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VA moves to fast-track data sharing with community providers – Healthcare IT News

Posted by timmreardon on 01/28/2018
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Chris Nerney, Contributing Writer | January 23, 2018
@chrisnerney

VAzProposed changes to federal regulations protecting the confidentiality of veterans’ medical records would make it easier for healthcare providers in the private sector to access patient data when they need it most – at the point of care.

The new rule proposed by Veterans Affairs (VA) Secretary David Shulkin, MD, allows VA providers to share individual health records with community providers without requiring a signed, physical note of consent from the patient before treatment.

Instead, health information exchange (HIE) providers would be responsible for confirming that a patient has agreed to allow the VA to share his or her medical data with a community provider. In lieu of a physical document signed by the patient, an electronic attestation could be used to request records from the VA.

“While an estimated three out of four veterans enrolled in VA’s health care system also seek medical care in the community, HIE community partners’ requests for their VA health records must frequently be denied because VA does not have a consent on file,” the VA explains in the Federal Register. “The primary obstacle is that veterans will often seek care in the community prior to having the opportunity to provide the consent form to VA and are then left without any means of getting the consent into VA’s physical possession promptly once they are at the community health care facility.”

These types of bureaucratic barriers have contributed to delays in care for veterans, which in turn can cause them to give up seeking treatment. A 2017 study published by the National Institutes of Health showed that 29 percent of veterans delayed seeking needed healthcare in 2010-2011, compared to only 17.2 percent of all Americans.

The proposed rule doesn’t eliminate the need for the VA to be able to access a signed consent from a veteran. It includes language requiring the HIE community provider make the consent form available to the VA within 10 business days by either storing the written form electronically or mailing the physical copy to the VA.

Alternately, the community provider can retain the patient’s written consent under a memorandum of understanding drafted and signed by VA and the provider, which would be required to follow VA record retention requirements.

The VA is accepting public comments on the proposed rule through March 20.

Article link: http://www.connectedcarewatch.com/news/va-moves-fast-track-data-sharing-community-providers

Gene therapy could make cancer care more unequal, and this map shows why – MIT Tech Review

Posted by timmreardon on 01/23/2018
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Revolutionary new cancer treatments won’t be available in many rural areas of the U.S.

by Emily Mullin  January 12, 2018

Two new cancer treatments have shown miraculous cures, but if you happen to live in Arkansas or Montana, or a handful of other rural states—let alone outside the U.S.—you’ll have to travel hundreds of miles to get them. And it’s by no means certain that they’ll eventually be available everywhere.

These groundbreaking gene therapies, Kymriah and Yescarta, were approved last year in the U.S. Not only are they hugely expensive—Kymriah is $475,000 and Yescarta is $373,000 for a one-time treatment—but for now you can get them only in certain urban areas. We mapped those locations below. (Current Kymriah sites are red; current Yescarta sites are blue; sites where both therapies are available are green; and planned Kymriah sites are orange. Click on the tab in the top left corner to see a drop-down list of all sites.) 

MITmap

As you can see, some of the biggest gaps are in rural states, where cancer already kills more people than it does in cities. That’s a problem because both therapies are given as a last resort when traditional cancer drugs have failed. By the time patients get Kymriah or Yescarta, they’re often very sick, so traveling long distances is hard and could delay treatment.

To be fair, it’s early days and the companies that market the therapies, Novartis and Gilead, have plans to eventually add more sites. But in the short term, some far-flung cancer patients may be out of luck. And even in the long term, there are factors that could limit their access.

Called CAR-T cell therapies, Kymriah and Yescarta involve a highly specialized process. Doctors extract T cells—one of the immune system’s weapons against disease—from patients and genetically alter them, essentially supercharging them against cancer cells. They then infuse the modified immune cells back into the body.

Many patients have had remarkable recoveries, but they can also suffer toxic and sometimes deadly side effects. Aaron Levine at the Georgia Tech School of Public Policy, who has studied the ethics of CAR-T cell therapies, says these side effects will likely be the biggest obstacle to making the therapies more widely available, “as only a small number of physicians and medical teams are prepared to address them.”

If a lot of patients suffer these side effects or die in the initial rollout of Kymriah and Yescarta, that could slow the addition of more sites.

Another factor is that right now, CAR-T therapies primarily treat rare cancers. Currently, Kymriah treats a type of childhood cancer called acute lymphoblastic leukemia, and Novartis thinks only about 600 patients a year will be eligible for it. Yescarta treats large B-cell lymphoma in adults, and Gilead estimates it could help around 7,500 people a year.

“The reality is, the market isn’t that big, so it doesn’t make sense to train everyone to do it,” Levine says. More CAR-T therapies are in development, but so far it’s unclear how well they will work for more common cancers.

There’s also the question of whether insurance will pay for these staggeringly expensive treatments. Only a handful of patients have been treated with Yescarta; hundreds more are waiting because of payment delays. If some insurers decide they won’t cover the cost, that could foil companies’ plans to expand treatment sites. “We need to watch out for a situation in which these therapies only become available to urban elites who live near academic medical centers,” Levine says.

Still, Levine is hopeful. “It’s still early enough for things to change and evolve,” he says.

Peter Emanuel, director of the Winthrop P. Rockefeller Cancer Institute in Little Rock, Arkansas, which is 350 miles from the nearest treatment site for Kymriah or Yescarta, isn’t worried about what the map looks like right now.

He says administering these therapies and managing potential side effects requires a large and specialized team of hospital workers, so it’s probably best—at least for now—that Kymriah and Yescarta are available only at hospitals with more resources.

The real test, says Emanuel, will be if and when new CAR-T therapies are approved for more common cancers. “At that point, I think it’s justified to expand the number of centers, and hopefully that expansion includes smaller cities and more rural states,” he says.

Article link: https://www.technologyreview.com/s/609890/gene-therapy-could-make-cancer-care-more-unequal-and-this-map-shows-why

Emily Mullin

Emily Mullin Associate Editor, Biomedicine

I am MIT Technology Review’s associate editor for biomedicine. I report from Washington, D.C., where I look for stories about how new technology is making us healthier and our medicine better. I am particularly interested in how these advances… More

What the Military Can Teach Organizations About Agility – MIT Sloan Management

Posted by timmreardon on 01/15/2018
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U.S. armed services are experimenting with ways to make faster — and smarter — decisions, and business should take note.

Agility0

Article link: https://sloanreview.mit.edu/article/what-the-military-can-teach-organizations-about-agility

GAO: $36.7 billion in Medicaid payment errors tied to poor oversight of national repository – Healthcare IT News

Posted by timmreardon on 01/13/2018
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While the number of states contributing data was up from 18 to 49, challenges hindered CMS’ ability to effectively manage the program.

By Jessica Davis January 09, 2018  02:03 PM

Gov-Accountability-Office-freeuse-712_0A lack of oversight of the national repository of Medicaid data caused an estimated $36.7 billion in payment errors in 2017, according to a new Government Accountability Office report. That’s up from an estimated $14.4 billion in improper payments in Fiscal Year 2013.

Transformed Medicaid Statistical Information System (T-MSIS) is CMS’ core effort to improve Medicaid data by increasing the scope of data and quality of state-reported data.

About 49 states began reporting that data to the national repository in November, up from just 18 states the year prior. The data help federal administrators to identify potential fraud and improve the efficiency of the program, but data aren’t sufficient enough for an effective oversight of the program.

[Also: Senators ask GAO for recommendations on unique patient identifiers]

“CMS has taken an important step toward developing a reliable national repository for Medicaid data,” the GAO report authors wrote. “However, data challenges have hindered states’ and CMS’s use of the T-MSIS data for oversight.”

