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Do not share your Tresiba® FlexTouch® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Do not take Tresiba® if you: are having an episode of low blood sugar are allergic to Tresiba® or any of the ingredients in Tresiba® Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are: pregnant, planning to become pregnant, or are breastfeeding taking new prescription or over-the-counter medicines, vitamins, or herbal supplements Talk to your health care provider about low blood sugar and how to manage it. Read the Instructions for Use and take Tresiba® exactly as your health care provider tells you to Do not do any conversion of your dose. The dose counter always shows the selected dose in units Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes Tresiba® is not for people with diabetic ketoacidosis Tresiba® is not for children who need less than 5 units of Tresiba® each day It is not known if Tresiba® is safe and effective in children under 1 year of age Tresiba® is available in 2 concentrations: 200 units/mL and 100 units/mL Do not take Tresiba® if you: are having an episode of low blood sugar are allergic to Tresiba® or any of the ingredients in Tresiba® Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are: pregnant, planning to become pregnant, or are breastfeeding taking new prescription or over-the-counter medicines, vitamins Continue reading >>
Is My Test, Item, Or Service Covered?
How often is it covered? Medicare Part B (Medical Insurance) doesn’t cover insulin (unless use of an insulin pump is medically necessary), insulin pens, syringes, needles, alcohol swabs, or gauze. Medicare prescription drug coverage (Part D) may cover insulin and certain medical supplies used to inject insulin, like syringes, gauze, and alcohol swabs. If you use an external insulin pump, insulin and the pump may be covered as durable medical equipment (DME). However, suppliers of insulin pumps may not necessarily provide insulin. For more information, see durable medical equipment. Your costs in Original Medicare You pay 100% for insulin (unless used with an insulin pump, then you pay 20% of the Medicare-approved amount, and the Part B deductible applies). You pay 100% for syringes and needles, unless you have Part D. To find out how much your specific test, item, or service will cost, talk to your doctor or other health care provider. The specific amount you’ll owe may depend on several things, like: Other insurance you may have How much your doctor charges Whether your doctor accepts assignment The type of facility The location where you get your test, item, or service Continue reading >>
Cost-effectiveness Of Switching To Insulin Degludec From Other Basal Insulins: Evidence From Swedish Real-world Data
Objectives: Health economic analysis from a healthcare and societal point of view was conducted to assess the cost-effectiveness of insulin degludec (IDeg) after switching from other basal insulins in people with type 1 diabetes. Material and methods: This was a prospective, open-label, single arm, observational follow-up from August 2013 to October 2015 of 476 consecutive patients at Danderyd Hospital (Stockholm, Sweden) who switched to IDeg from other basal insulins (99% basal insulin analogs). The IMS CORE Diabetes Model (CDM) was used to predict the cost-effectiveness of life-long treatment with IDeg vs. other basal insulins, based on a Swedish setting. Results: Mean (SD) duration of follow-up was 21.7 (6.0) weeks. Mean HbA1c decreased by 2.7 mmol/mol, mean basal insulin dose decreased by 13.1% (p < .0001), and mean bolus insulin dose decreased by 7.5% (p < .0001) after switching. Frequencies of non-severe daytime hypoglycemia and non-severe nocturnal hypoglycemia decreased by 12% (p = .0127) and 53% (p < .0001) respectively and severe hypoglycemia was reduced by 62% (p = .0225). The CDM predicted a gain in life expectancy of 0.33 years, a discounted gain in quality-adjusted life-years (QALYs) of 0.54, and lower estimated direct lifetime healthcare costs of SEK 22,757 for patients switching to IDeg. The incremental cost-effectiveness ratio (ICER) showed IDeg as dominant (i.e. higher effectiveness with a lower cost). Sensitivity analyses confirmed the results. Conclusion: Based on this prospective, real-world, follow-up and using the CDM, it was estimated that switching to IDeg from other basal insulins translated into QALY gains including improved life expectancy and health-related quality of life, as well as dominant ICER, meaning cost-savings for the healthcare sy Continue reading >>
Insulin Degludec May Be More Cost Effective Than Insulin Glargine Or Its Biosimilar
