Sorry, FTC: ‘Pay-for-delay’ isn’t going away
WHAT IT MEANS AND WHY IT’S IMPORTANT This week’s decision by the U.S. Second Circuit Court of Appeals could make political efforts to ban generic-branded patent settlements a lot more difficult.
(THE NEWS: Appeals court upholds decision to OK ‘pay-for-delay’ deals. For the full story, click here)
The Federal Trade Commission in particular, not to mention some members of Congress like Sen. Herb Kohl, D-Wis., has fought hard against so-called “pay-for-delay” settlements between branded and generic drug companies, contending that they delay patients’ access to generic drugs and cost consumers billions of dollars every year.
The concerns of opponents are understandable. Because generic and branded drug makers are supposed to be competitors, what seem on the surface like sweetheart deals must look positively Faustian to many people. But the judges in the appeals court affirmed that whatever their appearance, patent settlements don’t violate antitrust laws.
And the facts seem to support that decision. According to a report released in January by RBC Capital Markets, generic drug companies prevailed in 76% of cases that included settlements, but only in 48% of cases that went to trial. Meanwhile, according to a report released the same month by securities and investment banking firm Jefferies & Co., on average, patent settlements result in generic launch three years before patent expiration. Legally, a generic drug company must launch its version of a drug before or at the time of patent expiration.
While patent settlements often involve some type of monetary transaction, in many cases, the “pay” is in the form of a promise by the branded drug company not to launch an authorized generic, which is the branded drug sold under its generic name at a lower price. Under the Hatch-Waxman Act, the first generic drug maker to launch a knockoff of a branded drug is entitled to six months in which to compete directly with the branded version, but the authorized generic allows the branded drug maker to undercut the generic drug maker by marketing a supposedly “generic” version of its own.
Authorized generics have seen a bit of a pickup as well, and more activity on that front can be expected. On Tuesday, Greenstone, the generics arm of Pfizer, announced that it would create a new business called the Authorized Generics Alliance in order to market authorized generics under the Greenstone label.
PwC: Americans would use mobile devices to track, monitor health
SAN DIEGO Three-in-10 Americans recently surveyed by PricewaterhouseCoopers’ Health Research Institute said they would use their cell or smart phone to track and monitor their personal health, and 40% would be willing to pay for a remote monitoring device that sends health information directly to their doctor.
The findings of the survey and new report, titled "Healthcare Unwired," were presented Wednesday by PricewaterhouseCoopers at the mHealth Initiative 2nd International mHealth Conference. According to the report, wireless technology, remote monitoring and mobile devices are changing the nature of health care, making it possible to deliver care anywhere in ways that are proving to reduce healthcare costs and keep people healthier.
PricewaterhouseCoopers’ research included a nationwide survey of 2,000 consumers and 1,000 physicians regarding their use and preferences for remote and mobile health services and devices. The survey found:
- 31% of consumers said they would be willing to incorporate an application into their existing cell phone or smart phone to be able track and monitor their personal health information;
- 40% of consumers said they would be willing to pay for a device and a monthly subscription fee for a mobile phone application that would send text and e-mail reminders to take their medications, refill prescriptions or access their medical records and track their health;
- 27% of consumers said they would find medication reminders sent via text to be helpful, and men are twice as likely as women to say they would use a mobile device for health-related reminders; 40% of consumers also would be willing to pay for a remote monitoring device and a monthly subscription that would send data, such as heart rate, blood pressure, blood sugar and weight, automatically to their doctor;
- 56% of consumers said they like the idea of remote health care, and 41% would prefer to have more of their care delivered via mobile device;
- 88% of physicians reported they would like their patients to be able to track and/or monitor their health at home, particularly their weight, blood sugar levels and vital signs; and
- 57% of physicians said they would like to use remote devices to monitor the patients outside of the hospital.
PricewaterhouseCoopers’ Health Research Institute estimated the annual consumer market for remote/mobile monitoring devices and services to fall between $7.7 billion and $43 billion, based on the range that consumers said they would be willing to pay.
"Remote and mobile technology is making it possible to move healthcare delivery outside the traditional settings of physician offices and hospitals to wherever patients are,” stated Daniel Garrett, leader of the health information technology practice at PricewaterhouseCoopers. “New consumer-oriented business models and technologies are emerging. Companies that will be well-positioned competitively are those that can integrate mobile health into healthcare delivery and create value in the health system by helping doctors and their patients better manage health and wellness through mass personalization."
"There are significant opportunities for physicians, hospitals, health insurers, pharmaceutical companies and medical device manufacturers to market and differentiate themselves using mobile health," Garrett added.
Active phone prompts spur Rx adherence rates among consumers, CVS reveals
WOONSOCKET, R.I. Consumers are much more likely to adhere to their prescription medication therapy if given “a clear and active choice” in recorded telephone prompts from their pharmacy, new research into patient compliance from CVS Caremark demonstrated.
The company announced Thursday the results of a long-term research project into patient behavior, conducted by its Behavior Change Research Partnership. Those findings, presented at a Pittsburgh Business Group on Health symposium, underline a clear connection between encouraging patients to get their maintenance medications refilled and improved adherence rates.
“Ongoing research into how behavioral economics impacts healthcare choices found that when consumers are presented with a clear and active choice in a voice-recorded message to select automatic prescription refills, rather than a passive default notification, they are twice as likely to choose the automatic option,” CVS said.
CVS established the BCRP in March to study how behavioral economics impacts consumer healthcare decisions. The research group also was created “to help the company better understand why some patients stop taking maintenance medications for chronic illnesses,” the company noted.
The research results were presented by Troyen Brennan, CVS Caremark EVP and chief medical officer. “The preliminary findings show that by making choices clear and by streamlining messages, consumers sign up at twice the rate of those who are passively presented opt-in choices,” Brennan told Pittsburgh business leaders Thursday. “This research will help us develop programs to encourage people to stay on their medications, because nonadherence is costing the healthcare system billions of dollars every year.”
The BCRP research, titled “Active Choice,” is testing options in four communication channels, CVS said. Those channels include interactive Web sign-ins, in-bound customer calls to care centers, automated outbound telephone calls and direct mail.
“The testing shows some options offered to consumers today are overlooked because the choices are not readily transparent,” the company said. “Past industry studies show one-quarter of people receiving prescriptions never fill their first prescriptions, and patients with chronic diseases, such as diabetes and coronary artery disease, adhere to their ongoing medication regimen about half of the time.”
The BCRP panel is led by Punam Anand Keller of the Tuck School of Business at Dartmouth College, George Loewenstein of Carnegie Mellon University and Kevin Volpp of University of Pennsylvania’s Medical School and The Wharton School of Business. The presentation in Pittsburgh continued discussion of BCRP research that was first presented at a Centers for Disease Control and Prevention symposium in Atlanta last month.