Singulair users can expect to pay less for their prescriptions soon. WebMD reports that the Food and Drug Administration has given 10 generic drugmakers approval to begin making generic versions of the popular asthma and allergy drug.
Formally known as montelukast, Singulair blocks the action of body chemicals that cause symptoms of asthma and hay fever. The drug is meant to suppress the onset of asthma, rather than stop sudden attacks.
Singulair is usually taken in tablet form, and nine of the ten drugmakers will produce a generic chewable tablet. Teva Pharmaceuticals has received approval for the oral granule form.
In clinical trials, common side effects in patients taking Singulair were upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache, flu, runny nose, and sinus infection.
Generic drugmakers are basking in the glow of good news: A new report from the Generic Pharmaceutical Association states that the use of generics over brand-name drugs reduced U.S. drug spending by $193 billion in 2011 and more than $1 trillion over the past decade (see chart).
According to the Pharmalot blog, the report noted that the 22% rise in savings last year marked the largest single-year increase since 1998. The increase was attributed in part to expiring patents for such major brand-name drugs as the Lipitor cholesterol pill, the Zyprexa antipsychotic, and the Concerta ADHD medication. Additionally, generic versions of antidepressants, anticonvulsants and cardiovascular drugs accounted for 57% of the annual savings.
The report also found that generics that have entered the market since 2002 represented $481 bilion of the total savings. And in 2011, roughly 4 of every 5 prescriptions written in the U.S. were for generics, but they accounted for only about one-quarter of total drug spending.
As more brand-name medications lose patient protection, more generic drugs will take their place. As a result, generic utilization wll reach almost 87% by 2015, predicts IMS Health, which compiled the report.
Pharmaceutical techology in the news that’s two parts “remarkable” and one part “odd"… a pill that electronically records when it’s been taken.
MedCity News reports that the Food and Drug Administration has approved what is being called America’s first smart pill system. Simply swallow the pill as normal, and a tiny ingestible sensor activates when it reaches the stomach. A companion wearable patch then marks the ingestion time and passes the information onto a mobile phone application, which in turn can be accessed by caregivers and clinicians.
The system has been tested in conjunction with such conditions as tuberculosis, mental health, heart failure, hypertension and diabetes, said CEO Andrew Thompson of Proteus Digital Health, the pill’s creator and manufacturer. Proteus hopes the system will help to improve the prescription compliance rate in the U.S., which is currently around 50%.
The battery-operated, wearable patch lasts seven days and also works as a heart rate monitor and can measure body temperature and activity.
The Wall Street Journal Health Blog reports on high-tech efforts by southern Ohio health care providers to combat painkiller abuse:
“Starting this week, patients must submit to a fingerprint scan to see a doctor at one hospital system. At several pharmacies, patients must use fingerprint IDs to get their prescriptions filled.
“The one-year pilot program, announced Thursday, was green-lighted in recent weeks by the state’s Republican Gov. John Kasich. If the technology works, fingerprint scans could become more commonplace in Ohio – a state where an average of 67 opioid painkillers are prescribed to every resident each year, state data show.”
The biometric tools used to perform the scans are similar to those used by U.S. forces in Afghanistan and Iraq, the blog notes.
The rise in U.S. obesity over the past several decades has been accompanied by a increase in Type 2 diabetes. The best strategy for reducing the risk of the disease is a sensible weight loss program. But for those already afflicted, the solution is less clear.
The Wall Street Journal recently explored new strategies for treating diabetes. Revised guidelines for treating the disease suggest doctors eschew a one-size-fits-all program, instead varying treatments based on a patient’s age, general health and even personal preferences.
For example: Earlier standards advocated reducing the blood sugar of diabetes patients to a standard targeted level. But the new guidelines recommend that doctors reserve that strategy for younger patients, while using a less aggressive approach with older patients.
A more extreme approach for treating the disease is bariatric surgery, which results in dramatic weight loss. In spite of its potential complications, the treatment has increasingly found favor in the medical community as obesity rates have grown.
The latest guidelines do reaffirm a gradual boost in drug therapy dosage. But recent research suggests that hitting the disease early and hard may be a more effective approach.
On the KevinMD.com blog, Medical student Arvin Akhavan argues for a more transparent pharmaceutical pricing system:
“I consider myself well educated. I’m a college graduate and in the throes of professional school – in healthcare nonetheless. I have an open mind and I read quite a bit. But I still wouldn’t have guessed that Coumadin would cost my uninsured father in Texas $15 for thirty pills at CVS, but only $4 for the same number of tablets at Walmart (I can actually vouch for this number).
