Why the ‘free market’ for drugs doesn’t work and what we can do about it

https://theconversation.com/why-the-free-market-for-drugs-doesnt-work-and-what-we-can-do-about-it-70007

The United States faces a major problem with prescription drug prices. Even as the prices of most goods and services have barely budged in recent years, the cost of drugs has surged.

During the presidential campaign, both Hillary Clinton and Donald Trump cited the high cost of prescription drugs as an issue that needed to be addressed. Most recently, the president-elect took direct aim at the pharmaceutical industry, saying it’s “getting away with murder” and arguing “new bidding procedures” are necessary to lower drug prices.

Trump didn’t get into specifics about what that would mean, but the most often suggested way to lower drug prices has been to expand the ability of major government buyers, such as Medicare, to negotiate prices.

While such negotiations could result in lower prices, we believe, based on our experience as economists and public policy experts, an alternative using public utility pricing would work better and ensure the discovery and distribution of important new medications.

‘Medically necessary’

The recent drug price data are indeed frightening.

In 2015 spending on prescription drugs rose by 8.5 percent to US$309.5 billion, compared with a rise of just 1.1 percent for consumer goods and services. Spending for specialty drugs increased by an even heftier 15 percent, on average. Individual examples that made big headlines, such as Turing Pharmaceuticals raising the price of Daraprim (a lifesaving drug for people with weakened immune systems) from $13.50 to $750 a tablet, are even more extreme.

In a competitive market, prices of a product are forced down to their costs plus a fair profit. Drug companies, on the other hand, can get away with raising prices without losing customers because the demand for certain medications is insensitive to their cost. If a drug will save your life, you’ll probably pay whatever the cost, if you can.

The problem may soon get worse. Last May, Washington state’s Medicaid program was ordered to provide the hepatitis C drugs Sovaldi and Harvoni after a court ruled they were “medically necessary.” The Washington State Health Care Authority had previously provided Harvoni – which costs $94,500 for an eight-week course of treatment – and Sovaldi – $84,000 for 12 weeks – to only the sickest patients.

Since then, other participants in Medicaid and private insurance plans have filed similar suits. Some states, including Florida, Massachusetts and New York, have already altered their Medicaid programs to pay for such life-preserving expensive drugs.

If “medically necessary” rulings become more common, producers of these drugs will have no need to worry that higher prices will reduce sales. They will be able to charge whatever they want and increase revenue and profit without hurting unit sales because insurance providers will need to make such drugs available to their policy holders.

A proposed solution

So what can be done to fix the problem?

Allowing more government agencies to negotiate prices is one option. While this has lowered the prices paid by the Veterans Administration, it may not be the best way to go in a market like the one for many innovative new specialty drugs in which consumers have no good substitutes to choose from.

Economists have shown that negotiated outcomes are not always the most efficient ones. As an example, if the government were to push drug producers too hard in negotiations, the public could get a great deal on prices in the short term but that could end up discouraging the development and testing of new drugs, which would hurt everyone in the long run.

A better approach is to start with a public utilities method, which is frequently used when there is a natural monopoly in production, such as for water or power. In these cases, state and local governments typically allow a company to have a monopoly over the market but also establish regulatory commissions to determine “fair” prices. Such prices take into account current costs, the need for investment in production facilities and the need to earn a rate of return on capital invested.

A wrinkle with drug developers is that they can incur substantial costs in their quest for new medications, including dead-end ideas and extensive testing. A 2014 report put the cost to develop a new drug at $2.6 billion, while others put it at around half that.

Under our proposal, an independent federal panel consisting of scientists, medical professionals, public health experts and economists – perhaps working as part of the FDA approval process and called on when the price of a drug is above a specific threshold – would determine the maximum price a government buyer such as Medicare or Medicaid could pay for a new drug. It could also do the same for existing treatments – for example, it could have turned down Turing’s huge Daraprim price hike.

A key element of this idea is that the panel would develop methods to identify and set maximum prices for existing and prospective drugs that cure a serious illness, improve the quality of life, limit contagion or otherwise provide large benefits to society. These procedures would need to make sure that producers of these important new drugs are sufficiently rewarded for those costly efforts.

A defensible drug-pricing system

Tough negotiations can help lower how much the government has to pay for its purchases, yet they’re not always the optimal way to achieve intended long-term results. With drugs, we definitely need to lower prices but we also need to ensure drug companies can “win” as well to avoid compromising their ability to develop lifesaving medicines.

