Following NCCN Guidelines for Metastatic Breast Cancer Results in Lower Costs for Patients

Research from the O’Neal Comprehensive Cancer Center at UAB finds patients treated outside of NCCN Guidelines recommendations had significantly higher direct costs.

A new study from the O’Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), published in the October 2019 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that direct costs for metastatic breast cancer (MBC) patients increase dramatically when their treatment differs from recommendations in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Previous studies have found that guideline discordant care results in higher health care costs overall1, but this is the first study to look specifically at the cost burden for patients.

“We thought that it was important to explore potential differences in out-of-pocket costs, since financial toxicity is a growing issue among patients with metastatic breast cancer,” explained Courtney P. Williams, MPH, Division of Hematology and Oncology, O’Neal Comprehensive Cancer Center at UAB. “We found about one in five women received an anticancer treatment that wasn’t listed within the NCCN Guidelines. Those women were responsible for higher out-of-pocket costs—including deductibles, coinsurance, and copayments—in the year following their metastatic breast cancer diagnosis than those receiving an anticancer treatment listed within the guidelines. This finding is especially important for older patients, which made up about 75 percent of our sample, since financial and psychological distress could be worse for patients living on a fixed income.”

The retrospective study used the SEER-Medicare database to look at patient costs for 3,709 women diagnosed with MBC between 2007 and 2013 who survived at least a year after diagnosis. Treatment regimens were matched to the version of the NCCN Guidelines® for Breast Cancer that were available at the exact treatment date. The definition of guideline-concordant care varied depending on date due to NCCN’s frequent guideline updates.

The median patient cost for the year post-diagnosis was $5,171 for care that fit within contemporary NCCN Guidelines, versus $7,421 for care that deviated from them. Both overtreatment and undertreatment—as defined by the guidelines—ultimately resulted in higher patient costs.

“The observation that out-of-pocket costs may be greater for guideline discordant care is important for both patients and physicians to understand, especially when many guideline discordant treatments may not improve clinical outcomes,” commented Matthew P. Goetz, MD, Mayo Clinic Cancer Center, Member of the NCCN Guidelines Panel for Breast Cancer, who was not involved in this study. “Clinical trials should be prioritized as a way to offer patients access to new drugs/treatments that might not otherwise be available to them, while limiting out-of-pocket expenses.”

Non-approved use of bevacizumab accounted for the highest increase in patient expenses, and was also associated with worse outcomes. The article cited this fact as a “cautionary tale for physicians who add novel agents without proven benefit to treatment regimens,” and argued that it might be better to provide no treatment, than to provide a “guideline-discordant treatment associated with mild but persistent and bothersome adverse events.”

“NCCN Guidelines exist to provide recommendations based on scientific evidence and expert opinion,” said Williams. “Although there will always be circumstances where off-guideline treatment is warranted, physicians should aim to comply with current guidelines for the safety of the patient, both physically and psychologically, as well as to decrease adverse outcomes such as financial toxicity.”

To read the entire study, visit JNCCN.org. Complimentary access to “Guideline Discordance and Patient Cost Responsibility in Medicare Beneficiaries with Metastatic Breast Cancer” is available until January 10, 2020.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world.

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Consumer Warning for Erectile Dysfunction Pills

The U.S. Food and Drug Administration is warning consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by the FDA.

The FDA confirmed that consumers have received these drugs, without a prescription, which contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients including the elderly and those with impaired liver and kidney function. When sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, a person’s blood pressure can reach dangerously low levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Do not use these products. If you have used these products and became ill or otherwise experienced an adverse event, contact your health care provider. FDA continues to warn consumers that medications purchased from unapproved and/or unlicensed sources may be dangerous as they can be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.

The label on the blister packs for these unapproved drugs states that the products are manufactured in India by Acme Generics. The label also bears the name Sun Pharma. FDA is concerned the seller may also be distributing to U.S. consumers unapproved tadalafil as a generic for the prescription drug Cialis.

