Home
Services
Processes
About Us
News

+49 6173 / 39 41 0 16
Contact us

AMNOG

AMNOG negotiation guide

Calculate reimbursement realistically
Identify negotiation options
Estimate negotiation range

AMNOG Formular_2025

What kind of product will be negotiated?

Medicinal product

Orphan drug

Reserve antibiotic

Is there a comparative therapy?

Yes, patent-protected comparative therapy

Yes, the comparative therapy is generic

Nicht zutreffend (z. B. keine Vergleichstherapie oder patentgeschütztes vergleichbares Arzneimittel verfügbar)

Did the patent protected comparative therapy undergo an AMNOG benefit assessment?

Yes

What is the extend of the expected added benefit?

Major

Considerable

Minor

Non-quantifiable

What is the extend of the expected added benefit?

Major

Considerable

Minor

No added benefit

No or incomplete dossier submitted

Is there a type 2 reference price group?

Yes

What is the type of appropriate comparative therapy?

Patent-protected appropriate comparative therapy

Generic appropriate comparative therapy

In case of a patent-protected comparative therapy: Did the studies which are relevant for the assessment include more 5 % or more German patients?

Yes

Did the patent protected comparative therapy undergo an AMNOG benefit assessment?

Yes

Reserve antibiotic

For a reserve antibiotic the launch price does not need to be negotiated. The price will probably be negotiated on the level of the hospitals.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Generic
Expected extend of the added benefit	Major

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Not applicable
Expected extend of the added benefit	Major

Result

Negotiable premium price¹	< Launch price
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Not applicable
Expected extend of the added benefit	Considerable

Result

Negotiable premium price¹	< Launch price
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Not applicable
Expected extend of the added benefit	Minor

Result

Negotiable premium price¹	< Launch price
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Not applicable
Expected extend of the added benefit	Non-quantifiable

Result

Negotiable premium price¹	< Launch price
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Generic
Expected extend of the added benefit	Considerable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Generic
Expected extend of the added benefit	Minor

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Generic
Expected extend of the added benefit	Non-quantifiable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	Yes
Expected extend of the added benefit	Major

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	Yes
Expected extend of the added benefit	Considerable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	Yes
Expected extend of the added benefit	Minor

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	Yes
Expected extend of the added benefit	Non-quantifiable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	No
Expected extend of the added benefit	Major

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator – 15 %
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	No
Expected extend of the added benefit	Considerable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator – 15 %
Additional 20 % combination rebate possible²	Unlikely

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	No
Expected extend of the added benefit	Minor

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator – 15 %
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Type of Product	Orphan drug
Potential comparative therapy	Patent-protected
Comparative therapy was subjected to AMNOG	No
Expected extend of the added benefit	Non-quantifiable

Negotiable premium price

Upper limit¹	< Launch price
Lower limit	> Price of the cheapest comparator – 15 %
Additional 20 % combination rebate possible²	Possible

Starting position of the pharmaceutical company = launch price

Starting position of the statutory health insurance = price of the cheapest comparator

The negotiated premium price generally falls within the upper and lower limits displayed.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No added benefit
Reference price group type 2	Yes

Result

Negotiable premium price	Fix amount
Additional 20 % combination rebate possible¹	Possible

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	Yes

Result

Negotiable premium price	Reference price
Additional 20 % combination rebate possible¹	Possible

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No added benefit
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Generic

Result

Negotiable premium price	≤ Price of the ACT
Additional 20 % combination rebate possible¹	Possible

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Generic

Result

Negotiable premium price	< Price of the ACT
Additional 20 % combination rebate possible¹	Possible

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No added benefit
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price	≤ Price of the ACT – 10 %
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price	≤ Price of the ACT – 10 %
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price in the first 3 years²	< Price of the ACT
Negotiable premium price after 3 years²	≤ Price of the ACT – 10 %
Additional 20 % combination rebate possible³	Possible

In regard to the population of the studies relevant for the assessment.
If 5 % or more German patients are included in the studies relevant to the evaluation, the strict AMNOG guidelines introduced by the SHI Financial Stabilization Act are suspended. The premium price is initially valid for 3 years. If the pharmaceutical company proves that an active research department and active research projects exist in Germany, the negotiated reimbursement amount can remain valid beyond the 3 years. However, if there is no active research department and research projects in Germany, the reimbursement amount must be renegotiated after 3 years, taking into account the strict AMNOG guidelines.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	no added benefit
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price for the first 3 years²	≤ Price of the ACT
Negotiable premium price after 3 years²	≤ Price of the ACT – 10 %
Additional 20 % combination rebate possible³	Possible

In regard to the population of the studies relevant for the assessment.
If 5 % or more German patients are included in the studies relevant to the evaluation, the strict AMNOG guidelines introduced by the SHI Financial Stabilization Act are suspended. The premium price is initially valid for 3 years. If the pharmaceutical company proves that an active research department and active research projects exist in Germany, the negotiated reimbursement amount can remain valid beyond the 3 years. However, if there is no active research department and research projects in Germany, the reimbursement amount must be renegotiated after 3 years, taking into account the strict AMNOG guidelines.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No added benefit
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	No

