New Rapid Bolus Insulin Approved

This newly FDA approved rapid-acting insulin analog is aimed at reducing post-meal glucose spikes.

Lyumjev also known as insulin lispro-aabc, is approved for adults with Type 1 or Type 2 diabetes, can be taken before meals or even 20 minutes into the meal.

Insulin lispro-aabc (Lyumjev) by Lilly is comparable to Fiasp by Novo Nordisk since they are both very rapid-acting insulins that are detectable in the circulation within minutes of injection.

Insulin lispro-aabc (Lyumjev) appears in circulation approximately 1 minute after injection, peaks at 57 minutes and has an effective duration of about four to five hours. The safety and effectiveness of pediatrics with diabetes has not been established.

Description:

Insulin lispro-aabc (Lyumjev) is produced by recombinant DNA technology using a non-pathogenic strain of E coli. Insulin lispro-aabc differs from human insulin due to a switching of lysine and proline in the B28 and B29 position. Its chemical name is Lys(B28), Pro(B29) human insulin analog. See the package insert for more information.

Lys(B28), Pro(B29) human insulin lispro-aabc

Pricing:
Insulin lispro-aabc (Lyumjev) will be offered at the same price as lispro (Humalog). Lilly will also offer Lyumjev at $35 per month for people who are uninsured or have commercial insurance through its Insulin Value Program. The $35 cap applies regardless of the number of insulin doses required.

How supplied:
Insulin lispro-aabc (Lyumjev) comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter) and a variety of delivery options, including the Junior KwikPen® which allows for 0.5 unit dosing increments.

Lyumjev Injection: 100 units/mL (U-100) available as:
• 10 mL multiple-dose vial
– 3 mL 300 unit KwikPen® (5 pens)
• 3 mL 300 unit Junior KwikPen® 0.5 unit dose increment (5 pens)
• 3 mL 300 unit Tempo Pen™ (5 pens)
• 3 mL 300 unit cartridges (5 cartridges)

Lyumjev Injection: 200 units/mL (U-200) available as:
• 3 mL KwikPen® (2 pens with 600 units each)

Storage:
Discard opened or unopened insulin lispro-aabc (Lyumjev) vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days.

Stay tuned for more new insulin approvals and updates to our Insulin PocketCards!


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Mastery of this content is critical to ensure certification exam success and to improve clinical outcomes.

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AccreditationDiabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*  

The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.

Meds Management for Type 2 | Live Stream Webinar

Meds Management for Type 2 | Live Stream Webinar

June 25, 2020, at 11:30 am (PST) 
1.5 CE | $29.00 or No CEsFree

Have you heard a novel insulin formulation was FDA approved this week? What is all the news about metformin? How do we know which diabetes medication to start or add next?

Join Coach Beverly RN, MPH, CDCES, BC-ADM for an intensive live course that weeds out fact from fiction while detailing the latest diabetes medications and management algorithms.

During this live stream webinar, we will discuss diabetes medication benefits, considerations and critical information to share with people with diabetes and providers.

Coach Beverly will highlight the key elements of the latest Medication Guidelines by AACE and ADA. We will explore clinical factors to consider when determining the best strategy to improve glucose management in people with type 2 diabetes and discuss new medications.

Topics include:

  • Overview of classes and actions of diabetes medications
  • Medication updates and new recommendations
  • Using the ADA/AACE algorithms to improve diabetes care and outcomes

Webinar Join Options to view Level 2 Courses

  • Earn 1.5 CE for $29 | This option includes the video presentation, podcast, practice test, and additional resources. To register for some or all of our Level 2 Courses, click here.
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AccreditationDiabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*  

The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.

Medicare Caps Monthly Insulin Costs at $35

In March of this year, the Centers for Medicare and Medicaid Services (CMS) approved a $35 dollar monthly cap for Medicare Part D enrollees starting in 2021.

According to an ADA Survey, more than 1/3 of Medicare enrollees self-reported that cost limits their ability to purchase insulin.

In an attempt to make insulin more affordable for those enrolled in Medicare part D, CMS has agreed to limit the amount paid for monthly to no more than $35 per month. Insulins covered by participating plans will not be subject to the deductible or donut hole phases of Part D coverage.

Under this new option, Medicare enrollees with diabetes will pay $35 per each 30-day supply of a covered insulin prescription until they reach the catastrophic coverage phase, during which they will pay 5% co-insurance.

As beneficiaries have more consistent, predictable access to the prescription drugs they need, the model projects that health will improve and the total cost of care will decline for our nation’s senior population.

Medicare D Enrollment Cost

In exchange for these additional benefits, enhanced plans have slightly higher premiums, which are paid for by beneficiaries or through other means, such as a Medicare Advantage plan.