For example, the reported data was incomplete for all of the selected six states reporting data in August 2017 as the states said that “certain unreported elements were contingent on federal or state actions and others weren’t applicable to the state’s Medicaid program.”

Further, states failed to mention in documentation whether those elements would be reported in the future, or when they would report complete data.

Six of eight selected states actually expressed concerns about how T-MSIS data could be compared across states. While all states reported interest in information sharing across states, CMS hasn’t compiled or shared information about states’ data limitation – an act that would help states improve accuracy when comparing data between states.

Although CMS has taken those first steps to using T-MSIS data, it doesn’t yet have a plan or even a timeframe to use this data for oversight.

“As a result, important CMS goals for T-MSIS, such as reducing states’ reporting burden and enhancing program integrity activities, are not being fully realized,” the report authors wrote.

GAO officials recommend CMS improve the completeness and comparability of T-MSIS data to accelerate the program, in addition to articulating a specific oversight plan.

The U.S. Department of Health and Human Services agreed with those recommendations and said it would continue to work on obtaining complete T-MSIS data from states. Further, the agency said it will take steps to address data sharing limitations within states, along with helping states collaborate.

“Strong Medicaid data can help the federal government and the states move toward better health outcomes and improve program integrity, performance, and financial management,” HHS officials told GAO, according to the report.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

Topics:

Government & Policy

Article link: http://www.healthcareitnews.com/news/gao-367-billion-medicaid-payment-errors-tied-poor-oversight-national-repository

Will People Price Shop for Healthcare? – KelloggInsight

Posted by timmreardon on 01/13/2018
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A new study says yes, but only if the prices are easy to understand.

Based on the research of Elena Prager

Kellogg1For any medical procedure, from a minor checkup to major surgery, there can be significant uncertainty about a key component: the price.

Indeed, for healthcare, unlike most products and services, we typically don’t know the exact price we will have to pay until after we receive a bill.

But what if there was greater transparency about the exact out-of-pocket price we would pay for a given procedure and how much that price varies across hospitals or providers? Would that change the providers we choose?

The answer is of interest to policymakers, whose goal is to encourage consumers to be more price-sensitive, saving money for themselves and reducing spending in the system overall.

“There’s a decades-long debate in healthcare about whether you can actually get people to shop on price,” says Elena Prager, an assistant professor of strategy at Kellogg. “We tend to view medical services as a different kind of product where price may not matter much.”

In a new study, Prager investigates whether consumers respond to simplified price information in choosing healthcare providers.

She finds that, indeed, price shopping in healthcare is possible—but it involves presenting consumers with price information in a much more simplified way than insurers typically do.

Do Healthcare Consumers Price Shop?

Think about your own healthcare bills for a moment. Do the words “simple” or “clear” immediately come to mind? Likely not.

“Even when people get an explanation of benefits from insurers, pricing can still be pretty opaque,” Prager says.

This is a problem because policymakers and insurers are trying to motivate consumers to understand the cost–benefit trade-offs of their healthcare decisions, as well as the value they are getting for the money spent—both out of their own pockets and from the balance sheets of insurers. But in most cases people lack the information to make informed decisions.

“On one hand, we’re asking for people to pay for more and more of their care” due to, for example, increasing deductibles and the rising cost of healthcare, Prager says. “But on the other, we’re not giving them the right tools to make good decisions about those large monetary amounts. So it’s important to understand whether it’s even possible to design effective healthcare price-information systems.”

Much of the earlier research on how to encourage price shopping in healthcare often focused on high-deductible health insurance plans.

“Even for care that serious, people are willing to trade off hospital prestige or distance to their house in order to save money.”

The logic was simple: if consumers have to cover a larger amount of their care—based on deductibles that could run well into the thousands of dollars before insurance coverage kicks in—they would be more price-sensitive when choosing services or providers.

But findings showed people had little sensitivity to price even when using these high-deductible plans.

“That’s because high-deductible insurance only solves one piece of the price-sensitivity problem by giving people more skin in the game,” Prager says. “These plans still don’t give enrollees sufficient price information. So people still have to figure out what the actual price they pay will be.”

That may mean finding and adding up prices from multiple medical areas and providers, even when considering only a single procedure. There may be different bills from the hospital and from the doctors working at the hospital, and from anesthesiology, surgery, the hospital pharmacy, and more. The information is often difficult to find, if not impossible.

The Simpler, the Better

Prager’s research used unusually transparent data from an insurance system in Massachusetts.

The study examined private health insurance claims from multiple insurers from 2009 to 2012. But importantly for the research, all these insurers gave consumers very clear information on cost.

Additionally, in many of the health plans, these insurers group hospitals into “tiers” based on price. A hospital’s tier determines consumers’ out-of-pocket payment for a given procedure at that hospital.

“For any procedure, such as a knee replacement,” Prager said, “people on these plans could look at insurer-provided documentation and on a single page see the price menu for all hospitals in the state, by tier—first, second, or third—and exactly what their out-of-pocket price will be. And it’s a set dollar amount, not 10 percent or 20 percent or the total cost. Just $300 or $700 or whatever, end of story.”

In some health plans, the difference in cost from one tier to another was substantial; for others, there was little to no price differential; and others simply had the same copay for all hospitals without using tiers. This allowed Prager to compare how consumers responded to the option to price shop in a very transparent system.

The data studied included the insurance plans of over 200,000 enrollees and dependents, the out-of-pocket prices they saw while making treatment decisions, and how much they and the insurers paid for procedures. The researchers focused on inpatient services—such as major surgery or delivering a baby.

The Power of Presentation

Prager found that people in the study did indeed opt for lower-priced medical services when presented with clear, simple price information.

For example, she modeled how the same patient would behave when enrolled in different types of plans—those with large cost differences between hospitals and those with none. She found that total spending per hospital stay fell by 1.3 percent when consumers were presented with cost differences.

Prager predicts that providers in the lowest-priced tier would gain about 53 percent in patient volume over three years due to price shopping.

“People weren’t sure price shopping in healthcare was even possible,” she says. “These findings show that it is.”

Indeed, people in the study were making price-based decisions about inpatient treatment, the type of higher-stakes interventions that required overnight stays.

“Even for care that serious,” Prager says, “people are willing to trade off hospital prestige or distance to their house in order to save money. So we might expect to see even greater price-shopping behavior for less serious care.”

Still, it takes an extremely simple approach to presenting price information to help people make healthcare decisions. “We haven’t been good at providing that in the US system,” Prager says.

Greater availability of simple healthcare price information would be good news for consumers and insurers alike. Patients save out-of-pocket costs by choosing lower-priced services, and insurers can save even more.

“Hospitals can differ by thousands of dollars for a given procedure,” Prager says, “and insurer savings can be many multiples of what consumers save when choosing a lower-priced option. Though not a guarantee, that might lower insurance premiums in the long run.”

What About Providers?

What are the implications of Prager’s findings for hospitals, physicians, and other providers?

“The level of enthusiasm providers have about these results will differ by where they are currently in the price distribution,” Prager says. She breaks down providers into three broad categories similar to the tiers insurers use.

Low-priced providers should be “thrilled” about price shopping, she suggests, because they can keep prices where they are and enjoy more volume because price-sensitive consumers will pick them when presented with clear price information.

Medium-priced providers are more likely to lose patient volume to lower-priced competitors because consumers will choose price over reputation or other factors such as proximity to home. “That will siphon off some volume from providers priced in the middle,” Prager says, “but they can try to negotiate lower rates with insurers in subsequent years to get into a lower tier.”

