Reece's Piece's In a Diabetes World

Contributor: Seana-Pierre Williams, PharmD Candidate 2025, PCOM Georgia Campus School of Pharmacy

Earlier this year both Dexcom and Freestyle Libre stormed the Diabetes Technology market with an upgraded continuous glucose monitor (CGM). The new Freestyle Libre 3 and Dexcom G7 continuous glucose monitors will provide a significantly smaller device size and a highly anticipated enhancement in the devices’ features to improve the patient’s overall experience. Here’s what you should know about these new and improved versions of the CGM systems. 

Dexcom G7

The G7 is approximately 60% smaller than the previous G6 model and boasts a more circular shape. The sensor and transmitter have now been combined into one disposable device. The G7 now has a reduced warm up time from two hours with the G6 to now 30 minutes with the G7. Upon completion of the warmup period, the sensor will begin automatically. The wear time of the G7 remains the same as the previous G6 model, 10 days, with one major upgrade. The G7 sensors now carry a 12- hour grace period to replace an expiring sensor and new customizable alerts along with the ability to temporarily silence alarms. The mobile app for iOS and Android users- the Dexcom CGM app for the G7 is also redesigned to provide a “Clarity Card” which is a data summary of average glucose, Glycemic Management Indicator (GMI) and Time in Range (TIR) for the past 3, 7, 14, 30, or 90 days. The Dexcom G7 sends the glucose readings approximately every five minutes to the smartphone app or a receiver. The G7 reader or the smart phone being used can receive information from 20 feet away and stores up to 24 hours of data in case the phone or receiver is out of range. Once the receiving device is back in range, the data will be transmitted. The application of the G7 remains user friendly with the presence of a button on the applicator to press down to release the sensor.

Freestyle Libre 3

The Freestyle Libre 3 now provides real-time glucose readings sent to a compatible smartphone and can now be viewed with a quick glance without the need to scan. The sensor is now comparably smaller than the Libre 2 system, measuring at approximately 21mm in diameter with a new simple one piece applicator and optional real-time glucose alarms. The Libre 3 retains the 60-minute warmup period and the sensor starts upon first scan as with the Libre 2. The wear time for the Libre 3 remains the same as the previous Libre 2 model, 14 days. The Freestyle Libre 3 now sends the glucose readings automatically to the user’s smartphone every minute and can receive information from up to 33 feet away. The sensor stores 14 days of data in case the smartphone is out of range of the sensor. The Libre 3 now carries a new, simple one-piece applicator which requires a slight push down on the applicator to insert the sensor.

Affordability and Insurance

From an affordability and insurance standpoint, both the Dexcom and Libre 3 manufacturers offer programs to allow access to their respective CGM systems. Dexcom offers the “Dexcom G7 Simple Start” program for those with commercial insurance whose insurance plans have not yet added the G7 to their coverage. Under this program, the G7 sensors can be purchased for $89 a month at local pharmacies until coverage is added. Freestyle Libre offers a “Free Trial” program for eligible individuals to receive a free voucher for a trial of the system. This free trial comes with additional resources to help the new user get off to a good start. Commercially insured patients may pay up to $75 per month (depending on an individual’a coverage plan) for the sensors and is said to be more affordable than other CGM systems. Those who have questions regarding the Libre 3 sensors or are asked to pay over $75 can contact Freestyle Libre.  For those with Medicare coverage, both Dexcom G7 and the Freestyle Libre 3 are covered for eligible persons with diabetes.

What do these updates in both CGM systems mean for the person with diabetes?