“I would have thought it was safe to assume that drug prices are comparable across the board. After all, that’s how it usually works, right? When I buy gum, I have faith that I won’t pay triple the price at one convenience store compared to another. But with pharmacies, this just isn’t the case. […]
“That’s why transparency is so important to the prescription medication consumer. Few of us have any idea as to how much drugs should cost. And, since many states don’t require their pharmacies to release their drug costs unless someone is buying them, the consumer has no convenient way of amassing the information it needs to choose from the options.”
MedBen agrees that the more information about drug prices, the better. That’s why we encourage our pharmacy plan members to visit RxEOB online, to check retail costs of thousands of brand name and generic medications. Simply log on to the MedBen Access website and click on “My Rx”.
With two new weight loss drugs approved by the Food and Drug Administration within three weeks of each other, questions about their comparative effectiveness are inevitable. In response, WebMD has developed a Belviq/Qsymia FAQ. Here, we highlight their response to the question likely on the mind of potential users:
Which works better, Belviq or Qsymia?
There’s no way to know for sure. Qsymia and Belviq have never been tested in a head-to-head clinical trial.
In the placebo-controlled clinical trials that led to approval:
These numbers cannot be used to compare the two drugs, as the clinical trials had different designs.
Meanwhile, Healthday News talked to two health experts about how the drugs will affect the country’s obesity epidemic – and both said some perspective is needed:
“The bottom line is there’s no such thing as a magic pill and I hope that individuals do not think by taking this pill that it will ensure long-term weight loss,” said Keri Gans, a registered dietitian in New York City. “We need to be reminded that diet and exercise are still critical.”
And Dr. Michael Aziz, an internist at Lenox Hill Hospital in New York, said, “The problem that all the drug companies are overlooking is the fact that obesity is really multi-factorial. It’s not only related to diet and exercise but also to hormonal imbalances, stress and lack of sleep.”
The New York Times recently reported on doctors who double as pharmacists, dispensing drugs to patients themselves – often at greatly inflated costs.
The way it works: Physician dispensing companies serve as middlemen, helping doctors set up in-office pharmacies. They’re aided by drug distributors who repackage medications for office sale. And the three parties share the profits from selling the drugs at huge markups – sometimes as much as ten times the retail price.
The practice is most common among doctors who treat injured employees, as the workers’ compensation insurance rules in many states contain loopholes that allow them to bump up the cost to patients. And indeed, it is the workers – as well as employers, insurers, and taxpayers – that end up paying the higher prices.
It should be stressed that the vast majority of physicians don’t practice in this manner. But this is a perfect example of why it can pay to understand the real costs of health care products.
MedBen prescription plan members have a great resource to check and compare medication prices: RxEOB. Available through the MedBen Access website to registered members, this service allows users to enter drug names and see their retail costs, and check if lower-cost alternatives are available.
For over a decade, the pharmaceutical industry offered only one option for severely overweight people desiring a weight-loss drug – Xenical, which was rarely prescribed and only somewhat effective. But within the last three weeks, two competitors have entered the market.
The Food and Drug Administration has approved Qsymia (pronounced kyoo sim EE uh) for treatment of obesity, The New York Times reports. Clinical trials have demonstrated that the drug offers a greater potential for weight loss compared to Xenical and Belviq, which the FDA approved last month. Participants who took a regimen of middle-dose Qsymia lost an average of 8.4% of their weight after one year, while high-dose patients lost 10.6%.
However, like the two competing drugs, Qsymia has side effects that must be weighed against its benefits. Earlier tests revealed that usage raises the risk of birth defects if used by pregnant women and can cause elevated heart rates and cognitive problems.
Qsymia is expected to be available in the fourth quarter, according to Vivus, the drug’s manufacturer.
The Food and Drug Administration has approved the use of the drug Truvada for individuals who have tested negative for HIV, the Los Angeles Times reports.
Clinical studies have shown that if taken once a day, Truvada could reduce transmission of HIV, the virus that causes AIDS, by as much as 75% if used in combination with safe sex practices. The drug had previously been approved in 2004 to help treat people already infected with the virus.
Reaction to the approval has been mixed. Marjorie Hill, chief executive of the AIDS group GayMen’s HealthCrisis, called it a “big step” to preventing the spread of the virus. “It’s going to save lives,” Hill said.
But Michael Weinstein, president of the AIDS Healthcare Foundation, worries that making Truvada available to those who have tested negative will take more risks. “If you look back five years from today, you will see this decision by the FDA will cause there to be more infections, not less,” Weinstein said.
The FDA will require that individuals first have an HIV test before receiving a prescription to ensure they are not infected, and get a follow-up test every three months thereafter. A year’s supply of the drug costs $13,900.