High-priced, highly desirable providers “won’t really care about price shopping,” Prager says, “because patients are willing to pay whatever it takes to get their care there.” She points to the Harvard-affiliated academic medical centers in the study as examples. These providers have such strong reputations that fewer consumers are willing to switch away from them, even if the price difference is stark. This means less savings for consumers and, especially, insurers.

The good news for patients and insurers is that the number of tiered insurance networks that have easier access to simple price information has grown in the last decade or so.

Over 10 percent of people enrolled in the Affordable Care Act exchange plans are in plans that are structured this way, Prager says, and a growing number of large employer-sponsored plans are, too. At the same time, many other insurers remain overly reliant on complex pricing tools, typically online, through which enrollees can search for providers and prices by procedure and zip code—but prices are still presented in a complicated way.

“Those complex tools are the darling of the industry,” Prager says, “but they don’t always work as well as hoped because they leave a lot of uncertainty about pricing. Instead, providing a simple menu of tiered-network options and prices has serious advantages that should be even more highlighted going forward.”

Article link: https://insight.kellogg.northwestern.edu/article/will-people-price-shop-for-healthcare

How does health spending in the U.S. compare to other countries? – Kaiser Family Foundation

Posted by timmreardon on 01/09/2018
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By Bradley Sawyer and Cynthia Cox   Kaiser Family Foundation

Chart Collections           Health Spending

Posted: May 22, 2017

This chart collection takes a look at how spending on healthcare in the United States compares to other OECD countries that are similarly large and wealthy (based on GDP and GDP per capita). The analysis looks at 2015 health data from the OECD Health Statistics database.  These charts are based on data from the OECD, allowing for international comparisons; however, some values from OECD are reported as provisional or estimated and may not exactly match U.S. data reported in the National Health Expenditure Accounts. 

Kaiser11

As would be expected, wealthy countries like the U.S., tend to spend more per person on health care and related expenses than lower income countries. However, even as a high income country, the U.S. spends more per person on health than comparable countries. Health spending per person in the U.S. was $9,451 in 2015 –  22% higher than Luxembourg, the next highest per capita spender.

Kaiser12

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Article link: https://www.healthsystemtracker.org/chart-collection/health-spending-u-s-compare-countries

International Comparison Reflects Flaws and Opportunities for Better U.S. Health Care – Commonwealth Fund

Posted by timmreardon on 01/08/2018
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The United States Health System Falls Short

 

mirror-mirror-

           Exhibit 1. Health Care Spending as a Percentage of GDP, 1980–2014                             
Source: OECD Health Data 2016. Data are for current spending only, and exclude spending on capital formation of health care providers.

 

The United States spends far more on health care than other high-income countries, with spending levels that rose continuously over the past three decades (Exhibit 1). Yet the U.S. population has poorer health than other countries. 1 Life expectancy, after improving for several decades, worsened in recent years for some populations, aggravated by the opioid crisis. 2 In addition, as the baby boom population ages, more people in the U.S.—and all over the world—are living with age-related disabilities and chronic disease, placing pressure on health care systems to respond.

Timely and accessible health care could mitigate many of these challenges, but the U.S. health care system falls short, failing to deliver indicated services reliably to all who could benefit. 3 In particular, poor access to primary care has contributed to inadequate prevention and management of chronic diseases, delayed diagnoses, incomplete adherence to treatments, wasteful overuse of drugs and technologies, and coordination and safety problems.

This report uses recent data to compare health care system performance in the U.S. with that of 10 other high-income countries and considers the different approaches to health care organization and delivery that can contribute to top performance. We based our analysis on 72 indicators that measure performance in five domains important to policymakers, providers, patients, and the public: Care Process, Access, Administrative Efficiency, Equity, and Health Care Outcomes.

Our data come from a variety of sources. One is comparative survey research. Since 1998, The Commonwealth Fund, in collaboration with international partners, has supported surveys of patients and primary care physicians in advanced countries, collecting information for a standardized set of metrics on health system performance. Other comparative data are drawn from the most recent reports of the Organization for Economic Cooperation and Development (OECD), the European Observatory on Health Systems and Policies, and the World Health Organization (WHO).

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Article link: http://www.commonwealthfund.org/interactives/2017/july/mirror-mirror/

Wasted Medicine, Squandered Health Care Dollars – ProPublica

Posted by timmreardon on 01/01/2018
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Billions of dollars are routinely wasted every day by health care providers in the United States – and it’s driving up the costs of care for all of us.

ProPubica4A Hospital Charged $1,877 to Pierce a 5-Year-Old’s Ears. This Is Why Health Care Costs So Much.

An epidemic of unnecessary treatment is wasting billions of health care dollars a year. Patients and taxpayers are paying for it.

Read More

Other Entries

Want to Lower Health Care Costs? Stop Wasting Our Money.

by Marshall Allen

Dec. 28, 2017, 2:30 p.m. EST

This year ProPublica documented the many ways waste is baked into our health care system, from destroying perfectly good medication to junking brand new supplies. Eliminating the waste could insure millions of Americans.

A Prescription for Reducing Wasted Health Care Spending

by Marshall Allen

Dec. 21, 2017, 5 a.m. EST

A ProPublica series has illustrated the many ways the U.S. health care system leaks money. Health care leaders and policymakers suggest ways to plug the holes.

More States Hatch Plans to Recycle Drugs Being Wasted in Nursing Homes

by Marshall Allen

Dec. 1, 2017, 8 a.m. EST

After reading ProPublica’s story, lawmakers in Florida and New Hampshire say they plan to follow the example of an Iowa nonprofit that redistributes leftover medications to needy patients.

Seven Ways Patients Can Protect Themselves From Outrageous Medical Bills

by Marshall Allen

Nov. 28, 2017, 1:30 p.m. EST

Experts in reducing charges for medical services say patients need to push for detailed answers up front about the true costs of their care.

Senators Introduce Bill to Reduce ‘Colossal and Completely Preventable Waste’

by Marshall Allen

Nov. 1, 2017, 8 a.m. EDT

The senators cited a ProPublica story that found that drug companies have been making patients pay for oversized eyedrops and more liquid cancer medications than they need.

Drug Companies Make Eyedrops Too Big — And You Pay for the Waste

by Marshall Allen

Oct. 18, 2017, 5 a.m. EDT

The makers of cancer drugs also make vials with too much medication for many patients. The excess drugs are tossed in the trash — another reason health care costs are so high.

The Myth of Drug Expiration Dates

by Marshall Allen

July 18, 2017, 5 a.m. EDT

Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.

How Two Common Medications Became One $455 Million Specialty Pill

by Marshall Allen

June 20, 2017, 7 a.m. EDT

After I was prescribed a brand-name drug I didn’t need and given a coupon to cover the out-of-pocket costs, I discovered another reason Americans pay too much for health care.

America’s Other Drug Problem

by Marshall Allen

April 27, 2017, 5 a.m. EDT

Every year nursing homes nationwide flush, burn or throw out tons of valuable prescription drugs. Iowa collects them and gives them to needy patients for free. Most other states don’t.

About $765 Billion Is Wasted Each Year on Health Care. Can You Help Us Find It?

by Marshall Allen

March 9, 2017, 2 p.m. EST

What Hospitals Waste

Marshall Allen

March 9, 2017, 9 a.m. EST

The nation’s health care tab is sky-high. We’re tracking down the reasons. First stop: A look at all the perfectly good stuff hospitals throw away.

