Value & Dossier – Your Reimbursement Specialists

HS Value & Dossier GmbH

We are offering market access and reimbursement solutions for the different product life cycle phases

From study design to price negotiation

A new product has only one chance to enter the market successfully

We help you with passion to master the challenges of health policy

Innovative Medicines

Market Access Germany

Everything, from study design to price negotiations, shall be prepared and implemented optimally. We will gladly welcome the opportunity to support you and will guarantee a purposeful benefit dossier for the AMNOG process, an ideal strategy for market entry and an optimized price negotiation. Further information on the topic of innovative medicines.

Orphan Drugs

The benefit assessment of orphan drugs according to AMNOG basically follows the same procedure as the assessment of classical patented drugs. Read more about the topic orphan drugs or contact us.

ATMPs

ATMP

Medicinal product group to which special requirements apply. We develop an optimal benefit dossier and a specific negotiation strategy for you. Read more about ATMPs (Advanced Therapeutic Medicinal Products) or contact us.

Off-Patent Drugs

Market Access Germany

Reference prices, discounts and tenders play the most important role in this context. We manage them all for you and create the optimal strategy. Find more information on patent-free medicines or contact us.

Study Design

Market Access Germany

Is the basis for an effective and target-orientedmarket entry and access. We can help you to comply with approval and reimbursement requirements right from the start. Additional information on study design.

Medical Devices

Are you interested in market access for medical devices and the benefit assessment of medical devices? Well, you just arrived at the right address. Learn more about the topic Medical Devices or contact us.

Trainings and Tools

Market Access Germany

As a result of an enhanced professional understanding and confident communication, the negotiation process and the reimbursement process will be even more successful. See AMNOG as an opportunity! We train and coach you! Further information about training and coaching.

Pricing

Market Access Germany

The market and price analysis are the most important parameters for a successful pricing. Use our expertise, our EU reference price simulator and our fixed price calculator. For more information on pricing, click here or contact us.

EU HTA

Market Access Germany

The European Commission intends to implement various national health technology assessments (HTA), as a part of the reimbursement for drugs and medical devices, in a uniform and centralised manner. More information on EU HTA.

Market Access & Reimbursement for Pharmaceuticals and Medical Devices

Market access and reimbursement of drugs and medical devices are governed by complex legal and regulatory requirements. When initial market access is granted, a benefit assessment is required on behalf of the responsible institutions, which either represents an entry barrier in terms of a fourth hurdle or serves as a prerequisite for price negotiations. It is generally assumable that a „Health Technology Assessment“, in terms of a benefit assessment according to the criteria of evidence-based medicine, is necessary for all medical services that are newly included in the service catalogue of statutory health insurers. However, the processes may differ between different products and perforamance areas.

Market Access and Reimbursement of Drugs in Germany

Once new drugs are placed on the German market following marketing approval, they are also reimbursed by the health insurances. ermany is one of the few countries in both Europe and the whole world which allows the pharmaceutical company to set the innovative drug’s price itself at the time it enters the market and ensures its reimbursement.

ATMP

When entering the market, it is necessary to submit a benefit dossier to the Federal Joint Committee (G-BA). The early benefit assessment of drugs was launched in Germany in 2011 with the AMNOG (Arzneimittelmarktneuordnungsgesetz – Drug Market Reorganisation Law). The AMNOG regulations for early benefit assessment specify that new drugs have to be compared and evaluated in the sense of an early benefit assessment in relation to an appropriate comparative therapy. The assessment process starts with the submission of the benefit dossier at the time of market launch. The G-BA generally commissions IQWiG (Institute for Quality and Efficiency in Health Care) to perform the benefit assessment, which is published exactly three months after the submission. The benefit assessment is then followed by a hearing phase with written and oral statements. Results of the benefit assessment according to AMNOG are published 6 months following the market entry. The determined additional benefit of the new drug compared to the appropriate comparative therapy then serves as the basis for price negotiations with the GKV Spitzenverband. The price negotiations between the pharmaceutical company and the GKV-Spitzenverband again lasts 6 months and results in a negotiated reimbursement price for the new drug. More than 300 early benefit assessment processes have been conducted in Germany since AMNOG was introduced. The benefits and additional benefits of innovative drugs, excluding orphan drugs, are always measured and evaluated against thr appropriate comparative therapy. The difference between the medical benefit of the comparative therapy and the innovative drug is discussed in the price negotiations in terms of „value-based pricing“. The sales prices in the other European countries as well as the prices of comparable drugs and the (expected) sales volumes influence the negotiations. Since the AMVSG (Arzneimittelversorgungsstärkungsgesetz – Drug Supply Strengthening Law) came into force in 2017, the G-BA may request an early benefit assesment according to AMNOG also for drugs with known active substances receiving a new indication with data exclusivity. Thus, the new indication meets the same criteria regarding the additional benefit assessment and price negotiations that apply to other innovative drugs. Free pricing for these active substances is not applicable.

