Philips: Combined COPD Treatments Could Help Reduce Cost Of Care

Royal Philips (PHG) announced new data suggesting that combining home oxygen therapy or HOT with home non-invasive ventilation or HMV as treatment for chronically hypercapnic COPD patients is more effective and less expensive than HOT alone. Comparing the accumulated costs of devices, doctor visits, medication, and hospitalizations to HOT alone using a US economic model, HOT-HMV exhibited an average annual cost savings of $3,927 per patient.

The data were gleaned by an economic analysis of a Philips-sponsored, randomized clinical trial of 116 patients in the UK carried out by respiratory experts at St Thomas’ Hospital in London. Results of the five-year, multi-center study were announced at ATS 2017 and published in the Journal of American Medical Association, but the potential health economic impact was previously unknown.

The original trial data were used to develop an economic model from the US payer perspective. This analysis indicated the base-case incremental cost per quality adjusted life year or QALY gained was negative $50,856, suggesting HOT-HMV as a dominant strategy to both save costs and improve quality of life compared to HOT alone. A similar UK analysis demonstrated greater device costs, a savings of £2,328 per patient in doctor visits, medication and hospitalizations costs, and also indicated cost effectiveness.

https://bit.ly/2rWprYd

Oscar looking to expand to more state ObamaCare exchanges

• Oscar Health expects to expand into Arizona and at least three other Affordable Care Act (ACA) exchange marketplaces in 2019, Bloomberg reported.
• The payer reported a profit in the first quarter of this year and significantly improved the company’s medical loss ratio.
• According to the company’s regulatory filings obtained by Bloomberg, Oscar had a net gain of about $9 million combined in New York, Texas, Tennessee and Ohio, but lost about $3.6 million in California and about $1 million in New Jersey.

The news of Oscar Health making a profit and looking to expand comes two months out from when the company said profitability was “around the corner” after it raised $165 million from investors. The millions in investments came from such big names as Google parent Alphabet’s investment arm Capital G and life sciences arm Verily.

Launched in 2012 by Josh Kushner (brother of President Donald Trump’s son-in-law Jared Kushner) and Mario Schlosser, the New York-based payer initially focused on the ACA exchanges. After years of losses, including a $205 million loss in 2016, Oscar has turned around the finances. The company said it achieved an “underwriting profit” in 2017 and is in the black for the first quarter of 2018.

The payer has been growing in both the ACA marketplace and in other insurance areas over the past year. Oscar expanded to Cleveland, Austin and Nashville and returned to New Jersey this year. The company also expanded to other markets, including small business and Medicare Advantage, and partnered with Cleveland Clinic and Humana to offer co-branded health plans.

Payers in general have been doing well this year. Insurance companies like UnitedHealthcare, Aetna and Cigna all posted positive first-quarter earnings. What makes Oscar’s news noteworthy is that the company was losing money not too long ago and it’s found success in the ACA marketplace, a market that many large payers left over the past two years.

https://bit.ly/2wMH0Pn

Mayo Clinic sees revenues, operating income climb in 2018 Q1

• Mayo Clinic reported operating income of $198 million in the first quarter of 2018, up from $101 million in the same period a year ago.
• Revenues at the Rochester, Minnesota-based nonprofit health system totaled $3.1 billion, compared with last year’s $2.9 billion, on higher medical service revenues, even as expenses rose.
• Meanwhile, a group of nurses hired to help install Mayo’s new Epic EHR are accusing the vendor overseeing the project, HCI Group, of mistreatment and bungling assignments, MPRNews reports.

Nearly $2.6 billion in the quarter came from medical service revenue, which includes inpatient procedures requiring overnight stays, certain outpatient operations and emergency care for critical conditions and trauma. Mayo reported $629 million in medical services for Medicare patients and $80 million for Medicaid enrollees.

The strong growth in operating income came despite a year-over-year increase in expenses from $2.8 billion to $2.9 billion, according to unaudited financial statements.

Mayo has committed about $665 million to construction projects over the next three to five years. The projects involve patient care, research and educational facilities, the Clinic said.

Mayo said the rollout to Epic’s EHR, slated for completion this year, will cost approximately $294 million.

Mayo joins other nonprofit health systems posting strong financials. Adventist Health and UPMC both reported bumps in net income and revenues in recent earnings reports.

Still struggling is Catholic Health Initiatives with an operating income loss of $35.3 million in the third quarter of fiscal year 2018, more than twice its loss in the same period a year earlier

Meanwhile, for-profit health systems are seeing modest gains in earnings. Universal Health Services reported an 8.7% increase in net income for the first quarter — to $224 million from $206 million the prior year. Net revenue was $2.7 billion, versus $2.6 billion in 2017. HCA Healthcare also reported an increase in revenue and admissions.

