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Soaring Drug Prices Continue to Burden Consumers

No End in Sight

Maura McCaffrey

Maura McCaffrey says health plans work with drug companies to negotiate prices and with community physicians to assess patient needs, but rising costs continue to be a concern.

It’s a well-publicized issue in an election year, so it’s no surprise that lawmakers — including several presidential candidates — have been teeing off on soaring drug prices.

“Americans pay, by far, the highest prices for prescription drugs in the entire world,” Bernie Sanders recently noted. “A life-saving drug does no good if the people who need it cannot afford that drug.”

He pointed out that nearly one in five Americans between ages 19 and 64 did not get at least one prescription filled last year because they did not have enough money.

“There is no question that medicines help millions of people live healthier and longer lives, and can also prevent more expensive illnesses and treatments,” Sanders continued. “However, it is unacceptable that the United States now spends more than $370 billion on prescription drugs, and spending is rising faster than at any point in the last decade.”

Rising drug prices are having tangible effects on consumers, including those in Massachusetts. Among 16 carriers that recently testified before the state Division of Insurance, the first quarter of 2016 saw an average rate increase of 6.3%. They were asked to present the data used in determining their proposed rate filings for small-group plans in the second quarter of 2016. There are other reasons behind the increases, including the cost of expanding coverage under the Affordable Care Act, but drug prices are universally cited as a driving factor.

Meanwhile, even amid ever-louder complaints from lawmakers and the media, Pfizer, Amgen, Allergan, Horizon Pharma, and other manufacturers have raised U.S. prices for dozens of branded drugs since late December, with many of the increases between 9% and 10%, according to the Wall Street Journal. Overall, prescription-drug spending rose 12.2% in 2014, after just 2.4% growth in 2013, the Centers for Medicare and Medicaid Services reported.

What’s Happening?

There are a number of factors at play, ranging from the fact that the U.S. government doesn’t regulate drug prices to rising development and production costs; it can take more a decade and more than $1 billion to get a new drug approved. Still, there’s plenty of opportunity, industry critics say, to bring relief to patients.

“Their argument is we can — we can raise prices on this, the market will bear it, people like this drug, they rely on it, their physician will write it,” Marco Rubio recently told an audience on a campaign stop, blasting drug companies. “And so, because we can, we do. And it’s just pure profiteering.”

Insurance companies are feeling the pressure, Maura McCaffrey, president of Health New England (HNE), told BusinessWest. “Health plans have a responsibility to manage the pricing of these pharmaceuticals.”

They do this in two major ways, she explained. The first is to work with a pharmacy benefit manager, a third-party liaison between drug companies and insurers, to negotiate the drug prices. “Over the past year, Health New England did a very large renegotiation with its pharmacy contracts, and that has been very beneficial to members in Western Massachusetts.”

The second strategy is HNE’s clinical care assessment committee, which includes both primary-care and specialty physicians and meets eight times a year to discuss new medications — how they compare with current offerings and who the most appropriate patients would be.

“We come up with clinical criteria to make sure the right people have access to the right medications,” McCaffrey said, adding that, if the drug in question treats an uncommon condition, the committee will go into the local medical community to find additional specialists who can speak to that topic.

Difficult Spot

At the gathering before the Division of Insurance, Elin Gaynor, HNE’s assistant general counsel, cited several recent examples of unsustainable drug prices, including $259,000 per year for a drug treating cystic fibrosis, $118,200 per year for a breast-cancer medication, and more than $100,000 annually for a new hepatitis C treatment.

“As a community, we must be willing to tackle some very tough questions,” added Michael Caljouw, vice president of Government and Regulatory Affairs at Blue Cross Blue Shield of Massachusetts. “What is the right price for new drugs and therapies? What is the appropriate use of them? Who decides? How can we achieve a better balance between medical advances and affordability?”

In making coverage decisions, McCaffrey told BusinessWest, safety and effectiveness always trump cost. “Then, if it looks to be a safe and efficacious medication, we look at what else is on the market and compare the safety profiles and efficacy profiles. The last thing we do is compare the cost profiles. We do this every time.”

Dr. Peter Bach, a physician and director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, recently explained in the New York Times that drug manufacturers are hamstrung by the complexity of biology, government regulations, and shareholder expectations for high profit margins.

