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Beware the ‘Pharma Bros’, notorious for sharply raising drug prices

Pharma Bros travel the US, looking for cracks in the system to jack up fees

- JARED S HOPKINS ANDREW MARTIN

F or

at least the past three years, Todd Smith and Benjamin Bove have crisscross­ed the US, offering a sure-fire fix for struggling pharmaceut­ical companies. And wherever they go, the price of prescripti­on drugs tend to skyrocket.

While Martin Shkreli, nicknamed Pharma Bro, became notorious for sharply — and unapologet­ically — increasing drug prices, Smith and Bove have quietly plied their trade helping to kick-start drug company sales.

The Chicago-based duo has played an important role at no fewer than four companies that have raised prices on life-saving and other drugs by as much as 4,116%.

Their strategy is simple and, they say, good for patients: thwart efforts by health plans to block access to drugs — and serve up what Smith calls their “special sauce” to get those drugs into the hands of customers who need them.

The main ingredient­s include co-pays that are often zero, even for pricey drugs. Smith, 48, and Bove, 40, also offer the use of so-called speciality pharmacies — one of which they previously owned — to make it hassle-free for doctors and more affordable for patients. Yet critics point out that, over time, everyone might end up paying the price in the form of higher premiums.

“It’s totally a wrong way to frame the issue to say it’s free to the patient,” said Stephen Schondelme­yer, a professor of pharmaceut­ical economics at the University of Minnesota. “It’s ripping people off.”

If nothing else, Smith and Bove’s business strategy illustrate­s a drug-pricing ecosystem that many agree is deeply flawed. President Donald Trump has accused drug companies of “getting away with murder,” and his Health and Human Services Secretary, Alex Azar, has vowed to bring drug prices down. Yet the system is averse to change because so many of its key players continue to profit from its complexity and lack of transparen­cy. Patients, meanwhile, are faced with fewer choices and higher deductible­s and insurance premiums.

“These sophistica­ted traps are designed to pay off certain members of the supply chain in a way that exploits the employer, the insurance company and the consumer,” said Michael Rea, chief executive of Rx Savings Solutions, which has an app that allows patients to find lower drug costs.

Bloomberg News interviewe­d 19 former employees from seven companies where Smith or Bove have worked or consulted. They spoke about the sales strategies and their interactio­ns with the duo over the course of several years. All requested anonymity, either to protect profession­al relationsh­ips or because they signed nondisclos­ure agreements.

Both Smith and Bove declined requests for interviews.

Their “patient-access-centred model” is a “creative approach to ensure physicians and patients are not encumbered by the current broken system,’’ said Rand Walton, a spokesman for Novum Pharma LLC, where Smith serves as chief executive and Bove is an officer, records show.

Smith and Bove weren’t in positions to make pricing decisions at some of the companies, Walton said. The majority of the drugs that Smith and Bove have dealt with haven’t incurred significan­t price increases, he said. Walton declined to comment on Smith’s and Bove’s work as consultant­s.

A 2015 printed sales pitch, reviewed by Bloomberg News, was prepared for Kaleo Inc, a company that sells auto-injectors for severe allergic reactions and opioid overdoses. The document says Smith and Bove’s business model includes “proprietar­y” tools to increase the “fill rate” for prescripti­ons.

While many details remain murky, one former colleague from another company who is familiar with the business strategy said it involves using data analytics to identify gaps in the insurance system that might allow drugs to be covered, either through generous health plans or through insurers that tend to let price hikes on lesser-used drugs fall under the radar and get approved. They also target doctors likely to prescribe the drugs, former employees said.

“We absolutely do not and have never identified or targeted specific insurance plans,” said Walton.

Even so, once Smith and Bove arrived at a company, huge price increases often followed.

At Novum Pharma, the wholesale price of a tube of the skin gel Alcortin A jumped to $7,968 in 2016 from $189 in 2015, according to Connecture Inc, which tracks drug prices. That’s a 4,116% increase.

At Iroko Pharmaceut­icals LLC, the cost of an arthritis drug called Indocin nearly tripled in January, to $2,550 for 30 suppositor­ies.

At Kaleo, the wholesale price of a twopack of a naloxone auto injector called Evzio increased to $4,100 in 2016 from $575 when it was introduced two years earlier at a lower dose.

At Horizon Pharma Plc, the price of a bottle of Duexis, an arthritis medicine, rose to $1,030 in 2014, when Smith left the company, from $140 in 2011.

Walton, speaking on Novum’s behalf, said the wholesale price has no bearing on the cost of its products because it doesn’t consider factors such as patient assistance and rebates. He said the company has improved patient access to its products, resulting in “very low profits”, about $18 per prescripti­on.

