The Patient’s Bottom Line: Human Insulin is Not the Answer
Editor’s Note: People who take insulin require consistently affordable and predictable sources of insulin at all times. If you or a loved one are struggling to afford or access insulin, click here.
The Insulin Access Affordability Working Group convened by the American Diabetes Association published its Conclusions and Recommendations this month. While it is critical that there be peer-reviewed literature on the insulin access crisis we’re facing in the United States, I was shocked to find passages suggesting that human insulins like R and NPH might be part of a solution.
Before we unpack that, I want to acknowledge that this publication is important in the diabetes space. It encapsulates years of opinions, research, and stakeholder positions on the issue of insulin pricing. It provides an up-to-date look at the insulin supply chain and pricing and gives everyone working on this issue a document that is current, comprehensive, and peer-reviewed to point to. One major takeaway? Insulin is too expensive, and the increased costs are hurting people with diabetes – especially the uninsured or low income. This is something we obviously agree on.
But something else is happening in this piece, something that warrants all of our attention. Multiple times, the ADA publication makes implications about older and cheaper human insulin as a treatment option for people with diabetes. This opens the door for health insurance coverage decisions that could move the diabetes community backwards in access to the modern insulins that are the current standard of care.
This publication, a product of the American Diabetes Association, fails to protect or advocate for patients on this issue and is a massive, and frankly surprising, departure from previous statements from the ADA on the importance of modern analog insulin.
Insulin Type Breakdown
“Human insulin” refers to older insulins, specifically R and NPH, originally produced for sale in the 1980s. Before that, insulin was isolated from animals. “Human Insulin” was the first product created using bacteria and human DNA to manufacture human insulin in labs.
Human insulins include:
- R or “regular”: a short-acting insulin used at meal times. R insulin levels peak after about 90 minutes and stop working after 4 to 6 hours. Used for mealtimes and corrections on a human insulin regimen.
- N or NPH: also technically categorized as “short-acting”, but longer-acting than R or Regular. NPH insulin begins working after 1 to 3 hours and peaks between 6 and 8 hours. It continues working for up to 24 hours. When using human insulin, NPH is used to provide baseline insulin.
More recently, insulin analogs have been developed to better mimic the body’s metabolism.
Analog insulins include:
- Rapid-acting insulins (like Humalog or Novolog) taken at mealtimes to cover food and long-acting basal insulin. These peak after 40-50 min and last in the body for 3-5 hours.
- Long-acting insulins (Lantus, Basaglar, Toujeo, Levemir or even longer acting Triseba) which last 24 hours or more and provide a baseline without noticeable, disruptive peaks throughout the day.
- “Fast-acting” insulins – an emerging market including Fiasp and Afrezza providing options that are active in the body even more quickly than “rapid-acting” Humalog or Novolog. These insulins were not mentioned in the ADA report, but represent the latest in analog insulin innovation.
Human and Analog Insulins Are Not Interchangeable
Analog insulins are the current standard of care for people living with Type 1 diabetes. More than two thirds of people taking insulin (both Type 1 and Type 2) in “high-income” countries are using analog insulin today. Analog insulins have gained popularity as widely-recognized safer medications that allow for improved quality of life. In fact, a 2014 ADA publication states that analog insulin provides a decreased risk of hypoglycemia (especially at night), less weight gain in patients, increased flexibility for food and daily schedules, and overall better quality of life when compared to human insulin.
In emergency circumstances (like a sudden loss of employment or health insurance) people in the diabetes community should know that R and NPH insulin exist with a lower price tag. Walmart carries ReliOn brand human insulin – R, N, and a 70/30 combination that are available without a prescription in most states for as little as $25. Human insulins are far better than no insulin.
Yet you would be hard pressed to find an individual in the Type 1 diabetes community who would agree that an R and NPH regimen of the 80s and 90s is preferable or even comparable to the improvements provided by modern analog insulin.