Article link: https://www.propublica.org/series/wasted-medicine

Want to Lower Health Care Costs? Stop Wasting Our Money – ProPublica

Posted by timmreardon on 01/01/2018
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This year ProPublica documented the many ways waste is baked into our health care system, from destroying perfectly good medication to junking brand new supplies. Eliminating the waste could insure millions of Americans.

by Marshall Allen Dec. 28, 2017,

Probublic1Unused medical supplies sit in storage at a Partners for World Health facility in Portland, Maine. (Tristan Spinski, special to ProPublica)

Propublic1

This story was co-published with The Washington Post.

Wasted Medicine

Squandered Health Care Dollars

In Maine, there’s a warehouse the size of a middle school gymnasium, stuffed with brand-new medical supplies and gently used medical equipment. Several pallets are piled with boxes of surgical sutures, still in their shrink wrap, each box worth hundreds of dollars. Tubs overflow with diabetes supplies and surgical instruments that may run hundreds of dollars apiece. There are bins of bandages and gauze and saline and ostomy bags and every other medical supply you can imagine. These materials, unexpired, could easily stock any hospital or clinic. But each item has actually been thrown away by a local medical facility.

The cost of health care has been rising for decades, and Americans are paying the price. In a recent Gallup poll, people cited the high cost of care as their No. 1 financial concern. It’s an enormous problem, and trying to solve it all at once brings on panic and paralysis. But after reporting for a year on the ways the medical industry blows through our money, I have one idea: Let’s end the egregious waste that’s draining our health care system.

The National Academy of Medicine has estimated the health care system wastes around $765 billion a year — about a quarter of what we spend. Eliminating all the waste could allow us to insure 150 million Americans, the Academy of Medicine said, and saving half of it could provide groceries for every household in the country for a year. Eliminating the waste would also stop our rising health care costs from eating up our wage increases. My premiums go up 9 percent next year. Same thing happened last year. Odds are your costs are rising, too.

It’s hard to downplay what I found when I began investigating the issue. Hospitals throw out so many valuable supplies that a cottage industry of charities has sprung up to collect this stuff and ship it to the developing world — otherwise, all those goods in that Maine warehouse would be headed for a landfill.

Nobody tracks how much hospitals waste rather than donate, and I couldn’t track down where each item came from. But experts told me when hospitals change vendors for a type of supply, they often toss the old stuff. Or, if they take over a clinic or facility, they get rid of the items that come with it, even if they are unused and unexpired.

The operating room is a major source of wasted spending. One hospital tracked the value of unused items that went to waste during neurosurgery procedures in a single year. The total: $2.9 million — for one type of surgery at just one hospital. In that case, the surgeons hadn’t updated their system of telling the staff which supplies to prep for each operation. They were opening many items they didn’t need, which then had to be thrown away even though they were unused. The hospital updated its approach to make sure they aren’t setting up for operations with excess supplies.

I learned that nursing homes throw away hundreds of millions of dollars’ worth of valuable medication every year. They typically dispense drugs a month at a time for patients and often have them discontinued if the patient dies or transfers. The excess drugs get trashed, incinerated or even flushed down the toilets, contaminating our water supply. The chief executive of a pharmacy that serves nursing homes in Florida told me that his company alone throws away about $2.5 million a year in valuable medication.

In Iowa, the state government funded a program to recover these castoff nursing home meds and donate them to needy patients, for free. This year, they’re on pace to recover and redistribute $6 million in medication. My story led policymakers in Florida and New Hampshire to introduce legislation to try to replicate the Iowa program.

Drugs are a huge source of waste, partly because drug expiration dates don’t mean what we think they mean. The Food and Drug Administration makes pharmaceutical companies show their medication is safe and effective until its expiration date. It doesn’t make them find out how long they actually last.

Studies show it’s common for a drug to be safe after its expiration date. The FDA runs a program that tests and then extends expiration dates on drugs in the federal government’s stockpiles. Those same drugs get thrown away in pharmacies when they “expire,” even though many of them are in short supply. How much of our money does it waste? One midsize hospital in Boston throws away about $200,000 worth of drugs a year that hit their expiration date. If that’s true for other hospitals, the total would be about $800 million a year for hospital pharmacies alone.

Read MorePropublic2
A Prescription for Reducing Wasted Health Care Spending

A ProPublica series has illustrated the many ways the U.S. health care system leaks money. Health care leaders and policymakers suggest ways to plug the holes.

Meanwhile, drug companies are making eyedrops two or three times larger than what the eye can even contain. We are paying for the wasted medicine running down our cheeks. I spoke to the former head of research for Alcon Laboratories, a global leader in the eye care industry now owned by Novartis. He told me that in the early 1990s his team created a “microdrop” that eliminated the waste. The microdrops were effective and reduced the burning caused by larger drops. But Alcon’s leaders killed the project because they were worried it could reduce sales.

Vials of cancer drugs are also made too large, which one study said wastes about $1.8 billion a year in the valuable medication. Earlier this year, one drug company switched from a multiuse vial, which could be shared by patients, to a single-use vial that could not be shared, thereby increasing the amount of wasted cancer medication. The change would make the supply chain more reliable worldwide, the company said. But one cancer center calculated that the change would cost each patient an average of $1,000 in waste per infusion. Imagine: You’re fighting cancer and then get billed an extra thousand dollars for medication they toss in the trash. Two U.S. senators responded to my story by introducing legislation to solve the problem of oversized eyedrops and cancer drug vials.

These are not isolated examples or small sums being squandered. Let’s say my reporting identified about $10 billion in wasted spending. That’s a rough estimate because no one is actually tracking how much we’re wasting. What else could we be doing with that money? The Kaiser Family Foundation says it costs an average of $6,690 to pay one person’s insurance premium in 2017. At that rate, the $10 billion saved could insure about 1.5 million people for a year. Tell those people it isn’t important to reduce our wasted health care spending.

The Academy of Medicine did something smart when it reframed our health care overspending as waste. We may be a wasteful country, but we still teach our kids to eat everything on their plates. “Waste not, want not,” is baked into our cultural DNA. It’s a powerful concept because it’s a moral one. It’s wrong to squander the hard-earned dollars Americans are paying into the health care system and then demand they pay more.

We can’t be naive and think it will be easy to fix this problem. Our wasted spending represents revenue and profit for the medical industry. But our health care spending should not be an entitlement program for the medical industrial complex. I put together a prescription for reducing the wasted spending I identified. Our policymakers should stand up to the medical industry and stamp out the waste.

Article link: https://www.propublica.org/article/want-to-lower-health-care-costs-stop-wasting-our-money

Filed under: Health Care

America’s Social Contract with the Biopharmaceutical Industry – Medium

Posted by timmreardon on 12/31/2017
Posted in: Uncategorized. Leave a comment

Peter Kolchinsky, PhD

This is the first in a series of articles that aim to define the biopharmaceutical industry’s social contract with America, to examine practices that deviate from that contract, and to propose refinements to healthcare policy to ensure that our continued investment in scientific progress ultimately yields affordable, effective therapeutics for future generations.

Article 1: America’s Social Contract with the Biopharmaceutical Industry
Article 2: What happens when a drug won’t go generic?
Article 3: Protecting Off-Patent Sole-source Drugs from Price-Jacking

Please see Important Disclosures for Readers at the end.

Biopharm1

The public has long voiced outrage at pharmaceutical companies over high drug prices. Many patients feel the real pain of rising healthcare costs and frequently call for price controls on prescription drugs. But price controls are not the solution. In fact, high prescription drug prices aren’t even the problem.

Miscast as a bloated expenditure, high prices on branded drugs incentivize and attract society’s talent and capital to the biopharmaceutical industry to fund and research new cures and treatments that will eventually become inexpensive generic drugs. These resulting generics are one of humanity’s most valuable and underappreciated resources.

