Pharmaceutical Samples to Wrong Patients [PRMA]
[By Staff Writers]
Most free drug samples that physicians reserve for poor or uninsured patients actually go to wealthier patients who have insurance, reports a new study by the American Journal of Public Health [AJPH].
Patients with the highest incomes were the most likely to get free samples, according to the survey of nearly 33,000 Americans, while only 28 percent of those who got samples were poor, whether insured or not, with incomes less than twice the federal poverty level.
The Pharmaceutical Research and Manufacturers of America [PRMA] studies show 75 percent of physicians frequently or sometimes give out samples to help patients with out-of-pocket costs, while many poorer and uninsured folks never get to see a doctor and/or more often visit public health clinics or emergency rooms, where samples may not be available.
Assessment
Or, they forego care!
And so, what is your opinion on this finding; malicious or merely absent-minded?
Conclusion
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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs |














Drug-name Mix-ups Getting Worse
Kid given schizophrenia drug Zyprexa instead of Zyrtec for allergies
http://www.msnbc.msn.com/id/22901039
For your review.
-Ann
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Who Says … Free Drugs?
Free drug samples cost more in the long run. Patients given freebies spend nearly 40 percent more on meds, a new study says.
More: http://www.msnbc.msn.com/id/23783105
-Ann
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Top US Drug Pricing Average Jumps 646% from 2010 to 2014
According to a recent report by Evaluate Pharma:
• The Median price of the top 100 drugs was $9,400 in 2014.
• The Median price of the top 100 drugs was $1,260 in 2010.
• The Average patient population size served by top 100 drugs was 146,000 in 2014.
• The Average patient population size served by top 100 drugs was 690,000 in 2010.
• The Number of treatments costing >$100,000 per patient per year was 7 in 2014.
• The Number of treatments costing >$100,000 per patient per year was 4 in 2010.
Source: Evaluate Pharma [USA Sales]
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Specialty pharmacy drug costs
The two most significant long-term implications of rising specialty pharmacy drug costs are to create the pressure for another round of “health reform” and on international trade policy. These are obvious choices, I know, but let’s look closer and take a wonk on the wild side (“…and the wonks go doo, da-doo, da-doo, da-doo doodoo, doo, da-doo, da-doo, da-doo doodoo…” *).
The overall cost of the drug benefit has been rising steadily upward since drug coverage became a wide-spread benefit in the 1990s. In this past decade or so, rising costs have been driven almost entirely by spending for specialty pharmacy.
Most recently, costs related to some new market entrants such as Sovaldi®, Harvoni®, and Viekira Pak® – all for hepatitis C – have risen so fast they achieved low earth orbit and can see the International Space Station…by looking down.
There are really two broad types of specialty pharmacy though: manufactured drugs that are one or perhaps two molecules, regardless of how they are manufactured or delivered; and compounding pharmacy drugs. Compounding accounts for a surprising amount of the specialty pharmacy cost increase, but because it uses drugs manufactured by others, it can be managed with through tough negotiations, the use of a single compounding pharmacy, strict adherence to medical guidelines, preauthorization, a closed formulary, and benefits design. That leaves us with the manufactured molecules that have the long term implications.
We will bypass all but one of the short term implications related to the existing approaches to managing costs such as preauthorization, drug utilization review, step therapy, formulary control and the like, as well as the counter-measures used by the manufacturers. But one of the most common approaches is increased cost-sharing, and that’s the one that could get us to another round of health reform.
Increased cost-sharing for specialty pharmacy is not quite the same as upping the PCP office visit copay by $10. It now often includes separate deductibles and coinsurance being applied only to specialty pharmacy coverage, which for a lot of people is both good news and bad news. The good news is that cost-sharing goes away when they hit their annual out-of-pocket maximum, which may occur in the second month of coverage; the bad news is they are slowly going bankrupt because most people don’t have $6,600.00 (2015 single) / $13,200.00 (2015 Family) of spare cash every year in their savings or under the couch cushions.
This brings us to Health Reform II: The Next Act. The Affordable Care Act (ACA) was positioned as “health reform” but was really insurance reform that affected payers heavily and had little or no negative impact on the other sectors. Through the twin media techniques of orchestrated outrage and identifiable victim stories, heavily used in the run up to the ACA and so effective in obtaining mandated benefits from states, has now been applied to rising drug benefit cost-sharing, prodding many politicians to take action on behalf of the voters.
And; even post-ACA, payers remain the go-to place for politicians to take those actions. Multiple states are now considering “cap the copay” bills that would require state licensed insurers and HMOs to markedly limit cost-sharing; for example, one Oregon bill under consideration would cap cost-sharing at $100 per month.
“Cap the copay” and similar laws are like mowing the lawn to get rid of dandelions – it only appears to solve a problem that is actually growing. Specialty pharmacy costs, and really all healthcare costs related to pricing, in reality grow faster when richer coverage is required. Eventually those very real and ever-rising costs will force us as a society to once again grapple with national health policy about how we finance health care goods and services. Payers were first in the reform barrel. Pricing is likely to be next, though it may be confined to one sector, and specialty pharmacy or drug manufacturers overall seems to have raised its collective hand to be called on next.
