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Apple Develops Knee and Hip Replacement Monitoring App
on October 15, 2018 at 8:46 AM
As Apple pushes deeper into health care with the Apple Watch, CNBC reports that the company is developing a plan to help people who are recovering from knee and hip replacement surgeries.
Apple announced a partnership with medical device company Zimmer Biomet, to combine a new app along with health-tracking data from the smartwatch to help determine why certain patients recover faster than others from the procedures. The companies are also working together on a clinical study.
Apple has its sights set square on the $3 trillion U.S. health-care sector and is continuously exploring medical applications for the watch, most recently adding an FDA-cleared EKG sensor. When it comes to orthopedics, more than than 1 million Americans get knee and hip replacements every year, and Zimmer Biomet is among the biggest manufacturers of reconstructive products.
Apple and Zimmer Biomet have created a mobile app called mymobility, which aims to help guide patients through their surgery to improve their experience, as well as their health outcomes. It includes educational resources, exercise videos and a way for patients to contact their surgeon and care team with questions and concerns.
The Apple Watch will track steps and heart rate data, allowing patients to share that information with their doctors to provide a clearer picture of how they're doing after surgery and to analyze potential setbacks. For example, if a patient is concerned about the level of pain, the care team could see that the patient walked five miles the previous day, so the problem may be overexertion rather than a serious complication.
Apple and Zimmer Biomet are hoping to enroll 10,000 people in the U.S. in the study. The app is initially available only to patients who enroll in the study, but it will eventually be rolled out to everyone, a spokesperson for Zimmer Biomet told CNBC. Participants who don't own an Apple Watch will receive one for the duration of the project. Fitbit has also looked at using its fitness trackers to monitor patients after surgery.
Zimmer Biomet CEO Bryan Hanson said in a statement that the partnership with Apple marks "one of the largest evidence-gathering clinical studies in orthopedic history."
Apple Chief Operating Officer Jeff Williams said in a separate statement that the new app lets patients and doctors connect in a way that was "not previously possible through traditional in-person visits."
The study is the second of its kind for Apple. In September 2017, the company kicked off its Heart Study in partnership with Stanford University, testing to see if it could detect in people a type of heart health irregularity called atrial fibrillation.
Williams told CNBC in November that Apple is open to working with some of the largest health-care companies in the space and said, "We have taken a thoughtful approach to this and embraced the medical community."
Apple is tackling among the biggest and fastest growing segments of medicine. Given the aging of the population, the number of people who receive knee and hip replacement surgeries is expected to rise in coming years.
Dan Williamson, Zimmer Biomet's group president for joint reconstruction, told CNBC a goal for the study is to "reduce anxiety for the patient and make sure the surgeon has the level of visibility they need."
The company worked with Cedars Sinai hospital in Los Angeles to figure out the optimal amount of activity for people recovering from hip and knee replacements. They reported a magic number of 1,000 steps, meaning those that reached the milestone in the days after the procedure were usually discharged sooner than those who fell short.
In another medical use for the Apple Watch, the company said recently it is donating 1,000 watches for a new study to track binge eating. […]
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DEA Approves Importing Cannabis for Medical Research
on October 15, 2018 at 8:46 AM
It's no secret that the world is growing accustomed to the business of cannabis, but for $9.6 billion Canadian medical marijuana producer Canopy Growth, the future is approaching faster than many expect.
Canopy - which has gained traction on news of several-billion-dollar investments from Corona parent Constellation Brands - announced that it had shipped cannabis to the United States from Canada for medical research, a milestone in the U.S. government's acceptance of what it considers to be a Schedule 1 drug.
"Under [Drug Enforcement Administration] approval, we shipped, for the first time, legally - and I highlight 'legally' - cannabis from Canada to the U.S," Bruce Linton, the co-founder, Chairman and CEO of Canopy Growth, told CNBC's Jim Cramer.
"The DEA-approved partner, which we haven't announced yet, can actually begin to do medical research, clinical trials if necessary, [and] create the data set that enables people to know when, what, where, and maybe it can become federally regulated in the U.S. with some input that way," Linton said in an interview on "Mad Money."
Canopy's news comes less than one month after competing Canadian marijuana producer Tilray announced DEA approval to import cannabis to the United States for medical research at the University of California San Diego Center for Medicinal Cannabis Research.
California is one of eight states, excluding the District of Columbia, to fully legalize medical and recreational marijuana use. Thirty U.S. states currently have laws legalizing medical marijuana use in some form.
Today, the world has its eyes on Canada, where full legalization of adult marijuana use is set to take effect on Oct. 17. While the windfall will likely be massive for producers like Canopy, Linton is focused on the longer-term global opportunity.
Canada's legalization could be Canopy's key to seizing on that opportunity more than it already has, Linton added.
"Last week I was in the EU, the U.K. They know about Oct. 17 intimately and they're trying to figure out, 'Hm, if we're a government or businesses, how do we quit ignoring cannabis and govern it, regulate it, tax it and turn it into something that might be medicinal and for sure a much better formatted product for a party?'" he said.
"And so what's going to be the big bump isn't just Canada," he said. "If we do it right, Canopy leads. That gives us the position globally that then, all of a sudden, you add a zero or two to the number of people we're trying to serve."
U.S. shares of Canopy, the first cannabis company to be listed on the New York Stock Exchange, gained 5.64 percent Friday trading as the rest of the stock market recovered from its multi-day losing streak. […]
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CVS/Aetna Must Divest Aetna’s Part D Prescription Drug Plan
on October 12, 2018 at 10:31 AM
The Department of Justice announced that it is requiring CVS Health Corporation and Aetna Inc. to divest Aetna’s Medicare Part D prescription drug plan business for individuals in order to proceed with their $69 billion merger. The proposed divestiture to WellCare Health Plans, Inc. (WellCare), an experienced health insurer focused on government-sponsored health plans, including Medicare Part D individual prescription drug plans, would fully resolve the Department’s competition concerns.
"Today’s settlement resolves competition concerns posed by this transaction and preserves competition in the sale of Medicare Part D prescription drug plans for individuals," said Assistant Attorney General Makan Delrahim of the Justice Department’s Antitrust Division. "The divestitures required here allow for the creation of an integrated pharmacy and health benefits company that has the potential to generate benefits by improving the quality and lowering the costs of the healthcare services that American consumers can obtain."
