Glaxo Recalls Flu Vaccine Due To Potency Problem

The Gilmer Free Press

WASHINGTON, D.C. — GlaxoSmithKline is recalling remaining doses of a popular four-in-one flu vaccine because of effectiveness problems.

The company alerted U.S. customers Tuesday that the vaccine can lose potency over time and fail to adequately protect against some strains of the flu. The Flulaval Quadrivalent Thimerosal-free vaccine in prefilled syringes is designed to protect against four strains of influenza virus.

But Glaxo said in a letter it “cannot rule out potential suboptimal protection” in people who received the vaccine in early January or later. The letter was sent to about 1,000 customers throughout the U.S., including wholesale distributors, pharmacies, government agencies and physicians.

The recall affects about 1.7 million doses, but a company spokeswoman says it’s unclear how many of those actually remain on the market. More than 99 percent of the vaccines were distributed in 2014, before the product began losing potency, according to GlaxoSmithKline’s Anna Padula.

“The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern,” Padula said in a statement. The British drug and vaccine maker has also notified the Food and Drug Administration.

The recalled vaccines represent about 7 percent of the total 24 million flu vaccine doses Glaxo distributed in the U.S. this season.

Health authorities generally recommend getting the flu vaccine in the fall but many people don’t get vaccinated until later months. Flu season generally peaks around January or February.

Glaxo’s so-called quadrivalent vaccine is part of a new group of injectable and inhalable products that protect against four strains: two for Type A flu and two for Type B flu. Older vaccines traditionally only protected against three strains: two Type A strains and one Type B strain.

Glaxo said it launched the recall after company testing showed its vaccine’s potency against the B strains could fall below minimum effectiveness standards. Type B flu tends to strike children more than the middle-aged.

The Centers for Disease Control and Prevention recommends the flu vaccine for nearly everyone ages 6 months and older. Yet usually less than half of that target population follows the advice. Flu is particularly risky for seniors, children, pregnant women and people of any age with asthma, heart disease and other chronic diseases.

GlaxoSmithKline is headquartered in London, with U.S. operations in Philadelphia and North Carolina.

IMS: U.S. Prescription Drug Spending Jumped 13% in 2014

The Gilmer Free Press

TRENTON, NJ — U.S. spending on prescription drugs soared last year, driven up primarily by costly breakthrough medicines, manufacturer price hikes and a surge from millions of people newly insured due to the Affordable Care Act.

Spending rose 13%, the biggest jump since 2001, to a total of $374 billion, according to a report just released by the IMS Institute for Healthcare Informatics. After accounting for population growth and inflation, the increase equaled 10%.

A record 4.3 billion prescriptions were filled in 2014, many of them for inexpensive generic pills going to patients now insured through Medicaid in states that expanded eligibility for the government health program for the poor and disabled. The number of prescriptions covered by Medicaid rose by nearly 17%, and that increase accounted for 70% of growth in the number of prescriptions filled at retail pharmacies. Another sign of the Affordable Care Ac’s impact was that prescriptions paid for in cash, normally filled by uninsured people, declined 5.5%.

The higher spending, though, was mostly due to the many recent drugs with eye-popping price tags: tens of thousands of dollars for a year or course of treatment.

Last year saw an unusually high 42 novel medicines launched, 18 for rare diseases, those that affect fewer than 200,000 Americans. Ten of the new drugs were designated as breakthrough therapies, for conditions including multiple sclerosis, various cancers and hepatitis C.

Altogether, spending on prescription medicines in the U.S. rose by $43.4 billion last year, including about $10 billion due to price increases and $20.3 billion spent on prescriptions for new drugs.

That included a combined $11.3 billion spent on just four new medicines for hepatitis C, a liver-damaging virus so tough to eliminate that until recently, patients had to endure flu-like symptoms and other awful side effects for nearly a year, yet barely 60% were cured.

The new hepatitis C treatments cure upward of 90%, usually in 12 weeks. However, they carry list prices of $84,000 or more for a course of treatment.