Kaleo said Smith and Bove no longer work with the company, and it defended its pricing strategy. “In our view, the most important price is the price to the patient,” Kaleo said in a statement. “Since launching Kaleo’s enhanced patient-access programme in 2016, more Americans can obtain naloxone for $0 today than ever before.”

Iroko didn’t return messages seeking comment.

Horizon officials declined to be interviewe­d.

Unlike many other countries, the US doesn’t directly regulate the price of drugs, so companies can charge whatever the market will bear. Nonetheles­s, huge price hikes in recent years caused outrage among patients and lawmakers.

Shkreli — the founder of Turing Pharmaceut­icals who’s serving a seven-year prison sentence on unrelated charges — appeared before Congress, where he was asked to explain why his company’s medicine cost so much, as was Mylan NV chief executive Heather Bresch and Valeant Pharmaceut­icals Internatio­nal Inc chief executive Michael Pearson.

Smith and Bove, however, have maintained low profiles. They tend to work with smaller, privately held companies and rarely post on social media. Patients haven’t raised much of a stink about prices, either, because they pay little or no money at the drugstore to get their drugs.

Some of the largest insurers and pharmacy benefit managers have blocked Evzio and other high-priced drugs from coverage. Others allow exceptions or aren’t closely monitoring all claims. Smith’s and Bove’s approach depends on enough health plans covering the drugs to make a profit.

It was at Horizon that Smith and Bove appear to have honed much of their business strategy. Smith arrived in 2010 as a senior vice-president after stints at a half-dozen other healthcare companies, according to his LinkedIn page.

Bove, a management consultant with two master’s degrees from Northweste­rn University, came on board the next year. Prior to working at Horizon, the pair played together in a recreation­al basketball league, according to another former colleague. Their arrival at Horizon coincided with a volatile time for the company. Its first product, Duexis, an arthritis treatment that combines ibuprofen and the active ingredient in Pepcid, was approved in 2011. But a public offering later that year fell flat.

Strapped for cash, Horizon more than doubled the price of a bottle of 90 Duexis pills in March 2013, to $502, according to one former employee and Connecture data. Under the oversight of Smith, who was then the chief commercial officer, Horizon kept raising the price, the employee said. A bottle of Duexis now costs $2,482.

Horizon also bought the US rights to Vimovo, a competing product, in 2013, and raised its price.

Bove, meanwhile, oversaw a programme called Prescripti­ons Made Easy that sought to reduce hassles for doctors and costs for patients to mitigate barriers imposed by drug plans. It subsidised co-payments and routed prescripti­ons through a network of speciality pharmacies.

Speciality pharmacies are often used for complicate­d and expensive drugs. Horizon, however, turned to them to move more ordinary drugs. These pharmacies tend to spend more time than traditiona­l drugstores ensuring that a prescripti­on is approved for insurance coverage. They also often mail drugs directly to patients’ homes to make sure prescripti­ons are filled and refilled.

Horizon’s f ortunes i mproved as it expanded Prescripti­ons Made Easy, and in 2015, chief executive Timothy Walbert received a $93 million pay package. But Horizon’s tactics drew lawsuits and negative publicity.

One of the speciality pharmacies was Clybourn Park in Chicago, which Smith and Bove started in 2014 while working at Horizon, according to Illinois state and court records. They created the pharmacy specifical­ly to handle Horizon prescripti­ons, according to the records. Schondelme­yer, the Minnesota professor, said the arrangemen­t raises questions about whether the pharmacy was acting in the interest of patients or its owners.

An investor lawsuit against Horizon said the pharmacy instructed its employees not to discuss price with patients, and routinely refilled prescripti­ons without patient authorisat­ion. The lawsuit was dismissed earlier this year.

Smith and Bove sold their assets in the pharmacy in 2016, Walton said.

In November 2015, Horizon received a subpoena from federal prosecutor­s seeking documents related to its patient-assistance programmes and interactio­ns with speciality pharmacies. The investigat­ion is ongoing, according to a Feb 28 regulatory filing by Horizon. The company has said it is cooperatin­g and remains confident in its programmes.

Smith left the company in October 2014, and Bove followed later, according to LinkedIn and former employees. They started their own business, Novum Pharma, in 2015, along with a handful of financial and healthcare veterans.

Novum bought three skin gels, including Alcortin A, from Primus Pharmaceut­icals in 2015, and soon thereafter increased the prices. Aloquin jumped to $7,968 by the fall of 2016, from $201 before the purchase, and Novacort rose to $5,952, from $122, according to Connecture. They also took their business plan on the road. It’s not known how many companies they signed up as clients. But one of them was Iroko Pharmaceut­icals in Philadelph­ia, which sells pain management drugs. Smith and Bove were brought on at the start of 2017 to run the company, according to three former employees.

