epi pen pricing rising

[Deleted]

Aug 26, 2016 10:40:16 GMT -5 sophie said:

Aug 24, 2016 17:20:49 GMT -5 liane said:

I think that's quite a stretch as to poor physician prescribing.

I didn't mean to insinuate that it was the main cause or even the biggest. Whenever I have asked older physicians with decades of experience why they don't prescribe Afrezza, they reference Thalidomide, Diethylstilbestrol, Isotretinoin, etc as drugs that were proven safe but decades later were related to teratogenic effects. I'm sure the argument has been raised here before, so it's probably a waste of time to address it again, nor is it my intent to do so, but I wish there was a way to gauge the newest roadblocks that Afrezza is facing. From my very limited experience with older docs, they tend to let others prescribe new medications and then give it a few years before they start prescribing it. They don't want lung cancer on their conscience. 

What about poorly managed diabetes on their conscience by staying with the status quo? Their response was that the biggest problem with the status quo is adherence. There are outliers that just have a really hard time controlling their HbA1c, but for the most part, people find relief when they take their medication properly. Better the devil they know than the devil they don't, they say. Just passing along info. Might not be worth anything

I didn't mean to insinuate that it was the main cause or even the biggest.

— But you did mean to insinuate it regardless. Is this Psych 101? I think I will go through all your posts and pretty much reply with the same shit each time.

Whenever I have asked older physicians with decades of experience why they don't prescribe Afrezza, they reference Thalidomide, Diethylstilbestrol, Isotretinoin, etc as drugs that were proven safe but decades later were related to teratogenic effects.

— Yes, we know very well you like to reference the doctors you have spoken with in most of your posts.

I'm sure the argument has been raised here before, so it's probably a waste of time to address it again,

— It is.

From my very limited experience with older docs, they tend to let others prescribe new medications and then give it a few years before they start prescribing it. They don't want lung cancer on their conscience.

— Interesting. I think you have said this same thing before and I am only on your first handful of posts. So, these doctors want (or in your words “let”) other doctors prescribe drugs before they do because they are either: not concerned with keeping up with current literature or old and set in their ways, so they would rather other doctors (I am guessing those that keep up with current literature and innovation) to be the firsts and take all the risks, wait awhile for no “cancer, etc” and then consider prescribing. There is a fine line between being cautious and being ridiculously closed minded. There are some drs on this forum (Ripley's believe it or not) that advocate Afrezza so much and are inspired by the foundational values of MannKind that they spend their downtime on this forum to help educated people like me. I have learned a lot from one in particular. 

What about poorly managed diabetes on their conscience by staying with the status quo? Their response was that the biggest problem with the status quo is adherence.

— That’s sad.

There are outliers that just have a really hard time controlling their HbA1c, but for the most part, people find relief when they take their medication properly. Better the devil they know than the devil they don't, they say. Just passing along info. Might not be worth anything

— Becoming is superior to being

[madog365]

Aug 24, 2016 10:04:52 GMT -5 madog365 said:

That seems to be a popular dig on an inhaled epinephrine solution. Here's what CMO Urbanski said to counter:

"For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option."

The story for the media here is not about episphere. The story is about alternatives to the price gouging that Mylan is doing with the epipen. One of the alternatives is being developed by a company with a CMO who comes from Mylan and wants to see patients have more choices. I have seen this same type of story multiple times with different companies. 

Like I said there is a story here for the media and LA times is the first big publication to pick it up. More will follow. www.latimes.com/business/la-fi-mannkind-epipen-20160901-snap-story.html

Biz journals published an article today too. www.bizjournals.com/losangeles/news/2016/09/06/mannkind-developing-alternative-to-epipen-by-mylan.html

[prvs]

Sept 6, 2016 7:36:24 GMT -5 madog365 said:

Aug 24, 2016 10:04:52 GMT -5 madog365 said:

That seems to be a popular dig on an inhaled epinephrine solution. Here's what CMO Urbanski said to counter:

"For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option."

The story for the media here is not about episphere. The story is about alternatives to the price gouging that Mylan is doing with the epipen. One of the alternatives is being developed by a company with a CMO who comes from Mylan and wants to see patients have more choices. I have seen this same type of story multiple times with different companies. 

