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Showing posts with label Mylan. Show all posts
Showing posts with label Mylan. Show all posts

Tuesday, January 31, 2017

Drug Makers Sued over Insulin Price-Fixing

It is so clear now that pharmaceutical companies are mostly concerned about profits and have little concern whether their customers suffer, live or die. It is time to remove the company's right to fix their own prices. 

© Klaus Ohlenschläger


Eleven diabetes patients have filed a lawsuit in a federal court in Massachusetts accusing three big pharmaceutical companies of inflating the prices of lifesaving drugs by 150 percent and harming patients in the process.

Diabetes sufferers, who need daily doses of insulin to survive, watched as Sanofi, Novo Nordisk and Eli Lilly jacked up the price of insulin from $25 per prescription to as much $300-400 over five years, according to the complaint filed Monday.

Drug manufacturers usually rationalize drug price increases by claiming the high costs of research and development. In this instance, the plaintiffs claim, manufacturers admitted their price hikes were neither related to such costs nor any jump in production expenses.

In other words, it is simple greed! What does this mean for 3rd world countries? Do they get insulin much cheaper, or do they go without, suffer and die?

The suit referred to a February 2016 op-ed written by an endocrinologist in the New York Times, which revealed the price hike had nothing to do with production costs.

The lawsuit cites examples of how the opaque drug-pricing system left many people unable to afford their insulin treatment, which can cost some patients up to $900 a month.

Patients have resorted to injecting themselves with expired insulin or starving themselves to control their blood sugar. In another instance, a patient intentionally slipped into diabetic ketoacidosis – one step short of a diabetic coma – in order to get insulin from hospital emergency rooms.

“People who have to pay out of pocket for insulin are paying enormous prices when they shouldn’t be,” said Steve Berman, a lawyer whose firm represents the patients and is seeking to have it certified as a class action suit, according to the New York Times.

The complaint said the price hikes were the result of “a scheme and enterprise among each Defendant and several bulk drug distributors.”

In the scheme, drug makers set two prices for insulin treatments: a public price and a distributor price. While the lawsuit accuses the benefit managers of being complicit, Berman said the lawsuit focused on the drug makers because “they are playing the game, and they are the ones who publish the list price.”

Plaintiffs contend that “business is booming” for bulk drug distributors, (PBMs), with the three biggest distributors – Express Scripts, CVS Health, and OptumRX – “bringing in more than $200 billion a year in revenue. They also control over 80% of the PBM market, covering 180 million insured people.”

The suit argues these drug distributors, acting as middlemen, negotiate medicine prices with drug manufacturers on behalf of insurers, setting up “tiered formularies for their clients” which insurers then use “to determine how much of their members’ drug costs they will cover.”

Under those tiered formularies, distributors can exclude a more expensive drug, removing it from a formulary presented to health insurers. In turn, the insurance companies refuse to cover the more expensive drug, “giving them (PBMs) enormous control over drug purchasing behavior.”

The suit alleges PBMs also pocket the difference between the benchmark price and the undisclosed real price they secure, which are “wildly inflated.”

Drug companies were quick to declare they were law-abiding and the allegations lacked merit.

“We strongly believe these allegations have no merit, and will defend against these claims,” Sanofi said in a statement.

Lilly said it had followed all laws, adding, “We adhere to the highest ethical standards.”

A spokesman for Novo Nordisk said the company disagreed with the allegations in the suit and would defend itself.

“At Novo Nordisk, we have a longstanding commitment to supporting patients’ access to our medicines,” the company said.

In December, attorneys general in 20 states accused several drugmakers, including Teva Phamaceuticals and Mylan, of price fixing.

Mylan was cited for hiking the prices of the Epipen, a life-saving tool for severe allergy sufferers.

Teva Pharmaceuticals agreed on Monday to a Foreign Corrupt Practices Act related settlement after the Justice Department accused the company of bribing officials in Russia, the Ukraine and Mexico to increase profits for the company’s generic pharmaceutical drug, according to Legal News Online. The company agreed to pay $519 million in penalties and follow a compliance program laid out by the DOJ.

President Donald Trump has pledged to address the matter and said the industry was “getting away with murder.”

“I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market,” Trump said in a meeting with pharmaceutical executives on Tuesday. “That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars, big time.”

Trump also urged big pharmaceutical companies to move back to the US. 

“And I want you to manufacture in the United States. We're going to be lowering taxes, we're going to be getting rid of regulations that are unnecessary,” he said.

