Your specialists for market access and reimbursement

HS Value & Dossier GmbH

We offer you health policy solutions for all phases of the product life cycle

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

Here everything, from study design to price negotiations, must be optimally prepared and implemented. We are happy to support you and guarantee you a target-oriented benefit dossier for the AMNOG process, an optimal market entry strategy for successful reimbursement (outpatient and inpatient), An optimized price negotiation. Learn more here.

Orphan Drugs

2 groups of medicines subject to specific health policy frameworks and requirements. Here it is important to develop an optimal benefit dossier and a specific negotiation strategy. We would be happy to do this for you! Learn more about Orphan Drugs here or contact us directly without obligation.

ATMPs

Drug group subject to special requirements. We develop an optimal user dossier and a specific negotiation strategy for you. Learn more about ATMPs (Advanced Therapeutic Medicinal Products) or contact us directly without obligation.

Off-patent drugs

Here, fixed amounts, discounts and tenders are most important. We manage all three for you and create the best possible strategy. Learn more here or contact us directly without obligation.

Study design

Is the foundation for an effective and target-oriented market entry. We help you to meet the approval and reimbursement requirements right from the start. Learn more here or contact us.

Medical devices

A complex process? Not for us! See the framework conditions as an opportunity and not as a risk. We show you how. Learn more here or contact us directly without obligation.

Trainings and Tools

The better the technical understanding and the more convincing the communication, the better the conduct of negotiations and more successful the reimbursement process. See AMNOG as an opportunity! We train and coach you! Learn more here or contact us.

Pricing

The market and price analysis are most important for a successful pricing. Use our expertise, our EU price simulator and our fixed price calculator. Learn more here or contact us directly without obligation

EU HTA

The European Commission aims to centralize the various national health technology assessments (HTA), which are currently carried out as part of the national reimbursement of drugs and medical devices. Learn more here or contact us.

Market Access & Reimbursement for Pharmaceuticals and Medical Devices

Market access and reimbursement of drugs and medical devices are subject to complex legal and regulatory requirements. A key feature is that initial market access requires a benefit assessment by the competent institutions, which either represents an entry barrier in the sense of a fourth hurdle, or serves as a prerequisite for price negotiations. In principle, it can be assumed that a „Health Technology Assessment“ is necessary for all medical services that are newly included in the catalogue of services of the statutory health insurance, i.e. a form of benefit assessment according to the criteria of evidence-based medicine. However, the processes vary depending on the product and performance range.

Market access and reimbursement of drugs in Germany

If new drugs are placed on the market in Germany after marketing approval, they are also reimbursed by the health insurance funds. Germany is one of the few countries in Europe and worldwide where the pharmaceutical company can set the price for the innovative drug at the time of market entry and it will then be reimbursed. Orphan drugs have a special position in Germany. On the one hand, the additional benefit of orphan drugs is already proven by the approval. This is because the orphan drug status granted by the European regulatory authority depends not only on the rarity of a disease but also on the added benefit of the therapy for the patients concerned. This is reflected in the benefit assessment according to AMNOG in such a way that no appropriate comparative therapy is defined by the G-BA for orphan drugs. Rather, the benefit assessment is carried out on the basis of study data that were decisive for approval by the European Medicines Agency (EMEA). Another special feature is that orphan drugs are called upon to undergo a classic early benefit assessment as soon as a sales volume of 50 million euros in the outpatient sector has been exceeded within one year.

ATMPs, Advanced Therapy Medicinal Products, also represent a product group that is subject in principle to the regulations of early benefit assessment according to AMNOG. The group of ATMPs includes novel therapies such as gene therapeutics, somatic cell therapeutics and biotechnologically processed tissue products. Where novel therapeutics are attributed properties for the cure or prevention of disease in humans or when they can be used in or on the human body to restore, correct or interfere with human physiological functions mainly by a 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. Not all ATMPs are subject to early benefit assessment for drugs. Thus the G-BA decided in individual cases that ATMPs are regarded as a „new examination and treatment method“, so that here a procedure of benefit assessment is applied, which is subject to § 135 SGB V (German Social Code). In the case of ATMPs, it is therefore always necessary to check which procedure actually applies with regard to reimbursement. 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, provided that an approval has been obtained. In Germany, the generic market is characterized primarily by the fixing of fixed prices and the invitation to tender for discount agreements. Large parts of the generic market are regulated by reference prices and most health insurance companies have concluded discount agreements for a large number of generics, which mean that these preparations have to be given priority by pharmacies.