Insulin degludec (Tresiba) is a cost-effective alternative to insulin glargine U100 (Lantus) for patients with diabetes, and it is also likely to be more cost-effective than 2 newly marketed basal insulin analogues, including a biosimilar. Insulin degludec (Tresiba) is a cost-effective alternative to insulin glargine U100 (Lantus) for patients with diabetes, and it is also likely to be more cost-effective than 2 newly marketed basal insulin analogues, according to a recent study funded by Novo Nordisk and published in Diabetes Therapy. Marc Evans, MD, and colleagues used a short-term model to evaluate the costs and effects of treatment with insulin degludec versus insulin glargine over a 12-month period in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) from the perspective of the United Kingdom’sNational Health Service—that is, in light of the recent reduction in the price of insulin degludec and the addition of 2 new basal insulin analogues to the marketplace: insulin glargine U300 (Toujeo) and a biosimilar to insulin glargine U100 (Abasaglar). The cost-effectiveness model was designed to reflect a more generalizable patient population, including patientswith T2D on a basal-bolus regimen. It calculates costs associated with treatment and hypoglycemic events, andcalculates quality adjusted life years by applying a disutility per hypoglycemic event. Insulin degludec is a basal insulin with an ultra-long duration of action (more than 42 hours) and a flat and stable action profile; it has 4 times less day-to-day variation in glucose-lowering effect than insulin glargine U100. In clinical trials, insulin degludec showed equivalent reductions in glycated hemoglobin, a lower risk of hypoglycemia compared with insulin glargine U100, and a significantly lower Continue reading >>
Everything You Should Know About The New Insulins
Although many people can control their diabetes by eating well and exercising, medication is a necessity for others. Fortunately for these folks, there are more options than ever before to help control their blood sugar. And several new insulins have recently been added to the mix: Afrezza, Toujeo, Humalog U-200, Tresiba and Ryzodeg . Here we highlight these new weapons in the diabetes therapy arsenal. Afrezza: Could this be the end of insulin injections? A new insulin delivery system, Afrezza, was just approved by the FDA and is currently available. Afrezza is an inhaled, man-made insulin that is approved for adults with type 1 diabetes (the diabetes in which your own body produces antibodies against your insulin-producing cells) or type 2 diabetes (the type of diabetes where the insulin being produced does not work as it should combined with the body producing less insulin over time). Afrezza is a meal-time insulin taken before eating. This new insulin therapy may be added when your blood sugars can no longer be controlled by pill medication alone or when long-acting insulin injection is not enough to manage your diabetes. It is currently available in a cartridge form which is loaded into a small device. Cartridges come in four, eight and twelve units. Prior to eating, you would inhale the dose of insulin prescribed by your clinician. Long-acting insulin administration is still required if you have type 1 diabetes. Like other FDA-approved insulin products, Afrezza has potential side effects, such as low blood sugar. Also, the dosing is limited to four, eight, or twelve units or a combination of these units: for example, you cannot administer three units or 10 units with this insulin delivery system. Insurance coverage issues as well as possible higher co-pays – and, Continue reading >>
New Data Show Tresiba Is Cost-effective Option Vs Lantus
A new health economic analysis of two Phase IIIb trials has demonstrated that Tresiba (insulin degludec)… To continue reading this article and to access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space you need to be logged into the site and have an active subscription or trial subscription. Please login or subscribe in order to continue reading. Claim a week's trial subscription by signing up for free today and receive our daily pharma and biotech news bulletin free of charge, forever. Continue reading >>
Insulin Makers Become Casualties Of Pricing War
