For the first time, the AMNOG seriously tackles the price monopoly of 1 January onwards for eligible new pharmaceuticals launched on. Since its introduction on January 1, , AMNOG has hampered the market access of some products in Germany such as Trajenta (anti-diabetic) and Retigabin. AMNOG is here to stay. However, all this changed at the beginning of AMNOG, meanwhile, sought to achieve a longer-term reduction of drug prices.

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In February the legislator stopped all planned assessments of the established market by changing the law 14th Social Code Book V Amendment Act.

– AMNOG since

The decision could also depend on a patient’s disease state prior to initiating a new treatment. While a manufacturer can estimate the extent of additional benefit of a new substance over the comparator using indirect comparisons ICICs bear a high potential for bias.

Authentic innovations which 211 real progress for patient care will increase. For the evaluation of the additional benefit, the pharmaceutical companies must submit a 211 to the Federal Joint Committee at the time of the market launch of their medicinal product. In andIQWiG therefore developed appropriate scientific methods, newly organized procedures, and trained additional staff.

On the occasions when PFS is accepted as the primary endpoint, marketing authorization is typically conditioned on the new treatment not decreasing the 20111 when compared with the control in the study.

The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade.

Instead of using ICER, the German and French decision makers for pharmaceutical product reimbursement place their primary focus on determining the clinical benefit from clinical studies. This change will influence the treatment choices available to the physician and patient.

We highlight three key changes in the proposal that all pharmaceutical manufacturers should be monitoring to prepare for successful launches in Germany: The still relatively new law applies to all pharmaceutical products with a new active ingredient that have been launched beginning January 1, For one thing, removing a component in ajnog composite endpoint could reduce the power of the study.

The actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria. Stable contributions for the community of insured parties are a major asset.


The same subsection in ICH E9 also states that the primary endpoint should be specified in the protocol. We hope that IQWiG would consider taking advantage of the output from the above efforts in determining the net benefit. Combination of direct and indirect evidence in mixed treatment comparisons.

Implementation of AMNOG: An industry perspective

Therefore, reducing the number of events in the groups by removing a component from the composite endpoint leads to a larger variance for the log hazard ratio estimate and a wider confidence interval for the log hazard ratio.

Documents will be accepted ambog 27, 28 and 31 December from 8: Please include the required documents on CD or DVD, along with a cover letter signed by an authorized person including authorization, if applicable and addressed to the Federal Joint Committee: The second phase involves price negotiation.

IQWiG’s rationale is described briefly as below. Insofar as a nonmedicinal treatment is considered as the comparator, this must be deliverable within the framework of the statutory health insurance.

It further states that redefinition of the primary endpoint after trial results are known will almost always be unacceptable, since the biases this introduces are difficult to assess. In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis. Accordingly, in the early benefit evaluation, new medicinal products that are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly evaluated within a fixed-rate context section 35a subsection 1sentence 4, of Book Five of the Social Code.

Please include the required documents on CD or DVD, along with a cover letter signed by an authorized person including authorization, if applicable and addressed to the Federal Joint Committee:. The benefit of the medicinal product to be assessed is smaller than the benefit of the appropriate comparative therapy.

Third, the margins are based on the expectation of two large studies. The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints. Pharmaceutical companies will benefit from the new arrangements in the medium term. European Journal of Cancer 45— For medicinal products with no proven additional benefit, the National Association of Statutory Health Insurance Funds negotiates a refund rate with the pharmaceutical company in accordance with section b of Book Five of the Social Code.


No assessment along these social law criteria additional benefit is carried out on approval. If there are several indications, several comparative therapies may also be defined.

The same approach could be considered when another endpoint is used to make the benefit decision. Pharmaceutical companies may expect in future to receive a suitable refund rate for real innovations. If no added benefit can be determined, a reference price is allocated to the new drug or a price that is not allowed to be higher than that of the comparator therapy. This resolution is published without delay, and includes the G-BA’s decision on the pricing procedure for the new medicine.

Author information Article notes Copyright and License information Disclaimer. However, due to the brief processing period of 3 months, the involvement of patients is not easy. In the third year of early benefit assessments IQWiG determined the highest category of benefit for the first time, and in several cases. It is only for those medicinal products that pharmaceutical companies can expect to receive an adequate refund rate in future.

The process to determine reimbursement decisions under the new law consists of two phases and is described in Fig. Journal of Clinical Epidemiology These also stipulate that the expedient comparative therapy which in each case was determined by the resolution of the Federal Joint Committee, and its annual therapy cost, are considered to be the most important aspects.

AMNOG since 2011

On the rare occasions when a component of a composite endpoint is removed, we propose in Section 2. The Act hence obliges pharmaceutical companies to subject their new products to an early evaluation of their additional benefit, to be carried out by the Amog Joint Committee, after being launched on the market.

Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.