High branded-drug prices are necessary to grow this mountain of inexpensive generic drugs. At the same time, we can’t allow anyone’s child or aging parents to be denied the medication they need on account of cost. The reason why new drugs seem unaffordable lies not with branded drug prices but with the intentionally poor design and distribution of healthcare insurance in our country. Branded drugs can be made more affordable — without imperiling biopharmaceutical innovation — by ensuring that insurance properly covers patients, sparing them the euphemism of cost sharing (e.g. co-pays and deductibles).

Besides shielding patients from drug costs and improving immediate health outcomes, this proposal will drive the scientific innovation needed to build a legacy of inexpensive treatments for future generations. Alongside other grand objectives like universal access to clean water and energy efficiency, building this mountain of useful generic drugs as rapidly as possible should be a national and global priority, one that America has led and should continue to lead. If we stall this engine of progress through price controls or other blunt measures meant to ease costs today, we condemn the future to be no better than the present. In turn, the biopharmaceutical industry should do its part to ensure all branded drugs are eventually and adequately genericized.

An underappreciated resource

Biopharm2While high-priced branded drugs make up only 11% of all prescriptions¹, they are the source of most pharmaceutical revenue ($237 billion in 2015²). Typically after 10–15 years, branded drugs lose their patent protection, unleashing low-cost generic versions³ (in 2015 the US spent a comparatively modest $88 billion on generics, though these drugs make up 89% of all prescriptions⁴). Unlike almost any other aspect of healthcare, drugs constantly go generic, which keeps total spending on retail drugs around a mere 12% of total healthcare costs, about the same as it was in 1972.⁵ And even though drug spending remains the same percent of overall healthcare spending, we now have far more and better treatments.⁶

Each year, the biopharmaceutical industry produces new drugs that raise our collective health, give hope to patients suffering from debilitating diseases, and further our understanding of human biology. Because the underlying biological processes inside our cells and bodies are essentially unchanging, the drugs we use today will work just as well in a hundred years, with few exceptions (e.g. antibiotics become obsolete and require replacement as bacteria evolve to become resistant). Many drugs may even work better with improved diagnostics, delivery technologies, and insight into how to best combine therapies. Therefore, much of the scientific progress we achieve in our lifetime will also accrue to the benefit of future generations.

Generics, which the FDA ensures work just as well and meet the same safety standards as original branded drugs, offer huge cost savings within months of coming to market and, with few exceptions, remain inexpensive for the rest of time.⁷

We need only look to the past to understand what progress can be made. Too often, we discount the ingenious tools for preventing, treating, and curing diseases that have made America and the whole world richer.⁸ Over the last hundred years, advancements in medicine, particularly perinatal care, vaccines, and antibiotics, as well as hygiene and nutrition contributed to the nearly 30 years added to the average American’s life expectancy.⁹ Over the same period, global life expectancy doubled.¹⁰ Quality of life also improved with groundbreaking treatments for heart disease, pain, diabetes, and many

Biopharm3Cholesterol-lowering statins alone have contributed to the 50% decrease in death from both heart attacks and strokes throughout the developed world over the last few decades. When Pfizer’s patent on the best-selling statin Lipitor expired and generic versions entered the market, the price quickly dropped by 95% of the initial cost and has remained comparatively negligible ever since.¹² Gleevec, a highly successful drug that restores many years of life to patients suffering from chronic myelogenous leukemia (CML) and other cancers, has also recently gone generic, resulting in its price trending steadily downward. Today, our generic drug armamentarium includes treatments that manage blood pressure (ACEs, ARBs), cholesterol (statins, fenofibrate), diabetes (metformin, insulin), migraines (triptans, acetaminophen, NSAIDs), inflammation (steroids, methotrexate, 5-ASAs), chronic pain (gabapentin, tramadol), depression (SSRIs), schizophrenia (atypical antipsychotics), heartburn (H2 blockers, PPIs), hypothyroidism (levothyroxine), infections (antibiotics), enlarged prostate (alpha-blockers), insomnia (sedatives), ADHD (stimulants), Parkinson’s (dopaminergics), and cancers (anti-estrogens, anti-androgens, chemotherapies), as well as treatments that prevent heart attacks and strokes (blood thinners, anti-arrhythmics, beta-blockers). These represent just a glimpse of the medicines that biopharma can offer to humanity in this century if we continue to fuel and incentivize this industry.

The collective armamentarium of branded drugs will mostly be generic within 10–15 years and will add to our high-value, low-cost arsenal. These include better treatments for many of the conditions mentioned above as well as breakthrough therapies or cures for cystic fibrosis, HIV, Hepatitis C, and many cancers. Yet so many problems remain to be solved. We must discover how to treat and cure diseases that run from uncomfortable to excruciating to devastating. Initially expensive, these drugs will soon enough go generic and join our growing mountain of cost-effective medications.¹³

Branded drugs are worth the cost

Branded drug expenditures represent 1.8% of the US GDP.¹⁴ That’s a little more than a tenth of total healthcare spending and less than the 2.4% of GDP spent by the US government on roads, drinking water, and wastewater infrastructure, which few dispute as necessities worthy of investment.¹⁵ But because health insurance plans, including Medicare, engage in aggressive cost-sharing requiring co-payments as high as 20% of the price of a drug, vulnerable patients disproportionately carry the burden of building our common stockpile of generic treatments.¹⁶

Increased infrastructure investment stands as one of the last few areas of clear bipartisan agreement.¹⁷ We know that we need functional roads and water and sewage treatment facilities. We may even know that infrastructure spending will result in more jobs when Americans fix our roads and bridges.¹⁸ And yet, all this holds true for the drug industry: we all will eventually need what the millions of people employed directly or indirectly by the biopharmaceutical sector can create for us.

High-priced branded drugs power this entire biopharmaceutical ecosystem.¹⁹ Drug price controls would imperil it, signaling that some or even all the people involved should do something else for society, perhaps work in a different industry. Therefore, before we accidentally hobble or dismantle the biopharmaceutical industry in an effort to make today’s high-priced drugs cheaper as quickly as possible, we need ask whether branded drugs are “worth it” — essentially whether their price matches their value.

To understand a drug’s true value, consider each person that it will help as a branded drug in the present and as a generic in the future. Medicine has influenced every dimension of our lives, contributed to the advancement of art and technology that permeates our civilization by allowing innovators to live longer and healthier lives, and impacts our social fabric in immeasurable ways. Even a modest medical breakthrough that will someday go generic offers society high value for low cost.²⁰ We can collectively afford to make this investment.

This promise to create a mountain of low-cost therapies forms the core of the compact between drug developers and patients, which is to say all of us. Social contracts can be explicit, such as when Americans gave their representatives the power to govern them within the democratic precepts of the Constitution and the Declaration of Independence. In other instances, social contracts become implicit agreements between company and consumer. Google’s memorable motto “Don’t be evil” (now “Do the Right Thing”) became an implied promise to the user that “in exchange for using our services, we won’t do anything monstrous with the power you’ve given us.” Biotech operates on its own social contract with the American patient: “Yes, prices will be initially high on branded drugs. But after a patent expires, you enjoy the benefits of the cheap, effective generic versions for the rest of time.”

Others have proposed the notion of a social contract, notably with emphasis on keeping branded drug price increases in check while they are patent-protected.²¹ But as long as a drug ultimately will go generic, it’s not all that critical to the long-run price/value assessment whether it starts off at a lower price, climbs, and then goes generic, or if it starts off at a higher price, stays flat, and then goes generic.

