The Times is discontinuing the Prescriptions blog, which was created to track the debate and aftermath of the 2009 health care law. This change will allow us to direct limited production resources to other online projects. But we will continue our vigorous reporting on the health care industry, including coverage of patients, insurers, medical professionals and drug-makers, within the Business and Health sections and on the Well blog. Thanks to all of our readers.
Drug Costs Pose Smaller Financial Burden Amid Generic Boom
By Bruce JapsenThanks to greater use of generic drugs, the financial burden of prescription costs has become less of an issue for families in the United States, according to a new study by the RAND Corporation.
The study shows that the number of Americans living in a family that spent more than 10 percent of its income out of pocket on prescription drugs decreased from 2003 to 2008. The decrease in costs to families is in contrast to the preceding five-year period, from 1999 to 2003, when drug costs rose year after year and were a financial burden for an increasing number of families.
The study, released Wednesday afternoon, is published in the February issue of Health Affairs, an academic journal.
The study examined people under the age of 65, which is generally when people obtain drug coverage under the Medicare health insurance program for the elderly. Researchers studied uninsured Americans as well as those with public and private insurance, defining families with a “high financial burden” as those that spent more than 10 percent of their income on out-of-pocket costs for drugs.
The number of Americans with this financial burden rose to 4.3 percent of the United States population, or 10.8 million people, in 2003, when researchers said the burden of drug costs peaked. This compares with 2.9 percent of the population, or 7.1 million people, in the same situation in 1999.
Since 2003, the percentage of people living with a high cost burden fell to 3.1 percent of the population, or 8.3 million people, in 2008, the study showed.
“If prescription spending had not decreased, we’d be talking about an even higher overall burden for health care costs,” said the study’s lead author, Dr. Walid Gellad, who is a RAND researcher and an internist at the Veterans Affairs Pittsburgh Healthcare System. “There are still more than eight million people living in families with a high burden and drug prices are going up, but more people are being helped by taking cheaper drugs.” Read more…
Drug Makers Dial Down TV Advertising
By Bruce JapsenSpending on the advertising of brand-name prescription drugs on television — which not long ago was a fast-growing marketing venue for the pharmaceutical industry in the United States — has dropped more than 20 percent in the last five years.
According to new figures from Nielsen, spending on television advertising fell 23 percent to $2.4 billion from the beginning of 2007 to the end of last year. Spending in 2011 dropped 2 percent from 2010, and last year was the fourth consecutive year that such spending fell. Drug companies in the United States spent more than $3.1 billion on advertising pharmaceuticals on television in 2007, Nielsen said.
The decline is in sharp contrast to the decade-long drug-industry advertising spree that began in 1997, when the Food and Drug Administration loosened its regulations and allowed direct-to-consumer advertising of prescription drugs on TV.
Some industry analysts attribute part of the decline to controversy over such ads. Employers and health insurance companies have long complained that TV ads drive consumers to the latest, often most expensive, pills. And doctors complain that their patients often pressure them into prescribing these heavily advertised drugs.
Perhaps the most well-known criticism of TV advertising of pharmaceuticals arose in 2004 when Merck withdrew the once heavily advertised painkiller Vioxx after studies showed it increased the risk of heart attacks and strokes. Read more…
F.D.A. Approves Drug for an Advanced Skin Cancer
By Andrew PollackThe first drug for an advanced form of the most common type of skin cancer won approval from the Food and Drug Administration on Monday.
The drug, Erivedge, made by Genentech, was approved for adults with basal cell carcinoma that has spread elsewhere in the body or those who are not candidates for the surgery or radiation ordinarily used to treat the disease.
Basal cell carcinoma is usually a slow-growing and painless form of cancer that develops on skin frequently exposed to the sun, like on the face, according to the F.D.A. If confined to a small location on the skin, it is generally considered curable by surgery and radiation treatment.
In rare cases, however, the tumors cannot be treated that way. In some cases, known as locally advanced disease, they invade nearby tissues and can become disfiguring. In other cases, they become metastatic, spreading elsewhere in the body.
The F.D.A. said in a news release that the approval was based on an analysis of 96 patients
in a clinical trial with locally advanced or metastatic basal cell carcinoma. Some 30 percent of the patients with metastatic disease experienced a partial shrinkage of their tumors. For the patients with
locally advanced disease, 43 percent experienced either a complete or partial shrinkage.
Read more…
Despite Generic Rivals, Branded Drugs Still Sell Well
By Bruce JapsenThough the loss of patent protection on a brand-name prescription drug tends to lead to a sharp drop in sales for that product in the United States, such older medicines have become a booming business for the pharmaceutical industry in emerging markets.
