Budesonide is a synthetic corticosteroid with antiallergic and anti-inflammatory properties. Cortiment MMX (budesonide) is used to treat microscopic colitis. Since May, it has not been on the list of reimbursed drugs. As a result, it costs over a hundred times more than before – over PLN 400 instead of PLN 3. Gazeta.pl writes about the case.
- We recently wrote about the fact that Kadcyla, a drug used in the treatment of breast cancer, disappeared from the reimbursement list
- This is not the end of unpleasant surprises for some patients
- Cortiment MMX, used in microscopic colitis, is missing from the May list of reimbursed drugs
- Its price increased from PLN 3 to PLN 400
- More information can be found on the Onet homepage.
Microscopic Colitis
Microscopic Colitis (IBD) is an unexplained chronic inflammatory disease of the gastrointestinal tract. It is less dangerous than other bowel diseases, such as colitis ulcerosa or Crohn’s disease. It is estimated that the incidence is 0,2–5,5 cases per 100 thousand. people during the year, it mainly affects the elderly and women. IBD is often associated with autoimmune diseases such as rheumatoid arthritis, celiac disease, type I diabetes or Hashimoto’s disease.
The most common symptoms of IBD are watery diarrhea stomach pain and gas. Many patients are not properly diagnosed, the disease is not detected by endoscopy, and patients are often misdiagnosed as IBS (irritable bowel syndrome).
Budesonide – drug for IBD
Treatment of IBD with classic corticosteroid drugs or antibacterial chemotherapeutic agents was unsuccessful. Only oral budesonide turned out to be effective. It is recommended as a first-line drug, which mostly solves the problem.
However, the latest reimbursement list, effective from May 2021, does not include budesonide, or the drug Cortiment MMX. “Anyway, nothing else could fly out, because helpful drugs were removed earlier from it,” says Daniel Ptaszek, founder of the group on FB “Microscopic Colitis” in an interview with gazeta.pl. He emphasizes that in previous years, other preparations helpful in the treatment of IBD, such as Asamax, Pentasa and Entocort, have disappeared from the list.
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As a result, you will have to pay over PLN 400 for the Cortiment MMX for a package, which is enough for about a month. The minimum treatment in IBD lasts two months, although it may take several months or even years. Cortiment MMX earlier, with the refund, cost PLN 3.
Ineffective intervention
The Polish Society for the Support of People with IBD “J-elite” intervened with Minister Adam Niedzielski in April, before a new reimbursement list appeared. “The purchase of a fully paid Cortiment MMX, which costs PLN 404,75 for a package sufficient for a month, exceeds the budget of the average family, especially seniors” – argued in a letter to the minister. It did not bring these effects. The specificity has disappeared from the list.
Why? Gazeta.pl quotes the content of the letter received from the Ministry of Health on this matter.
«As there was no official indication yet, the drug was reimbursed under Art. 40 of the Reimbursement Act, after consulting the national consultant and the Transparency Council. Due to the registration of this indication and its inclusion in the Summary of Product Characteristics, the reimbursement in this mode has ended»Explains the ministry, adding that the continuation of the reimbursement requires a reassessment, which will include an analysis of effectiveness, efficiency and budgetary impact.
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The President of the Agency for Health Technology Assessment and Tariffs issued a positive reimbursement opinion at the end of May. «The President of the Agency, taking into account the position of the Transparency Council, available scientific evidence, clinical guidelines and reimbursement recommendations, considers public funding of the technology applied for as justified»- we read in the letter of 25 May.
Co dalej?
A positive opinion of AOTMiT does not automatically mean that the drug will return to the list of reimbursement drugs. First you need to conduct price negotiations. Their effect is difficult to predict, but patients are afraid that the price may not return to the previous level, amounting to a few zlotys.
«The health department will make every effort to ensure that the application is processed efficiently and the therapy reappears on the list of reimbursed drugs. J.At the same time, it should be pointed out that removing the indication from the list does not mean that the drug will no longer be available in pharmacies. He will be temporarily fully paid for this indication, and alternative therapies with other active substances are also availableand »writes Jarosław Rybarczyk from the MZ Communication Office.
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“The minister competent for health matters, with a view to obtaining the greatest possible health effects within the available public funds, will issue an administrative decision on reimbursement or refusal of reimbursement, taking into account 13 statutory criteria” – reads the final fragment of the letter quoted by gazeta.pl.
Also read:
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