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Saturday, April 6, 2019

Indivior: New Study Data in Patients with Opioid Use Disorder

Injecting opioid users may benefit from higher maintenance dose of SUBLOCADE™ (buprenorphine extended-release), a once-monthly injection for the treatment of moderate to severe opioid use disorder Indivior also reports results of study showing that therapeutic concentrations of buprenorphine reduce the magnitude of respiratory depression caused by fentanyl.

Indivior PLC (LON: INDV) today announced data from two new studies: the first provides insights into dosing of once-monthly SUBLOCADE™ (buprenorphine extended-release) injection for subcutaneous use (CIII) for the treatment of moderate to severe opioid use disorder in patients who inject opioids, and the second study reports on the impact of therapeutic plasma concentrations of buprenorphine in inhibiting the respiratory depression caused by fentanyl. The results were reported at the 50th Annual Conference of the American Society of Addiction Medicine (ASAM) in Orlando, Florida and follow yesterday’s announcement of results from the RECOVER™ study and the 18-month long-term safety study.
We are generating data to help the healthcare community and others understand the unique challenges faced by patients with opioid use disorder and potential ways to overcome them,” said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior. “Addressing this crisis, one patient at a time, means having the necessary information to make individualized decisions about optimal use of medically-assisted treatment to support each patient’s recovery—including proper dosing and length of treatment.”
Opioid injection users may benefit from higher SUBLOCADE maintenance dosesThis post-hoc analysis investigated patterns of abstinence in both injecting and non-injecting opioid users who participated in the SUBLOCADE Phase 3 double-blind, placebo controlled pivotal trial and the subsequent SUBLOCADE open-label long-term safety study (12 months of treatment). Abstinence was defined as negative urine samples plus negative self-reports of illicit opioid use.
Injecting opioid users (based on self-reports) treated with the SUBLOCADE maintenance dose regimen of 300 mg remained in treatment longer and had a higher study completion rate than those treated with the 100 mg maintenance dose. Furthermore, the mean percentage abstinence (Weeks 10–25) was higher among injecting users treated and maintained with SUBLOCADE 300 mg (58%) vs. those maintained with SUBLOCADE 100 mg (43%); the difference in group means was 15%. Among non-injecting users, the percentage with continuous abstinence was the same (28%) in both dose groups.
These findings are consistent with previous reports that injecting opioid drug users may benefit from higher doses of methadone or buprenorphine.1,2 “Indivior is planning additional studies to further characterize the patients for whom a higher maintenance dose of SUBLOCADE may be warranted,” said Dr. Heidbreder.

Livanova (LIVN) PT Lowered to $100 at Needham, Says Problems Temporary

Needham & Company analyst Mike Matson lowered the price target on Livanova (NASDAQ: LIVN) to $100 (from $120.

Medicare for All could cut hospital revenues by 16%

Medicare for All could have consequential repercussions for hospital finances, according to a new JAMA report.


KEY TAKEAWAYS

Implementing a “Medicare for All” system that extends the current fee schedule to all patients would result in net revenue losses north of $150 billion.
Hospital profit margins would likely decline from a current average of 7% to a projected negative 9%, representing an annual loss of nearly $86 billion.
On increasing public insurer payment rates to 100%, JAMA calls the approach “very expensive,” adding that it would “do little to encourage hospital efficiency.”
Implementing a “Medicare for All” system that extends the current fee schedule to all patients would result in net revenue losses north of $150 billion for hospitals nationwide, according to a JAMA report released Thursday.
If Medicare for All is implemented, those at greatest risk are hospitals operating with costs significantly higher than the Medicare payment rate, according to the report.
Hospital profit margins would likely decline as drastically as revenues, from a current average of 7% to a projected negative 9%, representing an annual loss of nearly $86 billion.
Similarly, hospitals would expect to fleece 1.5 million clinical and administrative jobs to reduce labor costs in the event of projected revenues shortfalls resulting from Medicare for All.
The JAMA report found that even if hospitals sacrificed their profit margin as a buffer, more than 850,000 jobs would still be lost as a result of outstanding revenue shortfalls.
The findings come as Medicare for All continues to dominate conversation among healthcare policymakers, especially progressive leaders in the Democratic Party, including several presidential candidates who have made it a centerpiece of their respective campaign platforms.

The JAMA report found that expanding Medicare into essentially a single-payer model would adversely affect hospitals which have a disproportionate share of commercially insured patients.
Several variations of Medicare for All call for the eliminationof the private insurance market.
However, more than one-quarter of hospitals that report negotiating with private insurers as the greatest price pressure for the organization also indicate that costs are “7% below the national average and do not lose money treating Medicare beneficiaries,” according to JAMA.
And while Medicare for All would effectively increase payments rates from public insurers to 100%, JAMA calls such an approach “very expensive,” adding that it would “do little to encourage hospital efficiency.”
The report estimates that annual federal Medicare spending would increase $40.7 billion while state and federal Medicare spending would total $25.6 billion.
Last month, a similar study by Navigant examined the potential financial effects on hospitals due to various Medicare expansion policy proposals, including Medicare for All.

