Colleen Hall

Patients who have type 1 diabetes spent a lot more to treat themselves in 2016 than in 2012. Specifically, insulin prices alone almost doubled, according to a report issued this week by the

"We conclude that increases in insulin spending were primarily driven by increases in insulin prices, and to a lesser extent, a shift towards use of more expensive products," wrote report authors Jean Fuglesten Biniek and William Johnson. The authors analyzed claims data from 3 large insurers.

The report authors noted that people with type 1 diabetes spent $5,705 on insulin in 2016, up from $2,864 in 2012.

The committee will several hearings in the coming weeks to hear from experts, as well as patients affected by rising drug prices.

Rep. Elijah E. Cummings, D-Maryland, who is the Chairman of the Committee on Oversight and Reform announced that he has sent letters to 12 drug companies seeking detailed information and documents about the companies’ pricing practices.

Current estimates project that diabetes was the most expensive chronic illness in the United States in 2017, at a total of more than $327 billion per year including $15 billion for insulin.²

In November of 2018, on the second anniversary of the Make Insulin Affordable initiative, the American Diabetes Association (ADA) announced that more than 400,000 diabetes advocates have joined the call for affordable insulin for all who need it. After its examination of the insulin supply chain, ADA and its Insulin Access and Affordability Working Group published recommendations and public policy solutions to address the problem.The

includes information and resources for people who are struggling to pay for insulin, including new patient assistance programs recently launched by the insulin manufacturers as well as private assistance programs. The site also includes important links to information about the health insurance marketplaces and how to become a Diabetes Advocate.

1.  Biniek Fuglesten J, Jonson W. Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices. Health Care Institute website. 2018; Accessed at: https://www.healthcostinstitute.org/research/publications/entry/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices

2. Economic Costs of Diabetes in the U.S. in 2017. American Diabetes Association.

2018; dci180007. https://doi.org/10.2337/dci18-0007.

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Patients who have type 1 diabetes spent a lot more to treat themselves in 2016 than in 2012.


Price of Insulin Doubles in Recent Years

Fentanyl topped the list of the the 10 most frequently mentioned drugs cited as in connection with drug overdoses, according to a new report from the CDC.

Between 2011 and 2016 fentanyl, heroin, hydrocodone, methadone, morphine, oxycodone, alprazolam, diazepam, cocaine, and methamphetamine were the leading drugs cited, often used in combination with each other, according to the report, published in National Vital Statistics.

Officials from various health agencies linked data from the 2011&#151;2016 National Vital Statistics System–Mortality files with electronic files containing literal text information from death certificates.

The researchers noted a change in the leading cause of overdose related deaths between 2011 and 2016, moving from oxycodone in 2011 to fentanyl in 2016. The report noted that "the rate of drug overdose deaths involving fentanyl and fentanyl analogs doubled each year from 2013 through 2016, from 0.6 per 100,000 in 2013 to 1.3 in 2014, 2.6 in 2015, and 5.9 in 2016."

Study limitations included the variability in reporting of the drugs that are cited in these reports, and the study authors noted that this limitation illustrates the importance of clear reporting on these issues so that health officals can properly "identify deaths involving newly approved prescription drugs and new substances of abuse," and design appropriate intervention strategies in response.

Hedegaard H, Bastian BA, Trinidad JP, et al. Drugs Most Frequently Involved in Drug Overdose Deaths: United States, 2011&#151;2016.

Top 10 Drugs Involved in Overdoses Identified in CDC Report

Patients with diabetes who have hypertension should, at a minimum, be treated to blood pressure targets of less than 140/90 mmHg, and even lower targets for some patients at higher risk of cardiovascular disease, according to a position paper released recently by the American Diabetes Association (ADA).

The ADA's recommendations, which include a newly added pictorial algorithm for the treatment of confirmed hypertension in people with diabetes, are featured in the the September issue of

The Association recommends that people with

have blood pressure measurements taken at every routine clinical visit and, for people with diagnosed hypertension, taken at home as well. Patients with an elevated blood pressure should have their blood pressure conï¬rmed with multiple readings, including measurements on a separate day, to diagnose hypertension, according to the panel.

Lifestyle management plans for lowering blood pressure are also highlighted in the guidelines and include suggestions on weight loss, nutrition, and increased physical activity. The statement also details, step-by-step, the recommended approach for the use of medication in the treatment of hypertension in people with diabetes, which depends on initial blood pressure, kidney health, response to treatment and adverse effects.

