Generic Drug Makers Facing Squeeze on Revenue

They call it the patent cliff.

Brand-name drug makers have feared it for years. And now the makers of generic drugs fear it, too.

This year, more than 40 brand-name drugs — valued at $35 billion in annual sales — lost their patent protection, meaning that generic companies were permitted to make their own lower-priced versions of well-known drugs like Plavix, Lexapro and Seroquel — and share in the profits that had exclusively belonged to the brands.

Next year, the value of drugs scheduled to lose their patents and be sold as generics is expected to decline by more than half, to about $17 billion, according to an analysis by Crédit Agricole Securities.“The patent cliff is over,” said Kim Vukhac, an analyst for Crédit Agricole. “That’s great for large pharma, but that also means the opportunities theoretically have dried up for generics.”

In response, many generic drug makers are scrambling to redefine themselves, whether by specializing in hard-to-make drugs, selling branded products or making large acquisitions. The large generics company Watson acquired a European competitor, Actavis, in October, vaulting it from the fifth- to the third-largest generic drug maker worldwide.

“They are certainly saying either I need to get bigger, or I need to get ‘specialer,’ ” said Michael Kleinrock, director of research development at the IMS Institute for Healthcare Informatics, a health industry research group. “They all want to be special.”

As one consequence of the approaching cliff, executives for generic drug companies say, they will no longer be able to rely as much on the lucrative six-month exclusivity periods that follow the patent expirations of many drugs. During those periods, companies that are the first to file an application with the Food and Drug Administration, successfully challenge a patent and show they can make the drug win the right to sell their version exclusively or with limited competition.

The exclusivity windows can give a quick jolt to companies. During the first nine months of 2012, sales of generic drugs increased by 19 percent over the same period in 2011, to $39.1 billion from $32.8 billion, according to Michael Faerm, an analyst for Credit Suisse. Sales of branded drugs, by contrast, fell 4 percent during the same period, to $174.2 billion from $181.3 billion.

But those exclusive periods also make generic drug makers vulnerable to the fickle cycle of patent expiration. “The only issue is it’s a bubble, too,” said Mr. Kleinrock. He said next year, the generic industry would enter a drought that was expected to last about two years.  Of the drugs that are becoming generic, fewer have exclusivity periods dedicated to a single drug maker.

In 2013, for example, the antidepressant Cymbalta, sold by Eli Lilly, is scheduled to be available in generic form. But more than five companies are expected to share in sales during the first six months, according to a report by Ms. Vukhac.

Heather Bresch, the chief executive of Mylan, the second-largest generics company in the United States, said Wall Street analysts were obsessed with the issue. “I can’t go anywhere without being asked about the patent cliff, the patent cliff, the patent cliff,” she said. “The patent cliff is one aspect of a complex, multilayered landscape, and I think each company is going to face it differently.”

Jeremy M. Levin, the chief executive of Teva Pharmaceuticals, the largest global maker of generic drugs, agreed. “The concept of exclusivity — where only one generic player could actually make money out of the unique moment — has diminished,” he said. “In the absence of that, many companies have had to really ask the question, ‘How do I really play in the generics world?’ ”

For Teva, Mr. Levin said, he believes the answer will be both its reach  — it sells 1,400 products, and one in six generic prescriptions in the United States is filled with a Teva product  — and what he says is a reputation for making quality products. That focus will be increasingly important, he said, given recent statements by the F.D.A. that it intends to take a closer look at the quality of generic drugs. Mr. Levin also said he planned to cut costs, announcing last week that he intended to trim from $1.5 to $2 billion in expenses over the next five years.

This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of this article misstated the country in which the pharmaceutical company Endo is based. It is an American company, not Japanese.

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Supreme Court keeps California in suspense on gay marriage

By Jessica Garrison, Los Angeles Times

December 3, 2012, 7:27 a.m.

The U.S. Supreme Court did not address the California gay-marriage case on Monday morning. The next time they can consider it is on Friday.

The case against Proposition 8, the 2008 ballot initiative that banned gay marriage in California, had been discussed by justices last Friday, but was not on the list of cases the court said it would review.

Many speculated that the court might have decided not to take the case, which would let an appeals court ruling on the matter stand. The 9th Circuit Court of Appeals found earlier this year that Proposition 8 was unconstitutional, clearing the way for same-sex marriage in California unless the Supreme Court decides to get involved.

