The high cost of prescription drugs in the United States (US) has been the focus of much discussion and debate in recent years, as price tags continue a precipitous march upward.
The issue is raised again, this time by researchers from Harvard Medical School in Boston, Massachusetts, in a new paper published in the August 23/30 issue of JAMA. Specifically, Aaron S. Kesselheim, MD, JD, MPH, an associate professor of medicine at Harvard, and colleagues examined the wave of price hikes that have occurred in the past few years.
From 2010 to 2012, the rise in drug cost was more modulated because of expiring patents on many widely used medications, note the authors. However, cost has now begun climbing once again, highlighted by several new and very expensive products that entered the marketplace, as well as steep price increases in older drugs.
Between 2013 and 2015, there was about a 20% increase in net spending on prescription drugs, which outpaced “a forecast 11% increase in aggregate health care expenditures,” they note.
Currently, the cost of prescription drugs now accounts for an estimated 17% of total healthcare spending, and coverage constitutes 19% of employer-based insurance benefits.
Blame Industry
In their paper, the Harvard group places the blame for high drug costs mainly on industry.
The high prices largely arise “from the approach the United States has taken to the granting of government-protected monopolies to drug manufacturers, combined with restriction of price negotiation at a level not observed in other industrialized nations,” they write.
In addition, unlike the situation in nearly every other advanced nation, the US healthcare system permits drug manufacturers to set their own price for any given product, they add.
Thus, pharmaceutical manufacturers are able to maintain high prices based on two market forces: protection from competition and negotiating power.
With that in mind, Dr Kesselheim and coauthors believe that the most “realistic” short-term strategies that would address escalating costs include enforcing more stringent requirements for the award and extension of exclusivity rights, enhancing and encouraging competition by ensuring timely availability of generic drugs, providing greater opportunities for meaningful price negotiation by government payers, and educating all stakeholders about making these choices.
“There are things Congress can do, such as promoting public funding of science to encourage future treatment development, investing in comparative effectiveness research, funding for the Federal Trade Commission, and re-examining policies that provide market exclusivity for noninnovative products,” he explained. “There are also things that physicians and patients can do, such as talk more about drug costs, look for less expensive evidence-based alternatives, and talk to their legislators.”
“I think it’s a multipronged issue,” Dr Kesselheim added.
Approached for comment, Joshua P. Cohen, PhD, research associate professor at the Tufts Center for the Study of Drug Development, Boston, agreed that there is a lack of national bargaining power in a multiple-payer system, such as the one that exists in the United States, and that state and federal regulations often prohibit payers from fully using their clout when negotiating deals with the drug industry.
Also commenting on the study, Holly Campbell, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization for the pharmaceutical industry, says that this study “advances a misleading narrative by understating how the competitive marketplace for medicines in the United States helps control costs and provides patients with access to innovative treatments and cures faster than in many parts of the world.
“In the United States, generic utilization rates are nearly 90 percent, competition occurs among brand name medicines and large, powerful purchasers negotiate aggressively,” said Campbell. “In fact, Express Scripts, the United States’ largest pharmacy benefit manager, now touts that hepatitis C treatment is less expensive here than in western countries thanks to their aggressive negotiation.”
Branded and Specialty Products
In their paper, Dr Kesselheim and colleagues set out to better understand the factors that have contributed to the most recent price escalation hike and possible policy options that could help curb rapidly increasing costs. They reviewed the literature published in peer-reviewed medical and health policy journals for an 11-year period beginning in 2005.
Even though these products make up only 10% of all prescriptions in the United States, they account for nearly three quarters (72%) of drug spending.
In the 8-year period between 2008 and 2015, the price tags for the most common branded drugs increased 164%, which was far in excess of the consumer price index of 12%.
While these high-priced products have historically been limited to drugs used to treat rare conditions, new high-cost products used to treat millions of patients have now entered the marketplace. As an example, a growing number of new oncology drugs now exceed $100,000 per course of therapy.
Increasing Competition
A lack of competition allows for manufacturers to set high prices for brand-name drugs, but the authors note that competition between branded agents generally doesn’t result in lower prices.
“In the United States, generic utilization rates are nearly 90 percent, competition occurs among brand name medicines and large, powerful purchasers negotiate aggressively,” said Campbell. “In fact, Express Scripts, the United States’ largest pharmacy benefit manager, now touts that hepatitis C treatment is less expensive here than in western countries thanks to their aggressive negotiation.”
Branded and Specialty Products
In their paper, Dr Kesselheim and colleagues set out to better understand the factors that have contributed to the most recent price escalation hike and possible policy options that could help curb rapidly increasing costs. They reviewed the literature published in peer-reviewed medical and health policy journals for an 11-year period beginning in 2005.
Even though these products make up only 10% of all prescriptions in the United States, they account for nearly three quarters (72%) of drug spending.
In the 8-year period between 2008 and 2015, the price tags for the most common branded drugs increased 164%, which was far in excess of the consumer price index of 12%.
While these high-priced products have historically been limited to drugs used to treat rare conditions, new high-cost products used to treat millions of patients have now entered the marketplace. As an example, a growing number of new oncology drugs now exceed $100,000 per course of therapy.
Increasing Competition
A lack of competition allows for manufacturers to set high prices for brand-name drugs, but the authors note that competition between branded agents generally doesn’t result in lower prices.
In 2010, note the authors, the estimated average postrebate prices for drugs were about 10% to 15% higher in the United States than in Canada, France, and Germany.
One example often cited is Medicare, which accounts for almost a third (29%) of the nation’s prescription drug expenditure, but it is prohibited by federal law from negotiating for lower prices. In addition, Medicare is also required to offer coverage to all products in certain therapeutic categories, such as oncology.
Conversely, other government programs are not bound by the same restrictions. Medicaid is entitled to receive a rebate (discount) of at least 23.1% of the average manufacturer price for most branded drugs and has protection against increased prices that exceed the inflation rate.
In the private sector, negotiating power is far more varied, especially with the advent of prescription benefit management companies, which have become prominent intermediaries that help employers or insurers promote appropriate prescription drug use and decrease its cost.
In some cases, note the authors, they have been able to negotiate prices for certain drugs, but aggressive negotiation still has not become the norm.
“For example, new data show patients in Europe wait an average of nearly 2 years longer to get access to cancer medicines compared to patients in the United States,” Campbell said. “Even after this wait, patients in Europe still have access to far fewer medicines.”
Campbell added that even as more Americans have coverage, many more patients are facing high pharmacy deductibles, rising out-of-pocket costs, and other barriers to care, putting their ability to stay on needed therapy at risk. “Instead of focusing on proposals that will stifle innovation, we need to concentrate on pragmatic solutions, including increasing competition for older medicines, modernizing the drug discovery and development process, removing barriers that limit paying for value and engaging and empowering consumers,” she said. “In doing so, we will enhance the private market and address costs holistically.”
JAMA. 2016;316:858-871.
Source: MedScape By R. Nelson, BSN, RN