Result

Negotiable premium price	≤ Price of the ACT – (10 % + 15 %)
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	No

Result

Negotiable premium price	≤ Price of the ACT – (10 % + 15 %)
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No or incomplete dossier submitted
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	No

Result

Negotiable premium price in the first 3 years²	≤ Price of the ACT – 15 %
Negotiable premium price after 3 years²	≤ Price of the ACT – (10 % + 15 %)
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	No added benefit
Reference price group type 2	No
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	No

Result

Negotiable premium price in the first 3 years²	≤ Price of the ACT – 15 %
Negotiable premium price after 3 years²	≤ Price of the ACT – (10 % + 15 %)
Additional 20 % combination rebate possible³	Possible

In regard to the population of the studies relevant for the assessment.
If 5 % or more German patients are included in the studies relevant to the evaluation, the strict AMNOG guidelines introduced by the SHI Financial Stabilization Act are suspended. The premium price is initially valid for 3 years. If the pharmaceutical company proves that an active research department and active research projects exist in Germany, the negotiated reimbursement amount can remain valid beyond the 3 years. However, if there is no active research department and research projects in Germany, the reimbursement amount must be renegotiated after 3 years, taking into account the strict AMNOG guidelines.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Minor
Appropriate comparative therapy (ACT)	Generic

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT
Additional 20 % combination rebate possible¹	Possible

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Minor
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price for the first 3 years – upper limit²	< Launch price
Negotiable premium price for the first 3 years – lower limit²	> Price of the cheapest ACT
Negotiable premium price after 3 years²	≤ Price of the cheapest ACT
Additional 20 % combination rebate possible³	Possible

In regard to the population of the studies relevant for the assessment.
If 5 % or more German patients are included in the studies relevant to the evaluation, the strict AMNOG guidelines introduced by the SHI Financial Stabilization Act are suspended. The premium price is initially valid for 3 years. If the pharmaceutical company proves that an active research department and active research projects exist in Germany, the negotiated reimbursement amount can remain valid beyond the 3 years. However, if there is no active research department and research projects in Germany, the reimbursement amount must be renegotiated after 3 years, taking into account the strict AMNOG guidelines.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Minor
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	Yes
ACT was subjected to AMNOG	No

Result

Negotiable premium price²	≤ Price of the cheapest ACT – 15 %
Additional 20 % combination rebate possible³	Possible

In regard to the population of the studies relevant for the assessment.
If 5 % or more German patients are included in the studies relevant to the evaluation, the strict AMNOG guidelines introduced by the SHI Financial Stabilization Act are suspended. The premium price is initially valid for 3 years. If the pharmaceutical company proves that an active research department and active research projects exist in Germany, the negotiated reimbursement amount can remain valid beyond the 3 years. However, if there is no active research department and research projects in Germany, the reimbursement amount must be renegotiated after 3 years, taking into account the strict AMNOG guidelines.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Minor
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	Yes

Result

Negotiable premium price	≤ Price of the cheapest ACT
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Minor
Appropriate comparative therapy (ACT)	Patent-protected
5 % or more German patients¹	No
ACT was subjected to AMNOG	No

Result

Negotiable premium price	≤ Price of the cheapest ACT – 15 %
Additional 20 % combination rebate possible²	Possible

In regard to the population of the studies relevant for the assessment.
Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Major
Appropriate comparative therapy (ACT)	Generic

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Considerable
Appropriate comparative therapy (ACT)	Generic

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Major
Appropriate comparative therapy (ACT)	Patent-protected
ACT was subjected to AMNOG	No

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT – 15 %
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Considerable
Appropriate comparative therapy (ACT)	Patent-protected
ACT was subjected to AMNOG	No

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT – 15 %
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Major
Appropriate comparative therapy (ACT)	Patent-protected
ACT was subjected to AMNOG	Yes

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Summary

Product type	Medicinal product
Expected extend of the added benefit	Considerable
Appropriate comparative therapy (ACT)	Patent-protected
ACT was subjected to AMNOG	Yes

Negotiable premium price

Upper limit	< Launch price
Lower limit	> Price of the cheapest ACT
Additional 20 % combination rebate possible¹	Unlikely

Note combination rebate: In accordance with Section 130e SGB V, a 20 % combination rebate applies to new active ingredients if they are dispensed at the expense of the health insurance fund in a combination with other new active ingredients specified by the Federal Joint Committee. The combination discount is only removed if the combination can show at least a considerable additional benefit.

Your compass in the AMNOG process

The AMNOG price calculator provides you with an initial indication of the possible reimbursement price for your product. Let us take the next step together – we will support you with strategy, dossier and negotiation.

Get in touch +49 6173 / 39 41 0 16

WS Value & Dossier GmbH
Rheinstraße 2
65760 Eschborn

+49 6173 / 39 41 0 16
ws@value-dossier.com

AMNOG

AMNOG Negotiation Guide

Calculate

Legal notice
Data privacy