But the matter will remain in suspense for a while longer. The court could continue to discuss the case at conferences this year and early next year in advance of possibly hearing the case in June. They could also hold the matter over for the fall. 

Gay-marriage activists expressed disappointment that there was no news Monday.

"We understand that it is a complex case, and if they need another week to reach the right decision, we're fine with that," said Adam Umhoefer, executive director of the American Foundation for Equal Rights, which is fighting to overturn Proposition 8.

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Induction Charging Comes to Public Transit

Say goodbye to catenary wires. Utah State University has unveiled an electric bus that charges through induction, topping off its batteries whenever it stops to pick up passengers.

Designed by USU’s Wireless Power Transfer team and the Utah Science Technology and Research initiative’s Advanced Transportation Institute, the prototype Aggie Bus is already on the road. It uses the same wireless charging principle as an electric toothbrush or a wireless smartphone charger, except optimized for a massive public-transit vehicle.

As in all modern inductive-charging setups, a transformer is “split” between the bus and a charge plate under the bus stop. When the bus drives over the charging plate, current flows with no physical contact required. Engineers at USU designed their system so that the Aggie Bus can be misaligned up to 6 inches from the charge plate and still get 25kW of power and 90 percent efficiency from the power grid to the battery.

Because of the fixed routes they run and frequent stops they make, induction charging is ideal for buses. Instead of charging up a massive battery overnight before a route, the Aggie Bus features a smaller battery setup that recharges every time the bus reaches a predetermined stop. The smaller batteries free up interior space, reduce downtime and lower battery costs — although induction plates must be added to bus stops.

Though the Aggie Bus is a working prototype, USU is working with Wireless Advanced Vehicle Electrification (WAVE) — a company spun-out from USU — in order to bring a commercialized bus to market. In mid-2013, WAVE and the Utah Transit Authority are planning to unveil a 40-foot induction-charged transit bus on the USU campus that’s capable of taking a 50kW charge. The project was funded by USU, who will purchase the bus, and a $2.7 million grant from the Federal Transit Administration.

Charging a bus through induction may be a new idea in the U.S., but bus routes with similar wireless charging systems have been in place in Torino, Italy, since 2003 and Utrecht, the Netherlands, since 2010. Ideally, induction charging would be used in city centers to replace noisy, smoky diesel buses. It would also work on already electrified routes, allowing cities to take down unsightly hanging catenary wires.

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Led Zeppelin will Reunite – for “Letterman” interview

LOS ANGELES (TheWrap.com) – The surviving members of Led Zeppelin will make a rare appearance together on “Late Show With David Letterman” on December 3, CBS said Friday.

Jimmy Page, Robert Plant and John Paul Jones will drop in on the late-night show for an interview – which isn’t quite the reunion that Zep fans have been patiently waiting for, but it might have to do. With the exception of a one-off tribute concert for Atlantic Records founder Ahmet Ertegun at London’s O2 Arena in 2007 – which was released as the DVD “Celebration Day” in October – Jones has largely been estranged from Page and Plant since the group’s 1980 breakup following drummer John Bonham‘s death.

The “Late Show” appearance won’t be the only time that Letterman hangs out with the rock legends – the group, along with Letterman, will be lauded at the 35th Annual Kennedy Center Honors in Washington, D.C., which will take place December 2 and air December 26 on CBS.

Music News Headlines – Yahoo! News

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Call That Kept Nursing Home Patients in Sandy’s Path

Chang W. Lee/The New York Times

Workers were shocked that nursing and adult homes in areas like Rockaway Park, Queens, weren’t evacuated.

Hurricane Sandy was swirling northward, four days before landfall, and at the Sea Crest Health Care Center, a nursing home overlooking the Coney Island Boardwalk in Brooklyn, workers were gathering medicines and other supplies as they prepared to evacuate.

Then the call came from health officials: Mayor Michael R. Bloomberg, acting on the advice of his aides and those of Gov. Andrew M. Cuomo, recommended that nursing homes and adult homes stay put. The 305 residents would ride out the storm.

The same advisory also took administrators by surprise at the Ocean Promenade nursing home, which faces the Atlantic Ocean in Queens. They canceled plans to move 105 residents to safety.

