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Pricing, Profits and Progress: Pharma’s Post-COVID Priorities

As post-pandemic recovery begins, big pharma remains in the spotlight. Jesse Mendelsohn explores pharma’s priorities on pricing, profits and
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As post-pandemic recovery begins, big pharma remains in the spotlight. Jesse Mendelsohn explores pharma’s priorities on pricing, profits and progress post-Covid.

It goes without saying that if pharmaceutical companies are not profitable, they will not survive. The need for firms to make a reasonable profit is paramount in today’s world; healthy pharmaceutical research and manufacturing are the keys to ending disease, curing chronic conditions, and discovering new therapies and vaccines that address the latest medical challenges.

Nowhere has this need for healthy companies been more apparent than during the current global coronavirus pandemic, with multiple manufacturers making COVID-19 vaccines rapidly available to the public. It can be reasonably argued that the upfront research and development of vaccine technologies leveraging mRNA – which can be widely applied against a number of viruses – will be the solutions that end our current pandemic and will effectively position society to be ready for the next.

Simply put, the revenues and profits from today’s mainstream drugs fund the scientific discovery that make tomorrow’s breakthrough drugs and critical vaccines possible. Against this backdrop, there has been substantial public debate about rising drug prices forced on consumers, including the trite notion that pharmaceutical companies are being “greedy” and seeking to price-gouge the public.

The Big Misconception

The truth about rising drug prices is more nuanced and merits exploration. The fundamental misconception among the public, the media and even some lawmakers is that higher drug list prices are the result of drug manufacturers being in a monopolistic position to endlessly raise prices on critical drugs like insulin and then rake in big profits.

If pharmaceutical companies’ steady price increases are wholly due to limitless greed or thirst for revenue growth, this certainly is not proven by the actual, factual financial results for these same companies.  While it is true that drug prices and pharma company revenues are going up, generating impressive cash flow, the pharma industry faces slow growth of topline revenue, lower overall profitability and financial valuations that are stuck in neutral. For drug companies, the combination of lackluster financial performance and simultaneous public and political scorn is a lose-lose proposition.

Is the Middleman at Fault?

A key reason for rising drug prices is the role of middlemen, in the form of health plans and pharmacy benefit managers (PBMs). These payers are best defined as entities that pay for or reimburse pharmacies for drugs dispensed to covered patients. In most cases, pharma manufacturers must pay health plans and PBMs in order to give their drugs preferred formulary placement – or to even have their drugs covered in these plans at all.

Manufacturers have been paying these rebates to PBMs, health plans and large employers for decades, because it gives them better access to patient populations via, for example, obtaining lower co-pays as compared to the competition. Rebate dollars are shared among pharmacy benefit managers, health plans and employers, and pharma companies must continually offer larger rebates to improve or even maintain formulary status and access to patients.

Quite often, middlemen like PBMs can earn as much revenue as a manufacturer on a given drug, and with just three major PBMs serving a majority of the market, their power is quite concentrated. The difference is, of course, that pharma manufacturers can typically spend a decade or more developing a given drug and are responsible for marketing it, while PBMs are responsible for managing claims, formularies, and overseeing discounts and rebates for drug makers – while doing little to support or drive innovation.

In the case of Eli Lilly, they reported that the list price of their Humalog (insulin) product rose from $391 to $594 from 2014 to 2018, yet the company’s net revenue (revenue after these PBM and other rebates are paid) per dose fell from $147 to $135 (per patient, per month) during the same period. The fees and rebates that Lilly was forced to pay have eaten into margin and, therefore, drove increased list prices. Yet the public experiences justifiable “sticker shock” at the steadily rising price of what is essentially a commodity drug while, after all rebates are paid, the manufacturer is making less on that same drug than they were years earlier. This is just one example of the cycle of rising drug prices created by PBM-mandated rebates.

What’s more, a recent USC study has closely associated the role of rebates to rising list prices and suggests that reducing rebates and increasing the level of transparency across the pharmaceutical distribution chain will be possible remedies for escalating prices. Further commentary from USC explains, “Understanding the relationships between list prices and rebates is important because it informs the degree to which policymaker efforts to lower drug prices should target manufacturers or other players in the system, specifically PBMs.”

Potential Public Remedies

Clearly, the cycle of rebates has something to do with increasing drug prices, and public and legislative pressure is poised to force changes to the current system.

A recent Supreme Court decision supported greater oversight and regulation of PBMs by individual states and includes provisions for enforcing contract transparency and documentation such as detailed annual reports. In addition, industry experts anticipate that the safe harbor changes for Medicare Part D rebates – effectively banning “behind the scenes” formulary-style rebates for Part D – will eventually be implemented by the federal government, although they are currently on hold. In addition to early executive action by the Biden administration, we’re expecting legislative activity by the 117th Congress. The industry itself is also responding, with a new policy agenda being advanced by PhRMA that includes endorsements for drug pricing reforms.

