Tagged Drug Costs

The High Cost Of Sex: Insurers Often Don’t Pay For Drugs To Treat Problems

For some older people, the joy of sex may be tempered by financial concerns: Can they afford the medications they need to improve their experience between the sheets?

Medicare and many private insurers don’t cover drugs that are prescribed to treat problems people have engaging in sex. Recent developments, including the approval of generic versions of popular drugs Viagra and Cialis, help consumers afford the treatments. Still, for many people, paying for pricey medications may be their only option.

At 68, like many postmenopausal women, Kris Wieland, of Plano, Texas, experiences vaginal dryness that can make intercourse painful. Her symptoms are amplified by Sjogren’s syndrome, an immune system disorder that typically causes dry eyes and mouth, and can affect other tissues.

Kris Wieland, left, of Plano, Texas, pictured with daughter Anne, was denied coverage by her Medicare Part D plan for a drug that replenishes vaginal estrogen, prescribed by her doctor.(Courtesy of Kris Wieland)

Before Wieland became eligible for Medicare, her gynecologist prescribed Vagifem, a suppository that replenishes vaginal estrogen, a hormone that declines during menopause. That enabled her to have sex without pain. Her husband’s employer plan covered the medication, and her copayment was about $100 every other month.

However, after she enrolled in Medicare, her Part D plan denied coverage for the drug.

“I find it very discriminatory that they will not pay for any medication that will enable you to have sexual activity,” Wieland said. She plans to appeal.

Under the law, drugs used to treat erectile or sexual dysfunction are excluded from Part D coverage unless they are used as part of a treatment approved by the Food and Drug Administration for a different condition. Private insurers often take a similar approach, reasoning that drugs to treat sexual dysfunction are lifestyle-related rather than medically necessary, according to Brian Marcotte, CEO of the National Business Group on Health, which represents large employers.

So, for example, Medicare may pay if someone is prescribed sildenafil, the generic name for Viagra and another branded drug called Revatio, to treat pulmonary arterial hypertension, a type of high blood pressure in the lungs. But it typically won’t cover the same drug if prescribed for erectile dysfunction.

Women like Kris Wieland may encounter a similar problem. A variety of creams, suppositories and hormonal rings increase vaginal estrogen after menopause so that women can have intercourse without pain. But drugs that are prescribed to address that problem haven’t generally been covered by Medicare.

Sexual-medicine experts say such exclusions are unreasonable.

“Sexual dysfunction is not just a lifestyle issue,” said Sheryl Kingsberg, a clinical psychologist who is the chief of behavioral medicine at University Hospitals MacDonald Women’s Hospital in Cleveland. She is the immediate past president of the North American Menopause Society, an organization for professionals who treat women with these problems. “For women, this is about postmenopausal symptoms.”

Relief may be in sight for some women. Last spring, the federal Centers for Medicare & Medicaid Services sent guidance to Part D plans that they could cover drugs to treat moderate to severe “dyspareunia,” or painful intercourse, caused by menopause. Plans aren’t required to offer this coverage, but they may do so, according to CMS officials.

The North American Menopause Society applauded the change.

“Dyspareunia is a medical symptom associated with the loss of estrogen,” said Kingsberg. “They had associated it with sexual dysfunction, but it’s a menopause-related issue.”

For men who suffer from erectile dysfunction, treatment can confer both physical and emotional benefits, according to experts in sexual health.

“In my clinical work, I see a lot of older couples,” said Sandra Lindholm, a clinical psychologist and sex therapist who is also a nurse practitioner in Walnut Creek, Calif. “They are very interested in sex, and they feel like they’re able to embrace their erotic lives. But there may be medical issues that need to be addressed.”

Roughly 40 percent of men over age 40 have difficulty getting or maintaining an erection, studies show, and the problem increases with age. A similar percentage of postmenopausal women experience genitourinary syndrome of menopause, a term used to describe a host of symptoms related to declining levels of estrogen, including vaginal dryness, itching, soreness and pain during intercourse, as well as increased risk of urinary tract infections.