“No one gets why we weren’t evacuated,” said a worker there, Yisroel Tabi. “We wouldn’t have exposed ourselves to dealing with that situation.”

The recommendation that thousands of elderly, disabled and mentally ill residents remain in more than 40 nursing homes and adult homes in flood-prone areas of New York City had calamitous consequences.

At least 29 facilities in Queens and Brooklyn were severely flooded. Generators failed or were absent. Buildings were plunged into a cold, wet darkness, with no access to power, water, heat and food.

While no immediate deaths were reported, it took at least three days for the Fire Department, the National Guard and ambulance crews from around the country to rescue over 4,000 nursing home and 1,500 adult home residents. Without working elevators, many had to be carried down slippery stairwells.

“I was shocked,” said Greg Levow, who works for an ambulance service and helped rescue residents at Queens. “I couldn’t understand why they were there in the first place.”

Many sat for hours in ambulances and buses before being transported to safety through sand drifts and debris-filled floodwaters. They went to crowded shelters and nursing homes as far away as Albany, where for days, they often lacked medical charts and medications. Families struggled to locate relatives.

The decision not to empty the nursing homes and adult homes in the mandatory evacuation area was one of the most questionable by the authorities during Hurricane Sandy. And an investigation by The New York Times found that the impact was worsened by missteps that officials made in not ensuring that these facilities could protect residents.

They did not require that nursing homes maintain backup generators that could withstand flooding. They did not ensure that health care administrators could adequately communicate with government agencies during and after a storm. And they discounted the more severe of the early predictions about Hurricane Sandy’s surge.

The Times’s investigation was based on interviews with officials, health care administrators, doctors, nurses, ambulance medics, residents, family members and disaster experts. It included a review of internal State Health Department status reports. The findings revealed the striking vulnerability of the city’s nursing and adult homes.

On Sunday, Oct. 28, the day before Hurricane Sandy arrived, Mr. Bloomberg ordered a mandatory evacuation in Zone A, the low-lying neighborhoods of the city. But by that point, Mr. Bloomberg, relying on the advice of the city and state health commissioners, had already determined that people in nursing homes and adult homes should not leave, officials said.

The mayor’s recommendations that health care facilities not evacuate startled residents of Surf Manor adult home in Coney Island, said one of them, Norman Bloomfield. He recalled that another resident exclaimed, “What about us! Why’s he telling us to stay?”

The commissioners made the recommendation to Mr. Bloomberg and Mr. Cuomo because they said they believed that the inherent risks of transporting the residents outweighed the potential dangers from the storm.

In interviews, senior Bloomberg and Cuomo aides did not express regret for keeping the residents in place.

“I would defend all the decisions and the actions” by the health authorities involving the storm, said Linda I. Gibbs, a deputy mayor. “I feel like I’m describing something that was a remarkable, lifesaving event.”

Dr. Nirav R. Shah, the state health commissioner, who regulates nursing homes, said: “I’m not even thinking of second-guessing the decisions.”

Still, officials in New Jersey and in Nassau County adopted a different policy, evacuating nursing homes in coastal areas well before the storm.

Contradictory Forecasts

The city’s experience with Tropical Storm Irene last year weighed heavily on state and city health officials and contributed to their underestimating the impact of Hurricane Sandy, according to records and interviews.

Before Tropical Storm Irene, the officials ordered nursing homes and adult homes to evacuate. The storm caused relatively minor damage, but the evacuation led to millions of dollars in health care, transportation, housing and other costs, and took a toll on residents.

As a result, when Hurricane Sandy loomed, the officials were acutely aware that they could come under criticism if they ordered another evacuation that proved unnecessary.

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Advertising: Ford Plan to Revive Lincoln Hinges on a New Brand

An unusual ad campaign features Abraham Lincoln, the president for whom the car brand is named.

DEARBORN, Mich. — In the fiercely competitive world of luxury cars, the Ford Motor Company’s Lincoln brand has long been stuck in the slow lane, with stodgy models, older buyers and a distinct lack of pizazz.

But Ford is determined to change that. On Monday, the company will announce upgraded customer service initiatives, a new brand name for Lincoln that plays down the Ford connection and an unusual advertising campaign that features Abraham Lincoln, the president for whom the brand is named.

