On AMNOG’s 10th Anniversary, G-BA’s Hecken Questions Whether 1-Year Free Pricing Is Too Long

Date: March 22, 2021 | Country: GERMANY | Region: EUROPE | Type: Pricing & Reimbursement | Keywords: #amnog #atmp #cellandgenetherapy #datacollection #gba #gkvsv #hta #iqwig 
#orphandrugs #pricenegotiation

PRICENTRIC BRIEF:

  • This year marks the tenth anniversary of Germany’s AMNOG system, which allows drugs entering the market one year of free pricing while the Federal Joint Committee (G-BA) and its lower assessor, the Institute for Quality and Efficiency in Healthcare (IQWiG) evaluate the added benefit of these drugs, ahead of pricing negotiations between pharmaceutical companies and Germany’s umbrella payer, GKV-Spitzenverband (GKV-SV)
  • However, AMNOG has not been without its problems, and, according to Professor Josef Hecken, Impartial Chairperson of G-BA, there are currently two challenges facing Germany’s drug assessors: the evaluation of drugs for which there is a “thin database” of supporting evidence and gaps in the new examination and treatment methods (NUB) in hospitals
  • Despite G-BA typically knowing within six months whether a drug offers additional benefit, free pricing is enabled for one year, with Hecken instead preferring “negotiated prices to apply from the time the G-BA decision is made, i.e. after 6 months.”

 

THE DETAILS

BERLIN, Germany – This year marks the tenth anniversary of Germany’s AMNOG system, which allows drugs entering the market one year of free pricing while the Federal Joint Committee (G-BA) and its lower assessor, the Institute for Quality and Efficiency in Healthcare (IQWiG) evaluate the added benefit of these drugs, ahead of pricing negotiations between pharmaceutical companies and Germany’s umbrella payer, GKV-Spitzenverband (GKV-SV).

According to G-BA, this process has been “financially effective,” leading to savings of around EUR 3.2 billion per year for the statutory health insurance system. Another plus: through data collection from studies, the system makes available much more clinical data and boosts transparency.

However, AMNOG has not been without its problems, and, according to Professor Josef Hecken, Impartial Chairperson of G-BA, there are two challenges currently facing Germany’s drug assessors: the evaluation of drugs for which there is a “thin database” of supporting evidence and gaps in the new examination and treatment methods (NUB) in hospitals.

G-BA now has a method of application-related data collection to ensure quality assurance, which provides for the collection of additional data amidst AMNOG and down the road (as has been the case with Advanced Therapy Medicinal Products; ATMPs). Yet, this process seems to question the integrity of the free year of pricing promise offered by AMNOG, as newer, innovative drugs often provide promising but unclear benefit. Even the year of free pricing opportunity has come under fire.

Despite G-BA typically knowing within six months whether a drug offers additional benefit, free pricing is enabled for one year. Hecken commented, “It doesn’t go together. Personally, I am in favor of allowing negotiated prices to apply from the time the G-BA decision is made, i.e. after 6 months.”

Shortening the duration of the free pricing allowance under AMNOG would most assuredly impact Germany’s standing as a first-launch market in Europe and have downstream effects, given Germany’s inclusion in many countries’ reference baskets.

The second problem deals with gaps in the new examination and treatment methods (NUB) in hospitals, particularly regarding ATMPs.

“If, for example, the G-BA sets quality requirements for use in clinics for drugs for novel therapies, so-called ATMP, the eligibility of reimbursement by the statutory health insurance is currently unclear due to the complex regulations for agreeing NUB fees in clinics,” said Hecken. “Despite a central approval of these drugs, their financing and reimbursement in the inpatient sector, unlike in the outpatient sector, is not guaranteed as a rule. In order to enable prompt, unbureaucratic care without individual applications for the generally seriously ill patients.”

Learn more about Pricentric ONE and our Global Pricing Solutions!

Contact us with your questions and global pricing needs, and an expert will follow up shortly.