In 2020, average monthly premiums in Part D are $32.09 for a basic plan and $49.32 for an enhanced plan.

Affordability continues to be a barrier for people living with diabetes’ access to insulin. We hope that these changes are a step in the right direction for making insulin affordable for all.

Click ADA Website here to read more.

See CMS.gov Newsroom announcement here.


We want to hear from you!

As changes like this happen, we find that feedback from our community helps us better understand how these changes apply to real-life situations. We want to know, how have these CMS changes impacted the people you work with? Fill out our quick survey to let us know!


Insulin Cost Savings |
Resources for Diabetes Specialists

“The cost of insulin is a real problem. It can lead to insulin rationing and at its worst, people have died due to a lack of insulin,” explains Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES & ADCES 2020 Diabetes Educator of the year.

Read our article Insulin Cost Savings | Resources for Diabetes Specialists for insulin cost-saving resources.


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Metformin XR Warning due to NDMA impurity

Some brands of long acting Metformin are being recalled since they contain higher than acceptable levels of NDMA (see list below).

The U.S. Food and Drug Administration has recommended recalls of certain metformin products that may contain the impurity N-nitrosodimethylamine (NDMA) above the acceptable intake limit.

Patients taking recalled metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.

Remind patients not to stop medication until they check with their provider.

Find more info on the FDA Website here

Recalled Products

  • The agency is also asking all manufacturers of extended release versions of metformin to evaluate their risk of excessive NDMA and to test at-risk product before each batch is released onto the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer must inform the agency and should not release the batch to the U.S. market.
  • FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.

For a complete listing of diabetes medications and insulin, download our DiabetesEd Medication PocketCards


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Medication Pocketcards Update | Free Resource Friday

We have updated our Medication Pocketcards!

Our four-sided medication accordion Pocketcards were designed by Coach Beverly Thomassian to assist in clinical practice and exam preparation. One of our best sellers, the Diabetes Medication PocketCard is perfect for all Diabetes Care and Education Specialists.

New June 2020 Updates:

  • Added Trijardy (new triple combo oral medication)
  • Deleted Insulin combo Ryzodeg (not available in the U.S.)
  • Deleted oral combo med Avandamet (no longer available)
  • Deleted warning for Dapagliflozin since no longer on package insert (Do not use in pts with bladder cancer)

Included in the Pocketcards:

  • Insulin Pocket Card
    • Front side: current insulins, including action times, dosing info
    • Backside: concentrated and Inhaled insulins 
  • GLP-1 Receptor Agonists, Injectables / Insulin + GLP-1 Combo
    • Front side: GLP-1 Receptor Agonists and Injectables 
    • Backside: Injectable/Insulin Combinations 
  • Oral Diabetes Medications – Complete listing of the 4 common oral medications including dosing range and considerations.
  • Other Oral  and Combo Oral Medications   
    • Front Side: Less commonly used oral medications
    • Backside: Complete listing of all the combined oral medications including doses available

Upcoming Live Streaming Webinar
Next Webinar Airs June 25, 2020, from 11:30 am to 1:00 (PST)

Our Level 2 Standards of Care Intensive Series is designed to engage students in deciphering and exploring the ADA Standards of Care from top to bottom. This straight forward program will provide you with information you can use in your clinical setting and also provides critical content for the diabetes educator exam.

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AccreditationDiabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*  

The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.

FDA Approves Diabetes Medication for Heart Failure

The FDA approved the diabetes drug dapagliflozin (Farxiga) to treat heart failure in people with or without diabetes.

The unique function of SGLT-2 Inhibitors

This medication belongs to the SGLT-2 Inhibitors class and is referred to as a “glucoretic.” The main action is the release of glucose through the proximal tubules in the kidney. This results in loss of glucose but is also associated with diuresis and reductions in heart failure.

Three of the SGLT-2s (canagliflozin, dapagliflozin, and empagliflozin) have been recognized by the FDA to reduce not only blood glucose but also lower risk of CV death, heart failure and preserve long term kidney function. These medications also significantly reduced hospitalization for heart failure in several trials.

Dapagliflozin is the first SGLT-2 to be FDA approved to reduce the risk of cardiovascular death and hospitalization for heart failure in people with or without diabetes.

Currently available SGLT2 Inhibitors

Download PocketCards Here

Heart failure is a life-threatening disease that affects about 64 million people worldwide. Roughly half of those with heart failure suffer from reduced ejection fraction, which dapagliflozin was Farxiga approved to treat. This FDA approval may open the door for other SGLT2 Inhibitors to expand outside of diabetes.

