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Monday, January 27, 2020

UK healthcare cost agency rejects J&J’s nasal spray for depression

The National Institute for Health and Care Excellence (NICE), which determines if a drug is included in Britain’s National Healthcare System (NHS), said there was a lack of evidence on how the treatment, chemically called esketamine, fared over rivals, and that it could raise costs.
In the draft guidance, NICE also questioned the effects of stopping the treatment, saying it was unclear if any improvement in symptoms would be maintained after a course, potentially adding to costs.
“Introduction of esketamine into clinical practice in the NHS will be complex because the structure and delivery of services would need to be changed,” said Meindert Boysen, director of the centre for health technology evaluation at NICE.
NHS currently manages treatment-resistant depression with oral medicines, followed by a second drug if symptoms do not improve. Sometimes the state-run health service combines drugs with psychological therapy.
Esketamine is approved as a combination therapy for adults with major depressive disorder who have not benefited from prior treatments.
It is chemically a mirror image of the anaesthetic ketamine that is often abused under the street name “Special K”, and hence requires that it be given under the supervision of a healthcare professional in a clinic.
“Estimates of the costs of providing the clinical service for esketamine were highly uncertain, as are the costs of repeated courses of the drug,” Boysen said.

In the United States, the spray is priced here at $590 for a 56 mg dose and $885 for 84 mg.
Esketamine received approvals from European and U.S. regulators last year, marking a new type of antidepressant in over 30 years and raising hopes for its relatively fast action to treat patients failed by prior treatments.
More than 264 million people of all ages suffer from depression worldwide, according here to the World Health Organization.
https://www.reuters.com/article/us-johnson-johnson-spravato-britain/uk-healthcare-cost-agency-rejects-jjs-nasal-spray-for-depression-idUSKBN1ZR017

FDA gives new priority review for Sanofi and Regeneron’s Dupixent

The U.S. Food & Drug Administration (FDA) regulatory body has accepted for priority review the use of Sanofi and Regeneron’s Dupixent product for children aged 6-11 with moderate-to-severe eczema, the companies said.
Sanofi and Regeneron added in a statement that if Dupixent won approval from the FDA, it would become the first biologic medicine available in the United States for such children.
The FDA is due to make its decision on May 26.
https://www.reuters.com/article/us-sanofi-dupixent/u-s-fda-regulator-gives-new-priority-review-for-sanofi-and-regenerons-dupixent-idUSKBN1ZR0HN

‘Obesity is America’s self-inflicted preexisting condition’

Consuming too many potato latkes and Christmas cookies has left its mark on our waistlines. Unfortunately for Americans and their medical care, the seasonal overeating seems to last all year. Indeed, the American Medical Association has declared that obesity is a disease.
It may be more accurate to describe obesity as a contributor to certain diseases. Obesity raises the risk of premature death, heart disease, high blood pressure, stroke, type 2 diabetes, gallbladder disease, breathing problems, certain cancers, and osteoarthritis. Certainly, obesity can result from certain uncommon diseases and hereditary factors, but most people become obese simply because they eat too many unhealthy foods and do not exercise.
At its last count, the Centers for Disease Control and Prevention (CDC) estimated that 40% of U.S. adults age 20 and over, 21% of teens, and 14% of preschoolers are obese. A December 2019 study that analyzed 26 years of body mass index (BMI [the relation of weight to height]) data concluded that half of U.S. adults will be obese (BMI>25) by 2030. Some 25% will be severely obese (BMI>35). Moreover, less than 5% of adults get the recommended 30 minutes a day of physical activity. And even when people living in “food deserts” were presented with healthy options, only 10% changed their evil ways of eating.
According to the CDC’s last comprehensive analysis, the annual medical cost of obesity in the United States to Medicare, Medicaid, and private insurers was $147 billion in 2008. And the medical costs for obese people were $1,429 higher than those of healthier weights.
The saddest development is the cultural normalization of obesity with lingerie models, singers, and television shows celebrating fatness. Do we high-five people with other lifestyle-related conditions such as alcoholism, emphysema, or coronary artery disease? Of course not.
The obese are easy targets for drug company peddlers of quick fixes or “providers” who want to extract money from third-party payors. U.S. pharmaceutical companies spent $6.1 billion on direct-to-consumer prescription drug advertising in 2017. Many ads feature chunky type 2 diabetics happily frolicking about, thanks to the drug company’s magic pill. The ads might as well say, “pass the chocolate cupcakes with statin sprinkles drizzled with insulin.” We all know the prescription of eating less and exercising more is free of charge.
Alas, we are losing the battle of the bulge. A recent study found that participants failed to lose weight despite reporting that they were exercising and watching their diet. The authors concluded that “many of [the participants] might not have actually implemented weight loss strategies or applied a minimal level of effort, which yielded unsatisfactory results.”
While politicians debate the merits of spending trillions of dollars on government-sponsored medical care, a correctable source of high medical costs is hiding in plain sight. Irrespective of who pays for medical care, rational economic decisions must be made. The Affordable Care Act (ACA) waved a magic wand and removed preexisting conditions from the underwriting equation when calculating premiums. A sick person and a healthy person of the same age could purchase insurance at the same price. Consequently, the ACA doubled the costs for people who made the effort to take care of themselves.
The ACA did allow a “tobacco surcharge” of up to 50% more for premiums. Why not an obesity surcharge? This would provide an incentive for consumers to take obesity seriously. Additionally, health-conscious persons would not have to pay for the bad habits of others through taxes to fund government health insurance programs or through higher private insurance premiums.
Those who are stricken with illnesses through no fault of their own need a path to affordable medical care. A good start for lowering costs would be eliminating costly middlemen by encouraging consumers to pay directly for day-to-day medical expenses. Expanding contribution limits and eligible uses of Health savings accounts would help pay for the more reasonably priced direct-pay surgery and other alternatives to insurance like direct primary care.
With regard to insurance, we need a revival of competition in the insurance market with multiple products and carriers. Once again, single men could opt to decline pregnancy coverage. We need to restore the pre-ACA availability of low-cost catastrophic (major medical) insurance policies to all ages. Even before mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the large majority of insurers offered guaranteed renewable policies. Here, assuming timely payment of premiums, at the end of the policy period, the insurer must renew coverage regardless of the health of the insured. Naturally, this valuable feature costs more but provides consumers with a strong incentive to not let the insurance lapse.
Let’s confront the elephant in the room. Health care policy should promote personal responsibility, rather than encourage free riders. In America, we are free to overeat and under-exercise, but we have no right to make innocent bystanders pay for the consequences.
Marilyn M. Singleton is an anesthesiologist.
Obesity is America’s self-inflicted preexisting condition

