Newest Proposed Treatment for Duchenne Muscular Dystrophy Abruptly Changes Hands.

Less than one month after our exploration of the recent colossal price markup of a simple drug used by a vulnerable and desperate group of children and their families, a dramatic turn of events occurred which may make things better or worse. In February, the pharmaceutical company Marathon announced its marketing plans for Emflaza, its brand name for deflazacort, a simple corticosteroid widely available in other countries but not in the United States. Emflaza had recently been approved by the FDA for the treatment of symptoms of Duchenne muscular dystrophy (Duchenne MD) in the United States.   Duchenne MD is a usually fatal genetic muscular disorder of young boys for which no curative therapy is currently available, but for which corticosteroids such as deflazacort and prednisone slow the progression of weakness.  Deflazacort– the most commonly prescribed all-purpose steroid in some countries– has been used in Canada and elsewhere for the treatment of Duchenne MD for some time.  The wrinkle in Marathon’s release was that it declared an annual charge of $89,000 per child for a drug sold in many other countries for a price a measured in pennies instead of dollars.

I have already expressed my puzzlement that the FDA gave its approval to Marathon based on clinical data collected many years old by another drug company that for undisclosed reasons walked away from FDA approval. I am still looking for reliable studies that confirm that deflazacort is superior to, or safer than prednisone to treat Duchenne MD. [Prednisone is the most prescribed corticosteroid in the United States. To say that it is inexpensive would be an exaggeration!]  Perhaps a clinician without ties to the pharmaceutical industry will provide us with evidence-based data that Emflaza is an essential or even a better drug for Duchenne MD, or worth the monumental cost for any incremental benefit.

Continue reading “Newest Proposed Treatment for Duchenne Muscular Dystrophy Abruptly Changes Hands.”

Is Emflaza the Latest Drug Pricing Rip-off or Not?

New Money from Old Drugs.  Are children with muscular dystrophy being served by the free market or taken advantage of?

I suspect that it is just because people are paying attention, but reports of unexplainably excessive pricing of both new and old drugs keep coming too fast to keep up with. I recently published a list of 447 drugs whose prices doubled or more between 2011 to 2015. Even that list was incomplete!  This week’s prize winner is Emflaza, a drug that was recently approved by the Food and Drug Administration (FDA) to treat Duchenne Muscular Dystrophy (DMD).

The price proposed by Marathon Pharmaceutical, LLC is $89,000 per patient per year. We may be getting desensitized to such patient-bankrupting offerings, but what makes Emflaza stand out from the offending crowd is that in Canada, where some of the original research appears to have been done, the same drug for the same disorder costs a dollar a pill or less.  As noted in the Wall Street Journal, the price set by Marathon is 50 to 70 times what most U.S. patients currently pay to buy the drug (illegally?) from on-line pharmacies in the United Kingdom.  The more I learned about Emflaza, the more troubled I became.  Allow me to share some of my discomfiture with you. Continue reading “Is Emflaza the Latest Drug Pricing Rip-off or Not?”

Mylan Drug Company Drops Price of EpiPen – Sort Of!

epipen-image550Mylan Pharmaceuticals is really feeling the heat.  An outpouring of outrage over its exorbitant pricing for EpiPen has caused it to announce plans to offer a generic version of the product for half the $600+ dollars of the branded version. The EpiPen is a self-injecting device used for life-saving rescue of individuals with anaphylaxis, a severe form of allergic reaction. (See my recent article for background.)  Mylan joined the new “gouge-em if you can” industry club by buying a old standard drug and jacking up the price to astronomical amounts assuming we patients had no recourse but to raid our kids’ college accounts to pay for it.  How broken is a system that has the same company selling the same drug at two vastly different prices in the same country?  I guess Mylan assumes it is still acceptable to rip-off patients with health insurance.  This face-saving move is yet another confirmation of the hypocrisy of our two-or-more-tiered healthcare system, and the absurdity of our drug pricing non-system. The only way for Mylan to get out of this public relations hole it is digging is to give EpiPen away for free as a public service to anyone who needs it! Continue reading “Mylan Drug Company Drops Price of EpiPen – Sort Of!”

Another Drug Company Rips Off the Public: Mylan’s EpiPen.

 Why do they do it?  Because they can– and because we let them!

