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Tuesday, April 9, 2019

CMS proposes expanding coverage for blood pressure test

The CMS on Tuesday proposed expanding Medicare coverage for ambulatory blood pressure monitoring, a diagnostic test that tracks a patient’s blood pressure over a period of days rather than at a moment in time.
The agency said the test may measure blood pressure and diagnose hypertension more accurately. The current national coverage determination for ambulatory blood pressure monitoring, issued in 2001, covers the test only for Medicare patients who are not being treated for high blood pressure but are suspected to have “white coat hypertension,” meaning their anxiety causes their blood pressure to spike while at the doctor’s office.
The CMS is proposing to extend coverage to patients suspected of having “masked hypertension,” which occurs when the blood pressure measurements in a doctor’s office are lower than outside a doctor’s office. It also is proposing to lower the blood pressure threshold from the current policy of 140/90 to 130/80 to align with the latest medical society recommendations.
“With the prevalence of chronic diseases, including high blood pressure, increasing among Medicare beneficiaries, it is critical that our agency closely monitor the evidence for interventions that could improve health outcomes for patients with these conditions,” CMS Administrator Seema Verma said in the announcement. “Today’s proposal to expand coverage of ambulatory blood pressure monitoring is supported by many years of evidence and would help ensure that beneficiaries have their blood pressure measured accurately, so they can receive the care that is best for them.”
The American Heart Association and the American Medical Association requested last year that CMS extend coverage of ambulatory blood pressure monitoring to more patients.
Federal data show that up to 55% of the Medicare population has hypertension, including nearly 40% of disabled Medicare beneficiaries. Patients with high blood pressure rack up inpatient costs at 2.5 times the rate of patients without high blood pressure and incur almost double the outpatient costs, according to the American Heart Association. Average inpatient and outpatient costs can be as much as $5,400 annually, according to AHA.
The CMS said it is seeking comments on the proposal for the next 30 days. A final decision will be issued no later than 60 days after the comment period ends.

Urgent need for new revenue streams to shape healthcare providers’ strategies

Building alternative revenue sources will play a bigger role in healthcare providers’ strategies, according to a new study.
Ninety percent of hospital and health system executives surveyed indicated that new revenue streams were an urgent priority expected to yield a return in the next three years, a new study from Boston-based Partners HealthCare and healthcare private equity firm Fitzroy Health found. Every participant acknowledged the need to diversify revenue.
A crescendo has been reached because of the downward revenue pressure, said Chris Coburn, Partners’ chief innovation officer and president of Partners HealthCare International. But there is no one-size-fits-all approach, he said.
The study looked at more than 1,400 novel revenue streams—defined as any revenue that is not based on traditional reimbursable medical services, government support or non-operating investments like securities and real estate—across 74 academic medical centers and large health systems. It broke them down into three parts: bringing care model innovations to market; transforming cost centers into profit centers; and increasing royalties from drugs, devices and diagnostics.
Licensing intellectual property, like Geisinger Health System licensing its patient-care management model to Epic Systems Corp. and Cerner Corp. for their clinical-decision support systems, would fall under the first category. Researchers also point to the University of Colorado Health’s digital health co-development fund and its partnership with RxRevu, which manages and measures medication prescribing patterns. An “outside-in” partnership between a health system and early-stage company can boost the market value of a venture through product development or proof of impact, according to the study.
The second track involves internal departments that serve external customers, like clinical-trial management support services. There are also wholly owned subsidiaries, such as Bon Secours Mercy’s revenue cycle service company Ensemble Health Partners, as well as independent companies like Prodigo Solutions, a supply chain management spinoff from the UPMC system.
A number of organizations have built massive ecosystems that offer the gamut of functions in healthcare, said James Stanford, a managing director at Fitzroy. As margins wane, many health systems’ have since outsourced services that aren’t part of their core businesses, he said.
“But for those that have developed commercial-grade offerings, there is a big opportunity and slice of revenue that would be going to other vendors,” Stanford said.
As for royalty generation, the study cited Children’s Hospital of Philadelphia’s spinoff of gene therapy company Spark Therapeutics, generating more than a $450 million return. Also, investment firm Deerfield Management has committed nearly $500 million to early stage drug research—including oncology, gene therapy and central nervous system treatments—at academic institutions, giving universities a financial buffer while allowing them to own the intellectual property.
The cost of failure has traditionally been so high and the probability of success has been so low that academia typically hasn’t been willing to produce novel therapies on their own, said James Flynn, a managing partner at Deerfield.
“But as science validates these treatments and cheaper pathways form, these institutions and investors will become more engaged,” he said.
There is more happening in therapeutic innovation involving efforts like mapping the human genome than ever before, Coburn said.
“This is a historic time we are in,” Coburn said, adding that alternative revenue sources should play a more prominent role in bond ratings given all the activity.
Health system operating margins hit 10-year lows in 2018 as costs outpaced revenue, according to a 2018 Moody’s Investors Service report. While its uncertain whether that pressure will subside in 2019, hospitals will likely have to pursue a combination of cost-cutting and revenue growth as they seek sustainable financial footing.
Non-operating income has buoyed providers amid the financial headwinds. But 2018 demonstrated how tenuous that dynamic was. Ninety-seven percent of the Partners-Fitzroy study participants excluded investment income from their budgets given the volatility.
“Inpatient admissions are declining, length of stay is declining—health systems have to adapt and find alternatives,” Beaumont Health Chief Operating Officer Carolyn Wilson told Modern Healthcare in March after the system announced a new commercial real estate venture.
This requires a mindset shift, said Lyndean Brick, CEO of healthcare consultancy Advis Group.
“Is healthcare a business? Yes of course,” she said. “But a lot of institutions have a hard time saying that it is a business. It is a business with a big social purpose.”
But it also requires a balance. Generally, new endeavors should align with organizations’ broader mission. It shouldn’t overburden a company’s core business as resources are reallocated, experts said. The portfolio of alternative revenue streams should also distribute risk, return and timing. That mindset shift also requires well-equipped personnel who can juggle consumer marketing, automated data analysis and venture capital management while keeping healthcare’s broader mission in perspective.
If a health system is contemplating spinning out a company, executives need to weigh whether the offering is more valuable as a product marketed externally or as a closely held source of proprietary differentiation, researchers recommended. Executives need hard data to determine if the endeavor fits within its target market. They also need to address the potential friction of the spinoff selling services at market rates back to the system, the extra work for senior leaders, new hires, or a potential exit if the relationship sours.
The more sophisticated organizations clearly define upfront what they want from each investment and set up milestones accordingly, Stanford said.
There will be more opportunities to partner and invest in new ventures. The hard part is realizing when strategies don’t align and saying no, Coburn said.
“Saying yes is the easy part of the business,” he said.