Seana-Pierre Williams offered to give an insight on how the cutting edge CGM technology has impacted her overall management of diabetes. As a person with diabetes who has struggled with type 1 Diabetes for 15 years, continuous glucose monitoring has been pivotal in managing this chronic illness. Seeing my blood glucose in real time allows for more accurate treatment decisions which I have used to improve the overall control of my diabetes. Having alerts to keep me on track offers me peace of mind especially since I live a very active lifestyle.  I can feel confident and safe that my CGM will alert me in times when I am outside of my blood glucose target ranges. Hypoglycemia is a life-threatening risk when using blood glucose lowering treatments, especially insulin since I am insulin dependent. Smaller size sensors offer me more discretion and comfort since I am constantly wearing a sensor. There is also the additional benefit of not having to finger stick unless my symptoms do not match what my CGM is displaying. Having used multiple CGM systems over the years, there are pros and cons with both Dexcom and Freestyle Libre. With the upgrades in Freestyle Libre 3 and Dexcom G7, more patients, like me, are able to manage our Diabetes with more comfort and confidence and can focus on living a normal day to day life. Once Diabetes has entered the discussion, your world is turned upside down. From lifestyle modifications to pharmacological intervention, continuous glucose monitoring is a powerful tool helping me to stay on top of things! When choosing a continuous monitor, just remember that each patient’s experience is unique. There are several patient factors that should be considered when deciding what CGM is best for you.

https://www.diabeteseducator.org/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-selection-training/dexcom-g7-libre-3-comparison

Contributor: Krishna Chavada, PharmD Candidate 2024, PCOM Georgia School of Pharmacy

Based on self-reported data, 1.3 million American adults have been diagnosed with Type 1 diabetes and use insulin. Maintaining blood glucose levels can become very difficult and it can become a burden to such patients’ lifestyle. To better manage such levels, automated insulin delivery systems were developed and have been lifesavers to persons with diabetes. Insulin pumps have become increasingly popular over time as a method to manage diabetes once placed under the skin. Throughout the day, the insulin the pump can give small doses of insulin as basal insulin, typically set up by your healthcare professional. The patient must enter in the amount of bolus, or mealtime, insulin is required based on their personal needs. The pump is typically the size of a deck of cards and typically doses are delivered more accurately with an insulin pump. Currently there are 6 insulin pumps that are recognized by the American Diabetes Association:

• Tandem T Slim X2 with Basal-IQ
• Tandem T Slim X2 with Control-IQ
• Omnipod 5
• Omnipod DASH
• Medtronic 770G/780G
• Medtronic 630G

Amongst these, you may find pumps that requires no calibrations throughout the day, such as the Omnipod 5, or insulin capacity up to 300 units, such as the Medtronic 770G/780G.

Boston University has brought a revolutionary device to the healthcare world, one that can be considered the “next-generation technology”. After completing long and successful clinical trial , the bionic pancreas, got approved for use in patients aged 6 years and older with Type 1 diabetes. It has been billed as the “first and only automated insulin-delivery system that delivers 100% of all insulin doses”. The iLet is an artificial device that can deliver personalized insulin doses every 5 minutes, dependent upon the glucose levels and the body’s reaction to previous insulin deliveries. Patients will have an easier time managing their diabetes without the stress of constantly having to calculate their insulin doses with adjustments. Patients will also be freed of having to monitor their glucose levels, optimizing their quality of life. One of the large benefits of the iLet system compared to insulin pumps is that it independently determines changes that are required for a patient in terms of basal rates, glucose correction factors, insulin correct factors, and other regimen parameters. Users must enter their body weight into the device’s software prior to initiating the regimen during the time of first use. Allowing patients to have this new level of ease in the management of Type 1 diabetes can be vital to transforming their day-to-day life. The most reported adverse effect with the use of the iLet was hyperglycemia (43%). Currently the iLet can be configured as an insulin only, glucagon only, or insulin-glucagon dual delivery system. The pocket-sized system is deemed to be a great breakthrough device. This fully automated bionic pancreas has shown improvement of HbA1c in persons with Type 1 diabetes, per the randomized, multicenter trial.

REFERENCES:

FDA Clears iLet Bionic Pancreas System for Type 1 Diabetes. www.medpagetoday.com. Published May 19, 2023. Accessed June 21, 2023. https://www.medpagetoday.com/endocrinology/type1diabetes/104599#:~:text=The%20pump%20can%20be%20configured

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FDA Clears Bionic Pancreas Developed in BU Lab for People with Type 1 Diabetes. Boston University. Published May 24, 2023. https://www.bu.edu/articles/2023/fda-clears-bionic-pancreas-for-type-1-diabetes/

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Commissioner O of the. FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery. FDA. Published May 22, 2023. Accessed June 21, 2023. https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery

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Bionic Pancreas System Safe, Cuts HbA1c in Type 1 Diabetes. www.medpagetoday.com. Published September 28, 2022. Accessed June 21, 2023. https://www.medpagetoday.com/endocrinology/type1diabetes/100956

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After the recent release of the 2023 American Diabetes Association (ADA) Standards of Care, you may be wondering whether metformin is still the one size fits all for the first line treatment of all persons with newly diagnosed type 2 diabetes. Please check on the link below to learn more. Also, if you are a primary care provider, pharmacist or pharmacy or medical learner, please submit to my YouTube channel, ReecesPiecesDiabetes.