Like I said there is a story here for the media and LA times is the first big publication to pick it up. More will follow. www.latimes.com/business/la-fi-mannkind-epipen-20160901-snap-story.html

The story seems like a soft bash aimed at MNKD's ability to survive as a going concern. Yes it talks about the epi development, but there are far more references to MNKD's difficulties. Even the epi story has one comment meant to sow doubt, pointing out that there are far fewer incidences of severe allergic reactions than diabetics. Never mind that schools and other public organizations are required to keep a stock of epinephrine present in case of emergencies. MNKD is just as able to take advantage of those laws as Mylan.

[brotherm1]

Consumer Reports calls for federal investigation in epi pen prices

www.pennlive.com/news/2016/09/mylan_heather_breach.html#incart_river_mobile_home

[lakers]

www.npr.org/sections/health-shots/2016/09/07/492964464/epipen-s-dominance-driven-by-competitors-stumbles-and-tragic-deaths

EpiPen's Dominance Driven By Competitors' Stumbles And Tragic Deaths


Mylan lobbied state legislatures for laws that require schools to stock EpiPens.

Rich Pedroncelli/AP
Thirteen year-old Natalie Giorgi probably didn't know the name of the company that makes EpiPen. But the Sacramento, Calif., girl's death from a peanut-induced allergy attack in 2013 inspired passage of the California law that made the Mylan product a staple at every school in the state.

It was Giorgi's story, not industry lobbying, that state Senate Minority Leader Bob Huff says inspired him to usher through the requirement that public schools stock the injectors. He says he was also influenced by one of his staffers, who has a child with life-threatening allergies.

"It was just sort of organic," Huff says about carrying the bill. "It seemed like we ought to do better to protect these kids."

Mylan, the company that raked in $1 billion last year for the EpiPen, takes credit for passing legislation in 48 states to ensure schools have them. But its political maneuvering is only one reason the company has, in its own words, become "the number one dispensed epinephrine autoinjector."

High-profile deaths in several states, particularly among school-age children, have helped fuel demand for consumer-dispensed epinephrine. At the same time, no other company has been able to effectively compete with Mylan's drug-delivery device. Patent rules, and competitors' manufacturing foibles, also have helped the company reign over the consumer epinephrine market.

When someone with a severe allergy goes into anaphylactic shock and can't breathe, "seconds count," Mylan CEO Heather Bresch said in a recent CNBC interview about the EpiPen, which now has a sticker price of $608 per two-pack. That's why, she said, "they need to be everywhere."

Bresch said lobbying is just one way the company has spent hundreds of millions "developing" the EpiPen since it acquired the patent in 2007.

Indeed, Mylan's presence in statehouses across the country has grown exponentially. The company added lobbyists in 36 states between 2010 and 2014, according to the Center for Public Integrity, outpacing every other U.S. company. And it spent more than $1.3 million lobbying in 16 states since 2012, according to the National Institute on Money in State Politics (Those are not the exact states that passed the school requirements, however.)

Just in the past several years, 10 states have passed laws requiring epinephrine in schools. Another 38 states have passed laws permitting them, according to the Food Allergy Research and Education advocacy group (FARE).

Nebraska appears to have been the first state with a school epinephrine requirement. High asthma rates in the state, as well as a couple of school-based child fatalities due to the respiratory illness, created an emergency response protocol that became law in 2006.

In California's case, Huff said he had never even heard of Mylan until the recent uproar over the EpiPen price increases. But the company is listed as a supporter of his bill, and FARE, which is partially funded by Mylan, was an official sponsor.


Heather Bresch, CEO of Mylan, says that EpiPens "need to be everywhere."

Michael Nagle/Bloomberg via Getty Images
FARE asserts that Mylan's money goes toward its education work, not its advocacy. It didn't disclose exactly how much of its funding comes from Mylan, but says funding from corporate partners amounts to less than 10 percent of its budget.

"In some states, momentum has been garnered by a fatality," says Jennifer Jobrack, senior national director of Advocacy at FARE, who says local lawmakers and activists call them in for help to craft policy.

"Legislators are looking for something they know will have a positive impact," Jobrack says.

Virginia's law, passed in 2012, came after 7-year-old Amarria Johnson died at a Chesterfield County school from a reaction to peanuts. A Texas teenager's death from fire ant bites led to that state's law permitting epinephrine in schools.