Tough competition between diabetes drugmakers, coupled with higher payer leverage, has sparked the question of whether formulary access has become a zero sum game: Does success for one mean failure for another? That is the current climate in the insulin market right now, pushing the leaders in the space to make bold moves. Last month, Danish diabetes drugmaker Novo Nordisk announced its veteran CEO Lars Rebien Sorensen would be stepping down at the end of the year, an expected move but several years ahead of schedule. His successor, Lars Fruergaard Jørgensen, gave some hint to the reasoning behind the leadership change, pointing to "unprecedented" competition and payer pressure. Several weeks later, Novo revealed plans to cut about 2.4% of its global workforce, trimming its R&D and headquarters staff in a move designed with that heightened competitive landscape in mind. Novo Nordisk, along with the French Sanofi and Indianapolis-based Eli Lilly, have long dominated the market for diabetes, and specifically insulin, in the U.S. Yet, a widening range of treatment options and greater leverage on the side of payers, has crimped margins and pitted the three companies in a battle for formulary access. Pricing Pressures Over the past two months, both CVS Health and United Health — two large pharmacy benefit managers — have removed Sanofi’s top-selling basal insulin Lantus (insulin glargine) from their 2017 formulary lists. In place of Lantus, CVS and United Health will give preferred placement to Eli Lilly and Boehringer Ingelheim’s Basaglar (glargine injection), a cheaper, follow-on biologic of Lantus. When Basaglar launches in the U.S. this December, it will be the fifth long-acting insulin on the market, joining Sanofi’s Lantus and Toujeo (glargine) and Novo Nord Continue reading >>
Price Tag On Old Insulin Skyrockets
Retired nurse Mary Smith was having trouble controlling her type 2 diabetes on her regular insulin regimen, so her doctor decided to put her on something stronger. Amber Taylor, MD, director of The Diabetes Center at Mercy Medical Center in Baltimore, wrote Smith a prescription for Humulin U-500 insulin, a much more concentrated form of the drug. It could deliver far more active ingredient at far less overall volume, which was important since Smith's insulin doses were getting high. But when Smith showed up at the pharmacy, she was told she'd have to shell out $900 for a vial. "There was no way I could afford that," Smith told MedPage Today as she recalled the pharmacy visit, which happened about a year ago. And the price has gone up since then: Now a single bottle of highly concentrated Humulin U-500 insulin that lasts a diabetes patient about one month costs $1,200 wholesale -- more than five times the $220 it cost in 2007. Those increases have far surpassed those for the less concentrated Humulin U-100, which only rose three times during that period, at a rate comparable to the rest of the insulin market, a MedPage Today analysis found. Although less than 5% of all diabetes patients are taking U-500, Taylor and other clinicians are wondering why an old insulin that had been on the market for many years and had remained relatively cheap suddenly became a valued commodity. "I've had patients with a $2,500 deductible who can't put down $1,200 for a bottle of insulin," Taylor told MedPage Today. "For them, it's pay the mortgage or buy my insulin -- what do you want me to do?" An Old Drug With a High Price Tag Insulin is an old drug. Eli Lilly first put it on the market in 1923, and its more concentrated U-500 formulation, which was made from beef pancreas, appeared in 19 Continue reading >>
A Cheaper Version Of The Lifesaving Diabetes Medication Just Launched In The Us
A Type 1 diabetes patient holds up bottles of insulin.Reuters/Lucy Nicholson A new form of insulin just hit American markets. It's called Basaglar, and it is 15% less than the list price of Lantus and Toujeo, two long-acting insulins made by Sanofi Aventis, 21% less than the list price of Levemir, and 28% less than Tresiba, two long-acting insulins made by Novo Nordisk. Basaglar was approved in December 2015, but had to wait a year before launching on Thursday. A spokeswoman for Eli Lilly, the company that makes Basaglar and other insulins, told Business Insider that the list price for a pack of 5 pens is $316.85 — that's before any discounts, or factoring in what insurance might cover. It is part of a group of medications called "follow-on biologics" and together, they are expected to save the US billions of dollars over the next decade. Why there's no generic form of insulin For people living with Type 1 diabetes and some who live with Type 2, injections of insulin — a hormone that helps people absorb and process the sugar in food — are a necessary part of daily life. And insulin, in one form or another, has been around since the 1920s. But because it's made of living cells, it’s what doctors call a biologic product, and it's more complicated and difficult to manufacture than the medicines most often produced generically. That's why Basaglar isn't considered a generic, it's called a "follow-on biologic." Others taking this approach have gotten approved as biosimilars, and like Basaglar have come in at a slight discount — roughly 15% — off the list price of the original drug. To become a follow-on biologic, Basaglar had to show that its version of the drug was "sufficiently similar to Lantus to scientifically justify reliance," and the drug had to be tested Continue reading >>
