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Increased Payer and Provider Support May Drive Billions of Dollars in Savings from Biosimilars

Sheila Frame, biosimilars

By SHEILA FRAME 

FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.

Organizations such as the American College of Rheumatology and the American Society of Clinical Oncology have issued educational documents to help guide providers in incorporating biosimilars into treatment plans, where appropriate. Yet, many doctors remain hesitant to prescribe them due to concerns about safety, efficacy, immunogenicity, effects of switching to a new biosimilar and the economic value to patients.

Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.

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The Importance of Patient Engagement in Post-Acute Care

Brian Holzer, patient engagement, post-acute care

By BRIAN HOLZER MD, MBA 

Leaders in hospitals and health systems as well as post-acute care providers such as skilled nursing facilities (SNFs) and Home Health Care (HHC) agencies operate in a complex environment. Currently, the health care reimbursement environment is largely dominated by fee-for-service models. However, acute and post-acute leaders must increasingly position their organizations to prepare for, and participate in, evolving value-based care programs—without losing sight of the current fee-for-service reimbursement structure.

With that said, the call to action for acute and post-acute providers working at both ends of the reimbursement spectrum is real. The time is now to innovate, test and adopt new post-acute care models to support each patient’s transition from hospital to post-acute settings, and eventually home to enable a better care experience for patients and their care teams.

This is especially relevant for Skilled Nursing Facilities (SNFs) and chains that meet the current Medicare requirements for Part A coverage. Increasingly, the SNF industry is under pressure from the Medicare program to improve coordination and outcomes. Medicare’s hospital readmission policy and value-based purchasing program (VBP), bundled payments, and ACOs encourage SNFs, and other post-acute settings, to avoid readmissions. In addition, earlier this year, the Centers for Medicare and Medicaid Services (CMS) finalized a new patient-driven payment model (PDPM) for SNFs, which will go into effect on October 1, 2019. The overhaul of the entire system will require significant staff focus and operational changes.

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What Does Congressional Gridlock Mean for the Rest of the Country?

Joe Molloy, health policy, Congressional gridlock

By JOE MOLLOY 

Often, a Congressional gridlock is essentially good. This is because the executive arm of government is forced to consider a bipartisan approach to issues if it’s to secure the approval of both Democrats and Republicans in Congress.

The outcome of the midterm elections indicates that the Republicans have managed to retain their control of the Senate, while Democrats have secured control of the House of Representatives.

Health a Central Issue During the Midterms

According to a survey by Health Research Incorporated, the three top issues of concern during the midterm elections were health, followed by Social Security and Medicare, with 59% of the respondents irrespective of age, race or geography citing health as the most significant.

Among Trump’s electoral promises was a complete repeal and replacement of Obamacare under the Affordable Care Act (ACA) with a policy that was apparently less expensive and more effective. On his first day of office, Trump signed an executive order instructing federal agencies “to take all reasonable measures that minimize the economic burden of the law, including actions to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act.”

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Health in 2 Point 00, Episode 62- AHIP in Nashville!

On Episode 62 of Health in 2 Point 00, Jess and I are reporting from Nashville—while enjoying some delicious barbecue. We’re in town for AHIP’s Consumer Experience & Digital Health Forum, where Jess did an amazing job as a moderator and I was on a panel. In this episode, Jess asks me about my key takeaways from the forum, what the deal is with Tivity Health acquiring Nutrisystem, and how I managed to get into a fight on Twitter while at AHIP. —Matthew Holt

Last Month in Oncology with Dr. Bishal Gyawali: November 2018

Keynote speech

There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.

In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.

The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data.
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Hotlines Aren’t Enough to Help People at Risk of Suicide

Cara Angelotta, suicide prevention, health policy

By CARA ANGELOTTA MD

Contrary to popular belief, the risk of suicide does not increase around the holidays. But, according to the Centers for Disease Control and Prevention, annual suicide rates in the U.S. have risen nearly 30 percent since 1999.

Much of the media coverage following the high-profile suicides of Kate Spade and Anthony Bourdain has followed recommended best practices to reduce risk of suicide contagion or “copycat” suicides by including warning signs a person may be at risk of suicide due to depression and contact information for the national hotline for suicide prevention. This overly simplistic approach implies that we can prevent all suicides by reaching out to loved ones in emotional distress and advertising the existence of mental health treatment.

As a psychiatrist who treats individuals hospitalized for acute suicide risk, I am concerned that much of the media coverage has belied the complexity of suicide. While we do not yet fully understand why suicide rates are rising, we do know that suicide is a complex public health problem that will require a multifaceted approach to reduce deaths. Increased awareness of depression as a treatable medical illness is an important but insufficient response to the suicide epidemic.

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Win, Lose, or Draw: Not all ACA Enrollees Gain from Increased Competition

By KATHERINE HEMPSTEAD PhD 

The 2019 ACA plan year is notable for the increase in insurer participation in the marketplace. Expansion and entry have been substantial, and the percent of counties with one insurer has declined from more than 50 percent to approximately 35 percent. While urban areas in rural states have received much of the new participation, entire rural states have gained, along with more metropolitan urban areas.