The Department’s Antitrust Division, along with the offices of five state attorneys general, today filed a civil antitrust lawsuit in the U.S. District Court for the District of Columbia to enjoin the proposed transaction, along with a proposed settlement that, if approved by the court, would fully resolve the Department’s competitive concerns. The participating state attorneys general offices represent California, Florida, Hawaii, Mississippi, and Washington.
CVS, the nation’s largest retail pharmacy chain, and Aetna, the nation’s third-largest health-insurance company, are significant competitors in the sale of Medicare Part D prescription drug plans to individuals, together serving 6.8 million members nationwide.
According to the Department’s complaint, the combination of CVS, which markets its Medicare Part D individual prescription drug plans under the "SilverScript" brand, and Aetna would cause anticompetitive effects, including increased prices, inferior customer service, and decreased innovation in sixteen Medicare Part D regions covering twenty-two states. The complaint alleges that the loss of competition between CVS and Aetna would result in lower-quality services and increased costs for consumers, the federal government, and ultimately, taxpayers.
Under the terms of the proposed settlement, Aetna must divest its individual prescription drug plan business to WellCare and allow WellCare the opportunity to hire key employees who currently operate the business. Aetna must also assist WellCare in operating the business during the transition and in transferring the affected customers through a process regulated by the Centers for Medicare and Medicaid Services, an agency within the U.S. Department of Health and Human Services.
CVS, headquartered in Woonsocket, Rhode Island, operates the nation’s largest retail pharmacy chain, owns a large pharmacy benefit manager called Caremark, and is the nation’s second-largest provider of individual prescription drug plans, with approximately 4.8 million members. CVS earned revenues of approximately $185 billion in 2017.
Aetna, headquartered in Hartford, Connecticut, is the nation’s third-largest health-insurance company and fourth-largest individual prescription drug plan insurer, with over two million prescription drug plan members. Aetna earned revenues of approximately $60 billion in 2017.
As required by the Tunney Act, the proposed consent decree, along with the Department’s competitive impact statement, will be published in the Federal Register.
Any person may submit written comments concerning the proposed settlement within 60 days of its publication to Peter Mucchetti, Chief, Healthcare and Consumer Products Section, Antitrust Division, Department of Justice, 450 Fifth Street NW, Suite 4100, Washington, DC 20530. At the conclusion of the 60-day comment period, the court may enter the final judgment upon a finding that it serves the public interest. […]
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NCCI Tracks Key WC "Hot Topics"
on October 12, 2018 at 10:31 AM
This year, NCCI tracked more than 800 state and federal workers compensation-related bills and monitored almost 200 workers compensation-related regulations. Legislation impacting workers compensation coverage for first responders continued to be a hot topic with more than 100 bills considered. Here are the key areas of legislative interest for the coming months.
The First Responder Bills addressed compensability for certain cancers and other diseases as well as compensability for post traumatic stress disorder.
California addressed this issue with AB 1749 which was signed into law this year. This new law was created as a result of the October 1, 2017, mass shooting in Las Vegas, Nevada. The new law provides that an employer, at its discretion or in accordance with specified policies, is not precluded from accepting liability for compensation for an injury sustained by a peace officer by reason of engaging in the apprehension or attempted apprehension of law violators or suspected law violators, or protection or preservation of life or property, or the preservation of the peace, outside the state of California.
Legalization of Marijuana. At least 25 states considered legislation to legalize marijuana for medical and/or recreational purposes this year; however, only a few states, including Louisiana, Oklahoma, and Vermont enacted laws. At this time, there are nine states, plus the District of Columbia, that have legalized the recreational use of marijuana, and three states, Idaho, Kansas, and Nebraska, that have not legalized marijuana in any form.
Opioids. In 2018, almost every state introduced legislation related to prescription drugs and about 20 states considered legislation addressing prescription drugs in workers compensation. Arizona and Hawaii passed legislation this session to address the use of opioids in workers compensation.
Gig Economy. In 2018, nine states considered legislation defining the term “marketplace contractor” to classify certain on-demand workers as independent contractors. Five of those states—Florida, Indiana, Iowa, Kentucky, and Tennessee—passed legislation in 2018.
The circumstances under which California businesses may classify workers as independent contractors rather than employees under California wage laws have been greatly narrowed by a decision the California Supreme Court issued April 30, 2018.
The landmark decision in the case known as Dynamex presumes that all workers are employees, sets out a new three-part "ABC" test businesses must satisfy in order to classify workers as independent contractors, and, as one expects in California, places the burden on the business, not the worker, to prove that any particular worker is properly classified as an independent contractor. The decision has immediate ramifications for businesses throughout California.
Air Ambulances. There is pending federal legislation which is intended to preserve state authority to regulate network participation, reimbursement, and balance billing of air carriers providing air ambulance services. Currently the federal Airline Deregulation Act of 1978 has been held to preempt state regulation of air ambulance fees in some litigation. California’s Court of Appeal denied defendant’s petition for writ of review in the en banc dec […]
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Prepaid Debit Cards for California Comp are Not New
on October 11, 2018 at 7:37 AM
SB 880 which became law this summer, would authorize an employer, with the written consent of the employee, to deposit disability indemnity payments for the employee in a prepaid card account. This seemed like a new and novel idea. Unbeknownst to most of the industry, prepaid debit cards have been approved to pay workers' compensation benefits in California for nine years. It is certainly not a new concept here.
Last April, the California State Fund let InsurCard know that S.B. 880 had been introduced in the California Legislature to allow debit cards as a method of payment for Workers Compensation (WC) claims. The bill at the time would have established a 5-year pilot program at the State Fund. If the pilot was successful, the program would then be expanded beyond the State Fund to other companies.
Bob Mendte, InsurCard’s President, was surprised to hear this news and noted, "We have been using debit cards for WC claim payments in California for nine years. In 2008, InsurCard received detailed written approval from the Workers Compensation Director and has offered the debit card in California since that time."
InsurCard then contacted the current Workers Compensation Director, George Parisotto, and the Bill’s sponsor to make sure they were aware of InsurCard’s work and extensive experience in the State. Before they met in May, the Director’s staff had reviewed InsurCard’s credentials and the fact that its approvals had been confirmed by the State on several occasions beginning in 2008.
The Director affirmed that InsurCard’s prior approvals would continue to be honored and he recognized that no complaints have been received by the State in the nine years InsurCard has offered its debit card for WC. InsurCard will continue to offer the program in California, one of the 44 states where it does business.
After InsurCard met with the State, the California Legislature changed the bill to allow all payors to use debit cards when the Bill takes effect in January 2019.
