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

Can You Manage Diabetes Well Without Lots of Money?

If you live in a country like the United States, where the majority of health insurance is privatized and there is no strong social safety net, it can feel as though managing a chronic disease like diabetes requires nothing but lots of money. And it does. As of 2017, diabetes cost the United States a staggering $327 billion dollars per year on direct health care costs, and people with diabetes average 2.3x higher health care costs per year than people living without the disease.

Diabetes is also devastatingly expensive personally: the cost of insulin has risen over 1200% in the past few decades, with no change to the chemical formula. In 1996, when Eli Lilly’s Humalog was first released, the price for a vial of insulin was $21. In 2019, that same vial costs around $275. Studies show that 1 in 4 people ration insulin simply due to cost. Diabetes Daily recently conducted a survey study, with almost 2,000 participants, of which an overwhelming 44% reported  struggling to afford their insulin.

So where does this leave patients who don’t have tons of money to spend on insulin and supplies, or who don’t have adequate health insurance coverage for the technology to help prevent complications? Can you manage diabetes well without lots of money? The short answer is yes. The long answer is a bit more complicated.

Best Practices for Managing with Less

If you have insurance coverage, but are unable to afford a continuous glucose monitor (CGM) or insulin pump, it’s advisable to follow best practices for optimal diabetes management. According to the Mayo Clinic, one should test their blood sugar:

  • Upon waking
  • Before meals and snacks
  • Before and after exercise
  • Before bed
  • More often during illness
  • More often when traveling or changing a daily routine
  • More often if on a new medication

One study has even shown that following a lower carbohydrate diet can improve health outcomes, reduce complications, and cut down on medication costs for people living with diabetes.

The study goes on to say that, “…insulin dependent diabetics can expect to half or third their insulin requirements. Less insulin injected results in more predictable blood sugars and less hypoglycemia.” However, no patient should ever feel pressured to follow a low carbohydrate diet solely to control the cost of their medications. There can be more effective ways to manage the cost of medications and supplies.

Photo credit: Adobe Stock

No Matter What You Think, Get Coverage

People with diabetes need health insurance coverage. In the short term, this makes sense, as insulin and things like insulin pumps, continuous glucose monitors, syringes, and test strips are expensive. But it also makes sense long term as well. People with diabetes can face serious complications as they age: diabetes is the leading cause of adult blindness and amputations, and is a leading cause of stroke, kidney failure, heart disease and premature death in its sufferers. Having health insurance helps pay for things like surgery, preventive screenings, doctors’ appointments and follow-up care, and any additional medicine and needs that’s needed.

It may seem cheaper to forego coverage, but don’t. Check to see if you’re eligible for Medicaid in your state. If you are, this comprehensive coverage will help you access affordable medication, doctors’ visits, emergency and preventive care. If Medicaid is not an option, see if you qualify for a tax subsidy on the federal or your state’s health exchange. There, you can find a range of affordable options that will cover your diabetes care and (especially) insulin prescriptions.

Get Help Paying for Insulin

Even if you have health insurance coverage, the cost of your insulin may be prohibitively high. According to the CDC, between 2007 and 2017, the percentage of adults aged 18-64 enrolled in a high deductible health plan rose from 10.6% to 24.5%. These plans have a high dollar amount that consumers must meet before their plan kicks in to help pay for things like prescriptions or hospital stays. Some high deductible health plans have deductibles as high as $10,000. This means that someone with diabetes could potentially pay the full $275 a vial for their insulin, every time they fill their prescription, until they reach their $10,000 deductible. These types of plans are cheaper monthly (have lower premiums), but don’t offer great coverage.

If you need help paying for your insulin, you can get low cost insulin through these assistance programs:

  • Eli Lilly’s $35 Co-Pay Program: Launched in early April in response to the COVID-19 crisis, Eli Lilly is introducing their Lilly Insulin Value Program, which allows anyone with commercial insurance and anyone without insurance to fill their monthly prescriptions of insulin for $35.
  • Novo Nordisk: Novo Nordisk has recently launched a $99 program, where people needing insulin assistance can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens or any combination of insulins from Novo Nordisk Inc. for $99.
  • Sanofi: Launched in 2019, Sanofi’s program allows people living with diabetes in the United States to pay $99 for their Sanofi insulins (with a valid prescription), for up to 10 boxes of pens and/or 10 mL vials per month.
  • Medicare: Medicare recently unveiled a pilot program that would cap the cost of insulin. The Medicare Part D Senior Savings Model would cap insulin co-payments to $35 per month, starting in January 2021. Seniors must sign up for a plan that will qualify under the pilot during the open enrollment period, which is October 15 through December 7.
  • Buy a State-Regulated Health Plan: If you live in Colorado ($100 per prescription per month), Illinois ($100 per 30 day supply), Delaware ($100 per 30 day supply), New York ($100 per 30 day supply), Utah ($30 per 30 day supply), West Virginia ($100 per 30 day supply), Maine ($35 per 30 day supply), New Mexico ($25 per 30 day supply), Virginia ($50 per 30 day supply), Washington ($100 per 30 day supply), or New Hampshire ($30 per 30 day supply) and you buy a state-regulated health plan, you are eligible for a copayment cap on insulin (implementation dates pending, but Colorado was the first bill to be implemented and it went into effect January 1st, 2020).

Check the fine print of any health insurance plans on the federal or your state’s exchange to see if they are eligible for the copayment cap. More states are introducing legislation in 2021, so keep an eye out for a bill proposing some similar changes in your state!

Get Help Paying for Supplies

Several companies have launched affordability programs in response to the COVID-19 pandemic. A few new programs are:

  • Dexcom: Is offering up to two shipments of 90-days of Dexcom G6 Continuous Glucose Monitoring System supplies, with each shipment consisting of one transmitter and three boxes of three sensors for $45 per 90-day supply shipment. For existing customers only, if you qualify.
  • Omnipod: Is offering a six-month supply of products (60 pods) free of charge. The program is focused on current US customers who have lost jobs and health insurance as a result of the pandemic.
  • One Drop: This online subscription package charges the consumer a monthly fee, and you get access to cheaper test strips, online personal health coaching, and a mobile app to track your progress. If your health insurance doesn’t adequately cover test strips, this can be an affordable and effective way to go.
diabetes advocacy

Photo credit: T1International Instagram

Advocate for Change

If you see or are experiencing injustice, you should always try and advocate for change. This means writing letters to your elected officials, calling your members of Congress, petitioning your health insurer, testifying for bills that support better health care coverage, and raising your voice to improve policies that will benefit all people living with diabetes. Get involved in the diabetes online community on Facebook or Twitter. Sign up to become an advocate with T1International. Donate to your favorite diabetes charity who’s working to make things better.

Show up at your state capitol and talk to people about what it’s like to live with diabetes, how expensive it is, and how crucial good coverage and affordable medications really are. You can live a great life with diabetes, but coverage, laws, regulations, and policies can always be better. And things won’t improve until we have everyone at the table, advocating for change.

How are you able to manage well with less to spend? What policies or changes would you like to see in the US healthcare system that would make management easier for you? Share this post and your story, below!

Source: diabetesdaily.com

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