While economists generally oppose government intervention in a “free market,” the current situation cries out for change. It is time to establish a defensible system for pricing drugs, one that both protects the public from price-gouging and encourages the development of new drugs.

Healthcare Triage: Gaming the System – Orphan Drugs Part 3

Healthcare Triage: Gaming the System – Orphan Drugs Part 3

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Even if the Orphan Drug Act were working properly, its enormous costs might outweigh its exiguous benefits. But it’s not working properly. Drug manufacturers are gaming the Act in at least three important ways. They’re the topic of this week’s Healthcare Triage.

Drugmakers Dramatically Boosted Lobbying Spending In Trump’s First Quarter

Drugmakers Dramatically Boosted Lobbying Spending In Trump’s First Quarter

Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.

Congressional records show those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115 percent from a year ago as several companies embroiled in controversies raised their outlays significantly.

“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”

Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sens. Bernie Sanders (I-Vt.) and John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.

Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” LaPira said.

Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.

PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter —more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.

In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.

When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.

“It’s quite literally hitting their bottom line,” LaPira said.

Drugmakers under fire more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.

Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.

Teva and Shire also more than doubled their spending. Teva was accused as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.

Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.

Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultra-conservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.

 

With Drug Costs In Crosshairs, Health Firms Gave Generously To Trump’s Inauguration

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Facing acute risks to their businesses from Washington policymakers, health companies spent more than $2 million to buy access to the incoming Trump administration via candlelight dinners, black-tie balls and other inauguration events, new filings show.

Drugmaker Pfizer gave $1 million to help finance the inauguration, according to documents filed with the Federal Election Commission. Amgen, another pharmaceutical company, donated $500,000. Health insurers Anthem, Centene and Aetna all gave six-figure contributions.

They joined a surge of corporate donors from multiple industries to break inauguration-finance records even as then-President-elect Donald Trump promised to “drain the swamp” of Washington influence-peddling.

But the stakes for the health industry were especially high as the new administration prepared to take power.

Two weeks before Pfizer’s donation, Trump told Time magazine: “I’m going to bring down drug prices.” At the same time, one of his top goals was repealing Obamacare — the Affordable Care Act — and its billions in subsidies for insurance companies and hospitals.

Also writing checks for the inauguration were drugmaker Abbott Laboratories, drug wholesaler Caremark, insurer MetLife and Managed Care of North America, a dental benefits manager.

Trump’s inaugural committee raised $107 million, more than twice as much as for any previous presidential investiture. President Barack Obama’s 2009 inauguration held the previous record of $53 million.

Obama banned corporate donations that year and limited individual donations to $50,000 but accepted corporate grants for his 2013 inauguration.

No health company gave more to Trump’s event than Pfizer, whose profits for Lyrica, Prevnar 13 and other high-priced medicines could come under pressure if the Medicare program for seniors is allowed to negotiate on cost, as Trump has suggested.

Lyrica alleviates nerve and muscle pain. Prevnar 13 is a vaccine against pneumococcal pneumonia.

Along with several other pharma companies, Pfizer is the subject of a Justice Departmentinvestigation over donations to charities that help Medicare patients avoid copayments for expensive drugs.

Pfizer CEO Ian Read is also a vocal advocate of cutting corporate income taxes, which Trump has pledged to do. The Obama administration thwarted Pfizer’s $160 billion deal to move its legal residency to low-tax Ireland to merge with Botox maker Allergen.

Pfizer’s $1 million donation entitled it to four tickets to a “leadership luncheon” with “select Cabinet appointees and House and Senate leadership,” according to a solicitation brochure obtained and posted online by the Center for Public Integrity.

“As it has been the case with previous presidential inaugurations, we made a financial contribution to the 58th Presidential Inaugural Committee and a group of our senior leaders participated in various official events,” said Pfizer spokesperson Sharon Castillo. She declined to identify the executives.

 

High Drug Prices Remain a Conundrum, Analysts Say

http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/64347?xid=nl_mpt_DHE_2017-04-07&eun=g1061559d0r&pos=11

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The problem of high prescription drug costs has no easy solution, analysts said Tuesday at an event here sponsored by Johns Hopkins University.

“It’s a major problem … and there’s no light at end of tunnel,” said Joshua Sharfstein, MD, associate dean for practice and training at Johns Hopkins University’s Bloomberg School of Public Health in Baltimore.