One of them, Sovaldi, was launched at the end of 2013 yet was the top-selling drug last year. It brought maker Gilead Sciences Inc. $7.9 billion.

Specialty medicines — drugs for complex, chronic and often expensive disorders including hepatitis C — last year accounted for a full third of prescription spending. That’s a likely harbinger of even higher prescription spending in years in the future.

The 2014 spending growth was somewhat restrained by insurers’ efforts to hold down their costs. More and more insurance companies have been shifting patients into plans that include high copayments for medicines, as well as large deductibles that must be met before insurance coverage kicks in.

IMS said that led to more prescriptions being abandoned at the pharmacy counters by patients who couldn’t afford their portion of the cost. That ultimately resulted in 8.4 million fewer prescriptions being filled at retail pharmacies in 2014, compared to 2013, by patients who were commercially insured, either through their employer or a new health exchange plan.

The IMS figures are based on list prices for brand-name drugs, though wholesalers usually get discounts and rebates amounting to about 6%. Generic drugs, which are often as much as 90% cheaper than the brand-name drugs they copy, don’t come with such large markdowns.

Last year, there were far fewer new generic drugs than in recent years, so generics reduced spending by only $11.9 billion, compared to the peak level of $30.7 billion in 2012.

U.S. prescription drug spending at a glance

Some figures on prescription medicine spending trends:

U.S. PRESCRIPTION SPENDING, 2014: $373.9 billion

U.S. PRESCRIPTION SPENDING, 2013: $330.5 billion

U.S. PRESCRIPTIONS DISPENSED, 2014: 4.33 billion

U.S. PRESCRIPTIONS DISPENSED, 2013: 4.24 billion

TOP DRUG TYPES BY PRESCRIPTION, 2014: Blood pressure, mental health, pain, antibacterials, cholesterol/blood fats, diabetes.

TOP DRUG TYPES BY SALES LEVEL, 2014: Cancer, diabetes, mental health, immune disorders, respiratory conditions, pain.

TOP DRUGS BY SALES, 2014: Sovaldi (hepatitis C), $7.9 billion; Abilify (schizophrenia), $7.8 billion; Humira (immune disorders), $7.2 billion; Nexium (severe heartburn), $5.9 billion; Crestor (cholesterol), $5.8 billion; Enbrel (immune disorders), $5.5 billion.

~~  Source: IMS Institute for Healthcare Informatics ~~

Medicare: New Hepatitis C Drugs Are Costing Medicare Billions

The Gilmer Free Press

Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C — 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. 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 Cavanaugh, director of Medicare and deputy administrator at the Centers for Medicare and Medicaid Services (CMS).

[Obama’s budget contains the most aggressive move yet to fight high drug prices]

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 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, lost patent protection and have faced competition from generics.

The new hepatitis C drugs, along with other expensive specialty medications in the pipeline, threaten to drastically increase the program’s costs. The federal government spent $65 billion on Part D in 2013, according to the Medicare Payment Advisory Commission. That figure doesn’t include monthly premiums paid by patients.

An analysis published last year on the Web site of the ­health-policy journal Health Affairs suggested that 350,000 Medicare beneficiaries have hepatitis C, although many don’t know it.

It generally takes the government more than a year to compile data on drug spending, but CMS provided the data on hepatitis C drugs to ProPublica in response to a Freedom of Information Act request and follow-up inquiries.

Medicare officials said they are watching the costs carefully, and early indications suggest that this year’s spending is on track to match or even exceed last year’s, Cavanaugh said.

“We’re all waiting to see when it plateaus or when it possibly goes back down,” he said in an interview. “When will that pent-up demand be sated?”

Medicare’s costs for the drugs, at least in 2014, appear to be far higher than those incurred by state Medicaid programs for the poor, which collectively spent $1.2 billion on the drugs in the first nine months of the year. (This data is preliminary; data for the entire year is not yet available.)