Adverse Events
To date, FDA is not aware of any adverse events associated with these particular unapproved versions of sildenafil or tadalifil. Health care professionals and consumers should report any adverse events related to this product to FDA’s MedWatch. Adverse Event Reporting program by:
•  Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
•  Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

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3D Printing for Medical Devices

3D printing is a process that creates a three-dimensional object by building successive layers of raw material.

Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).  The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

In the picture, models have been 3D-printed for (left to right, top) a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. Due to its versatility, 3D printing has medical applications in:
• Medical devices – regulated by FDA’s Center for Devices and Radiological Health (CDRH)
• Biologics – regulated by FDA’s Center for Biologics Evaluation and Research
• Drugs – regulated by FDA’s Center for Drug Evaluation and Research

Medical device manufacturers should refer to FDA guidance documents and Quality Systems regulations for more information on specific applications.

Additional Resources (see link) are available, including:
• The 3Rs of 3D Printing: FDA’s Role
Learn how the FDA reviews and researches 3D printed medical products to protect the public health.
• How 3D Printers Work
A resource from the Department of Energy and includes descriptions of different types of printing processes
• NIH 3D Print Exchange
Offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science. The goal of the project is to facilitate the application of 3D printing in the biosciences.
• American Society of the International Association for Testing and Materials (ASTM)
This is a collaborative, consensus organization that has published standards and test methods for additive manufacturing and 3D printing.
• America Make
A public private partnership whose members, including the FDA, are working together to innovate and accelerate 3D printing to increase our nation’s global manufacturing competitiveness.

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Working to Bridge Gaps in Rare Disease Product Development

There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. Many
of these diseases are serious or life-threatening and it is estimated that half affect children. Unfortunately, most rare diseases still do not have approved therapies.  In 2018 we saw a record number of novel drugs and biologics approved for rare diseases. In particular, there were 35 novel drugs and biologics approved in 2018 with orphan drug designation. This is the highest number since the passage of the Orphan Drug Act in 1983.

These approvals included drugs and biologics utilizing programs to facilitate and expedite development and review of medical products to address unmet medical need. Among the many new orphan therapies in 2018, the FDA approved the first drug to treat patients with a rare, inherited form of rickets, and the first orally-administered drug to treat Fabry disease. The FDA also approved a new biologic for patients when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The FDA will host a public meeting on April 29, 2019: ”Patient Perspectives of the Impact of Rare Diseases: Bridging the Commonalities.” This provides the opportunity to hear patients’ and caregivers’ perspectives on how rare diseases impact their daily lives and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases.

Additionally the grant review process will be enhanced by providing grant reviewers with patient perspectives gleaned from listening sessions with patients about rare diseases. These enhancements will build on new priorities in grant review. Specifically, to address the unmet needs for rare diseases, the Office of Orphan Products has made meaningful changes to both funding focus and review process for the Clinical Trial and Natural History grants programs. They are focusing on studies of rare diseases with unmet needs that use efficient and innovative trial designs, such as adaptive and seamless trial designs, use of modeling and simulations, incorporation of real world data, and basket and umbrella trials studying multiple rare diseases/products. Applicants are asked to incorporate patient input into their research proposals.

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Clinical Trial of B244 for the Treatment of Pediatric Atopic Dermatitis

AOBiome Therapeutics, Inc. a clinical-stage microbiome company focusing on the research and development of therapeutics for dermatological conditions, announced the administering of its lead product candidate, B244, to the first patient in the Company’s Phase 1b clinical trial to treat pediatric patients with atopic dermatitis (eczema). Data from the First Pediatric Study are Anticipated in the Second Half of 2019.

“There is a significant medical need for new therapies to treat children with atopic dermatitis due to the high and increasing incidence of the disease and the limited number of safe and efficacious options to treat this sensitive population,” said President & CEO, Todd Krueger.  In the United States, 13% of children (or 9.6 million) under the age of 18 years suffer from eczema. Of these, approximately one third have moderate to severe eczema. Additionally, many children who suffer from atopic dermatitis in their youth also go on to disproportionally suffer from certain diseases later in life, including 43% of children with severe atopic dermatitis before the age of 8 developing asthma and 45% developing allergic rhinitis according to one recent study.