Overall drug costs are growing 10%-12% a year, “far quicker than wages or medical cost growth,” he added. “And it inhibits our ability to address public health problems. When we have a challenge like hepatitis C, when people can’t get treatment because of the [high cost], we’re all at risk.”

Although many ideas for solving the problem are being discussed, none are moving forward, Sharfstein said. He noted that things could get worse if, for example, Congress were to pass something like the House Republicans’ American Health Care Act, which would have resulted in the loss of health insurance for an estimated 24 million people.

“If you take 24 million people off of insurance, that generates pressure to get as much out of every insured person for pharmaceuticals as possible,” meaning that drug prices could rise even higher, he said. “It’s entirely possible you’d see that shift continue, and it could really worsen all the different challenges we have.”

How Pharma Companies Game the System to Keep Drugs Expensive

https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive?utm_campaign=hbr&utm_source=facebook&utm_medium=social

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I help the University of Utah hospital system manage its drug budgets and medication use policies, and in 2015 I got sticker shock. Our annual inpatient pharmacy cost for a single drug skyrocketed from $300,000 to $1.9 million. That’s because the drug maker Valeant suddenly increased the price of isoproterenol from $440 to roughly $2,700 a dose.

Isoproterenol is a heart drug. It helps with heart attacks and shock and works to keep up a patient’s blood pressure. With the sudden price increase, we were forced to remove isoproterenol from our 100 emergency crash carts. Instead, we stocked our pharmacy backup boxes, located on each floor of our hospitals, to have the vital drug on hand if needed. We had to minimize costs without impacting patient care.

This type of arbitrary and unpredictable inflation is not sustainable. And it’s not the way things are supposed to work in the United States. Isoproterenol is a drug that is no longer protected by a patent. Theoretically, any drug company should be able to make a generic version and sell it at a competitive cost. We should have had other options to buy a competitors’ copy for $440 or less. But that’s not happening like it should. The promise of generic medications is getting further from reality each day. As the U.S. Senate considers President Donald Trump’s choice to head the Food and Drug Administration, now is the time refocus efforts on generic drugs.

 

Blame Game Over High Drug Prices Escalates With New Ad

https://www.bloomberg.com/news/articles/2017-04-06/blame-game-over-high-drug-prices-gets-worse-with-lobby-s-new-ad

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New punches were thrown in the blame game over U.S. drug prices Thursday.

Broadening its efforts to defuse outrage over skyrocketing prices, Pharmaceutical Research and Manufacturers of America, the industry’s lobbying association, started an advertising campaign urging insurers to share with customers more of the benefits of rebates they’ve negotiated. In response, the main health-insurance lobby pushed the blame back on drugmakers: “Enough with the distractions.”

Meanwhile, the head of one of the largest pharmacy benefit managers, who are often criticized by drugmakers for their lack of transparency, said his industry helps save money and manufacturers should stop faulting the middlemen.

Pharmacy benefit managers like Express Scripts Holding Co. — which manage drug benefits for employers and insurers, and privately negotiate prices on their behalf — receive discounts from manufacturers. The rebates lead to lower prices, but it’s up to insurers whether they are ultimately passed down to patients, Express Scripts Chief Executive Officer Tim Wentworth said in an interview on Bloomberg Television on Thursday.

“A hundred percent of the time, payers determine how they pass through,” he said.

Drug companies that raise prices “would blame the middleman,” the CEO said. Yet pharmacy benefit managers, or PBMs, are transparent with how they work within the health-care sector with payers. “For us it’s a real simple challenge: get the net cost as low as possible for our clients.”

Opaque System

The three main groups that are involved in the complex and opaque system of setting drug prices in the U.S. — drugmakers, insurance companies and PBMs — started to strongly fight off criticism months ago. The sector escalated its defense against Washington this year after drug prices became a frequent target for President Donald Trump. He’s threatened to use the government’s buying power to force prices down, which is the industry’s most dreaded option, but so far has not unveiled any specifics about how.

The new ad from PhRMA, which represents more than 50 companies and is one of the most powerful interest groups, is another step in its endeavor to demonstrate that other parts of the health-care industry are responsible for the costs faced by patients. In January, the group started a major initiative, including TV, radio and digital ads. Unlike most developed countries in the world, the U.S. doesn’t directly regulate medicine prices, and drugmakers have strongly resisted it.

The new campaign, “Share the Savings,” will include advertising across various mediums to educate the public about how the rebates for commercially insured patients with high deductibles and coinsurance aren’t passed along to consumers, PhRMA said in a statement. “Robust negotiations” have resulted in major discounts, the group said.

