Category Archives: Drugs & Medicines

The Cost of a Cure: Medicare Spent $4.5 Billion on New Hepatitis C Drugs Last Year

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Twenty-dollar bill in a pill bottleBy Charles Ornstein
ProPublica.

This story was co-published with the Washington Post.

Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C 2014 more than 15 times what it spent the year before on older treatments for the disease, previously undisclosed federal data shows.

The extraordinary outlays for these breakthrough drugs, which can cost $1,000 a day or more, will be borne largely by federal taxpayers, who pay for most of Medicare’s prescription drug program.

The most-discussed of the new drugs, Sovaldi, which costs $84,000 for a 12-week course of treatment, accounted for more than $3 billion of the spending.

But the expenditures will also mean higher deductibles and maximum out-of-pocket costs for many of the program’s 39 million seniors and disabled enrollees, who pay a smaller share of its cost, experts and federal officials said.

The spending dwarfs the approximately $286 million that the program, known as Part D, spent on earlier-generation hepatitis C drugs in 2013, said Sean Cavanugh, director of Medicare and deputy administrator at the Centers for Medicare and Medicaid Services (CMS).

The most-discussed of the new drugs, Sovaldi, which costs $84,000 for a 12-week course of treatment, accounted for more than $3 billion of the spending. Spending on another drug, Harvoni, hit $670 million even though it only came on the market only in October. Bills for a third drug, Olysio, often taken in conjunction with Sovaldi, reached $821 million.

Medicare also spent $157 million on older hepatitis C drugs in 2014, bringing the total spending for the category to more than $4.7 billion.

The spending surge is unlike anything Part D has seen. The nine-year-old program has benefited in recent years from a slowdown in prescription drug costs as several blockbusters, including the cholesterol-lowering drug Lipitor and the blood thinner Plavix, have lost patent protection and have faced competition from generics. Continue reading

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More states demand notification of use of biosimilars

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Three red-and-white capsulesBy Michael Ollove
Stateline

Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.

Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.

Notification laws require that patients and doctors are told whenever “biosimilar” imitations are substituted for brand-name biologics

.What keeps her up at night is a fear that a pharmacy could substitute a cheaper, not-quite identical drug for Cimzia without her or her doctor’s knowledge. It’s not only a return of her worst symptoms that she worries about. “If another medicine were substituted without telling me or my doctor, it could put my pregnancy at risk,” she said.

Fears like Crow’s have helped propel legislative attempts in many states this year to make sure that patients and doctors are notified whenever imitations deemed “interchangeable” by the US Food and Drug Administration (FDA) are substituted for brand-name biologics.

biosimilars

 

Already, Colorado has passed a notification law, and Utah has revised its earlier law. More than a dozen states are considering comparable measures.

Notification bills began popping up in states two years ago, but most were defeated in the face of opposition from manufacturers of biologic copies, which are called biosimilars, and from organizations representing pharmacists, who objected to the extra workload notification requirements might entail.  Continue reading

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Vashon parents try to get along despite deep divide over vaccination | The Seattle Times

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Vashon island mapEvery few years, stories appear about Vashon Island and its high percentage of unvaccinated kids. It happened again a few weeks ago in the wake of reports of measles outbreaks nationwide. Then the temporary publicity fades and this island of 11,000 goes back to the same old, same old. Which is: a deep divide between the pro and con camps that in most other ways are so much alike. Except that this time it got pretty vitriolic.

Vashon parents try to get along despite deep divide over vaccination | The Seattle Times.

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High-priced hepatitis C drugs largely cost-effective in U.S.: study | Reuters

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$100-dollar bill inside a capsuleNew hepatitis C drugs that shorten treatment times are largely cost-effective despite their hefty U.S. price tags, according to two new analyses.

The widespread use of a combination of drugs that include Gilead Sciences Inc’s Sovaldi, known generically as sofosbuvir, will nonetheless be a significant cost for the U.S. healthcare system, researchers wrote.

via Gilead’s hepatitis C drugs largely cost-effective in U.S.: study | Reuters.

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Specialty drugs save lives, come with daunting price tags – AP

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$100-dollar bill inside a capsuleDoctors hail many of these therapies as breakthroughs, since they can conquer or control diseases that were once almost untreatable.

But they can cost more than $80,000 for a single course of treatment and bury patients in debt, even those with insurance.

Patient advocates expect the problem to worsen as insurance coverage shrinks and use of specialty treatments grows.

via News from The Associated Press.

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FDA heads into uncharted territory of ‘biosimiliar’ drugs

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zarxio-86242357By Elana Gordon, WHYY

Mark McCamish spent more than five years preparing for a presentation he gave at the Food and Drug Administration’s headquarters this winter.

McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland’s Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of regulators that a company drug code-named EP2006 should be approved for sale in the U.S.

The drug, brand name Zarxio, is similar to but not quite identical to Amgen’s Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.

Industry representatives, patient advocates and investors paid close attention to the evidence under review. Some came in for the day from Europe, their suitcases propped against the wall. That’s because Novartis’ drug application represented uncharted territory.

