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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Friday’s Daily Piece: Lilly and Yposmed Collaboration Advances Automated Insulin Delivery

We currently have great options for automated insulin delivery with the Medtronic, Tandem and Omnipod insulin pumps. Another option for patients is on the horizon as Lilly and Ypsomed collaborate in an automated insulin delivery system. Currrently, Ypsomed has the mylife YpsoPump, an automated insulin delivery device, which is available in Europe. The unique features of this pump are its small size and icon based touch screen. Ypsomed is developing a version of the mylife YpsoPump for the U.S. with plans to submit for FDA approval in 2022. Once FDA approval is given, Lilly with commercialize the insulin pump in the U.S.

mylife YpsoPump insulin pump - mylife Diabetescare – International
mylife YpsoPump insulin pump - mylife Diabetescare – International

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#diabetes #insulin #delivery

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Saturday’s Daily Piece: Updated Guidelines for Diabetes Management in Chronic Kidney Disease

The Kidney Disease: Improving Global Outcomes (KDIGO) organization has released new guidelines for management of diabetes in chronic kidney disease. These guidelines take a multidisciplinary approach. Below are a few medication highlights of the 12 recommendations as well as a link with all of the recommendations.

  1. Treatment with an angiotension-converting enzyme inhibitor (ACEI) or angiotension II receptor blocker (ARB) to be initiated in person with diabetes, hypertension and albuminuria, and titrate to highest approved dose that is tolerated.
  2. Advising persons with diabetes who use tobacco to quit using tobacco products.
  3. Treating persons with type 2 diabetes, CKD and eGFR >/= 30 mL/min/1.73 m2 with metformin.
  4. Treating persons with type 2 diabetes, CKD and eGFR >/= 30 mL/min/1.73 m2 with SGLT2-inhibitor.
  5. In persons with type 2 diabetes and CKD who have not achieve their goal glycemic targets on metformin and SGLT2-inhibitor or are unable to tolerate these medications, a long acting GLP-1 receptor agonist is recommended.

https://www.acpjournals.org/doi/10.7326/M20-5938

DIABETES AND KIDNEY DISEASE – Southwest Florida's Health and Wellness  Magazine
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#diabetes #kidney #medications

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Saturday’s Daily Piece: Increasing Medicare Beneficiaries Access to CGM

Continuous glucose monitors (CGM) provide vital, timely glucose data for persons with diabetes to keep them safe from the dangers of hypo- and hyperglycemia. One group that unfortunately has had limited access to CGMs are Medicare beneficiaries with requirement that the CGM be approved as a therapeutic CGMs (can use them to make treatment decisions) plus beneficiary having to be on basal bolus insulin regimen and test four times daily. Yikes!! Such limitations which creates frustration. This week a ray of sunlight peaked through the clouds with CMS proposed changes which would increase access to CGMs for Medicare beneficiaries through providing access to all CGMs (not just therapeutic CGMs) as durable medical equipment (DME) and establish payment amounts for these items. Now if only CMS would revise rules to eliminate four times daily testing of glucose, and being on basal bolus insulin regimen requirements. Please click below for details.

https://www.cms.gov/newsroom/press-releases/new-cms-proposals-streamline-medicare-coverage-payment-and-coding-innovative-new-technologies-and

How an Amateur Race Car Driver Decided on a CGM: Diabetes Forecast®
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#CGM #Medicare #technology

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Insulin Pens: FDA vs. Reality

I am thrilled that the FDA clarified its intent (to November 2019 revisions of labelling of insulin pens) that health care professionals should dispense insulin pens to a single patient in the original sealed carton. Unfortunately, the reason insulin pens may not be dispensed to a single patient in the original sealed carton is that the pharmacy benefit managers (PBMs) penalize pharmacies for doing this. PBMs are very tricky in allowing only exactly a 30 day supply if the prescription is for a month’s supply so guess what insulin pens are taken out of their original sealed carton (box). FDA needs to instruct PBMs that they can not allow the original sealed carton(box) to be opened.

The Pros & Cons of Insulin Pens - Diabetes Insulin Type 1 Diabetes
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Sept/Oct Blog: Avenues for Insulin Access in COVID Era

Randy, a 30-year-old male, is discharged from his local hospital for diabetic ketoacidosis and a new diagnosis of type 1 diabetes. Unfortunately, Randy recently lost his health insurance and prescription drug coverage after being laid off his job due to COVID.  He goes to the local pharmacy to pick his new prescriptions for basal and bolus insulin where he is told that the cost would be $500, Randy’s eyes practically popped out of his face.  What??!! How could this be!!! Are you serious??!!  Randy is not alone as persons with diabetes on insulin therapy who have lost their jobs due to COVID will encounter a similar experience. As a pharmacist myself, I am compelled to point out it is not the pharmacist or the pharmacy’s fault for the price.

What is Randy to do? If he goes without his insulin, he will end up back at the hospital with a hyperglycemic (high glucose) emergency.  Well, avenues exist for assistance with affording insulin — while they are not perfect, they are a step in the right direction.   The three primary insulin manufacturers in the country, Lilly, Novo Nordisk and Sanofi, have patient assistance and copay card programs.  Below are the phone numbers to call to see if you qualify.