Thursday, January 12, 2017

Big Pharma Taking It on the Chin for Price Gouging

Big pharma CEOs are like sharks in a feeding frenzy with their extreme price-gouging.
Mylan's troubles might just take some of the enthusiasm out of their gorging.

EpiPen maker set to lose $800mn in 2017 as CVS & major insurer turn to rivals

© Jim Bourg / Reuters

Mylan, the controversial EpiPen maker, could lose much of the gains it made by hiking up the price of the lifesaving epinephrine auto-injector. Pharmacy chain CVS and insurance company Cigna have both announced they will turn toward the company’s rivals.

EpiPen administers a quick dose of epinephrine to counter a severe, life-threatening allergic reaction known as anaphylaxis. With competition to EpiPen from name-brand and generic options set to hit the market in the first half of 2017, CVS and Cigna both announced policy changes that will help consumers – and hurt Mylan. At least five state Medicaid programs are also pushing alternative injectors.

CVS, the nation’s second-largest pharmacy, announced Thursday that it will offer Adrenaclick, the authorized generic version of EpiPen made by Impax, at a cash price of $110 for a two-pack, about a sixth of the cost of Mylan’s name-brand injector.

“We recognized the urgent need for a less-expensive epinephrine auto-injector, and are proud to offer a low-cost option at all CVS Pharmacy locations,” the company said in a statement, adding that it will be offering Adrenaclick at “the lowest cash price in the market.”

The decision was made, in part, because nearly 150,000 people signed a petition asking for a lower-priced option, and “millions more were active in social media searching for a solution,” said Helena Foulkes, president of CVS Pharmacy.

Meanwhile, Cigna ‒ which Forbes ranked as the fourth-largest US insurance company ‒ announced that, effective January 7, it would no longer cover EpiPen. Instead, it will only cover Adrenaclick or Mylan’s generic version that launched in December for half the price.

"The generic version, available now in pharmacies, has the same drug formulation and device functionality as the branded medication, but at a substantial cost savings," Cigna spokeswoman Karen Eldred said in a statement.

Mylan anticipated the coverage change, the company told CNNMoney. The announcement, combined with President-elect Donald Trump’s remarks that drug companies are “getting away with murder” with their pricing during his press conference on Wednesday, sent Mylan’s stocks down 4.3 percent.

Medicaid programs are also changing their coverage of EpiPens, reported STAT, the Boston Globe’s health publication. Three states require Medicaid recipients to get prior approval for the brand-name injectors, while beneficiaries must obtain prior authorization in at least another five states.

Mylan CEO Heather Bresch told attendees of the JP Morgan Healthcare Conference on Wednesday that the pharmaceutical industry must revisit their pricing models and the interactions between the entire supply chain, The Street reported.

"I truly understand the outrage when you have no idea what something's going to cost," Bresch told CNBC in an interview, adding that she has now learned to look at things through a “patient lens.”

Not knowing what the pens cost is not the problem; knowing that they cost waaay too much is the problem. Mylan wanted to make a killing on Epipens, but apparently had no regard that they were in danger of killing their own customers by putting the pens out of reach for some.

"As I step back and try to look at everything... through this patient lens, it gives a different perspective, and we're continue to apply those learnings," Bresch said. "Most importantly, if EpiPen started this conversation, I will try at least to do everything in my power to see if through, and seeing it through means changing the way that pharmaceutical pricing, and... that patient lens needs to change dramatically."

Amazing! Now that Mylan is losing stock value and losing customers and losing hundreds of millions of dollars - Bresh has an epiphany. I would have been more convinced if she was actually concerned for the patients instead of the stock-holders.

Even before the CVS announcement, Bernstein’s Ronny Gal, a leading biopharma analyst, predicted that Mylan would lose at least $800 million through 2018 because of increased competition, FiercePharma reported. Along with Adrenaclick, which is already on the market, Kaleo’s Auvi-Q is set to launch in the first half of 2017, while Adamis has refiled another potential rival. On top of that, “at least one large distributor is apparently not carrying” Mylan’s generic version, Gal wrote.

Mylan posted $119 million in losses during the third quarter of 2016 after it set aside over $465 million in anticipation of a settlement with the federal government over Medicaid rebates for EpiPens.

In 2007, the West Virginia-based Mylan Pharmaceuticals bought EpiPen from the Merck Group. Selling for around $100 in 2008, the injector now retails for around $600. Since controversy about the company’s potential price-gouging erupted in August, Mylan began offering a discount on its name-brand device, as well as the generic version. The company is also under scrutiny for its political ties, as Bresch’s father is Senator Joe Manchin (D-West Virginia).