Biosimilars are a little like the generic drugs. The key difference is that they’re copycats of more complex medicines called biologics, made with living cells

.The FDA approved Zarxio on Friday, and it’s the first time the agency has approved a so-called biosimilar, or close copy of an existing biotech medicine.

Dr. Jay Siegel, chief biotechnology officer at Johnson & Johnson and a former FDA regulator, says biosimilars are a little like the generic drugs we’re used to. The key difference is that they’re copycats of more complex medicines called biologics, made with living cells.

“In a simplistic sense, biologics are typically much larger molecules, usually made by living organisms,” Siegel says. “They can be antibodies whereas most drugs are smaller chemical entities that can be synthesized in the laboratory,” he explains.

It is difficult to make exact copies of biotech drugs because they are manufactured differently than tablets or syrups. Continue reading

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Specialty drugs push US drug prices up 13% – AP

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$100-dollar bill inside a capsulePrescription drugs spending jumped 13 percent last year, the biggest annual increase since 2003, according to the nation’s largest pharmacy benefits manager.

Express Scripts Holding Co. said Tuesday that the jump was fueled in part by pricey specialty drugs that accounted for more than 31 cents of every dollar spent on prescriptions even though they represented only 1 percent of all U.S. prescriptions filled.

via News from The Associated Press.

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FDA finds little evidence of antibiotics in milk – AP

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Photo by Maciej Lewandowski

In response to concerns, the agency in 2012 took samples of raw milk from the farms and tested them for 31 drugs, almost all of them antibiotics.

Results released by the agency Thursday show that less than 1 percent of the total samples showed illegal drug residue.

Photo by Maciej Lewandowski

via News from The Associated Press.

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AMA Dermatology | George Washington was a pro-vaccine activist

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Turns out George Washington was a pro-vaccine activist. He had after all almost died of smallpox as a young man.

02a_3bGeorge Washington is familiar as America’s Revolutionary War general and inaugural president. But less known is that Washington, while audaciously battling the British Army, simultaneously waged a behind-the-scenes public health campaign against a serious, sinister, and pathological threat to American military readiness: smallpox.

via JAMA Network | JAMA Dermatology | George Washington and Smallpox:  A Revolutionary Hero and Public Health Activist.

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Drugs Using Testosterone Will Label Heart Risks – NYTimes.com

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Male Symbol by Rei-artur/Creative Commons LicenseThe Food and Drug Administration said Tuesday that manufacturers of testosterone drugs used by millions of Americans will be required to change labels for the drugs to warn that they could increase the risk of heart attacks and strokes and should not be prescribed to treat symptoms in men brought on by age, such as declining sexual drive.

via Drugs Using Testosterone Will Label Heart Risks – NYTimes.com.

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Health officials perplexed by vaccination skeptics – AP

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Boy gets shot vaccine injectionScientists have long assumed the problem is that some parents are simply misinformed, and providing them “corrective information” will clear things up. But some studies have shown that doesn’t seem to work. For example, in the last 15 years, a leading concern of many vaccine opponents is that shots trigger autism in children. One recent study found that some vaccine-opposed parents could be presented with medical evidence disproving that, and seemed persuaded. But they also said they still did not intend to vaccinate their kids.

via News from The Associated Press.

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Sign-up season is over, but the list of special enrollment events is expanding

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CalendarBy Michelle Andrews
KHN

When the annual sign-up period for individual Obamacare coverage ended earlier this month, it meant that in general, people are locked into their plans for the year.

There are exceptions, however, for those who experience life changes such as marriage, the birth of a child or the loss of their job-based coverage.

The list of situations that trigger a special, 60-day enrollment period will get longer in April, when a new rule issued by the Department of Health and Human Services takes effect.

The rule’s additional circumstances include:

  • Losing a dependent or dependent status because of divorce, legal separation or death. This provision would enable someone who no longer needs family coverage, for example, to switch to single coverage. Although not required until 2017, exchanges are encouraged to offer this as soon as possible.
  • An increase in an individual’s income to the federal poverty level in states that haven’t expanded Medicaid to adults with incomes up to 138 percent of the federal poverty level ($16,243 in 2015).At that income level, the person could qualify for premium tax credits that are available for those with incomes between 100 and 400 percent of the poverty level to make marketplace coverage more affordable.Last year, such individuals could also qualify for a special enrollment period, “but we read this as a bit broader,” says Sarah Lueck, a senior policy analyst at the Center on Budget and Policy Priorities. Last year, “you had to have applied for Medicaid to qualify.” Now, that’s not necessary.
  • If a court order requires someone to provide health insurance, the coverage must be available the first day the court order takes effect.“It’s extremely important for ensuring the coverage of children,” says Dania Palanker, senior counsel at the National Women’s Law Center.
  • People who are currently enrolled in non-calendar year plans will qualify for a special enrollment period when that coverage ends, even if they could renew them.

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

khn_logo_lightKaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

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