Semglee, A Low-Cost Basal Insulin, Comes to the US

This content originally appeared on diaTribe. Republished with permission.

By Karena Yan and Joseph Bell

A more affordable alternative to Lantus (insulin glargine) will cost $148 for five pre-filled insulin pens

Mylan and Biocon Biologics announced last month the long-awaited US launch of Semglee, a new insulin aiming to be deemed “biosimilar” to insulin glargine (basal insulin) by the FDA. A biosimilar drug is a biological product that is highly similar in structure and function to a product already approved by the FDA, known as the reference product. Semglee is said to be similar to Sanofi’s basal insulin Lantus; it has the same protein sequence and has a similar glucose-lowering effect. The FDA has yet to classify Semglee as “biosimilar” or “interchangeable” to Lantus due to the need for additional review – so for now, Semglee should be considered a new basal insulin option for people with diabetes. Semglee was previously approved in 45 countries, including Australia, Europe, Japan, and South Korea. We aren’t positive how “interchangeable” will go – would someone using Tresiba or Toujeo “next-generation basal” insulin want to go with Semglee instead? This is unlikely in our view.

Semglee is currently available by prescription in either a pen or a vial and can be used by people with type 1 or type 2 diabetes. It costs $147.98 for five 3 mL pre-filled pens or $98.65 for one 10 mL vial. Semglee is reported to be the cheapest available insulin glargine-equivalent on the market, with a 65% discount from the list price of Lantus. That calculation is a bit misleading as does not take into account discounts and rebates available with a variety of insulin brands; actual out-of-pocket costs can differ dramatically for individuals.

Happily for people who don’t qualify for patient assistance programs, Semglee represents a far more affordable option for people with type 1 and type 2 diabetes who take basal insulin. While biosimilars are usually not as inexpensive as “generic” versions of drugs, because biosimilars are more expensive to manufacture, they do provide cheaper alternatives to brand name drugs, in this case, Lantus (and Levemir, Tresiba, and Toujeo). Further, because Semglee is thought to be essentially equivalent to Lantus, it should provide an important and practical option for basal insulin users who are concerned about insulin costs and do not have a route to pay less – this is far more people than often considered.

It’s also key to note that Semglee is not technically considered a “biosimilar” drug – it is currently under FDA review to gain approval of this designation. The biosimilar designation would mean that Semglee officially has bioactivity and clinical efficacy that are not different from Lantus, but are not necessarily exactly the same. If it earns an “interchangeability” designation, pharmacists would be able to substitute Semglee for Lantus without consulting the prescribing healthcare professional. Semglee might also be substituted for Tresiba or Toujeo, two “next generation” more stable basal insulins.

Two biosimilar insulins are currently approved in the US: Basaglar, a basal insulin glargine approved in 2016, and Admelog, a rapid-acting insulin lispro approved in 2018. If Semglee gains an FDA biosimilar designation, it will become the third biosimilar insulin available in the US.

Mylan is offering a co-pay discount card and a patient assistance program to help people afford Semglee. The co-pay card is available to people with commercial health insurance – you may be able to receive up to $75 off each 30-day prescription. Learn more here. For people without prescription insurance coverage, you may be able to get Semglee for free – access the patient assistance program by calling Mylan customer service at (800)796-9526.

Source: diabetesdaily.com

How to Safely Transition to Multiple Daily Injections (MDI)

As the reality of living during a pandemic slowly starts to sink in, people are changing their expectations for what 2020 (and beyond!) looks like. Some people have delayed their weddings, or put plans for a baby on hold, and many people have lost their jobs.

In the US, where health insurance is so intimately tied to employment, which also, unfortunately, means that many people are currently without health insurance and are quickly searching for a plan that will work for them. This is infinitely more complicated when you’re living with diabetes, as health insurance is even more essential for your health and well-being, but this can also cause problems.

Coverage for diabetes supplies varies by insurance carrier. For example, many Medicaid programs across the United States do not have an adult CGM benefit, and some health insurance plans on the federal and state health exchanges will not cover the type of insulin pump you need and are used to. These transitions have many people considering a switch to MDI, or multiple daily injections. Here’s how to transition safely, if this is you.

Reasons for Switching to MDI

People may switch from their insulin pump back to multiple daily injections for any number of reasons, but some may include:

  • Needing a mental health or “tech” break
  • Diabetes burnout 
  • Not wanting pump sites and tubing during the summertime (when lots of heat, humidity, pool, and beach time can cause many headaches with sites coming out more frequently)
  • Losing health insurance, and new insurance doesn’t cover your preferred pump
  • Saving money (a 2019 study found that annual costs are ~$4,000 higher for pump therapy than for MDI therapy: $12,928 vs. $9,005, respectively)
  • Experiencing frequent pump and/or cannula malfunctions
  • Experiencing sensitive skin and adhesive issues at your pump site
  • Absorption issues with insulin pump therapy

Some people switch pretty frequently between insulin pump therapy and daily shots, while others stay strictly in one camp or the other for years, and only switch when they absolutely have to. Remember that you don’t have to justify your reasons to anyone.