Read more by click AstraZeneca diabetes drug gets U.S. nod to treat heart failure


Upcoming Live Streaming Webinar
Airs 11:30 am to 1:00 (PST)

Our Level 2 Standards of Care Intensive Series is designed to engage students in deciphering and exploring the ADA Standards of Care from top to bottom. This straight forward program will provide you with information you can use in your clinical setting and also provides critical content for the diabetes educator exam.

Mastery of this content is critical to ensure certification exam success and to improve clinical outcomes.


Sign up for Diabetes Blog Bytes – we post one daily Blog Byte from Monday to Friday. And of course, Tuesday is our Question of the Week. It’s Informative and FREE!  Sign up below!


AccreditationDiabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*  

The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.

Insulin Cost Savings | Resources for Diabetes Specialists

Dr. Diana Isaacs

Written by Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES & ADCES 2020 Diabetes Educator of the year

The cost of insulin is a real problem. It can lead to insulin rationing and at its worst, people have died due to a lack of insulin.

A recent survey reported that 26% of respondents living in the US rationed insulin at last once in the last year.

The retail price for a box of insulin pens is about $500. Many people need more than one box of pens per month. Even with health insurance, people struggle to afford this. I remember one of my patients telling me she was only taking half of her prescribed dose of insulin glargine because her daughter was taking the same insulin and they both needed it. This just broke my heart!

Fortunately, the Food and Drug Administration (FDA), as well as drug companies, have heard the outcries from people who require insulin to live. In response, there are some helpful new programs that make insulin more affordable. However, it can be difficult to navigate all of the new information. To help make navigation easier, we have created an Insulin Cost-Savings Resource Guide.

Here is a list of different strategies to access affordable insulin.

Why is insulin so expensive?

Insulin Patent was sold for $1 in 1923 to ensure affordability

Insulin is considered a Biologic Drug, which makes it more expensive to produce.

Insulin is made from recombinant DNA technology, making it a biologic drug. Biologic drugs depend on unique manufacturing conditions that are proprietary and difficult to exactly replicate. Therefore, when the drug brand name patent expires, other companies can’t make true generics.

Until recently, the pathway for approval was called a follow-on biologic. This is how Basaglar (insulin glargine) and Admelog (insulin lispro) are classified. In March 2020, the FDA announced that regulatory requirements would change allowing for biosimilar products. This may ultimately increase market competitiveness in hopes to further reduce insulin prices. Basaglar and Admelog offer about a 15-20% discount from their reference products of Lantus and Humalog, respectively. Many argue these cost savings is just not enough.

Generic Insulins

Because insulin is a biologic drug, a true generic must come from the same manufacturer. Recently Lilly and Novo Nordisk have created generic insulins.

Lilly offers generics of insulin lispro, insulin lispro mix 75/25, and insulin lispro junior kwik pen.

Novo Nordisk offers generics of their insulin, which they are calling a “follow on Brand” and includes insulin apart and insulin aspart mix 70/30.

Both Lilly and Novo offer approximately a 50% cost savings from the original insulin product and the pharmacist can make an automatic substitution if you ask.

Walmart and some other pharmacies also offer ReliOn insulins. These include Novolin R, Novolin N, and Novolin 70/30. These are slower acting insulins that may predispose people to more hypoglycemia, but they are only $25/vial or $44/5 pack of pens and do not require a prescription in most states. Access to these insulins can be truly life-saving in some circumstances. Every person with diabetes needs to be aware that they can purchase these insulins without a prescription if they are ever out of insulin.

New Programs that Cap Insulin Pricing

Lilly announced a program capping insulin co-pays at $35/month for those paying with cash or commercial insurance. This will dramatically lower monthly costs for many people with diabetes.

Sanofi has a Valyou program that allows up to 10 vials or 10 boxes of insulin pens for a maximum of $99/month. Of note, Sanofi’s program will only work for those without insurance.

Novo Nordisk recently started the My $99 insulin program. What’s unique about this program is that it will work for those with commercial insurance or government plans like Medicare. Most other programs exclude people with Medicare. This program covers up to 3 vials or 2 packs of pens.

Co-Pay Cards

Most insulins offer a co-pay card which can bring down the price of insulin most commonly to $0 to $25/month depending on the manufacturer and type of insulin. For any person with a commercial insurance plan, it’s good to check if a co-pay card is available for the insulin before picking it up from the pharmacy.

The things to be aware of about these cards are that they have maximum savings and sometimes that is much less than the total cost of the insulin. Also, they only work for people with commercial insurance meaning they won’t for people without health insurance or that have a government insurance plan like Medicare. They also do not always work if the drug is not covered on the insurance plan. In that case, it would be preferable to switch to an insurance-covered on the insurance plan.

