new now next
On September 17, Vivus announced that its obesity medication Qsymia (formerly Qnexa) is now available on the US market – this happened at least several weeks earlier than expected. Qsymia is a once-daily pill extended release combination intended to be used with diet and exercise by adults with a body mass index (BMI) greater than 30 kg/m2 or a BMI greater than 27 kg/m2 and a weight-related condition such as type 2 diabetes, high blood pressure, or high cholesterol (see new now next in diaTribe #45). As a reminder, the drug is available in four different doses to give users more flexibility and to ease the transition to the higher doses.
The recommended mid dose of Qsymia will cost approximately $135 per month (about $5 per day), the lower dose will cost $120 per month, the three-quarter dose will be about$163 per month, and the high dose will be about $184 per month (about $6 per day), although these prices may be somewhat higher depending on where the drug is purchased. Since only around 30% of prescriptions for weight-management drugs are paid for by private insurers and Medicare Part D does not cover weight-management medications as yet, it is likely that people who want to use Qsymia will have to pay these costs out of pocket initially. However, Vivus is optimistic that some employers will soon take on at least some of the cost of the drug. The company is also working with private insurers and the government to get Qsymia covered in the future.
Initially, Qsymia will be available through certified mail order pharmacies from Walgreens, CVS, and Kaiser Permanente (for members only), though expansion to other pharmacies is expected soon. Vivus’ ability to get Kaiser on board so early is particularly notable in our view, as it likely signals future potential for coverage by the very influential and cost-focused insurer. And indeed, we believe the Kaiser coverage speaks volumes about what may be available going forward – we suspect large employers over time who really want to help their employees will be covering it. For more information on Qsymia, speak with your healthcare provider or visit www.qsymia.com, and if you work at a company you would like to see cover it, speak with your benefits manager.
This news represents the end of a long and at times difficult road for Qsymia, one that we have spent the last few years covering extensively in diaTribe. For a complete timeline of Qsymia’s journey to approval, see the articles below (as a reminder, Qsymia was previously known as Qnexa). –AW
- “FDA Approves Vivus’ Obesity Medication Qsymia,” new now next in diaTribe #45
- “Dr. Arya Sharma discusses the recent approval of Vivus’ Qsymia, highlights the need for weight-maintenance drugs, and explains how societal views of obesity need to change,” diatribe dialogue in diaTribe #45
- “FDA Postpones Decision Date For Obesity Medication Qnexa,” new now next in diaTribe #42
- “FDA Advisory Recommends Approval Of Obesity Medication Qnexa,” new now next in diaTribe #40
- “Promising New Developments For Vivus’ Weight-Loss Drug Qnexa,” new now next in diaTribe #39
- “Vivus To Resubmit Weight-Loss Drug Qnexa To The FDA,” new now next in diaTribe #36
- “Qnexa, A Promising Weight-Loss Drug, Fails To Gain Regulatory Approval,” new now next in diaTribe #26
- “The Fate Of Vivus’ Weight-Loss Drug Qnexa Rests With FDA,” new now next in diaTribe #24
- “Lee Kaplan, MD, PhD Discusses ‘Bypassing By The Bypass’: A Perspective On Novel Obesity Therapies,” diaTribe dialogue in diaTribe #22
- “Qnexa: Treating Both Diabetes and Obesity,” new now next in diaTribe #21
- “The Next Generation of Weight-Loss Drugs,” new now next in diaTribe #18
Exercise and weight loss have been shown to significantly reduce a person’s risk of moving from prediabetes to type 2 diabetes. However, insurance coverage for these lifestyle-based prevention programs is relatively rare, which often makes them too expensive for many who are at the greatest risk. To that end, Senators Al Franken (D-MN), Richard Lugar (R-IN), and Jay Rockefeller (D-WV) recently introduced the Medicare Diabetes Prevention Act of 2012, which if enacted would provide seniors access to the Diabetes Prevention Program (DPP) through their Medicare benefits (read full details of the bill here). A landmark clinical trial found that the DPP reduced the risk of diabetes by 71% in people over 60. The program is currently offered at over 300 YMCA branches in 30 states (see new now next in diaTribe #23). Over 16 weeks, the DPP sets two main goals for its participants: to reduce body weight by 7% and to participate in at least 150 minutes of physical activity each week. The ADA has strongly endorsed both the DPP and the Medicare Diabetes Prevention Act.
