The Advisory Board of the Agency for Health Technology Assessment (AOTM) upheld its positive recommendation on the safety of long-acting insulin analogues in the treatment of type 1 and type 2 diabetes, according to a release published on the agency’s website.
Doubts on this subject arose in connection with reports of a possible carcinogenic effect of one of the long-acting analogues, i.e. glargine. The work on this subject was published on June 26, 2009 on the website of the Diabetologia magazine. Studies in Germany and Sweden have suggested that the use of glargine in patients with type 2 diabetes may be associated with a slightly increased risk of breast and colorectal cancer. However, the results of two analyzes from Great Britain did not confirm such a relationship.
Reports on possible side effects of using one of the long-acting insulin analogues were one of the arguments used by the Ministry of Health to delete these preparations from the draft reimbursement lists.
In February this year, the Ministry of Health commissioned us to prepare a safety analysis of long-acting analog insulins. The AOTM Consultative Council maintained its positive recommendation from 2008 regarding the financing of these preparations in the treatment of type 1 and type 2 diabetes, indicating that their safety must be monitored, as there are no reliable reports on this subject – AOTM spokesman Katarzyna told PAP Jagodzińska.
Due to the suggestions that insulin glargine may increase the risk of developing cancer, we conclude that no conclusive data has been provided. The MAH should be required to re-examine the safety of insulin glargine in 2 years, the Council members wrote in a press release.
The Council based its opinion on data from the available primary studies as well as the positions of key regulatory agencies (EMEA positions – European Medicines Agency and FDA – US Food and Drug Administration) as well as opinions of experts and scientific societies.
The second analogue, insulin detemir, received an equally positive opinion.
According to prof. dr hab. Maciej Małecki, MD from the Department and Clinic of Metabolic Diseases of the Collegium Medicum of the Jagiellonian University in Krakow, the opinion of the Consultative Board is only a confirmation of the facts that were obvious to the medical community and to diabetologists from the very beginning of the discussion on this topic.
Scientific studies suggesting an increased risk of cancer as a result of the use of one of the long-acting insulin analogues available on the market have been criticized from the beginning due to poor scientific methodology and interpretation errors. Several subsequent publications on this issue showed no cause for concern. Patients who receive all insulin available on the market can feel safe – commented the diabetologist for PAP.
As he recalled, the reimbursement of long-acting analogues is important for those diabetic patients for whom it is difficult to obtain satisfactory fasting glucose levels with the use of traditional insulins and in the case of frequent hypoglycaemia at night.
In the absence of reimbursement, the entire cost of purchasing long-acting analogues is borne by the patient. This cost is about PLN 200-400 per month, and many patients cannot afford such an expense – emphasized the specialist.
As patients, we are very pleased that the AOTM opinion on long-acting insulin analogues is positive and we hope that thanks to it the Ministry of Health will decide on their reimbursement at least partially, to the level of other insulins, told PAP Hanna Zych-Cisoń, vice president of the Polish Diabetes Association and president of the Pomeranian branch of PTD in Gdańsk, which has been suffering from type 1 diabetes for many years.
According to Zych-Cisoń, long-acting analogues enable some diabetic patients to maintain normal blood glucose levels and avoid serious complications of the disease, which include, among others, damage to the kidneys, retina, the so-called diabetic foot, cardiovascular disease. Thanks to them, patients can lead a normal life, e.g. go to school or work.
As the representative of diabetics emphasized, many patients finance these analogues on their own, and they are often people with very low incomes, because, for example, they are on a pension. We simply deserve a refund to the level of other insulins – she summed up. (PAP)