Health Brief: Teva Names New CEO

Government Brief

  • When President Donald Trump declared the opioid epidemic a national emergency a month ago, he reportedly caught most of his advisers by surprise, leaving them scrambling to come up with a plan to free up funding to address the crisis. The surprise announcement created a lag between Trump’s declaration and actual executive action, as administration officials conduct an expedited review of recommendations from the president’s opioid commission, which is led by Gov. Chris Christie (R-N.J.). (The New York Times)
  • A Senate push to stabilize the Affordable Care Act exchanges could include changes to make it easier for states to obtain waivers, such as letting states essentially copy each other’s applications and letting governors submit applications without approval from the state legislature. (Axios)
  • The Joint Commission, an organization that the federal government relies on to accredit hospitals, rarely revokes accreditations for hospitals that violate Medicare safety requirements. The result is that hundreds of hospitals with patient safety problems can boast the hospital watchdog’s “Gold Seal of Approval.” (The Wall Street Journal)

Business Brief

  • H. Lundbeck A/S’s Kaare Schultz was named as Teva Pharmaceutical Industries Ltd.’s new chief executive officer, ending a seven-month search by the world’s largest generic drug maker to find a new leader. Schultz could face pressure to split the company into two businesses, one focusing on patented specialty drugs and the other on cheap copycat medicines. (Bloomberg)
  • Yervoy, the current standard postoperative treatment used to prevent relapse in certain patients with advanced melanoma, is less effective than Opdivo, according to a new clinical trial that experts say could set a new standard of care for melanoma treatment after surgery. Bristol-Myers Squibb, which makes both drugs, funded the study. (The Washington Post)
  • While some observers see progress in Congress on the push to stabilize the ACA exchanges, health plan executives aren’t optimistic that it will come before they have to decide about participating in Obamacare. (Modern Healthcare)

Chart Review

Events Calendar (All Times Local)

No events scheduled
The Hill event on gene therapy 8 a.m.
Senate Finance Committee hearing on health care issues impacting costs and coverage 10 a.m.
Senate HELP Committee hearing on state flexibility 10 a.m.
The Hill event on the opioid epidemic 8 a.m.
Health Affairs briefing on innovation in medicine 9 a.m.
House Energy and Commerce subcommittee hearing on FDA’s regulation of OTC drugs 10:15 a.m.
House Energy and Commerce subcommittee hearing on Public Health Service Act workforce programs 10 a.m.
Senate HELP Committee hearing with health care stakeholders 10 a.m.
No events scheduled

Are middlemen really holding down the cost of medicines?

Biopharmaceutical companies set the list prices for their medicines, but it’s your insurer that ultimately determines how much you pay out of pocket. More than one-third of the list price of a medicine is rebated back to middlemen, like insurers and pharmacy benefit managers (PBMs). These rebates and discounts create savings of more than $100 billion, but these savings aren’t always shared directly with patients. Let’s talk about cost.


A Month Has Passed Since Trump Declared an Opioid Emergency. What Next?
Maggie Haberman, The New York Times

When President Trump announced in early August, following a presidential commission’s recommendations, that the opioid crisis was a “national emergency,” he called it “a serious problem the likes of which we have never had.” A month has now passed, and that urgent talk has yet to translate into urgent action.

Hurricanes drive addiction issues into public square
The Associated Press

In the whirr of preparations for Hurricane Irma, a needle exchange program in Miami’s Overtown neighborhood handed out extra syringes to heroin users. Others trying to break from the drug’s grasp picked up advance medication from methadone clinics.

Bannon: Hill Republicans said Obamacare would be replaced by Easter
David Cohen, Politico

Former White House chief strategist Steve Bannon said Republicans in Congress assured President Donald Trump that repealing and replacing Obamacare would be a quick process. In an interview on Sunday’s edition of “60 Minutes” on CBS, Bannon said congressional Republicans pledged to Trump they would be able to eliminate the Affordable Care Act by Easter — a timetable the Trump administration agreed to so it could move on to other matters.

A Rare Dementia Gene Runs In The Family, But He’s Fine — So Far
JoNel Aleccia, Kaiser Health News

John Janda knows he takes after his mother. At 68, the graying building contractor is sentimental, just as she was.

Dollar Gains as Korea Fears, Irma Abate; Oil Rises: Markets Wrap
Samuel Potter, Bloomberg

The dollar gained, Treasuries retreated and stocks advanced as an appetite for risk returned to global markets after an anticipated North Korean missile test failed to materialize and Hurricane Irma struck the U.S. with less force than feared. Gold, the yen and Swiss franc all fell.


What the Senate has in mind for the ACA’s “innovation waivers”
Sam Baker, Axios

The Senate HELP Committee this week is scheduled to resume its hearings on stabilizing the Affordable Care Act, and it’s already clear Chairman Lamar Alexander wants that effort to focus on the process by which states can obtain what are known as “innovation waivers.” How it works: States can already seek a waiver from many of the ACA’s mandates, including the one that requires insurance plans to cover certain “essential” benefits.

