Senators push to ban pay-tor-delay deals
WASHINGTON — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.
Reuters reported that Sens. Amy Klo-buchar, D-Minn., and Chuck Grassley, R-Iowa, were sponsoring a bill to ban so-called "pay-for-delay" settlements. Critics of such settlements say they delay patients’ access to cheaper generic drugs, while drug makers say the settlements are often necessary to allow generics to launch ahead of branded drugs’ loss of patent protection, and that delaying generic launch beyond patent expiry would be illegal anyway.
Branded and generic drug makers alike have strongly opposed attempts to ban the patent settlements, saying that requiring cases to go to trial will only further delay the availability of generics. Industry opposition has contributed to the defeat of previous bills to ban them, Reuters noted.
Report: Biosimilars could save $20 billion per year
While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.
A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.
The report, by auditing and finance firm Grant Thornton, argues that regulatory challenges, clinical trials and efficacy tests continue to present a "huge investment outlay." Over the next four years, the report found, branded biologics representing $40 billion in sales will come off patent, not to mention the $20 billion worth of products already off patent.
The Generic Pharmaceutical Association, a trade group representing generic drug makers, said the report "underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments."
"Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually," GPhA president and CEO Ralph Neas said.
Tech support for medication adherence
An oft-cited 1998 report, recently repeated again by the surgeon general in the January/ February 2012 "Public Health Report," estimated that 125,000 U.S. citizens die each year due to complications related to adherence. Also worrisome is the statistic that one-third to one-half of all patients don’t take medication as prescribed, and according to a 2011 study by Harvard, Brigham and Women’s Hospital and CVS, up to one-quarter of these never fill prescriptions at all. Couple that with the fact that the average adult older than 55 years juggles six to eight medications daily, and it becomes clear why lapses in medication use lead to sicker patients.
Much of the policy-making conversation about health care in recent years has sought to highlight anticipated cost savings from technology innovation. Critics say this is an outgrowth of the American "fix-it" mentality. Others say technical solutions have yet to take hold outside of medical accounting applications. But there is general agreement that in the area of technologies to nurture medication adherence, the ground remains fertile.
Simple? Only on the surface
Today’s research community has taken an increasingly nuanced view of the adherence conundrum. For instance, technology prototypes aimed at special populations are being developed, such as those for antipsychotics, needs of the aging and disabled, and users of contraceptives. These approaches may incorporate aspects of a particular disease model, or take into account additional challenges faced by multiple medication regimens, such as drug-drug and drug-food interactions. In addition, a number of patient and caregiver dimensions have been examined; in fact, a number of methods have been tried, ranging from the obvious — phone call reminders and nurse visitations — to the not-so-obvious, such as patient payments and computer-based games.
To better understand where technology initiatives have focused, as well as to understand where future opportunities lie, consider the medication use workflow model illustrated above. Each intiative can be seen as attacking one or more phases of the workflow to facilitate adherence. Prior to considering disease state or medication specifics, such products as Express Scripts’ ScreenRx and FICO’s medication adherence score may assess a patient’s risk for nonadherence. Analogous to FICO’s credit scoring technology, a medication adherence score helps insurers and providers target patients most likely to need assistance — technological or otherwise — to facilitate adherence.
The marketplace for smartphone applications to support at least notification, if not monitoring, of medication adherence also has grown steadily. The software is inexpensive, and sometimes easy to use, though results are generally superior when medication data is seeded from a hosted application rather than self-entered by patients — which is, unfortunately, the norm. As is clear from a survey of available apps, some do not include medication databases. Desktop or cloud-based applications can readily add audit trails to show when drugs start/stop and dosage changes occur, but such features are exceptional with low-cost mobile software — a serious deficiency.
Obstacles to adherence automation
Systems architects and software designers face obstacles on several fronts as the challenge of improving medication adherence is addressed. Progress in some of these areas is steady, while in others, the scope of the problem is only now becoming apparent (see obstacles to adherence automation chart).
Reports from the front line
The tip of the adherence spear, technology-wise, is a reminder-producing, adherence measuring device — probably a smartphone or something built from similar components. Drug Store News spoke with two providers of smart device adherence software. "Even with early innovators who understand the technology, it’s a long implementation cycle," said Montuno Software CEO and founder Jonathan Levene in describing an early-stage project under way with a major West Coast health system. "IT specialists may ‘get it,’ but major caregiver stakeholders need to be on board." The project entails preloading Montuno’s Dosecast device with a post-discharge medication prescription. While this offers patients superior data quality and ease of use, there’s more integration engineering. As Levene puts it, "moving away from simple ‘point solutions’ is the next wave of opportunity to integrate and simultaneously improve data quality."
This cautious sentiment is echoed by Krijn Van Der Raadt , GreatCall’s VP information technology and software development. "It’s never been a purely technical challenge to build a more seamless flow of data easier for patients to use. But this is a difficult arena to operate in. It doesn’t move as quickly as other markets we operate in," Van Der Raadt said. "We had paying Jitterbug Rx reminder customers who never set up their regimens. We learned that they found even relatively simple setup to be onerous, so we reached out by mail, phone and fax. You have only to look at the demise of Google Health to see that the goal of standardized health records across platforms and stakeholder communities remains a challenge." Nonetheless, Van Der Raadt believes persistence will have its rewards. GreatCall reported plans to continue expanding MedCoach and develop related apps, especially as integration opportunities arise.