BTIG analyst Sean Lavin upgraded AtriCure to Buy from Neutral with a $35 price target following the recent share slide, telling investors in a research note that its valuation warrants a second look. Lavin says that at the current valuation, he believes investors can be rewarded through quarterly beats and “enthusiasm” ahead of Converge data and notes that fundamentals have improved as the open business has stabilized.
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Tuesday, April 2, 2019
Monday, April 1, 2019
Amgen in New Phase 3 Outcomes Study for Cholesterol-Lowering Treatment
Amgen plans to conduct VESALIUS-CV, a multinational clinical outcomes study including at least 13,000 patients that will explore the potential of Repatha®(evolocumab) for the prevention of a first cardiovascular (CV) event in patients at high cardiovascular risk without a prior heart attack or stroke.1 The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years.1 The safety and efficacy of Repatha has not been established for this use. Named after the legendary scientist Andreas Vesalius, who was one of the first to accurately depict the anatomy and function of the heart,2 this study is an important addition to PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations), the growing clinical program for Repatha.
Sangamo To Host April 2, 2019 Conference Call For Clinical Update
Sangamo Therapeutics Inc. (Nasdaq: SGMO), a genomic medicine company, announced today that management will host a conference call on Tuesday, April 2nd at 8:00 a.m. Eastern Time to provide a clinical development update.
The conference call will be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 6063108. For those unable to listen in at the designated time, a conference call replay will be available for one week following the call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 6063108.
Colorecal cancer commonly misdiagnosed in patients under 50
A recent survey has found that a significant number of patients who develop colorectal cancer (CRC) before the age of 50 are misdiagnosed several times. Multiple misdiagnoses often results in the disease being diagnosed at an advanced stage, decreasing survival rates.
Despite deaths from colorectal cancer cases falling significantly in the past decade, the disease remains the second leading cause of cancer-related deaths in the US. This may be due to a sharp increase of colorectal cancer diagnoses in young adults aged 20 to 49 years old.
Dr. Ronit Yarden, PhD, MHSA, the study’s lead author and director of medical affairs at the non-profit Colorectal Cancer Alliance, described this increase as “alarming”, stating:
Despite declining incidence in older adults, there has been a rapid and alarming rise in colorectal cancer incidence among young adults in recent decades. We do not yet know the cause of the rising incidence in younger patients, and there is little awareness of this trend among health care providers.”Dr. Ronit Yarden, Lead Author
The study comprised 1,195 participants, 57% of which were diagnosed between ages 40-49, 33% diagnosed between 30-39, and 10 percent diagnosed before the age of 30.
Of these participants, 30 percent reported a family history of colorectal cancer, and eight percent had received a previous diagnosis of Lynch syndrome, which is a genetic condition associated with an increased risk of developing a number of different cancers, including CRC.
The survey, which was carried out over social media and funded by the Colorectal Cancer Alliance, aimed to “track the self-reported clinical psychosocial, financial and quality of life experiences of this often overlooked, group.”
It found that, while most patients over the age of 50 were diagnosed with CRC in its early stages, “most of the young-onset patients and survivors (71%) were diagnosed at advanced stages.”
Being diagnosed at stages III and IV meant the patients were forced to undergo aggressive therapies, resulting in a consequent decrease in their quality of life. Patients experienced neuropathy, anxiety, clinical depression, and sexual dysfunctions.
Why are younger people overlooked in colorectal cancer diagnoses?
Yarden hypothesizes that young people with colorectal cancer are often misdiagnosed as they “tend to be healthy.” She added, “Physicians may attribute patients’ symptoms to more common conditions, like hemorrhoids or inflammatory bowel syndrome, and may lack the urgency to refer patients to tests that may identify early-stage colorectal cancer.”
Yarden also acknowledges that there is a lack of awareness around colorectal cancer in younger people, and advises:
Young people need to be aware that colorectal cancer can happen at any age and it is not a disease of old people. Everybody should listen to their body and, if it doesn’t feel right, go to the doctor to be tested.”
She also emphasized the importance of recognizing the symptoms of the disease.
Symptoms of colorectal cancer include a change in bowel habits, including constipation, alternating bouts of constipation and diarrhea, and blood or mucus in the stool. Abdominal pain, a feeling that the bowels are never completely empty, and a constant need to go to the toilet can also be experienced.
Populations at a higher risk of developing CRC include African Americans, Alaska Natives and those with a family or personal history of colon or rectal polyps.
Although not involved in the research, Dr. Paul Oberstein, a medical oncologist and Medical Director at NYU Langone’s Perlmutter Cancer Center in New York spoke on the incidence of CRC in younger populations, stating that it was “still a rare thing” for younger people to develop colon cancer.
He added: “But it does happen, and I think for people who have signs of it – constipation, rectal bleeding or trouble going to the bathroom – they should get evaluated for cancer, among other conditions.”
Early screening could save lives
Oberstein offered advice on getting screened early if a patient has a family history of colorectal cancer.
“What’s really important is that people who have a family history of colon cancer – being any first-degree relative who had colon cancer at any age – that person should get screened at age 40 or 10 years before the family member’s diagnosis. So if your father had it at 45, get screened at 35.”
