United Therapeutics announced that key data from the FREEDOM-EV study of Orenitram extended-release tablets were shared during an oral presentation at the Pulmonary Vascular Research Institute Annual World Congress on Pulmonary Vascular Disease in Barcelona, Spain. The presentation was given by R. James White, M.D., Ph.D., Professor of Medicine, Pharmacology & Physiology in the Division of Pulmonary & Critical Care Medicine at the University of Rochester Medical Center and steering committee member for the FREEDOM-EV study. The primary endpoint of this pivotal, double-blind, placebo-controlled, event-driven trial in patients with pulmonary arterial hypertension was met. Orenitram decreased the risk of adjudicated clinical worsening events by 26% compared to placebo. These results were largely driven by delay in disease progression; Orenitram decreased the risk of disease progression by 61% compared with placebo. Mortality was similar between Orenitram and placebo groups at the end of randomized treatment. However, in participants for which data are available, Orenitram was associated with a 37% decreased risk of mortality compared with placebo. United Therapeutics has submitted the FREEDOM-EV study results to the U.S. Food and Drug Administration in support of a potential label amendment for Orenitram and is evaluating whether the results could support marketing applications outside the United States.
Thursday, January 31, 2019
Nuvectra can weather management change, says Piper Jaffray
Piper Jaffray analyst Matt O’Brien kept his Overweight rating and $25 price target on Nuvectra after the company announced an immediate departure of its CEO earlier today. The analyst says the company has a “suitable replacement in Dr. Parks”, adding that while the abrupt resignation was surprising, he sees Nuvectra management as “capable of weathering the transition”.
https://thefly.com/landingPageNews.php?id=2857373
https://thefly.com/landingPageNews.php?id=2857373
Titan Pharmaceuticals reports ‘positive’ initial results of Probuphine relaunch
Titan Pharmaceuticals, Inc. provided an update on the U.S. commercial relaunch of Probuphine implant, its unique six-month treatment for Opioid Use Disorder. Titan has successfully completed the program’s planned transition from Braeburn Pharmaceuticals. Important commercialization accomplishments include the recruitment and onboarding of highly qualified commercial and medical affairs personnel for all targeted geographies; the engagement of a leading public relations agency for the re-branding of Probuphine; and the retention of a well-known government relations firm to plan and execute a new lobbying strategy for the product. Titan also reengaged with health care providers who had previously treated patients with Probuphine, providing retraining and medical liaison assistance where needed and creating an integrated sales strategy to support them and their office staff. These accomplishments and other activities have contributed to a double-digit increase in total product shipments in the period following Titan’s assumption of responsibility for Probuphine sales in mid-June 2018. Based on preliminary information, total shipments of Probuphine during the rest of the year increased sequentially by over 20%. Titan expects to provide more details in its fourth quarter and full-year 2018 financial results, which it expects to release in late March 2019.
https://thefly.com/landingPageNews.php?id=2857365
https://thefly.com/landingPageNews.php?id=2857365
Trump administration to eliminate safe harbors for drug rebates to PBMs
The Trump administration wants to eliminate safe harbor protections for drug rebates negotiated by pharmacy benefit managers and instead, offer those protections to discounts passed directly to consumers.
The long-awaited rule (PDF), released Thursday evening, was under review at the Office of Management and Budget dating back to the summer.
Department of Health and Human Services Secretary Alex Azar said in a statement that eliminating the safe harbors would increase transparency in the black box of the pharmacy supply chain.
“Every day, Americans—particularly our seniors—pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen,” Azar said. “President Trump is proposing to end this era of backdoor deals in the drug industry, bring real transparency to drug markets and deliver savings to patients directly when they walk into the pharmacy.”
PBMs have shouldered a significant amount of blame in the public discourse over rising drug prices. Azar has been both a critic and defender of PBMs and the rebate system they operate in, saying that pharmacy benefit managers will be key partners in reforming the drug supply chain, but also that they’re an impediment to change.
Drug rebates negotiated by PBMs are, at present, protected from Stark Law and anti-kickback statute challenges. HHS is calling instead to offer those protections for discounts that are passed on to patients, saying it could especially benefit Medicare Part D patients with high out-of-pocket costs.
PBMs take the savings from negotiated rebates and typically apply it broadly across premiums instead of directly passing each discount on to their members at the counter.
In a statement, the Pharmaceutical Care Management Association CEO JC Scott said that eliminating the safe harbor protections could lead to concerns about access to some drugs. Scott highlighted several studies that indicate PBMs are not to blame for rising drug costs.
