Overview of prices for gene and somatic cell therapeutics in Germany. Prices are ex-factory prices unless marked otherwise. If the G-BA cannot sufficiently assess the benefit for a drug because of small trial populations, or accelerated authorization and therefore lack of clinical evidence, the result of the benefit assessment can be terminated. In these cases, the G-BA can request the collection of additional post-authorization data by the pharmaceutical company. The framework of the real-world data collection has to be decided on in collaboration with the G-BA, potentially creating additional challenges for the manufacturers.
The contracts for these reimbursement models, as well as associated negotiations, are strictly confidential and further details are not known. Nevertheless, these contracts represent a reimbursement model for existing and future high-priced medicinal products. This period may lead to some uncertainty until the maximum reimbursable price is set. However, this process takes on average at least 4 weeks until approval. In some cases as mentioned previously , special care contracts are negotiated to set incentives.
Most of the ATMPs are only available for inpatient treatment. For inpatient use, it is possible to apply for an extra budgetary reimbursement—the Neue Untersuchungs- und Behandlungsmethode NUB. This pathway is relevant, if the new drug is not sufficiently reimbursed or covered by an existing German diagnosis-related group G-DRG. Applications need to be repeated year by year until the cost for the new drug is implemented in the G-DRG system at least for 2 years.
Following the submission, every NUB application will be assigned a status, determining if a reimbursement negotiation is permitted:. If the NUB status is 1, 3, or 4, the hospital can negotiate add-on reimbursement with the health insurances.
Table 2 reflects the way innovative inpatient treatments have been incorporated into the DRG system over the past 5 years.
For the chimeric antigen receptor T-cell CAR-T therapies Kymriah and Yescarta, the first NUB was Status 2, followed by 4 and now 1, which perfectly reflects the route to market for a highly specialized inpatient-use medicine. As a new, innovative inpatient treatment, the application also includes necessary treatment components or steps, such as apheresis for material preparation.
These services are additional effort for the hospital and are only related to the new treatment. For these services, hospitals might face a reimbursement gap as usually no reimbursement code exists with inpatient reimbursement being very limited. As such, discussions started on how to sufficiently finance these additional efforts for the application of CAR-T—and probably for other gene and cell therapies. The challenges for a successful way to the market for ATMPs are mainly two: the assessment of evidence by the regulator and the affordability to payers.
Manufacturers should prepare for the G-BA to implement mandatory disease registries in cases of non-conclusive evidence at the time of market launch. The G-BA will be part of setting up the methods and requirements for these individual registries, and this will likely become the standard for ATMPs. ATMP price will be significantly reduced over time if a company is non-compliant in setting up a real-world registry.
From the payer perspective, the use of real-world evidence data is anticipated to rise significantly. Pay-for-performance agreements linked to clinical outcomes of a drug will rise, but discounts and other specifics of the contract will most likely remain confidential. Outlook for advanced therapy medicinal product price negotiations in Germany. HTA Quarterly. Spring We use cookies and tracking technologies to offer you a better browsing experience, analyze site traffic, and improve the website.
If you wish to prevent your data from being used by Google Analytics you can opt-out below. Accept cookies Google Analytics Opt-Out. Family Sponsorship Petition Form I Electronic Notification Form G Looks like you were working on a application just now. Applicants typically only require one service at a time. Because your friend referred you, your application with Boundless is discounted. Not sure if you qualify for a marriage-based green card?
Start by checking your eligibility. Get green card checklist. Learn what we do for you. Who needs to fill out the IA? How much does it cost to file Form IA? How long does it take to process Form IA? What supporting documents are required for Form IA? How and where should I submit my IA form? Start with your last or current employer and work your way backward for five years.
Only complete this section if you have not already provided the information in Part 2 of the form. In addition, you must also provide a daytime phone number, a cell-phone number if available , and an email address if available.
The spouse beneficiary must also sign and date Form IA unless the spouse beneficiary lives abroad. Remember, if any answer is not answered fully and accurately, your immigration application both I and IA will be delayed and may be denied. If an interpreter helped you understand the questions, this person is required to complete the questions in Part 5. Included with this information are name, address, contact information, business or organization name, and any certification the interpreter holds.
The interpreter is also required to sign and date the form. If you were assisted with completing your Form IA, this person is required to provide their name, address, contact information, a statement attesting to any accredited representation. The person who assisted you in preparing the form is also required to sign and date the form at this point. Use Part 7 if you need additional space in answering questions on this form.
If you use this space, or if you need to attach additional paper to complete an answer, make sure you type or print your full name and Alien Registration Number on the top of every page to assure these pages remain in your file should they become separated. Because Form IA is a supplemental form and filed at the same time as Form I, the processing time is the same — about 7 to 13 months.
If your spouse is already in the U S. If you do not file Form IA at the same time you file your I application, you will not be able to establish an immediate family relationship with your spouse. Need help with filing out Form IA? Home Services About Guides Menu.
Book a consultation. Written by. John Carter. Let us help you start your application today! What is Form IA?
0コメント