Patient Assistance Plans

These are programs offered through pharmaceutical companies for people without health insurance or that have Medicare but still struggle to pay for medications. There are various income requirements to be eligible, but depending on the program it can be 250-400% above the Federal poverty line. Many people are surprised to find that they are eligible, so this is a good option to look into which can make the insulin completely free. There is typically a packet of information that needs to be completed and then if eligible, the insulin is shipped to the prescriber’s office for the patient to pick up.


In summary, It can be challenging to keep all of this information straight. This is why I worked with a team of amazing diabetes care and education specialists at ADCES to create the Insulin Cost-Savings Resource Guide. We update this resource frequently and it includes links to patient assistance programs, co-pay cards, and other cost savings programs. We hope you find it useful and that your patients with diabetes will benefit.

Special thanks to our guest contributor for this article: Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES & ADCES 2020 Diabetes Educator of the year

References:

Conner F, Pfiester E, Elliott J, Slama-Chaudhry A. Unaffordable insulin: patients pay the price. The Lancet Diabetes & Endocrinology 7 (10), 748,2019.

For a summary of all this information, see the ADCES Insulin Cost Savings Resources Page.


Virtual Course Insulin Therapy, Pumps, & CGM + CV Risk Reduction Strategies
Earn 4.0 CEs | $69

Join Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES, and ADCES 2020 Diabetes Educator of the year as she reviews these important topics. As Diabetes Specialists, we are tasked with taking a leadership role in technology and cardiovascular risk reduction. Dr. Isaacs will address these topics with clinical insight and expert knowledge during these two virtual courses.

Session 1 | CV Risk Management with Pharmacology and Intensive Insulin Therapy | Recorded & Ready for Viewing!

Session 2 | Continuous Glucose Monitoring and Insulin Pump Therapy | Recorded & Ready for Viewing!

Objectives:

  1. Describe critical teaching content before starting insulin pump therapy.
  2. Describe appropriate candidates for insulin pump therapy.
  3. Discuss strategies to determine and fine-tune insulin pump basal rates.
  4. Discuss how to determine and fine-tune bolus rates including coverage for carbs and hyperglycemia.
  5. State important safety measures to prevent hyperglycemic crises.
  6. List inpatient considerations for insulin pump therapy and CGMs.
  7. Discuss features of available professional and personal CGMs and insulin pumps.
  8. Describe CV risk factors associated with diabetes and future event prediction.
  9. List different pharmacologic approaches to mitigate CV events.

$69 | Earn 4 CEs

These sessions are also included in our Virtual Conference.


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AccreditationDiabetes Education Services is an approved provider by the California Board of Registered Nursing, Provider 12640, and Commission on Dietetic Registration (CDR), Provider DI002. Since these programs are approved by the CDR it satisfies the CE requirements for the CDCES regardless of your profession.*  

The use of DES products does not guarantee the successful passage of the CDCES exam. CBDCE does not endorse any preparatory or review materials for the CDCES exam, except for those published by CBDCE.

New Triple Combo Pill for Type 2 Diabetes

The FDA made history last month by approving the first-ever triple combination pill for type 2 diabetes. This medication can help simplify the medication regimen for people living with type 2 diabetes.

As the director of the diabetes research unit at the University of Texas Health Science Center at San Antonio, Ralph A. DeFronzo, MD, said, “Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment.”

Known as Trijardy XR, this medication combines the SGLT2 inhibitor empagliflozin, the DPP-IV inhibitor linagliptin, and metformin extended-release. Both empagliflozin and linagliptin lower blood glucose and empagliflozin has the added benefit of reducing the risk of cardiovascular death and chronic heart failure for those living with cardiovascular disease or chronic heart failure.

Additionally, a trial that was presented at the American Diabetes Association (ADA) Scientific Sessions by Healio found that linagliptin will not increase the risk for a cardiovascular event, nor will it contribute to the progression of renal disease among people with type 2 diabetes. This trial, known as the CARMELINA trial, was conducted over six years, across a group of 6,000 people. The trial demonstrated that no “between-group differences for the incidence of nonfatal myocardial infarction, nonfatal stroke and CV death during a median of 6 years.”

  • Trijardy XR will be available in four dosages:
  • 5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin ER
  • 10 mg empagliflozin/5 mg linagliptin/1,000 mg metformin ER
  • 12.5 mg empagliflozin/2.5 mg linagliptin/1,000 mg metformin ER
  • 25 mg empagliflozin/5 mg linagliptin/1,000 mg metformin ER.

There is no information on pricing as of yet. Read more about Trijardy here.

Sign up for Diabetes Blog Bytes – we post one daily Blog Byte from Monday to Friday. And of course, Tuesday is our Question of the Week. It’s Informative and FREE!  Sign up below!

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