1. AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012? « IHS Healthcare and Pharma Blog 4/18/12 8:33 PM
IHS Healthcare and Pharma Blog
AMNOG One Year On: How Will German Health Reform Impact Pharma
Market Access in 2012?
Posted by Anne-Charlotte Honoré ⋅ February 2, 2012 ⋅ Leave a Comment
Filed Under Added Therapeutic Benefit Scores, AMNOG, G-BA, German health reform, IQWiG
2012 is already a busy period for German watchdog IQWiG. With five early benefit assessments
published since the New Year, and three more to come in February, IQWiG has never been so productive since the
implementation of the German health reform — AMNOG — which links pharmaceutical pricing to added therapeutic
benefit scores.
In 2011, it took German authorities over nine months to issue their first assessment under the new pricing scheme. One
year on, and only ten new therapies have gone through early benefit assessment. Sadly for the industry, first outcomes
confirm the G-BA’s tough approach towards innovation, and show how difficult it is to succeed in the delicate task of
selecting an appropriate comparator.
Brilique – First to Pass G-BA Test with Success
This aside, 2012 is already shaping up to be more active year, and we can expect many of the questions and uncertainties
surrounding AMNOG to be addressed. Ten novel therapies are already under early benefit assessment, and pricing
negotiations have started for AstraZeneca’s heart drug Brilique (ticagrelor).
The G-BA has issued final verdicts for Brilique, as well as Kowa Pharmaceuticals’ branded drug Livazo (pitavastatin). With
an important additional benefit (rating of 2) obtained in patients with non-ST-elevation myocardial infarction and in those
with unstable angina pectoris (UA), Brilique is the first to qualify for price negotiation with the health insurance under
AMNOG.
Kowa, however faces challenges, since Livazo has been incorporated into the reference-pricing system after it was found
to bring no additional benefit compared with other statins. This came as no surprise to Kowa, as statins have been
reference priced since 2005 in Germany. With AMNOG, the system is today common to all therapeutic areas, and entails
a risk of low prices for novel therapies that fail to outdo established alternatives.
Added Therapeutic Benefit Scores
Under AMNOG, the level of added therapeutic benefit granted to newly approved drugs is based on a scoring system
ranging from 1 to 6:
1: Major added benefit over comparator
2: Significant added benefit
3: Slight added benefit
4: Unquantifiable added benefit
5: No added benefit proven
6: Less than comparator
The score greatly impacts their pricing prospect of drugs in Germany. Those deemed to bring an incremental therapeutic
benefit (score ranging from 1 to 4) qualify for price negotiations, and may obtain a price premium over the appropriate
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2. AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012? « IHS Healthcare and Pharma Blog 4/18/12 8:33 PM
therapeutic comparator. But medicines which are either comparable or inferior in terms of patient-related outcomes (score
of 5 or 6) will get a non-negotiable price under Germany’s reference-pricing system.
So far, approximately 60% of novel therapies were considered to bring a therapeutic benefit in at least one patient
subgroup, and are thereby likely to enter into price negotiations with the statutory health insurance upon confirmation from
the G-BA.
The chart below shows the added therapeutic benefit scores granted by IQWiG to new medicines so far.
A Hurdle for Pharma Market Access in Germany: Comparator Selection
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3. AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012? « IHS Healthcare and Pharma Blog 4/18/12 8:33 PM
The G-BA’s stringent selection of the cheapest appropriate comparator is set to represent a significant hurdle for pharma
market access in Germany. Out of the ten products assessed last year, four have obtained poor innovation scores: Esbriet
(pirfenidone), Livazo (pitavastatin), Yellox (bromfenac) and Trajenta (linagliptin), and a majority of manufacturers have
struggled – sometimes declined – to provide comparative data versus the appropriate comparator selected by the G-BA.
What is certain is that deviating from the G-BA’s selected comparator, without sufficient justification, will result in a
negative pricing prospect. Boehringer Ingelheim paid the price for its choice of using a gliptin instead of the appropriate
comparator by obtaining a negative opinion for its new drug Trajenta.
Some Positive Verdicts from IQWiG
On the positive side, the good innovation scores granted to Brilique and prostate cancer drugs Zytiga (abiraterone) and
Jevtana (cabazitaxel) suggest that IQWiG has somehow evolved under the direction of Jürgen Windeler.
But has IQWiG really left its critical attitude towards the industry behind?
What is sure is that the health economic assessment body remains stringent and sticks to its principles. All three
medicines are admittedly innovative but, in IQWiG’s view, in a restricted patient population only. As for cancer medicines,
both Zytiga and Jevtana were shown to increase overall survival (OS) versus standard of care; endpoint which is clearly
preferred by the Institute. How IQWiG will deal with cancer drugs bringing an improvement in progression-free survival
(PFS) remains vague.
For Zytiga, Jevtana and Brilique, a price premium is expected over standard of care. That said, it’s worth remembering
that negotiations will take into account the different levels of innovation granted per patient subgroup.
Another sign of IQWiG’s rigorousness is the way it classified the respective added benefits of Hepatitis C treatments
Victrelis (boceprevir) and Incivo (telaprevir) as “unquantifiable” because both refer to the surrogate outcome “sustained
virological response” (SVR), which is not a patient-relevant outcome per se for IQWiG.
More to Come
Results of the early benefit assessment of Pfizer’s (US) Dupuytren’s contracture treatment Xiapex, Eisai’s (Japan) breast
cancer drug Halaven and GSK’s (UK) Trobalt are scheduled to be published by IQWiG this month.
About Anne-Charlotte Honoré
Anne-Charlotte Honoré is an analyst in the IHS Healthcare practice. She covers part of Western Europe as well as the
Nordic countries, and has an extensive knowledge of healthcare policy and regulatory environment in the region.
View all posts by Anne-Charlotte Honoré »
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