Saturday’s Daily Piece: Higher Dose Ozempic on the Horizon

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.

Image result for ozempic
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#FDA #diabetes #medication

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January Blog: Tips for Avoiding Medication Sticker Shock

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 drugA drug under a trademark name or specific name and is protected by a patent. For example, Lantus, Levemir (Reference: www.healthcare.gov)
Generic druga 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. 

Television Review: Sticker Shock on Discovery Channel
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Thursday’s Daily Piece: Insulin Resource – NovoCare Immediate Supply

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.

https://www.novocare.com/insulin/immediate-supply.html

Immediate Supply | NovoCare®
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#insulin #access #rationing

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Saturday’s Daily Piece: Avoiding a Surprise Increase in Copays at Pharmacy

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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Monday’s Daily Piece: Generic Glucagon Injection Kit Approved

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.

https://www.medscape.com/viewarticle/943385?nlid=138895_3901&src=wnl_newsalrt_201230_MSCPEDIT&uac=293412PG&impID=2804095&faf=1

Fresenius Kabi Introduces Glucagon Emergency Medicine Kit to Treat  Life-Threatening Episodes of Low Blood Sugar - Fresenius Kabi USA

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Monday’s Daily Piece: SGLT-2 Inhibitors Benefit in CKD

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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#SGLT2inhibitor #renal #cardiovascular #benefits

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Friday’s Daily Piece: Januvia Label Change

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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Thursday’s Daily Piece: Long, Longer, Longest: Once Weekly Insulin

Thanks to Taylor Guelda, PCOM PharmD Candidate 2021, for writing this daily piece.

Novo Nordisk created a pharmacokinetically novel long-acting insulin. Insulin icodec has a half-life of ~196 hours allowing for a once-weekly dosing strategy. When first hearing of once-weekly insulin I immediately think of how great that will be for adherence. On the flip side, I also think of the risk of hypoglycemia that could be associated with a once-weekly dosed insulin. A recently published study sought to investigate the safety and efficacy of once-weekly insulin icodec as compared with once-daily insulin glargine in insulin naïve patients with type 2 diabetes concurrently taking metformin with or without dipeptidyl peptidase 4 (DPP4) inhibitor. The results stated that the icodec group’s mean HbA1c decreased by 1.33% at week 26 and the glargine group decreased by 1.15% percentage points This was not found to be statistically significant. However, it is important to note the outcomes were not powered to detect significant differences between the groups. As far as safety, the majority of hypoglycemia with icodec was either mild (53.6% icodec vs. 37.7% glargine) or clinically significant without defined severe hypoglycemia. I definitely think more research needs to be done, but it is definitely exciting to see new potential possibilities for patients with diabetes in the pipeline.

Reference:

Rosenstock, J., Bajaj, H., Janež, A., Silver, R., Begtrup, K., Hansen, M., Jia, T. and Goldenberg, R., 2020. Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment. New England Journal of Medicine, 383(22), pp.2107-2116.

Once-weekly insulin efficacy similar to daily therapy in type 2 diabetes
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#weekly #insulin #diabetes

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Thursday’s Daily Piece: Steglatro – Last and Maybe Least

Currently, there are four SGLT-2 inhibitors on the market: Invokana, Farxiga, Jardiance and Steglatro. A lot of trials have been done surrounding this class of medications in regards to both cardiovascular and renal protection. Steglatro is what I would call the late bloomer of the group. It was the last agent to gain FDA approval as well as being last to report on cardiovascular (CV) (heart related) outcomes. Results from the VERTIS CV trial were recently published in October 2020. The VERTIS CV trial demonstrated that ertugliflozin is noninferior for reducing CV events in patients with T2DM and established ASCVD. Like it’s counterparts, Steglatro also demonstrated benefits for heart failure, although this was not tested statistically. On the other hand, no significant benefit was observed for ertugliflozin in regards to renal protection. The benefits on cardiovascular and renal outcomes don’t seem as strong compared to others in the same class. The trial still serves the purpose of confirming the important role of SGLT-2 inhibitors in treating type 2 diabetes patients with comorbid ASCVD.

Reference:

Cannon CP, Pratley R, Dagogo-Jack S, et al., for the VERTIS CV Investigators. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes. N Engl J Med 2020;383:1425-35.

Today’s daily piece is written by Taylor Guelda, PCOM SOP PharmD Candidate Class of 2021.

FDA Approves New Once-Daily Pill for Type 2 Diabetes: Steglatro | diaTribe
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#SGLT2inhibitor #diabetes #cardiovascular

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Wednesday’s Daily Piece: Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce risk of Cardiovascular event in Diabetic Kidney Disease

The aim of the SCORED trial was to assess the safety and effectiveness of sotagliflozin in reducing cardiovascular events among patients with type 2 diabetes mellitus and chronic kidney disease. Sotagliflozin is an SGLT2 inhibitor, but also inhibits SGLT1, which primarily exists in the gut and appears to delay glucose absorption. The results of this trial indicate that sotagliflozin has salutary effects on cardiovascular (heart) outcomes among patients with T2DM and CKD. The benefit was primarily in reduction of heart failure events, but there was also a reduction in cardiovascular (heart) death/MI (heart attack)/stroke, primarily due to reduction in MI (heart attack) and stroke. A reduction in renal (kideny) events was not observed, likely due to early cessation of the trial due to loss of funding.

https://www.endocrinologyadvisor.com/home/topics/diabetes/sglt2-inhibitor-sotagliflozin-cardiovascular-heart-failure-events-diabetes-ckd/?utm_source=newsletter&utm_medium=email&utm_campaign=ea-update-hay-20201201&cpn=&hmSubId=lgd8VCc5wdc1&hmEmail=6uDHAmJj0tD-ewCsWh7M6oKmz9R2geZa0&NID=&email_hash=51466cd2e70cdac06bc0cab2420cd276&mpweb=1323-113698-6605859

Today’s daily piece is written by Jipal Patel, PCOM SOP PharmD Candidate Class of 2021.

Sotagliflozin (LX4211)
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#kidney #heart #protection #diabetes

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