Ford’s chief executive, Alan R. Mulally, will begin the rebranding effort at an event outside Lincoln Center in Manhattan — the first in a series of moves meant to reverse Lincoln’s seemingly perpetual state of decline.

Ford will formally rechristen the brand as the Lincoln Motor Company and introduce a television spot that begins with an image of Lincoln, stovepipe hat and all. The brand’s first Super Bowl commercial is in the works, as is a revamped Web site that links consumers to a Lincoln “concierge” who can arrange test drives or set up appointments at dealerships.

Mr. Mulally will also announce the on-sale date in early 2013 for the radically redesigned Lincoln MKZ sedan, as well as plans for three new vehicles down the road.

If it seems like an all-out grab for attention, well, that’s exactly the point, said James D. Farley Jr., Ford’s head of global sales and marketing and the newly named chief of the Lincoln revival effort.

“The most important thing is for people to be aware that there is a transition going on,” Mr. Farley said. “We have to shake them up.”

The shake-up is long overdue and critically important to Ford, the nation’s second-largest car company behind General Motors.

As recently as the 1990s, Lincoln was the top-selling luxury automotive brand in the United States. Its large Town Car sedan and hulking Navigator S.U.V. defined the brand, and sales topped more than 230,000 vehicles a year.

But since then, Lincoln has been left in the dust by the German category leaders BMW and Mercedes-Benz, and Toyota’s Lexus division. This year, Lincoln ranks eighth in the American luxury segment, with sales down 2 percent, to 69,000, vehicles in the first 10 months of the year.

Its crosstown rival G.M. has had much better success reviving its Cadillac brand.

“Cadillac has been stabilized, but Lincoln is still muddling about,” said Jack Trout, president of the marketing firm Trout and Partners. “The big question is, how can Lincoln convince people it is more than just a gussied-up Ford?”

That task has now fallen to Mr. Farley, who left Toyota five years ago to join Ford just as Mr. Mulally’s transformation of the company was under way. Since then, Ford has introduced a succession of sleeker, more fuel-efficient and technology-laden models that have lifted sales and made it among the most profitable car companies in the world.

Lincoln, however, has not benefited from the turnaround. It accounts for only 3 percent of Ford’s total sales, down from 8 percent during the brand’s heyday. And since Ford has sold off foreign luxury divisions like Volvo and Jaguar, Lincoln is the sole upscale brand in the company.

“There is nothing more frustrating for us than to have someone who loves their Ford car and S.U.V., but goes out to buy a luxury model from another brand because we don’t have one,” Mr. Farley said.

The Lincoln comeback effort starts with the midsize MKZ, which has been redesigned with a sweeping grille, tapered body style and an all-glass retractable roof. It will be followed by three other new models, including a larger sedan and S.U.V.

But the brand’s image needs much more than better cars. Under Mr. Farley’s direction, a newly formed team of 200 people is intent on establishing the Lincoln Motor Company as a boutique luxury line known for personalized service.

Every customer who reserves an MKZ, for example, will be presented with an elegant gift upon receiving the car. Choices include a selection of wines and Champagne, custom-made jewelry or sunglasses, or a one-night stay at a Ritz-Carlton hotel.

Lincoln’s Web site will also have a consultant available 24 hours a day for live discussions about the products and to streamline the buying process. Prospective buyers will be given an opportunity for a “date night” with Lincoln, which includes a two-day test drive and a free meal at a restaurant.

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Egypt's top court postpones ruling amid pressure

CAIRO -- Egypt's highest court postponed ruling on a case against the constitutional assembly after Islamist supporters of President Mohamed Morsi blocked judges Sunday from entering their chambers in an escalating struggle over the nation’s political charter.

Protesters rallied in front of the Supreme Constitutional Court, which was expected to rule on the legitimacy of the constitutional assembly in defiance of Morsi’s decree that the assembly was not subject to judicial oversight. The case has heightened the political divisions and created a backlash against judges connected to the deposed regime of longtime autocrat Hosni Mubarak.

The judges announced the "suspension of court sessions until the time when they can continue their message and rulings without any psychological and material pressures," according to a statement released by the court.

The protest against the court was the latest skirmish in a separation-of-powers battle over the nation's constitution. The assembly approved a rushed draft constitution on Friday to preempt a court decision that was expected to rule against the body. Morsi ordered that the proposed constitution be voted on in a national referendum on Dec. 15, essentially sidelining the court.

