Breakthrough T1D is aware that, unfortunately, individuals are having trouble filling their prescriptions for 10mL Humalog, 10mL Insulin Lispro, and 10mL Novolog vials. It is unacceptable that some members of our community have had to face an additional hurdle to get this life-saving medication in their usual formulation.
We have been in contact with Eli Lilly, the manufacturer of Humalog and Insulin Lispro, and Novo Nordisk, the manufacturer of Novolog, to learn the status of this shortage and what the companies are doing to expedite 10mL vial availability. Based on these discussions, here is what we know about the shortage.
Eli Lilly
- Lilly has begun shipping 10mL vials again. They anticipate meeting the supply needs soon.
- Lilly voluntarily reported this shortage to the FDA, and the FDA is not posting about it because there are other formulations (insulin pens) available.
- Lilly has said, “We understand the importance of insulin, and we are committed to ensuring all people have access to the medicines they need. After careful consideration, Lilly has decided to discontinue manufacturing 3 mL vials of Humalog® (insulin lispro injection) [that were distributed only for hospital use.] The decision to discontinue the 3mL vials will help create greater supply resiliency and product availability by streamlining production and distribution processes.”
- All up-to-date information regarding this shortage is on Eli Lilly’s site at: https://www.lilly.com/our-medicines/humalog-and-lispro
Novo Nordisk
Novo Nordisk has shared the following statement:
“Novo Nordisk is currently experiencing a short-term disruption of NovoLog® vials due to a delay in shipment from our manufacturing site. We expect shipments to resume to a normal schedule starting mid-April. However, certain pockets of the country may take longer for the supply to flow downstream to patients. NovoLog® FlexPen® and PenFill® are currently available and not experiencing delays.
While NovoLog® vials are actively being shipped, there is currently not enough product to meet the full market demand as we catch up from previous backorders. This disruption is only affecting supply in the United States. If patients cannot find NovoLog® at their preferred pharmacy, we encourage them to try other local pharmacies for availability. If unsuccessful, we recommend patients speak with their healthcare provider about their treatment plan to determine the best course of action.
Novo Nordisk communicated the NovoLog® vial shortage to the FDA in Q1, advising that we were experience shipping delays and may not be able to meet full demand. However, it is up to the FDA’s discretion if they will post it as a drug shortage. In the event of a product shortage, Novo Nordisk allocates a proportional amount of product to each wholesaler based on their historical purchasing patterns.
The Novo Nordisk supply situation is not related to the temporary stock outs of Humalog and Lispro as announced by Eli Lilly. However, NovoLog® may see increased demand as a result which is not accounted for in our supply forecast. Novo Nordisk takes this situation very seriously and we are actively working to further increase NovoLog®
Due to the fluidity of supply, the best source for updated information is the Novo Nordisk Call Center at 800-727-6500. We sincerely apologize for any disruption to care that may be experienced, and we appreciate the patience and understanding of the healthcare professional community and patients.”
Breakthrough T1D is deeply concerned that this shortage occurred and appreciates Lilly and Novo Nordisk proactively looking at ways to ensure this will not happen again. This shortage is a reminder that people with T1D need more options to acquire insulin, which is why Breakthrough T1D is proudly supporting Civica, which will sell insulin for no more than $35 a vial or $55 for a pack of five pens in the future.