“Any proposals to eliminate PBM-negotiated rebates must consider the impact it will have on Medicare beneficiaries’ access to affordable prescription drugs and costs to taxpayers,” Scott said.
In addition to allowing safe harbors for savings directly to consumers, HHS is proposing protections for fixed fee agreements between pharmaceutical companies and PBMs. In this protection, service fees drug companies pay to PBMs for services applicable only to the manufacturer—not a payer—would be covered if they meet certain criteria.
On a call with reporters, a senior official at HHS said that the goal of the rule is to “correct the perverse incentives” in the drug supply chain that can lead to exclusive formularies and higher costs for patients. The official said the rule may be “the single most significant reform ever implemented” in addressing the way drugs are priced and paid for.
“We know that the incentives in the current system lead to higher list prices,” the official said. “Everyone in the supply chain benefits—except for the patient—when list prices go up.”
A senior official at the HHS Office of Inspector General said on the call that while the rule mainly impacts PBM rebates paid to members of federal payers, but the rulemaking could have ripple effects in the commercial sector.
The OIG official said the agency is seeking feedback on the potential impacts of the change.
The HHS official said the agency is targeting Jan. 1, 2020 to end the existing safe harbors and to launch the new ones within 60 days of the rule’s finalization. That said, PBMs and drug companies can begin these negotiations “now,” the official said, to bring down prices.
California sees 24% dive in new ObamaCare plan enrollments
- New enrollments in California’s Affordable Care Act marketplace dropped 23.7% for 2019, down to 295,980 from 388,344 last year. Officials are pinning the blame on loss of the federal tax penalty for people without health insurance. The plunge came despite a statewide bus tour to promote getting coverage ahead of the Jan. 15 deadline for 2019 open enrollment in the state, one of about a dozen states to run its own exchange.
- CMS Administrator Seema Verma, however, pushed back again the explanation given by the state-run exchange, known as Covered California. On Twitter, she noted the state’s $100 million advertising spend didn’t seem to help its numbers and pointed to slow enrollment in New Jersey, which has enacted its own mandate. “Mandates aren’t the answer, and advertising isn’t the answer,” she wrote. “Americans need more choices and more affordable healthcare options.”
- Overall enrollment was on par with 2018, with 1.5 million plan selections, according to an early analysis released Wednesday. The steady enrollment was driven largely by renewals, which increased 7.5% year over year to 1,217,903 for 2019, officials said.
The decline in new sign-ups was worse than anticipated and greater than the average 15.8% drop in the 39 states served by the federal marketplace, Healthcare.gov. Covered California officials attributed the difference to steady declines in enrollment in those states over the past four years.
The number of new enrollees in the federal marketplace plunged 49% from 4 million in 2016 to 2.1 million in 2019, in part because of the Trump Administration’s decision to drastically scale back public awareness campaigns ahead of the open enrollment season.
In addition to the penalty’s impact, the analysis found fewer new enrollees who selected bronze plans, the lowest premium option in Covered California. The number of new bronze plans fell 30.5% from 143,000 to 100,000. Among unsubsidized enrollees, the drop was even steeper — down 38.1%.
Enrollment in populations where English is not the preferred spoken language also declined, particularly among Mandarin speakers (28%), Spanish speakers (29%) and Korean speakers (46%).
Other demographics did not seem to affect coverage.
“With the reduction being evenly spread across demographics, the primary driver of the loss of new enrollees appears to be removal of the individual mandate penalty,” Peter Lee, executive director of Covered California, said in a statement.
Lee added that the decline in new enrollments “affirms the leadership Gov. Gavin Newsom has taken to propose an individual mandate and enhanced subsidies aimed at making coverage more affordable for Californians.”
The results reflect several actions last year likely to undermine enrollment in the ACA exchanges. First and foremost was Congress’ elimination of the individual mandate penalty. The other is the administration’s promotion of short-term and association health plans.
Still, the ACA exchanges are showing signs of stabilizing this year, with more payers in the exchanges and light premium increases, according to an Urban Institute report funded by the Robert Wood Johnson Foundation. The smaller premium increases are likely due to payers scaling back after over-adjusting for uncertainty in the 2018 plan year, according to the report.
Meanwhile, insurers continue to look for ways to limit risk, such as HMOs and narrow provider networks, which limit patient choice but give payers more control of costs.
CMS proposes more nontraditional benefits for Medicare Advantage plans
- Medicare Advantage plans will be able to offer more nonmedical supplemental benefits to patients with chronic illness under guidance CMS released Wednesday. The MA and Medicare Part D advance notice (Part II) and draft letter also put forward proposals aimed at combating the nation’s opioid epidemic, such as encouraging cost-sharing reductions for patients with chronic pain or those receiving addiction treatment.