Talk to Your Doctor

Once you’ve decided to switch back to MDI, you should contact your primary care physician or endocrinologist (or any other provider who you regularly see for diabetes care). They can help you develop a plan to convert your basal (pump) settings to a long acting insulin injection (Lantus, Levemir, and Tresiba are common brands). Additionally, they can help you navigate the transition for bolus doses, as well as help you figure out your insulin sensitivity and correction factors.

Stock Up on Supplies

Once you’ve spoken to your doctor (and have gotten some prescriptions for long-acting insulin), it’s time to stock up on supplies. You’ll need both short and long-acting insulins (for bolus and basal insulin replacements), syringes or pen needles, and alcohol swabs. It’s helpful to have plenty of low snacks, like juice and glucose tablets, on hand as well. A silver lining of MDI is that there are way fewer supplies you’ll need, and they cost less money.

Buckle Up for the Roller Coaster

Switching back to MDI after using an insulin pump will not be without issues. You may experience both more frequent high and low blood sugars as you navigate the transition, and figure out both how much and how frequent you need to dose insulin. Don’t be surprised if you find that you need much more insulin on injections than you needed on a pump (or vice versa). Everyone is different, and having a little patience (and plenty of low snacks handy) can go a long way.

Listen to Your Heart

It’s important to remember that people living with diabetes can have excellent control whether or not they use an insulin pump. Multiple daily injections is a form of diabetes therapy that works wonderfully for millions of people. That being said, you may have family or friends who will try and change your mind about switching back to MDI. Be let’s be clear: if you need a pump break (for ANY reason), listen to your heart. Don’t let people talk you out of it. Diabetes is for the long-haul, and sometimes taking a break (or going back to insulin injections permanently) is just what can be needed to achieve better physical and emotional health.

You Can Always Change Your Mind

Made the switch to MDI, and can’t stand it after 2 weeks? Remember, your diabetes management is just that, yours! No one will judge you if you are ready to go back on insulin pump therapy sooner than you anticipated. You are allowed to change your mind as many times as necessary to find the best therapy that will fit your lifestyle and meet your needs most effectively.

Have you made the switch to multiple daily injections from insulin pump therapy recently? How was your experience? Any advice to share? Please share your story below; we love hearing from our readers!

Source: diabetesdaily.com

Diabetes Deadliest Mistakes

Whether you are living with type 1 or type 2 diabetes, you likely take medication that helps keep you alive and functioning properly. We continually measure, count and remind ourselves to take our medication and/or insulin very meticulously to ensure we are taking the proper medication and correct doses.

But we are human, and mistakes do occur. Sometimes these mistakes can be deadly.

Recently, while mid-conversation, I managed to take 18 units of Fiasp instead of my long-lasting insulin, Tresiba. This has happened to me one time before when I was first diagnosed when I took 16 units of Humalog instead of Lantus. My endocrinologist sent me right to the hospital because at the time I was new, nervous and unable to handle it on my own. This time, the moment I released the needle from my skin my stomach dropped to my feet.

Fiasp is even faster-acting than Humalog and I knew I had minutes to ingest a whole lot of carbs to counteract the large amount of insulin I had just taken.

I managed to inhale over 200 g of carbs in 20 minutes in the midst of a mild panic attack. I was nauseous, jittery and scared for what lay ahead. The day wound up being a series of lows but I was lucky I came out of it unscathed. Had I not realized I took the wrong insulin I could have easily passed out, had a seizure or died. My original plan for the day was to kick it off with a walk to a nearby shopping center so had I not realized, my blood sugars could have plummeted and I could have been left for dead on the side of the road.

I got lucky. We all have gotten lucky. Some have not. Many of us, unfortunately, know people who have lost their lives due to a diabetes mistake; and yes, sometimes their own.

I asked our friends in the diabetes online community what their biggest and deadliest diabetes mistakes were and this is what they had to say.

“I forgot a snack after breastfeeding and had my first hypoglycemic seizure. The first reading they could get was 27.”

“I am a type 2 diabetic and sometimes get shaky and I know I need a snack. I grabbed a brownie as I left my house but I wasn’t feeling any better. I realized that I grabbed a low-carb brownie so it wasn’t going to help raise my blood sugar! I wound up having to stop for a soda.”

“I’ve mixed up my insulin before. 27 units of Humalog is much different than 27 units of Levemir!”

