No-Substitution List - SAL
Rebate contracts according to § 130a Abs. 8 SGB V are - besides reference pricing - the greatest threats for manufacturer of pharmaceuticals, for the rebate contract game drops reimbursement prices down to the bone. Rebate contracts are issued by the statutory sick funds (SHI) in TED. They are bound and regulated by the VOL A/B and follow a rigid procedure and strict bidding rules. Until today bid & tender were targeted in the clear majority at generic APIs. But in the last two years increasingly the sick funds issued bid & tenders for innovative and still patent protected drugs.
There remain just 2 instruments to avoid the rebate contract trap. On the one hand one can motivate the physician to put a cross in the „aut-idem“- field on the prescription. This leads to an exclusion of the substitution by the pharmacist. On the other hand, there is the possibility to put the active ingredient of the product on the No-Substitution-List (SAL). This is realized with an application at the G-BA.
There are a few criteria for the inclusion on the SAL:
- Amount of aut-idem decisions by the prescribing physicians
- Amount of non-replacements due to pharmacists’ decisions
- Solubility in water is low
- A narrow therapeutic range, in accordance with the criteria of „Critical Dose Drug“ (CDD)
- If the official package leaflet requires a kind of a drug-monitoring
- Greater variations in plasma level concentrations
- Great variations in the bioavailability
- Critical galenical forms like f.e.: retard capsules, entericcoated capsules, etc.
We will check your products to assess the chances for a listing on the no substitution list. If we will identify reasonable chances for your product, EPC HealthCare will prepare the appropriate application for the federal committee (G-BA). After the official application we will support you in hearings and around all phases of the assessment procedure by the G-BA until the final decision.