By Burke J. Balch, J.D., director of the National Right to Life Committee’s Powell Center for Medical Ethics
These days, as for some time past, much outrage is directed at pricey drugs, and both the government and insurance companies increasingly implement policies to keep patients from getting them.
To give one widely-publicized example, Members of Congress and others have been almost demagogic in shrill criticism of the $1,000 per pill cost of Sovaldi, a new treatment for Hepatitis C. They have done so despite the evidence, as summarized in a Forbes article from March 2014 that
“Sovaldi is extremely effective. The prior standard-of-care, Vertex Pharmaceuticals’ Incivek (telaprevir), when added to two other drugs (interferon and ribavirin) cures at most 80% of [previously untreated Hepatitis C] patients after 24 weeks, with nasty toxicity. In a similar combination, Sovaldi cures roughly 90% of patients in half the time, with virtually no side effects.”
In fact, the Forbes article notes, Sovaldi’s cost-per-cure is less than that of Incivek.
Now there is definitive data showing that, overall, the most expensive new drugs are worth their cost. An article in the October 2014 issue of Health Affairs reporting a comprehensive study of the matter is entitled “Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs.”
The article explains that the majority of new drugs currently being approved by the Food and Drug Administration (FDA), termed “specialty drugs[,] . . . are produced using advanced biotechnology and require special administration, monitoring, and handling.” This is in contrast to “traditional drugs,” which “are manufactured using simpler processes, are typically self-administered, and are most often dispensed through . . . retail pharmacies.”
These “specialty drugs,” it states, “are often many times more expensive than traditional drugs, which raises questions of affordability and value.”
Looking at specialty drugs approved by the FDA during 1999-2011, the study reported in the article evaluated: a) their additional cost in comparison with pre-existing treatments for the diseases they tackled; and b) the increased value the new drugs provided in saving lives and improving health in comparison with the pre-existing treatments.
The study then sought to measure the cost-effectiveness of the improvements. Stating that “[s]pecialty products were often introduced for diseases with substantial unmet health needs, such as cancer or multiple sclerosis,” the study authors concluded, “Our study suggests that specialty drugs often have higher costs than traditional drugs, but that they also tend to confer greater benefits and hence may still offer reasonable value for money. We found that five of the fifteen drugs with the largest additional costs were also among the fifteen drugs with the largest added benefits.”
In particular, they said, “specialty drugs can offer good value for various complex and burdensome diseases.”
The study offers strong evidence to rebut the oft-heard claim that in America pharmaceuticals are over-priced while our health care system allegedly provides inferior results to those in overseas countries where health care spending is sharply curtailed by government limits.
Despite its general conclusion, however, the study may well understate the value of specific new drugs which it deemed inadequately cost-effective. That is because the measure the study used to evaluate the increased value of the new specialty drugs over pre-existing treatment explicitly and intentionally treats preserving the lives of those deemed to have a low “quality of life” as of less value than preserving the lives of those without disabilities.
That measure is the “quality-adjusted-life-year” or “QALY.” As the article notes, “A year of perfect health is equal to one QALY, and a year of less-than perfect health is equal to less than one, depending on the level of impairment or disability.” In short, resources devoted to saving the lives of those with disabilities are deemed to be wasted, the degree of waste depending on the degree of disability.
Preserving the life of a person who uses a wheelchair is quite forthrightly and unapologetically treated as of less worth than preserving the life of one who can walk, because it is presumed that the wheelchair user has a lower “quality of life.” Tragically, this breathtaking bigotry has become all but universally accepted among health policy analysts; the article nonchalantly states, “The QALY is a standard metric of health impact that accounts for both length and quality of life.”
Because the study judged the value of the drugs in terms of the increased number of QALYs they achieved, in comparison with pre-existing treatment, a drug that preserved life for a longer period of time, but with a disability, might well be assigned a lower QALY than a drug that preserved life for a shorter period of time, but with no disability. Despite the article’s conclusion that new specialty drugs on average offer value for money, it nevertheless claimed “many new . . . drugs offer relatively modest benefits over preexisting care. Thirty-two percent of the drugs in our data set . . . offered no health benefit over preexisting treatments. Of the drugs that did offer health benefits, approximately one-third . . . offered less than 0.1 incremental QALYs . . . or roughly five weeks of perfect health. Two-thirds . . . offered less than 0.3 incremental QALYs . . . or roughly fifteen weeks of perfect health.”
How many of these drugs significantly expanded lifespans, but with disabilities? From the information in the article it is impossible to know.
For those of us committed to the equal dignity of all human life, there are two significant lessons to be drawn – that the discriminatory quality-of-life ethic’s tentacles are, tragically, deeply rooted in America’s health care system, dominating the views of its most influential policy-makers, and that we should be deeply suspicious of claims that “cost-effectiveness” analysis appropriately justifies limiting access to and spending on “expensive” life-saving drugs.