News about Reimbursement and prices

  • Three new reimbursement guidelines

    | 03 April 2018 |

    The Danish Medicines Agency has issued three new guidelines on reimbursement (in Danish only). This regards Guideline on application for general reimbursement and general conditional reimbursement, Guideline on periodic reassessment of the reimbursement status of medicines and Guideline on the making of health economic analyses of medicines.

  • The Danish Medicines Agency has a new website

    | 04 January 2016 |

    Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

  • CUG certificates for login to DKMAnet must be replaced

    | 12 June 2015 |

    The Danish Health and Medicines Authority has to replace the system used to issue Closed User Group (CUG) certificates to users of DKMAnet who cannot obtain a NemID employee certificate, i.e. primarily users employed in companies without a Danish CVR registration number. If you are currently using a CUG certificate of the old type to log in to DKMAnet, you must obtain a new certificate before 1 September 2015.

  • Updating of summaries of product characteristics due to changed ATC codes for 2015

    | 16 January 2015 |

    Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure, as well as the Mutual Recognition Procedure, should be aware that some ATC codes have been changed in 2015.

  • Reimbursement of medicines bought in another EU/EEA country

    | 16 January 2014 |

    From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered by the national health insurance in Denmark and have a health insurance card (the yellow card) and the medicine must be reimbursable in Denmark.

  • Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

    | 08 March 2012 |

    We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

  • Comments received on the reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

    | 06 March 2012 |

    The Danish National Board of Health has received a number of comments from stakeholders about the Reimbursement Committee's discussion of the reimbursement status of antidiabetic medicines (ATC group A10).

  • Decision on general conditional reimbursement for alendronate-containing medicines

    | 22 February 2012 |

    In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bones).

  • Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

    | 22 February 2012 |

    As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.

  • Applications for general reimbursement in 2011

    | 02 February 2012 |

    In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.

  • Review concluded regarding general reimbursement for Xarelto®

    | 25 January 2012 |

    The Danish Medicines Agency has completed its review of an application for general reimbursement for two new strengths of Xarelto®. The product maintains general reimbursement.

  • Review concluded regarding general reimbursement for Zomig Nasal®

    | 20 January 2012 |

    The Danish Medicines Agency has completed its review of an application for general reimbursement for Zomig Nasal®. The product has been granted general reimbursement.

  • Decision on general reimbursement for Yellox®

    | 17 January 2012 |

    The Danish Medicines Agency has completed its review of an application for general reimbursement for Yellox®. The product has been granted general reimbursement.

  • Review concluded regarding general reimbursement for Multaq®

    | 16 January 2012 |

    The Danish Medicines Agency has completed its review of an application for general reimbursement for Multaq®. The product is neither eligible for general nor general conditional reimbursement.

  • Reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

    | 13 January 2012 |

    On 22 December 2009, the Danish Medicines Agency announced that we would begin our reassessment of the reimbursement status of a number of groups of medicines, including antidiabetics (ATC group A10). Within a few months, the Reimbursement Committee will begin to discuss the reimbursement status of antidiabetics.

  • Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

    | 05 January 2012 |

    At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

  • Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

    | 04 November 2011 |

    The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

  • Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

    | 07 October 2011 |

    With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelatine).

  • The reimbursement for glucosamine is removed on 28 November 2011

    | 04 October 2011 |

    The Reimbursement Committee and the Danish Medicines Agency have reassessed the reimbursement status of glucosamine-containing medicines. We have decided to remove the reimbursement for these over-the-counter medicines on 28 November 2011. Glucosamine is used for the alleviation of painful osteoarthritis.

  • Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

    | 20 September 2011 |

    The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

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