In its analysis, Navigant found a medium-sized, nonprofit, multi-hospital system with revenues of more than $1 billion and a current operating margin of 2.3% would see revenues decline by around $330 million under Medicare for All, representing a margin drop of just over 22%.
The JAMA report does highlight some possible positive outcomes from implementing Medicare for All, including that hospitals could find new ways to become more efficient, such as through incurring less debt, negotiating improved rates in supply chain operations, or foregoing planned capital expenditures.
The job losses may even be offset by growth in non-healthcare industries, according to JAMA, meaning reduced healthcare spending under Medicare for All could “could stimulate a growth in employment (or wages) outside of the healthcare industry.”
Still, hospitals leaders have remained openly skeptical about the potential benefits of enacting such a program, with American Hospital Association CEO Rick Pollak rebuffing itin February as a policy that could “do more harm than good to patient care.”

Chambers of commerce stay bullish on association health plans, despite ruling

Despite a judge’s ruling last week that left association health plans in flux, state and local chambers of commerce are still committed to pushing forward with such plans.
Katie Mahoney, vice president for health policy at the U.S. Chamber of Commerce, said on a call with reporters Wednesday that the national chamber held a call with its state and local counterparts following the decision, and while there is concern about the future, the chambers are still focused on growing AHPs.
“This is a really important policy priority for them,” Mahoney said. “A lot of the chambers are continuing to be optimistic about moving forward despite some uncertainty.”
District of Columbia Judge John Bates ruled on Thursday that the Trump administration’s plan to expand association health plans overstepped legal boundaries with the goal of skirting Affordable Care Act coverage requirements.
Bates said the Department of Labor exceeded its authority under the Employee Retirement Security Income Act (ERISA) with the rule, which was finalized last summer.
Critics of such plans say they’re “junk” insurance as they lack the ACA’s consumer protections for other plans and could leave people with pre-existing medical conditions in the lurch.
Mahoney said that state and local chambers of commerce, however, are offering “very robust, substantial coverage” under the expansion and that there are several consumer protections baked into the Labor Department’s regulation.
For one, association health plans launched under the rule are not allowed to deny coverage to people with pre-existing conditions, she said.
“The coverage is good coverage, and it has significant consumer protections included in its regulatory framework,” she said.
Under the rule, more than 100 chambers have backed 16 association plans, Mahoney said, covering about 20,000 people. The chambers expect to have 300,000 members by 2020, she said.
Though many chambers are still enthusiastic about the prospect of AHPs, Mahoney said the U.S. Chamber of Commerce is concerned that the ruling could lead to fewer new plan launches.
“We are very concerned at the uncertainty that this throws” into the situation, she said.

Bayer, after cyberattack, finds ‘no evidence’ hackers obtained data

Nearly two years after Merck suffered a costly cyberattack, Bayer is the latest drugmaker to disclose that it’s been targeted by cybercriminals.
The company said it contained a cyberattack after detecting malicious software called Winnti in early 2018. Bayer says there’s “no evidence” hackers obtained any data.
“Our experts at the Cyber Defense Center have identified, analyzed and cleaned up the affected systems, working in close collaboration with the German Cyber Security Organization and the State Criminal Police Office of North Rhine-Westphalia,” a spokesman told FiercePharma. “Investigations of the Public Prosecutor’s Office in Cologne are ongoing.”

Bayer’s disclosure comes after Merck’s well-publicized cyberattack back in 2017. The company reported via Twitter in June of that year that it had been targeted by NotPetya software; in that attack, hackers took over computers and demanded a ransom. The ransom ended up being a spoof, as there was no way for users to retrieve their data.
Merck experienced a “disruption of its worldwide operations, including manufacturing, research and sales operations,” the company disclosed in a recent annual filing with the SEC. The company lost $410 million in sales through 2017 and 2018 due to the attack, plus suffering other expenses of $285 million. Merck is still fighting with certain insurers over claims from the attack.
It’s clear that pharma companies want to avoid becoming the next cyberattack victim. Merck has upped its defenses in response, the company said in its annual filing with the SEC. Before the Merck attack, hackers gained access to systems at three major European pharma firms between January 2014 and June 2015, security firm Symantec said in a 2016 report. Hackers in each case were financially motivated.