The clinical trial is an open-label, multicenter, Phase 1b study of B244, a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria (“AOB”), delivered as a topical spray twice daily and is designed to assess safety and tolerability in 36 pediatric patients aged 2 to 17 years with mild to moderate atopic dermatitis over a 28-day period. The AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

“Our goal is to alleviate both the symptoms that are associated with atopic dermatitis and to utilize AOB’s nitric oxide-mediated anti-inflammatory abilities coupled with its capability to reduce levels of pathogenic bacteria as a dual-modality approach to treatment,” said CMO, Dr. Judith Ng Cashin, M.D. “Current therapies for atopic dermatitis can cause side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244’s innovative nature represents a novel therapeutic opportunity to address the significant market need and to impact the lives of patients.”

In addition to the ongoing pediatric study, AOBiome is currently conducting a Phase 2 clinical trial investigating B244 for the treatment of adult atopic dermatitis with expected top-line data readout in 2019. See: www.clinicaltrials.gov.

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New Public Health Crisis? Study Urged on Marijuana Smoking & Lung Cancer

As marijuana becomes mainstream and usage rates skyrocket, some of the nation’s top cancer doctors are urging the Surgeon General to investigate the link between smoking marijuana and lung cancer.

Among the renowned doctors calling for more study is Dr. Joseph Friedberg, head of the Division of Thoracic Surgery at the University of Maryland School of Medicine. Publishing his concerns on SurvivorNet, the cancer site providing the latest information and treatment options from foremost cancer experts, Dr. Friedberg is calling for a federal study citing increased rates of lung cancer in their practices from patients whose only discernible risk factor is marijuana smoking. SurvivorNet released a documentary outlining the concerns surrounding the lack of research on the link between smoking marijuana and lung cancer in hopes of bringing widespread attention to the need for this study.

Dr. Friedberg states “Given the expanding legalization of marijuana, and the anticipated wave of increased use, there is clearly a need to study the cancer risks of marijuana with the same rigor that has been devoted to tobacco smoke. Both types of smoke contain some of the same carcinogens, so the widely held belief that tobacco smoke causes cancer and marijuana smoke does not is inherently flawed. “We have an opportunity to avoid a potential marijuana-related public health crisis similar to what we are still dealing with from cigarettes being introduced to the public without any health risk warnings.”

Previously, the only study on long term use of cannabis and lung cancer was a 2008 NIH study conducted in New Zealand which found that long term cannabis use increases the risk of lung cancer in young adults. The study cites other reputable scientific findings that state cannabis smoke is similar to tobacco smoke but with twice as many carcinogens and because people smoke joints without filters and hold the smoke in their lungs longer it can increase the risk of lung cancer. The major finding from this study was that for each joint-year of cannabis exposure, the risk of lung cancer increased by 8%, after adjustment for confounding variables including tobacco smoking.

A major differential risk between cannabis and cigarette smoking was observed, with 1 joint of cannabis similar to about 20 cigarettes for risk of lung cancer. This study was not extensive or long enough to be definitive but it raises concerns about the drug. This study would be the first of its kind to bring groundbreaking research and information to millions of Americans who smoke marijuana without understanding the potentially lethal side effects. Much like tobacco’s earliest days, if something is not done about this now, we risk another major health emergency.

SurvivorNet was founded to fill an urgent need for better information about cancer prevention and treatment. “By bringing attention to crucial findings from some of the country’s leading cancer doctors, we are hoping to save lives. We know marijuana is alleviating suffering for a great many cancer patients. We also think people who smoke and vape marijuana recreationally should have accurate information about whether there is an increased risk for cancer and then make their own choices. It’s clear a major national study is needed so we can really understand this issue.”

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Dr. John S. Macdonald Honored at 2018 Luminary Awards

John S. Macdonald, MD, is the Senior Medical Advisor for AGICC (Academic GI Cancer Consortium) and the consolidated Oncology Consortia of Criterium groups, including: AMyC (Academic Myeloma Consortium), ATOMIC (Academic Thoracic Oncology Medical Investigators Consortium) and ABRCC (Academic Breast Cancer Consortium). He is a leading supporter and advocate of the Translational Research methodology.

