new now next
On November 8, an FDA advisory panel voted 8-4 to recommend approval of Novo Nordisk’s ultra-long-acting basal insulin degludec (to be marketed under the name “Tresiba”), as well as the premixed combination of 70% degludec/30% fast-acting Novolog (to be marketed under the name “Ryzodeg”). As readers may know, the FDA generally tends to follow the recommendations of its advisory panels when making final decisions regarding approval of new drugs, but it is not required to. While the panel was enthusiastic about the benefits of degludec – specifically, potentially less hypoglycemia, particularly nocturnal hypoglycemia, a more flexible dosing schedule, and a flatter and more stable profile – the panel did acknowledge a possible increased cardiovascular risk associated with degludec compared to other basal insulins. Although most of the analyses so far suggest the evidence for this risk is not statistically significant, the panel unanimously recommended that Novo Nordisk undertake a large study (expected to be around five years and approximately 7,500 patients) to ascertain if there is in fact any increase in cardiovascular risk. Based on discussion and voting at the end of the day, we believe this decision was made to rule out any risk or liability and that most of the panel members did not believe there was a “real” risk. Unsurprisingly, and fortunately for Novo Nordisk, the panelists were in favor of conducting this study following approval, so it should not represent a stumbling block to degludec’s final approval by the FDA. There is no current timeline for the agency to make a final decision on both degludec and the degludec/aspart combination, though we will update readers once that timeline is made clear.
The advisory panel’s positive vote is certainly good news, though it wasn’t necessarily the expected outcome based on the often tense atmosphere during the meeting. Serious questions were raised not only about the potential cardiovascular risk but also about whether degludec really represents a significant improvement over currently available basal insulins. However, the majority of the advisory panel appeared to decide that these concerns were broadly outweighed by the drug’s benefits – again, a flatter and more stable profile, reduced risk of hypoglycemia (especially overnight), and the flexible dosing options afforded by degludec.
The product’s flexible dosing option appeared to be one of the most compelling advantages to the panelists, as its long duration of action is unmatched by any available insulin. While Novo Nordisk is officially recommending that degludec be taken at the same time each day, patients have the possibility of postponing or advancing the injection time as needed (a minimum of eight hours and a maximum of 40 hours between the injections). For instance, if your last degludec dose was on Monday at 9 am, your Tuesday dose could be taken at 5 pm, and your Wednesday dose could be taken at 9 am again. This is possible in both people with type 1 and type 2 diabetes due to the drug’s ultra-long-acting profile. The majority of panelists decided that these benefits had significant potential to close a real gap in treatment, and that gap could not wait for the five years it would take to complete the cardiovascular outcomes trial prior to approval. Multiple panelists on both sides of the final vote stressed how difficult a decision this was, weighing the demonstrated benefits against the relatively small possibility that the drug represents a cardiovascular risk.
DiaTribe Editor-in-Chief Kelly Close had a chance to speak on behalf of patients at the advisory committee meeting. Click here to read her remarks and here to view the slides she presented. Your Diabetes May Vary For more information on degludec, see new now next in diaTribe #46, new now next in diaTribe #37, and new now next in diaTribe #33. –AW/AB
On November 14, World Diabetes Day was commemorated at 574 blue-lit monuments around the world. The annual event is meant to be a rallying experience for the global diabetes community, illustrated by lighting buildings and monuments in the distinctive blue of the diabetes circle, the universally recognized symbol for diabetes. The November 14 date commemorates the birthday of Dr. Frederick Banting, the Canadian medical scientist and Nobel laureate who co-discovered insulin in the 1920s. We were glad to take part in the festivities at San Francisco's blue-lit Ferry Building, and we send big thanks to JDRF for organizing and for so many outstanding patient advocacy organizations present: ADA, Diabetes Hands Foundation, CarbDM, Diabetes and Sports Health Camps, and so many others. We are especially thankful for sponsors LifeScan, Novo Nordisk, and Sanofi Diabetes – without them, the gathering and blue lighting would not have been possible. The highlights of the night were a captivating performance by Velocity Circus and a 14-minute dancing Big Blue Test led by the Diabetes Hands Foundation's Manny Hernandez. –AW/AB
On World Diabetes Day in San Francisco, Manny Hernandez of the Diabetes Hands Foundation (DHF) announced that the DHF had exceeded its goal to get 20,000 people to take the Big Blue Test in 2012 (currently 23,825 tests have been logged!). Launched in 2009, the Big Blue Test has grown into a global campaign to raise awareness about the benefits of exercise for people with diabetes and to help support diabetes charities in the process. Those taking the test simply need to check their blood sugar, then exercise for 14 to 20 minutes, and then recheck their blood sugar afterward. The DHF reports that participants’ blood sugar drops an average of 20% after even that short period of exercise. Here at diaTribe, we can definitely attest to the efficacy of the Big Blue Test – it works! For more information on how to take the test, as well as many inspiring videos detailing the benefits of the test, check out BigBlueTest.org. More information on the Diabetes Hands Foundation is available at their website.