Opposition movements across the country have been protesting Morsi's power grab for more than a week, reviving the revolutionary fervor that brought down Mubarak in February 2011. The opposition says Morsi, who was elected in June, has made a sham of democracy and that the constitution raises the prospect that Islamic law could jeopardize civil rights.

Morsi and his Muslim Brotherhood have stressed that the president'’s expanded powers were necessary to blunt attempts by Mubarak-era courts from derailing Egypt’s political transition. If the constitution is passed, a new parliament -- the court dissolved an earlier Islamist-led legislature in April -- will be voted in early next year.

The Ahram Online news website reported that the constitutional court blamed Morsi and Islamists for the "lies" in a smear campaign to "taint the court’s image." The court added that it was operating in a "climate filled with hatred."

ALSO:

North Korea plans long-range rocket launch

Egypt's Islamists rally in support of President Morsi

Amid protests, Enrique Peña Nieto sworn in as Mexico's president

jeffrey.fleishman@latimes.com

 

 

 

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Geek Culture's 26 Most Awesome Female Ass-Kickers

Angelina Jolie extends her reputation as filmdom’s most compelling ass-kicker, Female Division, when Salt opens Friday. Midway through a summer freighted with testosterone, Jolie’s lithe Agent Salt is a potent reminder of the power of feminine fighters.

A minority presence in sci-fi and action realms even in 2010, women warriors remain the exception to the guy-centric rule in film, TV, videogames and comic books. But that’s changing, according to Action Flick Chick blogger Katrina Hill, who moderates the "Where Are the Action Chicks?" panel Friday at San Diego’s Comic-Con International.

"Compare the original Predator to this summer’s Predators," she said in an e-mail interview with Wired.com. "The original film was a complete boy’s club, with the only woman in the movie being a hostage. Today, Predators has a kick-ass chick mixed in as an equal amongst these other badass men. So there are steps being taken in the right direction. It just takes time."

The rise of the female fighter will be addressed at no fewer than three other female-dominated panels at this year’s Comic-Con (Thursday’s “Divas and Golden Lassoes: The LGBT Obsession with Super Heroines” and Friday’s “Girls Gone Genre: Movies, TV, Comics, Web” and “Women Who Kick Ass: A New Generation of Heroines,” which features Fringe’s Anna Torv and V’s Elizabeth Mitchell.)

Here’s a look at 26 sexy-fierce female ass-kickers who’ve relied on biceps and brains to periodically kick-start geek culture.

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German producers plan Pope Benedict biopic

MUNICH, Germany (Reuters) – Two German producers have bought the film rights to an upcoming biography of Pope Benedict by the Bavarian author of three best-selling interview books with the pontiff.

The Odeon Film company said producers Marcus Mende and Peter Weckert planned a film for international release based on a biography by journalist Peter Seewald due to be published in early 2014.

Seewald’s book-length interviews with Benedict – two as Cardinal Joseph Ratzinger and one as pope – have given readers many insights into the life and thoughts of the shy theologian who now heads the Roman Catholic Church.

Seewald has signed on as a consultant to the scriptwriter, Odeon Film said in a statement on Thursday. It gave no information about the schedule for the film or who might play the main role.

“The producers plan an international film that illustrates all aspects of the extraordinary life and work of Joseph Ratzinger from his birth on Easter night in 1927 in Marktl am Inn in Bavaria to his pontificate today,” it said.

Benedict’s predecessor Pope John Paul was the subject of a dozen documentary films around the world and two major television movies in the United States.

(Reporting by Tom Heneghan; editing by Andrew Roche)

Movies News Headlines – Yahoo! News

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Opinion: A Health Insurance Detective Story

I’VE had a long career as a business journalist, beginning at Forbes and including eight years as the editor of Money, a personal finance magazine. But I’ve never faced a more confounding reporting challenge than the one I’m engaged in now: What will I pay next year for the pill that controls my blood cancer?

After making more than 70 phone calls to 16 organizations over the past few weeks, I’m still not totally sure what I will owe for my Revlimid, a derivative of thalidomide that is keeping my multiple myeloma in check. The drug is extremely expensive — about $11,000 retail for a four-week supply, $132,000 a year, $524 a pill. Time Warner, my former employer, has covered me for years under its Supplementary Medicare Program, a plan for retirees that included a special Writers Guild benefit capping my out-of-pocket prescription costs at $1,000 a year. That out-of-pocket limit is scheduled to expire on Jan. 1. So what will my Revlimid cost me next year?