The Associated Press reports that the United States and other developed countries will experience slow growth in prescription drug spending over the next four years, according to a new forecast from IMS Health. The pharmaceutical data firm attributed the trend to a sharp rise in new low-cost generic drugs and slower increases in what those countries spend on brand-name medications.
Shed no tears for pharmaceutical companies, however… during the same period (2012 to 2016) emerging markets such as China, India and Russia will boost drugmakers’ bottom lines. Total spending worldwide will rise from about $956 billion in 2011 to just under $1.2 trillion in 2016, but rebates and discounts from drug companies will reduce the cost by about 15% that year, to a mere $1 trillion.
And while we’re on the subject… MedBen passes through 100% of negotiated discounts and delivers 100% of paid rebates back to the client. Additionally, we offer some of the most competitive generic drug discounts in the industry.
Our progressive approach to employee prescription benefits has consistently beat the odds by producing better-than-national results. Employers using the MedBen prescription program typically see cost trends of 5% lower than national trends, on average.
For further information about pharmaceutical planning, contract MedBen Vice President of Sales and Marketing Brian Fargus at 888-627-8683.
Most people still prefer face-to-face communication with their doctors when discussing medical matters. But regarding other aspects of health care, online interaction is increasingly the way to go.
As the results of a Accenture survey (via MedCity News) show, patients like having the ability to make appointments, receive reminders and refill prescriptions through websites, e-mail and mobile devices.
At MedBen, we have our own set of online tools for client convenience, including:
MedBen Access: With MedBen Access, plan members can check the status of a health claim, review benefit coverages, and more. For plan administrators, MedBen Access makes management of the company health plan simple and convenient.
RxEOB: This valuable site, available through MedBen Access, allows plan members to review personal prescription detail and benefit coverage, and compare lower cost alternatives. Employers also can use RxEOB to generate timely reports that will help them keep on top of cost trends.
MedBen Secure: MedBen Secure ensures that the personal health information of your plan members is fully protected. Employers can review or download current member reports, while multiple safeguards maintain privacy.
FSA/HRA Online System: MedBen FSA and HRA members can use this site to review claim submissions, check payments issued, see total deposits posted to date and get answers to a variety of questions.
More online services are available at MedBen.com.
In an effort to counter the growing prescription painkiller abuse crisis in the United States, The Food and Drug will require opioid medicine makers to fund safety training programs for doctors, Reuters reports.
Companies that make long-acting or extended-release opiods – including painkillers like oxycodone and methadone – must also provide information sheets to patients that promote proper use of the pills.
“The problem of prescription drug abuse and misuse is very real,” said Dr. Margaret Hamburg, the head of the FDA. “Educating healthcare professionals on how to safely prescribe (the medicines) is essential to address this critical public health issue.”
Overdose from prescription drugs has passed car crashes and the combined impact of cocaine and heroin as the leading cause of accidental death in this country.
One stumbling block to the FDA’s good intentions: the law does not require doctors to take the classes, which are scheduled to begin in 2013. Neverthess, Hamburg expects half of the nation’s 320,000 prescribers of painkillers to get the training by the program’s third year.
The Food and Drug Administration has approved the first in-home test for HIV, the virus that causes AIDS. An advisory panel to the government agency recommended its approval in May.
Sold over-the-counter, the OraQuick In-Home HIV Test allows people to self-administer the test in the privacy of their home. Users simply swab their upper and lower gums and obtain results within 20-40 minutes.
The agency stressed that a positive result from the test does not mean the user is definitely infected with HIV, but that they should consult a medical professional for additional testing.
A Medical News Today story on the FDA announcement notes that based on clinical studies, the test produces one false positive out of every 50,000 results and one false negative out of every 12 results.
Long-term use of prescription pain killers greatly increases the risk of death by overdose, according to a new Centers for Disease Control and Prevention study.
WebMD reports that the study found the number of people who abused opioid pain relievers for 200 to 365 days in the last year rose by nearly 75% between 2002-03 and 2009-10. In contrast, the overall number of people who used painkillers for less than 200 days and reported abuse or nonmedical use stayed constant over the two research periods.
(The WedMD article notes that “[n]onmedical use or abuse of prescription pain killers is defined as using the drug without a prescription or simply for the experience or feeling it causes.")
The biggest increases in abuse were seen among seen among men and young to middle-aged adults. People 35 to 49 years old saw a 135% increase, while abuse by 26- to 34-year olds was up 81%. Men reported a 105% increase between the two periods.
Based on their findings, researchers say about one million Americans 12 years and older would be classified as chronic prescription drug abusers in 2009-2010.
“These findings underscore the need for concerted public health and public safety action to prevent nonmedical use of these drugs,” wrote researcher Christopher M. Jones, PharmD, MPH.
