by Hélène Mauduit
BERLIN, Mar 3 (APM) - Germany's higher health technology assessment (HTA) body G-BA values quality-of-life data to decide on the level of its ratings, its head of pharmaceuticals has told APM.
"Quality of life data is an equally important criteria as side effects, symptoms and mortality endpoint for evaluating drugs," said Thomas Mueller said in an interview with APM this week.
Quality of life assessment can upgrade a rating to a higher level or downgrade it, he added.
"We balance quality of life with the other endpoints. We think that a drug that provides the same survival time than its comparator but a better quality of life should be rewarded," Mueller said.
For example, Pfizer's Xalkori in first line in non-small-cell lung cancer (NSCLC) (APMMA 50961), Eisai's Halaven (eribulin) in liposarcoma (APMMA 50711) and Novartis' Cosentyx (secukinumab) in plaque psoriasis (APMMA 45251) got a 'considerable added benefit' rather than a minor thanks to a proven improved quality of life.
Conversely, a low quality of life with a drug showing a considerable added benefit on the other endpoints will lead to one level lower - minor added benefit, Mueller said.
"So far, G-BA has never given a 'no added benefit' rating because of a lesser quality of life," he added.
For a drug with more side effects than the comparator, being able to prove that the quality of life is unchanged will be valued. "It shows us that the patient can deal with these side effects," Mueller said.
Not providing quality-of-life data can substantially reduce the rating. For this reason, G-BA ruled a no added benefit for Lilly's Portrazza (necitumumab) (APMMA 49616) and Gilead's HIV drug Genvoya (elvitegravir+cobicistat+emtricitabine+tenofovir alafenamide) (APMMA 48365).
"Our aim is to help doctors and patients to make a decision in individual cases. G-BA chairman Josef Hecken insists on that. Doctors and patients should know what are the main side effects and in what extent they affect the patient's quality of life," Mueller said.
In the last 25 G-BA decisions, about half of the files provided data on quality of life. The proportion is much lower on all G-BA decisions taken since 2011 but "the trend makes us optimistic for the future", Mueller said.
Almost all recently designed studies now include assessing quality of life and the topic is discussed on a regular basis at G-BA's early advice meetings with companies, he added.
Even if regulators such as the U.S. Food and Drug Administration and the European Medicines Agency do not consider quality of life data as "hard data" necessary for the approval, it is now known that "HTA bodies take them into consideration," he said.
Nevertheless, in about half of the files including these data, G-BA could not use them in the assessment for methodological reasons, said Mueller.
The questionnaire used in the study must be a validated instrument, disease-specific, give the patient's own assessment and the response rate must be over 70%, Mueller said.
G-BA acknowledges that quality-of-life data have limitations because the assessment varies highly according to the patient's personality, his or her social and emotional environment and the seriousness of the disease stage.
Questionnaires have to be improved and diversified to cover a maximum of diseases and must be simplified to be easier to fill in, Mueller said. G-BA financially supports research projects in that field through the German innovation fund, set up in 2016.
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