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Monday, August 27, 2018

Private Hospital Rooms Better for Preventing Central Line Infections


Private hospital rooms save lives by reducing the risk of a dangerous hospital-acquired infection, known as a central line infection. This was the conclusion of a new study published in PLOS ONE by Liam O’Neill, Sae-Hwan Park, and Frank Rosinia from the University of North Texas Health Science Center.
Examining discharge records for more than one million patients across 335 Texas hospitals, the research team found that patients who stayed in bay (double occupancy) rooms had 64 percent more central line infections than patients who stayed in private rooms. After adjusting for patient characteristics and risk factors, patients who stayed in bay rooms still had a 21 percent greater risk of a central line infection compared to patients assigned to private rooms. Central line infections are those acquired through central venous catheters and cause about 5,000 to 10,000 deaths each year.
Hospitals whose physical layout consisted of mostly private rooms had 33 percent fewer central line infections than hospitals with mostly bay rooms. The mortality risk due to central line infections was more than twice as high in hospitals with mostly bay rooms. A 10 percent increase in private rooms was associated with an 8 percent decrease in central line infections.
The chance of being assigned to a private room differed significantly by race and geographic region. African-Americans were 63 percent more likely and Hispanics were 44 percent more likely to stay in bay rooms. South and west of San Antonio, hospitals are older and bay rooms still predominate. Private rooms are more prevalent in the “Texas Triangle,” that encompasses Austin, Dallas, and Houston, since this region has seen the construction of new hospitals. According to study author Liam O’Neill, “We hope that our findings will start to change the conversation in hospital board rooms from ‘How much will private rooms cost?’ to ‘How many lives will they save?’ ”

Gilead Yescarta gets Euro OK for additional indications


— New Option for Adult Patients in Europe as Axicabtagene Ciloleucel Becomes the First CAR T to Receive European Approval for Two Types of Aggressive Non-Hodgkin Lymphoma —

Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission (EC) has granted Marketing Authorization for Yescarta® (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. The Marketing Authorization approves axicabtagene ciloleucel for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein.
Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy, which harnesses a patient’s own immune system to fight certain types of blood cancer. The cell therapy has been proven to induce complete response (no detectable cancer) in a proportion of patients with relapsed or refractory DLBCL and PMBCL, which are aggressive forms of non-Hodgkin lymphoma (NHL).
“Axicabtagene ciloleucel is a new and exciting way of treating cancer that offers a new option to patients with DLBCL and PMBCL in Europe,” said Professor Gilles Salles, Head of Hematology, South Lyon Hospital Complex. “Many patients with these aggressive forms of non-Hodgkin lymphoma who have not responded to or failed commonly available treatment options have a very poor prognosis and there is an urgent need for new therapies.”
The Marketing Authorization Application (MAA) is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL. In the single-arm trial, 72 percent of patients (n=73/101) who received a single infusion of axicabtagene ciloleucel responded to therapy, with 51 percent (n=52/101) achieving a complete response (as assessed by an independent review committee, median follow-up of 15.1 months). At one year following infusion, 60 percent of patients were alive (95% CI: 50.2, 69.2) and the median overall survival (OS) had not been reached (95% CI: not estimable [NE]).
Axicabtagene ciloleucel may cause side effects that are severe or life threatening, such as cytokine release syndrome (CRS) or neurological toxicities. In ZUMA-1, 12 percent of patients experienced Grade 3 or higher CRS and 31 percent experienced Grade 3 or higher neurologic toxicities. Overall 98 percent of patients recovered from CRS and/or neurologic adverse reactions. Treatment algorithms have been developed to manage some of the symptoms associated with both CRS and neurologic adverse reactions experienced by patients on axicabtagene ciloleucel.
The most common Grade 3 or higher adverse reactions include encephalopathy, unspecified pathogen infection, CRS, bacterial infection, aphasia, viral infection, delirium, hypotension and hypertension.
For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management) please refer to the EU Summary of Product Characteristics (SmPC).
“We are proud to be leading this frontier of cancer innovation that is bringing novel, personalized therapy to people living with these blood cancers,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “Our vision is for cell therapy to serve as the foundation for treating all cancer types. Today’s milestone is another step on this exciting and important journey.”
Axicabtagene ciloleucel was approved by the U.S. Food and Drug Administration on October 18, 2017.

Don’t blame older adults for big rise in Medicaid spend


Is the growing need for long-term supports and services (LTSS) by older adults driving big increases in Medicaid spending? Not according to a new study by Don Redfoot and my Urban Institute colleague Melissa Favreault. Indeed, they found that while Medicaid enrollment and expenditures for older adults grew in recent decades, it had far less effect on the program than increases in other Medicaid populations, especially younger people with disabilities. Older adults accounted for only about 13% of Medicaid spending increases from 1975 to 2011.
Their paper, published in the Gerontological Society of America’s Public Policy and Aging Report, found that over that period the number of Medicaid beneficiaries tripled from about 22 million to 68 million and program spending increased four-fold from $90 billion to $365 billion (in 2011 dollars).
Modest Medicaid growth for seniors
But most of those increases were driven by an explosion in enrollment by non-elderly beneficiaries and the resulting rise in costs. For example, while the number of Medicaid enrollees 65 and older increased by 20 percent over the period, it grew by nearly 300 percent among younger people with disabilities.  While this added to Medicaid costs, it also resulted in a big increase  in the share of insured adults and children.
Similarly, after adjusting for inflation Medicaid costs for older adults roughly doubled over the period, from $32 billion to $67 billion. But that pace of growth was far slower than for any other demographic group.
For instance, spending on children increased more than four-fold and spending on non-disabled adults under age 65 grew more than 250 percent.
People with disabilities