The push to require EpiPens got a high-level boost in 2013, as President Obama disclosed his daughter Malia's peanut allergy when he signed off on the federal law, which gives financial incentives to states that require the medication in schools. Co-author of the federal legislation, Rep. Steny Hoyer, D-Md., cited his 11-year-old granddaughter's peanut allergy when the EpiPen law passed the House. FARE and Mylan supported that as well.

With the help of these laws, Mylan's EpiPens are at 63,000 schools nationwide. The company also has distributed 500,000 of them for free through EpiPens4Schools.

The school giveaway program brings visibility and credibility to the EpiPen brand, building a consumer base beyond schools.

"It's kind of like the first hit's for free," says Nicholson Price, an assistant professor at the University of Michigan Law School. "You want to start people off with your product, and getting these products in at schools is a great way."

New York State's attorney general announced Tuesday it will investigate Mylan to determine whether it introduced "anticompetitive terms" into school contracts. STAT recently reported that participants of Mylan's EpiPen4schools program had to agree not to purchase EpiPen-like products for 12 months in order to get a discount.

Mylan also has a virtual monopoly on epinephrine autoinjectors simply because there are almost no other products like it, either branded or generic.

Mylan has a patent on the drug-device combo until 2025. If companies want to make a generic EpiPen, they have to sue Mylan in court to try to invalidate its exclusive rights on the injector, according to Jacob Sherkow, an associate professor at New York Law School.

Trying to create an EpiPen generic is an expensive and risky endeavor, says Sherkow. Even if a company is successful in court, manufacturing the device, which must be identical to the EpiPen, is also challenging.

Copying a chemical compound, like ibuprofen, is easier than reproducing a piece of hardware like the iPhone, says Sherkow. Patents are publicly available, and can act as an "instruction manual," but a lot can go wrong in the actual production of EpiPen syringes.

"The drug inside can't degrade or leak; they need to withstand shipping; they need to work at a wide range of temperatures; they need to be handled safely — to not accidentally inject the user with the needle," says Sherkow.

Teva Pharmaceuticals took on these challenges. It was granted FDA approval to make a generic EpiPen, but was blocked earlier this year after Mylan successfully argued that Teva's device was not identical, and was therefore unsafe.

Other companies have tried to make their own version of the epinephrine injector without attempting to copy the EpiPen. But their efforts haven't been very successful either.

Amedra pharmaceuticals makes Adrenaclick, which has an injector with two caps (EpiPen has only one.) But Amedra has limited manufacturing capabilities for the device and a barely visible market share, according to Price.

Auvi-Q, made by Sanofi, was taken off the market in October 2015 after concerns the device wasn't dispensing the proper dose of epinephrine.

More epinephrine products will be on the market in 2017. Teva's generic version of the EpiPen is expected to be reintroduced then, and Mylan will put out its own generic in the coming weeks.

It's too early to tell if more consumer choices will bring down EpiPen's price.

This story is part of a collaboration between NPR and Kaiser Health News. Former Kaiser Health News intern Zhai Yun Tan contributed to this report.

[Mnkd might be forced to partner for EpiHale or sell it outright to Teva, RLS, Sanofi to raise cash for Afrezza. If Mylan were smart, they should preempt by acquiring EpiHale. Together w/ EpiPen they would monopolize the Epi mkt for decades to come. It would be ironic that Mnkd may make more money from EpiHale than Afrezza. Lung risk is not an issue as EpiHale is an insurance but seldom used. Clinical trial should be short as Ray said. Kudos to Ray for single-handedly persuading the Boards to invest and expedite it when money is so tight.

Depending on how much or how desperate the BoD wants to right the financials, Mnkd could fetch between $1 and $2 per share from the outright sale of EpiHale in the IND stage. That's $470.5M to $951M. Incidentally $925M is the SNY's milestone bonus for Afrezza. What do you think is fair value for EpiHale at IND stage?

The proceed can be used to unlock SH value by commercializing Afrezza with sufficient time and funding, developing two other inhalable drugs, one that treats nausea in patients undergoing chemotherapy and another to treat a cardiovascular disease called pulmonary arterial hypertension, another large market, and more drugs. Mnkd may have to sacrifice EpiHale for the good of the co. EpiHale might be an Ace in the hole.]

[mnholdem]

New York Attorney General Launches AntiTrust Probe Into EpiPen Maker’s School Contracts

Source: khn.org/morning-breakout/new-york-ag-launches-antitrust-probe-into-epipen-makers-school-contracts/

MannKind is mentioned near the end of this article with a link to the Los Angeles Times article.