Take Abbott Laboratories, which on Wednesday, reported that one of its fastest growing business lines last year was that of established pharmaceuticals, or “branded generics” as they are known in the industry. Sales of such products, which include branded generics outside the United States, were up nearly 20 percent to $5.4 billion last year, the company said in a news release.
Abbott and other drug makers see older brands as important in countries like India and China, where the economies are growing stronger but access to safe prescription medicines, particularly generics, remains an issue.
In addition, the patent expirations of big-name drugs like Pfizer’s cholesterol pill, Lipitor, has manufacturers trying to continue to win brand equity in emerging markets, where regulations on generic substitution of brands may not be as strong. (In the United States, the introduction of a generic copy is almost automatic once a brand’s patent expires, and multiple generics often flood the market, analysts say.)
“As companies like Pfizer, Sanofi and others run into a lot of patent exposure issues, they’re going to be looking more aggressively at pushing into branded generic markets,” Jason Gerberry, generics and specialty pharmaceutical analyst at Leerink Swann in Boston, said in an interview. Read more…
Doctors Refer More Patients to Specialists
By Reed AbelsonThe specialist will see you now — and it’s one of the reasons that medical care has become more expensive.
In a study published Monday in Archives of Internal Medicine, an academic journal, researchers from Harvard Medical School found that the likelihood that a doctor referred a patient to another doctor, often a specialist, nearly doubled from 1999 to 2009.
Doctors decided to send their patients to other doctors 9.3 percent of the time in 2009, compared with 4.8 percent a decade ago, according to the researchers’ work. The estimated number of visits resulting in referrals more than doubled over the same period, from 40.6 million to 105 million, according to the researchers.
“This evolution in care patterns may be playing a role in the rising trajectory of health care spending in the U.S., as referrals to specialists may lead to increased use of higher-cost services,” the researchers say. While some of these referrals lead to necessary treatments, others are responsible for additional tests and procedures that do little to benefit patients, the authors say.
Either way, costs go up.
So why are doctors quicker now to send a patient to a specialist? Read more…
F.D.A. Delays Approval of New Diabetes Drug
By Andrew PollackThe Food and Drug Administration has decided not to approve the first of a new class of diabetes drugs, saying that more information was needed to assess the medicine’s safety and effectiveness.
The agency’s decision was announced Thursday morning by the developers of the drug, AstraZeneca and Bristol-Myers Squibb.
The companies said the F.D.A. wanted more data from continuing trials and might also require new clinical trials.
The decision is not a surprise, given that an advisory committee to the F.D.A. voted 9 to 6 in July against recommending approval. The committee cited a possible increased risk of bladder and breast cancers and of liver injury.
The drug, called dapagliflozin, has generated some interest among diabetes specialists because it has a novel mechanism of action that does not depend on influencing the production or use of insulin. Rather, it reduces blood sugar by causing more of the sugar to be excreted in the urine.
Numerous other companies have also been developing drugs of this type, which are called SGLT2 inhibitors.The drugs are aimed initially at Type 2 diabetes.
AstraZeneca and Bristol-Myers said they remained committed to developing dapagliflozin. While the companies did not estimate how long it could take to win approval, it could be years if new trials were required. European regulators have yet to decide whether to approve the drug.
In December, AstraZeneca suffered setbacks in the development of a drug for cancer and one for depression, while Bristol-Myers reported the failure of a liver cancer drug in a clinical trial. But Bristol-Myers has been showing some progress in drugs for treating hepatitis C.
The F.D.A. has become more cautious about diabetes drugs in part because of studies linking Avandia, a widely used diabetes drug from GlaxoSmithKline, to a possible increased risk of heart attacks.
New Questions Raised About Tamiflu’s Effectiveness
By Andrew PollackA new review of medical evidence continues to raise questions about the safety and effectiveness of the influenza drug Tamiflu, which the United States and other nations have spent billions of dollars to stockpile for use in a possible flu pandemic.
The review concluded that Tamiflu could reduce the duration of flu symptoms by about 21 hours, from the typical six or seven days. But the reviewers said they could not confirm two other purported effects of the drug often cited as reasons for using it in a pandemic – that it reduced complications of flu, like pneumonia or hospitalizations, and that it reduced transmission of the virus.
The reviewers said that their analysis was hampered by the fact that the drug’s manufacturer, Roche, had not supplied all the data from clinical trials that it had promised to provide.
“To this day, we have not received a single full study report from Roche,’’ said Peter Doshi, a postdoctoral fellow at the Johns Hopkins University School of Medicine and a co-author of the new review, which was published Tuesday by the Cochrane Collaboration, an international group of volunteer researchers who study medical evidence.