At the same time as entering the market, however, a beneficial dossier must be submitted to the Federal Joint Committee (G-BA). The early benefit assessment of drugs was introduced in Germany in 2011 with the AMNOG (Arzneimittelmarktneuordnungsgesetz). The AMNOG regulations for early benefit assessment provide that new drugs are compared and evaluated in the sense of an early benefit assessment compared to an appropriate comparative therapy. The evaluation process begins with the submission of the benefit dossier for market entry. The Federal Joint Committee generally commissions IQWiG (Institute for Quality and Efficiency in Health Care) to carry out the benefit assessment, which is published after exactly three months. Following the benefit assessment, there will be a consultation phase with written and oral comments. The result of the benefit assessment according to AMNOG will be announced 6 months after market entry. The determined extent of the additional benefit of the new drug compared to the appropriate comparative therapy then forms the basis for the price negotiations with the GKV central association.

The price negotiations between the pharmaceutical contractor and the central association of statutory health insurance companies again last six months and result in a negotiated reimbursement amount for the new drug. Since the start of AMNOG, more than 300 early benefit assessment procedures have been carried out in Germany. The benefits and added value of innovative medicinal products other than orphan medicinal products are always measured and evaluated in comparison with appropriate comparative therapy. The difference between the medical benefit of comparative therapy and the innovative drug is discussed in the price negotiations in the sense of „value-based pricing“. The selling prices in other European countries as well as the prices of comparable medicines and the quantities or expected sales play a role in the negotiations. Since the AMVSG (Arzneimittelversorgungsstärkungsgesetz) came into force in 2017, drugs with known active substances that receive a new indication with documentation protection can also be evaluated in the early benefit assessment according to AMNOG upon request by the G-BA. This means that the new indication is subject to the same requirements as other innovative medicines with regard to the evaluation of added value and price negotiations. However, there is no free pricing for these active ingredients.

Market access and reimbursement of medical devices

Innovative medical devices are handled differently in the outpatient and inpatient areas in Germany. While new medical devices in the outpatient area are only reimbursed once they have been included in the statutory service catalog, reimbursement is possible in the inpatient area if no new charge (NUB charge) is applied for this service, but reimbursement is possible within the existing DRGs (Diagnosis Related Groups). This is connected with the different regulation mechanisms in the outpatient and inpatient areas. In the outpatient sector, this means that a refund is only granted once a service has been permitted. In the stationary area, however, the prohibition provisio applies. New benefits are allowed until they are prohibited. This principle was broken with the introduction of § 137h SGB V. § 137h SGB V stipulates that for new medical devices with risk class 2b or 3, a benefit assessment must be carried out by the G-BA if the hospitals apply for a NUB fee from the InEK (Institut für Entgelttsystem im Krankenhaus) for these products.

Recognition as a NUB (new examination and treatment method) by the InEK at the request of the hospitals is initially aimed at receiving appropriate remuneration for a new, innovative medical device. At the same time, the application will trigger a benefit assessment procedure to determine whether there is an additional benefit, the potential for it or no additional benefit. Reimbursement for the new medical device is only granted if there is an additional benefit. A potential can be tested. A NUB will not be approved if no additional benefits and potential are seen in the innovative medical device. This principle of assessing the benefits of new medical devices also applies in the outpatient sector. In the context of § 137e SGB V, the manufacturer can apply to the G-BA to test the benefits and additional benefits of the new method with potential.

„Our claim is individual, company-specific solutions that concentrate on the value of the products and implement this within the framework of the required benefit dossiers“

 Dr. Willi Schnorpfeil

HS Value & Dossier GmbH advises innovative pharmaceutical companies and biotechnology companies in the AMNOG process. With our many years of expertise, our experienced employees, and our versatile partners, we support you in strategy development, in the preparation of your benefit dossier for the G-BA evaluation, and in price negotiations with the GKV central association. Motivation and objective is always the optimized reimbursement for your new product. The focus here is on detailed process experience and innovative, interdisciplinary approaches.

Please contact us!

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