While an estimated 10,000 people took the test in 2010 and 2011, the DHF set this year’s participation goal at 20,000, asking people to participate regardless of whether they have diabetes. (Participants without diabetes simply had to do the 14-20 minutes of exercise, not test their blood sugar.) This drive for the maximum number of participants is no accident – Roche Diabetes Care pledged to donate $5 for each entry logged at BigBlueTest.org. The successful completion of the DHF goal means that Roche will donate $100,000 to various humanitarian diabetes charities in the United States, the Dominican Republic, Ecuador, and Haiti. This new funding will help these charities provide urgently needed diabetes supplies, tests, treatment, and education to those who need them most. —AW
On November 13, Valeritas announced early user results for its V-Go Disposable Insulin Delivery Device. The small study tracked 23 people with type 2 diabetes using the device for 12 weeks; though a small trial, we thought the results were quite striking. The participants began the study with an average A1c of 8.8% and a fasting blood glucose of 205 mg/dl – but after 12 weeks, those using the device had reduced their A1c by 1.2% (to 7.6%) and dropped their fasting blood glucose by 70 mg/dl (to 135 mg/dl)! After the participants stopped using the V-Go, these numbers unsurprisingly went back up, although not quite to their original levels – A1c increased 0.6% (to 8.2%) and fasting blood glucose increased 29 mg/dl (to 164 mg/dl). Patient satisfaction was quite high, with participants giving the V-Go an average score of 9.1 out of 10 – pretty hard to top this! From what we can tell, Valeritas tried to design the V-Go to be an easy-to-use and discreet alternative to syringes and pens for type 2 patients – this early data sure suggests that patients seem to like the device, and the glycemic benefits are quite strong, perhaps because the V-Go makes it easier to take insulin, especially at meal times. Moreover, some initial reports suggest that the V-Go has made people comfortable with starting insulin therapy earlier than they would have with pens or syringes, which is encouraging for their long-term diabetes management.
While the V-Go might appear to resemble an insulin pump, it’s actually a lot simpler to use. The V-Go is a plastic, non-electronic, mechanical device that can provide basal-bolus therapy. It sticks to the body and administers insulin at a preset basal rate over the course of one day and allows users to deliver two-unit boluses by a two-step button push that can be done through clothing. It needs to be replaced at the end of each 24-hour period. While the V-Go is approved for anyone requiring insulin therapy, its intentional simplicity means the device is a better fit for type 2 patients, since its preset basal rate and two-unit boluses don’t offer the dosing flexibility many type 1 patients prefer. For a more complete overview of the V-Go, see new now next in diaTribe #28 that we wrote way back in 2009 to tell you a little about the device in the making that is now available. –AW
The past few months have seen the approval of a pair of new drugs designed to treat obesity, Arena’s Belviq (see new now next in diaTribe #44) and Vivus’ Qsymia (see new now next in diaTribe #45). While Belviq is slated to launch in early 2013, Qsymia launched this past September (see new now next in diaTribe #47), and monthly costs for Qsymia range from $120 to $184, depending on the dose. Because Medicare and more than two-thirds of private insurers are not currently covering weight-management medications, the expectation is that most potential users of Qsymia – and eventually Belviq – will need to pay out of pocket.
Some potentially good news on that front came on November 21, as Aetna announced that it would begin covering weight management drugs in certain patients. This announcement does come with several important caveats, not least of which is that many Aetna plans specifically exclude any obesity medications, and so neither Qsymia nor Belviq would be covered on those plans. However, Aetna members whose plans do allow for weight-loss drugs will be able to get coverage for either Qsymia or Belviq if (1) their BMI is greater than 30 kg/m2 or greater than 27 kg/m2 with one of five risk factors (coronary heart disease, high cholesterol, hypertension, sleep apnea, and type 2 diabetes); and (2) if they have failed to lose at least a pound per week after six months on a weight loss regimen. We think both points will be true for lots of patients and would encourage readers who would like to lose weight to look into it by calling their health insurance plans to inquire what their coverage is for obesity treatments. Specifically, those interested in the Aetna’s update can read it here.
We see this move as a step in the right direction for insurance coverage of Qsymia (and eventually Belviq), and we expect more payers will eventually follow suit. This particular announcement only moderately expands insurance coverage for the drugs, as Aetna has about 6% of Americans on its medical plans, and only an unknown number are eligible for obesity medication coverage. Nevertheless, any increased coverage really has to be considered good news, especially since Vivus has reported that around 30% of pending prescriptions have been abandoned by patients due to cost. We understand this too – losing weight shouldn’t cost patients so much who are trying to improve their metabolic health. Last, given how tough it is for most individuals to lose weight and/or maintain weight loss over the long-term, we hope insurers will view more frequent and continuous support (either in-person or virtual) as essential components to a successful weight loss program. –AW
In late November, Vivus launched its Get Started! Program, which gives potential users of its weight management medication Qsymia a chance to try the drug free for two weeks (as a reminder, Qsymia just launched in September). This is particularly encouraging news because an important concern about Qsymia and other obesity medications has been low reimbursement from insurers (and consequently, high out-of-pocket costs for patients). Specifically, Vivus is offering the 14-day free trial only for the lowest, starting dose of Qsymia, which currently costs about $120 per month (or about $60 for 14 days). The label for Qsymia recommends starting at a low dose and slowly increasing the dose over time, presumably to minimize side effects and to help patients tolerate the drug. The most common side effects of Qsymia include paresthesia (“pins and needles”), dry mouth, and constipation.
This $60 savings is available only through CVS’ and Walgreens’ certified home-delivery pharmacies – as a reminder, Qsymia is currently available through mail order pharmacies only, though this may change in the future. To qualify for this offer, you need to be a resident of the United States or its outlying territories and at least 18 years old. Your doctor must also fax two prescriptions for Qsymia to either CVS or Walgreens: one prescription for the 3.75 mg starting dose for 14 days (automatically free), and the other prescription for the subsequent 7.5 mg recommended dose for 30 days. Physicians in New York cannot fax prescriptions to these pharmacies; instead the prescription must be mailed to the pharmacy. The prescription must have been written or filled on November 16 or later to qualify for the Get Started! Program discount. For a complete guide to how the Get Started! Program works and who qualifies for the trial, visit http://www.qsymia.com/get-started-program.aspx. –AW