“In my last year before I quit drinking, there were 2 distinct times I can remember where I was so low and so drunk I couldn’t figure out how to get food to save my life. One time I had my friend help me. The other time I went back to sleep and miraculously woke up the next morning.”

“I took some expired test strips from someone in the diabetes online community. For days I kept reading really high and couldn’t understand why. Finally, I rage bolused and took a hefty correction dose. I started seeing spots and beads of sweat formulated all over my entire body. My reading was 28. Turns out those test strips were bad and I could have killed myself trying to save a couple of bucks.”

“I forgot to check my blood before I had breakfast and had a banana and shot up to 500!”

“I recently bolused for a snack twice. I was low in the middle of the night but the snack was larger than needed to fix so I did took a partial bolus and went back to sleep. I woke up and didn’t remember taking any insulin so I did it again. Rollecoasting ensued. I’ll mess up worse, I’ve only been at this for 2.5 years.”

“Bolused for 80 carbs instead of 8 before a workout without realizing it. Dexcom alerted and I quickly realized how much IOB I had. Apple juice and gels to the rescue.”

“I’m on Zyloprim for my gout and I fill my pill case once a week. I accidentally put Zolpidem in and was wondering why I kept waking up so damn tired!”

It is safe to say that managing our condition can be risky at times. We are administering medication and insulin, which can be extremely dangerous if the wrong dose is given. We must remain diligent at all times to avoid errors, all the while realizing that we are human and we do make mistakes. Have grace with yourself.

Have you ever made a dangerous mistake? Comment and share below, hopefully, we can help each other to avoid similar occurrences.

Source: diabetesdaily.com

What to Do If You Need Insulin Right Now

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

What to Do If You Have No Insulin at All

Go to the emergency room. Under US law (The Emergency Medical Treatment and Active Labor Act), the emergency room cannot turn you down in a life-threatening emergency if you do not have insurance or the ability to pay.

If Emergency Room staff is telling you they cannot treat you, stay put. Be clear that you are in a life-threatening emergency because you have type 1 diabetes (T1D) but do not have insulin. Do not leave. Please note that urgent care centers are not required to abide by the same laws.

Once you are stabilized and before you leave the hospital, hospital staff is required to meet with you to make sure you understand that you are leaving the hospital of your own accord. At this time, let the hospital staff person know about any financial situation you are in. Some hospitals are aligned with charities that can help you pay. Other hospitals offer payment plans based on your situation. No matter your financial situation, know that your life is the most important thing.

What to Do If You Have Some Insulin, But Are About to Run Out

Utilize Kevin’s Law

If you have an existing prescription at your pharmacy, but have not been able to get ahold of your healthcare provider to renew the prescription, you may be able to take advantage of Kevin’s Law. Kevin’s Law was named for a man with T1D who passed away after not being able to access his insulin prescription over the New Year’s holiday. Under the law, pharmacists are able to provide an emergency refill of insulin in certain states, without the authorization of a physician to renew the prescription. Rules around the law vary from state to state and not all states have the law in place. Kevin’s Law only applies to those who have an existing prescription and, depending on where you live, your insurance may or may not cover the refill. Learn more about Kevin’s Law, including whether or not your state has it, here. Please note, your pharmacist may not know the law by name, or know that the law exists. If you are in a state with Kevin’s Law and working with a pharmacist who is unaware, stay put and ask to speak to someone else in the pharmacy.

Ask Your Physician for Samples

While this is not a long-term access option, your care provider may be able to provide you with a few vials/pens for free, and bringing your HCP into the access conversation means that they can help direct you to other options that might be available to you, like local community health centers with insulin available.

Utilize Patient Assistance Programs – Standard out of Pocket Cost $0

  • If you take Lilly insulin (Humalog, Basaglar) call the Lilly Diabetes Solutions Call Center Helpline at 1-833-808-1234
    for personalized assistance. You may be eligible for free insulin through LillyCares.
  • If you take Novo Nordisk insulin (Fiasp, NovoLog, NovoRapid, Levemir, Tresiba) and demonstrate immediate need or risk of rationing, you can receive a free, one-time, immediate supply of up to three vials or two packs of pens by calling 844-NOVO4ME (844-668-6463) or by visiting NovoCare.com
  • If you take Sanofi insulin (Admelog, Lantus, Toujeo): the Patient Connection Program provides Sanofi insulins to those who qualify, which is limited to those with no private insurance and who do not qualify for federal insurance programs and who are at or below 250% of the federal poverty level – with a few exceptions.

