Lenalidomide generic and T-prescription changes

Accord, Hexal and Aliud are the first to offer generic lenalidomide. The active ingredient, which belongs to the immune modulators, is used as monotherapy or combination therapy for multiple or follicular myeloma. Revlimid receives exclusive approval for additional indications. For example, it can be prescribed for mantle cell lymphoma or myelodysplastic syndromes.

Lenalidomide is ranked fourth among the top 30 drugs with the highest net costs per year. According to the Drug Ordinance Report (2021 edition), these amount to EUR 696.9 million. Within the framework of the treatment of multiple myeloma, 2.6 million defined daily doses (DDD) were prescribed in 2020. Compared with 2019, the number of prescriptions increased by 14.7 percent. DDD net costs amount to EUR 270.61. In the indication multiple myeloma, 2.6 million DDDs were prescribed in 2020.

Changes to the T-recipe

Normally, the prescribing physicians issue the associated instructions along with additional patient brochures. Due to the prescriber no longer knowing which preparation the person is receiving due to the discount agreements, pharmacies should take over the issuance of the instructions for use. The T-prescription form must be adapted for this. Until the new form is ready, all T-prescriptions that are already in circulation are valid. Both the templates from the BfArM announcements on 11 February 2020 and those from 6 January 2016, 17 June 2011 and 8 December 2008 remain valid.

During the transition period, doctors must observe the following points when prescribing:

  1. Aut-idem should be possible
    After the 20th amendment of AMVV enters into force (probably in March), the phrase “… and current information for the use of the corresponding finished medicinal products …” shall be deleted.
    Consequence for the pharmacy: Relevant instructions for use are handed out when the product is handed over.
  2. Aut-idem should not be possible – Case A: no operating instructions are issued
    Even during the transitional period until the regulation enters into force, the doctor can state that only a specific generic medicine should be dispensed.
    Consequence for the pharmacy: If the prescriber (s) tick the aut idem field but do not provide any associated instructions for use, the above clause must be removed. The pharmacy must hand over the instructions for use.
  3. Aut-idem should not be possible – Case B: Issuance of operating instructions
    Even during the transitional period until the regulation enters into force, the doctor can state that only a specific generic medicine should be dispensed.
    Consequence for the pharmacy: If the prescriber (s) crosses the aut-idem field and provides the associated operating instructions, the above-mentioned part of the sentence need not be deleted. The pharmacy does not have to hand over the instructions for use.

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