Low sexual desire is another common complaint among women and men. A drug called Addyi was approved in 2015 to treat low sexual desire disorder in premenopausal women. But many insurers don’t cover it.

Unfortunately, medications that treat these conditions may cost people hundreds of dollars a month if their insurance doesn’t pick up any of the tab. A 10-tablet prescription for Viagra in a typical 50-milligram dose may cost more than $600, for example, while the price of eight Vagifem tablets may exceed $200, according to GoodRx, a website that publishes current drug prices and discounts.

In recent years, much more affordable generic versions of some of these medications have gone on the market.

Generic versions of Viagra and Cialis, another popular erectile dysfunction drug, may be available for just a few dollars a pill.

“I never write a prescription for Viagra anymore,” said Dr. Elizabeth Kavaler, a urogynecologist at Lenox Hill Hospital in New York City. “These generics are inexpensive solutions for men.”

There are generic versions of some women’s products as well, including yuvafem vaginal inserts and estradiol vaginal cream.

But even those generic options are often relatively pricey. Some patients can’t afford $100 for a tube of generic estradiol vaginal cream, said Dr. Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive medicine at Yale University School of Medicine.

“I’ve asked, ‘Did you try any of the creams?’ And they say they used up the sample I gave them. But they didn’t buy the prescription because it was too expensive.”

Can California Beat The Federal Government In Lowering Drug Prices?

California Gov. Gavin Newsom says he’s done waiting for the federal government to curtail the rising cost of prescription drugs.

Newsom has his own plan to ease that financial burden — one he hopes other states can join or replicate.

The Democratic governor said he intends to use California’s might as the world’s fifth-largest economy to demand lower prices directly from drug companies for millions of Medicaid enrollees, state government workers and, eventually, Californians in the private sector.

“I recognize deeply the anxiety so many of you feel around the issues related to the cost of prescription drugs,” Newsom said in a Facebook Live video when announcing his initiative. “And I hope California’s efforts here can lead the way to other states to consider the same.”

Newsom said later he’s already “talking to other state governors about how they can participate.”

Whether he can deliver on his ambitious pledge to take on big pharmaceutical companies is far from certain. The plan he introduced his first day in office is based on broad ideas, with few details and start dates that may be years away.

States have taken smaller steps to rein in drug prices and achieved limited savings. But the issue has stymied lawmakers at the federal level, including President Donald Trump, who called for lowering the cost of prescription drugs in his State of the Union address last week.

Lawmakers face an array of challenges that make reform hard, such as secretive drug pricing and the political influence of the pharmaceutical industry, one of the most powerful lobbies in the country, said Rachel Sachs, an associate professor at Washington University in St. Louis who specializes in health law.

“Drug pricing is one of the most complicated areas within a complicated health care system,” Sachs said.

In California, the amount the state government spends on prescription drugs has risen 20 percent per year since 2012, according to Newsom’s executive order.

To stem that rise, he wants the state Department of Health Care Services — which oversees Medi-Cal, the country’s largest Medicaid program, for low-income residents — to negotiate prescription drug prices for all of its roughly 13 million enrollees by 2021.

Currently, the vast majority of Medi-Cal enrollees get their prescription drugs through managed-care plans that contract with the state to provide Medi-Cal coverage — a fragmented system that doesn’t yield the best price for consumers, the Newsom administration argues.

With the state in charge of negotiations, Medi-Cal could save $150 million a year, the administration said, and Medi-Cal enrollees could go to virtually any pharmacy, as opposed to the limited options authorized by their health plans.

Although the concept of bulk purchasing might sound good, health experts say, the state faces barriers.

Federal law requires Medicaid programs to cover most drugs approved by the Food and Drug Administration. That leaves states without one of the biggest bargaining chips available to the private sector: the ability to tell drugmakers they won’t buy their products.

But California can get creative, said Jennifer Kent, the health department’s director. For example, the state can create a preferred drug list that gives drugmakers an incentive to reduce their prices. If a medication is on the list, doctors don’t need to obtain preauthorization from Medi-Cal to prescribe it, making it more accessible and thus more likely to be used by patients, Kent said.

