Pricing & Patient Access

Americans are spending more on prescription drugs than in other countries
November 4, 2015

Rising costs for prescription drugs are straining budgets around the globe. The 34 countries in the Organization for Economic Cooperation and Development, which includes the United States, spent $800 billion on pharmaceuticals in 2013, a new report finds. That’s a full 20 percent of total health spending.

And here’s one key finding: the US spent twice the OECD average on pharmaceuticals purchased at retailers in 2013. The group average was about $500 per person. In the United States, it was $1,026 per person.

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Pricing & Patient Access  / Uncategorized

Valeant’s unsavory ways are a lesson for everyone
November 3, 2015

J. Michael Pearson is not your typical drug executive. The head of Valeant Pharmaceuticals built his company into a moneymaking machine by acquiring other drug makers and products, not by investing in research and development. The approach contradicted longstanding industry doctrine, but it won high praise from investors. For years, the Canadian drug company’s stock went nowhere but up.

Not anymore. A slew of questions about its business practices has turned Valeant from a Wall Street darling into a Main Street poster child for questionable behavior. Federal prosecutors have issued subpoenas. Lawmakers are conducting investigations. Pharmacy benefit managers stopped doing business with a company that was important to Valeant’s operations. And now, many investors are bailing. The drug maker’s stock has lost more than 60 percent of its value since the beginning of August.

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Marketing  / Pharmacy Benefit Managers  / Pricing & Patient Access  / Research & Development

Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, AbbVie and..
November 3, 2015

Rise and shine, everyone. Another busy day has arrived. And this is shaping up to be a pleasant one, too. A warm sun is enveloping the Pharmalot campus, where the official mascots are snoozing and we are exercising our new coffee kettle. As usual, there is much to do and we assume you can relate. So time to get cracking. Here are a few items of interest for you to peruse. Have a productive day and keep us in mind when something interesting happens…

Valeant Pharmaceuticals sought to reassure doctors that cutting ties with Philidor Rx Services, a mail-order pharmacy, would not disrupt their ability to prescribe its drugs; The South African government is considering a recommendation by Doctors Without Borders to allow generic versions of the Lopinavir HIV drug after shortages resulted in interruptions to some treatments; and AbbVie has vowed to keep biosimilars of its Humira rheumatoid arthritis treatment from reaching the US market before 2022.

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AIDS  / Biosimilars  / Cancer  / FDA  / Generics  / Mergers and Acquisitions  / Pharmacy Benefit Managers  / Pricing & Patient Access  / Research & Development  / Uncategorized  / Vaccines

Will a compounded version of Martin Shkreli’s drug really make a difference?
November 2, 2015

When a compound pharmacy trumpeted plans last month to sell a cheap version of Martin Shkreli’s pricey anti-infective drug, the move was greeted with cheers worthy of a World Series championship. This was hardly surprising. Shkreli’s Turing Pharmaceuticals boosted the price of its Daraprim drug to $750 from $13.55 less than a month after buying the decades-old, life-saving medicine from another drug maker. But then, Imprimis Pharmaceuticals announced plans to make a combination medicine containing the same active ingredient in Daraprim and charge just $99 for a bottle of 100 capsules, or about $1 each.

But whether this move will derail Shkreli’s plan to dominate the market is actually unclear. For the moment, there are two key questions. One is whether enough doctors will prescribe the low-cost, compounded alternative? Another unknown is whether the availability of this new product might somehow derail the potential for antitrust investigations into Shkreli’s company?

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AIDS  / Compound Pharmacies  / FDA  / FTC  / Pricing & Patient Access  / Quality Control  / Uncategorized

Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, Mylan and..
November 2, 2015

Good morning, everyone, and welcome to another working week. The weekend respite went by rather quickly, yes? Well, it generally does. Nonetheless, we hope you enjoyed yourselves and prepared for another round of meetings, deadlines and whatever else may be lurking. To cope we are not only brewing cups of stimulation and purchased a new coffee kettle. Given our intake, we were overdue. So please join us. Meanwhile, here are some tidbits. Have a smashing day and do stay in touch…

Charlie Munger, who is Warren Buffett’s business partner, says Valeant Pharmaceuticals’ strategy of buying drugs and boosting prices may be legal, but is “deeply immoral”; The Securities and Exchange Commission is investigating whether Mylan failed to properly disclose real estate deals involving the company and its lead outside director; and a Pfizer plant in China that was inspected by FDA in order to ship drugs to the US kept a second set of quality and manufacturing records that didn’t match official ones.

