Search This Blog

Tuesday, April 2, 2019

Over-the-Counter Meds Save Health Care System Billions

On average, each dollar spent on over-the-counter (OTC) medicines saves the U.S. health care system $7.20, totaling nearly $146 billion in annual savings, according to a report released March 18 by the Consumer Healthcare Products Association (CHPA).
The CHPA worked with research firm IRI to consult published data sets and economic modeling and to survey more than 5,000 consumers on how they would treat symptoms if OTC medicines did not exist. Prescription drug costs were based on data from Symphony Health. The nine major therapeutic categories of OTC medicines analyzed were for acute and chronic self-treated conditions: allergy, analgesics, antifungals, cough/cold/flu, lower and upper gastrointestinal (GI), medicated skin, sleep aids, and smoking cessation.
According to the report, the value of OTC medicines is generated from nearly $95 billion in clinical cost savings (avoided doctor’s office visits and diagnostic testing) and nearly $52 billion in drug cost savings (lower-priced OTCs versus higher-priced prescription drugs). Three categories of OTC medicines — medicated skin, lower GI, and upper GI — made up 61 percent of the total OTC savings, driven primarily by the price difference between OTC and prescription products. Approximately $73.6 billion, or 50.3 percent of total savings, were captured by commercial insurance plans.
“The evidence is clear that OTC medicines help ease the tremendous burden on the health care system by empowering consumer self-care, thereby allowing over-stretched health care practitioners to focus on the diagnosis and treatment of patients with more serious diseases and medical conditions,” Scott Melville, president and chief executive officer of the CHPA, said in a statement.

Uninsured, Medicaid Covered Get Short Shrift on Hospital Stays

Folks who aren’t covered by private insurance are much more likely to get booted out of the hospital early, a new study finds.
Uninsured patients were also more than twice as likely to be transferred to another hospital and 66% more likely to be discharged outright, compared with people with private insurance, the findings showed.
People on Medicaid had nearly 20% increased odds of being transferred, but about the same odds of being discharged as those covered by private insurance, the researchers said.
“It suggests there is a disparity in access to hospital care. Based on the insurance card in your pocket, you may have different access to different hospitals for the most standard inpatient care they offer,” said lead researcher Dr. Arjun Venkatesh. He is director of Emergency Department Quality and Safety Research and Strategy with the Yale School of Medicine.
Since 1986, federal law has required hospitals to treat anyone who shows up at an emergency room for treatment, regardless of insurance status.
But experts have been hearing anecdotes for some time suggesting that hospital patients with no or low-quality insurance tend to get “dumped,” either through discharge or transfer to another hospital, Venkatesh said.
However, it’s tough to pin this down because many transfers that occur really are needed to make sure people get the care they require, he noted.
“You really do need to get transferred if, say, you have an injury to a hand and you need a hand surgeon at another hospital,” Venkatesh said.
So he and his research team picked pneumonia, chronic obstructive pulmonary disease (COPD) and asthma as three common conditions that any hospital could treat, and made their analysis even more conservative by only including hospitals that had intensive care units.
The researchers then examined more than 215,000 emergency department visits for those lung conditions that occurred in 2015 and were logged as part of a federal database used to track emergency department care in the United States.
The investigators found that people with private insurance had a much better chance of remaining as long as necessary in the hospital, compared with the uninsured and Medicaid patients. The association held even after the research team took into account other factors, such as patient income and the hospital’s ability to provide critical care.
“The insurance type they had was still very predictive of whether they would be transferred to another hospital,” Venkatesh said. “That’s just not really explicable.”
The concern is that patients who are transferred or discharged early might not be fully healed, and their condition might suffer as a result of leaving the hospital, he explained.
While the study did not examine the cause of these disparities, financial incentives for hospitals could play a role, said Venkatesh. Hospitals are not reimbursed for admitting uninsured patients and they receive lower payments for Medicaid, he noted.
Eliot Fishman, senior director of health policy for Families USA, called the findings “upsetting,” and places the study in the context of the ongoing national debate over health care coverage for everyone. Families USA is a consumer health care advocacy group.
“I think there’s a broader conversation that is starting to happen in the country about moving toward a more universal, more equal system of health insurance coverage,” Fishman said.
“As inappropriate as the behavior described in this article is, I think that does feed into the conversation around moving towards a more universal platform of payment, not just for hospital services, but for medical services in general,” Fishman added.
Venkatesh suggested that policy makers who want to change this practice could look at amending federal health care law to better structure emergency care in the United States.
“We haven’t really said what is the kind of universal access to hospital-based care that everybody in the country should get, and how we should finance and pay for that,” Venkatesh said.
In the meantime, federal agencies like the U.S. Centers for Medicare and Medicaid Services could develop regulations aimed at preventing such disparities in care, he added. These disparities also could be weighed as a factor when hospitals apply for accreditation or certification.
The new study was published online April 1 in JAMA Internal Medicine.
More information
The Kaiser Family Foundation has more about the uninsured in America.
SOURCES: Arjun Venkatesh, M.D., director, Emergency Department Quality and Safety Research and Strategy, Yale School of Medicine, New Haven, Conn.; Eliot Fishman, Ph.D., senior director, health policy, Families USA; April 1, 2019, JAMA Internal Medicine, online

