Changed reimbursement for drugs for acid-related disorders – background and importance

What will be changed?

The change comprises medicinal products of the type H2 receptor antagonists, the medicinal products sucralfate and misoprostol as well as two medicinal products from the group of proton pump inhibitors. The three other proton pump inhibitors, the group of antacids and the medicinal product alginic acid are not affected. The table below lists the reimbursement status for all medicinal products in ATC group A02 for the treatment of heartburn, sour eructations and ulcers, listed here with the name of the active substances – regardless whether the reimbursement status of the medicinal product is changed or unchanged. The actual names of the medicinal products can be seen in the factbox to the right.

Reimbursements as of 15 November 2010 for medicinal products for the treatment of heartburn, sour eructations and ulcers (A02).

When do the changes become effective?

The above changes of reimbursement will become effective on 15 November 2010. Within the next five months, general practitioners and their patients who are treated with one of the medicinal products losing their reimbursement must therefore decide upon the patient’s future treatment if the patient is to continue to receive reimbursement.

The general practitioner may change the treatment to one of the medicinal products omeprazole, lansoprazole or pantoprazole, which are cheaper and just as effective – in some cases even more effective.

If, in the opinion of general practitioner, special reasons exist for not changing the treatment, he or she may apply to the Danish Medicines Agency for single reimbursement for the individual patient.

What is the medical background for these changes?

This change of the reimbursement status of some types of medicine for heartburn, sour eructations or ulcers is based on a medical recommendation from the Reimbursement Committee. The Committee’s recommendation has been submitted for consultation with a number of relevant scientific societies and other stakeholders, whose consultation responses are also available at our website (in Danish only). The Committee’s recommendation is available via the fact box to the right.

The group of proton pump inhibitors – omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole – are characterised by a high degree of class effect, and they are recommended equally in treatment guidelines, cf. the list at the end. Against this background, the medicinal products omeprazole, lansoprazole and pantoprazole will maintain general reimbursement, whereas rabeprazole and esomeprazole will lose their reimbursement. The decision is based on the class effect in combination with the price aspect – rabeprazole and esomeprazole are considerably more expensive without providing a better therapeutic effect.

All the other drugs for acid-related disorders – the so-called H2 receptor antagonists as well as the medicinal products misoprostol and sucralfate – are less effective and cost more than omeprazole, lansoprazole and pantoprazole and will therefore also lose their reimbursement. For the same reason, the group of antacids and alginic acid will continue to be non-eligible for general reimbursement.

Why is the Danish Medicines Agency making changes of reimbursement?

The Danish Parliament has charged the Agency with the task of reassessing the reimbursement status of all medicinal products on an ongoing basis. The aim of the reassessment procedure is to incorporate experience from everyday clinical practice and the actual use of the medicinal products and assess whether the conditions on which the original reimbursement decisions were made remain valid or whether they have changed over time. In other words, we must assess whether the current reimbursement status has contributed to a rational use of the medicinal products in practice. One of the criteria that must be met in order for a medicinal product to become eligible for general reimbursement is that the therapeutic value of the medicinal product must be reasonable relative to its price.

Now, the Danish Medicines Agency has reassessed the reimbursement status of all drugs for heartburn, sour eructations and ulcers with this aim in view. Many people have considered the change of reimbursement to be a cost-cutting measure, but that is not the case. The change of reimbursement is intended to prompt a rational medicinal treatment, i.e. an equally effective treatment at a lower cost – in some cases even a more effective at a lower cost. It is rational to prescribe the less expensive medicinal products that are eligible for general reimbursement and only prescribe the more expensive medicinal products in situations where it is warranted by special considerations. In such well-founded, exceptional cases, the general practitioner may apply for single reimbursement for the individual patient.

What will the changes mean for the overtreatment in the area?

Against the background of new knowledge, experts agree that too many patients are being treated with these medicinal products and that many of them may not necessarily need constant and continuous treatment, but may be able to control their treatment as required – symptom-controlled treatment. The changes of reimbursement are not caused by this overtreatment, but hopefully, the increased focus on these patients in connection with the changes of reimbursement and the general practitioner’s considerations as regards choice of treatment can help to reduce this overtreatment.

What are the financial implications of the change?

For the individual patient, the expenses will be the same or lower after the change. The expenses will be the same if the patient is treated with a medicinal product which does not lose its general reimbursement. If the patient is switched from an expensive medicinal product which loses its reimbursement to a less expensive medicinal product eligible for reimbursement, the expenses will be lower.

For each individual patient who switches from a treatment with e.g. one of the more expensive proton pump inhibitors to omeprazole, lansoprazole or pantoprazole, the average annual savings (for region and patient) will be around DKK 2000.  A change of product may not necessarily require an extra consultation with a general practitioner – for instance, the change could take place if a visit to the general practitioner is planned within the next five months – but the expenses for any extra consultation will only need to be paid once and will be considerable lower than the medicinal expenses saved.

For further information, please contact Head of Department for Reimbursement Karen Kolenda on tel. +45 4488 9348.

National and international guidelines etc.:

1. IRF. National Recommendation List. Rekommandation og Baggrundsnotat for midler mod mavesyrerelaterede forstyrrelser (A02), revised on 10 February 2009. (http://www.irf.dk/dk/rekommandationsliste/national_
   rekommandationsliste.htm)
2. Danish College of General Practitioners. Dyspepsi - Udredning og behandling af voksne med symptomer fra øvre mave-tarm-kanal. Copenhagen: Danish College of General Practitioners, 2009 (http://www.dsam.dk/flx/publikationer/kliniske_vejledninger/)
3. Swedish Council on Health Technology Assessment. Ont i magen – Metoder för diagnos och behandling av dyspepsi, Statens beredning för medicinsk utvärdering, SBU, Report no. 150, Stockholm: 2000 (http://www.sbu.se/sv/Publicerat/Gul/Ont-i-magen---metoder-for-diagnos-och-behandling-av-dyspepsi/)
4. National Institute for Health and Clinical Excellence (NICE). Dyspepsia: Managing dyspepsia in adults in primary care. Clinical guideline no. 17. London: 2004 (http://guidance.nice.org.uk/CG17