Mylan, the manufacturer of the EpiPen, an auto-injector used to inject epinephrine beneath the skin, has raised the price of its product some 800% between 2009 and 2016.  The active drug itself is a traditional generic that costs very little. Mylan has copied a business model of buying a standard drug that is essential for some and jacking up the price to more than what desperate people are willing or able to pay.  It was easy to do so because Mylan lost its major competition and because individuals with “good” health insurance are insulated from having to pay the full price in the drugstore. The price of the usual prescription for EpiPen is reported to have risen from $100 in 2009 to around $600 today.  The pricing of this medical device that makes it convenient to carry and administer epinephrine is another of the innumerable examples of the failure of our healthcare system to protect the interests of individuals with medical needs and to tolerate predation such as this. Continue reading “Another Drug Company Rips Off the Public: Mylan’s EpiPen.”

Medicare Updates Its Prescription Drug Utilization Database.

An improved goldmine of information not otherwise available to the public and a flood of opioids.

On August 18, CMS released the second iteration of its cost-and-utilization database of prescription drugs written for patients covered by Medicare Part-D Medicare which includes beneficiaries in Part-C Managed Care and stand-alone Medicare Part-D Prescription Drug Plans. Compared to the updates of Medicare’s other 2013 public-use healthcare utilization files, this release seemed delayed and I feared the program’s continuing implementation had been quashed by the pharmaceutical industry lobby and its friends as was a 2013 initiative to provide the public with average retail drug prices. The wait was worth it.

Although restricted to the two specific Medicare populations mentioned above comprising some 70% of all Medicare beneficiaries, the database is unique in that the names and other identifying information about individual prescribers are disclosed to the public. Although the drug companies themselves know who is prescribing their products, to my knowledge, this degree of transparency for the public is unique – and therefore doubly valuable. The top 25 opioid prescribers to this population are listed below. Continue reading “Medicare Updates Its Prescription Drug Utilization Database.”

Update On The Rising Prices of Insulin Between 2013 and 2016.

Earlier this month I published a survey of the cost of insulin to the Medicaid and Medicare programs of Kentucky and the nation.  Fully 9.1% of the total cost of Kentucky’s outpatient Medicaid drug program went to pay for the several brands of Insulin still available. It was obvious that some brands cost a lot more per prescription or claim than others and that the most expensive brands were prescribed most often!  I used this critically important drug as an example of how the market for prescription drugs in America is badly broken.  Since then I stumbled on two additional federal databases that provide additional insight into how much these drugs cost at the local pharmacy counter where the rubber hits the road. These are federal surveys that determine the National Average Retail Prices paid by the consumer (NARP), and the National Average Drug Acquisition Cost (NADAC) for the pharmacy.  Both these programs provide data at the cost per milliliter level, and otherwise facilitate apple-to-apple comparisons of the different brands.  In brief, the additional data confirm that in 2013, for the same size bottle, the newer insulin analogs cost 71% more than the older “human” insulins.  By 2015, all prices had increased; some substantially.  Valuable information about the retail prices of drugs is being kept from public inspection. Continue reading “Update On The Rising Prices of Insulin Between 2013 and 2016.”

Soaring Insulin Prices Highlight Broken Pharmaceutical Policy.

Just business– or greed?  You be the

Discovered and patented almost 100 years ago, insulin is a critical drug for the treatment of both childhood Type I and adult onset Type II diabetes mellitus.  Diabetes is a costly disease for our society in more ways than one.  In 2015, the cost to the Kentucky Medicaid program for insulin alone annualizes to $101.8 million.  Insulin consumed 9.1% of Kentucky Medicaid’s entire non-hospital drug expense while making up only 1.1% of all prescriptions.  In 2013, the last year in which Medicare Part-D drug utilization data are available to me, insulin consumed 7.3% of total Medicare reimbursement for drugs in Kentucky costing a total of $141.8 million.  In both federal programs, insulin consumed a larger portion of the drug budgets in Kentucky than nationally.  A review of several reasons why insulin has become so expensive illustrates what is very wrong with our national drug policy. Continue reading “Soaring Insulin Prices Highlight Broken Pharmaceutical Policy.”

Prescription Drug Utilization and Costs for Kentucky Medicaid in 2014.

The jointly managed state and federal Medicaid program has always been an important part of the American patchwork healthcare system. The Medicaid expansion of the Affordable Care Act and other changes to eligibility have not only increased the number and diversity of Medicaid beneficiaries, but also Medicaid’s potential financial and clinical ability to shape other healthcare segments in the same way that the Medicare program has done. However, not all of Medicaid’s structural practices may be worth promulgating. I suggest that the way Medicaid has chosen to select eligible drugs for its formularies nor the way its has paid for them are worthy of emulating. To start a new thread in these pages, I begin with a survey of drugs prescribed to Kentucky Medicaid beneficiaries in 2014. I freely admit that I will be learning along with my readers who I hope will participate in the process of exploration and understanding.