Dr. Nilofer Azad, who was also not involved in the research but is an associate professor of oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore and a member of the AACR Stand Up 2 Cancer Colorectal Cancer Dream Team said:
When you have symptoms that are consistent with a diagnosis of colorectal cancer, you should be evaluated the same way a person would be evaluated if they were 30 years older. The default should be to rule out serious conditions, including cancer, rather than making assumptions that something is not cancer or benign.”
Misdiagnosis is common
63 percent of the survey respondents reported that they had waited from three to 12 months before consulting a doctor about their symptoms, as they were not aware they might indicate colorectal cancer.
Regarding subsequent misdiagnoses, 67 percent of the survey respondents stated they had seen at least two physicians, with some seeing over four physicians before receiving a colorectal cancer diagnosis.
Limitations of the study were recognized, which included self-reported responses, the fact that the study was carried out over social media, and that further studies analyzing larger groups of patients comparing results with older patients have not yet been carried out.
The authors believe that the study “indicates that medical professionals and young adults need to be aware of the increasing incidence rate of young-onset CRC, the signs and symptoms, and the importance of timely screening when those symptoms are present, regardless of age.”
The study was announced during a media preview of the AACR Annual Meeting 2019 and will be presented at the conference itself. For more information
MediciNova ‘excited’ by SPRINT-MS Phase 2b trial subgroup analysis results
MediciNova announced results from its subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. This subgroup analysis was conducted based on recent feedback MediciNova received from the FDA that relapsing secondary progressive MS is different from non-relapsing secondary progressive MS as non-relapsing secondary progressive MS is the only type of secondary progressive MS without available therapy. The purpose of the subgroup analysis was to provide information about which types of progressive MS subjects responded best to MN-166 treatment in terms of the clinically significant endpoint of the risk of confirmed disability progression compared to placebo, as measured by EDSS. Confirmed disability progression was a secondary endpoint in this Phase 2b trial but would be considered a primary endpoint in Phase 3. Unlike the magnetic resonance imaging endpoint of whole brain atrophy, which is not a clinical endpoint, confirmed disability progression is the most important clinical endpoint and is the basis for FDA approval of progressive MS drugs. The trends for reduction in the risk of confirmed disability progression were highest for the subgroup of subjects with Secondary Progressive MS without Relapse, in which MN-166 demonstrated a 46% risk reduction compared to placebo as indicated by the hazard ratio of 0.538. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, “We are excited with the results of our subgroup analysis. Although two drugs have recently received FDA approval for relapsing secondary progressive MS, there remains a very large unmet medical need for secondary progressive MS patients without relapses as there is still no drug approved for long-term treatment of these patients. Based on our extensive analysis of the SPRINT-MS data including this subgroup analysis, we are finalizing the optimal trial design for what we believe will be a very successful Phase 3 program and we plan to submit this trial design to the FDA shortly. With a convenient oral administration, a very favorable safety and tolerability profile, and the potential for better efficacy than other drugs for progressive MS, we believe ibudilast could become the best-in-disease drug.”
Telehealth use surged in 2017
Telehealth use jumped 53% from 2016 to 2017, outpacing all other sites of care, according to a new report.
Telehealth utilization grew nearly twice as fast in urban than rural areas over that span, according to a new white paper from Fair Health, which parsed its database of 28 billion commercial insurance claims, the largest repository in the country. National use of urgent-care centers increased 14%, followed by retail clinics at 7% and ambulatory surgery centers at 6%, while emergency department utilization declined 2%.
“Telehealth has become a rather prominent source of service for mental health conditions,” said Fair Health President Robin Gelburd, adding that it has broken down the barriers to mental healthcare related to stigma and access.
In 2017, most people used telehealth for injuries like bruises and open wounds, acute respiratory infections and digestive problems. Neither injury or digestive system issues were among the top uses in 2016. Mental health, which topped the telehealth utilization list in 2016, was fifth in 2017 at 7% of claims, compared with 13% for the aforementioned uses.
Pediatric and young adults accounted for a larger share of those who used telehealth, but the age 31-to-60 demographic continued to use it the most.
Telehealth is a widely touted tool since it is often a cheaper and more convenient means to access care. More states are rolling out new laws facilitating virtual care delivery, although there are still impediments, particularly on the federal level. This can make investments in the technology inherently riskier.
“Telehealth is almost like a living laboratory as the policies and regulations get developed,” Gelburd said.
Texas, for instance, amended its state laws in 2017 to allow providers to care for patients virtually without first having an in-person meeting.
But Medicare pays for telehealth services only if the beneficiary is in a rural area with a shortage of health professionals or lives in a county outside of a metropolitan area. It also limits which providers can bill for such services.
Providers who have national licensure compacts can’t follow up with patients virtually if the individual is in a noncompact state.