The ACA Expanded Insurance Coverage of Contraceptives. Prices Soared.

In today’s Los Angeles Times, Cato senior fellow Dr. Jeffrey A. Singer and I note that once the Affordable Care Act’s contraceptives‐​coverage mandate took full effect in 2014, “prices for hormones and oral contraceptives stopped falling and instead skyrocketed. By 2019, they had risen three times as fast as prices for prescription drugs overall.” Here we provide the underlying data.
The Affordable Care Act (ACA) dramatically expanded insurance coverage for prescription contraceptives such as “the pill.” From August 2012 through January 2014, the federal government phased in the ACA’s requirement that nearly all private health insurance plans must cover all Food and Drug Administration‐​approved prescription contraceptives with no cost‐​sharing. In addition, from 2014 through 2017, the ACA enrolled an estimated 5 million previously uninsured women of child‐​bearing age in either private insurance plans subject to that mandate or in Medicaid, which also covers prescription contraceptives with no cost‐​sharing.
As a result of these changes, the share of consumers who are sensitive to the price of contraceptives plummeted. The Kaiser Family Foundation reports that, among women with large‐​employer coverage who use oral contraceptives, “the share experiencing out‐​of‐​pocket spending…declined from 94 percent in 2012 to 11 percent in 2017.” From 2012 through 2014, ACA‐​mandated coverage of contraceptives all by itself “account[ed] for nearly two‐​thirds (63%) of the drop in out‐​of‐​pocket spending on retail drugs” across all consumers.
The ACA’s reshaping of the market for oral contraceptives precisely coincided with a dramatic increase in prices for those items. Since December 2009, the U.S. Bureau of Labor Statistics’ (BLS) Producer Price Index (PPI) has measured the prices manufacturers receive for a sample of domestically produced hormones and oral contraceptives. The nearby figure shows what happened to real prices for hormones and oral contraceptives before and after the ACA’s contraceptives‐​coverage mandate took effect.
Before the mandate took effect — i.e., during a period when consumers more often paid for oral contraceptives directly — price changes for hormones and oral contraceptives generally followed a path similar to that of non‐​prescription drugs, which insurance typically does not cover, and which also fell in real terms. Prices for hormones and oral contraceptives actually fell by 12 percent in real terms.
As the mandate began to take effect and as the ACA made oral contraceptives seem “free” to more purchasers, prices for hormones and oral contraceptives began to rise. By the time the mandate took full effect in early 2014, prices for hormones and oral contraceptives reversed five years of real reductions and caught up to the 17 percent growth in real prices for other prescription drugs.
Once the mandate took full effect, prices began to rise rapidly. From May 2013 through May 2019, while real prices for non‐​prescription drugs and prescription drugs overall rose just 12 percent and 37 percent, respectively, prices for hormones and oral contraceptives rose 108 percent. That’s nearly three times the rate of price growth for other prescription drugs.
The PPI for hormones and oral contraceptives has limitations as a measure of prices for hormonal contraceptives in general and oral contraceptives in particular. First, it samples and estimates changes in the initial prices drug manufacturers receive, not the ultimate prices insurers and consumers pay. Second, it samples and estimates changes in prices only for domestically produced drugs, excluding drugs produced in other countries and Puerto Rico. Third, it encompasses drugs other than contraceptives that may have an important influence on the index.
Unfortunately, the BLS neither discloses which drugs it samples nor the relative contributions of contraceptives versus other hormonal drugs. The PPI for hormones and oral contraceptives is therefore an imperfect measure because it does not necessarily reflect the changes in consumer prices for all hormonal contraceptives available to consumers, and may instead reflect changes in (non‐​consumer) prices for non‐​contraceptive hormonal drugs. The BLS’s Consumer Price Index (CPI) for prescription drugs lacks some of these shortcomings. Unfortunately, the BLS does not publish CPIs for prescription drugs at the level of therapeutic class.
Even with these limitations, these data suggest that trying to make oral contraceptives “free” for insured consumers had the unintended consequence of making them far more expensive for insurance companies and women who buy them without insurance, including young women who prefer not to purchase them through their parents’ insurance.
In the Cato Institute book Overcharged, Cato adjunct scholars Charles Silver and David Hyman explain why paying for health care through insurance often causes prices to rise. Despite the supposed purchasing power of third‐​party payers, insurers are not very good at reducing prices. When consumers don’t care about prices, they actively resist attempts by third‐​party payers to negotiate lower prices. This dynamic gives providers, including manufacturers of oral contraceptives, free rein to raise prices.
In a forthcoming Cato Institute white paper, Singer and I propose taking away the FDA’s power to require women to obtain a prescription before purchasing birth control pills.
Michael F. Cannon is the Cato Institute’s director of health policy studies.
https://www.cato.org/blog/aca-expanded-insurance-coverage-contraceptives-prices-soared