Last week, the Food and Drug Administration approved the first prescription weight loss pill in over a decade. But prior to that, another government panel essentially said it was a bad idea.
The Boston Globe reports that the US Preventive Services Task Force recommended that doctors instruct obese patients to diet, exercise and get weight-loss counseling, but did not advise prescribing diet drugs.
“One of the problems with drugs is that the clinical trials just show short-term outcomes,” said Dr. David Grossman, a Seattle pediatrician who led the USPSTF panel that issued the updated recommendations. “Once a person stops taking the drug, we don’t know what happens with long-term weight gain.”
The Pharmalot blog, commenting on the Globe story, notes that the FDA is feeling the pressure from the growing obesity crisis in this country – so its approval last week of the diet drug Belviq could be interpreted as something of a desperation move, especially considering that the medication offers only minimal help in losing weight.
Indiana and Ohio will be the first two states to test a program designed to make it easier for doctors, pharmacists and emergency departments to access patients’ prescription drug records.
Reuters reports that the Obama administration is launching the pilot program in hopes of reducing the number of overdoses from prescription drugs, currently the leading cause of accidental deaths in the United States.
Even though 49 states already allow prescription drug monitoring programs, which collect information from pharmacies and practitioners, the difficulty in navigating through the data has put off potential users. Lack of real-time information is also a concern.
“Part of the problem we have with the prescription drug abuse problem is we are always playing catch-up,” said Marty Allain, a senior director at the Indiana Board of Pharmacy. “We are moving towards early identification of a problem and toward the preventive side of a problem – to keep things from getting worse or to prevent problems for some patients in the first place.”
MedBen maintains its own prescription drug database – albeit one geared toward patient, not provider, use. RxEOB allows members to review personal prescription history, detail and benefit coverage, plus offers lower cost drug alternatives to save you out-of-pocket expense. To make a visit, simply log on to the MedBen Access site and click on “My Rx”.
For the first time in over a decade, the Food and Drug Administration has approved a prescription diet pill. Lorcaserin, which will be sold under the name Belviq, was approved for use by obese people (those with a body mass index of 30 or more) and overweight people with a BMI of 27 or more who have at least one weight-related health condition, according to NPR.
“Obesity threatens the overall well-being of patients and is a major public health concern,” Janet Woodcock, director of the FDA’s drug center, said in a statement. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Observing “a healthy diet and lifestyle” is indeed important, as the drug itself provides relatively small weight loss. Studies found that about half of patients taking Belviq lost only about 5% of their body weight after a year. But with roughly one-third of Americans considered obese, the FDA decided that some additional help, however minor, was warranted.
Notable side effects of the drug include headache, dizziness, fatigue, nausea, dry mouth, and constipation. Arena Pharmaceuticals, the maker of Belviq, must monitor the drug’s safety through continued study, as a condition of its approval.
There is no word yet when Belviq will be available in pharmacies, or its cost.
As primary care doctors expand the number of patients they accept, and the number of those patients taking medications rises, pharmacists have taken on an increasingly important role. And some drugstore chains, as well as independent pharmacies, are hoping to foster customer loyalty by making their pharmacists even more accessible:
“They are counseling patients face-to-face and on the phone, contacting patients who don’t refill prescriptions and checking for potential interactions between drugs prescribed by different doctors. Pharmacists can’t actually prescribe drugs, but with a patient’s permission they can call the physician to discuss recommended medications that may have been overlooked and ask whether the doctor wants to prescribe them.
“Many patients, especially those with chronic conditions like diabetes and heart disease, don’t adhere to medication regimens. Studies show only 25% to 30% of medications are taken properly, and only 15% to 20% are refilled as prescribed.
“Pharmacy groups and drugstore chains say an enhanced role for the pharmacist makes it easier for patients to stay on the wagon and significantly reduces unnecessary hospitalizations and emergency-room visits that can occur when patients skip their meds.”
The Pharmalot blog reports that drugmakers may spend about $1.58 billion on online advertising this year, nearly a 25% leap from 2011, according to a market research analysis from eMarketer. But while dollars-and-cents spending will continue to go up over the next few years, actual spending growth is expected to drop dramatically during this period (see chart).
Does this mean pharmaceutical companies are backing off on their advertising efforts and putting more money into other areas, such as research and development? Not exactly. “Drugmakers have been slow to shift to online tactics. Without definitive online marketing guidelines from the FDA for direct-to-consumer advertising, many marketers prioritize spending in print and broadcast media, for which there is a clearer road map. The shift to digital is under way, but has not progressed as quickly as it has in less-regulated industries,” the firm writes.
eMarketer also notes that the growing emphasis on newer drugs that target more specific patient populations have led drugmakers to refocus their marketing efforts at patients and health care providers.