The answers I got ranged from $20 a month to $17,000 a year. One of the first people I phoned said that no matter what I heard, I wouldn’t know the cost until I filed a claim in January. Seventy phone calls later, that may still be the most reliable thing anyone has told me.

Like around 47 million other Medicare beneficiaries, I have until this Friday, Dec. 7, when open enrollment ends, to choose my 2013 Medicare coverage, either through traditional Medicare or a private insurer, as well as my drug coverage — or I will risk all sorts of complications and potential late penalties.

But if a seasoned personal-finance journalist can’t get a straight answer to a simple question, what chance do most people have of picking the right health insurance option?

A study published in the journal Health Affairs in October estimated that a mere 5.2 percent of Medicare Part D beneficiaries chose the cheapest coverage that met their needs. All in all, consumers appear to be wasting roughly $11 billion a year on their Part D coverage, partly, I think, because they don’t get reliable answers to straightforward questions.

Here’s a snapshot of my surreal experience:

NOV. 7 A packet from Time Warner informs me that the company’s new 2013 Retiree Health Care Plan has “no out-of-pocket limit on your expenses.” But Erin, the person who answers at the company’s Benefits Service Center, tells me that the new plan will have “no practical effect” on me. What about the $1,000-a-year cap on drug costs? Is that really being eliminated? “Yes,” she says, “there’s no limit on out-of-pocket expenses in 2013.” I tell her I think that could have a major effect on me.

Next I talk to David at CVS/Caremark, Time Warner’s new drug insurance provider. He thinks my out-of-pocket cost for Revlimid next year will be $6,900. He says, “I know I’m scaring you.”

I call back Erin at Time Warner. She mentions something about $10,000 and says she’ll get an estimate for me in two business days.

NOV. 8 I phone Medicare. Jay says that if I switch to Medicare’s Part D prescription coverage, with a new provider, Revlimid’s cost will drive me into Medicare’s “catastrophic coverage.” I’d pay $2,819 the first month, and 5 percent of the cost of the drug thereafter — $563 a month or maybe $561. Anyway, roughly $9,000 for the year. Jay says AARP’s Part D plan may be a good option.

NOV. 9 Erin at Time Warner tells me that the company’s policy bundles United Healthcare medical coverage with CVS/Caremark’s drug coverage. I can’t accept the medical plan and cherry-pick prescription coverage elsewhere. It’s take it or leave it. Then she puts CVS’s Michele on the line to get me a Revlimid quote. Michele says Time Warner hasn’t transferred my insurance information. She can’t give me a quote without it. Erin says she will not call me with an update. I’ll have to call her.

My oncologist’s assistant steers me to Celgene, Revlimid’s manufacturer. Jennifer in “patient support” says premium assistance grants can cut the cost of Revlimid to $20 or $30 a month. She says, “You’re going to be O.K.” If my income is low enough to qualify for assistance.

NOV. 12 I try CVS again. Christine says my insurance records still have not been transferred, but she thinks my Revlimid might cost $17,000 a year.

Adriana at Medicare warns me that AARP and other Part D providers will require “prior authorization” to cover my Revlimid, so it’s probably best to stick with Time Warner no matter what the cost.

But Brooke at AARP insists that I don’t need prior authorization for my Revlimid, and so does her supervisor Brian — until he spots a footnote. Then he assures me that it will be easy to get prior authorization. All I need is a doctor’s note. My out-of-pocket cost for 2013: roughly $7,000.

NOV. 13 Linda at CVS says her company still doesn’t have my file, but from what she can see about Time Warner’s insurance plans my cost will be $60 a month — $720 for the year.

CVS assigns my case to Rebecca. She says she’s “sure all will be fine.” Well, “pretty sure.” She’s excited. She’s been with the company only a few months. This will be her first quote.

NOV. 14 Giddens at Time Warner puts in an “emergency update request” to get my files transferred to CVS.

Frank Lalli is an editorial consultant on retirement issues and a former senior executive editor at Time Warner’s Time Inc.

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