Hygieia signs commercial agreement with BCBS of Michigan, granting zero copay coverage of BGM + insulin guidance service to type 2s with A1c >7% – July 6, 2018

In a nice pilot-to-market victory, Hygieia recently announced that it has signed a three-year commercial agreement with Blue Cross Blue Shield of Michigan (BCBSM), making its d-Nav insulin guidance service (specialty clinics + insulin titration + remote care + BGM) available at no cost – including no co-pays – for fully-insured type 2s. Beginning this fall, the d-Nav Service will be available to all BCBSM members in Southeast Michigan who use insulin to treat their type 2 and have an A1c >7%.

The agreement follows a direct BCBSM investment in Hygieia to support the cost of a 1,000-patient, 12-month reimbursement study. At ADA, a poster presented extremely compelling nine-month data from the demo project: A1c at the nine-month mark dropped a remarkable 2.3% (from a high baseline of 9.4%). For individuals taking one or more expensive medication (GLP-1 agonists, DPP-4 inhibitors, SGLT- 2 inhibitors) at baseline, average prescription savings were $6,172 per patient-year. Across the entire population, prescription savings were $1,736 per patient-year. 90-day interim results from the pilot were shared in February, and Hygieia’s six-month RCT data was also presented as an oral presentation at ADA.

Though this is a US commercial agreement, we assume that the d-Nav BGM with built-in titration still needs to obtain FDA clearance. The current device is not cutting-edge in terms of user experience, though patients in the study reportedly appreciated its simplicity. Manual docking to a cellular-enabled station is one way to transmit the device’s data, though sending the results “is definitely not a requirement” for the insulin titration service. A next-gen fully-integrated cellular-enabled version of d-Nav is in the works.

As of February, there were ~600 people using d-Nav globally – to our surprise, the service has not scaled particularly quickly, despite some very promising pilot/demonstration results. CEO Dr. Eran Bashan anticipates this latest agreement will generate “significant growth for Hygieia.” The Hygieia device is CE marked, and as of last September, the NHS was paying about £150 per patient per month for the d-Nav service.

  • We’ve followed up with Hygieia on a number of different items, and will report back with more: (i) global user base; (ii) status of integration with Amalgam Rx; (iii) confirmation of FDA clearance; (iv) status of cellular-enabled meter; (v) further US commercialization plans.


-- by Brian Levine, Adam Brown, and Kelly Close