This week we continue to look at gender medicine- how diseases may manifest themselves differently, and how medications may affect differently- depending on whether you are male or female.

An editorial in Nature in 2010 urged us to “put Gender on the Agenda,” as increasingly we are seeing from research results that there are distinct gender-based differences in disease incidence and activity, and treatment methods, especially medication. Cancer, for example, is the second leading cause of death among women and men, (Anderson, R.N., Deaths: Leading Causes for 2000. National Vital Statistics Reports. 2002, National Center for Health Statistics: Hyattsville, MD), however mortality rates and the disease course differ according to gender.

In looking at cancer, we see that in general, more women are screened but more men are diagnosed, and that “The gender differential in cancer incidence rates is comparable to ethnic and racial disparity in magnitude, and yet, most studies fail to look for it.” That is beginning to change with recent studies and clinical trials seeking to reduce disparities by including more women.

If we look at lung

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“Women are from Venus, Men are from Mars.” “Women think differently than men.”

These viewpoints appear to be widespread and popular, fueling spirited and on-going debate in the media and the arts, but what about healthcare and medicine?

Most medical research over the years has focused on white men as subjects, and results were then extrapolated to include everyone else. From an ethical perspective, there were some humanistic reasons for this, e.g., protecting women and children from experimental research that may not have benefited them. In many cases, however, research focused on those in positions of power. This situation is slowly but surely changing, and we are now witnessing the rise of Gender Medicine.

A very interesting article in Clinical Chemistry and Laboratory Medicine, entitled “Gender Medicine: A Task for the Third Millennium,” defines gender-specific medicine as the study of how diseases differ between men and women in terms of prevention, clinical signs, therapeutic approach, prognosis, and psychological and social impact. They

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Biosimilars are defined as “similar versions of an existing biological medicine by a different manufacturer.” Biosimilars may be used to treat difficult-to-manage conditions including rheumatoid arthritis, multiple sclerosis, chronic pain, HIV and cancer, among other conditions. Because they are more complex and more difficult to manufacture than other pharmaceuticals, rigid compliance to regulations and quality control are crucial to avoid contamination and drug shortages. Their complexity also means that they are more expensive for the patient.

A recent article by NBC News suggests that “the number of patients who could benefit from these more sophisticated therapies will only continue to grow, in some cases by 15% annually.” But how will we afford them?

Changes are afoot in many health insurance plans, and some new rules state that any cost-savings must be weighed against severe health consequences, particularly where obtaining prior approval (an often lengthy process) or “step therapy” where a number of cheaper drugs are tried before moving on to more expensive ones.

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Healthcare costs continue to be a concern, despite efforts underway to reduce them through healthcare reform initiatives.  One area, in particular, is worrying patients and physicians alike: specialty drugs or biologics. An article in Workforce Management reports that specialty drugs “make up about 17% of employers’ total drug costs, even though just 1% of the workforce takes them.”  Reuters reports that “approximately 57 million Americans rely on specialty drugs,” with the average prescription costing $1,766.00 in 2011.

“Specialty drugs are high-cost drugs used to treat complex or rare conditions, such as multiple sclerosis, rheumatoid arthritis, hepatitis C and hemophilia. The drugs are often self-injected or administered in a physician’s office or through home health services,” according to Wellmark. Specialty pharmacies specialize in the delivery and clinical management of specialty drugs.  It is reported that the average cost per specialty medication is $2,000.00 per month,

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Today, we are hoping to provide answers to some of your questions about the Donut Hole! Tell us about your experiences. We would love to hear from you.

 1.    What is the donut hole? To answer that question, we first need to understand Medicare and Part D.

According to Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services, Medicare is the federal health insurance program for people 65 or older, people under 65 with certain disabilities, and people with End-Stage Renal Disease (permanent kidney failure).  People with Medicare have the option of paying a monthly premium for outpatient prescription drug coverage. This prescription drug coverage is called Medicare Part D.

Basic Medicare Part D coverage works like this:

  • You pay out-of-pocket for monthly Part D premiums all year.
  • You pay 100% of your drug costs until you reach the $310.00 deductible amount.
  • After reaching the deductible, you pay 25% of the cost of your drugs, while the Part D plan pays the rest, until the total you and your plan spend on your drugs reaches $2970.00.
  • Once you reach this limit, you have hit the coverage gap referred to as the “donut hole,” and you are now responsible for the full cost of your drugs until the total you have spent for your drugs reaches the yearly out-of-pocket spending limit of $4,550.
  • After this yearly spending limit, you are only responsible for a small amount of the cost, usually 5% of the cost of your drugs.

2.    What is the structure, e.g., cut-offs, coverage amounts and patient payment percentages?

The “donut hole” refers to a gap in prescription drug coverage under Medicare Part D. In, 2013, once you reach $2,970 in prescription drug costs (which include both your share of covered drugs and the amount paid by your insurance), you will be in the

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