After catching up with Zogenix management, Piper Jaffray analyst Danielle Brill says she believes Fintepla’s efficacy is superior to other available agents for Dravet Syndrome. The analyst continues to like the shares into 2019 and reiterates an Overweight rating on the name with a $72 price target. Brill expects a positive FDA panel/approval in Q3 of 2019 to drive shares higher next year. Further, she sees additional upside if labeling is favorably differentiated from competitor drugs.
Thursday, December 6, 2018
Wednesday, December 5, 2018
Infective Endocarditis: Spike in N.C. Linked to Opioid Epidemic
Target Audience and Goal Statement: Internists, surgeons, family physicians, cardiologists, hospitalists
The goal is to examine hospitalization trends for drug use-associated infective endocarditis (DUA-IE) during 2007-2017, the proportion of hospitalizations with surgery, patient characteristics, length of stay and associated costs, and the relationship to the opioid epidemic.
Questions Addressed by the Study
Does the current standard of care for patients with infective endocarditis (i.e., prolonged course of intravenous antibiotics often accompanied by surgical valve replacement) need revisiting, given concerns regarding postoperative injection drug use and the associated risk for prosthetic valve infection? Are there state-by-state differences in the trends in DUA-IE and heart valve surgery? What are the relationships with the opioid-abuse epidemic?
Study Synopsis and Perspective
Over the last 2 decades, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). Concurrent with this phenomenon, several studies have noted an alarming rise in drug use-associated infective endocarditis (DUA-IE) linked to hospital admissions nationwide. This trend may be a less commonly discussed consequence of the opioid epidemic.
DUA-IE is a microbial infection of one or more heart valves that occur after injecting drugs. Typically, the tricuspid valve is affected, and this manifestation is less severe, but over time, there could be an increase in left-sided and multivalve involvement.
The standard of care for this often-severe disease is a long course of intravenous antibiotics and may also include valve surgery; however, the latter procedure is controversial because of concerns over postoperative injection drug use, which could heighten the risk for associated prosthetic valve infection.
Source
Annals of Internal Medicine, published online Dec. 3, 2018; doi: 10.7326/M18-2124
Study Highlights: Explanation of Findings
The rise in DUA-IE cases has been particularly acute in North Carolina, as reported in 2017 by Aaron Fleischauer, PhD, co-author of the new study, and colleagues, in the CDC’s Morbidity and Mortality Weekly Report. The researchers reported a 12-fold increase in DUA-IE related hospitalizations from 2010 to 2015, with the most acute spike beginning in 2013, in alignment with the rapid growth of the opioid epidemic. State-specific complexities that may have shaped the health and infrastructural dynamics in this particular state include suboptimal syringe programs, growing (albeit suboptimal) access to opioid treatment, and a large uninsured population, the team noted.
And while this study focused on one state, it is worth noting that a greater than twofold increase has been reported for DUA-IE cases nationwide during 2000 and 2013 – a trend reflected in several national studies. Although a lack of granular clinical information may limit the generalizability of any given database analysis, taken together with other studies, the inference is that these findings may have nationwide implications.
In the new study, posted online in Annals of Internal Medicine, Asher J. Schranz, MD, of the University of North Carolina at Chapel Hill, and colleagues, used data from the North Carolina Hospital Discharge Database (covering approximately one million annual hospitalizations) to examine annual trends, characteristics, and charges related to DUA-IE hospitalizations. In addition, the researchers wanted to estimate the number of heart valve surgeries that were performed for patients with DUA-IE.
The focus of the study was on adults ages 18 and older hospitalized for IE from 2007 to 2017. The researchers also aimed to report the demographics of the patients with DUA-IE undergoing surgery and estimate the charges, durations, and outcomes of these hospitalizations.
