Sotagliflozin, a drug that works in the kidneys to increase amount of glucose released into urine for elimination, is currently pending FDA approval for treatment of type 2 diabetes. Data from clinical trial for sotagliflozin revealed possible reduction in hospitalization or urgent visits for heart failure and cardiovascular (heart) related death in persons with diabetes and chronic kidney disease. The concern with this study is lack of power so further studies are needed. To learn more, please click below.
I am super excited about this study of once weekly semaglutide (you may recognize the injectable brand of Ozempic) plus lifestyle interventions (changes to eating habits and moving more) in persons without diabetes and with body mass index of 30 or greater for weight loss. Semaglutide works in the satiety center (which controls hunger) in the brain to decrease hunger which works great in combination with changing eating habits and moving more. The results of the study are promising. I hope that semaglutide will be approved for weight loss in persons without diabetes, and this study is a step towards making this approval happen in the future.
We have been taught to store insulin in refrigerator (35.6 – 46.4 degrees Fahrenheit) at least until first use of the vial or pen then at at 77 degrees for up to two – four weeks (varies depending on product). A study by researchers from Doctors Without Borders and the University of Geneva has shown that refrigeration might not be necessary. In this study, they test insulin in more real world conditions with temps ranging from 77 to 98.6 degrees Fahrenheit for four weeks. Interestingly in the study the insulin only lost no more than 1% potency (current regulations allow for up to 5% potency). These findings particularly helpful for places of fewer resources where access to refrigeration is limited.
Novo Nordisk has submitted to the FDA for approval of higher dose (2 mg) Ozempic which is currently available in 0.5 mg and 1 mg once weekly injectable doses. The potential for additional lowering of hemoglobin A1c and weight loss with higher dose. Recently, Trulicity (also an injectable once weekly GLP-1 agonist) was FDA approved for higher dosing (3 mg and 4.5 mg). I look forward to the FDA approving the 2 mg dose of Ozempic as this provides more options for persons with type 2 diabetes to have greater decrease in glucose and weight loss.
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WE are in a new year! Thank goodness 2021 is here.
Each January many people have changes to their health insurance whether it’s a new health plan, changes in the amounts of deductibles, copays, and/or new drug formulary. Since the start of the year, I have worked with several individuals with diabetes to help make their diabetes medications more affordable that experienced changes to their health insurance plans. Even for the most well versed in health insurance, all of these changes can be overwhelming and confusing. Here are some very practical money saving tips to consider before you head to the pharmacy to pick up your prescriptions this month:
-Make sure that your pharmacy has your updated health insurance information
-Inquire as to whether you have lower prescription copays by getting 90 day supply as opposed to 30 day supply
-Inquire as to whether your health insurance plan has lower copay for using mail order pharmacy (I cringe typing this sentence as I am a firm believer in patient choice of their preferred pharmacy)
-Look up your preferred drug formulary for your health insurance (****warning this change even if your overall health insurance plan did not change), and learn the preferred brand name and generic medications for the class of drugs that you have been taking
-Always ask if cash price is less than your copay particularly for generic medications
-Check price on GoodRx as it may be lower than your insurance copay particularly for generic medications
-For brand name drugs, check the pharmaceutical manufacturer website for copay or savings cards
-If you can not afford your medications, please talk with your pharmacist and your medical provider’s office. Please DO NOT simply go without the medication until your next telehealth or office visit.
Brand name drug
A drug under a trademark name or specific name and is protected by a patent. For example, Lantus, Levemir (Reference: www.healthcare.gov)
Generic drug
a medication that is approved to be the same as a brand name drug specifically with regards to dosage form, strength, safety, route of administration and quality. (Reference: www.fda.gov)
Drug formulary
a list of medications (brand and generic) covered by your health plan. Often drug formularies have tiers with least expense medications (generics) as tier 1 and most expensive as tier 3 or4). (Reference: Goodrx.com)
I hope that this blog has provided you with tips that will prevent you from the experience of rationing or simply not getting your medications because of cost.
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#avoiding #medication #cost #shock
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So person with diabetes presents to the emergency room due to significantly elevated glucose after rationing insulin due to recent job loss. Unfortunately this scenario happens way too often these days. It breaks my heart. I have a passion for helping people with financial resources so they can afford their medications. A resource that I use on a weekly basis is NovoCare Immediate Supply. I have provided the link below – if you are a person with Medicare Part D, please call 1-800-910-0454 to enroll. While this is not a long term solution by any ways, it can provide short term help with accessing insulin. Basically, it provides a month supply of NovoNordisk insulin (i.e. Novolog, Fiasp, Levemir, Tresiba) (pens and/or vials) at no cost. Persons with diabetes or healthcare professionals can click on the link to enroll and get the copay card. Once you have the card, simply take to the pharmacy – make sure you have a prescription for insulin.