Please follow me on Twitter (@ReecesPiecesDi), Instagram (reecespiecesdi) and You Tube (ReecesPiecesDiabetes).

As I reflect on November being National Diabetes Awareness Month, I can recall my first encounter with diabetes. I remember visiting my grandparents in Thomasville, and my grandfather would take his insulin before meals. I was rather young, curious and had really no true understanding of Diabetes!  Being inquisitive, I asked to see his diabetes medicine. In his study, he had his insulin vial and syringes sitting on top of the table. Upon seeing them, I was alarmed and scared due to my fear of my needles. I wondered how someone is able to inject themselves multiple times a day-everyday- for the rest of their life!!!

Fast forward 15 years when I began to learn about diabetes in pharmacy school – I must admit that it was much less personal and rather academic in nature (absorbing information to pass the test rather than truly understanding it).  Not until after pharmacy school did I get  up close and personal with diabetes again. I worked with a national diabetes foundation project in which I trained pharmacists to serve as diabetes coaches for employees with diabetes of a large employer in central Georgia. In this role, I also served as a diabetes coach myself. I got to know Barbara really well in this process as we were paired to work together.  We met at the local track to walk on several occasions and talk through her challenges in living with diabetes. I really began to understand what it is like to live with diabetes as I developed more of these one on one relationships and provided support.

I am like many folks who struggle with weight management and healthy eating challenges.  I have had prediabetes off and on for the last several years. My inspiration to stay on track (and get back on track at times) comes from the people with diabetes that I work with day in and day out.  I feel the pain and struggle and yet, I also bask in the joy of the achievements along the way that I experience walking side by side with each person with diabetes.  Most recently, I recall the experience of  joy as Billy lowered his hemoglobin A1c down from over 10% to 7% (a few tears were shed along the way) and an older person with diabetes finally getting the personal CGM that is compatible with their iphone. Yet, I also recall the frustration of another individual not understanding why their glucose is running 300 – 500 mg/dL after being consistently at or below 150 mg/dL (many tears were shed). My professional calling is to work alongside persons living with diabetes and educating learners about the whole person approach to managing and caring for the person living with diabetes. I honor each person living with diabetes as they face the daily challenges and victories along the way. I am inspired by each of you. 

Contributors: Alexandrea Coleman and Dion Blocker, PharmD Candidates Class of 2023, PCOM Georgia School of Pharmacy

What is diabetes? People commonly make the mistake of thinking that diabetes is only about having high blood sugar levels. Having consistently high blood sugar levels isn’t that big of a deal right? Wrong! Diabetes is a highly complicated condition. Diabetes can cause many different kinds of disturbances that affect many different organs – including the heart and kidneys. Uncontrolled diabetes is notorious for being the culprit of changes that can result in life-threatening kidney dysfunction. As you can see, protecting the kidneys should be a priority for patients with diabetes. This priority is especially important for patients who already have kidney disease. 

Don’t you wish there was a drug class that could slow down the progression of kidney disease for people with diabetes? I am way ahead of you! A class of drugs that does this already exists!

The sodium-glucose cotransporter-2 is a transporter that reabsorbs glucose and sodium in the kidneys. If this transporter is blocked, sodium and glucose are allowed to leave the kidneys in hordes; which leads to the body urinating out tons of glucose and extra water. A class of drugs was designed to target this exact action. The drugs are named the “sodium-glucose cotransporter-2 inhibitors”, or SGLT2 for short. When it comes to certain disease states, healthcare providers are always looking at a patient’s medication list to see if something they are taking is contributing to their current condition. SGLT2 is a special drug class where they actually add benefits across disease states. They are not only able to aid in the treatment of type 2 diabetes, but they have also been able to show that they can slow the progression of kidney disease in patients. They have even been shown to benefit patients that have a higher risk of having fatal heart events. 