BriaCell announces clinical trial collaboration agreement with Incyte

BriaCell Therapeutics announced a clinical trial collaboration and supply agreement with Incyte. Under the terms of the agreement, BriaCell will evaluate combinations of novel therapeutics for the treatment of patients with advanced breast cancer. Under the agreement, Incyte will provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT, in advanced breast cancer patients.
https://thefly.com/landingPageNews.php?id=2887629

Minimally invasive uterine fibroid treatment safer, as effective as surgery

Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared to myomectomy, according to new research presented at the Society of Interventional Radiology's 2019 Annual Scientific Meeting.  Women who received this minimally-invasive treatment also had a slightly lower need for additional treatment than those who underwent surgery.
UFE is a minimally-invasive treatment for uterine fibroids that is less painful, preserves the uterus and allows women to get back to their lives sooner than surgical options. However, past research suggests U.S. women, a majority of whom will experience uterine fibroids by age 50, are largely unaware of UFE despite more than 30 years as an evidence-based treatment.
"Women have options for treating their uterine fibroids. UFE and myomectomy are procedures with similar efficacy and durability for treating fibroids, but UFE has fewer complications and shorter hospital stays," said Jemianne Bautista-Jia, MD, radiology resident at Kaiser Permanente and lead author of the study. "There are important factors women should consider when choosing between the procedures, including risk of bleeding, possibility of infections, and recovery time."
In the retrospective cohort study, researchers analyzed treatment outcomes of 950 uterine fibroid patients from Jan. 1, 2008 through Dec. 31, 2014. Half of the patients underwent UFE, a non-surgical treatment that eliminates the blood supply to fibroids, causing them to shrink or disappear. The other half were treated surgically through myomectomy.
After an average seven-year follow up, the study found that women who underwent myomectomy had a higher rate of postprocedural complications, including a 2.9 percent rate of blood transfusion, significantly higher than 1.1 percent of patient who were treated using UFE. The two methods were comparably effective based on the rate at which secondary interventions were needed.
A uterine fibroid (leiomyoma) is a noncancerous tumor that occurs in the muscle cells of the uterus. These growths do not spread to other regions of the body and are typically not dangerous. While some women do not experience symptoms, others have very heavy and prolonged bleeding that can be debilitating, as well as pelvic pain and abdominal enlargement.
Learn more about UFE and fibroids at sirweb.org/fibroidfix.
Abstract 137: Comparison of uterine artery embolization and myomectomy for treatment of symptomatic uterine fibroids: A long-term retrospective analysis.
https://www.biospace.com/article/releases/minimally-invasive-uterine-fibroid-treatment-safer-and-as-effective-as-surgical-treatment/

NFL Alumni Partners with UNC’s Center for the Study of Retired Athletes

NFL Alumni (NFLA) today announced a partnership with the University of North Carolina’s Center for the Study of Retired Athletes (CRSA).
This partnership will provide NFLA members the opportunity to participate in the CRSA’s ongoing research and clinical programs which are aimed at improving the quality of life for former athletes.
“The CSRA has welcomed nearly 1,400 former athletes to our Chapel Hill-based center since opening our doors in 2001,” says Dr. Kevin Guskiewicz, CSRA’s Executive Director. “We look forward to working closely with NFL Alumni leadership to identify predispositions to chronic medical issues in former players. We also will help treat those who may have already been afflicted.”
The Center’s research and clinical programs have helped improve the quality of life for hundreds of former athletes and helped these former players fully participate in many aspects of life after sports. Former players may be screened for research study opportunities by completing the Center’s General Health Survey. If eligible, players then will visit on-site clinics to be evaluated and introduced to potential interventions addressing issues affecting the highest quality of life.
“NFL Alumni is proud to announce its new partnership with the UNC’s Center for the Study of Retired Athletes,” says NFL Alumni CEO Beasley Reece. “This partnership will assist members in managing their health with unique screenings that will provide educational resources for a better quality of life. We are pleased to be teaming with the staff at CSRA who support our “Caring for Our Own” mission.
NFL Alumni, a non-profit organization, is comprised of former NFL players, coaches, staffers, cheerleaders, spouses, and associate members whose mission is to serve, assist and inform former players and their families. The Alumni offers a variety of medical, financial, and social programs to help members lead healthy, productive and connected lives, as well as community initiatives under its “Caring for Kids” programs. Pro Football Legends is the commercial marketing arm of the NFL Alumni. For more information, please visit www.nflalumni.org.