Orphan drugs have a unique status in Germany. They are considered to have an additional benefit once they have been approved. This is due to the fact that the orphan drug status granted by the European approval authority depends on the rarity of a disease and on the additional benefit of the therapy for the affected patients. This is reflected in the AMNOG benefit assessment as no appropriate comparative therapy will be defined for orphan drugs by the G-BA. Rather, the benefit assessment is carried out based on study data that were decisive for its approval by the European Medicines Agency (EMEA). As a further special aspect, a classic early benefit assessment for orphan drugs is requested, if a sales volume of 50 million euros in the outpatient area has been exceeded within one year. ATMPs, Advanced Therapy Medicinal Products, also represent a product group which are principally subject to the regulations of the early benefit assessment according to AMNOG. The group of ATMPs includes novel therapies likelike gene therapeutics, somatic cell therapeutics and biotechnologically engineered tissue products. As far as novel therapeutics ascribe properties to cure or prevent human diseases or if they may be used in or on the human body to restore, correct or modulate human physiological functions mainly by pharmacological, immunological or metabolic action, they are biological medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council. However, not all ATMPs are subject of early benefit assessment for medicinal products. Thus, the G-BA has decided in some individual cases that ATMPs are considered as a „new examination and therapy method“, resulting in the application of a benefit assessment procedure which is covered by § 135 SGB V (German Social Code). Therefore, ATMPs should always be examined regarding to the actual reimbursement procedure.

ATMP

In Germany, patent-free drugs are no longer subject to benefit assessment. Generic drugs with the same active ingredient can enter the German market at any time, as long as they have an approval. The the generic market in Germany is mainlyis characterized by fixed prices and the tendering oftender discount contracts. Major parts of the generics market are regulated by reference prices and most health insurances have agreed on discounts covering a large number of generics. As a result, these medicines have to be sold preferentially by pharmacies.

Market Access and Reimbursement of Medical Devices

Innovative medical devices are handled differently in the german outpatient and inpatient areas. In the outpatient sector, new medical devices are only reimbursed once they have been included in the statutory service catalog. In the inpatient sector, reimbursement is only possible in the framework of existing DRGs (Diagnosis Related Groups) if no new fee (NUB fee) is applied for for for this service. This is due to the different regulation mechanisms in the outpatient and inpatient areas. In the outpatient area, the reservation of authorisation applies, which means that reimbursement is only granted once a treatment has been permitted. By contrast, the reservation of prohibition applies to the inpatient area. New health services are allowed unless they have been prohibited. This principle changed with the introduction of § 137h SGB V. § 137h SGB V specifies that a benefit assessment for new medical devices with risk class 2b or 3 has to be performed by the G-BA,  if hospitals apply for a NUB fee from the InEK (Institut für Entgelttsystem im Krankenhaus –  Institute for Hospital Fee Systems).

The InEK‘ s approval as NUB (Neue Untersuchungs- und Behandlungungsmethode – New Method of Examination and Treatment) at the request of the hospitals is initially intended to provide appropriate remuneration for a new, innovative medical device. Now, the application also initiates a benefit assessment procedure to determine an additional benefit, the potential for it or no additional benefit. A reimbursement for the new medical device is only given in cases of additional benefit. In case of a potential benefit, a trial can be performed. A NUB is not granted in case of no additional benefit or any potential in the innovative medical device is considered. This principle also applies to the outpatient sector. The manufacturer may request a trial at the G-BA in accordance with § 137e SGB V to evaluate the benefits and additional benefits of the new method with potential.

„We offer individual and business-specific solutions which focus on the product’s value and implement them appropriately in the required benefit dossiers“

 Dr. Willi Schnorpfeil

HS Value & Dossier GmbH advises innovative pharmaceutical and biotechnology companies in the AMNOG process. Based on our long and valueable expertise, our qualified employees and our versatile partners, we support you in strategy development, in preparing your benefit dossier for the G-BA evaluation, and in price negotiations with the GKV-Spitzenverband. Both the motivation and the objectives are always the optimized reimbursement for your new product. Our focus is on detailed process experience and innovative, interdisciplinary approaches.

Contact Us!

HS Value & Dossier GmbH
+49 6173 3941016
hs@value-dossier.com