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

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

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