Lagging Pharmacies Court the Chronically Ill

America’s two biggest pharmacy chains are attempting to reverse their sagging fortunes by becoming go-to treatment centers for people with chronic illnesses.
CVS Health Corp. and Walgreens Boots Alliance Inc. are remodeling hundreds of stores into medical-service centers targeted at customers with conditions like diabetes, heart disease and hypertension. The idea is to make customers just as likely to stop in for medicine, consultations and lab tests as for lipstick or a candy bar.
The need is urgent. Both chains are under tremendous pressure to find new ways to counter slowing revenue from prescription drugs, which drive the bulk of their sales. On Tuesday, Walgreens shares fell 13% after it gave a gloomy full-year earnings outlook, weeks after CVS did the same. CVS shares have fallen 34% since its $70 billion acquisition of insurer Aetna Inc. as its has struggled to convince investors the combination will prove lucrative.
Drug-pricing pressure isn’t letting up. Both companies are getting hurt as generic-drug makers scale back price cuts and pharmacy-benefit managers squeeze pharmacies across the board on both generic and brand-name drugs.
Meanwhile, looming over both Walgreens and CVS is Amazon.com Inc.’s foray into prescription-drug sales. Amazon said last year it was buying online pharmacy PillPack Inc. for about $1 billion, a move that factored into CVS’s decision to acquire Aetna, people familiar with the situation said at the time. Walgreens cited Amazon’s PillPack deal as a potential threat to its business in its latest annual report.
“It’s clear that the drugstores that we are used to knowing will not be the store of the future for sure, so we have to change,” said Walgreens Chief Executive Stefano Pessina in a recent interview.
But previous attempts to remake the drugstore concept with in-store medical services have had mixed results — and led to a high-profile embarrassment for Walgreens, whose disastrous partnership to offer in-store blood testing with now-defunct Theranos Inc. ended in a legal settlement in 2017.
Walgreens declined to comment on its venture with Theranos, which has been engulfed by charges it deceived investors about the capabilities of its technology, beyond saying the deal was done under previous management.
Now, the chains are focused on a challenge that has long frustrated the broader U.S. health-care system: getting patients with chronic diseases to take better care of themselves.
Roughly 60% of Americans have at least one chronic condition and four in 10 adults have more than two, according to the U.S. Centers for Disease Control and Prevention. Many patients have trouble taking their medicines as prescribed and slip back into poor health habits — or go untreated until they end up in the emergency room. The CDC estimates that chronic conditions account for roughly 90% of the nation’s $3.3 trillion in annual health-care spending, much of it for in-hospital care.
CVS and Walgreens say their vast networks, the ease of access and the data they collect on pharmacy customers make them uniquely positioned to help those with chronic conditions comply with their treatment plans.
“It’s bringing more health services to a more convenient location that doesn’t disrupt your day and has a consumer bent to it,” said Alan Lotvin, CVS chief transformation officer. “We inculcate it into your everyday routine so it’s not, ‘Oh I’m going to the doctor today.'”
The gains could be big in getting people needing costly medicines to actually fill their prescriptions, not least for CVS who could leverage Aetna’s insurance savings from reduced health-care costs. For both pharmacy chains, it could help increase both prescription income and foot traffic to stores.
But there are a lot of obstacles, perhaps the biggest of which is getting customers to take the drugstore chains seriously as health-care providers.
“It’s mind boggling to me that they can say the center of the health-care system will be a retail outlet that sells Doritos as well as prescription drugs,” said Lawton Burns, a health-care management professor at the University of Pennsylvania’s Wharton School of Business.
Others say the chains could have an edge over health systems and hospitals that have long tinkered with ways to improve access to care for the chronically ill.
“The current solutions aren’t working,” said Sanjay B. Saxena, who works with insurers and health systems at Boston Consulting Group. “We aren’t addressing the fact that health care has not caught up with the rest of what consumers expect in their life. Chronic disease keeps getting worse and the costs associated with that are going up.”
CVS sees roughly 1,000 of its more than 9,800 retail stores becoming bigger hubs, offering a range of medical services, while Walgreens envisions a similar setup for about 1,500 of its 9,600 U.S. locations. Those locations — CVS calls them “health hubs” and Walgreens terms them “neighborhood health destinations” — will anchor a broader network of more traditional drugstores that will be tweaked to focus more on health and less on traditional retail.
Walgreens has struck partnerships with about a dozen companies in recent years on ways to monitor patients’ health and behavior, and advise them accordingly. With partners, it already has some 400 clinics inside stores, with treatments such as flu shots administered by nurse practitioners, and more than a dozen urgent-care centers.