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Drug addiction: Is brain stimulation the answer?

Transcranial magnetic brain stimulation has allowed researchers to reduce how “excited” the brains of chronic cocaine and alcohol users become in response to drug cues.

For chronic alcohol users, the sight of a liquor bottle can trigger their addiction. But what if there was a way to reduce the ‘power’ of such cues?

Drug addiction is a chronic disease affecting 5.4 percent of the population worldwide.

In 2016, more than 64,000 people in the United States are thought to have died from a drug overdose.

According to most recent estimates, about 21.5 million U.S. individuals aged 12 and above live with a substance abuse disorder.

While the exact causes of drug addiction are unknown and researchers do not yet fully understand what causes someone to become addicted to a drug, we do know that, over time, drug abuse triggers changes in the brain that perpetuate the addiction cycle.

For example, we now know that the brain’s reward-processing circuits are thrown off balance in drug addiction, as the brain gets an excessive amount of the neurotransmitter dopamine.

Sometimes dubbed the “sex, drugs, and rock ‘n’ roll” neurotransmitter, dopamine plays a crucial role in reward-mediated motivation and learning, as well as in experiencing pleasure.

When the brain gets too much dopamine from drugs, it learns to continue to search for that “high” in favor of the “lesser” pleasure that it would normally get from other, daily rewards, such as consuming a chocolate bar or getting recognition at work.

These neurobiological underpinnings make addiction a so-called brain disease. Despite this, until now, researchers had not come up with treatments aimed at the neural circuits involved in the condition.

Now, however, researchers at the Medical University of South Carolina in Charleston may have found a treatment that successfully targets these brain circuits.

Supervised by Colleen Hanlon, Ph.D., researchers successfully used a noninvasive brain stimulation technique called transcranial magnetic stimulation (TMS) to blunt the brain’s response to the appeal of alcohol and cocaine in chronic users.

The findings were published in the journal Biological Psychiatry: Cognitive Neuroscience and Neuroimaging.

Treating the brain’s reward center

The researchers carried out two experiments at once, both of which were led by first study author Tonisha Kearney-Ramos, Ph.D. One study involved 24 participants with alcohol use disorder, and the second involved 25 participants with cocaine use disorder.

The study participants had one session of TMS and one control, or “sham,” session that imitated a TMS session without delivering any stimulation to the brain.

TMS allows for specific targeting of brain areas. In these experiments, both groups of participants received stimulation that focused on a brain region key for addiction and reward-processing: the ventromedial prefrontal cortex.

After the sessions, Kearney-Ramos and colleagues took scans of the participants’ brains using functional MRI in an effort to assess their response to drug cues such as seeing a liquor bottle.

TMS was found to have significantly reduced the brain’s reactivity to drug cues.

Dr. Cameron Carter, the editor of the journal that published the findings, explains what the results mean for treating drug addiction.

“Since cue reactivity has previously been associated with abstinence,” he says, “these [findings] suggest a common mechanism for treatment effects across disorders.”

Kearney-Ramos and her colleagues conclude, “This is the first sham-controlled investigation to demonstrate, in two populations, that VMPFC [stimulation] can attenuate neural reactivity to drug and alcohol cues in frontostriatal circuits.”

Hanlon also weighs in, saying, “Here, for the first time, we demonstrate that a new noninvasive brain stimulation technique may be the first tool available to fill [a] critical void in addiction treatment development.”

“Therefore, these results have a tremendous potential to impact both basic discovery neuroscience as well as targeted clinical treatment development for substance dependence.”

Colleen Hanlon, Ph.D.

“These results,” the study authors conclude, “provide an empirical foundation for future clinical trials that may evaluate the efficacy, durability, and clinical implications of VMPFC [stimulation] to treat addictions.”

https://bit.ly/2KEr3wH

AstraZeneca hyperkalemia med OKd by FDA

AstraZeneca announced that the FDA has approved Lokelma, formerly ZS-9, for the treatment of hyperkalemia in adults.3 Hyperkalemia is a serious condition characterized by high levels of potassium in the blood. Lokelma is a highly selective, oral potassium-removing agent. The FDA approval comes on the back of Lokelma receiving authorization from the European Commission for the treatment of hyperkalemia in adult patients and it is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials.

https://bit.ly/2IDWuq3

Simpler scan effective in deciding stroke treatment

A study led by a neurologist from McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth) showed that a computed tomography (CT scan) could be sufficient for determining thrombectomy treatment in stroke.

The late-breaking results were presented by Amrou Sarraj, M.D., today at the European Stroke Organization Conference in Sweden.