As reported in the study, 2,602 (11%) of the 22,825 IE hospitalizations were for DUA-IE, and valve surgeries were performed in 285 (17%) of DUA-IE cases. The researchers found that DUA-IE cases increased 12-fold and there was a 13-fold increase in DUA-IE hospitalizations with valve surgery. Similar increases were not observed in the comparison group, consisting of patients with endocarditis, but with no medical history of drug abuse disorders.
Surgery was performed in 7% of IE hospitalizations and 17% for DUA-IE ones. The tricuspid valve was involved much more often in surgery for the latter (39% vs 11%), the investigators found.
In the last year of the study, individuals who used drugs accounted for 42% of all endocarditis valve surgeries performed in the state, Schranz and co-authors reported. The data had been previously presented as an abstract at IDWeek in October.
Compared with other patients with DUA-IE, the problem seemed to be more common in younger (median age 33 vs 56), uninsured (35%), or Medicaid-insured patients (38%), the researchers said. The demographic characteristic of this subgroup included being mostly white (89% vs 63%) and more commonly female (47% vs 33%).
Of note, the investigators said that one in 10 of the hospitalizations ended with a discharge against medical advice (DAMA). Apart from being stressful for both doctor and patient, DAMAs could lead to the abrupt discontinuation of treatment, disease progression, and death. Because the availability of post-discharge intravenous antibiotics is limited across the U.S., there is a need for evidence-based alternatives to drive treatment of affected patients, Schranz and colleagues stated.
Researchers of a separate recent studyobserved fewer DAMAs and fewer readmissions among patients hospitalized for serious infections who also received counseling for their opioid addictions.
While DUA-IE-related hospitalizations are still relatively rare, they can be life-threatening, resulting in prolonged hospital stays, and negatively reshaping the quality of life of each affected patient, said Schranz and co-authors. Moreover, since the length of the median DUA-IE hospital stay was almost 1 month (median 27 vs 17 days), accruing more than a quarter of a million dollars in median costs ($250,994 vs $198,764), the rise in DUA-IE cases will also negatively impact payers. It is worth noting, the team said, that although any injection could result in IE, the most common drug-related causes were opioids, including heroin.
“Given that each case of hospitalization and surgery for infective endocarditis costs more than $250,000, it is ‘almost certainly’ cheaper to approach the problem with comprehensive outpatient treatment programs employing pharmacotherapy for opioid use,” wrote Schranz and colleagues. They added that regrettably, treatment of DUA-IE may prove futile if the habit of nonsterile drug use persists after treatment.
“A rational public health approach would prioritize funding of inpatient and outpatient drug use disorder treatment, harm reduction, and other activities to prevent infective endocarditis,” the team said. “Furthermore, in cases where substance abuse disorder treatment programs are non-existent or limited, there may be a need to integrate care such as infectious diseases, cardiac surgery, and addiction care.”
In an accompanying editorial, Alysse G. Wurcel, MD, MS, of Tufts University Medical Center of Boston, argued for a re-evaluation of the dogma, demanding 6 weeks of intravenous treatment for patients with IE. She wrote that being mindful of hospital stays and suboptimal prognoses for patients with DUA-IE, many of whom are in the infectious diseases community, have been using these alternative treatment strategies with successful outcomes.
Published research, even at the case-study level, might provide more evidence of the benefits of a shorter course of treatment, oral- or long-acting injectable antibiotics in appropriate cases, Wurcel said.
Nicole Lou wrote the original MedPage Today story on which this CME update was based.
Primary Source
Annals of Internal Medicine
Secondary Source
Annals of Internal Medicine
Mylan Launches Generic for Prevacid SoluTab Delayed-Release Oral Tablet
Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Lansoprazole Delayed-Release (DR) Orally Disintegrating Tablets (ODT), 15 mg and 30 mg, a generic version of Takeda’s Prevacid SoluTab DR ODT.
Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has the same indications as the reference listed drug, including treatment of active ulcers of the stomach and small intestine, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. The introduction of Lansoprazole DR ODTbolsters Mylan’s gastroenterology portfolio, which is one of the company’s major therapeutic areas, and further drives access for patients.