In addition, the sheer size of California’s Medi-Cal program can help drive down prices, Kent said.

“I think of us as the third-largest public purchaser in the nation” behind Medicare and the Department of Veterans Affairs, Kent said. “We cover a very significant number of people.”

But representatives for California health plans and pharmacy benefit managers, the middlemen who negotiate with drugmakers on behalf of health plans and government entities, say their organizations already work to find the best prices for consumers. They haven’t publicly opposed Newsom’s plan but have expressed skepticism.

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said in a written statement that its companies are set to save the California Medi-Cal program $8.59 billion in projected costs from 2016 to 2025.

Drugmakers have launched a national campaign that blames insurers for failing to pass along more than $150 billion a year in rebates and discounts to consumers.

In addition to negotiating for Medi-Cal enrollees, Newsom wants to get a better deal for state workers. He has directed his administration to study how agencies could band together in a separate drug-purchasing pool to buy prescription drugs as one entity.

Currently, more than 20 state agencies negotiate drug prices separately.

Newsom said he envisions private purchasers — including small businesses, health plans and self-insured Californians — eventually joining these state agencies at the bargaining table in a bid to “marshal public and private parties” for lower drug prices.

A report last year by the National Academy of Sciences found that spending on biopharmaceuticals accounts for nearly 17 percent of America’s annual health care bill, and that many people have difficulty paying for the drugs they need.

Among the report’s recommendations to lower costs: The federal government should consolidate its purchasing power and directly negotiate prices for all federal health care programs, including Medicare and Department of Veterans Affairs coverage. However, legislation to do that within Medicare has stalled repeatedly over the years and remains controversial.

Trump’s proposal last year to link Medicare spending for certain drugs to what other industrialized countries pay has gone nowhere. Last month, the Trump administration proposed a new prescription drug discount plan that would steer the rebates drug companies now give to insurers directly to consumers.

In the absence of federal action, states have sought to curb drug prices on their own. Among those efforts: a Connecticut law requiring drug companies to justify price increases, a California law requiring them to report price hikes, and a New York cap on drug spending in the state’s Medicaid program.

Twenty-eight states and the District of Columbia belong to multistate purchasing pools, mostly for their Medicaid programs. But data about how much money these pools have saved is scarce, said Edwin Park, a research professor at Georgetown University’s Center for Children and Families.

“I think there are real opportunities and real interest in the states about leveraging their buying power,” said Trish Riley, the executive director of the National Academy for State Health Policy. “The states can’t wait for federal action.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Americans Cross Border Into Mexico To Buy Insulin At A Fraction Of U.S. Cost

When Michelle Fenner signed up to run this year’s Los Angeles Marathon, it got her thinking: Tijuana, Mexico, is only a 2½-hour drive from L.A. Why not take a trip across the border and buy some insulin for her son?

“It’s so easy to just go across the border,” mused Fenner.

This idea had been in the back of Fenner’s mind for a while. Her son was diagnosed with Type 1 diabetes nine years ago, meaning he needs daily injections of insulin to live. The list price of the modern generation of insulin has skyrocketed since his diagnosis. On one trip to the pharmacy last year, Fenner was told that a three-month supply of insulin would cost her $3,700.

That same supply would cost only about $600 in Mexico.

So, when she booked her trip to Los Angeles, Fenner said, “I decided we need to update our passports and go and get more insulin.”

Fenner is not the only one thinking like this. The U.S. government estimates that close to 1 million people in California alone cross to Mexico annually for health care, including to buy prescription drugs. And between 150,000 and 320,000 Americans list health care as a reason for traveling abroad each year. Cost savings is the most commonly cited reason.

‘Right To Shop’ Legislation

In Utah last year, the Public Employee Health Plan took this idea to a new level with its voluntary Pharmacy Tourism Program. For certain PEHP members who use any of 13 costly prescription medications — including the popular arthritis drug Humira — the insurer will foot the bill to fly the patient and a companion to San Diego, then drive them to a hospital in Tijuana, Mexico, to pick up a 90-day supply of medicine.

