Download Insulin Lispro Frequently Asked Questions and more Schemes and Mind Maps Medicine in PDF only on Docsity!
Drugs and Devices Division
Insulin Lispro Frequently Asked Questions
1. What is the difference between Admelog® and Humalog®?
Admelog and Humalog are both insulin lispro products. Insulin lispro is an anti- diabetic medicine for the treatment of patients with diabetes. Admelog (insulin lispro) is approved by Health Canada as a biosimilar to Humalog. Admelog (insulin lispro) and Humalog (insulin lispro) are manufactured and marketed by different companies.
2. What is the funding status of Admelog (insulin lispro)?
Admelog (insulin lispro) has been listed on the Ontario Drug Benefit Formulary/Comparative Drug Index (Formulary) as a General Benefit with the December 2020 update (effective December 18, 2020).
3. What is the funding status of Humalog (insulin lispro)?
Effective with the January 2021 Formulary update (effective January 29, 2021), there will be changes to the funding status of the following Humalog products:
DIN
Brand Name
Generic Name
Strength & Dosage Form
MFR
02229704 Humalog ® Insulin Lispro
100U/mL Inj Sol- 10mL Pk
Eli Lilly Canada Inc.
09853715 Humalog ®
Insulin Lispro
100U/mL Inj Sol- 5 x 3mL Pk
Eli Lilly Canada Inc.
Humalog ® KwikPen ®
Insulin Lispro
100U/mL Inj Sol- 5 x 3mL Pk
Eli Lilly Canada Inc.
Drugs and Devices Division
Humalog ® Junior KwikPen ®
Insulin Lispro
100U/mL Inj Sol- Pref Pen 5 x 3mL Pk
Eli Lilly Canada Inc.
The changes will be as follows:
- The above Humalog products will no longer be listed on the Formulary as a General Benefit (GB).
- The above Humalog products will be listed on the Formulary as a Limited Use (LU) benefit ONLY for the following indication:
RFU Code 599: For the treatment of diabetes mellitus for only those patients currently established on Humalog therapy.
(LU authorization period: Indefinite)
- New starts for the above affected Humalog products will not be accepted. However, the above Humalog products will continue to be funded for ODB eligible patients who have been established on Humalog. 4. What is the rationale behind changing the funding status for insulin lispro?
Admelog (insulin lispro) was approved by Health Canada as a biosimilar to Humalog (insulin lispro). Biosimilars have similar efficacy and safety as originator biologics and present an opportunity to achieve better value for money for biologic drugs that will help to support long-term sustainability and accessibility of Ontario’s public drug programs.
5. How will these changes impact patients?
As of the December 2020 Formulary update, ODB eligible patients should receive Admelog when starting treatment with insulin lispro.
Drugs and Devices Division
update, with the appropriate RFU code or temporary transition code (where applicable).
When a prescription for insulin lispro is received, pharmacists should verify whether the prescription is for Admelog (insulin lispro). If the prescription is for Admelog, pharmacies must use the applicable drug identification number when submitting a claim for Admelog:
DIN
Brand Name
Generic Name
Strength & Dosage Form
MFR
02469901 Admelog Insulin Lispro
100U/mL Inj Sol- 10mL Pk
Sanofi- Aventis Canada Inc.
02469898 Admelog Insulin Lispro
100U/mL Inj Sol- 5 x 3mL Pk
Sanofi- Aventis Canada Inc.
02469871 Admelog Insulin Lispro
100U/mL Inj Sol- 5 x 3mL SoloSTAR Pref Pen Pk
Sanofi- Aventis Canada Inc.
9. What are biosimilars?
Biosimilars also referred to as subsequent entry biologics or follow-on biologics, are biologics that are similar to, and would enter the market after the patent or data protection rights for an innovator biologic has expired. They are similar to generic drugs. However, unlike generic drugs, biosimilars are not deemed bioequivalent to, nor interchangeable with, their reference drugs. Health Canada evaluates all the information provided to confirm that the
Drugs and Devices Division
biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them.
Please refer to Health Canada’s fact sheet on biosimilars for more information:
https://www.canada.ca/en/health-canada/services/drugs-health- products/biologics-radiopharmaceuticals-genetic-therapies/applications- submissions/guidance-documents/fact-sheet-biosimilars.html
Additional information:
For pharmacies:
Please call ODB Pharmacy Help Desk at: 1-800-668-
For all other health care providers and the public:
Please call ServiceOntario, Infoline at 1-866-532-3161 TTY 1-800-387-5559. In Toronto, TTY 416-327-