Thrombectomy surgery can be performed to remove a large blood clot lodged in a blood vessel. It has been shown to be an effective treatment for improving clinical outcomes in stroke up to 24 hours from onset. Stroke is the leading cause of long-term disability and fourth leading cause of death globally. Imaging must be done to determine the location of the clot and whether the patient is a good candidate for thrombectomy. Physicians use non-contrast simple CT and/or advanced CT with an injected contrast dye (CT perfusion) to see the area.

“The results show that simple imaging, while not perfect, may be good enough. This basic technique is faster, which means patients could potentially be treated more quickly,” said Sarraj, associate professor of neurology at McGovern Medical School at UTHealth. “The advanced imaging of CT perfusion isn’t available everywhere, so this could open up the door to identify more people for potential treatment, especially in remote areas.”

Sarraj was principal investigator of the study, Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT). The clinical trial enrolled 445 patients who received both simple and advanced imaging at nine academic health centers across the U.S. from January 2016 to February 2018. Senior author was Gregory Albers, M.D., of Stanford University.

The results showed that patients who were treated based on simple imaging had identical clinical outcomes to those treated based on advanced imaging. In addition, those patients who had a good imaging profile—a smaller area of dead brain tissue—had the same clinical outcomes regardless of which imaging was used.

“If those treated using simple imaging can do as well as those treated by CT perfusion, this is an extremely important breakthrough that warrants further exploration and testing because it could broaden the number of patients having and benefiting from thrombectomy,” said Sarraj, who is also director of UTHealth’s vascular neurology fellowship program and an attending physician at Memorial Hermann-Texas Medical Center.

However, the study also revealed that 42 percent of patients who were excluded from thrombectomy by one of the imaging profiles, but had a good profile on the other type of imaging, had positive clinical outcomes.

“Our results should not be interpreted that advanced perfusion images are not necessary or should not be acquired at all as they still identified a group of patients that may be treated with thrombectomy when CT alone was not enough. The numbers involved are significant because 17.6 percent of patients could have been excluded from having surgery if the CT or CT perfusion were relied on alone, so there’s a real opportunity here to help more people if both forms of imaging are available,” Sarraj said.

The study did not randomize patient selection by simple imaging versus advanced imaging.

“Although this was the first large cohort study with pre-specified imaging criteria, analyses and objectives to look at imaging type selection, there is room for further refinement to truly test our initial findings and see if they are more affirmative and conclusive,” Sarraj said.

 Explore further: Brain-scan guided emergency stroke treatment can save more lives

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5 takeaways from the first look at cancer’s biggest conference

Every year tens of thousands of cancer researchers, doctors, investors and analysts travel to Chicago in early June for the annual meeting of the American Society of Clinical Oncology. It’s the largest conference in the drug industry’s hottest field.

Research at the conference often highlights progress from key clinical studies of cancer therapeutics, impacting the market fortunes of the drugmakers which make them.

After the close of the market yesterday, some 5,000 abstracts for studies set to be presented at the meeting were posted online. While the data contained within those study snapshots is incomplete, investors and analysts have taken to digging through the documents for clues as to how important drugs are performing.

Read on for five (early) takeaways of what to expect from ASCO when it kicks off in two weeks:

Case for immunotherapy plus chemo looks even stronger

While cancer immunotherapy has impressed with strong efficacy in some cancer types, too many patients still don’t see a benefit.

In hopes of boosting the number who do, drugmakers across the industry have invested in studies testing combinations of immunotherapies with other drugs. Results have been mixed, as successes have come alongside setbacks.

What’s become clear, however, is that combining immunotherapy with chemotherapy appears to be effective in driving further benefit. Merck & Co.’s Keytruda stands out in this regard, having won approval for treating non-small lung cancer (NSCLC) when combined with chemo.

But, as updates included in several ASCO abstracts suggest, rival drugs also appear to pair well with chemo in first-line NSCLC.

Bristol-Myers Squibb’s Opdivo (nivolumab) plus chemotherapy drove a 26% reduction in the relative risk of progression-free survival versus chemo alone, data from an abstract of the pharma’s closely watched CheckMate-227 trial shows.

Elsewhere, an abstract of Roche’s IMpower-150 study detailed the overall survival benefit from a combination of the Swiss pharma’s Tecentriq paired with chemo and the older cancer drug Avastin (bevacizumab).

Updates from several other key studies by Merck and Roche are still under wraps and will be revealed at the conference.

“We think the market in 1L NSCLC is becoming even more competitive as [Bristol-Myers] and Roche demonstrate comparable efficacy in their own combinations, and the role of PD-1/chemo combo is further consolidated with more positive data,” wrote Leerink analyst Geoffrey Porges in a May 17 note.