“The average cost of an eligible drug in the US is over $4,500 per month and is 40-60% less in Mexico,” PEHP clinical services director Travis Tolley said in an announcement of the program in October.

The program was part of a “Right to Shop” bill championed by health care economist and Utah state representative Norm Thurston in 2018. Thurston said there is not yet enough data to know how much in savings the program provides; the first patients traveled to Tijuana in December.

But, Thurston said, he expects that in the next six months, savings will likely be “in the ballpark of $1 million.”

There are some questions about traveling abroad to buy prescription drugs, however. The first: Is it legal?

According to the Food and Drug Administration, “in most circumstances, it is illegal for individuals to import drugs into the United States for personal use.” But the agency’s website does provide guidance about when it could be allowed. And the U.S. Customs and Border Protection’s website has a whole section on traveling with medications in its “Know Before You Go” guide.

While the guidelines may still raise questions, Thurston said, this sort of purchase for personal use is a widely established practice.

“When we talked to people about this, there has never been a single person who has been prosecuted for doing it. And it happens every day at every border crossing all over the country,” Thurston said.

“The general understanding is you can bring up to a 90-day supply of a prescription from overseas, even though it’s a technical violation,” said Nathan Cortez, a law professor at Southern Methodist University.

“My sense is the FDA does not want to worry about individuals going overseas and bringing back small amounts of prescriptions that last a few months,” Cortez said, adding, “That doesn’t mean the FDA couldn’t change its mind at any point and start cracking down.”

A second major concern that comes up in any discussion of medical tourism is about the quality of that imported medicine. According to the FDA, the reason it’s mostly illegal to import drugs is because the agency “cannot ensure the safety and effectiveness” of those drugs. In 2017, the World Health Organization estimated that 10 percent of drugs in developing countries were either substandard or falsified.

To address that problem, the Utah program sends its patients only to a designated, accredited Mexican hospital. Individual patients like Michelle Fenner are left to take their own precautions.

“You get a little nervous. You want to make sure that you have a reputable pharmacy,” Fenner said. To get pharmacy recommendations, she has been consulting with friends and acquaintances who have purchased insulin in Mexico. She’s calling those pharmacies now to make sure they have the type of insulin she wants to buy. When the March 24 marathon gets closer, she’s planning to call ahead with her order.

Fenner, who splits her time between Dallas and Arvada, Colo., said the amount she’s expecting to save on insulin could warrant multiple trips to Mexico every year.

Global Savings

Fenner is just one of the growing number of activists online who are discussing the great lengths they go to — sometimes literally — to afford insulin. Lija Greenseid is another. Her daughter has Type 1 diabetes.

Almost one year to the day after her daughter’s diagnosis, Greenseid and her family were visiting Quebec City, Canada, in July 2014. Her daughter’s blood sugar started spiking and Greenseid feared her insulin might have gone bad, so she went to a pharmacy. With no prescription and fearing that her daughter’s life was on the line, Greenseid was prepared to pay a fortune.

Instead the box of insulin pens that normally costs $700 in the U.S. was only around $65 or so.

“At that point I started tearing up. I could not believe how inexpensive it was and how easy it was,” Greenseid said.

“I said to [the pharmacist], ‘Do you have any idea what it’s like to get insulin in the United States? It’s just so much more expensive.’ And he turned to me and said, ‘Why would we want to make it difficult? You need insulin to live.’”

The more Greenseid traveled with her family, the more they realized how inexpensive insulin was everywhere except in the United States. In Nuremberg, Germany, she could get that $700 box of insulin pens for $73. The same box was $57 in Tel Aviv, Israel, $51 in Greece, $61 in Rome and $40 in Taiwan.

“We get so accustomed in the United States to thinking that health care has to be difficult and so expensive that people don’t even consider the fact that it could be so much easier and less expensive in other places,” Greenseid said. “In fact, that is the case in most countries.”

This story is part of a partnership that includes Side Effects Public Media, NPR and Kaiser Health News.