Coronavirus concerns abruptly ends exchange program at Philly school

As the Philadelphia Department of Public Health works to determine if an exchange student at William Penn Charter is infected with the coronavirus, school officials say they are ending their exchange program.
Following state and federal protocols, the Chinese student is currently in isolation pending tests for the coronavirus.
The child felt unwell last week and has received medical treatment, and is reportedly feeling better.
The student is one of 18 students and three chaperones who are here as part of an exchange program.
But on Monday night, Action News has learned that the school is making arrangements to have all exchange students return home.
In a letter obtained by Action News, the school told parents, “While we have no test results of the exchange student who felt unwell last week, and no new reports of illness within the group (we did a screening of all of the exchange students and chaperones today, and they showed no symptoms of illness), in consultation with Alpha Exchange we have decided to end the China exchange.”
“The exchange students will not be in class tomorrow, and Alpha Exchange is making plans for their lodging and safe return home. We have made arrangements for the students to depart tomorrow morning from Timmons House. We regret that this program has been complicated, and now terminated, because of events that were beyond the control of the people who were excited for all the learning that this cultural exchange had promised,” the school added.
Officials at William Penn Charter in East Falls are working with health officials to determine whether an exchange student from China might be infected with the coronavirus.
The exchange student under evaluation is among a group of teens who caught a connecting flight out of Wuhan City, ground zero for the illness, before arriving in the U.S. earlier this month.
The letter states the risk that the student is ill with the coronavirus is very low.
For most people, the coronavirus is similar to the flu and generally resolves itself rather quickly.
Test results are due in the coming days.
https://6abc.com/health/penn-charter-investigating-possible-case-of-coronavirus/5881409/

Surface Oncology +14% as FDA clears two INDs

Surface Oncology (NASDAQ:SURF) is up 13.8% postmarket after the FDA cleared Investigational New Drug applications for antibody candidates SRF617 and SRF388.
It’s planning to initiate clinical trials to advance both the programs.
The company’s also moving forward on a restructuring that will cut the workforce by about 35%, and says with that, cash and equivalents are projected to fund the company through 2022.
SRF617 targets CD39; SRF388 targets IL-27.
https://seekingalpha.com/news/3534966-surface-oncologyplus-14-fda-clears-two-inds

Oppenheimer makes bear case for Inspire Medical

Inspire Medical Systems (NYSE:INSP) is 2.1% lower in thin postmarket trade after an initiation at Underperform by Oppenheimer.
The firm set a price target of $50, implying 36% downside. Shares had declined 2.6% during the regular session.
https://seekingalpha.com/news/3534970-oppenheimer-makes-bear-case-for-inspire-medical