China’s new policy to speed up international drug approvals by accepting overseas data
On 10 July 2018, the China Drug Administration (CFDA) released a new guiding principle to allow companies to use overseas clinical trial data in their applications for new drug approvals. Read more here.
Recently, Medicare published two CRs associated with the NGS NCD, identifying covered tests and associated CPT and ICD-10 diagnosis codes. These CRs (CR11655 and CR11749) indicated that MSK-IMPACT and MyMRD NGS Panel were nationally covered under the NGS NCD.
G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case
In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without complete clinical data at the time of approval.
The National Health Commission of China recently released a clinical practice to regulate physician prescribing behavior for novel cancer therapies which echoes the government's efforts to control costs.