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.
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#FDA #insulin #pen
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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)
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 Program
Covered Insulin
General Eligibility
COVID Specific
Proof income
To obtain application
Lilly Cares
Humalog, Basaglar, Humulin, Humalog Mix
Must not have prescription coverage, or has Medicare Part D; must be meet total household guidelines
Must 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.
Must 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 Level
So what copay card programs are available (note: COVID has led to changes in copay card programs — positive change)
Copay Card Program
Covered insulin
Amount of insulin
Who is eligible
To 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 neeed
Those 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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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.
Exciting technology news to share…as is often the case, diabetes technology is approved in Europe before being approved in the U.S. FreeStyle Libre 3 has been cleared in Europe for those four years of age and older. My favorite aspects of this newer version are NO scanning and much smaller size. So FreeStyle Libre 3 is truly a real time CGM (on demand). It will be a bit of time before U.S. approval however we know it is on the horizon. Now, on a side note, we must continue our advocacy effects for access to technology for persons with diabetes.
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#Libre #CGM #realtime #diabetes
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A novel once weekly insulin, insulin icodec, (an experimental basal insulin analogue) was found to be as safe and effective as once daily insulin glargine in a Phase 2 trial. No study participants had previously received long term insulin treatment. The 250 study participants were on metformin with or without a DPP-IV inhibitor, and with hemoglobin A1c (A1c) above 7%. A similar drop in A1c was seen in both groups as well as both groups had low incidence of clinically significant or severe hypoglycemia. To learn more, please click below.
Empagliflozin, Jardiance, has been fast tracked by FDA for reducing death and preventing hospitalization for heart failure in adults with or without diabetes with a previous heart attack.
Empaglifozin trial, EMPACT-MI study, is studying the effect of the drug on all cause mortality (death) and hospitalization for heart failure in adults with or without the diabetes who had a heart attack or history of chronic heart failure. This study is part of a large program, EMPOWEER clinical program, which is studying the impact of empagliflozin on the spectrum of cardiac (heart), renal (kidneys), and metabolic (i.e. diabetes) conditions. This makes perfect sense as diabetes does not occur in a silo but rather with heart, kidney and other metabolic conditions.
The $35 Lilly insulin copay card program introduced a few months ago after COVID began is being extended. What makes this card different? It provides $35 copay for insulin for persons without health insurance or with commercial insurance (state or federal heath insurance programs are not included in this copay program). The program covers most Lilly insulin products and all insulin lispro (Humalog) U-100 formulations. Please click below for more information.
FDA has approved higher doses (3 mg and 4.5 mg) of dulaglutide based on data from the AWARD-11 trial. So what does this mean for the person with diabetes? We now have additional dosing options for dulaglutide which provide greater reduction in hemoglobin A1c and weight. My only potential concern is increased incidence of nausea with these higher doses. These new doses of dulaglutide will be available in pharmacies later this month. For more details, please see the two links below.
I absolutely love diabetes technology and feel strongly that all persons with diabetes should have access CGM as well as when on basal bolus insulin regimen access to insulin pump. Some good news this week with regards to a new system, and expanded indication and coverage.
MiniMed 770G system, Medtronic’s latest hybrid closed loop system is now FDA approved for ages 2 and older.
2. FDA has expanded age indication for Freestyle Libre 2 as the system is now approved for ages 4 and older.
3. Medicare has expanded coverage for Freestyle Libre 2, an integrated CGM system. For more details, please click below.
I love using technology particularly CGMs as it provides insight for both the person with diabetes and healthcare professional on the patterns in the glucose and assessing the factors (there are SO many!!) that impact the glucose. Unfortunately, not all persons with diabetes have access to personal CGM at this time. An alternative that I have found to be very helpful is the professional CGM. So what is the professional CGM?
I have found the professional CGM to be particularly helpful for persons with diabetes who do not currently have personal CGM and would like to have more insight into their glucose patterns.
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#diabetes #professional #CGM
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