InsurCard’s "Total Payment Solution" pays Workers Comp benefits to both claimants and healthcare providers with two network-branded cards: a personalized, reloadable plastic prepaid card for Workers Compensation indemnity payments to injured workers; and a virtual prepaid card for payments directly to healthcare providers. Both products have been praised by the industry for making electronic payments simpler, faster and secure.
InsurCard’s Instant-Issue Property card program lets adjusters deliver benefits to policyholders instantly and is used for property, auto, liability and catastrophe claims. The program is built on an existing, tested platform, ready to deliver in just a few weeks. For information, visit www.insurcard.com. […]
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Online Dealer Indicted for Fake Oxycoodone Pills
on October 11, 2018 at 7:37 AM
Suspected drug dealer Trevon Lucas was indicted by a federal grand jury for distributing fentanyl that caused the death of a La Jolla resident, identified only as C.A.S. in court filings.
According to statements made by prosecutors at his detention hearing, C.A.S. was found dead in his mother’s home on the morning of June 30, 2018. Evidence obtained from C.A.S.’s cellular phone and a parking lot surveillance camera indicate he met Lucas to purchase prescription oxycodone pills around 11:20 p.m. the night before his mother found his body. Law enforcement officials recovered counterfeit oxycodone pills that contained fentanyl from C.A.S.’s residence, and the medical examiner has since identified fentanyl intoxication as the cause of death.
Lucas and three other residents of the Highland / San Bernardino area - Cenclair Fields, Donovan Carter, and Kevin Chandler - were also indicted for their roles in an ongoing conspiracy to distribute pharmaceutical pills containing hydrocodone. Law enforcement officials have gathered evidence indicating that Lucas and Carter posted advertisements on a well-known website to illegally sell prescription pills.
"Fentanyl is claiming record numbers of victims, most of whom don’t even know they’re swallowing a pill that’s laced with the deadly drug," said U.S. Attorney Adam Braverman. "Those who sell fentanyl resulting in death will be held accountable for their callous and reckless disregard for human life."
"We’re seeing a dangerous trend of drug dealers and cartels cutting various drugs with fentanyl, which is a recipe for death," said District Attorney Summer Stephan. "When you sell fentanyl to another human being, you are providing them with toxic poison that can kill them in a matter of seconds. Even a tiny amount of fentanyl can be deadly, which is why we’re working with our partners at the U.S. Attorney’s Office, and Drug Enforcement Administration to address this disturbing trend."
"Unless you buy your prescription pills from a legitimate pharmacy, it’s very likely you’ll get fake prescription pills laced with deadly fentanyl," said DEA Special Agent in Charge Karen Flowers. "Individuals seeking to make an easy buck are putting fentanyl into fake pills and passing them off as legitimate prescription medications. DEA and our law enforcement partners will continue to target and relentlessly pursue the individuals who are selling fake prescription pills laced with deadly fentanyl to citizens in our community."
Lucas, Carter, Chandler, and Fields made their initial appearances in federal court Friday, October 5, before U.S. Magistrate Judge Barbara L. Major, followed by a detention hearing. Judge Major detained Lucas based on the seriousness of the charges against him, while setting bonds for Fields, Carter and Chandler. Their next hearing is scheduled for November 9, 2018 before U.S. District Judge Cathy Ann Bencivengo.
Lucas is the fifth person since January to be charged in the Southern District of California with Distribution of Fentanyl Resulting in Death. This case involved a collaborative effort between the United States Attorney’s Office and the San Diego County District Attorney’s Office. […]
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Researchers Consider Non-Drug Therapies Over Opioids
on October 10, 2018 at 8:43 AM
When it comes to non-drug therapies for back pain, U.S. insurance plans vary widely in what they will cover, claims a new study reported by Reuters Health..
Private and public insurers are missing important opportunities to promote alternatives to opioids, the investigators write in JAMA Network Open.
In fact, researchers found, insurers often provide little or no coverage for evidence-backed interventions for chronic pain such as acupuncture and psychological counseling.
"Insurers can be part of the problem or part of the solution," said study coauthor Dr. Caleb Alexander, an associate professor at the Center for Drug Safety and Effectiveness at the Johns Hopkins School of Public Health in Baltimore, Maryland. "We see a lot of variability in coverage of non-drug treatments for chronic pain. We have a long way to go."
Alexander and his colleagues examined the 2017 versions of 45 insurance plans - 15 Medicaid, 15 Medicare Advantage and 15 major commercial plans - to see what non-drug treatments for low back pain were covered. Nearly all the plans covered physical and occupational therapy.
But despite evidence in the literature to support use of acupuncture, 30 of the 45 plans explicitly did not cover it.
Of the 15 Medicaid plans, just three covered psychological interventions for chronic pain. The researchers could not determine the coverage policies regarding psychological interventions for the Medicare or commercial plans.
Therapeutic massage was almost never covered.
While certain types of non-drug therapies were covered by most policies, some insurers had steep co-pays. "You can provide all the coverage in the world, but if it’s not affordable for patients nobody is going to use it," Alexander said.
Even in the case of physical therapy, a well-established treatment for low back pain, the researchers found barriers to use. Some plans covered two visits, some six, some 12. Some allowed patients to refer themselves for physical therapy, while others required referral by a doctor.
Ultimately, it can be easier to prescribe a medication.
"All too often doctors reach for the quick solution, prescription drugs, especially opioids, to manage pain that would be more effectively and safely treated with non-pharmacological approaches," Alexander said. "This is a system that is designed with, and fosters, the idea that there is a pill for every ill. And we’re here 20 years after the start of the opioid epidemic, paying the price for that."
The new study is underscores a "very relevant problem, given the public health crisis we’re in now," said Dr. Alka Gupta, co-director of the Integrative Health and Wellbeing Program at NewYork-Presbyterian and an assistant professor of medicine at Weill Cornell Medicine in New York City.
"Low back pain is the second most common reasons for primary care visits," Gupta said. "Over the last several years we’ve seen more and more effective treatments coming out. Those were included in the updated guidelines released by the American College of Physicians in February. We’ve also seen that insurers have been slow to adapt their policy coverage to reflect that information." […]
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Dairy Worker Sentenced for Faking Injury
on October 10, 2018 at 8:43 AM
Yolo County District Attorney Jeff Reisig and Colusa County District Attorney Matthew Beauchamp announced that 32-year-old, Daniel Ayala, of Colusa, was sentenced to 365 days of county jail, 5 years felony probation, and an $890 fine.
