Category: Drugs

Can it really be a negotiation?

The United States House and Senate are on the cusp of passing what remains of the original “Build Back Better Bill” into a pared-down “Inflation Relief Bill.” What remains in the bill remains to be seen, but should it pass, it contains a major section, “Prescription Drug Pricing Reform,” that includes a “Price Negotiation Program to Lower Prices for Certain High-Priced Single Source Drugs.” The ability of the government to negotiate or have any sort of control over drug pricing is probably the one issue most resisted by the pharmaceutical industry. The bill is difficult for mere-mortals to understand with references to various internal and external laws. I do not fully understand all of it yet. In brief, the bill allows Medicare to “negotiate” with drug manufactures for 10 to 20 drugs at a time per year over the next few years. We customers will not see much effect for a while. Medicare will select the drugs to be negotiated from among the top 50 Part-B and Part-D drugs ranked by the total cost to Medicare and its beneficiaries. Since the top 50 drugs make up almost half of Part-D total drug costs, the potential impact on Medicare beneficiaries and drug companies alike may be great. The remainder of this article will explore the top-50 drugs of pre-pandemic 2019.

For the purposes of this article, I used Medicare’s Public Use File: Part-D Utilization 2019 Drug Summary. The file summarizes the total drug cost and unique numbers of prescribers and beneficiaries for each of 1847 generic (chemical-name) drugs, broken down additionally into 3380 brand names or marketed versions of each generic. These are presented below in list and tree map formats.

Continue reading “Prescription Drug Pricing Reform in the Inflation Relief Bill”

If I were King of Medicare.

I am still learning how best to extract useful information from the public-use Medicare Part-D Drug Utilization and Cost files. I view these as experiments of nature worth mining for what they can tell us about the clinical and business aspects of healthcare.  The last few articles I have written focused on the utilization and cost of Insulin, highlighting the seemingly unjustified increases in this life-saving drug for diabetics.  In this tweak, I learn how to combine data from drugs in the same therapeutic category including all the brand and generic versions of individual drugs within categories. I am still wrestling with technical issues related to presenting multiple groups in a single TreeMap visualization, but as an example, I will show that in 2015 three groups of drugs– insulin, opioids, and drugs used to treat Hepatitis-C–  cost the Medicare program 17.6% of the total cost of all Part-D drugs but comprised only 7.2% of all prescriptions.  These drugs were expensive for different reasons that I will illustrate.

I particularly like the TreeMap data-visualization format because it allows hundreds if not thousands of drugs to be compared at the same time and facilitates identification of unexpected or unjustified outliers much easier.  Since Medicare is now standardizing the formats of these drug files, changes in utilization and cost can be tracked over several years.  I believe that placing such analyses into the service of policy makers and payers can allow savings of billions of dollars without compromise of care. Continue reading “How To Save Big Money on Prescription Drugs.”

I want to use this post to explore enhancements to Medicare’s Part-D drug utilization-and-cost files using Insulin as an example.  I have previously dissected the public use files released by the Centers for Medicare and Medicaid Services (CMS) to explore a number of health policy issues.  These included utilization and cost of medical services by hospitals and other providers; quality and safety issues related to hospitals; the overall monstrous rises in prices of generic and other drugs; and prescribing patterns of opioids by individual practitioners. Other analyses examined insulin utilization and cost for Medicare and Medicaid beneficiaries. The rapid (and large) increases in the price of insulin are exemplars of the gut-punch impact of drug prices on individuals and our healthcare system.  Drug companies have diabetics and their public and private payers over a barrel.  Large numbers of patients with diabetes need the drug to keep them healthy if not alive.  In mid-2016, CMS updated and standardized their Medicare Part-D databases making them comparable for the three initial calendar years of 2013 through 2015.  I took this opportunity to take another look at Insulin.   Although only some 70% of all Medicare beneficiaries are enrolled in Part-D Drug benefit programs, I suggest that prescribing patterns to these Medicare beneficiaries are not very different than those for non-Medicare adult patients and can be generalized.  To make the initial data available to some new colleagues and simply just to get a start somewhere, I placed my first peeks into the enhanced Medicare databases on my Tableau Public Site in three sets of interactive tables and visualizations individually for 2013,  2014, and 2015. Continue reading “Updated Look at the Rapidly Rising Cost of Insulin in Medicare Part-D Program.”

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.”