BERLIN, Sep 13 (APM) - Added benefit ratings given by Germany's health technology assessment (HTA) body G-BA are not relevant as prescription guidelines, according to three major regional doctors' associations.
G-BA's ratings are "an element for pricing and should in no way interfere with the freedom to prescribe", wrote the associations of statutory health insurance doctors (KV) of Bavaria, Bade-Württemberg and Westphalia-Lippe in an open letter sent to health minister Herman Groehe on Monday.
The three KVs ask the minister to rewrite the draft drug law AM-VSG to make this point clear.
Under the bill, an IT information system would be set up to transmit G-BA's ratings to doctors within a month of each decision. The aim is that doctors will be better and more rapidly informed on G-BA's rulings and will adapt their prescription habits, as health insurers are requesting (APMMA 46432).
For instance, doctors should reduce prescriptions of a new drug if it gets a 'no added benefit' assessment. Under the German system, a new drug can be launched as soon as it gets marketing approval and G-BA publishes its rating six month later.
Added benefit ratings are often based on one clinical trial conducted in an "artificial population", the KVs say. This information cannot be regarded as "a 'side guideline' on prescribing" and "cannot replace the uncontroversial and high-quality national care guidelines and those from medical societies".
The three KVs are also asking for health insurers not to be able to use G-BA's conclusions in their controls of physician prescribing.
The KVs also consider that G-BA ratings are too complex to help doctors decide which drugs to prescribe.
Assessments by G-BA give three levels of qualitative rating - hint, indication or proof - and five levels of quantitative rating - lesser benefit, no added benefit, minor, considerable or major added benefit, say the KVs.
"What should a doctor do if he has a choice between two drugs, one with proof of a minor added benefit and one with a hint of considerable added benefit? Does the higher qualitative rating overweight the lower quantitative rating? And what should he do if the patient does not belong to any of the subgroups studied?"
In the case of Gilead's hepatitis drug Sovaldi (sofosbuvir), there are six subpopulations and doctors have to choose between three treatment strategies based on five drugs, they say.
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