By Hélène Mauduit
BERLIN, 8 June (APM) - Drug ratings published by Germany's health technology assessment (HTA) body G-BA are diverted from their initial pricing purpose and turned into cost-control tools, a conference has heard.
The added benefit procedure introduced in Germany in 2011 by the AMNOG law "was meant for pricing, but we now feel that it has shifted slightly towards a cost-control tool", said AstraZeneca Germany head Hans Sijbesma during a symposium on cancer drugs sponsored by the company at the Berlin's medical "capital city congress" on Thursday.
Even if cancer drugs more often have positive ratings from G-BA than non-oncological drugs, three of them were withdrawn from the German market after G-BA assessments, Sijbesma said.
One of these - AstraZeneca's Tagrisso (osimertinib) - was pulled after getting a 'no added benefit' assessment, although only for one year. It returned to the market in November 2017 after G-BA upgraded its rating in a second assessment (APMHE 55236
There is a risk of new drugs not being launched in Germany or being withdrawn because they cannot prove added benefit with the data available at the time of the assessment, Sijbesma said, referring to Tagrisso.
Manufacturers are less likely to launch drugs in Germany because of AMNOG's deterrent effect, as shown by pharma lobby BPI in 2015, he added (APMHE 44961
G-BA ratings are already used by health insurance companies or regional associations of statutory doctors (KV) to influence prescriptions, although this is beyond the scope of the AMNOG law, said Stephan Schmitz, chairman of German oncologists and haematologists association BNHO.
"What is written in G-BA ratings is useful for doctors, but it does not describe the up-to-date state of medical knowledge," he said.
There are clear "breaches in doctors' freedom of choice" to prescribe the drugs they consider necessary and the most appropriate for their patients.
Regional associations of statutory doctors - which negotiate annual drug budgets at regional level with health insurance companies - use added benefit ratings as 'false' arguments to put pressure on doctors' prescriptions, Schmitz said. For instance, the Bavarian association told prescribers that they should not prescribe drugs with 'no added benefit' ratings.
For physicians, these kinds of instructions sound like threats, he added. When prescriptions are audited, health insurers may demand reimbursement ("regress") for prescriptions that are not considered economically effective.
This issue was taken to the G-BA many times, without success, Schmitz said. "The response was: 'despite these instructions, doctors maintain their freedom of choice' ".
The 'no added benefit' rating given to Pfizer's breast cancer drug Ibrance (palbociclib) in May 2017 (APMHE 53139
) triggered a wave of treatment interruptions, said Doris Schmitt, board member of the breast cancer patients' association PATH foundation.
"Doctors were destabilised by the rating and stopped prescribing Ibrance overnight. You can imagine the effects on patients with metastatic breast cancer," she said.
Doctors' information system the next threat
Sijbesma expressed concerns that controls on physicians' prescriptions will increase through the "doctor's information system" (AIS) planned by the German government.
The AIS's aim is to inform prescribers more quickly and precisely about G-BA's ratings. As the detailed regulation on the AIS is expected in the coming weeks or months, speculation is running high on its content, whether it will only provide a summary of G-BA ratings or also other information on prices or economic efficiency.
Medical information in the AIS should not be limited to G-BA ratings, but should absolutely include medical guidelines, even if they are incomplete or dated, Schmitz said.
What doctors need is information about how drugs work in real life, said Johannes Bruns, secretary general of the German Oncology Society (DKG).
Thanks to the AMNOG procedure, physicians have wider access to clinical data used in the approval process. However this reflects "the situation in labs" and not how the drugs are used or the outcomes of treatments.