Dr. Macdonald was one of a few select honorees at The Ruesch Center for the Cure of Gastrointestinal Cancers Annual Luminary Awards on November 30th, 2018.

Dr. Macdonald successfully developed and led the Comprehensive Cancer Center at St. Vincent’s in New York City between 1997 and 2007. He is widely recognized as an industry and academic expert in gastrointestinal oncology and has written and lectured on the advantages of translational research. In addition to his responsibilities at Saint Vincent’s, Dr. Macdonald served as Chief of Medical Oncology there, and as the Lynn Wood Neag Endowed Professor of Medicine at the New York Medical College. He is acknowledged as a leading educator in Medical Oncology. 

Macdonald pioneered the use of chemoradiation after surgical resection of gastric cancers. This treatment regimen, aptly named the “Macdonald Regimen,” has helped turn the idea of a cure into a reality for thousands of patients with gastric cancers. This has also paved the way for the development of new treatment options for gastric cancers.  “[Macdonald] is a groundbreaking researcher, dedicated educator, and outstanding clinician,” said Sunnie Kim, MD, of the Ruesch Center for the Cure of Gastrointestinal Cancers, prior to presenting Macdonald with his award. “He has changed the lives of countless patients with some of the deadliest cancers.”

Dr. Macdonald has authored over 400 articles, abstracts and book chapters and has been both published in, and editor of, many prestigious medical journals. Macdonald has received numerous awards and distinctions, including being named among Good Housekeeping’s Best 300 Doctors in America and, over a seven-year period, New York magazine’s Best Doctors in New York.

Visit the website to see Dr. Macdonald’s profile and all the Consortia groups.

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The Emerging Breast Imaging Standard

Many breast imaging centers have launched high risk screening clinics to augment their existing services. This has already become the new standard, as organizations look for justification to expand patient services, recommend breast MRI screening exams, and provide referrals for genetic counseling.  Offering a service dedicated to screening patients for high risk, without the proper tools, can put more stress on the breast imaging workflow.

The problem is that many systems are not set up to function on this plane. Subsequently, some sites resort to manual data entry on risk model websites to calculate each score individually. Calculated risk models, such as Tyrer-Cuzick and the Gail Model, are simply not built into the RIS mammography tracking module, mammography information system, or EMR module.

Some programs offer standalone, web-based risk platforms only, although this method adds to system fragmentation, redundancy, and increased room for error. This is especially true when the reader wants to add the risk score to their finding report, or if the site wants to include risk-related information in the patient notification letter.

Tyrer-Cuzick version 8 has 25 elements and family history factors alone, so the time required to enter this for every patient, every study, and every day adds up fast. In most cases, the facility is already required to enter this information into their existing mammography tracking solution and, in order to generate the risk score, that same information has to be re-entered into an online calculator.

MagView, however, has considered this workflow and incorporated several breast cancer risk models into their base program. They offer automated calculations for all available risk models, such as Tyrer-Cuzick, Gail, BRCAPro, and Claus. In their program, patients can enter breast cancer risk factors in advance of the appointment using a patient history portal, saving the facility staff countless hours a day. The patients can also use the patient history tablet module for electronic submission to the breast center and MagView system.

These factors are saved from year to year, so the patient only needs to modify any changes in the previous history on subsequent visits. The calculators are built into the program, so no external websites or third-party programs are needed. The data is then used in the automatic risk calculation, and the radiologists can see the score in real-time, affecting their decision on follow-up recommendation. Scores can automatically be included in the finding reports, saving the readers additional time, and patients can be notified with automated text inserted into the letter based on their score.

Evidence has shown that including risk information in both the finding reports and patient letters has increased awareness along all fronts, especially when qualifying patients for additional imaging, like breast MRIs. One site reported a 100% increase in breast MRI referrals from their previous workflow using their RIS mammography tracking module as a reporting tool.