Ayala plead no contest to one count of felony workers’ compensation insurance fraud. As part of the plea agreement, Ayala’s remaining felony counts were dismissed in the interest of justice. The defendant’s county jail time is stayed pending successful completion of probation and a monthly restitution payment of $350 per month to fulfill his court-ordered restitution in the amount of $19,324.68.
While working for Greenwood Dairy in Orland, CA in January 2014, Daniel Ayala claimed he was injured while working.
Ayala received $15,876.63 in workers’ compensation benefits due to his reported injury. Based on Ayala’s medical complaints from his reported industrial accident in January 2014, Ayala was diagnosed with cervical strain and disc herniation according to his probation report.
Zenith Insurance contracted a private investigations company who recorded Ayala performing activity and tasks not consistent with his reported injury and his clinical symptoms. Ayala intentionally misrepresented his industrial injury in order to obtain workers’ compensation benefits that he would not otherwise be entitled to.
This case was investigated by the Fresno County District Attorney’s Office. The Fresno County Superior Court determined this case would be best prosecuted in the county of Colusa. The Colusa County District Attorney’s Office is a member of the Yolo County DA’s multi-jurisdictional Workers’ Compensation Insurance Fraud Program which covers the counties of Colusa, Sutter, and Yuba.
The Yolo County multi-jurisdictional Workers’ Compensation Insurance Fraud unit works to prevent and investigate claimant fraud, medical provider fraud, premium fraud, and uninsured employers. The most common type of workers’ compensation insurance fraud is claimant fraud, which Daniel Ayala was convicted of. Claimant fraud occurs when an employee lies or omits a material fact in order to obtain benefits that they would not have otherwise been entitled to. Examples would be to lie about how an injury occurred, the extent of their injury, or not to report outside employment and income. […]
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Coventry Reports on Topical and Specialty Drugs
on October 9, 2018 at 10:17 AM
Coventry recently announced the release of the fourth part of its 2017 Drug Trends Series, which is based on all calendar year transactions billed through its PBM Program, First Script, as well as transactions from medical bill review to reflect the total pharmacy experience for their client base.
This fourth installment of the series is dedicated to topicals, specialty medications, and regulatory development. Although topicals and specialty drugs represent only 6% of total aggregate prescriptions, they account for 17.9% of total aggregate cost, thus warranting increased attention.
Although topicals and specialty drugs represent only 6% of total aggregate prescriptions, they account for 17.9% of total aggregate cost, thus warranting increased attention. Topicals represent 4.8% of total prescriptions and 12.8% of total drug cost and are being prescribed as an alternative to some oral medications; however, the lack of clinical efficacy and exorbitant pricing eliminates them as a favorable first-line therapy option. While they are declining in the managed environment due to utilization controls they continue to increase in the unmanaged space.
Specialty medications, which are typically used to treat patients with complex, chronic conditions, have become widely discussed in workers’ comp due to their significant costs. Although they represent approximately 1% of drug utilization, they account for nearly 5% of prescription drug costs. Key trends from this fourth part included:
Managed Topical Medications
- Cost per claim has decreased modestly over the last 2 years, 0.3% (2016) and 1.9% (2017).
- Utilization has fallen by at least 6% per year over the last 2 years.
- Cost per script has increased for the last 3 years, from a high of 20.9% (2015) to a low of 4.9% (2017).
Unmanaged Topical Medications
- Cost per claim has increased over the last 2 years, 9.1% (2016) and 29.4% (2017).
- Increasing utilization has occurred for the last 2 years (1.5% in 2016 and 9.8% in 2017).
- Cost per script has increased at least 7% each year spiking at 17.9% in 2017.
Managed Specialty Medications
- 7-8% increases in cost per claim per year.
- Specialty usage, although less than 1% of all scripts, has increased by at least 9% per year.
- Cost per script has experienced a 3-year downward trend (1.7% in 2017), influenced by declining use of hepatitis C medications
Unmanaged Specialty Medications
- Significant fluctuations in cost per claim trending up 22.1% in 2016 and down 22.5% in 2017.
- Specialty usage accounted for less than 2.5% of all scripts and has decreased between 2-6% per year.
- Cost per script, influenced by varying usage of medications used to treat anemia, rose 24.6% in 2016 and fell 17.8% in 2017. […]
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Drugmaker Faces Uphill FDA Battle on New Opioid
on October 9, 2018 at 10:17 AM
The FDA put out its in-house assessment of Trevena’s new pain med, now up for review, and at first blush it’s not looking good for the biotech today.
In an assessment of the drug’s efficacy and safety, insiders tagged Trevena’s treatment for a mixed set of data that highlighted how morphine often produced better pain relief for the target patient population. The biotech’s opioid, furthermore, has "high abuse potential," according to the FDA, raising a red flag for analysts who have watched lawmakers and the FDA organize a nationwide campaign against opioid abuse.
Investors added up the warnings, and beat a hasty retreat. Trevena’s shares $TRVN lost more than half their value in a short time, with most betting against the biotech at their upcoming outside panel review this week.
Trevena was cited by the FDA on the trial design, chided for creating an endpoint on the comparative respiratory safety burden of their drug and morphine - which has well documented problems on that score - uncertain over its clinical meaningfulness.
The FDA called out the drug for causing adverse events, including "hepatic adverse events and QT prolongation."
Efficacy was also a mixed bag, with morphine significantly outperforming their drug at key doses.
In FDA’s analysis for Study 3002, two of the three doses of oliceridine (0.35 mg and 0.5 mg) demonstrated a statistically greater reduction in pain intensity than placebo, but the 0.1 mg dose did not. In Study 3002, morphine demonstrated a greater reduction in pain intensity relief than two of the doses of oliceridine (0.1 mg and 0.35 mg) that was statistically significant. The reduction in pain intensity by morphine was not greater than that of the highest oliceridine dose (0.5 mg). Currently, Trevena is only seeking approval of the 0.1 mg and 0.35 mg doses.
There have been questions circulating about this drug, their data and the company as a whole since early 2017, when analysts first started questioning the Phase III results and the way it stacked up - or didn’t - against morphine. The company was forced to undergo a painful restructuring and the CEO, Maxine Gowen, officially stepped down at the beginning of this month.
It’s not unusual for in-house reviews to take the most skeptical view of a drug, but Trevena appears to have fallen well short of the kind of grade needed to win over outside experts on Thursday. We’ll see what the experts say, leaving the FDA to come to a final decision. But Trevena is fighting an uphill battle. […]
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Apple Develops Knee and Hip Replacement Monitoring App
on October 15, 2018 at 8:46 AM
As Apple pushes deeper into health care with the Apple Watch, CNBC reports that the company is developing a plan to help people who are recovering from knee and hip replacement surgeries.
