“Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations

Abstract

Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market. Better alignment of the clinical perspective and close collaboration between all involved parties is required to achieve and maintain optimization of patient care.

Varying results of early benefit assessment of newly approved pharmaceutical drugs in Germany from 2011 to 2017: A study based on federal joint committee data

“…The list is not comprehensive and some drugs may have been reintroduced. Staab compared EBA results of withdrawn medicines with clinical guideline recommendations . Of the withdrawn drugs, 82% (18 of 22) were recommended by at least one guideline.…”

How Far is Germany From Value-Based Pricing 10 Years After the Introduction of AMNOG?

“…This is mainly because producers in order to survive in the market will reduce their prices until their producer surplus is completely depleted. This may even lead to lower prices than in the monopsony without an 'all or nothing' supply, with innovative producers with higher average costs exiting the market in the long run, as it has been already the case with some market withdrawals of drugs in Germany after the introduction of AMNOG [27]. From this behavior of the (absolute) monopsonist, reduced and delayed introductions of drug innovations are postulated despite a temporary monopoly position owing to time-limited patent protection [28].…”

Organizational structure and funding of health technology assessment agencies around the world

“…Компании-производители и/или другие заинтересованные стороны могут принимать участие в процессе оценки лекарственного препарата следующим образом. Предварительный отчет, подготовленный ОТЗагентством после первичного анализа поданных данных, направляется компании-производителю и другим заинтересованным участникам для комментариев - так происходит в Англии [3,6,14,23,24], Бельгии [11][12][13][14][15], Германии [16, [45][46][47] и Нидерландах [22,[41][42][43][44]. В Австрии, например, если в процессе рассмотрения заявки выясняются факты, которые могут послужить причиной отказа в возмещении, компания-производитель имеет возможность дать пояснения и внести изменения в досье [8][9][10].…”