MSD Germany hoping for more flexibility in AMNOG procedure

By Hélène Mauduit
BERLIN, 19 Apr (APM) - The German subsidiary of Merck & Co is hoping for more flexibility in the AMNOG drug assessment and pricing procedure, country manager Susanne Fiedler told APM.
"I consider AMNOG to be a transparent system with clear rules. It provides visibility and predictability. However, it lacks flexibility," Fiedler said in an interview with APM on Tuesday.
"Some positive changes have already been introduced; things should continue that way. The system must remain open to improvements," she said.
The AMNOG procedure is challenging for drugs with multiple successive indications, Fiedler said. An assessment is made with health technology assessment (HTA) bodies IQWiG and G-BA on each new indication, followed by price negotiations with umbrella payer group GKV-Spitzenverband (GKV-SV). Each dossier requires a lot of time and human resources, Fiedler said.
This is the case for immuno-oncology drugs such as Keytruda (pembrolizumab), which has been assessed five times so far, but also applies to other kinds of drug.
Keytruda is already approved in melanoma, in first and second-line use in non-small cell lung cancer (NSCLC), in classical Hodgkin lymphoma (cHL) and in locally advanced or metastatic urothelial carcinoma. Two more approvals are expected in 2018 in use in combination with pemetrexed in NSCLC and in head and neck cancer.
Getting multiple successive approvals is a growing trend, Fiedler said. "The procedure is not tailored for such situations. We have to find solutions," she added.
One change was already introduced in 2017, in the drugs care reinforcement law (AM-VSG) (APMHE 52162). A single procedure for successive indications of the same drug can now be requested if two or more approvals are expected within six months of each other. MSD will soon make use of it for Keytruda, Fiedler said.
However, "six months is too short," she continued. "Either we extend the period to 12 months, for instance, or we find other ways."
MSD also hopes that G-BA will take into account progression-free survival (PFS) data - and not only overall survival data - in its assessment of cancer drugs. Several companies have already requested this, without success so far (APMHE 55737).
"It is preferable to provide overall survival data, but this is often not possible because of the initially severe condition of patients included in studies. Furthermore, a gain in PFS is meaningful for patients and their relatives," Fiedler said.
Other HTA bodies such as England's NICE and France's Transparency Commission appear to be more open to PFS, she added.
G-BA should take more kinds of data into account, for instance real world data. "IQWiG and G-BA are currently quite rigid in comparison with other HTA bodies on that matter," Fiedler said.

Maintaining dialogue

Fiedler is convinced it is worth continuing to put forward certain issues and requesting changes in order to maintain the dialogue with G-BA.
"Some positive steps have already been taken," she said.
G-BA has shown openness to exchanging views, notably in hearings with pharma companies and medical experts during the assessment procedure and also through clear statements, she continued.
Fiedler welcomed the fact that G-BA had indicated on several occasions in a 'no added benefit' ruling that a drug was nevertheless "a therapy option in individual cases".
G-BA meant that this could be useful in price negotiations with GKV-SV (APMHE 52366).
Pricing negotiations with GKV-SV remain tough but "price negotiations are not easy anywhere", she said.
"Germany is still the country where a drug can be launched as soon as it gets EU approval, and is the market a drug is launched in first. This is very valuable," she continued.

Up to five launches in 2018

MSD Germany will launch new diabetes combination Steglujan (ertugliflozin+sitaglitptin) in the second quarter of 2018 as its third launch of the current year, Fiedler said.
Steglujan was approved on 23 March by the European Commission after a positive opinion from European Medicines Agency's advisory committee CHMP in January (APMHE
Two drugs have already been launched, Prevymis (letermovir) against cytomegalovirus (CMV) in February (APMHE 56833) and Clostridium difficile prevention drug Zinplava (bezlotoxumab) at the beginning of April.
The fourth and fifth launches may occur in the fourth quarter, with HIV drug doravirine, filed by the European Medicines Agency (EMA) at the beginning of April, alone and in combination with lamivudine and tenofovir disoproxil.
No launch date has been communicated for two other diabetes drugs containing ertugliflozin which were also approved in March, ertugliflozin alone under the brand name Steglatro and fixed combination Segluromet (ertugliflozin+metformin), Fiedler said.
Neither has MSD provided a German launch date for its biosimilar of Roche's Herceptin (trastuzumab), Ontruzant, approved in the EU in November 2017, she added. The marketing approval holder is Samsung Bioepsis but MSD has signed an agreement for its marketing in the EU.



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