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Also known as the day President Donald Trump is getting his second annual physical. Last year, Dr. Ronny L. Jackson attributed the president’s “excellent health” to good genes and God. Will this year be different with a new physician?

The headliner from this week was obviously the State of the Union address, so let’s get right to it.

Trump’s pledge to end the HIV epidemic was greeted with cautious optimism — laced with a heavy dose of skepticism. The administration’s plan involves targeting HIV hot spots and increasing access to medications that treat and prevent the disease. However, the lack of specific details in Trump’s address have HIV advocates nervous. “To date, this administration’s actions speak louder than words and have moved us in the wrong direction,” said AIDS United.

The Associated Press: Trump Launching Campaign to End HIV Epidemic in US by 2030

Kaiser Health News: Trump Pledges To End HIV Transmission By 2030. Doable, But Daunting.

When it comes to high drug prices, Trump had very simple instructions for Congress: “Do more.” The response, as you can imagine, was mixed. Some Democrats saw it as an invitation to work on an issue that could be one of the few bipartisan successes emerging from the current Congress. Others don’t have any interest in getting on board with the president’s policies — which include capping U.S. drug payments based on prices paid abroad.

Stat: Democrats Can’t Decide How to React to Trump’s Call for ‘More’ on Drug Pricing

Meanwhile, in his address, Trump used a pretty wonky (as in, in the weeds) metric to praise his administration’s efforts on bringing down drug prices. The consumer price index, at best, doesn’t tell the full story of costs, and experts say that, given how complicated the system has become (i.e. with rebates), it has outlived its usefulness.

Stat: Trump Claims Drug Prices Have Fallen. But He’s Cherry-Picking That Data

Recent controversies over abortions provided Trump the perfect opportunity, as he starts to gear up for 2020, to give a little love to a highly valued segment of his base. Virginia’s governor had made comments last week that led to accusations that he supported infanticide; and New York just passed a bill that protects against efforts to roll back Roe v. Wade. Trump used those incidents as a springboard to call on Congress to ban “late-term abortions.” And the language he used in the speech — “All children — born and unborn — are made in the holy image of God” — is being seen as a play for evangelical voters.

The Associated Press: With Anti-Abortion Push, Trump Woos Evangelicals Again

Doctors weighed in on the debate with this reality check: Clinically, there is no such thing as a “late-term abortion.” See what else they say the president got wrong.

The New York Times: What Is Late-Term Abortion? Trump Got It Wrong

Childhood cancer also got a shout-out in the SOTU. Although it has an 80 percent cure rate, scientists say that number is skewed by the tremendous progress that’s been made against childhood leukemia. Other pediatric cancers have a long way to go. (And so they are welcoming the $500 million with open arms and a distinct list of ideas.)

Stat: Scientists Have Ideas to Spend Trump’s Money for Childhood Cancer

Former Rep. John Dingell died on Thursday at age 92. Lawmakers and politicians praised the country’s longest-serving congressman, calling him a “beloved pillar of the Congress” who is leaving behind “a towering legacy.” One common thread in the heartfelt messages was the impact he had on America’s health care. “He had a long tradition of introducing legislation on the first day of each new Congress to guarantee health care for every single American,” former President Barack Obama wrote. “Because of him, we’ve come closer to that vision than ever before. And when we finally achieve it — and we will — we’ll all owe him our gratitude.”

The Washington Post: Colleagues, friends remember John Dingell, an ‘American legend’ and ‘beloved pillar of Congress’

Fresh off their midterm victories, Democrats are wasting no time setting up hearings to secure protections for people with preexisting conditions. Any legislation would be mostly symbolic because it would face an all-but-certain death in the Republican-controlled Senate, but it solidifies talking points that have been successful for Democrats recently.

The New York Times: Democrats Unite to Begin Push to Protect Pre-Existing Condition Coverage

If you’re confused about Trump’s rebate proposal join the (very crowded) club. But here’s the bottom line: Most patients will pay a little more since their premiums will go up (because insurers would no longer be able to apply rebate money from the drugs to lower premiums). However, people who take outrageously expensive medication will get relief. Experts say the trade-off is worth it.