The bottom line is, increased high risk screening has improved the detection of cancers by ensuring patients who are at a high risk receive the care and additional imaging they need. In a recent study of BRCA mutation carriers and women of 20% or higher lifetime risk for breast cancer, sensitivity for breast cancer detection was 90.0% using MRI versus 37.5% for mammography and 37.5% for ultrasound (Source: Journal of Clinical Oncology. 2015;33(10):1128-35).

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Hong Kong Dept of Health Approves Biktarvy® for HIV, following FDA and EC

In Phase 3 Clinical Trials, Biktarvy® Demonstrated High Efficacy and Zero Resistance Through 48 Weeks

The triple-combination, single-tablet therapy combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone – Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF). BIC/FTC/TAF provides a convenient once-daily dosing STR without regards to food. Furthermore, BIC/FTC/TAF’s use is not restricted by the patient’s baseline viral load, CD4 cell count or HLA-B 5701 status.

“Safety and resistance profiles are important considerations for HIV patients, as the disease requires long-term care. In addition, potent treatments with convenient dosing can potentially improve adherence and outcomes for patients,” said Dr Chan Kai Ming, Specialist in Infectious Disease, Consultant in Internal Medicine, Union Hospital, Hong Kong.

The Hong Kong Dept of Health has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*. Hong Kong is the first market in Asia to approve Biktarvy. BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018 and the European Commission on June 21, 2018.

The approval was based upon data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,414 participants, and BIC/FTC/TAF met its primary efficacy objective at 48 weeks in all four studies, with no participants in any of the four BIC/FTC/TAF studies developing treatment-emergent virologic resistance. There were no cases of renal discontinuation, proximal renal tubulopathy or Fanconi syndrome in the BIC/FTC/TAF arms at 48 weeks. Additional ongoing studies not included in the marketing authorization application involve dedicated studies in women, adolescents and children.

“We welcome the timely approval of BIC/FTC/TAF in Hong Kong, a novel treatment option for people living with HIV,” said Andrew Hexter, Vice President and GM for Gilead Sciences Asia. “We are committed to serving the needs of HIV patients and medical communities in Asia, and are working with public health authorities to make the treatment available in this region.”

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September is Blood Cancer Awareness Month

September was designated as National Blood Cancer Awareness Month in 2010 by the United States Congress. Approximately every 3 minutes one person in the United States is diagnosed with a blood cancer. That means that during September, Blood Cancer Awareness Month, more than 14,000 people will be informed that they have one of these terrible diseases.

Blood cancers are a group of diseases that affect the production and function of blood cells. The three main types are leukemia (found in blood and bone marrow), lymphoma (affects the body’s lymphatic system) and myeloma (impacts plasma cells). Nearly 172,000 people in the U.S. are living with a blood cancer, according to Kevin Radelet, executive director, Leukemia Research Foundation.

In recognition of Blood Cancer Awareness Month, the Leukemia Research Foundation is conducting a social media initiative called The Heroes Among Us to increase awareness about ALL blood cancers, including leukemia, lymphoma, multiple myeloma, and myelodysplastic syndromes.

The LRF Facebook?and Instagram pages will highlight Heroes through uplifting stories. You will have the opportunity to share, mention and comment on posts on Twitter, YouTube, and LinkedIn too.

Several buildings in downtown Chicago — LRF is located in Northfield, IL — will “light up orange” in recognition of Blood Cancer Awareness Month. Click here for details.

Here’s how you can participate:
? Share on social media channels online using hashtags: #LRFHeroes?and/or #HeroesWearOrange
? Share the link to the heroes stories with friends, family members and colleagues
? Buy a bag of orange ribbons and share them!?Send an email?to request ribbons
? Please donate today?to help LRF continue to raise awareness and funding for research and patient programs.
? For other ways to get involved, sign up for events, or volunteer, please click here.

Headquartered in Northfield, IL., the Leukemia Research Foundation is dedicated to conquering all blood cancers by funding research into their causes and cures and enriching the quality of life of those touched by these diseases. For more information, visit www.allbloodcancers.org or call 847-424-0600.

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