China Establishes a Regulatory Pathway for Companion Diagnostics

by | Jul 8, 2020 | Blog

The Chinese government has implemented a series of efforts to improve access to novel oncology therapies, one example of this is the significant reductions via state-level price negotiations. The National Health Commission of China, the Health Ministry body in China, recently released a clinical practice to regulate physician prescribing behavior for novel cancer therapies, this echoes governmental efforts to control costs.

Novel oncology therapies include small molecular drugs and monoclonal antibodies. There are three key takeaways from the guideline which have implications for therapy and CDx manufacturers:

  1. Biomarker Testing: Biomarker testing is mandatory prior to therapy prescribing
  2. Restricted Use of Non-reimbursed Therapies: Unreimbursed oncology drugs’ use is restricted in the sense that prescription right is limited to senior specialists only. Oncology therapies which are not can only be prescribed by senior specialists
  3. CDx Market Authorization: CDx’s must be registered with the China Food and Drug Administration (CFDA)

Biomarkers Testing

To maximize physician compliance with guidance for cancer diagnosis and therapy selection, the 2019 guideline states that the prescription of the targeted therapies and monoclonal antibodies must be based on analyses, The guideline even tries to specify by name which drug would require biomarker tests (see Table 1).

Table 1. Classification by biomarker testing availability

Lung Cancer Gefitinib   Erlotinib Icotinib Afatinib Dacomitinib Osimertinib Crizotinib Alectinib Ceritinib Bevacizumab   Recombinant Human Endostatin Anlotinib Nivolumab Pembrolizumab Everolimus

The First Implication for Therapy and CDx Manufacturers

Given the relatively low biomarker testing rates that exist today, there will likely be an interim period of declining prescribing rates. Nonetheless, this creates an opportunity for therapy and Companion Diagnostics manufacturers to collaborate to increase patient access to CDx’s and as a result of these targeted therapies.

Restricted Use of Non-reimbursed Therapies

The guideline has categorized the unreimbursed drugs as “Restricted Use”. Essentially, the restriction is designed to limit the prescribing right to specialists, in some cases, this may require supervision MDT or formulary committee review.

To use the Lung cancer example again, among the lung cancer drugs listed in Table 1, three drugs – Dacomitinib, Nivolumab, Pembrolizumab are “Restricted” drugs and prescription could only be done by a senior oncologist.

The Second Implication for Therapy and CDx Manufacturers

Therapy manufacturers, particularly those with an oncology portfolio, have traditionally worked closely with KOLs and specialists. Guidance on the restricted prescribing rights on non-reimbursed therapies strengthens the need for these relationships to be continually strengthened.

CDx Market Authorization

The guideline states that tests used by the health providers platform and reagents), must be authorized by (better known as CFDA). This will result in increased regulatory oversight of lab-developed tests (LDTs) within China and is reflective of similar trends seen in other markets (e.g., USA and EU).

Notably, the guideline uses the term “CDx,” however to date there is no pathway for CDx’s. All cancer tests, with or without CDx status are classified as Class III tests (the highest risk level). Thus, it is not an uncommon phenomenon that targeted therapies are available without a corresponding biomarker test.

In recent years we have observed an increase in the number of therapy and CDx coordinated CFDA registrations as a result of voluntary collaboration between pharma and CDx players. The industry’s efforts have also led to an increased understanding of companion diagnostics of CFDA.

The Third Implication for Therapy and CDx Manufacturers

In June, CFDA initiated preparatory work for the development of “The Technical Guidance for Synergizing the development of CDx with the Targeted Drugs”, this is string indicator that the CFDA will likely introduce a dedicated pathway for CDx’s, this will provide clarity and a structured pathway for CDx manufacturers entering the Chinese market.

Advanced diagnostics is a key business area for Veranex (formerly Boston Healthcare Associates) as well as Specialty Drugs. We also have a deep understanding of the evolving healthcare landscape in China. Our in-market experts closely monitor the policy and market trends in the strategic markets like China to help clients stay on top of industry trends and develop strategies and action plans to tap into the opportunities or tackle the issues. Please contact us to see how we can help.


[1] Clinical Practice Guideline for Novel Anti-cancer Drugs (2019)