“It is really the federal government,” said Dr. Jay Sanders, CEO of the Global Telemedicine Group and adjunct professor of medicine at Johns Hopkins University. “They are the ones who need to say for the Medicaid and Medicare patient population, ‘I don’t care whether you are in the inner city, a suburban or rural area, if you use telemedicine we will reimbursement you.’ “
Outside of telehealth, retail clinic claims grew 674% from 2012 to 2017, a slower pace than from 2011 to 2016. Rural and urban areas nearly matched in utilization.
Most people used retail clinics in 2017 for respiratory infections, which aligned with 2016. Those were followed by exposure to communicable diseases, general symptoms, ear infections, examinations and urinary tract infections.
Most people who used retail clinics were age 51 to 60, followed by those age 31 to 40 and pediatric patients.
“Looking at a deal like CVS and Aetna, there is a sense that retail clinics will be a very integral and a growing component of the healthcare system,” Gelburd said.
Still, there is some progress to made in both retail and urgent-care settings regarding communication, staffing levels and data sharing to ensure care isn’t duplicated, she said.
For urgent-care centers, utilization grew 1,434% from 2008 to 2017, more than seven times that of EDs. Growth in urgent-care use from 2008 to 2017 was slightly higher in rural than in urban areas. But from 2016 to 2017, growth was flat in rural areas compared with 15% in urban areas.
As in retail clinics, acute respiratory infections were the most common diagnostic category in urgent-care centers in 2016 and 2017. Those were followed by general symptoms, sprains, strains, breaks and fractures, joint/soft tissue issues, UTIs, other injuries, and ear infections.
The age 31-to-40 demographic used urgent care the most, followed by pediatric patients. The average charge of a 15-minute visit was about $60 less at a retail clinic than at an urgent-care center.
One can get a good sense of how care is evolving by looking at the distribution of claims by diagnosis, Gelburd said.
Retail clinics were predominantly used for vaccines. They are now used more like primary-care outposts for ear or respiratory infections. Telehealth, which was mostly used for mental health and dermatology, is now seeing more respiratory and digestion cases, she said.
“We are seeing the evolution in real time and the broadening and blurring of lines between different types of venues,” Gelburd said.
CMS finalizes Medicare Advantage pay raise, ups encounter data use
Medicare Advantage plans are getting a pay raise and more flexibility to tailor benefits for chronically ill patients next year, the CMS said Monday. But Advantage plans’ payments will also be based on a higher percentage of patient “encounter data,” a change that health insurers have fought hard to avoid.
The CMS on Monday finalized a rule giving Medicare Advantage plans a 2.53% pay raise in 2020. The agency had initially floated giving plans a 1.59% pay bump for next year. The final rate is less than the 3.4% raise Advantage plans received for 2019, which was one of the biggest pay raises plans have received in years.
The final rule also allows Medicare Advantage plans more flexibility to offer supplemental benefits to patients with chronic illnesses that aren’t necessarily going to cure their conditions but that will address the social and environmental factors that can harm health. Plans will also be able to tailor benefits or reduce cost-sharing to meet a certain members’ needs.
For instance, Verma said a Medicare Advantage plan could pay for home air filters or carpet shampooing for a patient with asthma, or pay for heart-healthy meals for a beneficiary with heart disease. She noted that in the original Medicare program, 27 million people have chronic conditions. The agency also said it is encouraging plans to take advantage of the flexibilities to offer targeted benefits to patients with chronic pain or those undergoing addiction treatment.
With this new flexibility, “Coverage is determined by what a person needs, not just what’s on a list of allowable items or services,” Verma explained.
The change, which was called for by the Bipartisan Budget Act of 2018 is a significant departure to previous policy, which allowed coverage only for services that prevented, improved or cured a patient’s conditions. Previously, plans were also barred from offering different benefits to different sets of patients. The CMS began introducing flexibility starting in 2019 by allowing plans to pay for in-home supports, such as grab bars and wheelchair ramps, for their plan members.
In comments to the CMS due in March, health insurers largely supported the increased leeway in what supplemental benefits they could offer patients. But most of them railed against the agency’s proposal to increase the amount of encounter data it uses in calculating patient risk scores to 50% from 25%, saying encounter data is often inaccurate and will lead to lower funding for the plans.
The CMS didn’t back down. Verma said the agency has been monitoring encounter data and feels comfortable moving ahead with plans to increase its use in the risk-adjustment model “because of the work we’ve done with the plans around improving the accuracy.”
Federal payments to Medicare Advantage plans are adjusted based in part on patient risk scores. Generally, the sicker the person, the higher the risk score and, consequently, the higher the payment an Advantage plan receives. Plans have been accused of manipulating risk scores to nab higher payments, however.
The CMS has been using encounter data to calculate risk scores since 2016, but insurers have never embraced it. In a letter to the CMS in March, Cigna Corp. even said it was concerned the agency “may be using the EDS transition to reduce MA payments without providing full information about the impact to stakeholders and others.”
Beyond encounter data, the CMS also said it is moving ahead with plans to adjust payments to reflect patients’ total number of medical conditions, in addition to viewing each condition individually. This change is required by the 21st Century Cures Act. The CMS said it will implement what it called the “alternative payment condition count model,” which accounts for some additional diagnoses, including dementia and ulcers. Insurers had supported the alternative model in their comments to the CMS.
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