What they’re not saying, he went on, is that they take advantage of laws that force insurers to include virtually all expensive drugs in their policies, and an industry philosophy that demands that every new healthcare product be available to everyone — no matter its cost or how little it actually helps.

In late 2014, the New England Journal of Medicine detailed a number of ways drug companies take advantage of this system. For instance, they buy up the rights to inexpensive generic drugs, lock out competitors, and raise prices. In one example, albendazole, a drug used to treat certain kinds of parasitic infection, was approved 20 years ago and, as recently as 2010, had a wholesale cost of $5.92 per day. Three years later, it was $119.58.

“Many of these drugs remain key therapeutic tools. The number of prescriptions for albendazole has increased dramatically in part because the drug has increasingly been used to treat parasitic infections in refugees,” explained the report’s authors, Drs. Jonathan Alpern, William Stauffer, and Aaron Kesselheim.

“The Centers for Disease Control and Prevention recommends presumptive treatment of refugees arriving in the U.S. if they have not had prior treatment,” they went on. “Because the people who need albendazole are generally disadvantaged, the costs resulting from the enhanced demand and associated price increases are largely borne by the patients themselves through substantial out-of-pocket payments or by taxpayers through public insurers such as Medicaid and the Refugee Medical Assistance program.”

The albendazole situation is hardly unique, they added. “It is well-known that new, brand-name drugs are often expensive, but U.S. healthcare is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive.”

For example, the price of captopril, which is used for hypertension and heart failure, increased by more than 2,800% between November 2012 and November 2013, from 1.4 cents to 39.9 cents per pill. Similarly, the price of clomipramine, an antidepressant also used for obsessive-compulsive disorder, increased from 22 cents to $8.32 per pill, and the price of doxycycline hyclate, a broad-spectrum antibiotic introduced in 1967, increased from 6.3 cents to $3.36 per pill.

The practice infuriated a number of U.S. lawmakers, who teed off on drug companies last month during a session of the Senate Special Committee on Aging.

“I find it so disturbing and unconscionable that a company would buy up a decades-old drug that it had no role in developing … and then would hike up the price to such egregious levels that it’s having an impact on patient care,” said U.S. Sen. Susan Collins, who chairs the committee.

Beyond the Status Quo

Solutions have been difficult to come by, but Bach suggests one: what if insurance companies weren’t required to cover all drugs? He explained that, in Europe, many countries reject a handful of drugs each year based on their high cost and relatively low effectiveness — so companies are forced to offer their products at attractice prices.

As a result, prices in Europe for prescription drugs are typically 50% below what U.S. consumers pay. The pharmaceutical industry might argue, he went on, that drug spending accounts for just 10% of all healthcare spending, but that equals around $300 billion per year — no small number.

And those costs are being passed on to patients. The Wall Street Journal noted that Lilly’s drug Cyramza will cost the average Medicare patient $2,600 per month without supplemental insurance — more than most Medicare-age people earn each month, before taxes.

It would make sense, Bach argued, to do one of two things: free insurers and government programs from the requirement to include all expensive drugs in their plans, or demand that policymakers set drug prices in the U.S. equal to those seen in Europe. “Either approach would be vastly superior to the situation we have today.”

The New England Journal of Medicine report offered another strategy for bringing prices under control. The authors suggest that substantial increases in the price of an unpatented drug could trigger the FDA to issue a public announcement seeking other manufacturers for generic versions of the product. Companies responding to such a request could receive expedited reviews of their manufacturing processes, and generic-drug user fees could be waived to further increase incentives for potential competitors.

Meanwhile, they concede, there is little that consumers can do.

“Some patients seek to acquire these drugs in other countries, since many of them are widely and inexpensively available outside the U.S., but such foreign sources may be of variable quality. Until regulatory and market solutions are implemented to reduce prices for these older drugs, patients requiring such drugs and the physicians treating them will continue to be faced with difficult choices.”

McCaffrey said Health New England is trying to maintain as much consumer choice as possible, but not at the expense of ballooning rates.

“Going into 2016, one of our top priorities is to make sure people have access to the medications they need,” she noted, “but at the same time make sure we can control premiums for them so they can afford the health insurance that gives them access to the medications they need.”

Joseph Bednar can be reached at [email protected]

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