Microsoft Corp. is helping Walgreens develop software that would manage patient engagement, while Alphabet Inc.’s Verily Life Sciences unit will develop a pilot project to get patients to take their medications as prescribed. Walgreens has also opened two in-store primary-care clinics in the Kansas City area with insurer Humana Inc. and has replaced its ill-fated Theranos partnership with a blood-testing deal with clinical-lab operator LabCorp to open at least 600 centers at Walgreens stores over the next four years.
Mr. Pessina, the CEO, says data collected by Walgreens can ultimately be used to flag unhealthy behaviors in consumers. Among Walgreens’ new features will be an app that encourages customers to log their diets and other information and that alerts users to the consequences of their choices.
That fright factor will encourage people, such as diabetics not following their recommended diet, to make better choices, Mr. Pessina said, including taking prescriptions regularly and keeping up with recommended diagnostics.
Walgreens has opted for partnerships over big acquisitions, which Mr. Pessina said carry too much risk.
CVS, meanwhile, wants full control over its assets. That thinking drove the chain’s Aetna acquisition, as well as its deals for the walk-in MinuteClinic chain and pharmacy-benefits manager Caremark more than a decade ago.
“These systems and operations can talk to one another, we can set the culture,” said Kevin Hourican, president of CVS Pharmacy, who oversees the company’s retail operations.
Aetna is central to its latest mission. With access to its insurance rolls, CVS pharmacists will be able to reach out directly to customers with chronic health conditions and encourage them to come to the store for a consult on services they can access. If CVS’s approach works, Aetna’s data can then be used to demonstrate savings and, the company hopes, woo other insurers into using its model.
Also central to the plan is an overhaul of the MinuteClinic network.
Today, roughly 1,100 MinuteClinic locations, located inside CVS pharmacies and Target stores and staffed primarily by nurse practitioners, address immediate and simple health issues, such as flu shots or treatments for a sore throat. CVS is aiming to shift the clinics toward managing complex and chronic cases, for example equipping them with retinal imaging systems to carry out eye exams that are part of annual physicals recommended for diabetics.
But wading deeper into health care, particularly complicated chronic conditions, could put the companies at greater risk of medical malpractice claims, said Nicholson Price, a professor at the University of Michigan Law School who has written on health law and ethics.
Patients today don’t interact much with their pharmacists, Mr. Price said, so building a system in which pharmacists aid in carrying out treatment is a big shift. “Once you get into more actively managing chronic conditions you start to ask, ‘Would a physician’s assistant or nurse practitioner be expected to recognize some sort of complications that are arising?” he said.
Shirlette Williams, a Type 2 diabetes patient in Buffalo, N.Y., says she couldn’t fathom using a drugstore as her medical provider. The 54-year-old says she relies on a combination of a health clinic near her home and regular visits with a diabetes educator and nutritionist, and that she would question a drugstore’s motives in treating her condition.
“I wouldn’t go to CVS or Walgreens to manage my condition because I feel that a drugstore’s priority would be to sell me drugs,” Ms. Williams said. “While the idea could be a good one for people who don’t have a health-care provider in their neighborhood, I’d feel more confident if my pharmacy and health-care provider were separate entities.”
Both companies say people who have visited stores with the new format have responded positively and that further changes will help consumers make the leap more confidently.
“Care coordination with our pharmacists and patients’ providers is often critical to better outcomes, and benefits all parties including patients, payers and providers,” a Walgreens spokesman said.
Both companies say they will comply with health-privacy laws and won’t share data with the retail side of the business.
CVS says its existing capital budgets will cover costs of reinventing stores nationwide. A Walgreens spokesman said investments would be made “in a financially disciplined manner,” declining to further quantify.
Unlike CVS, which stopped selling tobacco products in 2014, Walgreens has continued to sell cigarettes in most of its stores, drawing criticism from federal regulators, lawmakers as well as activists who say that tobacco products don’t belong in a health store. Mr. Pessina says the chain is testing some tobacco-free stores and is encouraging employees in others to offer aids to quit smoking to customers buying cigarettes.
One recent weekday afternoon, Mr. Pessina, the company’s CEO, walked through a store near the company’s Deerfield, Ill., headquarters. In an area called the “health corner” were signs for optical, lab, hearing and pharmacy services. As Mr. Pessina quizzed the in-store optometrist about the number of visitors he was getting, a customer shuffled by pushing a shopping cart with a case of Bud Light. Across the store, a woman had her blood pressure checked.
Mr. Pessina said he’s convinced moving away from traditional retail is the only way forward. “We are also a retailer,” he said. “But we are above all a pharmacy.”

Friday, April 5, 2019

Alder Biopharm CEO: Our engagement with the FDA has been fantastic

In an interview on CNBC’s Mad Money, Alder Biopharmaceuticals CEO Bob Azelby said: Many migraine patients are seeing their doctors frequently… Our engagement with the FDA has been fantastic… We are in a good place from an inventory standpoint… We have advantages in robustness and speed of response with eptinezumab.