Apple announced a partnership with medical device company Zimmer Biomet, to combine a new app along with health-tracking data from the smartwatch to help determine why certain patients recover faster than others from the procedures. The companies are also working together on a clinical study.
Apple has its sights set square on the $3 trillion U.S. health-care sector and is continuously exploring medical applications for the watch, most recently adding an FDA-cleared EKG sensor. When it comes to orthopedics, more than than 1 million Americans get knee and hip replacements every year, and Zimmer Biomet is among the biggest manufacturers of reconstructive products.
Apple and Zimmer Biomet have created a mobile app called mymobility, which aims to help guide patients through their surgery to improve their experience, as well as their health outcomes. It includes educational resources, exercise videos and a way for patients to contact their surgeon and care team with questions and concerns.
The Apple Watch will track steps and heart rate data, allowing patients to share that information with their doctors to provide a clearer picture of how they're doing after surgery and to analyze potential setbacks. For example, if a patient is concerned about the level of pain, the care team could see that the patient walked five miles the previous day, so the problem may be overexertion rather than a serious complication.
Apple and Zimmer Biomet are hoping to enroll 10,000 people in the U.S. in the study. The app is initially available only to patients who enroll in the study, but it will eventually be rolled out to everyone, a spokesperson for Zimmer Biomet told CNBC. Participants who don't own an Apple Watch will receive one for the duration of the project. Fitbit has also looked at using its fitness trackers to monitor patients after surgery.
Zimmer Biomet CEO Bryan Hanson said in a statement that the partnership with Apple marks "one of the largest evidence-gathering clinical studies in orthopedic history."
Apple Chief Operating Officer Jeff Williams said in a separate statement that the new app lets patients and doctors connect in a way that was "not previously possible through traditional in-person visits."
The study is the second of its kind for Apple. In September 2017, the company kicked off its Heart Study in partnership with Stanford University, testing to see if it could detect in people a type of heart health irregularity called atrial fibrillation.
Williams told CNBC in November that Apple is open to working with some of the largest health-care companies in the space and said, "We have taken a thoughtful approach to this and embraced the medical community."
Apple is tackling among the biggest and fastest growing segments of medicine. Given the aging of the population, the number of people who receive knee and hip replacement surgeries is expected to rise in coming years.
Dan Williamson, Zimmer Biomet's group president for joint reconstruction, told CNBC a goal for the study is to "reduce anxiety for the patient and make sure the surgeon has the level of visibility they need."
The company worked with Cedars Sinai hospital in Los Angeles to figure out the optimal amount of activity for people recovering from hip and knee replacements. They reported a magic number of 1,000 steps, meaning those that reached the milestone in the days after the procedure were usually discharged sooner than those who fell short.
In another medical use for the Apple Watch, the company said recently it is donating 1,000 watches for a new study to track binge eating. […] -
DEA Approves Importing Cannabis for Medical Research
on October 15, 2018 at 8:46 AM
It's no secret that the world is growing accustomed to the business of cannabis, but for $9.6 billion Canadian medical marijuana producer Canopy Growth, the future is approaching faster than many expect.
Canopy - which has gained traction on news of several-billion-dollar investments from Corona parent Constellation Brands - announced that it had shipped cannabis to the United States from Canada for medical research, a milestone in the U.S. government's acceptance of what it considers to be a Schedule 1 drug.
"Under [Drug Enforcement Administration] approval, we shipped, for the first time, legally - and I highlight 'legally' - cannabis from Canada to the U.S," Bruce Linton, the co-founder, Chairman and CEO of Canopy Growth, told CNBC's Jim Cramer.
"The DEA-approved partner, which we haven't announced yet, can actually begin to do medical research, clinical trials if necessary, [and] create the data set that enables people to know when, what, where, and maybe it can become federally regulated in the U.S. with some input that way," Linton said in an interview on "Mad Money."
Canopy's news comes less than one month after competing Canadian marijuana producer Tilray announced DEA approval to import cannabis to the United States for medical research at the University of California San Diego Center for Medicinal Cannabis Research.
California is one of eight states, excluding the District of Columbia, to fully legalize medical and recreational marijuana use. Thirty U.S. states currently have laws legalizing medical marijuana use in some form.
Today, the world has its eyes on Canada, where full legalization of adult marijuana use is set to take effect on Oct. 17. While the windfall will likely be massive for producers like Canopy, Linton is focused on the longer-term global opportunity.
Canada's legalization could be Canopy's key to seizing on that opportunity more than it already has, Linton added.
"Last week I was in the EU, the U.K. They know about Oct. 17 intimately and they're trying to figure out, 'Hm, if we're a government or businesses, how do we quit ignoring cannabis and govern it, regulate it, tax it and turn it into something that might be medicinal and for sure a much better formatted product for a party?'" he said.
"And so what's going to be the big bump isn't just Canada," he said. "If we do it right, Canopy leads. That gives us the position globally that then, all of a sudden, you add a zero or two to the number of people we're trying to serve."
U.S. shares of Canopy, the first cannabis company to be listed on the New York Stock Exchange, gained 5.64 percent Friday trading as the rest of the stock market recovered from its multi-day losing streak. […] -
CVS/Aetna Must Divest Aetna’s Part D Prescription Drug Plan
on October 12, 2018 at 10:31 AM
The Department of Justice announced that it is requiring CVS Health Corporation and Aetna Inc. to divest Aetna’s Medicare Part D prescription drug plan business for individuals in order to proceed with their $69 billion merger. The proposed divestiture to WellCare Health Plans, Inc. (WellCare), an experienced health insurer focused on government-sponsored health plans, including Medicare Part D individual prescription drug plans, would fully resolve the Department’s competition concerns.
"Today’s settlement resolves competition concerns posed by this transaction and preserves competition in the sale of Medicare Part D prescription drug plans for individuals," said Assistant Attorney General Makan Delrahim of the Justice Department’s Antitrust Division. "The divestitures required here allow for the creation of an integrated pharmacy and health benefits company that has the potential to generate benefits by improving the quality and lowering the costs of the healthcare services that American consumers can obtain."