[lakers]

As of June 30, the company had $63.7 million in cash, enough to stay afloat into the first quarter of next year, Chief Executive Matthew Pfeffer told analysts last month. That’s when MannKind expects to file an application with the FDA and potentially begin clinical trials of its inhalable epinephrine.

A rare stumble for biotech pioneer Alfred Mann
A rare stumble for biotech pioneer Alfred Mann
Financially, the question for MannKind is whether sales of Afrezza can pick up enough over the rest of this year to offset the potential cost of clinical trials for the new product. Pfeffer said that question should be answered well before the company would hope to start new trials.

“I think we’ll know the future of Afrezza before we get to that stage,” he said.

Another option might be for the company to find a strategic partner — a prospect made more likely by the intense media coverage of Mylan’s series of steep increases in the price of the EpiPen, from about $50 per shot in 2007 to more than $300 today.

“There’s a lot of interest in [EpiPen] alternatives,” he said. “It’s not inconceivable that we could get a partner to help us with the funding of that trial. That’s not our current game plan, but it’s something we could consider.”

MannKind also expects that the clinical trials would take much less time than those for Afrezza, which needed to prove that long-term use did not decrease lung function. That was a problem with an earlier inhalable insulin developed by Pfizer that was pulled off the market.

When the FDA approved Afrezza, it required a warning that it should not be used by people with asthma and other lung conditions. But diabetics may take insulin several times a day, while life-threatening allergic reactions are generally rare events.

“It's hopefully something you never have to use, which makes that less of an issue," said Pfeffer, who hopes clinical trials could begin and end next year, with the product hitting the market by late 2018.

MannKind is developing two other inhalable drugs, one that treats nausea in patients undergoing chemotherapy and another to treat a cardiovascular disease called pulmonary arterial hypertension, but epinephrine is the priority.

The company started work on epinephrine about a year ago, long before the recent spate of news stories about the EpiPen price increases. While it’s not clear how much a dose of inhalable insulin might cost, Pfeffer said the product would almost certainly be cheaper than EpiPen.

He noted a study that showed it’s difficult to get enough epinephrine into the body by inhaling it — though that study looked at older epinephrine inhalers used to control asthma attacks. Pfeffer said MannKind’s product would carry a stronger dose of epinephrine aimed specifically at stopping anaphylaxis.

Pistiner also said that respiratory symptoms, such as shortness of breath, often accompany severe allergic reactions. If someone can’t breathe, an inhaler doesn’t do much good.

“Most kids who experience anaphylaxis have respiratory [symptoms],” he said. “That’s a very real challenge.”

Pfeffer said MannKind is aware of that issue, but that since respiratory symptoms typically don’t start until several minutes into an anaphylactic attack, there would be time to use an inhaler before symptoms become life-threatening.

“Most people want to be pretty sure before they stab themselves in the leg with a big needle,” he said. “That’s often why people wait too long. We thought we could put epinephrine into a form that’s not as intimidating to people so that people would use it sooner in the process with less hesitation.”
www.latimes.com/business/la-fi-mannkind-epipen-20160901-snap-story.html

[lakers]

Teva to meet with FDA on problems with generic EpiPen
September 10, 2016 12:00 AM
By Patricia Sabatini / Pittsburgh Post-Gazette

Teva Pharmaceutical Industries indicated Friday that U.S. regulators may be interested in speeding up another review of the company’s application to sell a generic version of Mylan’s EpiPen.

After the Food and Drug Administration rejected Teva’s initial application for the emergency allergy treatment in February, Teva requested a meeting with the agency for guidance on how to proceed, said Sigurdur Olafsson, head of global generic medicines for Teva.

“We didn’t get a response,” he said during a presentation to New York analysts on Friday.

But in the wake of a firestorm in recent weeks over the skyrocketing cost of the EpiPen, the FDA has responded, he said.

“The FDA has come back to us and we will have a meeting with them very, very quickly,” Mr. Olafsson said. “I think everybody understands that there is an opportunity.”

The EpiPen auto-injector, which has limited competition, has risen in price some 500 percent in recent years, triggering a backlash from users, lawmakers and consumer and medical groups who accuse Mylan of price-gouging.