Lilly Diabetes Solution Center (1-833-808-1234)

Novo Nordisk NovoCare (1-844-668-6463)

Sanofi Patient Savings Program (1-855-984-6302)

Minnesota governor signs emergency insulin access bill

Before calling, it will be helpful to know and have written down the information required to apply.  The information is very basic: contact information, date of birth, household income, active prescription at the pharmacy, cost of insulin for a month supply, amount of deductible, method of insulin administration (vial/pen, pump, syringe), dosage, amount of insulin you have on hand, type of insurance and whether you are a U.S. resident. 

One unique program is Novo Nordisk NovoCare Immediate Supply (insulin at no cost to person with diabetes).  This program covers all NovoNordisk insulin (i.e. NovoLog, Fiasp, Levemir, Tresiba) and is designed to prevent rationing of insulin.   Person may or may not have health insurance, must have a valid prescription for covered insulin and attest to financial need.  It can only be used once in a lifetime. To obtain an immediate supply card, https://www.novocare.com/insulin/immediate-supply.html or call 1-844-668-6463.

So what programs are out there for insulin patient assistance? 

Patient Assistance ProgramCovered InsulinGeneral EligibilityCOVID SpecificProof incomeTo obtain application
Lilly CaresHumalog, Basaglar, Humulin, Humalog MixMust not have prescription coverage, or has Medicare Part D; must be meet total household guidelinesRequired1-833-808-1234 https://www.lillycares.com/lilly-cares-application  
Novo Nordisk NovoCareFiasp, Novolog, NovoRapid, Levemir, TresibaMust not have prescription coverage, or has Medicare Part D; persons who are Medcaid eligible who have applied for and been denied Medicaid; total household income must be at or below 400% of the federal poverty level Documentation showing loss of healthcare benefits (job termination notice, job status change, proof that COBRA benefits being offered); no proof income; if approved, will receive a 90-supply on insulin. NovoCare will check back with person to determine continued eligibility.Required (but NOT for those impacted by COVID-19)1-844-668-6463 https://www.novocare.com/content/dam/diabetes-patient/novocare/redesign/General/PAP-Application-EN.pdf
Sanofi Connection ProgramAdmelog, Apidra, Lantus, ToujeoMust have prescription coverage, not eligible for Medicare or Medicaid; for those enrolled in Medicare Part D, must also spend at least 2% of annual household income on prescription medication covered through Part D in the current calendar year; annual household income of >/= 400% of the current Federal Poverty LevelNot required1-855-984-6302 http://www.sanofipatientconnection.com/

So what copay card programs are available (note: COVID has led to changes in copay card programs — positive change)

Copay Card ProgramCovered insulinAmount of insulinWho is eligibleTo obtain card
 Lilly $35/month Humalog, Basaglar  Those without health insurance, and those covered by commercial/private insurance (including high deductible plans) Call Lilly Diabetes Solution Center at 1-833-8081234
 Lilly 40% discounted price through BlinkHealth   Those without health insurance, and those with high deductible plan https://www.blinkhealth.com/
 Novo Nordisk My$99Insulin Program Fiasp, NovoLog, Levemir, Tresiba Up to 3 vials or 2 packs of insulin pens, or any combinations of insulin from NovoNordisk Those without health insurance, and those covered by commercial/private insurance (including high deductible plans)Call 1-844-668-6463 or visit https://www.novocare.com/
 Sanofi ValYou Savings Program ($99/Month) Admelog, Apidra, Lantus, Toujeo Up to 10 boxes of pens or 10 vials (can be a mix of long acting and short acting as neeedThose without prescription medication insurance Call 1-855-984-6302 or visit https://www.admelog.com/insulins-valyou-savings-program?utm_source=vanityurl&utm_medium=redirect&utm_campaign=valyou  

Other options also exist including purchase human insulin (Humulin R and NPH) without a prescription from Wal-mart (Reli-On brand for $25 per vial), generic version of insulin lispro (Humalog) ($137.35/vial and $265.20 for pack of five KwikPens) and asking your providers office for samples. From experience, I would much rather a patient contact the clinic office if they need a prescription sample to help get them through as opposed to going without insulin.  This will allow the provider to help them determine the best avenue for insulin access.

Back to Randy, the pharmacist helped him get access to his basal bolus insulin through the NovoNordisk Immediate Supply program, and helped to connect him with a local indigent (safety net) clinic.  The pharmacist asked Randy to call if he needed anything or had difficulty getting connected with the indigent clinic.

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#insulin #access #COVID

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Friday’s Daily Piece: Dapagliflozin’s DAPA-CKD Results Led to FDA Breakthrough Therapy Designation for Chronic Kidney Disease

The results of the clinical trial, DAPA-CKD, which studied dapagliflozin (Farxiga) in adults with chronic kidney disease with or without type 2 diabetes on, has led the way for the FDA giving dapagliflozin breakthrough therapy designation (BTD) for adults chronic kidney disease with or without type 2 diabetes. Breakthrough therapy designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 

To learn more about the findings of DAPA-CKD and the newly earned BTD, please click on links below.

https://www.healio.com/news/endocrinology/20200924/dapackd-dapagliflozin-prolongs-survival-in-ckd-with-without-type-2-diabetes?M_BT=4557970002905

https://www.healio.com/news/endocrinology/20201002/dapagliflozin-earns-breakthrough-therapy-designation-for-ckd-with-without-type-2-diabetes?M_BT=4557970002905

4 Main Complications From Farxiga | by Terry Crane | Medium
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#CKD #diabetes #FDA #dapagliflozin

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