The bill suggests that extending access to the DPP to all Medicare beneficiaries could prevent as many as three million people with prediabetes progressing to diabetes between now and 2020. Because medical expenses for people with diabetes are more than double those without the condition, the total savings are estimated at over $190 billion over the next decade. The bill could also pave the way for further expansion of coverage so that even more of the estimated 67 million Americans with prediabetes can gain affordable access to the DPP. Unfortunately, the congressional monitoring site GovTrack gives the bill a relatively low probability of being passed, though our fingers are crossed, and we will continue to keep tabs on its progress over the coming months. If you’re looking for ways to advocate for the bill’s passage, check out Kerri Morrone-Sparling’s sum musings in diaTribe #46. –AW
On August 17, the FDA approved Mylan’s new generic versions of Actos (pioglitazone), a once-daily oral tablet for the treatment of type 2 diabetes originally sold by Takeda. Mylan, Teva, and Ranbaxy all plan to sell generic versions of the drug. The introduction of generic Actos should substantially reduce the price of the drug. One estimate suggests the current price of $270 for 30 mg Actos could drop to $153 this time next year, and by 2015 the price could be as low as just $15, and no more than about $90. This means Actos now has significant potential as a low-cost treatment for type 2 diabetes, which could mean healthcare providers will become more likely to recommend its use.
Actos belongs to a class of medications called TZDs (short for thiazolidinediones). These drugs potently lower blood glucose levels by making the body more sensitive to insulin. First approved in 1999, Actos is currently the only drug in this medication class to be widely available in the US and Europe. The first drug in this class, Warner-Lambert’s Rezulin, was pulled from the market in 2000 because of liver toxicity. GlaxoSmithKline’s Avandia, was also approved at almost the same time as Actos but became restricted in 2010 due to concerns about an association with heart attacks (see new now next in diaTribe #24).
Actos also has a number of side effects including weight gain and bone fractures, and clinical studies have more recently revealed an increased risk of bladder cancer in people taking Actos (see new now next in diaTribe #34). An NIH-backed study found that people taking Actos for more than five years were two to three times more likely to develop bladder cancer than those taking other diabetes medications. As a result, the use of Actos as a type 2 diabetes treatment has declined by about 40% in the past year. Despite these concerns, use of Actos at low doses is still endorsed by many leading diabetologists because of the drug’s unique benefits on insulin resistance. Also, the link with bladder cancer is based on the five-year analysis of a Takeda-backed study – the more recent eight-year analysis suggests the link between Actos and bladder cancer was weaker than previously thought, and did not appear to be statistically significant for any of the groups tested.
Of the three companies selling generic versions of Actos, Teva and Mylan also plan to launch generic versions of Actoplus Met, a combination therapy that incorporates both Actos and metformin in a single pill. The FDA applies the same stringent safety requirements to generic drugs as it does to their brand name counterparts, meaning that the risk of bladder cancer is no different in the generic tablets than it currently is in Takeda’s Actos. With these safety concerns in mind, we suspect many doctors and nurses will shy away from use – that said, the lower price is certainly attractive and some believe that much lower doses confer much lower risk for side effects. –AW
On August 29, J&J’s chronic pain drug Nucynta ER (tapentadol) was granted FDA approval for the management of the pain associated with diabetic peripheral neuropathy (DPN). Diabetic neuropathy is one of the most common complications of diabetes, affecting about half of all people with diabetes at some point in their lifetimes. Peripheral neuropathy, which primarily affects the legs and feet, is one of the most common forms of this condition. Improved blood glucose control can slow down and sometimes even reverse the damage to nerves, but medications and devices are often still needed to treat the pain and numbness of neuropathy. Nucynta ER is the third drug to gain FDA approval to treat DPN, following Eli Lilly’s antidepressant Cymbalta (duloxetine) and Pfizer’s anticonvulsant Lyrica (pregabalin). Last month also saw the approval of NeuroMetrix’s pain management device Sensus for DPN (see new now next in diaTribe #46).