The duo also began working with Aqua Pharmaceut­icals in 2017. There, they monitored how prescripti­ons are filled and began implementi­ng a speciality pharmacy model, according to two former employees. No major price increases have yet been made.

Aqua didn’t return messages seeking comment.

The two men started working with Kaleo as consultant­s in 2015, according to former employees. “First and foremost … I am a sales person,” Smith wrote in an Aug 14, 2015, email. “I have held many positions in pharma/biotech but sales is absolutely my passion.”

The company was started by twin brothers, Eric and Evan Edwards, who were afflicted with severe childhood allergies. After college, they set out to design a better way to inject epinephrin­e, the medication that counteract­s such allergic reactions.

Their i nvention, called Auvi-Q and approved in 2012, was about the size of a credit card. Among the features that set it apart from Mylan’s ubiquitous EpiPen were audio and visual cues to assist users.

By the time Smith and Bove arrived, Auvi-Q was struggling against fierce competitio­n from EpiPen. It was ultimately pulled from the market in 2015 by its licensing partner, the French drugmaker Sanofi, after a voluntary recall over dosage.

Evzio wasn’t catching on either. Too many patients were frustrated by the need for prior authorisat­ions, high deductible­s and other barriers imposed by health plans, the company said. In 2015, about two-thirds of prescripti­ons weren’t filled.

Smith proposed a “radical change in commercial tactics (sales force, price, co-pay)”, according to the 2015 sales pitch.

He was named chief commercial officer, but it was short-lived because employees complained about conflicts with his other companies, Novum and Clybourn Pharmacy, the latter of which Kaleo used as a speciality pharmacy, the employees said. Smith went back to being a consultant.

Before the two men arrived, Kaleo’s sales force had been targeting a mix of patients, including those on Medicare and Medicaid, as well as those with addiction issues, former employees said. Under the new plan, Kaleo shifted its efforts to customers with private insurance. By 2017, they represente­d 75% of Evzio prescripti­ons, up from fewer than 50% two years earlier, according to data compiled by Bloomberg.

On Feb 1, 2016, Kaleo raised the price of Evzio fivefold, which “allows us to begin a large-scale reinvestme­nt back into ensuring patients have access to Evzio at a low cost and without typical insurance and pharmacy hassles,” said a Kaleo PowerPoint presentati­on from January 2016, reviewed by Bloomberg.

The new business plan put pressure on the sales staff to deliver. Quarterly bonuses could reach $100,000, but sales representa­tives were expected to reach goals in a dozen weeks. Turnover was unusually high, according to former employees.

Kaleo’s revenues grew to $56 million in 2016, from $21 million in 2014, according to financial statements. But those gains were offset by higher sales and administra­tive costs, and the company still lost money. In February 2017, dozens of members of Congress demanded to know why Evzio’s price had spiked. The company responded by sending a letter addressing their concerns.

A bigger problem was competitio­n from a new naloxone nasal spray called Narcan. Marketed by Adapt Pharma Inc and approved by the FDA at the end of 2015, Narcan cost just $125 per dose. Faced with this rival and growing resistance from insurers, Kaleo last year reintroduc­ed Auvi-Q, its original epinephrin­e drug.

It relaunched the drug in early 2017. EpiPens — whose rising price had caused a national furore — then cost $600 for two. The price of Kaleo’s two-pack: $4,500.

It’s the wrong way to frame the issue to say it’s free to the patient. It’s ripping people off. STEPHEN SCHONDELME­YER PROF OF PHARMACEUT­ICAL ECONOMICS, UNIV OF MINNESOTA

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 ??  ?? Martin Shkreli in Washington, Feb 4, 2016. Shkreli, a former pharmaceut­ical executive, was sentenced to seven years after being convicted of fraud for just over $10 million.
Martin Shkreli in Washington, Feb 4, 2016. Shkreli, a former pharmaceut­ical executive, was sentenced to seven years after being convicted of fraud for just over $10 million.
 ??  ?? EpiPen autoinject­ion epinephrin­e pens manufactur­ed by Mylan NV for use by severe allergy sufferers are seen in Washington, Aug 24, 2016. Rising prices for them caused a national furore.
EpiPen autoinject­ion epinephrin­e pens manufactur­ed by Mylan NV for use by severe allergy sufferers are seen in Washington, Aug 24, 2016. Rising prices for them caused a national furore.

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