- The proposed policies build on a rule in effect this month allowing MA plans to include benefits like transportation to medical appointments and home meal delivery. “We’ve really opened it up now as part of this proposal to any benefit that improves or maintains healthcare,” CMS Principal Deputy Administrator for Medicare Demetrios Kouzoukas told reporters.
- The expected average change in revenue for 2020 MA plans as a result of the policy changes would be an increase of 1.59%, the agency said, down markedly from the 3.4% increase for 2019.
Medicare Advantage enrollment is a growth area for payers aimed at seniors who want more benefits beyond traditional Medicare. The number of seniors in an MA plan rose 8% from 2016 to 2017, according to the Medicare Payment Advisory Commission. CMS has previously said 270 plans were offering the new, more flexible benefits for 2019.
Additional benefit options will be good news for companies looking to capitalize on growing awareness of the effects socioeconomic factors have on health outcomes. Uber and Lyft both have dedicated healthcare platforms, for example.
Also on the tech front, Apple is reportedly in talks with multiple MA plans, looking for partnerships involving the Apple Watch, which can help wearers track their activity levels, flag changes in heart rate and detect major falls.
CMS has been active lately in its proposals for the MA program. Earlier this month, the agency announced two new voluntary payment models, including one expanding access to telehealth and providing mechanisms to reward beneficiaries for healthy behaviors.
Part I of the advance notice, released in late December, proposed a change to the methodology for calculating risk adjustment payments for MA plans to include more encounter data. Comments on both parts are due by March 1, and CMS expects to release the final rate announcement and call letter by April 1.
In the proposals released Wednesday, CMS also suggested changes to its Part C and D star ratings methodology, including removing three measures starting in 2022 for “low statistical reliability.” The measures are adult BMI assessment (Part C), appeals auto-forward (Part D) and appeal upheld (Part D).
New VA rules reignite privatization debate
- The Department of Veterans Affairs proposed new standards to make it easier for veterans to seek care outside the VA. The changes, due to take effect in June, include dropping the wait time requirement from 30 days to 20 days for primary and mental care and 28 days for specialties.
- Changes also include shifting one requirement from driving distance (40 miles) to driving time (30 minutes). For specialty care, the VA is proposing a 60-minute average drive time standard.
- The proposals come several years after the agency got a black eye in a scandal showing officials falsified data on patient wait times and amid fears the Trump administration wants to privatize the agency.
The measures are part of the agency’s implementation of last year’s MISSION Act, which critics say marked another step toward privatizing the VA. The right leaning Koch brothers helped fund these efforts, but most veterans’ groups oppose them. That’s in large part because, in many cases, VA care is exceptionally good — if exceptionally slow.
Veterans who rely most on VA care tend to be younger, poorer and live in rural areas, a 2016 RAND report found, while only 25% of veterans live within an hour of a VA medical facility.
Veterans’ groups held their fire for now while they study the new rules. Still, Rory Riley, a consultant for veterans organizations such as the National Organization of Veterans’ Advocates, called the new access standards a “step in the right direction.”
Changing the driving distance standard to drive time, for example, makes the standards better align with TRICARE. In all, Riley told Healthcare Dive, the VA proposed standards are similar to TRICARE’s existing standards for TRICARE Prime, which many veterans are already familiar with.
“TRICARE hasn’t been ‘privatized’ despite using very similar access standards and utilizing a mix of DoD and community providers. A good policy choice, as opposed to a political one, is integrating the best of both government and community care,” Riley said. “I’m the first one to criticize VA when I think they’ve done something that is misguided, but I actually think these standards are a good faith effort to implement the MISSION Act, which the VA is legally required to comply with.”
Other changes include the ability to access urgent care, as long as the provider is in the VA’s community care network — though they may be charged a copayment.
Leadership at the VA has been in turmoil in recent years, with the fired VA Secretary David Shulkin, warning in a New York Times op-ed days after his ousting that the private sector is “ill-prepared” to handle veterans, “particularly when it involves the mental health needs of people scarred by the horrors of war.”
Current VA Secretary Robert Wilkie tried to get an edge on critics who may lambast the access standards for enabling privatization.
“Although these new standards represent an important win for America’s Veterans, they will not be without controversy,” the secretary said. “Some will claim falsely and predictably that they represent a first step toward privatizing the department.”
He cited recent studies from Rand, Dartmouth and JAMA that show the VA is outperforming the private sector in quality and customer service.
A 2014 Congressional Budget Office report showed 70% of veterans enrolled in the VA’s system already receive most of their care in the private sector.
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