Regeneron’s cemiplimab stays on track

Five PD-1/L1 inhibitors are currently approved in the U.S., with Keytruda (pembrolizumab) and Opdivo far ahead of rivals.

The clinical and commercial success of the checkpoint blockers has sparked a frenzy of ‘me-too’ drug development, raising questions of where drugmakers looking to enter the market can make a mark.

Such doubts haven’t stopped Regeneron from pushing forward with testing of its own PD-1 inhibitor cemiplimab, though. The biotech is aiming first at cutaneous squamous cell carcinoma (CSCC), an indication for which the other immunotherapies aren’t approved.

Regeneron, and its partner Sanofi, presented positive data last December and submitted the drug for U.S. approval earlier this year. Data included in the ASCO abstract of the study revealed little new information, highlighting a roughly similar 47.5% response rate among CSCC patients.

For the first time, however, investors got a glimpse of the drug’s efficacy in the more lucrative — but more competitive — lung cancer market. Early results from 21 patients in a Phase 1 NSCLC study showed treatment with the drug led to a 29% overall response rate. While good, that’s not exactly a sign of market-beating efficacy.

“[Regeneron]’s cemiplimab looks like a PD-1 antibody, which it is,” Evercore ISI analyst Josh Schimmer noted dryly in a May 16 note to investors.

Regeneron claims its drug will be third to market, not sixth, hypothesizing that blocking the PD-1 receptor rather than the PD-L1 ligand is more effective. Investors are still waiting for proof.

Investors aren’t sold on Nektar combo just yet

In February, Bristol-Myers bet $1.85 billion on the promise of an experimental early-stage immunotherapy developed by Nektar Therapeutics, hoping to pair the drug with Opdivo. The companies plan to test the two drugs together across nine different cancers.

At ASCO, data from a Phase 1/2 study known as PIVOT will be presented for several solid tumor types — giving investors a more detailed look at what attracted Bristol-Myers to Nektar’s compound.

Early signs from the abstract, which includes efficacy data from only 60 patients, raise some questions though. Response rates from the combo in melanoma and kidney cancer dropped a touch lower from previous updates.

Opdivo has already demonstrated benefit in these indications, so investors are looking for signs adding Nektar’s drug yields a significant efficacy boost.

“We’re still not convinced that NKTR-214 has been dosed to add meaningful incremental effect over PD-1 antibody alone — so will look towards the full dataset to better inform our perspective,” Evercore’s Schimmer wrote.

Worth noting, however, is the fact that 22 patients in the Phase 2 portion of the study had only one follow-up scan, meaning results could improve over time. Look to the conference itself for a clearer reading on whether Bristol-Myers’ bet was well placed.

Loxo outshines rival in RET-mutant cancers

Loxo Oncology first captured investor attention at last year’s ASCO meeting, presenting impressive data for its experimental drug larotrectinib in patients whose cancer expressed a rare genetic abnormality known as TRK fusion. The biotech has since parlayed that data into a $1.5 billion deal with German pharma Bayer.

Now, as ASCO approaches, investors will be focused on another pipeline drug known as LOXO-292.

Designed to treat cancers with a genetic mutation known as RET, the drug drove a 69% overall response rate among RET-positive patients with non-small cell lung cancer and a type of thyroid cancer, according to an abstract of the Phase 1 study.

Notably, no dose-limiting toxicities were observed and the drug appeared relatively well-tolerated, with no Grade 3 adverse events attributed to LOXO-292.

The results also appear to stack up well against data from Blueprint Medicine’s rival candidate BLU-667, analysts noted. Shares in Loxo surged by nearly 20% in Thursday morning trading.

Jounce gets bounced by shaky data

Investors were less impressed with data from Jounce Therapeutics.

Shares in the Cambridge, Massachusetts-based biotech fell more than 30% Thursday as markets digested interim results from a Phase 1 study of the company’s ICOS agonist JTX-2011.

Data included in the study abstract showed low response rates to the drug, given as monotherapy or paired with Opdivo in patients with gastric cancer and triple-negative breast cancer (TNBC).

Of seven gastric cancer patients given JTX-2011, only one saw a partial response. Among 19 patients given Jounce’s drug with Opdivo, two experienced a partial response and two had ongoing stable disease. In TNBC, one partial response was reported in 15 patients given the combo.

Patients in the study were heavily pretreated and immunotherapy has not seen as much success in TNBC as of yet.

In a May 16 statement, the company sounded an optimistic note and indicated updated results would be presented at ASCO.

Recommended Reading:

•  American Society for Clinical OncologyAbstract search

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