But the biggest increase by far was for people with disabilities—a category that includes some seniors but mostly younger people. For them, Medicaid costs jumped by nearly 600 percent–from $23 billion to $155 billion in 2011 dollars. By 2011, people with disabilities accounted for nearly 43 percent of all Medicaid spending, while the program spent about 18 percent on seniors.  That’s a dramatic change from 1975, when Medicaid spending on older adults outpaced spending on younger people with disabilities.

Interestingly, while overall Medicaid spending growth for most populations was driven by increases in enrollment rather than hikes in per-person costs, the trend was very different for seniors. Older adults accounted for about 13 percent of new Medicaid spending from 1975-2011, but only about 2.5 percent of that was due to greater enrollment. Most, nearly 10.5 percent, was caused by increases in per person costs.
As the authors write, “population growth alone is a poor predictor of growth in the number of beneficiaries, and that growth…alone is a poor predictor of growth in expenditures.”
Medicaid’s asset test
What did account for the relatively modest boost in Medicaid spending on older adults?
Don and Melissa identified a number of factors, some demographic, some related to care delivery and overall health status, and some resulting from public policy.
For example, the health and finances of older adults has improved, and rates of widowhood have declined—all trends likely to slow the growth of Medicaid enrollment for seniors.
At the same time, growing numbers of older adults are getting care at home, a less costly setting than nursing facilities. But two other policy factors also may have played key roles.
First, the asset test that helps determine financial eligibility for Medicaid is not indexed for inflation, and its income test is tied to a relatively slow-growing inflation factor. For instance, unmarried older adults generally are barred from enrolling in Medicaid if they have non-housing assets that exceed $2,000—a limit that has not changed since 1989. Thus, as the wealth of many older adults is increasing, the asset test is not and the percentage of seniors eligible to enroll in Medicaid is shrinking.
A cloudy crystal ball
A second major policy reason was the creation of the Medicare Part D drug benefit in 2005 which shifted drug costs for low-income seniors from Medicaid to Medicare. As a result, Medicaid spent $871 million on prescription drugs in 2011, down from $10.6 billion prior to enactment of Part D.
What does this experience tell us about the future?
Importantly, the pattern of aging in America over the four decades from 2011-2050 is likely to resemble the trend from 1975-2011. Assuming no changes, Don and Melissa project that Medicaid enrollment among aging Baby Boomers will increase until it peaks at about 3.5 million in the early 2040s.
However, under current restrictive income and asset tests, the share of seniors benefitting from Medicaid will fall from about 4.9 percent in 2015 to 4.5 percent in 2020 and to 4.2 percent by 2025. If income and assets are allowed to rise at the same rate as wages, the share of seniors enrolled in Medicaid would increase by an additional 0.2 percentage points by 2035.
It may not be about the Boomers
Keep in mind, though, that the crystal ball about future Medicaid enrollment and costs is cloudy. How will changes in prevalence of dementia affect Medicaid enrollment? What about the longer lives of younger people with disabilities? And how will federal and state policymakers change Medicaid, both on the health care side and on the LTSS side? The program has undergone enormous change since Congress passed the Affordable Care Act in 2010—a pace that may not slow in coming years.
While we can’t predict the future, Don and Melissa have shown that in the recent past, older adults have had relatively little effect on Medicaid spending. And their work should serve as a warning: Don’t assume that aging Baby Boomers will drive big increases in Medicaid spending in the coming years.

Zimmer Biomet warning letter ‘not the end of the world,’ says Piper Jaffray


Piper Jaffray analyst Matt O’Brien says the warning letter disclosed this morning by Zimmer Biomet is “not the end of the world.” The company expects to respond to the warning letter in the next 15 days and does not anticipate it will have a material impact on its financial results, O’Brien tells investors in a research note. The analyst does not view the letter as a “huge issue” since Zimmer can still manufacture from the facility and any additional cash requirements should be manageable. He keeps a Neutral rating on the shares.

Medtronic price target raised to $108 from $95 at Argus


Argus analyst David Toung raised his price target on Medtronic to $108 and kept his Buy rating, saying the company delivered strong Q1 sales growth from its Brain Therapies and Pain Therapies segments after divesting its underperforming assets. The analyst adds that the company has been able to offset the impact of tariffs but remains concerned abut the future trade impediments and currency volatility since China is one of its largest international markets. Toung further notes Medtronic’s attractive valuation of 18.6-times his expected FY19 earnings, below the 19.1-times average of his covered med-tech peers.

Novartis receives EC approval for Kymriah


Novartis announced that the European Commission has approved Kymriah. The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. Kymriah developed in collaboration with the University of Pennsylvania is a ground-breaking one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimeric antigen receptor T cell, or CAR-T, therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the FDA.

Johnson & Johnson to host conference call


Conference call to discuss Phase 3 MARINER and COMMANDER HF studies for XARELTO will be held on August 27 at 8 am