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FDA  / Laboratory Tests  / Mergers and Acquisitions  / Pricing & Patient Access  / Product Recall  / Quality Control  / Rare Diseases  / Research & Development  / Uncategorized

Pharmalot.. Pharmalittle.. As the weekend nears.. we’re catching up on Valeant and…
October 30, 2015

And so, another working week will soon draw to a close. You were waiting for this moment, yes? This is, of course, our treasured signal to daydream about weekend plans. As usual, our agenda is rather modest. We plan to putter around the castle and catch up on some reading. And what about you? This is, of course, a nice time of year to watch the leaves fall, preferably in a location that does not require you to do any raking. Or better yet, you could search for the Great Pumpkin. Intriguing, yes? Whatever you do, have a jolly old time. But please, be safe. See you soon…

Valeant Pharmaceuticals has cut ties with Philidor Rx Services, which is now shutting down. And yesterday, CVS Health, Express Scripts and Optum Rx, the three largest pharmacy benefits managers in the US, decided not to work with the mail-order pharmacy; As drug makers race to launch CAR T cells, which may be the most effective treatments ever seen for leukemia and other blood cancers, they are grappling with how to make them widely available in a reliable and cost-efficient way; Pfizer faces political risks in Washington if it proceeds with a bid for Allergan, but with little chance of legislation to curb such tax inversion deals, the Obama administration may be able to throw up only limited obstacles; and In nearly 100 news articles describing 36 cancer drugs, words like “breakthrough” and “miracle” were used, even though 50 percent of the time those drugs were not approved by the FDA.

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Cancer  / Drug Development  / FDA  / Generics  / Legislation  / Mergers and Acquisitions  / Pharmacy Benefit Managers  / Pricing & Patient Access  / Research & Development  / Uncategorized

FTC raises anticompetitive concerns about FDA naming proposal for biosimilars
October 29, 2015

What’s in a name? A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits.

At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine. Essentially, the FDA appeared to be trying to appease as many people as possible, but that hasn’t worked.

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Antitrust  / Biosimilars  / FDA  / FTC  / Patient Safety  / Pricing & Patient Access

Most Americans want Washington to lower prescription drug prices
October 28, 2015

For those who believe that opinion polls are proxies for temperature readings, the pharmaceutical industry could use an aspirin.

Amid ongoing turmoil over prescription drug prices, a new poll finds that 77 percent of Americans want the White House and Congress to ensure that expensive drugs for treating chronic conditions – such as cancer, HIV, hepatitis, and mental illness – are affordable. And 63 percent want government action to lower drug prices, in general. In fact, these were the two health care items that mattered most to the more than 1,200 adults who were queried by the Kaiser Family Foundation.

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AIDS  / Cancer  / Direct-to-Consumer Advertising  / FDA  / Hepatitis C  / Pricing & Patient Access

Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Theranos, Amgen and..
October 28, 2015

Top of the morning to you. And a fine one, it is. Although a bit cloudy here in New England, our spirits remain sunny. As you know, our philosophy, courtesy of the Morning Mayor, is quite simple: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will search for a cup of stimulation. And of course, here is your menu of morning tidbits. Have a smashing day and do keep us in mind for interesting developments…

The FDA issued inspection notices to Theranos for using its blood-collection device without securing needed approval; The FDA approved a virus called Imlygic for treating advanced-stage melanoma, a development that could herald a new age of viral therapies; The debate over drug prices, and complaints from consumer advocates about safety concerns, have fueled Senate Democratic resistance to pharma-friendly provisions in the 21st Century Cures Act; Walgreen Boots Alliance agreed to buy Rite Aid for about $9.4 billion, in a move that would create a drug store giant as companies across the US health care industry look for ways to bulk up; and Breast Cancer Now, a UK health charity, is urging Roche to drop the price of its Kadlyca key breast cancer drug before the National Health Service stops funding it next week.

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Alzheimer's  / Cancer  / FDA  / Layoffs  / Legislation  / Litigation  / Marketing  / Patents  / Pricing & Patient Access  / Quality Control  / Uncategorized

Budget requires generic makers to pay Medicaid rebates tied to inflation
October 27, 2015

For those concerned about the rising cost of pharmaceuticals, Congress is proposing some relief. The two-year budget deal proposed by lawmakers this week unexpectedly includes a provision that would require generic drug makers to pay additional rebates to state Medicaid programs for any medicine that increases in price faster than the inflation rate.

The move comes at a time of rising concern over drug prices. The cost of new medicines for hard-to-treat diseases, such as cancer and hepatitis C, worry public and private payers, who call them budget busters. And there is growing outrage at companies such as Valeant Pharmaceuticals and Martin Shkreli’s Turing Pharmaceuticals for buying drugs and then boosting the prices to sky-high levels.

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Generics  / Legislation  / Pricing & Patient Access  / Uncategorized