We recently had a chance to talk with Dr. Keith Candiotti, a professor at the University of Miami School of Medicine and consultant to J&J for Nucynta ER. Notably, he suggested that Nucynta ER could be particularly useful for people who are experiencing especially intense pain from DPN, or an exacerbation of their existing pain. This is because Nucynta ER works by directly increasing the activity of the brain’s pain relief, known as the opioid receptors. This also means Nucynta ER treats DPN in a fundamentally different way than Cymbalta and Lyrica. This is great news because DPN affects so many different aspects of the brain and body, which makes it notoriously complicated to treat, and there’s no guarantee a drug therapy that is successful for one person will work for others. Nucynta ER is specifically approved to treat the painful symptons of DPN when a continuous, round-the-clock opioid analgesic is required. Adding more treatment options for DPN is always needed, and we’re hopeful Nucynta ER can provide some relief for those who have not had success with Cymbalta or Lyrica. –AW
During the US Open tennis tournament earlier this month, Larry Soler of the Partnership for a Healthier America (PHA) announced a pair of new initiatives to promote fitness and combat obesity in children (see the diaTribe dialogue with Mr. Soler in diaTribe #35). Children should be getting at least 60 minutes of physical activity every day, but past estimates suggest just 42% of elementary school students and only 29% of high school students are at this benchmark – and those figures are likely overly generous estimates in our view.
To help children be more active, Mr. Soler announced a major commitment from the United States Tennis Association (USTA): building 3,200 kid-sized tennis courts in 2012 in addition to the 3,000 it previously built in 2011, all of which improves both the availability and child-friendliness of the sport. These courts are a little over half the size of a regular court, and the USTA advises children to use specially designed kid-sized rackets and balls, which are significantly slower than those used by adults. Encouragingly, the USTA has already exceeded the 3,200-court goal and is on track to build an impressive 8,600 child-friendly courts by the end of the year. The Association is complementing that major achievement by providing child-specific training to 12,000 new and current tennis coaches, teachers, and volunteers, as well as $150,000 worth of new tennis equipment to programs for children ten and younger. Considering 30 million Americans played tennis in the past year, we hope this partnership can make a dent in the childhood obesity epidemic. We also very much hope to soon see an agreement with Partnership for a Healthier America and a life sciences company – we urge them to rally! –AW/AB
The World Health Organization (WHO) recently released its World Health Statistics 2o12 report, compiling data from 194 countries. The report estimates that about 9% of women and 10% of men worldwide have elevated levels of fasting blood glucose – notably, this is the first major report to our knowledge that includes data on blood glucose levels. The report also offers a long-term outlook on the spread of noncommunicable diseases (NCD), which includes diabetes and obesity. Diabetes is only directly responsible for about 3.5% of NCD deaths, although it bears pointing out that diabetes, elevated glucose levels, and obesity all increase the risk of even deadlier NCDs such as cardiovascular disease, cancer, and coronary heart disease. Indeed, elevated blood glucose, physical inactivity, and being overweight or obese are risk factors that combined account for an estimated 17% of global deaths.
About 12% of the global population is obese, although there’s extreme variance between regions – in the Americas, 36% of people are overweight and a further 26% are obese, while only 11% are overweight and a further 3% are obese in Southeast Asia. Obesity currently accounts for about 2.8 million deaths every year worldwide, primarily due to its links with type 2 diabetes, high blood pressure, and cholesterol. The WHO hopes to act on this alarming new data by setting targets to prevent and control NCDs, including the development of a global monitoring system to pinpoint the regions most at risk. It is still early days for these efforts, but hopefully this latest confirmation of these disturbing trends will spur governments to action. We are not, however, holding our breath waiting for the US government to act in the near future. –AW
A new study from the University of North Carolina and the Chinese Center for Disease Control (CCDC) has found that diabetes is four times more common among Chinese teenagers (1.9%) than it is among their American counterparts (0.5%). This is despite the fact that, according to the researchers, type 1 diabetes is virtually unknown among East Asian youth. Although prediabetes remains much more common in American children (20%) than it does for Chinese children (8.4%), and the overall prevalence of diabetes in China (6.9%) is actually lower than that of the United States (9.3%), Hong Kong (9.8%), and South Korea (8.1%), the relatively high incidence of diabetes among China’s youth may point to a serious national health problem down the road for the world’s most populous nation. Worse yet, obesity and prediabetes appear to be significantly more common among Chinese children ages 7-11 than for adolescents ages 12-18, suggesting the country’s youth diabetes crisis is skewed quite young and getting worse.–AW