The Department’s Antitrust Division, along with the offices of five state attorneys general, today filed a civil antitrust lawsuit in the U.S. District Court for the District of Columbia to enjoin the proposed transaction, along with a proposed settlement that, if approved by the court, would fully resolve the Department’s competitive concerns. The participating state attorneys general offices represent California, Florida, Hawaii, Mississippi, and Washington.
CVS, the nation’s largest retail pharmacy chain, and Aetna, the nation’s third-largest health-insurance company, are significant competitors in the sale of Medicare Part D prescription drug plans to individuals, together serving 6.8 million members nationwide.
According to the Department’s complaint, the combination of CVS, which markets its Medicare Part D individual prescription drug plans under the "SilverScript" brand, and Aetna would cause anticompetitive effects, including increased prices, inferior customer service, and decreased innovation in sixteen Medicare Part D regions covering twenty-two states. The complaint alleges that the loss of competition between CVS and Aetna would result in lower-quality services and increased costs for consumers, the federal government, and ultimately, taxpayers.
Under the terms of the proposed settlement, Aetna must divest its individual prescription drug plan business to WellCare and allow WellCare the opportunity to hire key employees who currently operate the business. Aetna must also assist WellCare in operating the business during the transition and in transferring the affected customers through a process regulated by the Centers for Medicare and Medicaid Services, an agency within the U.S. Department of Health and Human Services.
CVS, headquartered in Woonsocket, Rhode Island, operates the nation’s largest retail pharmacy chain, owns a large pharmacy benefit manager called Caremark, and is the nation’s second-largest provider of individual prescription drug plans, with approximately 4.8 million members. CVS earned revenues of approximately $185 billion in 2017.
Aetna, headquartered in Hartford, Connecticut, is the nation’s third-largest health-insurance company and fourth-largest individual prescription drug plan insurer, with over two million prescription drug plan members. Aetna earned revenues of approximately $60 billion in 2017.
As required by the Tunney Act, the proposed consent decree, along with the Department’s competitive impact statement, will be published in the Federal Register.
Any person may submit written comments concerning the proposed settlement within 60 days of its publication to Peter Mucchetti, Chief, Healthcare and Consumer Products Section, Antitrust Division, Department of Justice, 450 Fifth Street NW, Suite 4100, Washington, DC 20530. At the conclusion of the 60-day comment period, the court may enter the final judgment upon a finding that it serves the public interest. […] -
NCCI Tracks Key WC "Hot Topics"
on October 12, 2018 at 10:31 AM
This year, NCCI tracked more than 800 state and federal workers compensation-related bills and monitored almost 200 workers compensation-related regulations. Legislation impacting workers compensation coverage for first responders continued to be a hot topic with more than 100 bills considered. Here are the key areas of legislative interest for the coming months.
The First Responder Bills addressed compensability for certain cancers and other diseases as well as compensability for post traumatic stress disorder.
California addressed this issue with AB 1749 which was signed into law this year. This new law was created as a result of the October 1, 2017, mass shooting in Las Vegas, Nevada. The new law provides that an employer, at its discretion or in accordance with specified policies, is not precluded from accepting liability for compensation for an injury sustained by a peace officer by reason of engaging in the apprehension or attempted apprehension of law violators or suspected law violators, or protection or preservation of life or property, or the preservation of the peace, outside the state of California.
Legalization of Marijuana. At least 25 states considered legislation to legalize marijuana for medical and/or recreational purposes this year; however, only a few states, including Louisiana, Oklahoma, and Vermont enacted laws. At this time, there are nine states, plus the District of Columbia, that have legalized the recreational use of marijuana, and three states, Idaho, Kansas, and Nebraska, that have not legalized marijuana in any form.
Opioids. In 2018, almost every state introduced legislation related to prescription drugs and about 20 states considered legislation addressing prescription drugs in workers compensation. Arizona and Hawaii passed legislation this session to address the use of opioids in workers compensation.
Gig Economy. In 2018, nine states considered legislation defining the term “marketplace contractor” to classify certain on-demand workers as independent contractors. Five of those states—Florida, Indiana, Iowa, Kentucky, and Tennessee—passed legislation in 2018.
The circumstances under which California businesses may classify workers as independent contractors rather than employees under California wage laws have been greatly narrowed by a decision the California Supreme Court issued April 30, 2018.
The landmark decision in the case known as Dynamex presumes that all workers are employees, sets out a new three-part "ABC" test businesses must satisfy in order to classify workers as independent contractors, and, as one expects in California, places the burden on the business, not the worker, to prove that any particular worker is properly classified as an independent contractor. The decision has immediate ramifications for businesses throughout California.
Air Ambulances. There is pending federal legislation which is intended to preserve state authority to regulate network participation, reimbursement, and balance billing of air carriers providing air ambulance services. Currently the federal Airline Deregulation Act of 1978 has been held to preempt state regulation of air ambulance fees in some litigation. California’s Court of Appeal denied defendant’s petition for writ of review in the en banc dec […] -
Prepaid Debit Cards for California Comp are Not New
on October 11, 2018 at 7:37 AM
SB 880 which became law this summer, would authorize an employer, with the written consent of the employee, to deposit disability indemnity payments for the employee in a prepaid card account. This seemed like a new and novel idea. Unbeknownst to most of the industry, prepaid debit cards have been approved to pay workers' compensation benefits in California for nine years. It is certainly not a new concept here.
Last April, the California State Fund let InsurCard know that S.B. 880 had been introduced in the California Legislature to allow debit cards as a method of payment for Workers Compensation (WC) claims. The bill at the time would have established a 5-year pilot program at the State Fund. If the pilot was successful, the program would then be expanded beyond the State Fund to other companies.
Bob Mendte, InsurCard’s President, was surprised to hear this news and noted, "We have been using debit cards for WC claim payments in California for nine years. In 2008, InsurCard received detailed written approval from the Workers Compensation Director and has offered the debit card in California since that time."
InsurCard then contacted the current Workers Compensation Director, George Parisotto, and the Bill’s sponsor to make sure they were aware of InsurCard’s work and extensive experience in the State. Before they met in May, the Director’s staff had reviewed InsurCard’s credentials and the fact that its approvals had been confirmed by the State on several occasions beginning in 2008.
The Director affirmed that InsurCard’s prior approvals would continue to be honored and he recognized that no complaints have been received by the State in the nine years InsurCard has offered its debit card for WC. InsurCard will continue to offer the program in California, one of the 44 states where it does business.
After InsurCard met with the State, the California Legislature changed the bill to allow all payors to use debit cards when the Bill takes effect in January 2019.
