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SummaryThe list price stays. The volume moves. Section 130e SGB V does not change reported prices but the demand structure, and for pharmaceutical wholesale that is the decisive difference. A single tender result can make a medicine's sales collapse, without a new competitor entering the market, without the price falling, without anything changing in the therapy. This article deepens the section 130e mechanism from the supply-chain perspective. It is written for professionals, not patients.
The BStabG is adopted and, with promulgation, section 130e is in force. What at first looks like a price-regulation topic is in practice a demand-structure topic, and that concerns pharmaceutical wholesale directly. The message for the distribution stage fits in one sentence: the list price stays, the volume moves. Four immediate fields of action follow for wholesalers, which we return to at the end.
Under section 130e SGB V (recast), health insurance funds may, for the first time, sign rebate contracts for patent-protected medicines too. The text allows funds to form groups of medicines with patent-protected active ingredients of therapeutically comparable effect within a therapy area and to tender them exclusively and across active ingredients. In a pilot phase until 31 December 2030 this applies to five defined substance groups.1 Decisively, assessing therapeutic comparability and forming the concrete tender groups lies with the funds, not the G-BA; funds can select from the five pilot groups which active ingredients they define as equivalent and include in a tender.
The result: a fund awards an exclusive contract to one manufacturer. The text is clear that contract physicians must prescribe the group's rebated medicines unless medical reasons argue otherwise in an individual case, so the prescribing flow structurally follows the tender winner.1 What does not change is the list price. For the pilot-group products this is usually not the original manufacturer selling price but the reimbursement amount agreed under section 130b SGB V, carried in the price and product directories since 2014 and billed across the distribution stages.10 What changes is the purchase volume. That is the difference wholesalers must understand.
The decisive point for the distribution stage: a rebate under section 130a(8) SGB V, the contract form section 130e refers to, is paid directly by the pharmaceutical company to the fund. It therefore runs past wholesale and pharmacy, not through them, and it is confidential.10 From this follows a consequence easily overlooked: an exclusive tender is not visible in wholesale price data. Purchase and selling prices stay unchanged. The tender becomes recognisable only through volumes, and by then the award is already made. Whoever relies on price movements for monitoring will structurally miss a tender award.
To gauge the scale: the statutory health insurance's net costs for medicines reached a record 59.3 billion euro in 2024, making medicines the second-largest GKV spending item.3 Patent-protected products accounted for 54 percent of the costs while making up only seven percent of prescribed daily doses,3 roughly 32 billion euro. All five section 130e pilot groups sit in this segment.
| Substance group | Therapy area | Active ingredients (selection, not exhaustive) |
|---|---|---|
| PD-1/PD-L1 inhibitors | Immuno-oncology | e.g. pembrolizumab (Keytruda®), nivolumab (Opdivo®), atezolizumab, durvalumab, cemiplimab |
| JAK inhibitors | Rheumatology, dermatology, haematology | e.g. baricitinib (Olumiant®), upadacitinib (Rinvoq®), ruxolitinib (Jakavi®), tofacitinib (Xeljanz®) |
| PCSK9 inhibitors | Cardiology / lipid metabolism | e.g. evolocumab (Repatha®), alirocumab (Praluent®), inclisiran (Leqvio®) |
| CGRP antagonists | Neurology / migraine prophylaxis | e.g. erenumab (Aimovig®), fremanezumab (Ajovy®), galcanezumab (Emgality®), eptinezumab (Vyepti®), rimegepant (Vydura®) |
| PARP inhibitors | Oncology (incl. gynaecology, prostate) | e.g. olaparib (Lynparza®), niraparib (Zejula®), talazoparib (Talzenna®), rucaparib (Rubraca®) |
The active-ingredient names are a selection and expressly not exhaustive; the current marketing-authorisation status is decisive. Exact supplier counts per group can be determined via an ATC query in the pharmazie.com PharMonitor for the respective date; GKV spending per individual pilot group is not publicly available.
The principle is familiar from the generic market, and the parallel is instructive. Since rebate contracts for generics were introduced in the mid-2000s, a recurring pattern has shown:
In the patent market this risk sharpens structurally. The five pilot groups span different product types: JAK and PARP inhibitors, like rimegepant, are small-molecule oral drugs, while the PD-1/PD-L1 inhibitors and CGRP antibodies are biologicals. Precisely for biologicals, production cycles are long and inflexible and fermentation processes complex, so capacity can be scaled up only to a limited degree at short notice. With annual therapy costs in the six-figure range and life-threatening conditions, a shortage weighs differently than for a generic antibiotic.
