Reassessment of reimbursement status for medicinal products in ATC group C08CA

29 October 2008

The Danish Medicines Agency has assessed the question of the future reimbursement status for medicinal products in ATC group C08CA (dihydropyridine calcium channel blockers) which are used for the treatment of cardiovascular diseases. In making our assessment, we have included updated information about prices and consumption of these medicinal products.

On this basis, we expect to attach a reimbursement condition to medicinal products in ATC group C08CA containing isradipine, nifedipine, nitrendipine, lacidipine and lercanidipine, restricting it to: 
“Patients with hypertension or any other type of cardiovascular disease requiring treatment where treatment with less expensive dihydropyridine calcium channel blockers

  • is not tolerated or
  • in exceptional cases has been deemed inappropriate by a doctor based on an overall clinical assessment of the patient’s condition.”

Consultation
Companies holding marketing authorisations for medicinal products of the concerned ATC group have been asked to submit any comments to the assessment. The consultation letter of 14 October 2008 can be downloaded from the factbox to the right. The consultation deadline is Tuesday 11 November 2008.

Any relevant stakeholders will be informed
A notification about the Danish Medicines Agency’s assessment has also been sent to the Danish Society of Cardiology, Danish Endocrine Society, Danish Hypertension Society, Danish Society for Vascular Surgery, Danish Surgical Society, Danish Medical Society, Danish Society of Nephrology, Danish Paediatric Society, Danish College of General Practitioners, Danish Stroke Society, Danish Society of Geriatrics, Danish Society of Internal Medicine, Danish Society of Clinical Pharmacology, Danish Patients and Disabled Peoples Organisations Denmark. In addition, the Danish National Board of Health and the Institute for Rational Pharmacotherapy will be notified.

For further information, please contact the Reimbursement Department: medicintilskud@dkma.dk.

Danish Medicines Agency, 15 October 2008.

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