U.S. sales for Lansoprazole DR ODT, 15 mg and 30 mg, were approximately $168 million for the 12 months ending September 30, 2018, according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing approximately $85.9 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $50.3 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
De Blasio Says He Was Unaware Emergency Management Chief Was Fired
New York Mayor Bill de Blasio has traveled the U.S. for five years promoting his progressive politics, insisting it didn’t interfere with governing — until this week when he was weekending in Vermont with U.S. Senator Bernie Sanders and didn’t know that a deputy had fired the city’s crisis manager.
Deputy Mayor Laura Anglin and Office of Emergency Management Director Joseph Esposito met Friday to discuss the city’s response to a Nov. 15 snowstorm, which ended in an argument in which the deputy fired the agency head without consulting the mayor. At a news conference Tuesday, De Blasio said he had decided weeks ago to let Esposito go, but had taken no action.
Esposito’s dismissal has ignited reactions ranging from outrage to disbelief among dozens of City Council members. De Blasio learned about it Monday, he said, after the Wall Street Journal had already reported it. Esposito, his crisis manager, told council members he’d tried to personally contact the mayor. But de Blasio said he never got the message.
“Saturday goes by, Sunday goes by, no one’s calling and saying if there’s any new information,” de Blasio said at a news conference Tuesday. “It’s not until Monday morning that I’m starting to hear in the public domain the things that I’m not hearing from anyone directly, and that’s when it was time to cut through it and have a straightforward conversation with everyone and say, ‘What’s happening here?’”
Calm Competence
Esposito, 68, a 45-year police veteran with a reputation for calm competence, had been department chief before de Blasio appointed him to head the agency that coordinates response to crises such as terrorist attacks and catastrophic storms.
De Blasio refused to discuss the incident until Tuesday, when he confirmed that Esposito had been fired, though Esposito remains on the job until a replacement is found. The mayor told reporters he wanted to “set the record straight,” yet questions remain.
The mayor said he decided to remove Esposito weeks before the snow storm. Why then, did he take no action, he was asked at the news conference. Running the city is complicated, he replied.
“When you’re talking about an organization this big — we have 380,000 employees and we have a $90 billion budget and so much going on every day,” de Blasio said.
The mayor also declined to state the precise reason for dismissing Esposito, but said he should have dismissed him personally. Given how long Esposito had served this city, de Blasio said, “I think that it would have been smarter to do that way.”
CVS Launches New Approach to Pricing of Pharmacy Benefit Management Services
CVS Health (NYSE: CVS) today announced that it is introducing a new approach to the pricing of Pharmacy Benefit Management (PBM) services. The new Guaranteed Net Cost pricing model simplifies the financial arrangements underlying PBM contracts and focuses on helping plan sponsors deliver savings through PBM cost management strategies such as formulary, utilization management and performance pharmacy networks. This new model more closely aligns PBM incentives with plan sponsors’ objectives than current pricing models by providing greater cost predictability. The company has been actively briefing benefit consultants as well as current and prospective clients on the new model. As a result, clients, including both existing and new clients who are transitioning to CVS Caremark as their PBM, have already chosen to adopt the Guaranteed Net Cost model starting in 2019.
“We see a real opportunity to offer clients a simpler economic model that leverages proven PBM cost management strategies to provide predictable drug costs,” said Derica Rice, President, CVS Caremark. “As a result, CVS Health is introducing a straightforward, more holistic approach that enables plan sponsors to clearly see the net cost of their pharmacy benefit and select their PBM provider based on that criteria.”
Current pricing models offer discounts and rebates, but do not provide net cost predictability, and the variability between PBMs can make it difficult to draw direct comparisons. CVS Health’s new Guaranteed Net Cost pricing model guarantees the client’s average spend per prescription, after rebates and discounts, across each distribution channel – retail, mail order and specialty pharmacy. The model focuses on a simple concept – net cost per claim. Under the new model, CVS Caremark will pass through 100 percent of rebates to plan sponsors and take accountability for the impact of drug price inflation and shifts in drug mix. With the Guaranteed Net Cost model, clients continue to have the option to implement point-of-sale rebates to provide plan members visibility into the net costs of their medication.