Bayer board says pursuit of Monsanto was done diligently

Bayer’s non-executive board reaffirmed its support for top management’s decision to acquire seed maker Monsanto last year, after losing high-profile lawsuits to U.S. plaintiffs who claimed Monsanto’s Roundup weedkiller caused their cancer.

In documents posted on the company’s website on Monday, the non-executive supervisory board said an expert opinion it commissioned from lawfirm Linklaters found that Bayer’s management had complied with their duties when acquiring Monsanto for $63 billion last year.
“The Supervisory Board extensively discussed this expert opinion and based on this also comes to the conclusion that the Board of Management acted in compliance with its duties,” it said.
Bayer shares have lost more than 35 percent of their value, equivalent to about 33 billion euros in market capitalisation, since August, when a U.S. jury found Bayer liable because its Monsanto unit did not warn of Roundup’s alleged cancer risks. It suffered a similar courtroom defeat last month.
Although the German drugs and pesticides maker is appealing the verdicts, more than 10,000 similar cases are pending in state and federal courts, with analysts predicting the company will have to pay out billions of dollars in settlements.
Shareholders are expected to express their discontent at Bayer’s annual general meeting on April 26.
Monday’s statement by the non-executive board was published in a joint reply from Bayer’s management and supervisory boards to countermotions brought by some shareholders for the AGM.
Chief Executive Werner Baumann, who broke cover on his pursuit of Monsanto within weeks of taking the top job in 2016, has said in newspaper interviews that he enjoys the backing of the supervisory board.
The supervisory board in Germany’s two-tier corporate board system has to sign off on larger transactions and Bayer’s non-executive Chairman Werner Wenning backed the Monsanto deal throughout, according to sources familiar with the matter.
The U.S. Environmental Protection Agency, the European Chemicals Agency and other regulators have found that glyphosate, the active ingredient in Roundup, is not likely carcinogenic to humans.
The World Health Organisation’s cancer arm in 2015 reached a different conclusion, classifying glyphosate as “probably carcinogenic to humans.”

B Of A Hikes Pfizer Price Target, Estimates Citing Orphan Drug Catalysts

Large-cap pharma stocks have seen a mixed performance in year to date, and among this group, Pfizer Inc. PFE 0.34% is poised to benefit from some key second-half catalysts, according to an analyst at Bank of America Merrill Lynch.

The Analyst

Jason Gerberry reiterated a Buy rating on Pfizer and raised the price target from $45 to $48, attributing the revision to higher estimates, with double-digit EPS growth in the 2020-2023 timeframe and pipeline optionality.

The Thesis

Pfizer may soon transform from being a fringe player in the orphan drugs to a mainstream company, given three upcoming catalysts in the segment, Gerberry said in a note.
The analyst sees the Vyndaqel launch in cardiomyopathy as a catalyst, citing bullish feedback of KOL physicians on immediate conversion of existing U.S. patients. Long-term orphan drug launch analysis suggests scope for market expansion and in turn upside to BofA’s above-consensus forecast, the analyst added. Gerberry estimates peak sales of $2 billion for the drug.
Gerberry also sees upside optionality in DMD gene therapy candidate ‘9926 for which a Phase 1 data readout is scheduled for mid-2019. If the data is positive, the analyst said, Pfizer can directly launch a Phase 3 trial by year-end 2019, same as the timeline for the lead competitor Sarepta Therapeutics Inc SRPT 4.55%.
The analyst said the Phase 3 data for rivipansel in Phase 3 sickle cell anemia is likely to be the third catalyst.
Collectively, the three catalysts could lead to 3-6 percent valuation upside and possible re-rate on validation of orphan pipeline.