But hold on now, most drug manufactures are not even U.S. companies. We can’t just pick on Pfizer and leave the others alone, and that brings us to international trade policy. The U.S. is the only major first-world nation that does not negotiate or outright control drug pricing. Each nation does so to a different degree, but all do it. The corollary is a limitation on profit margin. So if the average global margin for drug manufacturers is around 20% or so (the makers of the new hepatitis C specialty drugs do considerably better than that), and if margins are constrained in other nations due to pricing negotiations or controls, then where does it get made up?
Let’s see, take the denominator of the hypotenuse, multiply by Avogadro’s number, divide by Planck’s constant, carry the remainder and you get your answer: the people in the U.S., whose motto should be “Proudly subsidizing the cost of drugs for every other nation on the planet.”
But to be fair, not only is it unreasonable to expect any publicly traded company to willingly walk away from higher profit margins (an instantaneous career-limiting move for any executive who even considers it), it is also unreasonable to expect them to do what our government will not: address this as a trade policy issue. A drug manufacturer cannot simply tell another nation that they will not agree to any price concessions and will instead stop making an important drug available. That’s the fast track to having a nation bypass their patent and license another company to make a generic or biosimilar version. And once that becomes available, it cannot be stopped at the borders of the nation that took the action, potentially flooding the global market.
Because the drug manufacturers cannot do this on their own, it falls to the federal government to negotiate trade agreements with other nations to address this. Ignoring means continuing a generous subsidy to other nation’s economies, paid for by everyone in the U.S. who uses or depends on patented pharmaceuticals, including specialty pharmacy drugs.
[* Apologies to the late and sorely missed Lou Reed.]
Peter R. Kongstvedt MD FACP
[Principal, P.R. Kongstvedt Company, LLC]
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Pushing back on exorbitant drug prices
The Center for American Progress has released a report that includes an arresting suggestion for controlling the prices of prescription drugs.
Under the Bayh-Dole Act, in certain circumstances, the federal government may exercise its “march-in rights” to license patents that resulted from federally funded research but that are now owned by drug companies. These rights apply when a drug company has not achieved “practical application” of the research—meaning that its benefits are not “available to the public on reasonable terms.” They also apply when “action is necessary to alleviate health or safety needs.” Thus, if a drug company is not charging a reasonable price for a drug, or if its pricing harms public health by substantially restricting access to the drug, the federal government is well within its rights to ensure the availability of cheaper generic versions.
Prior to Bayh-Dole, the federal government kept the rights to inventions arising from federally financed research. In 1980, Bayh-Dole allowed researchers—typically, university scientists—to treat that those inventions as their own. At the same time, however, the federal government retained “march-in rights” to assure that any federally financed invention is “available to the public on reasonable terms.” If it isn’t, the government can license the invention itself.
Since most drugs are developed in part with NIH funding, Bayh-Dole provides an instrument for restraining drug prices—at least in principle. Peter Arno and Michael Davis first laid out the idea of using Bayh-Dole to license drug manufacturers’ patents to generic competitors in a 2001 paper. “Unfortunately,” they observe in a related op-ed, “no one is enforcing it.”
That remains the case today. In 2013, the National Institutes of Health (NIH) rejected a petition asking the agency to exercise its march-in rights by saying that it “continues to [believe] that the extraordinary remedy of march-ins is not an appropriate means of controlling prices of drugs broadly available to physicians and patients.”
Maybe it’s an appropriate means, maybe it’s not. I don’t know. But is it legal?
Senators Bayh and Dole, for example, have said that the statute isn’t about controlling abusive pricing practices: “Nowhere in the text of the law are there any references to ‘reasonable price’ that should be dictated by the government. This omission was intentional.” Others have made the same claim at greater length.
One of Bayh’s former staff members, Joseph Allen, explains further that, when Bayh-Dole was enacted, the fear was that dominant companies might secure exclusive licenses for promising, NIH-funded university inventions—and then squelch inventions that might cannibalize their existing businesses. March-in rights enable the federal government to force universities to license their inventions to other companies that might develop them.
As a legal matter, however, the question isn’t what Congress was thinking when it passed Bayh-Dole. It’s what the statute that it enacted means. And on that front, CAP makes a powerful and straightforward argument that the federal government could conclude that a drug is “not available on reasonable terms” if its price is exorbitant. In contract negotiations, price is a term. Indeed, it is often the most important term. Why would you read a statute written like that to exclude any consideration of prices?
I don’t know that using march-in rights to slash the cost of high-priced drugs would be a good idea. But it looks to me like CAP’s proposal is on solid legal footing. Given CAP’s influence in the Clinton campaign, and the growing chorus of concerns associated with drug pricing, it’s worth keeping an eye on Bayh-Dole.
http://theincidentaleconomist.com/wordpress/pushing-back-on-exorbitant-drug-prices/
Nicholas Bagley via Ann Miller RN HA
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1 in 3 Americans Experienced a Prescription Drug Price Hike
Consumer Reports recently released an analysis on consumer healthcare spending trends. Here are some key findings from the report:
• 1 in 3 Americans said they experienced a prescription drug price hike in the past year.
• 47% of those who experienced a price increase did not comply with the Rx to save money.
• One quarter of those who experienced a drug price increase used their credit card more often.
• 18% of Americans put off a doctor’s visit because of cost.
• 8 in 10 doctors said they were concerned about their patients’ ability to afford their treatments.
• 25% of patients said they had a conversation with their practitioner about the cost of their treatment.
Source: Consumer Reports, June 21, 2016
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