The new review said that data on 60 percent of the patients in the clinical trials of Tamiflu had never been published in medical journals. “If we look only at published reports, the extreme danger is that we are going to arrive at conclusions that are biased and that nobody should trust,’’ Mr. Doshi said.
The Cochrane Collaboration has reviewed the evidence on Tamiflu in the past, and it has clashed with Roche before over access to data. The new review was financed by the National Institute for Health Research in Britain.
Roche said in a statement that it had provided the Cochrane group with “3,200 pages of very detailed information, enabling their questions to be answered,’’ and that it had made full study data available to regulatory authorities. Read more…
More Health Clinics Pop Up Inside Retailers
By Bruce JapsenThe growth of health clinics inside retail stores rebounded in 2011 and is poised for a “second spring” this year, driven by well-capitalized retailers and grocers, according to a new report.
The number of retail clinics jumped 11.2 percent to 1,355 in 2011 after slow growth in 2010 and 2009, according to a report by Thomas Charland, chief executive of Merchant Medicine, which tracks the growth of retail medical care services. The number of retail clinics rose only 3 percent in 2010 and had flat growth in 2009 when the financial crisis and the related poor real estate market caused some smaller operators to close their doors. This followed several years of rapid growth.
New entrants from the supermarket industry like Safeway are starting to expand rapidly. Walmart is also hoping to become a serious player in the clinic business, seeking proposals from established medical care companies instead of the start-ups it tried working with a few years ago.
“This is definitely big players lining up to take advantage of the growth in people wanting more convenient health care,” Mr. Charland said in an interview Monday. “Before, we had a lot of smaller players just go away. We are going to see a bunch of new things start to happen.”
CVS Caremark’s MinuteClinic subsidiary already has partnerships with at least a half-dozen major health care systems, including the Cleveland Clinic and the Henry Ford Health System. Walgreen has a partnership with Ochsner Health System in New Orleans and is open to partnerships with individual hospitals and doctors across the country, the company has said.
“You are starting to see a newfound cooperation in the marketplace between retailers and their local hospital systems and physician groups,” Mr. Charland said. “Physician resistance is slowly melting away.” Read more…
Walgreen Girds for Fight Over Customers
By Bruce JapsenThe Walgreen Company, bracing for potentially hundreds of thousands of customers to switch to another pharmacy when the new year begins on Sunday, is introducing a national plan it hopes will minimize customer disruption from its contract battle with its pharmacy benefits manager, Express Scripts.
For customers who want to remain, Walgreen’s plan includes a special discount in January to customers for its prescriptions savings club. For those moving on, Walgreen has staffed up 24-hour call centers and instituted computer changes to permit the transfer of multiple prescriptions to other pharmacies in the customer’s network.
Express Scripts and Walgreen have been battling over payment issues for months. Because Walgreen has been unsuccessful at persuading most of their customers who have their drug coverage managed by Express Scripts to switch to another pharmacy benefit manager, called a P.B.M., come Sunday hundreds of thousands of customers will have to pay more for their drugs or switch to another pharmacy.
“Even as much as we have communicated this, a lot of folks don’t know what a P.B.M. is or what Express Scripts is, so we want to make sure we are helping patients through this,” Walgreen’s chief executive, Gregory D. Wasson, said in an interview. “There are hundreds of thousands of patients across the country that are going to be inconvenienced, and frankly, they are going to be upset. They are upset because they don’t want to be leaving Walgreen’s and they are looking at ways to stay with us.”
Walgreen, based in Deerfield, Ill., is the nation’s largest pharmacy chain with more than 8,200 outlets in the United States. Its retail stores operate under the Walgreen’s and Duane Reade names.
Though those enrolled in Express Scripts-managed drug plans will have better coverage and pay less by using another pharmacy, Mr. Wasson believes discounts Walgreen will offer through its prescription savings club will be competitive on generic drugs and most therapeutic categories.
Walgreen is offering promotional pricing of $5 for individual membership and $10 for family members from Jan. 1 to Jan. 31 to be in the program, which offers one-year discounts on prescriptions. Normally, membership is $20 a year for individuals and $35 for families. A telephone number, 1-800-Walgreens, and the company’s Web site, Walgreens.com, will offer Express Scripts-related information.
Walgreen said last week that negotiations with health plans and employers resulted in retaining about 10 million of the 90 million prescriptions managed by Express Scripts that were filled in the fiscal year ended Aug. 31.
Express Scripts said Friday that it, too, has been working to minimize disruption of its customers who have used Walgreen’s pharmacies but expects most to have their prescriptions filled at other pharmacies.
“An overwhelming number of our clients are moving forward without Walgreen’s,” an Express Scripts spokesman, Brian Henry, said in an interview. “The feedback from clients and members is that they are moving, planning to move or have moved. We have been working with clients and reaching out to members for months.”