This class of medication can provide a multitude of benefits for patients, across disease states. Prior to the release of this drug class, most diabetes therapies were targeted specifically to treat diabetes and did not add any additional benefits to other conditions the patient may currently have. In the most recent update to the ADA guidelines, you will see that patient treatment no longer goes straight to Metformin for all patients. It is actually preferred now that patients be placed on SGLT2i therapy first, if they have kidney or heart risk factors. 

Let’s meet a patient to practice and see the added benefits of SGLT2-inhibitors:

BC, a 64-year-old male, has been seen in your clinic for the treatment of his type 2 diabetes. When assessing his past medical history, you note that he also has a diagnosis of stage 3 chronic kidney disease with no other medical conditions. BC wants to discuss the medical conditions that he currently has and what he can do to improve his quality of life. He wants to get his medical conditions under control so that he can improve his life expectancy. This would be an ideal candidate for a SGLT2-inhibitor. It would not only help the patient to improve their diabetes, by increasing the amount of glucose that is being excreted in the urine, but it would also provide dual benefits and slow the progression of his current kidney disease. 

What are my options when it comes to SGLT2-inhibitors and what are the doses?

• Invokana (canagliflozin)
  • Starting dose: 100 mg once daily 
  • Maintenance dose: 300 mg once daily
    • Only titrate to this dose if the patient can tolerate the starting dose 
  • Patients with an eGFR of 45 to less than 60 mL/min/1.73m² should limit the dose to 100 mg once daily 
  • If the eGFR is less than 45 ml/min/1.73m², it is not recommended to use this medication 
• Farxiga (dapagliflozin)
  • Diabetes:
    • Starting dose: 5 mg once daily 
    • Maintenance dose: 10 mg once daily
      • Only titrate to this dose if the patient can tolerate the starting dose 
    • Not recommended for patients who have an eGFR of less than 45 mL/min/1.73m².
  • Heart failure:
    • Maintenance dose: 10 mg once daily
      • Do not need to use a starting dose 
    • No dose adjustments are needed for patients with eGFR > 30 mL/min/1.73m²
• Jardiance (empagliflozin)
  • Starting dose: 10 mg
    • May titrate up to 25 mg if the patient tolerates the starting dose 
  • Do not initiate therapy if eGFR is less than 45 mL/min/1.73m²
    • Stop therapy if eGFR is less than 45 mL/min/1.73m²
  • If a patient has a diagnosis of heart failure, therapy can be continued as long as eGFR ≥ 20 mL/min/1.73m² 
• Steglatro (ertugliflozin)
  • Starting dose: 5 mg, take in the morning and it can be taken with or without food
    • May titrate up to 15 mg, as long as the patient tolerates the starting dose 
  • Do not initiate if eGFR < 30 mL/min/1.73²
    • Not recommended for initiation in patients with eGFR 30 to 60 mL/min/1.73²   
    • Therapy should be discontinued if the patient’s eGFR is consistently between 30 to 60 mL/min/1.73²  

References: 

1. American Diabetes Association Professional Practice Committee; 11. Chronic Kidney Disease and Risk Management: Standards of Medical Care in Diabetes—2022. Diabetes Care 1 January 2022; 45 (Supplement_1): S175–S184.
2. Invokana [package insert]. Titusville, NJ: Janssen Pharmaceuticals, 2013. 
3. Farxiga [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP, 2020. 
4. Jardiance [package insert]. Indianapolis, IN: Boehringer Ingelheim Pharmaceuticals, Inc., 2016. 
5. Steglatro [package insert]. Whitehouse Station, NJ: Merck & CO., INC., 2017. 

Contributors: Yeunju Kim and Erica Wong, PharmD Candidates Class of 2023, PCOM Georgia School of Pharmacy

Sometimes when life deals you lemons, you don’t always get lemonade!  Managing your glucose levels is not always the type of daily activity that is easy to do. Bob is a 50 year old male with a past medical history of type 2 diabetes with presence of diabetes related neuropathy along with several other pain related conditions. Bob’s current medication regimen includes both basal bolus insulin regimen, as well as long-term use with opioid-pain medication and steroid injections for the treatment of pain. The increasing stress levels has contributed to a hemoglobin A1c slightly above 9%  and average daily glucose ranges from 270 mg/dL to 295 mg/dL, despite his insulin therapy.