With a near monopoly on the market for delivering a pre-filled dose of potentially life-saving epinephrine, Mylan steadily raised the price of the EpiPen from around $100 a pair when it acquired the product in 2007 to more than $600. The sting for many families who must keep the medication on-hand is compounded by the device’s one-year shelf-life.

Mylan has responded to the recent uproar by expanding its discount assistance program and promising to start selling a half-price generic version of the EpiPen that is identical to the brand name product.

Teva’s Mr. Olafsson didn’t say when Israel-based Teva, the world’s biggest generic drug maker, might re-submit its marketing application for its generic auto-injector. But he reiterated his forecast for bringing the lower-cost alternative to the EpiPen to market late next year or early in 2018.
[This coincides w/ Mnkd's time frame. Teva could acquire EpiHale as another delivering method as an insurance for second time failure.]

Meanwhile, lawmakers continue to probe Mylan’s pricing practices on several fronts.

Most recently, the U.S. Senate’s permanent subcommittee on investigations this week announced a preliminary inquiry into the matter.

Also on Friday, Sen. Chuck Grassley, R-Iowa, said he wasn’t satisfied with Mylan’s response to a letter he sent to the company Aug. 22 with questions about EpiPen pricing.

Mylan’s seven-page reply, which Mr. Grassley released publicly, “doesn’t provide the full picture that I requested, and it doesn’t answer all of my questions,” he said in a statement. “It’s an incomplete response and wouldn’t satisfy my constituents.”

www.post-gazette.com/business/healthcare-business/2016/09/10/Teva-to-meet-with-FDA-on-problems-with-generic-EpiPen/stories/201609100058

But without strong competitors, Mylan's EpiPen still holds an estimated 94 percent market share in the United States.

Teva's application for a copycat version has been in question since February, when the Food and Drug Administration flagged "major deficiencies" in the Israeli drugmaker's device.

"We requested a meeting with the FDA," Sigurdur Olafsson, Teva's head of global generic medicines, said in a webcast overview of the company's generics medicines business. He said Teva did not get a response, but after "the media attention in the last two weeks, the FDA has come back to us and we will have a meeting very, very quickly."

Given the recent "political noise on EpiPen," the FDA may now be more inclined to approve Teva's generic version, Evercore ISI analyst Umer Raffat said in a webcast message to clients. [EpiHale is guaranteed to be expedited by FDA.]

Analysts had expected Teva to alter its autoinjector's design to remedy a dosing issue cited by the FDA, but Olaffson said the company was not planning any modifications to its device at this point.
mobile.reuters.com/article/idUSKCN11F25K

[lakers]

BUSINESS SEP 6 2016, 2:40 PM ET
Industry Insiders Estimate EpiPen Costs No More Than $30
by BEN POPKEN
SHARE
advertisement

Mylan says middlemen and suppliers have forced them to jack-up the prices on EpiPens by hundreds of dollars, but two industry insiders say the company pays no more than $30 per device.

Meanwhile, some patients are forced to pay a little over $600 out of pocket for a two-pack of the lifesaving medication. Mylan sparked outrage last month when it was revealed the company had hiked up costs for the drug by over 400 percent since it acquired the brand. At the same time, CEO Heather Bresch's salary soared over 600 percent to nearly $19 million in 2015.

SOURCES ESTIMATE MYLAN PAYS NO MORE THAN $30 PER EPIPEN
A third expert pegs Mylan's cost even lower, at about $20. Kevin Deane, head of medical technologies for PA Consulting Group, a global technology and design firm that sold a drug delivery technology company to Pfizer in 2004, told NBC News that the base components for each EpiPen, including the plastic cap, tube, and needle, might cost between $2 to $4 to purchase. Pharmacists contacted by NBC estimate that the epinephrine inside costs less than $1.

Additionally, based on industry norms, Mylan would have to pay a licensing fee to companies involved in research and development of the device. This amount might generally multiply the price that Mylan pays Pfizer's wholly owned subsidiary Meridian Medical Technologies, which manufactures the epinephrine auto-injector between two and five times, said Deane.[Cricket licensing could be a cash cow.]

advertisement

"What they've been doing is they've been making little updates to it, refinements to make it work better," said Deane. "But it essentially is the same core technology that was there for many years," he said.

In a call with NBC News, Pfizer spokeswoman Rachel Hooper declined to comment on or confirm the pricing arrangement, citing confidential contract agreements, a position echoed by Mylan.