VALNEVA to Present on Lyme, Chikungunya Vax Candidates

Valneva SE (“Valneva” or “the Company”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, announced today it will present on its Lyme disease and chikungunya vaccine candidates on April 16th, 2019 at the 19th World Vaccine Congress in Washington, D.C.
Valneva’s Chief Executive Officer, Thomas Lingelbach, will provide an update and discuss next steps for VLA15, the Company’s vaccine candidate against Lyme disease. Lyme is the most commonly occurring vector borne illness in the Northern Hemisphere with an estimated 300,000 Americans contracting the disease each year[1]. VLA15 has been shortlisted in the “Best Prophylactic Vaccine” category of the 2019 Vaccine Industry Excellence (ViE) Awards, held in conjunction with the World Vaccine Congresseach year.
Valneva’s Chief Medical Officer, Dr. Wolfgang Bender, will also present on the Phase 1 development of the Company’s chikungunya vaccine candidate, VLA1553. He will also discuss next steps for the potential single-shot vaccine.

Encouraging Economic Outcomes for Medtronic HeartWare HVAD System

Medtronic plc (NYSE:MDT) today announced data showing promising economic outcomes for the Medtronic HeartWare HVAD System after analyzing multiple clinical studies.
The economic analyses of the HVAD System – a left ventricular assist device (LVAD) that helps a failing heart pump and increases the amount of blood that circulates through the body – were presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions.
The first analysis showed that heart failure patients who received the HVAD System through a less-invasive thoracotomy procedure in the LATERAL study incurred lower hospitalization and medical supply costs than patients who received a ventricular assist device (VAD) through the traditional sternotomy implant procedure. The average total cost per patient in the thoracotomy (LATERAL) study was $204,107 compared to $260,492 for (non-study) traditional median sternotomy VAD cases

