NMPA Approves the First Medical Device Through Real-World Data Program

Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program.

The program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers, including one represented by China Med Device.

What’s the Device?

The glaucoma treatment system comprises gel stent and injector. The NMPA Approval Notice states that “the gel stent and injector are for patients with refractory glaucoma who failed previous surgical treatment or in patients with primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.”

The gel stent is a soft, permanent, subconjunctival implant that shunts fluid from the anterior chamber to the subconjunctival space. Approximately 6-mm long and the width of a human hair, the stent comes preloaded in a disposable Xen injector and is implanted through a small, self-sealing corneal incision. The stent’s collagen-derived non-inflammatory gelatin material allows it to conform to the ocular tissue, possibly minimizing many of the issues seen with synthetic materials such as migration, erosion and corneal endothelial damage.

The number of people with glaucoma in China was 13.12 million in 2015, according to a study published by Peking University, China. Allergan’s minimally invasive gel stent will benefit the huge population with lowering Intraocular pressure and reduced topical medication use without the inherent risk of traditional drainage surgery.

How to Obtain Real-World Data?

On December 13, 2019, NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft).” The document specifies the sources of RWD as following:

1. Data derived from electronic health records (EHRs)
2. Medical claims and billing data
3. Data from product and disease registries
4. Patient-generated data, including from in-home-use settings
5. Data gathered from other sources that can inform on health status, such as mobile devices.
6. Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.

What Does the Real-World Data Do?

The real-world data collected in the Boao Medical Pioneer District was used to “evaluate ethnical differences” of the glaucoma treatment system, NMPA says in the notice.

The Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft) describes eleven situations where RWD can be utilized in China:

1. To be used in Clinical Evidence Report (CER) for comparison of same type products
2. To be used with existing clinical evidence to support product registration
3. To be used as supplementary data to support product registration
4. To be used as the external control for single group experiment
5. To provide clinical data for the establishment of single-arm objective performance criteria
6. To support modification of Scope of Application and Intended Use
7. To support modification of clinical claims in package insert
8. To support post-market studies on products which are granted Conditional Approval
9. To be used for the evaluation of long-term safety and efficacy of high-risk implants or similar medical devices
10. To be used for clinical evaluation of a medical device for treatments of rare disease throughout the full Life Cycle to expedite the product registration
11. To be used for post-market surveillance

Commitment of post-market research is required after obtaining the approval. Currently Allergan’s Enrollment Status is till “recruiting” (see ClinicalTrials.gov link HERE), with 65 patients participated.

Another Clinical Pathway

New drugs and devices that have been approved overseas but have not been marketed in China can be licensed for import in the Boao Medical Pilot Zone, and patients can apply and use them through Real-World Data program.

Real-World Data will become a major clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary.

Certain protocols and guidelines need to be followed for the Real-World Data to be admitted as part of the clinical evidence for submission. The China Med Device client who participated in this pilot program will benefit from this new policy.

What’s the implication for reimbursement?

China is a one payer system society covered under the 3-tier social insurance scheme, including urban employee, urban residents and rural residents.  Coding, coverage and payment also differ on a provincial level; with the affluent, coastal cities usually have more favorable coverage policies and higher reimbursement.

The first step is to secure a charge code and the application is initiated by hospitals.  Afterwards, manufacturers can then work with hospitals to get the code on the provincial reimbursement list (aka “the Big Green Book”).  In the China glaucoma market, iTrack from Ellex has applied for a charge code with Tong Ren hospital in 2018, and the price is 6500RMB (about 940USD).