The New York Times: How Trump’s Latest Plan to Cut Drug Prices Will Affect You

How does a drug that, until December, was free to patients now have a $375,000 price tag? Paint Sen. Bernie Sanders (I-Vt.) … curious … to say the least.

Stat: Sanders Calls Price of a Rare Disease Drug ‘Immoral Exploitation’

Court watchers were eagerly awaiting the Supreme Court’s decision on a Louisiana admitting-privileges law — the first real gauge of how the new dynamics of the court will play out with abortion decisions. The Louisiana restrictions are quite similar to ones knocked down in a 2016 ruling, but the court is also more conservative than it was at that time. For now, Chief Justice John Roberts disappointed his conservative colleagues by joining with the liberal justices in issuing a stay on the law. The decision likely means the court will take up the issue in its next term, which starts in October.

The New York Times: Supreme Court Blocks Louisiana Abortion Law

Medicaid expansion advocates were ecstatic last year when ballot initiatives proved a successful way to circumnavigate red-state legislatures that had been blocking changes to the program. This week, a bucket of cold water has doused that enthusiasm as lawmakers in both Utah and Idaho scramble to counter the expansion as much as possible. While the proposals — like adding work requirements — gain popularity in red states across the country, the fact it’s happening at all after voters OK’d the expansion highlights the reality that ballot initiatives can do only so much.

The New York Times: In Utah and Idaho, G.O.P. Looks to Curb Medicaid Expansions That Voters Approved

In a startling, horrifying trend, veterans have been killing themselves in VA parking lots in what experts see as a protest against a system that failed them. The latest was a Marine colonel who, dressed in his uniform blues and medals, sat on top of his military and VA records and shot himself with a rifle outside the Bay Pines Department of Veterans Affairs. “It’s very important for the VA to recognize that the place of a suicide can have great meaning. There is a real moral imperative and invitation here to take a close inspection of the quality of services at the facility level,” said Dr. Eric Caine, director of the Injury Control Research Center for Suicide Prevention at the University of Rochester.

The Washington Post: Parking Lot Suicides at Veterans Hospitals Prompt Calls for Better Staff Training, Prevention Efforts

Meanwhile, USA Today released a comprehensive analysis on the quality of VA hospitals versus civilian ones. Some of the scores came back positive (death rates, on the whole, were lower at VA facilities); others that look at preventable infection rates and bedsores hinted at neglect. USAT offers a very cool look-up tool if you want to see how your clinic fared.

USA Today: Death Rates, ER Waits: Where Every VA Hospital Lags, Leads Other Care

An HHS official is arguing that pulling separated migrant children from their sponsor homes to reunite them with their families would do more harm than good psychologically at this point. Jonathan White, an official leading HHS’ reunification efforts, said in a court filing that it would make more sense for the government to focus on children who were still in custody. The ACLU called the position a “shocking concession that it can’t easily find thousands of children it ripped from parents, and doesn’t even think it’s worth the time to locate each of them.”

The Associated Press: US Sees Limitations on Reuniting Migrant Families

In the miscellaneous file for the week:

• There’s a long history of mistrust between the African-American community and medical professionals, and Virginia Gov. Ralph Northam’s photo involving black face pressed sharply against that never-healed wound. (At the time, Northam was graduating from medical school on his way to becoming a pediatrician.)

The Associated Press: Blackface Photo Reopens Long History of Bigotry in Medicine

• Anecdotal evidence was thick on the ground that women were seeking emergency contraception in the wake of Trump’s election victory. Now there are numbers to back it up.

The Hill: Demand for Certain Forms of Contraception Increased After Trump’s Election: Study

• Could an infamous party drug really help quiet suicidal ideation in the midst of an ever-worsening crisis? This fascinating history on the use of ketamine is well-worth the read.