FDA posts tentative approval of Teva’s Icatibant

https://thefly.com/landingPageNews.php?id=2890352

Frequency shows early positive results for small-molecule hearing loss therapy

Concertgoers, rejoice: An early safety study of Frequency Therapeutics’ hearing loss drug treatment has cleared its first hurdles while showing some signs of hearing improvement in certain patients.
Frequency’s lead candidate, FX-322, is a cocktail of small-molecule drugs designed to activate the body’s healing abilities. By triggering dormant cells within the ear, the treatment hopes to spur the growth of the fine hairs that sense and translate sound waves, which can be damaged over time. The drug showed no serious adverse events in the phase 1/2 study following a single injection given through the eardrum.
Additionally, some adult patients with stable sensorineural hearing loss—with a history of either chronic noise exposure or sudden hearing loss—showed improvements in hearing range tests and word scores compared to placebo, the company said.
Frequency said it plans to publish and present the full study results at an upcoming otolaryngology meeting and launch a phase 2a study of FX-322 before the end of the year.
“While the focus of this study was safety, we are excited to see initial results in sensorineural hearing restoration as there are currently no treatments to restore hearing for these patients,” Frequency’s CEO, president and co-founder David Lucchino said in a statement.
“Furthermore, this data provides support for our small-molecule-driven regenerative medicine platform, which has the opportunity to address numerous degenerative diseases,” Lucchino added.
The double-blind phase 1/2 study randomized 23 patients to high- and low-dose FX-322, as well as placebo. Participants were evaluated two weeks after the injection, and were monitored for three months.
“If successful, our lead development program would represent the first time ever that hearing could be restored in humans with a therapeutic,” said Marc Cohen, Frequency’s executive chairman. “We are defining a new mode of regenerative medicine: activating progenitor cells within your body to repair damaged tissue.”
Frequency secured $42 million in funding through a series B round this past January to advance FX-322’s clinical testing and the company’s regenerative medicine work in other applications.
The round was led by Taiwania Capital Management and Axil Capital, a healthcare-focused venture fund spun out of Mizuho Securities. New backers included Yonjin Capital and DF Investments, while previous investors Polaris Founders Capital, Alexandria Venture Investments, CoBro Ventures, Korea Investment Partners and Emigrant Capital also participated, bringing the company’s total funding to $87 million.
Meanwhile, Frequency’s rival in the space, Decibel Therapeutics, recently brought on the company’s former chief medical officer for its own. There, Peter Weber will oversee Decibel’s gene therapy approach to treating hearing loss as well as inner-ear balance issues and tinnitus being developed in partnership with Regeneron Pharmaceuticals.
Frequency instead hired Bill Chin, formerly CMO and executive VP for science and regulatory advocacy at PhRMA, executive dean for research at Harvard Medical School and senior VP for discovery research and clinical investigation at Eli Lilly & Co.

XOMA Acquires Royalty Rights to Five Hematology Candidates

XOMA Corporation (NASDAQ: XOMA) announced today it has agreed to acquire the rights to potential royalty payments and a portion of the potential milestone payments associated with five hematology assets from Aronora, Inc. Three of the assets are anti-thrombotic candidates that are covered by a collaboration with Bayer, a global leader in hematology therapeutics. Two of the collaboration assets are in early to mid-stages of development and the third is a Phase 2 candidate that is subject to an option. In addition, XOMA agreed to acquire the rights to potential royalty payments and a portion of the potential upfront and milestone payments associated with two unpartnered hematology programs from Aronora.
The transaction diversifies XOMAs royalty interest portfolio by expanding into hematology indications, and these innovative anti-thrombotic candidates have the potential to address very large market opportunities. The fact that three assets are part of an ongoing collaboration between Aronora and Bayer, a company for whom we have tremendous respect, strengthens our belief in the potential of these therapies to address significant unmet medical needs, said Jim Neal, Chief Executive Officer at XOMA. These assets possess the characteristics we have established for our royalty aggregator business model: outstanding development partner, mid-stage to early clinical stage of development, important therapeutic categories, and sizable potential royalty opportunities. Aronoras expertise in hematology, with an advanced focus on anti-thrombotic monoclonal antibodies, intrigued our team.
The five royalty interest assets XOMA acquired from Aronora are:
Three Bayer collaboration monoclonal antibody (mAb) programs targeting factor XI/XIa: BAY1213790 in Phase 2 clinical development; BAY1831865 in early clinical development; and Aronoras AB023 (xisomab 3G3) in Phase 2 development; and,
Two proprietary hematology programs at Phase 1 and preclinical stage: AB002, a thrombin analog, and AB054, a factor XII mAb, positioned for acute cardiovascular events, medical device associated clots, and/or inflammation.
Under the terms of the agreement, XOMA will make an initial $6 million payment subject to closing conditions defined in the agreement. XOMA will make an additional payment of up to $3 million to Aronora upon fulfillment of certain other conditions. In return, XOMA will receive, on average, low single-digit royalties on future sales of these five products and 10 percent of the milestones associated with each of the assets. In addition, XOMA could pay Aronora sales-based milestones on each asset if XOMAs royalty receipts related to each program exceed certain thresholds. XOMA expects this transaction to close within the next 90 days.