Selected Important Safety Information
Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®. Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment Accidental mix-ups betwe Continue reading >>
Novo Nordisk Launches Xultophy 100/3.6 (insulin Degludec And Liraglutide Injection) In The United States - May 3, 2017
Novo Nordisk Launches Xultophy 100/3.6 (insulin degludec and liraglutide injection) in the United States - New combination treatment option for adults with type 2 diabetes now available in pharmacies - Eligible patients pay as little as $1 per day with the Xultophy 100/3.6 Savings Card, some restrictions apply PLAINSBORO, N.J., May 3, 2017 / PRNewswire / --Novo Nordisk, a world leader in diabetes care, today announced the availability of its new combination therapy Xultophy 100/3.6 (insulin degludec and liraglutide injection, 100 units/mL and 3.6 mg/mL) at pharmacies nationwide. Xultophy 100/3.6 combines long-acting basal insulin Tresiba (insulin degludec U-100) with the #1 prescribed glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy Victoza (liraglutide)1 in a single, once-daily injection. Xultophy 100/3.6 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).2 For more information about Xultophy 100/3.6, visit www.Xultophy10036.com . In clinical studies, Xultophy 100/3.6 reduced A1C and lowered blood sugar for 24 hours, including before and after meals.2 Xultophy 100/3.6 can be taken any time of day with or without food.2 "Continuing research and development to find safe and effective medications for people living with diabetes is important, particularly for those who require additional A1C-lowering options," said Dr. Steve Edelman, Founder and Director, Taking Control of Your Diabetes. "Now that Xultophy 100/3.6 is available, patients with type 2 diabetes who are uncontrolled on basal insulin have a new combination that can help achieve their individualized treatment goals." Nov Continue reading >>
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Tresiba (insulin Degludec) Vs. Lantus (insulin Glargine)
www.adverahealth.com © 2016 Advera Health Analytics 1 For more information contact us Drug Evidence Review: © Copyright. 2016 Advera Health Analytics, Inc. All rights reserved. This material MAY NOT BE REPRODUCED, DISPLAYED, MODIFIED, DISTRIBUTED or LINKED TO without the express prior written permission of the copyright holder. Advera Health Analytics Inc.’s research may be cited but not excerpted in its entirety. For permission, contact Sharon Miller Actionable Intelligence: Tresiba (insulin degludec), the FDA- approved long-acting injectable insulin analog, seems to have a similar safety profile to its comparator Lantus (insulin glargine), based on their matching labeled serious adverse events (AEs). In head-to-head clinical trials comparing these two insulin analogs, Tresiba (insulin degludec) was statistically non-inferior to Lantus (insulin glargine) in reducing glycosylated hemoglobin levels, fasting glucose levels & confirmed hypoglycemic episodes, but the rate of nocturnal hypoglycemic events were significantly reduced especially in type 2 diabetes patients treated with Tresiba (insulin degludec). Both the drugs had similar rates of serious AEs through the clinical trials. Based on real-world adverse events reported for Lantus (insulin glargine), our analytics have identified: non-labeled Active RxSignals for serious events such as liver transplant, cerebral thrombosis, and myelitis transverse; an RxScore of 43.88; and an RxCost per prescription of $1.62. Drugs Covered: Tresiba (insulin degludec), Lantus (insulin glargine [rDNA origin] injection) Indications Covered: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1 Drug Classes Covered: Insulins and analogues for injection, long- acting MoA Covered: Insulin Receptor Agonists Overview Novo Nordis Continue reading >>
Key Facts About Basaglar: A Less Expensive Long-acting Insulin