Image: US-HEALTH-DRUGS-CONSUMER-POLITICS-MYLAN
A boy holds an Epipen that he uses to counteract allergic reactions. LUCAS TRIEB / AFP - Getty Images
"We do not comment on the terms of third-party contracts," said Mylan company spokeswoman Julie Knell.

The System

advertisement

In a recent CNBC interview, embattled Mylan CEO Heather Bresch tried to shift blame for EpiPen's spiraling costs onto the "four to five hands" that touch the product between Mylan and the consumer.

But under standard industry practices, besides the portion to your insurer, most of those middlemen only take a single digit percentage.

And while the supply chain particulars or even the premium prices are not themselves unusual in the context of the U.S. healthcare system, Adam Fein, president of Pembroke Consulting, a healthcare firm that advises drug makers on commercial issues, said Mylan did do two things that were different.

ESTIMATED GROSS PROFIT PER $600 EPIPEN 2-PACK: MYLAN $274. INSURER $249. PBM $40. PHARMACIST $27. WHOLESALER $10. SOURCE: PEMBROKE CONSULTING
Mylan ended up with a monopoly because of the failure of the government and competition to put viable alternatives on the market, he said, and they "aggressively increased prices last year."

In 2015 EpiPen's price rose 30 percent — more than double the average branded drug price increase of 12.4 percent, according to a recent IMS Institute report and an analysis by Connecture, a health insurance technology and data analytics company.

This profit-taking led to impressive margins for Mylan, which posted $1 billion in sales for the past two years, following years of awareness campaigns and legislation that increased the number of patients being prescribed the device and schools stocking it.

A model provided to NBC News by Pembroke Consulting broke down the gross profit to each of those intermediaries, based on industry norms and using the costs stated by Bresch. For illustration purposes, it assumes a list price of $600 per two-pack.

Under this model, your insurer keeps $249. The pharmacy benefits manager that negotiates between Mylan and your insurer gets $40. Your local pharmacist keeps $27. The wholesaler gets $10.

"Many people will only pay a copayment of say $50," said Fein. "The insurer would pick up the remaining cost of more than $300. But if the patient has a high deductible plan, then the insurer could pocket the $300 rebate and not share it with the patient."

advertisement

Bresch stated that Mylan then gets $274 in the transaction. From there, it must pay for "manufacturing, distribution, regulatory, patient assistance program, My EpiPen Savings program, disease awareness initiatives and product donations," according to a slide displayed during Bresch's CNBC interview and distributed in a press release afterward.

"Mylan works with pharmacy benefit managers (PBMs) and insurers to provide coverage and access to our products; however, those entities, along with the payors, make the decision regarding choice and pricing of products," said Mylan's Knell. "As aligned with standard industry practice, we pay rebates to PBMs and insurers to allow for patient access to EpiPen at the lowest possible cost."

Mylan didn't respond to an NBC News request to itemize those costs, but a Mylan spokesperson told NBC that "all of those costs would clearly make the $274 number significantly lower."

"WHETHER YOU LIKE IT OR NOT, IT'S THE WAY THE WORLD WORKS."
"Mylan in a very inartful way tried to deflect blame by pointing to the system," said Adam Fein, president of Pembroke Consulting. "Whether you like it or not, it's the way the world works."

One lawmaker who has been vocal on the EpiPen price increase took a dim view of the information about Mylan's costs.

"There's no reason an EpiPen, which costs Mylan no more than $30 to make, should cost families more than $600," said Vermont Senator Bernie Sanders in a statement emailed to NBC News. "The only explanation for Mylan's outrageous price increase is that the company values profits more than the lives of millions of Americans."

PlayMylan CEO Defends Price of EpiPen, Insists Company Isn't Price-Gouging Facebook Twitter Google PlusEmbed
Mylan CEO Defends Price of EpiPen, Insists Company Isn't Price-Gouging 2:40
Competition Blocked

Pharmaceutical companies will sometimes pay PBMs steeper discounts in order to shut out their competition, said Fein. And, in the past, two of the biggest PBM companies have excluded EpiPen competitors from coverage: In 2014, Express Scripts excluded AuviQ (PDF), and in 2015 Caremark didn't cover Adrenaclick (PDF). This meant that if your insurance company was their customer, you would not be able to get the EpiPen alternative without paying full retail price.

