December 22, 2020 - No Comments!

Yescarta Managed Access Agreement

NHS England and the National Institute for Health and Care Excellence (NICE) are working with pharmaceutical companies to address uncertainty about the effectiveness of new cancer treatments. This usually involves collecting additional data during a period of access to management, during which patients can access treatment. The additional data will help NICE decide whether a new treatment should be funded on a regularly. Now, Yescarta is provisionally covered by the Cancer Drug Fund. The details of the trade agreement were not mentioned, so it is not clear how much of a rebate offered to Gilead to earn the refund. New drugs on the market in Germany are freely included within the first 12 months after launch, during which an HTA is implemented and a reimbursement recommendation is issued by the Joint Federal Committee (G-BA). This HTA will be used in subsequent (capping) price negotiations with the GKV Spitzenverband, the umbrella organisation of Germany`s 109 health insurers (January 2019) [25.26]. Innovative pricing and reimbursement mechanisms such as obR have historically been rare in Germany, but the introductions of Kymriah® and Yescarta® illustrate some evolution in this regard. Both Novartis and Gilead have entered into interim agreements for results-based discounts for Kymriah® and Yescarta® during the initial 12-month free pricing period (with the possibility of renewal). These OBR systems have been agreed with several health insurers, including two subsets of insurers.

These two organizations are VDEK (an organization of six health insurance companies) (TK, Barmer, DAK-Gesundheit, KKH, HKK and HEK) and GWQ ServicePlus (an organization representing several medium-sized insurers). The agreements with these various health insurance companies affect a total of more than 41 million people [27], or nearly 60% of the 70 million Germans covered by compulsory health insurance [26], representing a considerable market share. The German system allows additional funds for hospitals that introduce new and more expensive therapies that are not properly covered by existing DRG rates. Hospitals wishing to use new and more expensive therapies may apply to the Institute for Hospital for Hospitalverg-tung (InEk) a new examination and treatment status (NUB) for the new therapy allowing hospitals to negotiate additional costs with insurers (if granted). The deadline for NUB applications expires each year on the 31st. A NUB 114 code has been established for 2019 for "the administration of CAR-T cells for the treatment of hematological diseases" (NUB-Status 1) [32], which helps to reduce a significant barrier to patients` access to both CAR-T cell therapies through a formal process of negotiating additional funding. NUB rates paid by insurers to hospitals are only for the drug and do not cover other related costs, for example. B apheresis, administration, toxicity management, etc. In the absence of additional funding agreements, these costs must be covered by existing DRG rates, but existing DRG rates are considered insufficient to cover all of these costs.

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