InsurCard’s "Total Payment Solution" pays Workers Comp benefits to both claimants and healthcare providers with two network-branded cards: a personalized, reloadable plastic prepaid card for Workers Compensation indemnity payments to injured workers; and a virtual prepaid card for payments directly to healthcare providers. Both products have been praised by the industry for making electronic payments simpler, faster and secure.
InsurCard’s Instant-Issue Property card program lets adjusters deliver benefits to policyholders instantly and is used for property, auto, liability and catastrophe claims. The program is built on an existing, tested platform, ready to deliver in just a few weeks. For information, visit www.insurcard.com. […] -
Online Dealer Indicted for Fake Oxycoodone Pills
on October 11, 2018 at 7:37 AM
Suspected drug dealer Trevon Lucas was indicted by a federal grand jury for distributing fentanyl that caused the death of a La Jolla resident, identified only as C.A.S. in court filings.
According to statements made by prosecutors at his detention hearing, C.A.S. was found dead in his mother’s home on the morning of June 30, 2018. Evidence obtained from C.A.S.’s cellular phone and a parking lot surveillance camera indicate he met Lucas to purchase prescription oxycodone pills around 11:20 p.m. the night before his mother found his body. Law enforcement officials recovered counterfeit oxycodone pills that contained fentanyl from C.A.S.’s residence, and the medical examiner has since identified fentanyl intoxication as the cause of death.
Lucas and three other residents of the Highland / San Bernardino area - Cenclair Fields, Donovan Carter, and Kevin Chandler - were also indicted for their roles in an ongoing conspiracy to distribute pharmaceutical pills containing hydrocodone. Law enforcement officials have gathered evidence indicating that Lucas and Carter posted advertisements on a well-known website to illegally sell prescription pills.
"Fentanyl is claiming record numbers of victims, most of whom don’t even know they’re swallowing a pill that’s laced with the deadly drug," said U.S. Attorney Adam Braverman. "Those who sell fentanyl resulting in death will be held accountable for their callous and reckless disregard for human life."
"We’re seeing a dangerous trend of drug dealers and cartels cutting various drugs with fentanyl, which is a recipe for death," said District Attorney Summer Stephan. "When you sell fentanyl to another human being, you are providing them with toxic poison that can kill them in a matter of seconds. Even a tiny amount of fentanyl can be deadly, which is why we’re working with our partners at the U.S. Attorney’s Office, and Drug Enforcement Administration to address this disturbing trend."
"Unless you buy your prescription pills from a legitimate pharmacy, it’s very likely you’ll get fake prescription pills laced with deadly fentanyl," said DEA Special Agent in Charge Karen Flowers. "Individuals seeking to make an easy buck are putting fentanyl into fake pills and passing them off as legitimate prescription medications. DEA and our law enforcement partners will continue to target and relentlessly pursue the individuals who are selling fake prescription pills laced with deadly fentanyl to citizens in our community."
Lucas, Carter, Chandler, and Fields made their initial appearances in federal court Friday, October 5, before U.S. Magistrate Judge Barbara L. Major, followed by a detention hearing. Judge Major detained Lucas based on the seriousness of the charges against him, while setting bonds for Fields, Carter and Chandler. Their next hearing is scheduled for November 9, 2018 before U.S. District Judge Cathy Ann Bencivengo.
Lucas is the fifth person since January to be charged in the Southern District of California with Distribution of Fentanyl Resulting in Death. This case involved a collaborative effort between the United States Attorney’s Office and the San Diego County District Attorney’s Office. […] -
Researchers Consider Non-Drug Therapies Over Opioids
on October 10, 2018 at 8:43 AM
When it comes to non-drug therapies for back pain, U.S. insurance plans vary widely in what they will cover, claims a new study reported by Reuters Health..
Private and public insurers are missing important opportunities to promote alternatives to opioids, the investigators write in JAMA Network Open.
In fact, researchers found, insurers often provide little or no coverage for evidence-backed interventions for chronic pain such as acupuncture and psychological counseling.
"Insurers can be part of the problem or part of the solution," said study coauthor Dr. Caleb Alexander, an associate professor at the Center for Drug Safety and Effectiveness at the Johns Hopkins School of Public Health in Baltimore, Maryland. "We see a lot of variability in coverage of non-drug treatments for chronic pain. We have a long way to go."
Alexander and his colleagues examined the 2017 versions of 45 insurance plans - 15 Medicaid, 15 Medicare Advantage and 15 major commercial plans - to see what non-drug treatments for low back pain were covered. Nearly all the plans covered physical and occupational therapy.
But despite evidence in the literature to support use of acupuncture, 30 of the 45 plans explicitly did not cover it.
Of the 15 Medicaid plans, just three covered psychological interventions for chronic pain. The researchers could not determine the coverage policies regarding psychological interventions for the Medicare or commercial plans.
Therapeutic massage was almost never covered.
While certain types of non-drug therapies were covered by most policies, some insurers had steep co-pays. "You can provide all the coverage in the world, but if it’s not affordable for patients nobody is going to use it," Alexander said.
Even in the case of physical therapy, a well-established treatment for low back pain, the researchers found barriers to use. Some plans covered two visits, some six, some 12. Some allowed patients to refer themselves for physical therapy, while others required referral by a doctor.
Ultimately, it can be easier to prescribe a medication.
"All too often doctors reach for the quick solution, prescription drugs, especially opioids, to manage pain that would be more effectively and safely treated with non-pharmacological approaches," Alexander said. "This is a system that is designed with, and fosters, the idea that there is a pill for every ill. And we’re here 20 years after the start of the opioid epidemic, paying the price for that."
The new study is underscores a "very relevant problem, given the public health crisis we’re in now," said Dr. Alka Gupta, co-director of the Integrative Health and Wellbeing Program at NewYork-Presbyterian and an assistant professor of medicine at Weill Cornell Medicine in New York City.
"Low back pain is the second most common reasons for primary care visits," Gupta said. "Over the last several years we’ve seen more and more effective treatments coming out. Those were included in the updated guidelines released by the American College of Physicians in February. We’ve also seen that insurers have been slow to adapt their policy coverage to reflect that information." […] -
Dairy Worker Sentenced for Faking Injury
on October 10, 2018 at 8:43 AM
Yolo County District Attorney Jeff Reisig and Colusa County District Attorney Matthew Beauchamp announced that 32-year-old, Daniel Ayala, of Colusa, was sentenced to 365 days of county jail, 5 years felony probation, and an $890 fine.