"patients with a confirmed blood pressure ≥160/100 mmHg should have prompt initiation and timely titration of 2 drugs or a single-pill combination of drugs demonstrated to reduce cardiovascular events in patients with diabetes, in addition to lifestyle therapy (Grade A recommendation).

Treatment include drug classes demonstrated to reduce cardiovascular events in patients with diabetes: ACE inhibitors, angiotensin receptor blockers (ARBs), thiazide-like diuretics, or dihydropyridine calcium channel blockers. Multiple-drug therapy is generally required to achieve blood pressure targets (Grade A recommendation).

An ACE inhibitor or ARB is the recommended first-line treatment for hypertension in patients with diabetes and urine albumin-to creatinine ratio  ≥ 300 mg/g creatinine (Grade A recommendation) or 30—299 mg/g creatinine (Grade B recommendation). If one class is not tolerated, the other should be substituted. (Grade B recommendation).

For patients with an ACE inhibitor, serum creatinine/estimated glomerular filtration rate and serum potassium levels should be monitored (Grade B recommendation)."

The Association provides detailed information regarding pregnancy, diabetes, and hypertension. The statement emphasizes that women with preexisting hypertension or mild gestational hypertension (blood pressures less than 160/105 mmHg), and no evidence of end-organ damage, should not be treated with antihypertensive medications, as there is no benefit that clearly outweighs the potential risks. Blood pressure targets and potential medication guidelines are also included for pregnant patients with diabetes who do require treatment for hypertension.

Antihypertensive treatment for people with diabetes in the absence of hypertension is addressed, with the position statement indicating there is little evidence that blood pressure medication improves health outcomes in this group of patients. Additionally, the statement offers recommendations for adults who are 65 years of age and older who have diabetes and hypertension.

“In the past two decades, we have seen a decrease in ASCVD morbidity and mortality in people with diabetes, and evidence indicates that advances in blood pressure control are likely the key to such improvements,” the Association’s Chief Scientific, Medical & Mission Officer William T. Cefalu, MD, said in a press release.

“As medical and pharmacological developments occur, it is imperative that medical providers, diabetes educators and patients stay abreast of the most current care recommendations that can lead to improved cardiovascular health for people with diabetes and will ultimately result in better overall health and fewer diabetes-related complications.”

1. ADA. Diabetes and Hypertension: A Position Statement by the American Diabetes Association.

2017; 40(9): 1273-1284. http://care.diabetesjournals.org/lookup/doi/10.2337/DCi17-0026. Accessed Sept. 11, 2017.

2. American Diabetes Association Issues Updated Diabetes and Hypertension Position Statement [news release]. Arlington, Virginia. ADA website. Aug. 22, 2017. http://www.diabetes.org/newsroom/press-releases/2017/american-diabetes-association-updated-diabetes-and-hypertension-position-statement-2017.html. Accessed Sept. 11, 2017.

The ADA's recommendations, which include a newly added pictorial algorithm for the treatment of confirmed hypertension in people with diabetes, are featured in the the September issue of Diabetes Care.

ADA Officials Make Recommendations for Patients with Diabetes and Hypertension

The FDA has approved delafloxacin (Baxdela, Melinta Therapeutics), a fluoroquinolone designed to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.

The Baxdela New Drug Application (NDA) approvals were supported by 2, phase 3 studies in patients with ABSSSI, demonstrating that IV and oral Baxdela monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours, according to a statement from Melinta.

Baxdela was well tolerated with a 0.9% discontinuation rate in the phase 3 studies due to adverse events. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies.

According to the statement from Melinta, the 450 mg tablet is bioequivalent (area under the curve) to, and interchangeable with the 300 mg IV dose, and can be dosed without regard to food. “Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine. Approval of new therapies like Baxdela, which is effective against methicillin-resistant Staphylococcus aureus (MRSA) and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients,” Dr. David Hooper, professor of medicine, Harvard University, and chief of Infection Control, associate chief, Division of Infectious Diseases, Massachusetts General Hospital said in the statement.

Melinta Therapeutics anounces US FDA Approval of Baxdela for acute bacterial skin and skin structure infections. NEW HAVEN, Conn. Melinta website. Accessed June 19, 2017.

Colleen Hall

Articles

Price of Insulin Doubles in Recent Years

Top 10 Drugs Involved in Overdoses Identified in CDC Report

ADA Officials Make Recommendations for Patients with Diabetes and Hypertension

FDA Approves Skin Infection Antibiotic Medication