Market Access and Market Penetration of Pharmaceuticals – More than just Benefit Assessment.
The pharmaceutical sector is one of the most highly regulated fields of health care. At the same time, social legislation and the related partially sub-statutory regulations offer leeway for alternative sales and access channels.
Besides methodical technical accuracy, the so-called AMNOG-based benefit assessment process also requires a great deal of strategic foresight, communicative skills and the bundling of all interests within and outside of the company. SKC has the most comprehensive experience in this field.
- Within the framework of market access and specifically the early benefit assessment, SKC develops optimal strategies in the context of international plans and expectations together with the firm. SKC structures, controls and manages the entire benefit assessment process and works together with specialized service providers, cooperation partners and the staff of the client to develop the value dossier. The position of the company is strengthened by systematic, relentless, but solution-oriented criticism (“sparring”).
- Due to our work with more than 30 companies on questions in the field of early benefit assessment as well as a continuous extended evaluation of all precedents from the procedure documentation SKC is able to support companies in these critical decisions with its experience and fact-based approach.
- The benefit assessment procedure for new pharmaceutical compounds on the basis of §35a SGB V (German social code) provides that the pharmaceutical manufacturer submits a comprehensive value dossier to the German HTA authority (Gemeinsamer Bundesausschussa, G-BA) on the very day that the new product is launched in Germany. This dossier builds the basis for the subsequent benefit assessment procedure. As this is the central document for all the following steps in the process, the preparation of the document needs meticulous attention and a clear and stringent strategic logic. Not only do the formal specifications need to be met precisely, but also must the value story of the new product be told in a captive way. The story line of the dossier defines the tactics and the strategy for the subsequent steps (written statement, oral hearing, price negotiation and arbitration procedure).
- To offer our clients a tailor-made solution that respects the individual situation from one source, we hired a team of experienced medical writers and scientists, who develop parts of the dossier or the entire benefit dossier which will be harmonized with the collectively designed dossier strategy. This reduces interfaces and coordination loops with different agencies and service providers and increases the efficiency of the entire process. We integrate the international perspectives, as we respect the conditions of other HTA authorities (e.g. the British NICE, the French HAS) and discuss these with our clients.
- SKC psychologically and professionally prepares the staff of its clients for the G-BA hearing procedure and negotiations. The employees are accustomed to the specific situation and learn to securely function with the help of realistic scripts.
- In our work with the client’s team we always combine three essential aspects:
- In-depth and very detailed knowledge of the particular case and the respective evidence, debate at eye level;
- Experience from the many benefit assessment procedures which we have accompanied, complemented by each comprehensive evaluation of relevant precedents;
- Great didactic and psychological competencies.
- This specific mix differentiates us from plainly content-driven training of companies working in the field of dossier preparation and from mostly content-lacking offers made by coaches specialized on sales, negotiation or appearance.
- Throughout the price negotiations with the GKV-SV we support our clients locally in the team room (“on-site coaching”), as members of the negotiating team or by taking over the conduct of negotiations.
- The reference price systems have a major impact on the European and on the non-European business case (e.g. Japan). Conversely, the prices in other European countries also directly affect the German price in regard to the reimbursement amount negotiations. SKC systematically assesses the various dependencies in the European reference price system and presents these scenarios transparently. This way, the ones responsible for the pricing are sure to reobtain certainty in their decision.
- Furthermore, SKC supports the coordination with the European or international organizations, as our experience has shown that the mediation of specific German complexity to the centers is a special challenge.
- If required, SKC also carries out its own market research on pricing.
- SKC transparently and comprehensively evaluates the commercial value of products, product candidates and the entire portfolio for companies or third parties. The main focus lies on the questions of reimbursement potential in Germany and other European markets from the perspective of market access.
- As a basis for the evaluations SKC uses existing sources of the company or, if required, SKC conducts its own research and market analysis. Where possible and applicable, SKC also works with pseudonymized SHI data.
- Together with the company, SKC develops specific value stories for the products and supports the company with the identification and a customized approach for the relevant stakeholders and key players.
- The stakeholders involved in in the respective process (e.g. early benefit assessment, changes of the G-BA Rules of Procedure) are profiled and prioritized by SKC. Individual communication measures are derived, suitable communication channels are identified and the stakeholders are integrated within the scope of legal regulations.
- In the area of stakeholder and public affairs management, SKC benefits from its contacts and knowledge from more than a decade of consulting experience in healthcare – for payers, service providers, manufacturers and their associations as well as for politics. The existing excellent contacts in the SKC-network are purposefully utilized to deliver the key messages accurately. Furthermore, SKC has carried out various successful projects with the most important stakeholder group in the system: with patients, their advocacy groups and their representatives.
- Alexion Pharmaceuticals
- Astellas Pharma
- Bayer Vital
- Berlin Chemie
- Bristol Myers Squibb
- Destin Arzneimittel
- Laboratoires C.T.R.S.
- Roche Pharma
- Shionogi & Co.
- Shire Deutschland
- United Therapeutics
- UCB Germany
- Verband forschender Arzneimittelhersteller
Your Contact Person
Prof. Matthias P. Schönermark, M.D., Ph.D.