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Why the drug pricing debate is focused on insulin

The treatment has been around for over a century but insulin has still become the centre of the
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The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. Ben Hargreaves looks at why insulin’s price is so controversial and whether this could be set to change.

It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone. The medical intervention was a success, inspiring the first wave of insulin treatments developed from cattle and pigs. Later, synthetic ‘human’ insulin was developed in 1978 and then commercialised by Eli Lilly in 1982 as Humulin. In recent years, there have been more developments in the area of diabetes management, with the emergence of metformin and more recently semaglutide and dulaglutide.

However, despite these alternative diabetes treatments, insulin is still essential for people living with type 1 diabetes and is also necessary for some individuals living with type 2 diabetes. In the US, approximately 37.3 million Americans have diabetes and a further 96 million have pre-diabetes, according to the US Centers for Disease Control. The disease is estimated to cost the US economy $327 billion per year, due to the medical costs, alongside lost work and wages. It is estimated that people diagnosed with diabetes have more than twice the average medical expenses compared with people without diabetes.

The cost of medical treatment of diabetes is now at the centre of a debate in US politics, as the House of Representatives recently voted to approve legislation to limit cost-sharing for insulin under private health insurance and Medicare. The Affordable Insulin Now Act, as it is known, still has to pass through the Senate, but is just one part of a wider movement to try to reduce the cost of diabetes treatment in the US.

Insulin rationing

One of the major headlines that has emerged from the debate on insulin pricing is that one in four people have had to ration insulin supplies to cut the cost of their diabetes care, per research conducted by the American Diabetes Association. The same study revealed that 24% of people used savings, loans, or money from their stimulus check to pay for diabetes care. The pandemic has also had a disproportionate impact on those with the lowest income in the diabetes community, with approximately half of low earners reporting that they had lost some or all income.

This is what the Affordable Insulin Now Act is taking aim at, with its attempts to introduce a cap of insulin prices at $35 per month or 25% of an insurance plan’s negotiated price, whichever of the two is lower. The reason a price cap is being targeted is due to the rapid increase in the cost of insulin products over the last few decades. According to research, one vial of Humalog (insulin lispro) cost $21 in 1999, but this increased to $332 in 2019, representing a price increase of 1480%.

For its part, PhRMA, a trade group representing the pharma industry, recently published its own research finding that rebates, discounts and other payments from pharma companies to pharmacy benefit managers, insurers, the government and others, “lowered the cost of the most commonly used insulins by 84% on average in 2021.” The organisation noted that the average net cost of these insulin products is 20% lower than in 2007.

In a statement, PhRMA president and CEO, Stephen Ubl, said, “Too often these savings are not shared with patients. Unfortunately, the current drug pricing bill fails to take a holistic approach to addressing a system that drives affordability challenges for patients. By taking steps to hold middlemen accountable, Congress can help fix a broken system and lower patient costs at the pharmacy counter.”

Potential biosimilar impact

Outside of Congress, there is another element that could reduce the cost of insulin, in the form of biosimilars. Due to a change in the classification of insulin, the door for biosimilars to insulin products was opened up in the US, which allowed for the first biosimilar to be approved midway through last year. This has led to other organisations looking to enter the market with further biosimilars, such as Civica Rx. The non-profit drugmaker plans to launch biosimilars of Sanofi’s Lantus (insulin glargine), Novo Nordisk’s Novolog (insulin aspart) and Eli Lilly’s Humalog (insulin lispro) by 2024. The organisation plans to offer the biosimilars at a ‘significant discount’ to the price charged to uninsured individuals.

GlobalData, a market intelligence company, concluded that Civica’s goal of drastically reducing the price of the insulin products, compared to the branded products, would ultimately lower the cost of all products on the market. One company that received approval for an insulin biosimilar in the US is Viatris, for its Semglee (insulin glargine-yfgn) product. In a recent fourth quarter investor call, Sanjeev Narula, chief financial officer at Viatris, stated that the company was seeing “solid uptake” of its biosimilar. However, the company also announced at the same time that it was selling its biosimilars portfolio to Biocon for $3.3 billion, amid a commercial environment where even brand products were seeing ‘80% to 90% erosion’ due to biosimilar competition on price, noted Rajiv Malik, president at Viatris.

Innovation to end debate?

One common defence of price increases across a broad range of pharmaceutical product has been that the profit generated is reinvested back into the development of new treatments. In the diabetes space, there have been a number of breakthroughs that the industry can highlight, such as the approval of Novo Nordisk’s Ozempic (semaglutide injection) and Eli Lilly’s Trulicity (dulaglutide).

The two treatments are GLP-1 receptor agonists, which have been found in research to be beneficial in body weight loss, protection of islet β cells, promotion of islet β cell proliferation and have minimal side effects. When asked about what other innovations Novo Nordisk is aiming to achieve in diabetes control, a spokesperson for the company told pharmaphorum: “We are developing new types of insulin to further improve management of the condition. We are currently conducting a large-scale phase 3 programme with a once-weekly basal insulin, insulin icodec, that we hope will reduce the disease burden even further.

“Beyond this, we also aim to develop a glucose-sensitive insulin, which would only be activated in the body of the patient when glucose levels rise. The hope is that this will lead to better glucose control and lower risk of dangerously low blood sugar events,” the spokesperson added. The company is also working on combining the effects of GLP-1 with other treatments, such as with an analogue of the hormone amylin, to improve outcomes in type 2 diabetes.

Regarding the overall progress for patients living with either type 1 or 2 diabetes, the spokesperson noted that prior to the development of insulin, diabetes was ‘essentially a death sentence’. By comparison, in the present day, the life expectancy for an individual living with diabetes is close to that of a person without diabetes.

Novo Nordisk is also pursuing a “curative treatment approach”, which could be achieved through a cell therapy for type 1 diabetes that the company is working on, the spokesperson said.

A cure for type 1 diabetes could effectively end debate on the price of insulin and allow the industry to point towards the success that can be achieved through allowing it to work on treatments within the current system. However, with the cell therapy treatment still at the early stage, the discussion of insulin pricing looks set to continue, as the Affordable Insulin Now Act moves towards the US Senate.

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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2 hours ago

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March 9, 2024

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

“When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

“It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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Walmart joins Costco in sharing key pricing news

The massive retailers have both shared information that some retailers keep very close to the vest.

Published

4 hours ago

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March 9, 2024

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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Walmart has really good news for shoppers (and Joe Biden)

The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.

Published

5 hours ago

on

March 9, 2024

By

As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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