For persons with type 2 diabetes and comorbidities that can significantly increase glucose and/or create wide variations in daily glucose levels, find themselves to be at a higher risk of diabetes-induced complications. In such persons, a continuous glucose monitoring system (CGM) is strongly preferred. CGMs, including recently FDA approved Freestyle libre 3, is typically recommended for those who have uncontrolled glucose levels, higher risk for hypoglycemia, variable deviations between discordant A1c, finger-stick readings, or suspected medication non-adherence.¹ 

Abbott’s Tiny Freestyle Libre 3 Cleared in EU. Medgadget. Mar 2020. (https://www.medgadget.com/2020/10/abbotts-tiny-freestyle-libre-3-cleared-in-europe.html)

The Freestyle Libre 3 CGM style, unlike Freestyle Libre 2, is designed to track real time glucose level automatically every minute instead of having to scan every 8 hours. Another benefit of Freestyle Libre 3 compared to other CGMs is that it is the smallest, thinnest, and most accurate 14-day continuous glucose monitoring system currently available in the market. For persons like Bob who require close monitoring of glucose to manage their type 2 diabetes, a commitment to scanning the sensor will not be an issue since Freestyle Libre 3 automatically tracks real time glucose level and shows trends using collected data. 

Comparison between Dexcom G6 vs FreeStyle Libre 2 & 3 ^2,3,4,5

Side note: Dexcom G7 is expected to be FDA approved in 2022.

References:

1. Add continuous glucose monitoring to your practice: a step-by-step guide. Aafp.org. Published March 15, 2021. Accessed June 13, 2022. https://www.aafp.org/pubs/fpm/blogs/inpractice/entry/cgm_guide.html
2. FreeStyle Libre 3 System. Freestyle.abbott. Accessed June 13, 2022. https://www.freestyle.abbott/us-en/products/freestyle-libre-3.html
3. FreeStyle Libre 2 System. Freestyle.abbott. Accessed June 13, 2022. https://www.freestyle.abbott/us-en/products/freestyle-libre-2.html
4. Dexcom. Dexcom. Accessed June 13, 2022. https://www.dexcom.com/
5. Abbott’s FreeStyle® libre 3 system receives CE Mark – features world’s smallest, thinnest sensor with best-in-class performance at the same low cost for people with diabetes. Abbott MediaRoom. Accessed June 13, 2022. https://abbott.mediaroom.com/2020-09-28-Abbotts-FreeStyle-R-Libre-3-System-Receives-CE-Mark-Features-Worlds-Smallest-Thinnest-Sensor-with-Best-in-Class-Performance-at-the-Same-Low-Cost-for-People-with-Diabetes

Contributors: Shatiya Grant and Pegah Tavana, PharmD Candidates Class of 2022, PCOM Georgia School of Pharmacy

VG, a 62-year-old female, has lived with type 2 diabetes for the past fifteen years.  She has tried numerous medications for treatment of her diabetes. VG has been frustrated that many of the medications will lower her glucose; however, they also increase her risk of having low glucose and leaves her feeling hungry.  She has struggled with achieving and maintaining a healthy weight for years, and just simply wants to find a medication that will lower her glucose and help her lose weight.  Today, she has a six month visit with her primary care provider (PCP) to check her hemoglobin A1c (A1c).  Her A1c is 9%.  Her PCP mentions a medication, semaglutide, as a possible treatment option for her diabetes, and VG is excited it comes in either a pill or injection formulations.  VG’s PCP encourages her to research this medication before committing to taking it for her diabetes.

Rybelsus® and Ozempic® are both brand names for a drug called semaglutide, both are FDA approved to control blood sugar levels in persons with type 2 diabetes; however they each have a unique form of delivery. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue which acts by activating a GLP-1 receptor that is found in the pancreas and this leads to improved insulin release. It also works on the liver by blocking release of excessive amounts of glucose and delays gastric emptying so one feels full longer, and lastly works in the hunger center in the brain to suppresses appetite. This leads to weight loss and can be seen as a favorable side effect from the drug. Additionally, semaglutide provides cardiovascular risk reduction benefits, which decreases risk of having a heart attack, stroke, and death.