Guaranteed Net Cost is calculated using plan utilization and expected rebate value, and applying projected drug price inflation and expected shift in drug mix (e.g., movement from brands to generics). Any plan design decisions clients choose to implement to help manage appropriate drug utilization or encourage the use of lower-cost therapeutic alternatives would further positively impact overall plan drug costs.
“As a PBM, our job has always been to help our clients manage costs in the face of escalating drug prices without compromising clinical care, so they can continue to provide an affordable benefit to their members,” added Rice. “By simplifying the PBM economic model, we can focus on maximizing the impact of PBM strategies that help reduce costs for clients and consumers, and continue to develop additional innovative tools and approaches.”
To date, through the application of PBM tools, CVS Caremark has been successful in helping to improve adherence and keep drug cost inflation under control for clients despite steady price increases by manufacturers. In 2017, drug price growth for CVS Caremark PBM clients was only 0.2 percent, despite manufacturer price increases of nearly 10 percent. In addition, improvements in medication adherence helped reduce overall health care costs for CVS Caremark PBM clients by $600 million in 2017.
Foundation Meet Eyes Ways to Treat Kidney Failure at Home
A team of kidney professionals, patients and caregivers met in Baltimore Nov. 30 to work through ways to remove barriers to home dialysis so more patients will treat kidney failure at home rather than in a center.
The first KDOQI Home Dialysis Conference was held a year ago. On Nov. 30, a group of more than 70 invited clinicians, researchers, policy makers, patients, care partners, and industry representatives gathered to launch the “Home Dialysis Quality Initiative,” a major, multi-disciplinary effort. The National Kidney Foundation produces clinical practice guidelines through the NKF Kidney Disease Outcomes Quality Initiative (NKF KDOQI)™. This program has provided evidence-based guidelines for all stages of chronic kidney disease (CKD) and related complications since 1997.
“There was palpable energy in the room that those present are ready to spread throughout the nephrology community so that we can achieve a ‘home-first’ philosophy,” said patient advocate and conference co-chair Erich Ditschman, a kidney patient himself.
Research suggests that patients who treat their kidney failure at home live happier, healthier lives than those who must follow the rigid schedule of dialysis centers. Patients who perform dialysis in their homes have lower rates of depression, unemployment and have more overall flexibility.
“I was delighted to see the enthusiasm of all of the participants to make home dialysis the first therapy for patients with end-stage kidney disease,” said Michael Rocco, MD, MSCE, conference co-chair, nephrologist, and Professor of Medicine at Wake Forest University in Winston-Salem, NC.
Over the last year, three working groups designed projects that could overcome barriers to getting, or keeping, patients on home dialysis, including overcoming lack of training and support for care partners. Based on the presentations and the feedback at the conference, a new KDOQI initiative will be designed to raise awareness about home dialysis, find ways to encourage home dialysis as a first choice for treatment for kidney failure and prevent home dialysis patients from quitting treating at home because they are burned out. The teams found that creating opportunities for mentorships among patients and caregivers and education of all kidney professionals and patients are key to successful home dialysis.
“KDOQI has been improving care and outcomes for all stages of kidney disease for over 20 years, by educating patients and professionals, providing peer mentors and working with CMS to help align payments with the best clinical practices,” said Kerry Willis, PhD, Chief Scientific Officer of NKF. “We look forward to applying this model to home dialysis.”
Amy Bassano, Deputy Director for the Center for Medicare & Medicaid Innovation (CMMI), presented a keynote, which provided a roadmap for how CMMI develops new care models and payment. She discussed how CMMI has already been developing a care model for home dialysis.
