Orphan drugs in Germany

Orphan drugs and the specific market access challenges are at the core of our expertise.

For the market access of orphan drugs in Germany, there are specific challenges that the manufacturer faces due to the rarity of the disease, like small population size and studies of lower evidence levels. As a result, there is a considerable uncertainty about the added value of the drug which can lead to intense and sometimes strenuous negotiations with high rebates. Pharmaceutical companies planning to introduce new orphan drugs into the German market should prepare a sound strategy well in advance to ensure a successful market entry.

SKC consulting is a strategic consultancy focussed on the increasingly challenging market access environment of innovative drug products. We support the successful market access both on a strategic and an operational level.

In total we supported the market access of more than 40 orphan drug products.

As market access special forces, the strategic challenges of orphan diseases, ATMPs, repurposed drugs and products altering the treatment paradigm are our specialty.

Orphan drugs are a core topic of our publications and white papers. Further, SKC was main sponsor of the Orphan Drugs & Rare Diseases Conference series in 2018 and 2019. Our presentation topics were amongst others "Risky business: success and failure in orphan drugs' business model" and "Orphans, gene therapies and ATMPs – solving the pricing & reimbursement conundrum".

Please find a selection of our recent articles below.

Our mission


We facilitate that patients with diseases for which no or only limited treatment options are available receive access to effective treatments.

White paper, publications and blogs

Publication (2021):

A claims data study in Germany

SKC Whitepaper (2020)

Market Access for Gene Therapies 2.0

Publication (2019)

Orphan drugs after GSAV

Market Access Strategy


We can build your sound market access strategy at an early stage, giving you and all parties involved valuable orientation throughout the entire market access process.

Strategic Pricing & Pricing Negotiations


Gain confidence for your decisions with us! We analyze with you individual pricing mechanisms and the European reference price system.

Value Dossier


With our agile value dossier, you receive an evidence-based value line of argumentation that strategically and logically incorporates the product's value story into the entire document.

Pharma & Biotech


SKC is the partner of choice for German market access and the AMNOG process.
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