Left in the lurch: Ongoing uncertainty is taking a toll on health insurers
Mara Lee and Shelby Livingston, Modern Healthcare

For nearly a year, health insurers have operated under a cloud of political and regulatory uncertainty that has taken a toll on finances, and for some, their day-to-day operations. Even though Congress shifted its focus from bulldozing the Affordable Care Act to stabilizing the troubled individual market in the short term, big questions remain, particularly around future funding for cost-sharing reduction subsidies that insurers say are crucial to steadying that business line.

U.S.-based UnitedHealth proposes buying Chile’s Banmedica

Chilean healthcare company Banmedica SA told local regulators late on Friday that it had signed a non-binding agreement to sell all its shares to U.S.-based UnitedHealth Group Inc. “If the transaction materializes, the price to be offered in the takeover bid for each share of the company would be 2,150 pesos ($3.47),” Banmedica said in a statement to regulators.


Hospital Watchdog Gives Seal of Approval, Even After Problems Emerge
Stephanie Armour, The Wall Street Journal

Patient-safety problems were so serious at Cooley Dickinson Hospital in Northampton, Mass., that the federal Medicare agency threatened to cut it off. Most patients never knew.

Irma forces at least 35 hospitals to evacuate patients. Here’s a rundown
Max Blau, Stat News

At least 35 hospitals in Florida, Georgia, and South Carolina have either closed entirely or ordered partial evacuations in advance of Hurricane Irma. The decisions come as officials have ordered nearly 7 million people to leave their homes, causing a mass exodus north before the storm begins to lash the Florida coast.

Pharma, Biotech and Devices

Teva Picks Lundbeck’s Schultz to Revive Israeli Drugmaker
Yaacov Benmeleh, Bloomberg

Teva Pharmaceutical Industries Ltd. named H. Lundbeck A/S’s Kaare Schultz as its new chief executive officer, ending a seven-month search for a new leader to revive sales and reduce debt at the world’s largest maker of generic drugs. Schultz, 56, will move to Israel and be based at Teva’s headquarters in Petach Tikva, the Israeli company said in a statement Monday, without proving a time-frame for the changes.

New clinical trial might change the standard treatment for melanoma
Laurie McGinley, The Washington Post

In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get. The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer.

Botox Maker Allergan’s CEO Defends Selling Drug Patents to Native American Tribe to Thwart Rivals
Sy Mukherjee, Fortune

Say you’re a pharma company with a key product which brings in about $1.49 billion in annual sales, or a little less than 10% of your revenue stream. Competitors that want to introduce cheaper, generic rivals are hounding you in court while others are challenging the patent through a separate federal entity. What can you do?

Roche shares hit by trial flops, fears over biosimilar defense
John Miller, Reuters

Roche shares fell in early trading on Monday after trial failures added to the Swiss drugmaker’s challenge of replacing patent-expired medicines with lucrative new drugs. Its skin cancer treatment Zelboraf flopped, the company said on Monday, while similar drugs from Novartis achieved their goals.

Health IT

Could Apple be taking a bite out of EHRs?
Rachel Z. Arndt, Modern Healthcare

On Tuesday, Apple executives will deliver a keynote address—the inaugural event at the Steve Jobs Theater in Cupertino, Calif.—showing off new software and gadgets. There’s rampant speculation that the company will unveil new iPhones.

A Message from PhRMA:

Ever wonder who decides what you pay for your medicines? It’s not who you might think. Biopharmaceutical companies set the list prices for their medicines, but it’s your insurer that ultimately determines how much you pay out of pocket. More than one-third of the list price of a medicine is rebated back to middlemen, like insurers and pharmacy benefit managers (PBMs). These rebates and discounts create savings of more than $100 billion, but these savings aren’t always shared directly with patients. Let’s talk about cost.

Opinions, Editorials and Perspectives

Hospital Consolidation Demands Closer Scrutiny
Gerard Scimeca, Morning  Consult 

Health care providers have been consolidating at an increasing rate in recent years. Nowhere is this more prevalent than in hospitals, where individual institutions and hospital systems are merging and buying one another at an alarming rate.

The Ground Has Shifted on U.S. Health Care
The Editors, Bloomberg

Congress’s failed effort to undo Obamacare this year revealed an important political shift in the U.S.: Americans are no longer content to let people go without health insurance. As the Affordable Care Act has taken root, most have come to believe the federal government has a responsibility to make sure everyone is covered.

Obamacare doesn’t deserve a bailout
Orrin Hatch, The Washington Post

Since the day Obamacare became law — having passed with only support from Democrats — Republicans have worked to repeal the partisan law and replace it with patient-centered reforms. While the effort has been underway for more than seven years, only recently have we had a chance to make good on our promises and undo the harm Obamacare has inflicted on the American people.

A new cancer drug may be the first in a line of revolutionary treatments
Editorial Board, The Washington Post

THE FOOD and Drug Administration approved a new treatment last month for acute lymphoblastic leukemia, an aggressive disorder of the blood and bone marrow that is the most common childhood cancer in the United States. On its face, this may not seem like big news.

Research Reports

Medically Necessary but Forbidden: Reproductive Health Care in Catholic-owned Hospitals
Elaine L. Hill et al., The National Bureau of Economic Research

The United States has recently seen a large increase in hospital mergers and acquisitions, and Catholic hospital systems have actively participated in this. As of 2016, 40% of the largest healthcare systems were faith-based, with 141 mergers between Catholic and non-Catholic systems since 1997.