Ayala plead no contest to one count of felony workers’ compensation insurance fraud. As part of the plea agreement, Ayala’s remaining felony counts were dismissed in the interest of justice. The defendant’s county jail time is stayed pending successful completion of probation and a monthly restitution payment of $350 per month to fulfill his court-ordered restitution in the amount of $19,324.68.
While working for Greenwood Dairy in Orland, CA in January 2014, Daniel Ayala claimed he was injured while working.
Ayala received $15,876.63 in workers’ compensation benefits due to his reported injury. Based on Ayala’s medical complaints from his reported industrial accident in January 2014, Ayala was diagnosed with cervical strain and disc herniation according to his probation report.
Zenith Insurance contracted a private investigations company who recorded Ayala performing activity and tasks not consistent with his reported injury and his clinical symptoms. Ayala intentionally misrepresented his industrial injury in order to obtain workers’ compensation benefits that he would not otherwise be entitled to.
This case was investigated by the Fresno County District Attorney’s Office. The Fresno County Superior Court determined this case would be best prosecuted in the county of Colusa. The Colusa County District Attorney’s Office is a member of the Yolo County DA’s multi-jurisdictional Workers’ Compensation Insurance Fraud Program which covers the counties of Colusa, Sutter, and Yuba.
The Yolo County multi-jurisdictional Workers’ Compensation Insurance Fraud unit works to prevent and investigate claimant fraud, medical provider fraud, premium fraud, and uninsured employers. The most common type of workers’ compensation insurance fraud is claimant fraud, which Daniel Ayala was convicted of. Claimant fraud occurs when an employee lies or omits a material fact in order to obtain benefits that they would not have otherwise been entitled to. Examples would be to lie about how an injury occurred, the extent of their injury, or not to report outside employment and income. […] -
Coventry Reports on Topical and Specialty Drugs
on October 9, 2018 at 10:17 AM
Coventry recently announced the release of the fourth part of its 2017 Drug Trends Series, which is based on all calendar year transactions billed through its PBM Program, First Script, as well as transactions from medical bill review to reflect the total pharmacy experience for their client base.
This fourth installment of the series is dedicated to topicals, specialty medications, and regulatory development. Although topicals and specialty drugs represent only 6% of total aggregate prescriptions, they account for 17.9% of total aggregate cost, thus warranting increased attention.
Although topicals and specialty drugs represent only 6% of total aggregate prescriptions, they account for 17.9% of total aggregate cost, thus warranting increased attention. Topicals represent 4.8% of total prescriptions and 12.8% of total drug cost and are being prescribed as an alternative to some oral medications; however, the lack of clinical efficacy and exorbitant pricing eliminates them as a favorable first-line therapy option. While they are declining in the managed environment due to utilization controls they continue to increase in the unmanaged space.
Specialty medications, which are typically used to treat patients with complex, chronic conditions, have become widely discussed in workers’ comp due to their significant costs. Although they represent approximately 1% of drug utilization, they account for nearly 5% of prescription drug costs. Key trends from this fourth part included:
Managed Topical Medications
- Cost per claim has decreased modestly over the last 2 years, 0.3% (2016) and 1.9% (2017).
- Utilization has fallen by at least 6% per year over the last 2 years.
- Cost per script has increased for the last 3 years, from a high of 20.9% (2015) to a low of 4.9% (2017).
Unmanaged Topical Medications
- Cost per claim has increased over the last 2 years, 9.1% (2016) and 29.4% (2017).
- Increasing utilization has occurred for the last 2 years (1.5% in 2016 and 9.8% in 2017).
- Cost per script has increased at least 7% each year spiking at 17.9% in 2017.
Managed Specialty Medications
- 7-8% increases in cost per claim per year.
- Specialty usage, although less than 1% of all scripts, has increased by at least 9% per year.
- Cost per script has experienced a 3-year downward trend (1.7% in 2017), influenced by declining use of hepatitis C medications
Unmanaged Specialty Medications
- Significant fluctuations in cost per claim trending up 22.1% in 2016 and down 22.5% in 2017.
- Specialty usage accounted for less than 2.5% of all scripts and has decreased between 2-6% per year.
- Cost per script, influenced by varying usage of medications used to treat anemia, rose 24.6% in 2016 and fell 17.8% in 2017. […] -
Drugmaker Faces Uphill FDA Battle on New Opioid
on October 9, 2018 at 10:17 AM
The FDA put out its in-house assessment of Trevena’s new pain med, now up for review, and at first blush it’s not looking good for the biotech today.
In an assessment of the drug’s efficacy and safety, insiders tagged Trevena’s treatment for a mixed set of data that highlighted how morphine often produced better pain relief for the target patient population. The biotech’s opioid, furthermore, has "high abuse potential," according to the FDA, raising a red flag for analysts who have watched lawmakers and the FDA organize a nationwide campaign against opioid abuse.
Investors added up the warnings, and beat a hasty retreat. Trevena’s shares $TRVN lost more than half their value in a short time, with most betting against the biotech at their upcoming outside panel review this week.
Trevena was cited by the FDA on the trial design, chided for creating an endpoint on the comparative respiratory safety burden of their drug and morphine - which has well documented problems on that score - uncertain over its clinical meaningfulness.
The FDA called out the drug for causing adverse events, including "hepatic adverse events and QT prolongation."
Efficacy was also a mixed bag, with morphine significantly outperforming their drug at key doses.
In FDA’s analysis for Study 3002, two of the three doses of oliceridine (0.35 mg and 0.5 mg) demonstrated a statistically greater reduction in pain intensity than placebo, but the 0.1 mg dose did not. In Study 3002, morphine demonstrated a greater reduction in pain intensity relief than two of the doses of oliceridine (0.1 mg and 0.35 mg) that was statistically significant. The reduction in pain intensity by morphine was not greater than that of the highest oliceridine dose (0.5 mg). Currently, Trevena is only seeking approval of the 0.1 mg and 0.35 mg doses.
There have been questions circulating about this drug, their data and the company as a whole since early 2017, when analysts first started questioning the Phase III results and the way it stacked up - or didn’t - against morphine. The company was forced to undergo a painful restructuring and the CEO, Maxine Gowen, officially stepped down at the beginning of this month.
It’s not unusual for in-house reviews to take the most skeptical view of a drug, but Trevena appears to have fallen well short of the kind of grade needed to win over outside experts on Thursday. We’ll see what the experts say, leaving the FDA to come to a final decision. But Trevena is fighting an uphill battle. […]