Economic theory and common sense lead most to believe that increased competition is unquestionably good for consumers. Yet in the paradoxical world of the subsidized ACA marketplace, things are not so simple. In some markets, increased competition may result in a reduction in the purchasing power of subsidized consumers by narrowing the gap between the benchmark premium and plans that are cheaper than the benchmark. Even though the overall level of premiums may decline, potential losses to subsidized consumers in some markets will outweigh gains to the unsubsidized, suggesting that at the county level, the losers stand to lose more than the winners will win.

One way to illustrate this is to hypothetically subject 2018 marketplace enrollees to 2019 premiums in counties where new carriers have entered the market. Assuming that enrollees stay in the same metal plan in both 2018 and 2019, and that they continue to buy the cheapest plan in their metal, we can calculate how much their spending would change by income group.

Under these assumptions, in about one quarter of the counties with federally facilitated marketplaces (FFM) that received a new carrier in 2019, both subsidized and unsubsidized enrollees would be better off in 2019, meaning that they could spend less money and stay in the same metal level. In about thirty percent of these counties, all enrollees are worse off. In almost all of the rest, about forty percent, there are winners and losers, but in the aggregate, the subsidized lose more than the unsubsidized win. Overall, in about 70 percent of FFM counties with a new carrier, subsidized enrollees will lose purchasing power, while in about 66 percent of these counties, unsubsidized customers will see premium reductions. In population terms, about two-thirds of subsidized enrollees in counties with a new carrier will find plans to be less affordable, while a little more than half of unsubsidized enrollees will see lower premiums.

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Medicaid Expansion is Evidence the Health Policy Debate Defies Political Divides

Joe Molloy, health policy, Congressional gridlock

By JOE MOLLOY 

Among all the talk of waves and tides of the close midterm races around the country, there were tremendous results on election day for Medicaid expansion. Three states – Idaho, Nebraska, and Utah – passed ballot initiatives approving the policy.

On top of that, in Kansas and Maine, governors who had vetoed the policy in the past were replaced with candidates promising to enact it.

This was obviously great news for supporters of Medicaid expansion with the total number of expansion states firmly at 36.

What were the issues?

In Idaho, the Expansion ballot initiative was designed to provide insurance covers for individuals under the age of sixty-five and whose income is below 138 percent of the federal poverty level and who are not eligible for any other state insurance cover.

Among the proponents of Medicaid in Idaho was State representative Christy Perry a Republican and staunch Trump supporter. She had over the years attempted to push for the expansion through the state legislature but faced resistance from statehouse leaders.

The scenario in Idaho applies to Utah and Nebraska, with the ballot initiative being necessitated by the strong opposition from the majority of Republicans and statehouse leaders. In Utah, opponents of the Expansion argued that the initiative would bankrupt the state treasury. In Nebraska caution was given against reliance on federal government financing for state programs noting that often the national government scale back or neglect supporting state programs without proper transitional mechanisms.

However, it was difficult to debate against the fact that Medicaid would free up resources invested by the state governments in local insurance programs and that the federal government is legally obliged to pay 90% of the cost of the policy.

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The Disruptive Potential of Employer-Centered Care

Lawrence Leisure talking about Centered Care

By LAWRENCE LEISURE 

When it comes to health care prices, the burden piled on payers can seem almost cartoonishly heavy. News stories on the state of the industry read as though some satirist decided to exaggerate real systemic flaws into cost-prohibitive fiction. A particularly painful example hit the presses earlier this year, when a writer for Reuters revealed that the cost of a full course of oncology treatment skyrocketed from $30,447 in 2006 to $161,141 in the last few years. The change was so unbelievable as to verge on dark comedy — but there isn’t much to find funny in the situation when lives and health outcomes are on the line.

For the average employee in my home of Silicon Valley, the price crunch is challenging regardless the size of your paycheck. For local employers, however, the dilemma can be even more pointed. Today, employees of companies, large and small, expect their employer to provide comprehensive health care benefits and are largely unaware of or insensitive to the factors exacerbating market problems today. Providing these benefits, however, is easier said than done.

Employers and insurers alike face a multitude of barriers to connecting employees with affordable care. Recent research suggests that prices will increase at an average clip of 5.8% annually between now and 2024, well above the expected rate of inflation. Even worse, the increased consolidation of healthcare providers has drastically undermined the negotiating power that payers would otherwise have in more competitive markets. In Northern California, for example, major health systems, including Sutter Health, sparked outrage and protest as they have managed to amass enough of the region’s hospitals, outpatient facilities, and primary care offices to diminish regional competitors and set what many view as unacceptably high rates — all the while knowing that the lack of local competition makes it challenging for the major health insurers to push back.

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THCB Spotlight: Jesse Ehrenfeld, AMA

By ZOYA KHAN

Today, we are featuring Dr. Jesse Ehrenfeld from the American Medical Association (AMA) on THCB Spotlight. Matthew Holt interviews Dr. Ehrenfeld, Chair-elect of the AMA Board of Trustees and an anesthesiologist with the Vanderbilt University School of Medicine. The AMA has recently released their Digital Health Implementation Playbook, which is a guide to adopting digital health solutions. They also launched a new online platform called the Physician Innovation Network to help connect physicians with entrepreneurs and developers. Watch the interview to find out more about how the AMA is supporting health innovation, as well as why the AMA thinks the CVS-Aetna merger is not a good idea and how the AMA views the role of AI in the future of health care.

Zoya Khan is the Editor-in-Chief of THCB as well as an Associate at SMACK.health, a health-tech advisory services for early-stage startups.

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