Memorandum

Voluntis achieves FDA clearance and CE mark for Basaglar and Tresiba; Available at pilot centers in several US states – November 16, 2017

Executive Highlights

  • With FDA clearance and CE marking of automated titration guidance for Lilly’s Basaglar (biosimilar insulin glargine) and Novo Nordisk’s Tresiba (insulin degludec), Voluntis’ Insulia type 2 basal insulin titration is now compatible with all five major basal insulins.
  • Voluntis aims to launch NPH and GLP-1/basal combination titration in 2018.
  • Insulia is now available in the US at pilot centers in several different states, though the company is not ready to share user base metrics. (We’d speculate it’s in the hundreds.)
  • Payer interest is reportedly strong – Voluntis has established payment based on a per-patient-per-month fee, but there is also a risk-sharing component based on pre-specified outcomes goals.
  • In France, the broad rollout of Insulia (basal-only) and Diabeo (basal-bolus) is accompanied by strong National reimbursement: €750 (~$883) per patient-year for Diabeo, and up to €600 (~$707) per patient- year for Insulia, a bonus for realized cost savings, and up to €340 (~$400) per patient-year for remote monitoring. That means even the most basic version is reimbursed at €50 per month – very encouraging.
  • See our full Q&A with Voluntis below.

Voluntis announced earlier today that its basal insulin titration app Insulia has received FDA 510(k) clearance and the CE mark to integrate Lilly’s Basaglar (biosimilar insulin glargine) and Novo Nordisk’s Tresiba (insulin degludec). Following FDA clearance last December, this makes Insulia now compatible with every major basal insulin (also Lantus, Levemir, and Toujeo). The company is working to develop and commercialize automated titration for NPH as well as GLP-1/basal insulin combinations, with a goal to launch in 2018. Last December, we were also told that Voluntis intended to bring basal-bolus titration to the US market (already available in France), though no timing has ever been given, as far as we know.

The press release notes that Insulia is now available throughout the US with a prescription from a healthcare provider (providers can enroll their clinics here). Despite the “broadly available” designation, Voluntis told us in a Q&A (below) that Insulia is currently being rolled out in pilot centers in several different states, and they are not yet ready to share the number of patients or prescribers using Insulia. Indeed, the app on Google Play has just “10-50 installs”, and neither the iTunes or Play stores show any reviews.

In the US, Voluntis is working directly with payers to cover Insulia under the medical and pharmacy benefits, citing “strong” interest. The company is also in talks with commercial health plans, pharmacy benefit managers (PBMs), and government payers. On pricing, Voluntis charges a monthly utilization fee for patients actively using Insulia, but also shares risk with partners by setting outcomes goals. Nice! We wonder what percent of the average contract is risk-based and what the deal terms look like. We’re glad to hear that payers are interested, though we don’t have the sense that this is “truly” broadly available. Hopefully strong ROI from the pilot locations will be enough to nudge other payers into coverage.

Meanwhile, in France, a nationwide rollout of both Insulia (basal only) and Diabeo (basal-bolus) is underway. The National Health Payer, which covers 60 million lives, will reimburse up to €750 (~$883) per patient-year for Diabeo, and up to €600 (~$707) per patient-year for Insulia, plus a bonus payment according to realized healthcare cost savings. Perhaps most exciting, the care teams get a specific reimbursement of up to €340 (~$400) per patient-year to remotely monitor patients using Diabeo or Insulia! That also means even the most basic version of Insulia is reimbursed at €50 per month – very encouraging. This is the sort of incentive structure that we want to see more of, especially as more app move to titrate insulin and provide remote support.

  • Voluntis hopes to launch soon with partners Ascensia (previously expected in “4Q17”) and Livongo (previously expected in “2017”). At this point, the company is in the midst of integrating Insulia into their respective products. No updates were given specifically on the partnership with Sanofi (pilots in North America and the EU in “2017”), though Voluntis said the pharma giant has been “instrumental in contributing to Insulia going global.” The faster insulin titration can be brought to the masses the better – we have a vision of one day looking back at insulin “in the wild” (without the aid of automated titration) as antiquated! It’s hard to know how long it will take the get there.
    • Fortunately, Voluntis doesn’t have to bear the burden of bringing titration to the masses alone; the competitive landscape is growing. There are over 10 players in the insulin titration field by our count, including seven systems FDA-cleared (some patient-facing and some provider facing). This areas has at least 12 partnerships to speak of. It’s encouraging to think that the majority of players have come emerged in the past year, building up the dose titration and pen dose capture landscape with great rapidity. Still, we’re waiting on a real launch and adoption – we suspect business and service models and plugging into clinical workflow are among the toughest barriers.

Q&A with Voluntis

Q: How many current Insulia users are there in the US? How many current prescribers are in the US?

A: We are currently rolling out the solution with pilot centers in several different states. It’s a bit early to share specific information but we hope to divulge more soon.

Q: How much does the product cost on a monthly basis? What is the reimbursement model? What is the reimbursement process?

A: In the US, we are working directly with payers to cover the product under the medical and pharmacy benefits with reimbursement operationalized via established claim submission channels. We’ve priced Insulia at a level that allows payers to realize strong ROI over a near-term time horizon and value across multiple areas. Voluntis has established a monthly utilization fee for patients actively using Insulia and we share risk with our partners by setting outcomes goals and entering into value-based coverage agreements.

In Europe, we are starting our nationwide commercial launch in France. There, we are rolling out Insulia as well as Diabeo, our basal-bolus solution. These solutions will be reimbursed by the National Health Payer (covering 60 million lives) up to €750 per patient per year for basal-bolus patients, and up to €600 per patient per year for basal-only patients. There is also a bonus payment according to realized healthcare cost savings. The care teams get a specific reimbursement of up to €340 per patient per year to remotely monitor these patients using these solutions. This is a virtuous coverage framework, providing incentives to the key stakeholders so they can better manage diabetes using digital solutions.

Q: Which US payers cover Insulia now, if any?

A: We’re actively working on contracting with commercial health plans, pharmacy benefit managers, and governmental payers to ensure expanded coverage of the product. Although we cannot identify specific payers by name, we can say that payer interest is strong due to value across both the medical and pharmacy benefits. We anticipate coverage of digital insulin titration to be a standard benefit inclusion over the coming years.

Q: What are the statuses of the Livongo, Sanofi, and Ascensia projects?

A: We have an excellent, long-standing relationship with Sanofi, who has been instrumental in contributing to Insulia going global. We also continue to have great working relationships with Livongo and Ascensia. We’re in the middle of integrating their products with Insulia and we hope to launch soon with both.

Q: Is reimbursement holding back a true broad launch of the product?

A: Insulia is broadly available today. Any HCP or clinic can sign up on insulia.com and we’ll try to get in touch with patients’ HCPs to sign them up if individuals are interested as well. We’re looking at every aspect to drive utilization. Of course, that includes reimbursement and we’re negotiating with payers now. But we’re also looking at collaborating with more health systems and providers.

 

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