Genericization without undue delays is the only critical feature of the contract. Consider the biopharmaceutical industry as putting novel branded drugs on a conveyer belt that over 10–15 years transports them to the top of the generic drug mountain– that final moment when the drug goes generic and falls off the conveyer onto the eternal generic mountain is the ultimate fulfillment of the industry’s end of the social contract.

There is more work to do in this regard. In the case of Gleevec, its price has been floating gently down after it went generic rather than fallen off a cliff, as Lipitor’s did. FDA approval of more generics would help speed the fall. In the case of biosimilars — which are as close as we can scientifically come to making a generic version of complex drugs such as antibodies and enzymes that are manufactured in biological systems — we are only just beginning to witness and assess the market dynamics around adoption and price erosion. But considering the cost of biologics production is in most cases roughly 5–15% of a biologic drug’s price, biosimilars may eventually be sold for at least a 70% discount. Companies will pursue every legal means at their disposal to prevent the uptake of biosimilars, as we have seen many innovators do to forestall generic entrants.²² The generics industry and the Federal Trade Commission estimate that America is losing out on almost $10 billion of savings each year due to such stall tactics, which is a problem and makes for many galling headlines, but it’s also less than 3% of total drug spend²³. Arguably the industry as a whole can afford to solve this public relations headache by swearing off excessive cleverness, and regulators should pursue avenues to accelerate genericization without impacting innovation, but regardless, those stall tactics fail in the long run and prices fall as competition sets in, as they have been steadily falling for Gleevec and its generics. For the few drugs where no true generic could ever exist — say, in the case of certain cell or gene therapies — new pricing mechanisms for the synthetic genericization of such drugs can and should be created, adapting pricing schemes already in place for pandemic vaccines and other biodefense products.

If we agree that the high prices of branded drugs legitimately drive investment towards society’s ownership of more and better generics, then we also need to condemn those who steal generics away from society. Making sure that drugs go generic and thereafter remain inexpensive is the long-term value side of the social contract. Therefore, when a company takes a formerly inexpensive generic and raises the price well above the cost of production without improving the drug, that company violates the contract. Several companies have recently exploited loopholes that regulators should seek to close quickly, for example by accelerating the approval of more generics to keep prices down and making sure that generic manufacturers can access samples of an original drug to help them demonstrate the equivalence of their generic product, both of which the FDA has vowed to do.²⁴

Imagine though, that all new drug development stopped, and all current branded drugs immediately went generic, for example through price controls or by invalidating their patents. Total drug spending would fall by approximately 70%, resulting in a one-time 9% reduction in healthcare spending, equating to about 1.5% of US GDP. Within a few years though, healthcare costs would revert to previous levels due to the rising costs of hospitals, surgeries, and other non-genericizable services.²⁵ Meanwhile, our mountain of generic drugs would cease growing — the conveyer belt will grind to a halt. Therefore, in exchange for a modest and temporary savings in our collective budget, we would destroy biopharma’s innovative core that, as of this moment, is advancing new treatments for migraines, bone fractures, cancer, diabetes, and countless other diseases that send patients, young and old, to hospitals each year. As overall costs continued to grow, the public would realize what Congress and insurance companies already know: the bulk of healthcare costs stem from hospitals and services, none of which will ever go generic.²⁶

A call to end cost-sharing

Some argue that the biopharmaceutical social contract places responsibility on drug companies to make sure that patients have access to their drugs²⁷. This stance ignores the role of payers, private insurance companies as well as Medicare, in implementing high co-pays and other cost-sharing mechanisms to discourage patients from using medications that their physicians prescribe. The cost of most branded drugs could be cut in half and the majority of people in America still couldn’t afford to pay Medicare’s required 20% co-pay.

The tactics companies employ to try to make sure that patients can afford their share of the cost of a drug, such as co-pay assistance, are sometimes portrayed as bribes that companies pay patients to take their medications. Payers may worry that a pharmaceutical company has inappropriately marketed a drug, encouraging physicians to prescribe it to patients who don’t need it. When this happens, the government should prosecute and punish companies, but it’s inappropriate to cast suspicion on every doctor-patient interaction that results in a prescription for a high-priced drug and then, via cost-sharing, coerce patients into second-guessing their physicians. Many companies have programs to provide free drug to patients without insurance. And yet, many patients don’t realize that such programs exist, assume that they won’t be able to afford a drug, and don’t bother getting a prescription filled. Physicians are often too busy to explain the details of co-pay assistance to each patient. These barriers to access create their intended result: fewer patients fill prescriptions that their physicians write.

We have also entrusted our government and insurance companies to distribute the costs of healthcare across our population and across time so that people unfortunate enough to be sick don’t suddenly find themselves choosing between the branded drugs they need and their mortgage payments. Insurance practices in America conform to laws passed by our elected representatives. So if the politicians we elect to Congress allow insurance companies to turn away people based on pre-existing conditions or to charge high co-pays, then we have harmed ourselves.

A common complaint is that healthcare is more expensive in the US than anywhere else in the world but that our outcomes lag far behind.²⁸ This has little if anything to do with pharmaceuticals. On the contrary, the US enjoys faster approvals of innovative drugs, giving many US patients access to important medicines, such as cures for hepatitis C, years before they are used widely in Europe.²⁹ At the same time, the US makes the most use of generic drugs — more than any major healthcare market. While 89% of prescriptions filled in the US are for generics, throughout Europe generic utilization remains far lower, from Switzerland (17%) to France (30%) to Spain (47%) to Germany (80%).³⁰ Therefore, although Europeans pay less than Americans for branded drugs initially, they pay branded prices for longer because they don’t switch to generics as quickly as possible. As much as it is popular to cite how much more the US pays for a new drug, there are also many examples of older drugs for which Europe pays more. While the US has already cured many patients suffering from hepatitis C, for example, Europeans are spending more money on older, less effective treatments.³¹ Despite having the most advanced technologies, the US system, through cost-sharing, non-comprehensive insurance, and bureaucracy, makes healthcare unaffordable and practically inaccessible for some, which then weighs on healthcare outcomes for these individuals and also shows up in national statistics.³²

Copays and deductibles imposed upon patients force many to stop taking their medications as prescribed, leading to worse outcomes and higher long-term costs. Even small co-pays and fees — as low as $1 to $5 — reduce drug adherence and cause patients to avoid necessary care.³³ Approximately 50% of patients fail to adhere to their prescriptions due in part to high co-pays, while high deductibles push patients to cut out valuable preventative services. Greater cost-sharing is also associated with increased emergency room visits.³⁴ Low-income patients are often the most vulnerable. Indeed, the very term “cost-sharing” disguises what could be more aptly described as an institutionalized failure to insure.

If we truly hope to expand access and unburden patients of the financial hardship of getting sick, then rather than blaming the innovators for the prices of their newest drugs, let’s upgrade our insurance system to one that actually provides proper insurance to everyone. Spending should be spread more evenly instead of hitting patients with toxic cost-sharing when they are sick and most vulnerable. Cost-sharing just adds insult to injury. Imagine if, after being mugged, the victim had to make a co-pay to have the police show up.

Cutting out-of-pocket costs would lead to improved adherence, better health outcomes, and lower long-term healthcare spending, provided that physicians do not encourage patients to over-utilize an “all you can eat” healthcare system. While this is an important caveat, it does not justify cost-sharing, which shifts the responsibility of setting an appropriate level of care from knowledgeable physicians to distressed patients. Co-pays and deductibles are intended to make sure that individuals have some “skin in the game” and think twice before seeking unnecessary treatments. However, few patients can tell the difference between a necessary and unnecessary treatment when the person prescribing the treatment is a doctor.

