and Washington), giving the researchers two years before the expansion and two years after to look for differences between those states and the five comparison states. They also accounted for changes in each state’s population during the same time period.
As part of the study, the researchers focused only on the kinds of appointments where it would have made sense for the doctor or other provider to prescribe one of the high-value medications or treatments based on the patient’s risk factors or health history. They also included visits where providers could have prescribed low-value types of care such as opioid pain medicines for back, neck or head pain, or antibiotics for upper respiratory tract infections.
In all, they found that the number of all Medicaid visits, and the number of Medicaid visits by patients who were likely new Medicaid enrollees, both went up in expansion states but not in non-expansion states. Total Medicaid visits went up by 35%, with 16 more per 100 adults living in the state.
The total number of adult visits, and the visits by patients with Medicare or private insurance, did not change significantly in either group of states.
There was also a 19% increase in the likelihood that a clinic visit by a new Medicaid enrollee would include high-value care in expansion states. In non-expansion states the likelihood that a visit by a new Medicaid enrollee would include high-value care dropped by 24% in the same timeframe.
"Our findings dispel a frequently stated concern that access to clinicians and quality of care would be reduced for people enrolled in other insurance types in states that expanded Medicaid," said Fendrick.
In addition to Parzuchowski and Fendrick, who are members of IHPI, and Mafi, the study’s authors are UCLA’s Carlos Oronce, Rong Guo and Chi-Hong Tseng.
The study was funded by a National Institute on Aging K76 Career Development Award, and by the VA Office of Academic Affiliations and Michigan Medicine
Evaluating the accessibility and value of U.S. ambulatory care among Medicaid expansion states and non-expansion states, 2012–2015, DOI: 10.1186/s12913-023-09696-x, https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09696-x
JOURNAL
BMC Health Services Research
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Evaluating the accessibility and value of U.S. ambulatory care among Medicaid expansion states and non-expansion states, 2012–2015
ARTICLE PUBLICATION DATE
3-Jul-2023
New study: Black women with hypertensive disorders of pregnancy have increased stroke risk
Researchers estimate a 66% increased long-term risk of stroke
Peer-Reviewed PublicationBoston) – U.S. Black women have a disproportionately higher burden of both preeclamptic pregnancy and stroke compared with white women, but virtually all existing evidence on the association between the two medical conditions has come from studies of white women.
A newly published study focuses on data gathered over 25 years from 59,000 Black women in the Black Women’s Health Study (BWHS) and is led by researchers from Boston University Chobanian & Avedisian School of Medicine and Slone Epidemiology Center. The study, published in the New England Journal of Medicine Evidence, finds that Black women with a history of hypertensive disorders of pregnancy (HDOP) have an estimated 66% increased long-term risk of stroke.
“Our results may explain, in part, the disproportionately high incidence of stroke in Black women relative to other populations,” said corresponding author Shanshan Sheehy, MD, ScD, assistant professor of medicine at the school and an investigator at the Slone Epidemiology Center.
Researchers looked at U.S. Black women enrolled in the BWHS , including 42,924 participants who had given birth and were free of cardiovascular disease before entry into the analysis. Biennial questionnaires had asked about preeclampsia, gestational hypertension, and stroke, among other conditions. Medical records were sought for self-reports of stroke and were reviewed by neurologists.
Over the period from 1995 through 2019, there were 1,555 strokes, including 310 among 4,938 women with a history of HDOP. Women who reported a history of HDOP were estimated to have 1.66 times the risk of stroke relative to parous women who had not had those pregnancy complications; for history of preeclampsia in particular, the estimated HR was 1.53. The association was present both among younger women (age less than 60) and older women. It was also present among women who were not overweight in young adulthood as well as women who were overweight or obese at that time.
Preeclampsia affects approximately 2 to 8% of pregnancies and is the second leading cause of maternal mortality worldwide. Preeclampsia/eclampsia among Black women in the U.S. is 60% higher than among white women (70 per 1,000 deliveries in 2014 for Black women vs. 43 per 1,000 for white women). In recent years, rates of severe preeclampsia have been increasing for Black women.
The American Heart Association (AHA) guidelines recently added pregnancy complications to their list of risk factors for stroke. However, the recommendations were based largely on data from women of Northern European ancestry and the AHA has called for more research on risk of stroke in women, especially women from underrepresented populations.
“Our study provides evidence that pregnancy history may be an important factor for risk assessment and prevention of long-term stroke,” said Sheehy. “Cardiovascular screening recommendations for Black women in particular should take the history of HODP into account.”
This study was funded by the National Institutes of Health, R01CA058420, U01CA164974, and R01MD015085. Dr. Aparicio is supported by an American Academy of Neurology Career Development Award and from the Boston University Aram V. Chobanian Assistant Professorship.
JOURNAL
NEJM Evidence
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Hypertensive Disorders of Pregnancy and Risk of Stroke in U.S. Black Women
ARTICLE PUBLICATION DATE
6-Jul-2023
Alzheimer's drug Leqembi has full FDA approval in the U.S. now and that means Medicare will pay for it
Drug is not currently approved in Canada
The Food and Drug Administration (FDA) endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It's the first medicine that's been convincingly shown to modestly slow the cognitive decline caused by Alzheimer's.
Japanese drug-maker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.
The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.
"This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease," said FDA's neurology drug director, Dr. Teresa Buracchio, in a statement.
The drug's prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases. The label notes that those problems are seen with other plaque-targeting Alzheimer's drugs.
Leqembi is not approved in Canada, though clinical trials have been run in Toronto.
Drug costs more than $26K for one year
The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer's patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn't pay for routine use of drugs like Leqembi until they receive FDA's full approval.
There were concerns that the cost of new plaque-targeting Alzheimer's drugs could overwhelm the program's finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year's supply of IVs every two weeks.
The vast majority of Americans with Alzheimer's get their health coverage through Medicare. And private insurers have followed its lead by withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive FDA's full endorsement.
WATCH: New Alzheimer's drug met with hope and caution
An FDA decision on full approval for Aduhelm is still years away.
Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrolment in a federal registry to track the drug's real-world safety and effectiveness.
Medicare "will cover this medication broadly while continuing to gather data that will help us understand how the drug works," Brooks-LaSure said.
Some Medicare patients could be responsible for paying the standard 20 per cent of the cost of Leqembi, though the amount will vary depending on their plans and other coverage details.
Hospitals and medical clinics have cautioned that it may take time to get people started on the drug.
Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding.
The imaging and administration services carry extra costs for hospitals beyond the drug itself.
Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.
"We want to ensure that appropriate patients only are the ones that get this product," said Alexander Scott, a vice president with Eisai.
Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion.
Some Alzheimer's experts say that delay is likely too subtle for patients or their families to notice.
But federal health advisers said the difference could still be meaningful and recommended that FDA fully approve the drug at a public meeting in June.
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