The Perverse Effects of Maryland Drug-Price Bill

http://www.realclearhealth.com/articles/2017/04/04/the_perverse_effects_of_maryland_drug-price_bill_110530.html?utm_source=RealClearHealth+Morning+Scan&utm_campaign=2ee066e433-EMAIL_CAMPAIGN_2017_04_04&utm_medium=email&utm_term=0_b4baf6b587-2ee066e433-84752421

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As President Trump said, health care is “complicated.”

When it comes to health care in America, virtually everyone claims to have the same broad goals: Accessibility to decent care that is affordable and not have it cost businesses and government (read: taxpayers) a fortune.

Good intentions abound, but politically feasible solutions are in short supply, and many bad or simplistic ideas are bandied about by policymakers on both sides of the aisle. A case in point is a Maryland bill that would crack down on “price gouging” by prescription-drug makers. The bill, which passed the House of Delegates on March 20 with an overwhelming, bipartisan margin of 137-4 and will probably be taken up by the Senate in the next few days, seems like a no-brainer. As Maryland Attorney General Brian Frosh said: “We’ve seen in Maryland and all over the country drug prices [are] skyrocketing.

However, the devil is in the details, and devilish it is. The bill, H.B. 631, excludes pricey brand drugs and only targets generic-drug makers, whose medicines save Maryland residents and taxpayers about $3.7 billion a year. If the bill becomes law, the state Attorney General could take generic drug makers to court for price increases that are vaguely described as “unconscionable.” Unconscionable is a legal doctrine used when consumers have no option to purchase an essential product at inflated prices. However, under the proposed Maryland law, it could be invoked when a generic maker increases the price of a pill from 15 cents to 50 cents but not when the manufacturer of a brand drug increases its price from $300 to $500 per pill.

Generics are a proven solution to high drug costs that saved America approximately $227 billion in 2015, including $90 billion for Medicare and Medicaid. Generics account for 89 percent of all prescriptions written, but only 27 percent of U.S. spending on medicines. In short, generics and a new class of off-brand drugs called biosimilars reduce health care costs and get affordable medicines into the hands of patients who need them most.

 

Quest to Lower Drug Prices Pits Trump Against Formidable Opponents

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Aiming to significantly reduce medication prices presents the president with golden opportunities and a set of daunting challenges, healthcare industry experts say.

President Donald Trump has said medication prices are too high and he plans to address the problem.

During his presidential campaign, Trump called for Medicare to negotiate drug pricing. In January, the president criticized the lobbying efforts of pharmaceutical companies and suggested again that the federal government should negotiate drug prices.

Although he faces high hurdles, the president appears to be on the right track, says Olusegun Ishmael, MD, MBA, an emergency room physician at Paris Community Hospital in Paris, IL, and former insurance company executive.

“The biggest insurer in this country is the U.S. government—between the Veterans Administration, Medicaid, and Medicare. The government should do the same thing that UnitedHealthcare and all the Blues do to negotiate pricing based on their volume,” he says.

Insurers and foreign governments have been leveraging their purchasing power to negotiate drug prices for decades, Ishmael says.

“If someone walks into CVS or Walgreens without insurance and wants to get a prescription, they will pay almost twice as much as the UnitedHealthcare pricing. The reason is volume—it is a numbers game. As an insurer, when I have a certain amount of volume, I go to my pharmacy benefit management company and say, ‘I am bringing you a million lives.'”

GOP chairman: Drug prices ‘high on our agenda’

GOP chairman: Drug prices ‘high on our agenda’

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House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said Tuesday that dealing with high drug prices will be “high on our agenda.”

The comments come after Walden attended a meeting at the White House earlier in the day with President Trump and the CEOs of several major drug companies, at which Trump pressed the companies to bring their prices down.

However, Walden pointed to solutions that are less far-reaching than what Democrats and Trump have proposed, such as allowing Medicare to negotiate drug prices. Instead, Walden said there could be legislation to speed up the Food and Drug Administration’s approval process for a new competitor to a drug that currently lacks competition.

Walden said that implementing the 21st Century Cures Act, passed by Congress last year, to speed up the FDA’s approval process, is also an important part of the picture.

Trump has gone farther than most Republicans in the past on drug prices, calling for Medicare to negotiate. Trump did not directly call for that policy on Tuesday, though.

Getting any drug pricing legislation through Congress would be a tall task, given how fraught the issue is and the resistance of many Republicans to government action on the issue.