If a doctor prescribes an expensive branded drug despite the availability of generics or less expensive but similar therapies, it makes sense to nudge patients towards switching. The problem is when payers try to discourage patients from taking uniquely beneficial drugs for which there are no substitutes. Behavioral economists conceded long ago that humans do not always behave rationally, often undervaluing their future selves. When insurers place significant cost burdens on a patient, they nudge individuals to indiscriminately reduce their use of both low-value and high-value treatments and services, often with costlier downstream consequences.

Specific private and government insurance practices were designed with high co-pays, maybe thoughtlessly or maybe heartlessly, to make patients believe that drugs are unaffordable. Yet, the 1.8% of GDP that America spends on branded drugs does not have to feel unaffordable to any of the people who need these medications, just as our nation’s road and drinking water infrastructures are considered a basic resource available to all.

Insurance companies should address overutilization of services and unnecessary prescriptions by confirming that physicians adhere to standard of care guidelines, not by underinsuring patients so they are financially discouraged from following their doctors’ advice. And insurers should align physician incentives with the quality of care rather than the quantity of care. Fortunately, there are many ongoing experiments being run by hospitals, physician networks, and insurers to figure out how to do just this.³⁵

A ‘fair price’ conundrum

Insurance only serves its function if everyone, especially healthy people, pays what they can. Just as taxes grow in proportion to income, insurance companies should ensure that an individual pays their highest rates during their highest income years, which also happens to be when they are younger and most likely to be healthy. It makes little sense to increase costs on people when they are older, have less income, and yet are most likely to need healthcare. The young, healthy, working-age population might not like paying more, but they will eventually find themselves in need of the medicines whose development they helped fund while they were younger. Until insurance functions properly, patients driven to desperation by cost-sharing will understandably find government-imposed drug-price controls appealing, regardless of the consequences to the biopharmaceutical ecosystem.

There has always been difficulty establishing a drug’s cost-effectiveness, a quantification of whether it is “worth it”. One can make the case that a patient with elevated cholesterol who skips treatment to save money will only end up costing himself, his family, and society more if he later suffers a heart attack, and that, therefore, the patient and society should rationally want the patient to get preventative treatment. However, the cold hard math of dollars spent and saved does not always support this conclusion because it depends on the cost of the treatment and the value one places on life. An oft-cited macabre bit of trivia is that smokers save taxpayers’ money on Medicare and Social Security by dying more quickly and earlier than non-smokers. If it were all about money, we should be encouraging smokers to keep lighting up. But we are using a calculus that heavily weighs well-being, which basically means that the benefits of healthcare are unquantifiable, at least in America. As a society, we have not come to terms with how to put a price on life (one could argue that the EPA sets the value of a statistical life at $10M in 2016, FDA just under at $9.5M, and the Department of Agriculture at $8.9M³⁶) and seem to believe that paying whatever it takes to treat or prevent pain, disability, and death is always the “right” choice, or at least the American choice. Anyone who puts money over life is considered heartless.

Yet we know that our inability to say “no” to effective medications on the basis of cost makes us vulnerable to price gouging, and we know that drug companies know this, calling into question whether drug companies are charging a “fair” price, even as we struggle to define what fair is. Some would argue that fair means pegging prices to the cost of drug development, calling for every company to disclose what it cost them to develop each drug. Others suggest it’s only fair to charge for a drug if it works, although in practice we often do not know if a drug is working for a specific patient.

Neither of these suggestions would be impossible to implement in some form and, through transparency, might even help make drug development more efficient. The drug industry’s profit margins are roughly 20%, which some say are too high. But we know that there isn’t room to reduce branded drug prices by half, for example, at least not without cutting salaries and laying off people. There are no doubt inefficiencies in every company, but which specific expenses are unnecessary is debatable. Profit margins appear modest for an industry accused of being a price gouging monopoly.

There is a good chance that, after every R&D expense has been audited by Congress and when companies are only allowed to charge for drugs that work, the industry will be found to be justified in charging a collective 1.8% of US GDP for branded prescription drugs. Where would the public outrage then turn? Maybe it will finally turn where it needs to focus, on the lack of universal insurance in America and the heartless practice of imposing cost-sharing on the sick and vulnerable. Inadequate insurance coverage and high co-pays are at the root of why patients go without. Insurance companies and government policies are standing in the way of patients accessing medications that could help them.

There would be less outrage if patients could count on their insurance plans to pay in full for whatever drug their physicians prescribed. Controlling the prices of the more expensive branded drugs is counter-productive and, in the long run, irrelevant, as long as those drugs will go generic.

The central element of the biopharmaceutical social contract, as we see it, has little to do with what price is fair for a branded drug. That’s an unwinnable debate and a search for unquantifiable value. Instead ask whether or not a drug will eventually go generic, offering society reassurance that there is an end in sight to the high cost of any new drug. Basically, whatever the branded price, that high cost is finite, whereas the value society will enjoy is infinite. Some might think that hepatitis C drugs approved since 2015 were indisputably overpriced, yet when the first hepatitis C drugs came to market, the public outcry over their high cost for a short course of treatment was hardly universal. Many articles pointed to how much more cost-effective these curative drugs were compared to previous HCV therapies or HIV medications that cost less but must be taken chronically. And the more productive the biopharmaceutical industry has become, the more likely it is that multiple competitors come to market with comparable drugs within a few years of one another, spurring some price competition even before generics set in, as has happened with treatments for hepatitis C, diabetes, and cholesterol management. It’s increasingly rare for any drug company to enjoy a monopoly for very long.

Indisputable price-gouging, like price-jacking an old generic drug, does happen, but on a comparatively small scale. These practices can and should be eliminated (the FDA has already taken steps to do so by approving generics more quickly). There may even be a role for price controls by having the government contract with manufacturers of old single-source generics (i.e. those supplied by just one company, usually because the residual demand for these older drugs is too small to sustain multiple competitors), ensuring a continuous supply at a modest profit margin.

Populist demands to cut drug prices may tempt some, but the innovative edge of the pharmaceutical industry is powered by the willingness of the US market to reward groundbreaking research. Even European pharmaceutical companies would likely not bother investing in the development of many kinds of new drugs if they couldn’t count on selling them in the US. Hitting the biopharma industry with price controls in reaction to understandable but misdirected outrage would only rob ourselves and our children of the compounded growth of our giant mountain of generic drugs. If we conflate investing in new drugs that we will someday “pay off” with simply spending money on expensive healthcare services (which never go generic), then we may make the wrong budget cuts and thereby only worsen our long-term costs and outcomes.

Consider a home mortgage. A borrower spends 15–30 years paying off a mortgage, typically while younger and employed. Those mortgage payments can be substantial, but once the house is paid off, it is lived in rent free and then passed down to children and grandchildren. By comparison to drugs, doctors, surgeries, and treatments such as dialysis are pure rent and will remain expensive forever — we can only hope to prevent the need for these expensive services with inexpensive drugs.³⁷ A heart bypass and a cardiac surgeon may never go generic, but cholesterol lowering statins, which prevent hospital admissions and even surgeries, will be cheap indefinitely.

When President Kennedy proposed that Americans send a man to the moon, he asked the country to boldly commit to a goal that would require substantial funding, partnerships between government and corporations, and immense intellectual capital. He explained that “in a very real sense, it will not be one man going to the moon — if we make this judgment affirmatively, it will be an entire nation. For all of us must work to put him there.”³⁸ Individual scientists and research teams will be the ones to discover the next generation of cures and treatments, but their successes will be the product of a collective societal effort. Just as the Apollo Program produced breakthroughs in engineering, computing, and our understanding of spaceflight, let us recognize that the high cost of today’s new drugs fuels and inspires the continued discovery of tomorrow’s medical advances, providing high-value, affordable generics that will benefit us all for the rest of time.