If you’ve been using a long-acting insulin like Lantus, you might have heard about a friendly competitor called Basaglar which is coming soon to pharmacies. Basaglar is insulin glargine known as a biosimilar (also called a follow-on biologic). Because of the manufacturing process it isn’t considered a generic, but there are no differences from Lantus in regard to safety, purity and potency. To get to know Basaglar better, here are some details you’ll want to be aware of. What is the difference between a biosimilar and a generic? Generic drugs are copies of a brand name drug, and their manufacturing process can be replicated exactly through chemical reactions. Biologics are made using manufacturing processes and living organisms that are unique to each manufacturer. Therefore, it is not really possible to make an exact copy of a biologic. For an in-depth look at the definition of biosimilar, see here. Is Basaglar less expensive than Lantus? The cost of Basaglar is estimated to be about 20% cheaper than Lantus. It is manufactured by Eli Lilly as a KwikPen. Basaglar won’t be sold in a vial form. Will my insurance switch me to Basaglar? In some cases, yes. CVS Health has announced that Basaglar will be on formulary in place of Lantus. Is it really equivalent to Lantus? Yes, the onset, peak and duration of action are almost identical. Will my dose be the same as the insulin I’m currently taking? Your healthcare provider will tell you exactly how to make the switch. In general, Lantus and Basaglar can be interchanged unit for unit. If you were on Levemir, the conversion will also be unit for unit. If you were taking Levemir twice a day, the total number of units will likely be given as one Basaglar injection. If you are switching from Toujeo or NPH, your dose might Continue reading >>
How To Get Insulin At A Cheaper Price
Insulin can be expensive. If you’re one of the 6 million Americans with diabetes relying on this main-stay treatment, you could be paying out-of-pocket costs anywhere from $120 to $400 per month, according to a 2015 New England Journal of Medicine commentary. Drugs such as Lantus (insulin glargine) and Levemir (insulin detemir) have seen significant cost increases, according to a recent trend report by pharmacy benefit manager Express Scripts. One reason for the high prices is the lack of generic options for insulin. So for now, you’re stuck having to search around to find affordable options. Where do you shop for more affordable insulin? For some people though, high drug costs can mean making difficult financial choices. Our national polls show people might cut back on groceries and paying bills to pay for their medications. To minimize your costs, consider these options: Prescription Assistance Programs If you don’t have health insurance or are without drug coverage, look into applying for a patient assistance program (PAP). Through the nonprofit NeedyMeds, you can find some programs that offer free or low-cost insulin as long as you meet the eligibility requirements. Those are usually based on your insurance status, income, and diagnosis. You might also qualify for a diagnosis-specific program that can help you save on syringes, pumps, and other diabetes supplies. Pharmacists are also a great resource and can help you find a PAP that meets your financial needs. Switch Drugs Another way to save is by asking your doctor whether there’s a lower-priced insulin that’s right for you. While “long-acting” is a more popular type of insulin, it's also more expensive, but that doesn’t necessarily mean it works better. “It’s mostly a marketing ploy,” says M Continue reading >>
Changes To Insulin Brands Covered By Formulary
Back to News/Alerts Directory Thank you for being part of the HMSA network and caring for our members. We’ve been working with providers and the business community to curb the rising cost of prescription drugs while making sure that our members have access to the medications they need. The cost of insulin has increased dramatically over the past several years. To keep insulin accessible and affordable, we’re making changes to the list of insulin brands that we pay for on behalf of our members. Starting December 1, 2016, Novolin® (with the exception of ReliOn® Novolin products), Novolog®, and Lantus® will be the preferred insulin brands on our commercial plan formularies. Below is a list that includes insulin brands that will be non-formulary or non-preferred on December 1, 2016. Your patients who continue on these products will pay more out-of-pocket and may even have to pay for the full cost of the drug. We’re providing a three-month transition period from December 1, 2016, to February 28, 2017, to give you time to switch your patients to preferred products. Insulin Name Essential Select / Choice / Metallic Afrezza Apidra Basaglar Humalog Humalog Mix Humulin N&R Humulin Mix Levemir ReliOn Novolin ReliOn Novolin Mix Ryzodeg Tresiba NF MN-PA Humulin R U-500 Lantus Novolin N&R Novolin Mix Novolog Novolog Mix 1 1 Toujeo NF 3 NF = non-formulary MN-PA = Medical necessity prior authorization required. If your patient isn’t insulin-dependent, consider other antidiabetic drugs, some of which are generic, have favorable dosing regimens, and preferable side effect profiles. If your patient is on an insulin that will become non-formulary or non-preferred and you believe they need to stay with their current medication, please request a non-formulary exception for them. Continue reading >>