As the new year starts, many people experience changes in their drug formulary (list of preferred medications for your health plan) whether they have a Medicare Part D plan or employer based health plan. Often, the change goes unnoticed until person goes to pharmacy to pick up a refill and finds out their copay has increased significantly. Please do not blame the pharmacist or pharmacy – they are only the messenger. So how can you prevent this from happening to you? Become a student seeking to understand your health plan and what is covered in terms of health services and medications. Access and review your drug formulary to check to see if your current medications are covered — check online at your health insurance plan’s website or call your health insurance plan. If your current medication(s) are no longer covered, look for alternatives. Your pharmacist or a pharmacy intern (a student who is enrolled in a school/college of pharmacy who is working at the pharmacy) can help you as you seek to understand your drug formulary and look for alternatives. Some physicians offices have ambulatory care pharmacists (like myself) (pharmacists who work in the physicians office with a focus on non-medication dispensing activities) who can also help you. Please use these tips to avoid surprises when you go to the pharmacy to pick a refill this January — also, please remember to not blame the pharmacist or pharmacy as your insurance determines the copay.
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#diabetes #medications #copays
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FDA approved the first generic glucagon injection kit (manufactured by Amaphastar Pharmaceuticals) which is therapeutically equivalent to Eli Lilly’s branded Glucagon injection kit. The generic injection kit is approved to treatment severe hypoglycemia (typically defined as blood glucose < 54 mg/dL) and as a diagnostic test (in gastrointestinal (aka stomach related) radiologic imaging). It is similar to Lilly’s branded glucagon kit in that it involves a multistep mixing process. The advantage the generic has over the branded injection kit is a lower cost although the mixing is still cumbersome (when considering its use for severe hypoglycemia). The newer products (which are not available generically) have the advantage of ease of use with either the intranasal (Baqsimi) or prefilled pen or syringe (Gvoke HypoPen and Gvoke PFS) which personally I would prefer in an emergency of severe hypoglycemia. Please click below to learn more.
Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.
We know that SGLT-2 inhibitors are a proven medication to help treat type 2 diabetes beyond just their glucose lowering benefits. Robust research supports both their benefit in both cardiovascular and kidney disease. Canagliflozin was the first SGLT-2 inhibitor show benefit in patients with CKD in the CREDENCE trial. This trial found canagliflozin dosed at 100 mg once daily in persons with type 2 diabetes and diabetic nephropathy reduces the risk of end-stage kidney disease, worsening serum creatinine, and death from renal or cardiovascular disease when compared to placebo. Empagliflozin was next to show a benefit in CKD through DAPA-CKD study. This study revealed that empagliflozin dosed at 10 mg every day in persons with CKD with and without type 2 diabetes led to less progression of CKD, renal related death, or cardiovascular related death when compared to placebo. Lastly, dapagliflozin is currently being assessed for its role in CKD in persons with and without diabetes with the study EMPA-KIDNEY with expected outcomes available in 2022. These trials leave no doubt that the SGLT-S inhibitors play not only an important role in type 2 diabetes but also in renal and cardiovascular disease.
References:
Perkovic V, et al. “Canagliflozin and renal outcomes in diabetic nephropathy”. The New England Journal of Medicine. 2019. 380(24):2295-2306.
Heerspink, et al. “Dapagliflozin in patients with chronic kidney disease”. The New England Journal of Medicine. 2020. 383(13):1436-1446.
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Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.
At the beginning of December, the FDA released a statement that sitagliptin (Januvia) does not improve glycemic control in pediatric patients. This statement was based on the results of three studies that used Januvia in patients age 10 to 17 with uncontrolled type 2 diabetes. When they compared Januvia to placebo there was not a significant difference in the reduction in HbA1c. Due to the results of the studies, updates have been made to the prescribing information of Januvia and other sitagliptin containing products (Janumet, Janumet XR). These agents are not recommended in pediatric patients with type 2 diabetes. Januvia and related products should only be used in type 2 diabetes patients age 18 years and older. Current FDA approved medications in the management of type 2 diabetes in the pediatric population include: metformin, insulin, and Victoza.
Reference: New studies show diabetes drug not proven to improve blood sugar control in pediatric patients. [press release]. Silver Spring, MD: US Food and Drug Administration; December 4, 2020.
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