Rybelsus® is a once daily pill, whereas Ozempic® is a once weekly injection, which is a longer-acting dosage form. Rybelsus® is available in 3mg, 7mg and 14mg. It is recommended to start Rybelsus® with a 3mg tablet taken once daily in the morning on an empty stomach with 4oz of water for the first 30 days and then the dose may be increased to 7mg and then again to 14mg.  Ozempic® is a prefilled single injection pen, which is administered subcutaneously into the abdomen, upper arm, or thigh. The usual starting dose is a 0.25 mg injection once a week (on the same day each week) and may need to be increased to 0.5mg after 30 days then 1mg after another 30 days depending on shared decision making of the person with diabetes and their healthcare provider. It is strongly recommended that you rotate the injection site each time and to not inject in the same spot due to fatty deposits which may not allow the drug to be absorbed as well and cause it to be less effective. If a dose is missed within 5 days, take it as soon as possible. However, if it has been longer than 5 days, skip the dose and continue the next dose as scheduled. Unused Ozempic® pens are stored in the refrigerator, but once used it can be stored at room temperature or refrigerated.

Both Rybelsus® and Ozempic® have similar side effects. Gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal pain are the most common side effects. These adverse effects appear to be dose-related which is why it is advisable to start at a lower dose so that your body can get accustomed to the drug before increasing the dose. Ozempic® is an injection so it is important to note that some people may also experience injection site reactions that include redness, swelling, itching, and stinging. This is generally no cause for concern and goes away in a few days. It is also important to be aware that these medications have been associated with acute pancreatitis and may also mask the initial signs of pancreatitis including nausea, vomiting, and abdominal pain. People who have been diagnosed with or have had a family member diagnosed with medullary thyroid carcinoma or multiple endocrine neoplasia type 2 should not use any form of semaglutide. This medication has not been studied in persons with gastroparesis. Since semaglutide delays gastric emptying, it is not recommended for persons with gastroparesis.

Semaglutide is a wonderful drug in the world of diabetes and offers many benefits to people including cardiovascular benefits, weight loss, and of course reducing blood sugar levels. Ozempic® offers the benefit of once-weekly dosing which may be a benefit for some patients. While others may lean towards Rybelsus® since they can get the same great health benefits without the need for an injection. To conclude, selection of the most appropriate formulation can be made on an individual basis to best suit their preferences and needs.

Back to VG, after she completes her thorough research, she agrees with her PCP that semaglutide would be a good option.  While talking with her PCP a couple of weeks after her office visit, VG and her PCP choose the once daily, Rybelsus®. They both feel this treatment is most ideal since VG has a needle phobia and prefers oral over injectable formulation.  VG shares her excitement with her best friend, who also has type 2 diabetes, about the oral semaglutide she is now taking  and how it has improved both her glucose values and her weight loss.  VG’s best friend decides to talk with her PCP about the possibility of semaglutide for treatment of her diabetes because she really likes the idea of a once weekly injectable formulation.

References:

Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol (2012) 8:728–42.  10.1038/nrendo.2012.140

European Medicines Agency. Ozempic® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/ozempic-epar-product-information_en.pdf (Accessed February 2, 2022)

Food and Drug Administration . Rybelsus® Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf (Accessed February 3, 2022).

Contributor: Ahmed Mawri, PharmD Candidate Class of 2022, PCOM Georgia School of Pharmacy

Biologic medications are commonly used to treat conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and many others. Biologic insulins, such as Basaglar®, are becoming more popular today and will become even more prevalent in the future for the treatment of diabetes. Previously, there were concerns with potential differences in the efficacy and safety between the biosimilar product and its reference insulin. However, after the recent FDA approval of Semglee®, a true biosimilar biologic, those concerns can be put to rest as it has been proven to be noninferior in efficacy while maintaining similar safety profiles to its reference insulin. What is even more special about Semglee®, is that it became the first interchangeable biosimilar product in the U.S. to receive FDA approval on July 28^th, 2021. 