Utilize CoPay Cards – Standard out of Pocket Cost $35 – $99 per Month

Copay cards that reduce the out-of-pocket cost you pay at the pharmacy exist for most types of insulin. Some copay cards can be emailed to you within 24 hours. Currently, copay programs exist for:

  • Lilly, capping copays at $35 per month for those with no insurance or with commercial insurance
  • Novo Nordisk, capping copays at $99 for those with no insurance or with commercial insurance
  • Sanofi, capping copays at $99 for those without prescription medication insurance
  • Mannkind, capping copays at $15 for some of those with commercial insurance

Unfortunately, copay cards are typically not available for those insured through Medicaid or Medicare. Use the tool from the Partnership for Prescription Assistance to search in one place for discount programs and copay cards you qualify for here. Please be aware that you will need to search by brand name (i.e. Humalog, Novolog), not just “insulin.”

Get R & NPH Human Insulins – Standard out of Pocket Cost $25-$40 per Vial

R (Regular) and N (NPH) human insulins are available over-the-counter in 49 states and cost much less ($25-$40 per vial at Walmart) than analog insulins such Novolog, Humalog, Lantus, or Basaglar. They also work differently than analog insulins – they start working and peak at different times – but in an emergency situation can be a resource. Speak with the pharmacist or your healthcare provider if possible before changing your regimen and keep a very close eye on your blood sugar levels while using R & N insulin.

Research Available Biosimilar (Generic) Insulins

The biosimilar insulin market is changing rapidly as the FDA adopts new regulatory pathways to more efficiently approve interchangeable insulins that may be available for a lower price. Ask your healthcare provider for the most up-to-date options for you. A few options available are:

  • A generic version of Humalog — Insulin Lispro — is available at pharmacies in the U.S. for $137.35 per vial and $265.20 for a package of five KwikPens (50% the price of Humalog.) If you have a prescription for Humalog, you do not need an additional prescription for Lispro; your pharmacist will be able to substitute the cheaper option. Insulin Lispro is not currently covered by insurance.
  • Authorized generic versions of NovoLog and NovoLog Mix at 50% list price are stocked at the wholesaler level. People can order them at the pharmacy and they’ll be available for pick up in 1-3 business days

If you have enough insulin to last you a few days, but need to figure out where to get a more reliable, consistent supply, visit our Get Insulin page to find further resources.

Source: diabetesdaily.com

Diabetes Love Letter: From Briana to Husband

By Briana Payne

Dear Aaron,

You are my husband, best friend, father to our children, and partner in crime. You were there in the instacare clinic on a Sunday morning April 24, 2016, when I got the dreaded diagnosis of diabetes. We later confirmed the following week that it was type 1 diabetes because I had the antibodies present that come with type 1. I walked into an instacare clinic confused why I was urinating so much, and found out it was sugar in my urine that was dumping out of my system, since I was dealing with undiagnosed diabetes. We thought it was a simple UTI that I could fix, and quickly found out it was a lifetime autoimmune disease.

Photo credit: Briana Payne

When I first got diagnosed, you were the one giving me my Levemir injections. Nine months into the diagnosis, I gave a continuous glucose monitor a chance. You helped me to put it on my body, especially in harder to reach places, like the back of my arm, or near my backside. You’ve always been patient with me and figuring out my diabetes with the technology, injections, cost of insulin, glucometers, diabetes appointments, etc.

Aaron, thank you for your sacrifices finding a job that will provide good insurance for me to switch to when I turn 26 in April 2020. You went out of your way to get a better insurance plan that will make your paychecks a little bit smaller, because you want to be able to afford our healthcare costs the best way.

Photo credit: Briana Payne

This disease is not pretty, nor is it cheap. I’ve dealt with some high and low blood sugars that have affected me, and you have been patient with me through it all. There are times to this day that I still feel guilty that I got this autoimmune disease six weeks after we got married. You could have left me after discovering that your new wife had a new chronic illness, but you didn’t. You have always been a very loyal and dedicated man — I cannot thank you enough. Amidst all of the struggles with costs and the daily to-dos is with this disease, I know we can continue to navigate this life together.

Happy Valentine’s, Aaron. Thanks for being my valentine.

Love,

Briana

Source: diabetesdaily.com

Insulin Pump Use and Exercise Strategies

This content originally appeared on Diabetes Motion. Republished with permission.Whether you have type 1 or type 2 diabetes, if you use insulin, you may choose to use a specialized insulin pump for both your basal and bolus insulin delivery (1). Pumps have a small catheter placed under your skin and are programmed to cover your […]
Source: diabetesdaily.com

Should People With Type 2 Diabetes Consider this Cheaper Insulin?

With analog insulin costing patients a great deal, should those with type 2 diabetes consider older but cheaper human insulins like R and NPH? A recent study looked at how blood sugar management was affected by this switch in older adults with type 2 diabetes. Analog insulins include brands such as Humalog, Novolog, and Apidra, […]
Source: diabetesdaily.com

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