What’s Next: How Should Pharma Companies Respond?

In a time when profitability – along with the ability to freely spend on research and development – remains in question, pharma companies are looking for ways to respond to current market conditions.

The industry is increasingly turning to Silicon Valley technologists, instead of Washington regulators, to find new ways to optimize revenue at every point in the product lifecycle. Part of a comprehensive strategy is to focus on best practices for launching drugs into the market and then sustaining marketplace momentum through optimizing relationships with distribution channels/networks and payers. In addition, implementing systems and technologies that help optimize revenue by eliminating revenue leakage is crucial.

Companies must effectively manage rebate programs to capture as much revenue as possible while maintaining legal compliance and strive for full visibility when it comes to gross-to-net profits. Forecasting and pricing simulations are also key, as new technology solutions can help drug makers comply with policy and simplify drug delivery, payments and price negotiation by breaking down barriers and streamlining processes. Only by continuously optimizing global revenue and being prepared for ongoing price changes can a company survive in today’s turbulent pharmaceutical marketplace.

About the author

Jesse Mendelsohn is vice president at Model N. He is an experienced executive, business analyst and consultant in the realm of pharmaceutical regulatory compliance and government pricing.

The post Pricing, Profits and Progress: Pharma’s Post-COVID Priorities appeared first on .

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International

Beloved mall retailer files Chapter 7 bankruptcy, will liquidate

The struggling chain has given up the fight and will close hundreds of stores around the world.

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It has been a brutal period for several popular retailers. The fallout from the covid pandemic and a challenging economic environment have pushed numerous chains into bankruptcy with Tuesday Morning, Christmas Tree Shops, and Bed Bath & Beyond all moving from Chapter 11 to Chapter 7 bankruptcy liquidation.

In all three of those cases, the companies faced clear financial pressures that led to inventory problems and vendors demanding faster, or even upfront payment. That creates a sort of inevitability.

Related: Beloved retailer finds life after bankruptcy, new famous owner

When a retailer faces financial pressure it sets off a cycle where vendors become wary of selling them items. That leads to barren shelves and no ability for the chain to sell its way out of its financial problems. 

Once that happens bankruptcy generally becomes the only option. Sometimes that means a Chapter 11 filing which gives the company a chance to negotiate with its creditors. In some cases, deals can be worked out where vendors extend longer terms or even forgive some debts, and banks offer an extension of loan terms.

In other cases, new funding can be secured which assuages vendor concerns or the company might be taken over by its vendors. Sometimes, as was the case with David's Bridal, a new owner steps in, adds new money, and makes deals with creditors in order to give the company a new lease on life.

It's rare that a retailer moves directly into Chapter 7 bankruptcy and decides to liquidate without trying to find a new source of funding.

Mall traffic has varied depending upon the type of mall.

Image source: Getty Images

The Body Shop has bad news for customers  

The Body Shop has been in a very public fight for survival. Fears began when the company closed half of its locations in the United Kingdom. That was followed by a bankruptcy-style filing in Canada and an abrupt closure of its U.S. stores on March 4.

"The Canadian subsidiary of the global beauty and cosmetics brand announced it has started restructuring proceedings by filing a Notice of Intention (NOI) to Make a Proposal pursuant to the Bankruptcy and Insolvency Act (Canada). In the same release, the company said that, as of March 1, 2024, The Body Shop US Limited has ceased operations," Chain Store Age reported.

A message on the company's U.S. website shared a simple message that does not appear to be the entire story.

"We're currently undergoing planned maintenance, but don't worry we're due to be back online soon."

That same message is still on the company's website, but a new filing makes it clear that the site is not down for maintenance, it's down for good.

The Body Shop files for Chapter 7 bankruptcy

While the future appeared bleak for The Body Shop, fans of the brand held out hope that a savior would step in. That's not going to be the case. 

The Body Shop filed for Chapter 7 bankruptcy in the United States.

"The US arm of the ethical cosmetics group has ceased trading at its 50 outlets. On Saturday (March 9), it filed for Chapter 7 insolvency, under which assets are sold off to clear debts, putting about 400 jobs at risk including those in a distribution center that still holds millions of dollars worth of stock," The Guardian reported.

After its closure in the United States, the survival of the brand remains very much in doubt. About half of the chain's stores in the United Kingdom remain open along with its Australian stores. 

The future of those stores remains very much in doubt and the chain has shared that it needs new funding in order for them to continue operating.

The Body Shop did not respond to a request for comment from TheStreet.   

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Government

Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Government

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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