 It is important we define the terms interchangeable and biosimilar.  

 -Biosimilar: A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from a biological product already approved by the FDA (also called the reference product). In simpler terms, you can expect the same safety and effectiveness from the biosimilar as you would the reference product  

-Interchangeable: An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The  substitution may occur at the pharmacy similar to how generic medications are substituted for brand name drugs.  

 Approval of these insulin products can provide patients with additional safe, high quality, and potentially cost-effective options for diabetes therapy. It may be difficult to differentiate a biosimilar insulin to a generic drug. Conceptually, they are very similar, but the term “generic” is used only when referring to nonbiologic/small molecule medications because they contain the exact same active ingredient as their reference drug (brand name). Whereas insulin is a large protein which cannot be precisely replicated so they do not contain the same exact active ingredient. There are even differences between the very same biosimilar medications with different lot numbers.  

How are biosimilars approved?  

FDA approval of all biologics requires thorough and exhaustive investigation to ensure safety and efficacy. The reference drug is the single biologic which is already approved by FDA.  The reference drug is what the proposed biosimilar product is compared to. The goal of developing a biosimilar product is to provide data comparing the proposed biosimilar to its FDA approved reference product to demonstrate biosimilarity. Instead of generating the same full profile of nonclinical and clinical data as the reference drug, the manufacturer must only show that the proposed biosimilar product is highly similar to, and has no clinically meaningful differences from the FDA approved reference product.  

 This is done by including data from analytical studies, animal studies, and clinical studies.

 -Analytical studies demonstrate that the biological product is highly similar to

the reference product by providing chemical information about the biologic’s

purities, contaminants, and quality.

 -Animal studies help assess toxicity of the proposed biosimilar product 

- A clinical study or studies sufficient to demonstrate safety, purity, and potency of the proposed biosimilar product in one or more of the indications for which the reference product is licensed. This typically includes assessing immunogenicity, pharmacokinetics, and, in some cases, pharmacodynamics and may also include a comparative clinical study. 

In March 2010, Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which created an expedited route for approval of biosimilars to provide the public with more access to safe and effective biologic products. The expedited pathway provides more treatment options potentially reducing drug costs through competition. The abbreviated licensure pathway does not mean that the biosimilar product is held to a lower standard. The data required for approval of a biosimilar or interchangeable product is extensive.  If a biosimilar manufacturer can demonstrate that its product is biosimilar to the reference product, then it is scientifically justified to rely on existing scientific knowledge about the safety and effectiveness of the reference product to support approval. This allows for a potentially shorter and less costly drug development program for a biosimilar.  

 Biosimilar insulins provide us with additional safe, high-quality options for treatment of diabetes. The abbreviated licensure pathway allows for faster access to these medications and allows for competition among the manufacturing of these drugs which could lead to more cost-effective options.  

References

Blevins, TC, Barve, A, Sun, B, et al. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study. Diabetes Obes Metab. 2019; 21: 129– 135.  https://doi.org/10.1111/dom.13495  

Kim AP, Bindler RJ. The Future of Biosimilar Insulins. Diabetes Spectr. 2016;29(3):161-166.  doi:10.2337/diaspect.29.3.161  

Center for Drug Evaluation and Research. Biosimilar development, review, and approval.U.S. Food and Drug Administration, https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval.  Published October 20, 2017. Accessed October 28, 2021.

Special thanks to Joanna Ho, PharmD Candidate Class of 2022 PCOM Georgia SOP, for reviewing blog

To learn some create tips on how to pay for and manage diabetes treatment, please click on the link below for an article in Money Greek.

https://www.moneygeek.com/insurance/health/paying-for-and-managing-diabetes-treatment/#expert=sara-mandy-reece

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The annual time for selecting a Medicare Part D plan for 2022 has arrived. If you or a family member are Medicare eligible and on insulin therapy, please make sure to select a Part D program that has Senior Savings Model for insulin (or has a insulin savings model). Also, make sure to select enrollment in the Senior Savings Model once you enroll in the Medicare Part D plan with Senior Savings Model. This model will provide for reduced monthly costs for insulin. Please click on the link below to learn more.

https://www.medicare.gov/drug-coverage-part-d/what-medicare-part-d-drug-plans-cover

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