“CMS and HHS leadership are committed to realigning payment incentives to ensure kidney patients receive the highest quality care in the most appropriate setting and that includes increasing the utilization of home dialysis,” Bassano said.
This conference was partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Engagement Award Initiative (EAIN-6117).
How is CKD Treated?
The best treatment is early detection when chronic kidney disease can be slowed or stopped. Early treatment includes diet, exercise, and medications. However, once kidneys fail, treatment with dialysis or a kidney transplant is needed.
Dialysis comes in two forms: hemodialysis or peritoneal dialysis. Hemodialysis is a treatment (usually 3–4 times a week) that removes wastes and extra fluid from your blood. It can be done at home or at a dialysis center. During hemodialysis, your blood is pumped through a dialysis machine, where it is cleaned and returned to your body. With peritoneal dialysis, your blood is cleaned inside your body through the lining of your abdomen using a special fluid that is periodically changed. Peritoneal dialysis can be done at home, at work, at school, or even during travel.
A kidney transplant places a healthy kidney into your body from a deceased donor or from a living donor, such as a close relative, spouse, friend, or generous stranger. A kidney transplant, however, is a treatment, not a cure. Antirejection and other medications are needed to maintain the transplant.
Over 475,000 ESRD patients receive dialysis at least 3 times per week to replace kidney function. 121,000 people started ESRD treatment in 2014, of which 118,000 started dialysis. Over 200,000 Americans live with a kidney transplant. 100,000 Americans are waiting on a kidney transplant right now. But only about 19,000 will receive one this year, one-third of which will come from living donors.
Nurse Practitioners Back Fed Scope of Practice Law Recommendations
Today, the American Association of Nurse Practitioners (AANP) issued the following statement regarding the Administration’s recent release of a report entitled Reforming America’s Healthcare System through Choice and Competition. Prepared by the Department of Health and Human Services (HHS) in cooperation with the Departments of Treasury and Labor, and the Federal Trade Commission, the report describes the extent to which state and federal laws, regulations, guidance, and policies discourage choice and competition in health care markets.
According to the report, “States should consider changes to their scope-of-practice statutes to allow all healthcare providers to practice to the top of their license” utilizing their full skillset. The report further notes, “economic analysis indicates that expanding APRN SOP, consistent with APRN education, training, and experience, would have clear consumer benefits, particularly in rural and poorer areas.”
“We commend the Administration’s efforts to ensure access to high-quality care is not harmed by needless barriers to practice. We wholeheartedly agree that outdated scope of practice laws need to be removed and all healthcare providers should practice to the top of their license, utilizing their full skill set,” said Joyce M. Knestrick, Ph.D., APRN, C-FNP, FAANP, President of AANP. “We share the aim of the Administration that we all should be working together striving to create a health care system that works for patients and providers alike. We are encouraged and agree with the Administration’s recommendation that patients suffer when faced with barriers to access resulting from outdated scope of practice laws.”
“The report’s acknowledgment adds to the growing chorus and the body of research showing that patients and families greatly benefit from expanded access to NP-provided care. We look forward to continuing our work with state and federal lawmakers to increase patient access to affordable, high-quality care across the country,” said David Hebert, CEO of AANP. “We call on the Administration to take further action toward retiring needless barriers to care for patients and request the Secretary use his regulatory authority to help make these changes. AANP looks forward to working with the Administration, Congress, and state legislatures to ensure patients have access to health care delivered by their provider of choice.”
The American Association of Nurse Practitioners (AANP) is the largest professional membership organization for nurse practitioners (NPs) of all specialties. It represents the interests of the more than 248,000 licensed NPs in the U.S. AANP provides legislative leadership at the local, state and national levels, advancing health policy; promoting excellence in practice, education and research; and establishing standards that best serve NP patients and other health care consumers. As The Voice of the Nurse Practitioner®, AANP represents the interests of NPs as providers of high-quality, cost-effective, comprehensive, patient-centered health care. For more information and to locate an NP in your community, visit WeChooseNPs.org.
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