Many Medicaid programs, as well as private insurance companies, took a more restrictive approach toward the drugs than Medicare did, often requiring that patients have advanced liver disease to be eligible to receive the pills.

Medicare has a more permissive standard, requiring the insurance companies that administer Part D on its behalf to cover medically necessary drugs for any indication approved by the Food and Drug Administration or recommended in clinical guidelines.

The new hepatitis C drugs have a higher cure rate — 90% or higher — than previous treatments, as well as fewer harmful side effects. Some studies have shown that, despite their price tag, the drugs justify their cost based on the better quality of life they provide and the health expenses that patients avoid in the future.

[‘I had hepatitis C and didn’t know it. You may have it, too.’]

“Curing hepatitis C will likely go on to prevent liver cancer, go on to prevent patients needing liver transplantation, go on to save health-care dollars down the road,” said Adam Peyton, a liver specialist at the University of Miami Health System in Florida who prescribed $13.5 million worth of hepatitis C drugs in Part D last year. “It’s upsetting that there’s been so much negative publicity for such a positive breakthrough in medicine.”

Still, the drugs may not save money for Medicare, even in the long run. A recent study in the Annals of Internal Medicine suggested that only about one-quarter of the $65 billion needed to pay for the new drugs for eligible patients (not just those on Medicare) would be offset by avoiding hospitalizations and other treatment costs. The vast majority of patients with hepatitis C do not go on to get liver transplants.

Federal taxpayers cover the preponderance of the cost of treating patients in Part D, but enrollees also have to pick up a share, which can vary based on their drug usage. Once a Medicare enrollee spends $4,700 out of pocket on drugs — in this case, just a few days of a prescription — “catastrophic” coverage kicks in. At that point, Medicare picks up 80% of the cost, the health plan pays 15%, and the patient pays the remaining 5%.

Some costs probably will be passed along to Medicare beneficiaries who do not have hepatitis C, in the form of higher deductibles and maximum out-of-pocket costs, said Jack Hoadley, a research professor in the Health Policy Institute at Georgetown University.

For example, next year the standard drug deductible in the program — the amount a patient has to spend before coverage kicks in — will increase to $360 from $320.

Senator Bernard Sanders (I-VT) has been a critic of the high price of the new drugs, particularly Sovaldi. “The cost of Sovaldi is not only an economic issue in terms of the impact of the cost of this drug on the VA, on Medicaid, on Medicare, it is a moral issue, and that is how many people in this country will suffer, how many will die very painful deaths because of the excessive costs of this particular product,” Sanders said in a written statement to ProPublica.

This year, an additional competitor has come on the market, the Viekira Pak made by AbbVie, giving insurance companies leverage to negotiate larger rebates in exchange for a spot on their preferred-drug lists. Those rebates can slice 40% to 50% off the list prices of the drugs.

The law that created Medicare Part D does not allow the government to negotiate rebates directly, but it allows the private insurance companies that administer the program to do so. Details of the rebates are confidential.

Gilead Sciences, the maker of Sovaldi and Harvoni, has defended its prices, saying they are fair given the value the drugs provide to patients. In a statement, the company said that it has “established one of the most comprehensive patient assistance programs in the industry to help ensure cost is not a barrier to Sovaldi and Harvoni for patients in the U.S. with high co pays or who lack adequate insurance.”

Medicaid experts acknowledge that anticipated legal challenges may compel state Medicaid programs to stop rationing the new drugs.

Medicare patients with hepatitis C recognize how much the drugs cost but say the results have changed their lives.

Robert Serrano, 61, one of Peyton’s patients, who said he is on Medicare because he is disabled, said Sovaldi cured him. He had a liver transplant in October 2008, but the disease had started to attack his new liver.

“It was a long road for me with this condition that I had and the medications,” he said. “Now at least I’m able to cut grass and do the little things I didn’t do in life. It’s been a blessing.”

~~  ProPublica ~~

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