"In 2014 and 2015, we leveraged the competition between EpiPen and Auvi-Q to earn additional discounts for our clients," said Express Scripts spokesman Brian Henry, saving their customers $750 million and $1 billion in those two years, he said. Caremark did not respond to a request for comment.

No Quick Fix

Amid a backlash so widespread that it's launched its own parody video game, lawmakers have called for price rollbacks and investigations. In late August, Democratic presidential candidate Hillary Clinton announced a plan to track prescription drug price hikes, fine companies whose increases weren't justified, and make it easier for competition to bring down prices. Mylan's first round of answers to Congress were due September 5th.

PlayEpiPen Prices Rocket Along with Drugmaker Executive's Pay Facebook Twitter Google PlusEmbed
EpiPen Prices Rocket Along with Drugmaker Executive's Pay 1:11
In response to the upset, Mylan is giving insured patients a $300 coupon, is launching its own cheaper generic EpiPen version, and increased the number of patients eligible for financial assistance.

Even before the crisis emerged, Mylan said it was taking steps to increase EpiPen access and affordability. Mylan said that it has given away more than 700,000 free EpiPens to schools since 2012. When its coupon program for insured customers was $100, it said nearly 80 percent of those customers were getting their auto-injectors for $0.

"...TAKING IMMEDIATE ACTION TO HELP ENSURE THAT EVERYONE WHO NEEDS AN EPIPEN AUTO-INJECTOR GETS ONE."
"We have been a long-term, committed partner to the allergy community and are taking immediate action to help ensure that everyone who needs an EpiPen Auto-Injector gets one," said Bresch in a statement. "We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter."

On Tuesday that schools program became the source of its own new controversy, with New York State state Attorney General Eric Schneiderman launching a probe into whether the company had violated antitrust laws by requiring participating schools to agree to not buy any products from Mylan competitors for 12 months. Senators Blumenthal and Klobuchar also called for a new FTC investigation into the same.

"There are no purchase requirements for participation in the program, nor have there ever been to receive free EpiPen Auto-Injectors," Mylan spokeswoman Nina Devlin wrote NBC News in a statement. "Previously, schools who wished to purchase EpiPen Auto-Injectors beyond those they were eligible to receive free under the program could elect to do so at a certain discount level with a limited purchase restriction, but such restriction no longer remains."

Ben Popken BEN POPKEN TWITTERFACEBOOKGOOGLE PLUSEMAIL
TOPICS CONSUMER, INVESTIGATIONS
FIRST PUBLISHED SEP 6 2016, 2:35 PM ET
www.nbcnews.com/business/consumer/industry-insiders-estimate-epipen-costs-no-more-30-n642091

[lakers]

EpiPens, which counteract potentially fatal anaphylaxis, contain the drug epinephrine.
And just $1 or so worth of epinephrine is used in the auto-injection device. That device itself is believed to cost just several more dollars to make.
People who have created workarounds for EpiPens have spent just $15 or so on the syringes.
That gap between cost and price have delivered some very nice revenue for Mylan, where EpiPen is a leading product. The company reported $9.45 billion in revenue for 2015 — up from $7.7 billion the year before — and $1.46 billion in income. A reported $1 billion in revenue comes from EpiPen, up from the $200 million in revenue at the time Mylan first acquired the devices.

While Mylan has aggressively sought to expand the market for EpiPens by getting them placed in schools and trying to get them mandated for all airlines flying in the United States, the company didn't have to spend a nickel actually creating the product.
The EpiPen was acquired by Mylan in 2007, along with other products from Merck.
The device itself had been around decades before that. EpiPens were invented at a Maryland company called Survival Technology in the 1970s by engineers who included a man named Sheldon Kaplan.
Originally called the ComboPen, the devices were bought by the U.S. Department of Defense for use in delivering medicine that would counteract the effects of nerve agents. Kaplan later tweaked the ComboPen to deliver epinephrine to counter the effects of anaphylaxis.
www.cnbc.com/2016/08/25/epipens-cost-just-several-dollars-to-make-customers-pay-more-than-600-dollars-for-them.html

[lakers]

The Insurance Rip-Off At The Heart Of The EpiPen Scandal
www.forbes.com/sites/matthewherper/2016/08/30/the-consumer-rip-off-at-the-heart-of-the-epipen-scandal/#71aa41c92a87