July 8, 2020
New recommendations about medicines by Danish Medicines Council
On June 25, 2020, Danish Medicines Council (Medicinrådet) issued five recommendations (on C1-esterase inhibitor, talazoparib, lorlatinib, pembrolizumab, trastuzumab), two drug recommendations (for breast cancer and melanoma), one protocol for the treatment guide for chronic liver inflammation and one supplement to a treatment guide for chronic rheumatoid arthritis

Recommendations:

  • C1-esterase inhibitor is not recommended for prophylactic treatment in patients with hereditary angioedema, because healthcare costs for the drug will be unreasonably high. Even if the drug has an added value of unknown size and is therefore probably better for the patients than the intravenous treatment used today
  • Talazoparib is not recommended for patients with locally advanced or metastatic HER2 breast cancer with BRCA1/2 mutation, because the health care costs of the drug will be unreasonably high if we recommend it. The effect of talazoparib cannot be categorized, which means that the data is not good enough for Medicines Council to comment on drug safety. However, talazoparib has no worse effect than chemotherapy and is better tolerated than chemotherapy. The additional cost of talazoparib is too high in relation to the benefits.
  • Lorlatinib is not recommended for patients with incurable non-small cell lung cancer and Anaplastic Lymphoma Kinase (ALK) translocation (also called ALK-positive). Also, it is not recommended as second-line or third-line treatment for incurable non-small cell lung cancer, as costs are unreasonably high, with the uncertainties about its efficacy and side effects.
  • Pembrolizumab is recommended as the first-line systemic palliative treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck expressing PD-L1 with CPS ≥ 1, both as monotherapy and in combination with platinum and 5-FU
  • Trastuzumab emtansine (T-DM1) is recommended for patients with early HER2+ breast cancer who did not achieve a complete response to neoadjuvant therapy. It has some added value comparing to the standard treatment, while healthcare costs for the drug are reasonable
Drug recommendations and treatment guide on

  • CDK4/6 inhibitors for ER +/HER2- locally advanced or metastatic breast cancer Link
  • Adjuvant treatment in melanoma Link
The protocol for the treatment guide for chronic liver inflammation was approved. Pharmaceutical companies have the opportunity to contribute literature for the specified time period June 17 - July 2, 2020.

A supplement to treatment guide on chronic rheumatoid arthritis was issued in relation to subcutaneous infliximab and tofacitinib Link

See the full details in Danish here.

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