Dosing for meals is much more difficult using a “short-acting” regular human insulin because it does not peak until 90 minutes after injection – taking the pre-bolus to a whole new level. A steady basal rate is also not possible with NPH as your only tool – requiring specifically timed meals every day and risking lows at the times the insulin is peaking. Human insulin types are not short acting enough to efficiently cover meals and correct highs, and not long-acting enough to provide a stable basal rate.
Furthermore, while R insulin has been used in pumps in the past, many pumps used by patients today are not approved for use with anything except rapid-acting analog insulins (like Humalog or Novolog). Insulin pump therapy is not discussed in the ADA report’s access considerations.
The ADA recommendations are based on studies that look at whether both human and analog insulins are “effective”. And sure, while they both technically function as insulin, any study like this fails to take into account the massive strides offered by analog insulins in improving daily life, mental health, ability to maintain a job. in fielding the real-life curveballs of Type 1 diabetes. Access to the highest quality modern insulin is about true quality of life and long-term wellbeing in the actual world we live in. This is also about making sure that the standard of care does not move backwards.
A Problematic Recommendation
One of the recommendations of the working group reads: “Until there is a systematic plan that addresses a change in benefit design to lower out-of-pocket insulin costs for people with diabetes, human insulin may be a valid alternative to more expensive analog insulins for some patients.”
Rather than cut to the core of the insulin pricing issue, this recommendation offers only a sad, dangerous consolation prize.
If you’re an insurance company making decisions based on the bottom line, you’re paying attention to this part of the discussion.
Pretend, for a moment, that you are An Executive at A Health Insurance Company. What do you think when you read a publication from the American Diabetes Association suggesting some patients might benefit from a much cheaper version of a drug you’re currently paying very high prices for?
The ADA spells it out: “While the prices of both types of insulin have increased, the difference in pricing between them has substantially added to insulin costs both to the healthcare system and to many patients (human insulins are available at the pharmacy for $25 to $100 per vial compared with human insulin analogs at $174 to $300 per vial).”
And indeed, here’s what insurance company stakeholders had to tell the ADA about their concerns when it comes to insulin pricing: “Private and public payers are paying for the majority of the costs as list prices continue to rise… [we] want more information on the therapeutic benefits of more expensive analog insulins.”
Anyone living with a chronic illness can tell you exactly what it means when a health insurance company “would like more information on the therapeutic benefits” of something more expensive. As people with Type 1 diabetes, we are repeatedly forced to prove that, yes, we STILL have diabetes. Along a similar line, the insurance company needs to be convinced of why they should part with their money and continue to cover very expensive analog insulins.
But this ADA publication doesn’t reinforce the importance of analog insulin to patients living with diabetes. It opens the door to calculated cost-benefit decisions made by stakeholders who are not incentivized by the patient’s best interests. It does not double down on the safety and wellbeing benefits provided by newer insulins. As an organization claiming to represent the interests of people living with diabetes it is irresponsible not to raise these concerns.
Is it out of the question to fear the moment an insurance company decides to remove analog insulin from their formulary and decide only to cover a cheaper human insulin? When pressed, that company will be able to use this report as source material. That’s wrong.
The improvements provided by analog insulins are incremental but substantial. Better insulin timing has transformed the lives of people living with diabetes. The cost-benefit equation is so unbalanced not because the insulins aren’t better – but because they’re so much more expensive. They shouldn’t be.
The $300+ price tag for a vial of analog insulin is at the root of the issue. It’s the number the insurance company would like to stop footing the bill for. It’s a number bankrupting Americans without health insurance or on high-deductible plans. It’s the unbalanced half of the cost-benefit equation that might lead an insurer to wonder “why not just cover human insulin instead”?
Any solution must cut to the heart of the pricing issue – without compromising quality of care for people living with diabetes in the meantime. On behalf of patients, we need to do better than this. The American Diabetes Association has a responsibility to do better than this and an obligation to not make suggestions that could lead to even less access to the best insulins on the market.
Read more coverage of access issues from Beyond Type 1.