Individual Therapy or No Therapy at All: Impact of Patient Individual Therapies As ACT in the German AMNOG Process

Author(s)

Joey Rehkopf, MSc, Malte Glüsen, MSc, Jacob Sebastian Vinzens, MSc, Ingo Hantke, Dr. rer. nat., Matthias P. Schönermark, PhD, MD.
Kintiga, Hanover, Germany.
OBJECTIVES: Based on the G-BA rulings up until this point, patient individual therapies can be assigned as an appropriate comparator therapy (ACT) with or without explicitly stating drugs that need to be considered for the therapy. This analysis compares the impact of patient individual therapies as ACTs, with or without designated drugs, on the price levels and rebates in Germany.
METHODS: All available G-BA procedures with a patient individual therapy as an ACT were identified and analysed for drug prices, net rebates and other factors, based on whether the G-BA included designated drugs for the patient individual therapy or not. In a second step, the analysis was rerun with the exclusion of antiviral therapies.
RESULTS: 152 procedures with a patient individual therapy as an ACT were identified, of which 91 procedures included designated drugs as an ACT and 61 procedures did not. In comparison, procedures with designated drugs as an ACT on average received lower additional benefit ratings (70 % vs. 54 % no added benefit) and lower price levels, as well as higher net rebates after negotiations. All 28 procedures on antiviral therapies did not include designated drugs in their ACT.
CONCLUSIONS: The most prevalent therapeutic area with drugs with a patient individual ACT is oncology. Drugs that do not need to compare themselves against designated drugs in an individual therapy seem to have a higher chance of reaching a higher additional benefit and therefore a lower rebate. This is especially important, since per “Guidance on the Scoping Process” an individualised treatment will always comprise different treatment options with designated drugs.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

HTA200

Topic

Clinical Outcomes, Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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