I will demonstrate an overlap in the use of drugs by both federal programs but also illustrate major differences. It will be obvious that many beneficiaries who are excluded from employment-based or ineligible for Medicare coverage are dependent on Medicaid for their health care. You might even become more concerned about recent promises to reverse Medicaid expansion and cut its roles.  I will highlight the extraordinary cost of some new drugs such as those for the curative treatment of hepatitis-C.  I will show that the cost to the system of every-day commonly used drugs overshadows that of the high-flying cancer drugs that are frequently featured in our news reports. You may be surprised to see how frequently opioid narcotics are prescribed. You should be concerned about the exploding costs of necessary and successful medically assisted drug treatment for opioid addiction. You will be as surprised as I at the personal and financial burden of depression and other mental disorders. Finally, you will probably be disappointed and maybe even a little angry about how little our public policy seems to be guided by the prevalence of the illnesses that most frequently affect us. Continue reading “Prescription Drug Utilization and Costs for Kentucky Medicaid in 2014.”

Prescription of Medicare Part-D Drugs Nationally: $Billions Left On The Table.

In my last article, I profiled the outpatient drugs prescribed to elderly and disabled Medicare beneficiaries of Kentucky in 2013. While I still had the analytical templates still in hand, I extended that analysis to all 50 states. Initial inspection suggests that the relative pattern of drug prescription (and dispensing) is not greatly different than that of Kentucky. It may not be a surprise that we of the Bluegrass state consume relatively more hydrocodone, oxycodone, and gabapentin relative to other drugs, but less oral anticoagulant. A more granular comparison of Kentucky to the the the nation will require a different approach. This Medicare data allows us to separate out the proportion of a given drug product that is dispensed and billed as a generic drug; a brand name drug; or as alternate preparations such as long-acting, tamper-resistant, or solid vs. liquid. The big take-away for me is that despite the supervision of Medicare’s prescription drug programs by pharmacy benefit managers and others, much money is being spent in less than a medically defensible manner– or is frankly wasted. We as a nation are leaving billions of dollars on the table for pharmaceutical companies and those who market and distribute their products. I will summarize below national utilization and cost figures and make available an Excel file supporting the graphics.

Background. I have been exploring the inaugural release of Medicare prescription drug utilization since its publication last spring. (We should get the numbers from calendar year 2014 in the next few months, but I have Medicaid 2014 in-hand and up-next!). The database does not include all Medicare beneficiaries, only those in Medicare Managed Care or in Medicare Part-D Drug plans, but that makes up a majority of bebefuicuarues. The proportions vary from state to state, but the Medicare programs covers eligible individuals over the age of 65, and some individuals who have been certified as disabled. There is a sizable proportion of individuals who are eligible for both Medicare and Medicaid for other reasons. I frankly do not at present have a good handle on the numbers of beneficiaries in these and other categories that may be included within the present data. Continue reading “Prescription of Medicare Part-D Drugs Nationally: $Billions Left On The Table.”

A Different Look At Drug Prescribing in Kentucky.

Visualizing prescription patterns for Medicare patients with an eye to safety and cost.

In the name of quality, accountability, and paying for results, what began as a trickle of information previously unavailable the public about utilization, cost, and outcomes of medical services became a torrent. The challenge for professionals and patients alike is how to evaluate and act upon all this data. I include myself among the learners. My readers may have guessed correctly that I like to look at spreadsheets, pivot tables, and maps. Exciting new ways of looking at such “big data” are also becoming available. “Data visualization” is a current buzzword and I am experimenting with it.  In this article I use a new way to summarize the number of prescriptions and associated cost for all drugs prescribed for Kentucky Part-D and Medicare managed care beneficiaries in 2013. This segment of Medicare patients received over 25 million prescriptions and refills that year with a total cost of $1.6 billion. I will show that a few dozen drugs comprised half the volume and cost of all prescriptions, attempt to shock you again with the volume of opioids and other controlled narcotics prescribed to the elderly and disabled, introduce you to Kentucky’s most rapidly growing drug of abuse, and illustrate in one fell swoop how America can save $Billions nationally without any decrease in safety or quality of care. Does this sound like a late-night TV come-on?  Read on. Continue reading “A Different Look At Drug Prescribing in Kentucky.”