Since 1 April 2026 the exchange duty in the pharmacy applies to biologicals too, based on the new section 40c of the G-BA drug directive, which governs when a prescribed biological may be replaced by a cheaper biosimilar or bioidentical.9 For wholesale this mechanism is familiar: it acts same-substance and at the pharmacy. Section 130e works differently, and that is where its significance lies. A pharmacy cannot exchange between two different active ingredients; cross-substance tenders cannot be implemented at the dispensing stage. So the legislator acts a step earlier, at the physician's prescription, which is why the text expressly regulates contract physicians' duty to prescribe.1 For procurement this means: under section 40c the active ingredient stays in the assortment and the supplier changes; under section 130e a whole active ingredient can drop out of the tendering funds' prescribing. That is a different order of assortment risk.
The PCSK9 inhibitors serve well as an example because the group has few therapeutic alternatives, so concentration effects show especially clearly. The active ingredients available in Germany include evolocumab (Repatha®), alirocumab (Praluent®) and inclisiran (Leqvio®), with a narrowly framed prescribing indication.4 With an exclusive tender in this group the concentration effect would be especially pronounced, provided funds assign the active ingredients to a common tender group: the tender winner could unite much of the tendering funds' rebated prescribing volume, while the others typically lose purchase volume and production must cover the winner's raised demand. A particularity: inclisiran (Leqvio®) has a different mode of action (siRNA rather than a monoclonal antibody) and a different dosing schedule (a half-yearly injection rather than every two to four weeks). Therapeutic comparability within the PCSK9 group is medically debated, but the group formation lies with the funds, not the G-BA.
Step 1, portfolio check. Wholesalers carrying one or more of the five pilot groups should check now which PZNs belong to PD-1/PD-L1, JAK, PCSK9, CGRP or PARP. IFA data and ATC codes enable the identification.
Step 2, tender monitoring. Section 130e is in force with the BStabG. Funds may now begin preparations, and group formation, equivalence assessment and tender design realistically take several months.1 First tenders appear plausible for late 2026 or early 2027, though firm timetables do not yet exist. Whoever reacts only when the exclusive contract becomes known reacts too late.
Step 3, review the supplier profile. If a core product sits in one of the five groups, how concentrated is the supplier structure, and are there alternatives to the current main supplier, so a rapid adjustment is possible if the main supplier loses a tender?
Step 4, align stock planning to tender scenarios. The question is not whether tenders come but when and for which products. Stock strategies based on steady offtake are vulnerable to abrupt demand shifts, so scenario planning with tender-winner and tender-loser cases should now be built into purchasing. A real-time view that overlaps tender movements with shortage data, such as our drug shortage database for Germany, is the decisive early indicator of supply risk. The underlying pricing detail is set out in our overview of pharmaceutical pricing and market access in Germany.
The list price stays, the volume moves. That sentence captures section 130e from the distribution stage, and the volume question is the more existential for wholesale: inventory-value risk for products without an award, supply risk at the award winner. The generic market indicates the mechanisms that can arise; in the patent market, with high-priced biologicals, complex production and life-threatening indications, the stakes are higher. Those who now know the five pilot groups, build tender monitoring and align stock planning to scenarios hold an advantage, and the preparations on the fund side are likely starting now. The time for wholesalers is now, not after the first exclusive award. pharmazie.com supports this with tender tracking, winner identification, demand early-warning and a link to shortage data, exclusively for healthcare professionals.
1 Bundesministerium für Gesundheit / Bundestag: GKV-BStabG, section 130e SGB V recast (BT-Drucks. 21/6130, 21/7023); entry into force after BGBl. promulgation, summer 2026. bundesgesundheitsministerium.de
3 Wissenschaftliches Institut der AOK (WIdO): Arzneimittel-Kompass 2025. GKV net costs for medicines 2024: 59.3 billion euro; patent-protected share 54% of costs at 7% of prescribed daily doses. wido.de
4 G-BA benefit-assessment database: assessments of PCSK9 inhibitors and PARP inhibitors. g-ba.de
9 Gemeinsamer Bundesausschuss: section 40c of the drug directive (exchange of biotechnological medicines in the pharmacy), in force since 1 April 2026. g-ba.de
8, 10 Section 129 SGB V with the framework contract on drug supply (priority of rebated medicines on dispensing); section 130a(8) SGB V (rebate contracts, direct settlement between manufacturer and fund) and section 130b SGB V (reimbursement amount).