Bloomberg: Ketamine Could Soon Be Used to Treat Suicidal Ideation

• “It’s like throwing a match into a can of gasoline,” experts say of the measles outbreak in the Pacific Northwest. Are they just the norm now? And why were there so many kids who weren’t vaccinated?

The New York Times: ‘A Match Into a Can of Gasoline’: Measles Outbreak Now an Emergency in Washington State

CNN: Measles Rarely Kills in the US — But When It Does, Here’s How 

I was delighted this morning over the fact that scientists had a major breakthrough in creating a way to take insulin in pill form because of … turtles! Last week hedgehogs, this week turtles. I swear the Breeze isn’t turning into an animal news newsletter (or is it?). Have a great weekend!

Podcast: KHN’s ‘What The Health?’ A ‘Healthy’ State Of The Union

Health policy played a surprisingly robust role in President Donald Trump’s 2019 State of the Union address.

The president laid out an ambitious set of health goals in his speech Tuesday to Congress and the nation, including reining in drug prices, ending the transmission of HIV in the U.S. during the next decade and dedicating more resources to fighting childhood cancer.

Meanwhile, in Utah and Idaho, two of the states where voters last fall approved expansion of the Medicaid health program, Republican legislatures are trying to scale back those plans.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Margot Sanger-Katz of The New York Times and Alice Ollstein of Politico.

Among the takeaways from this week’s podcast:

  • The Trump administration is proposing to change the drug rebates in Medicare so that consumers purchasing the medicines get more of the savings and the middlemen negotiating the deals get less. But that effort could lead to increased insurance premiums — a consequence that could have significant political repercussions.
  • Trump’s pledge to end HIV transmissions in 10 years was a bit of a surprise since the disease had not been much of a priority in earlier moves by the administration.
  • The efforts to restrict Medicaid expansion approved by voters in Utah and Idaho show the limitations of referendums and could impact a move to get a Medicaid expansion question on the Florida ballot.
  • An intriguing study this week showed that medications to treat cardiac problems saved Medicare money. The results were surprising because generally public health officials suggest that prevention is important to improve health but doesn’t necessarily save money.

Also this week, Rovner interviews KHN senior correspondent Phil Galewitz, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a man with a minor problem — fainting after a flu shot — and a major bill. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: NPR’s “Texans Can Appeal Surprise Medical Bills, But the Process Can Be Draining,” by Ashley Lopez

Margot Sanger-Katz: The Los Angeles Times’ “In Rush to Revamp Medicaid, Trump Officials Bend Rules That Protect Patients,” by Noam N. Levey

Anna Edney: Bloomberg News’ “Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate,” by Cynthia Koons and Robert Langreth

Alice Ollstein: The Washington Post’s “’It Will Take Off Like a Wildfire’: The Unique Dangers of the Washington State Measles Outbreak,” by Lena H. Sun and Maureen O’Hagan

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale

The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past two years, the result of its actions to streamline a cumbersome process and combat anti-competitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Donald Trump noted at a White House event last month. The Food and Drug Administration has approved more than 1,600 generic drug applications since January 2017 — about a third more than it did in the last two years of the Obama administration.

But more than 700, or about 43 percent, of those generics still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36 percent of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who co-sponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more, but suspects anti-competitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner Brilinta and HIV medication Truvada. They also include six different generic versions of Nitropress, a heart failure drug, whose price spiked 310 percent in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33 percent of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10 percent a year, said Scott Knoer, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past two years haven’t been brought to market.

Erin Fox, a pharmacist at the University of Utah who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list — like dextrose 10 percent injection, to treat patients with low blood sugar — would have been helpful to combat shortages the past few years. “This comes up with shortages a lot — it looks like there are more suppliers than there really are,” Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting six, seven, eight years,” said Robert Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects, or because a more effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anti-competitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, Gottlieb said, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti, an associate professor at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Conti said. Then they can launch and hike the price.

To be sure, the FDA under Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in — once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Davis said. Consolidation has led to three large buying groups covering 90 percent of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”


To identify approved drugs that have not reached the market, KHN used the FDA’s Orange Book database — as of Jan. 2 — to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past two years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.