Acknowledgements: I’m grateful to Aaron Hiltner and Chris Morrison for their invaluable and substantive thought-partnership and drafting/editing and to everyone who engaged with me in the constructive debates that led up to this article.

Article link: https://medium.com/the-biotech-social-contract/kolchinsky-tbsc-1-dafc2fe803e5

Sources

¹ http://www.gphaonline.org/media/generic-drug-savings-2016/index.html.

² https://www.cdc.gov/nchs/data/hus/hus16.pdf#094; http://www.gphaonline.org/media/generic-drug-savings-2016/index.html.

³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4899342/.

⁴ http://www.gphaonline.org/media/generic-drug-savings-2016/index.html.

⁵ https://data.oecd.org/healthres/pharmaceutical-spending.htm; https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf.

⁶ http://content.healthaffairs.org/content/23/1/10/F1.expansion.html; https://www.cdc.gov/nchs/data/hus/hus16.pdf.

⁷ http://www.nejm.org/doi/full/10.1056/NEJMp1704907?af=R&rss=currentIssue#t=article.

⁸ https://data.oecd.org/healthstat/potential-years-of-life-lost.htm;
https://data.oecd.org/healthstat/life-expectancy-at-birth.htm#indicator-chart.

⁹ http://u.demog.berkeley.edu/~andrew/1918/figure2.html; http://gamapserver.who.int/gho/interactive_charts/mbd/life_expectancy/atlas.html; http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2626194; https://ourworldindata.org/life-expectancy/.

¹⁰ http://gamapserver.who.int/gho/interactive_charts/mbd/life_expectancy/atlas.html; https://ourworldindata.org/life-expectancy/.

¹¹ http://u.demog.berkeley.edu/~andrew/1918/figure2.html; http://gamapserver.who.int/gho/interactive_charts/mbd/life_expectancy/atlas.html; http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2626194; https://ourworldindata.org/life-expectancy/

¹² https://hbr.org/2014/11/the-real-cost-of-high-priced-drugs

¹³ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4899342/

¹⁴ The most recent figures come from 2015. In 2015, the U.S. spent $325B on retail drugs and an estimated $128B on non-retail drugs, for a total of $453B. For retail drugs, branded drugs made up 73% of all spending. If we apply the same estimate to non-retail drugs, we see that the U.S. spent $331B on branded drugs. The U.S. GDP was $18.0366T in 2015, leading to a calculation of 1.8%. https://www.cdc.gov/nchs/data/hus/hus16.pdf#094; https://aspe.hhs.gov/system/files/pdf/187586/Drugspending.pdf; http://www.gphaonline.org/media/generic-drug-savings-2016/index.html.

¹⁵ From the above footnote we see that the U.S. spent $331B on branded drugs. The U.S. spent $3.2056T on healthcare. $331B/$3.2056T = 10.3%. See https://www.cdc.gov/nchs/data/hus/hus16.pdf#094. For GDP spent on roads, drinking water, and wastewater infrastructure see https://www.cbo.gov/publication/52463.

¹⁶ http://www.healthsystemtracker.org/brief/payments-for-cost-sharing-increasing-rapidly-over-time/#item-start.

¹⁷ http://i2.cdn.turner.com/cnn/2017/images/03/08/rel4d.-.budget.pdf.

¹⁸ https://www.brookings.edu/blog/future-development/2016/12/13/will-more-infrastructure-spending-increase-us-growth/.

¹⁹ http://www.gphaonline.org/media/generic-drug-savings-2016/index.html.

²⁰ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4899342/.

²¹ https://www.allergan.com/news/ceo-blog/september-2016/our-social-contract-with-patients.

²² https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4899342/

²³ http://www.gphaonline.org/media/cms/REMS_Studyfinal_July2014.pdf; https://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdf

²⁴ https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drug-competition/.

²⁵ https://data.oecd.org/healthres/health-spending.htm; https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/Proj2015.pdf.

²⁶ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf.

²⁷ https://www.biocentury.com/biocentury/strategy/2017-09-01/25th-back-school-issue-repair-social-contract

²⁸ http://www.nejm.org/doi/full/10.1056/NEJMp1708704

²⁹ http://www.who.int/intellectualproperty/events/en/R&Dpaper2.pdf; http://eprints.lse.ac.uk/71641/7/Wouters_Comparing%20generic%20drug%20markets_2017_author%20LSERO.pdf

³⁰ http://www.gphaonline.org/media/generic-drug-savings-2016/index.html; http://eprints.lse.ac.uk/71641/7/Wouters_Comparing%20generic%20drug%20markets_2017_author%20LSERO.pdf

³¹ http://www.worldhepatitisalliance.org/news/jul-2016/treatment-hepatitis-c-has-more-doubled-2013-yet-99-people-are-still-being-denied-life

³² http://www.commonwealthfund.org/publications/in-the-literature/2016/nov/2016-international-health-policy-survey-of-adults; http://www.nejm.org/doi/full/10.1056/NEJMp1708704

³³ http://www.kff.org/medicaid/issue-brief/the-effects-of-premiums-and-cost-sharing-on-low-income-populations-updated-review-of-research-findings/

³⁴ https://jamanetwork.com/journals/jama/fullarticle/1108322

³⁵ http://catalyst.nejm.org/simple-case-health-insurance-complexity/ ; http://www.choosingwisely.org/

³⁶ https://www.bloomberg.com/graphics/2017-value-of-life/

³⁷ http://www.nbcnews.com/health/health-care/surgery-prices-surge-innovation-consolidation-under-obamacare-n191901 ; https://hbr.org/2014/11/the-real-cost-of-high-priced-drugs

³⁸ https://www.nasa.gov/vision/space/features/jfk_speech_text.html


Peter Kolchinsky, PhD

Peter Kolchinsky is a founder, Portfolio Manager, and Managing Director at RA Capital Management. Peter is active in both public and private investments in companies developing drugs, medical devices, diagnostics, and research tools, and serves as a Board Member for various public and privately held companies, including Dicerna Pharmaceuticals, Inc. and Wave Life Sciences Ltd. Peter also leads the firm’s outreach and publishing efforts, which aim to make a positive social impact and spark collaboration among healthcare stakeholders, including patients, physicians, researchers, policy makers, and industry. He authored “The Entrepreneur’s Guide to a Biotech Startup” and served on the Board of Global Science and Technology for the National Academy of Sciences. Peter holds a BS from Cornell University and a PhD in Virology from Harvard University.

Important Disclosures for Readers

The opinions in this article are my own, subject to change, and may not reflect the opinions of RA Capital Management or anyone with whom I am affiliated. With regard to data and anything presented as fact, I’ve made an effort to be accurate and cite sources I believe to be accurate, but it’s possible I’ve erred or that my sources were inaccurate, in which case hopefully not in ways that materially impact the overall argument. If you think you’ve spotted an error, please contact me to help me improve my reasoning. While you probably already know this, regulations I’m beholden to as an investor nonetheless require me to remind you that nothing may turn out the way I want things to or predict that they might in this article, whether with a company, the healthcare system, or the economy in general. This article may reference specific companies to provide real-world examples of otherwise generalizable abstract concepts; nothing in this article is intended to be taken as investment advice in any company or in my firm. To help you judge my conflicts of interest, let me draw your attention to the possibility that I or my firm may have invested, may be invested, or someday may invest in the securities of companies mentioned in these articles. If I or my firm have a relationship or investment position in any company mentioned in an article, that would be specifically disclosed in the text of the article at the time of publication and will be accurate as of the time of initial publication but may change thereafter.

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