Diasome

Project Background

Diasome, a clinical stage pharmaceutical company, has developed an insulin delivery system called Hepatic Directed Vesicle (HDV) insulin. HDV enables a small portion of current insulin products to be directed to the liver, restoring the liver’s physiological role in glycemic equilibrium. This technology has been shown to decrease hypoglycemic events in patients with type 1 diabetes, making it unique in the diabetes treatment space. HDV could also potentially improve overall glycemic control which, combined with it benefits in hypoglycemia, could provide a substantial advance in the treatment of diabetes.

Project Objective

We were tasked with developing a positioning strategy for either the acquisition of Diasome, or for their HDV technology to be licensed. Based on independent research and conversations with Diasome management we determined the positioning would ultimately be similar for acquisition and licensure, then took the following approach to developing the appropriate strategy.

1. Identify the important stakeholders for HDV if it were to be adopted

2. Collect primary data, analyze existing data, and conduct interviews with key opinion leaders to assess HDV’s value and potential barriers for each stakeholder

3. Conduct a brief market analysis to understand comparable products and precedence for acquisitions in this space

4. Analyze and translate information gathered from data to develop our strategy

Project Results

Given the nature of Diasome and the overall diabetes treatment landscape, the team identified the key stakeholders as Acquirers, Patients, Providers, and Payers. Based on analysis of the unique needs of each of those stakeholder groups detailed below, three overarching recommendations were presented to Diasome to guide their positioning for licensure or sale:

1. Provider acceptance is the key to success for diabetes products, so for Diasome to convince an acquirer, the company must demonstrate a clear path to adoption of HDV insulin by providers

2. Diasome’s most effective argument for that adoption is that their product improves patient safety and overall patient wellness, all at a low manufacturing cost and minimal patient burden

3. HDV insulin is most compelling to all stakeholders as a pre-mix additive to insulin, given that and the current diabetes market, the "Big Three" insulin manufacturers are the optimal acquirers

Data Analysis and Stakeholder Interviews

To test our primary hypothesis, we needed to connect with three key stakeholder groups: patients, physicians, and payers. Between those groups, there was already detailed information available for payers at the onset of the project (from a previously conducted survey of payers). Insights from the two remaining key stakeholder groups needed to be collected and analyzed by our team.

The patient-focused data came from an online survey hosted by Diasome’s preferred platform, Thrivable, and provided insight into two core questions: “Are patients willing to try something new? If not, what would prevent them from doing so?” and “Do patients consider hypoglycemia a big enough issue to try something new?” The survey recorded the perspectives of 182 insulin-dependent Type 1 and Type 2 patients aged 18 and older in the United States.

The physician-focused data came from Zoom interviews with KOLs, primarily endocrinologists. The conversations were meant to provide insight into the following core questions: What unmet needs exist with current diabetes treatment protocols? How significant is hypoglycemia in the clinical management of diabetes? Based on the current data, do physicians consider Diasome / HDV Insulin a viable treatment modality? What (potential) barriers do providers see to wide-spread adoption of Diasome? We connected with 5 physicians/experts over the course of the project.

Underlying Key Recommendations by Stakeholder Group

The final recommendations made to Diasome, in terms of how they should position themselves, were segmented based on the target stakeholder group.

Patients: The patient-centric recommendations were developed based on the results of the online survey and were focused on answering the two previously mentioned core questions. We recommend that Diasome should:

1. Focus on getting physicians to adopt & recommend the product, as it is the largest driver of patient adoption

2. Focus the patient-centric messaging on how lack of hypoglycemic incidents improves quality-of-life, to target those whose hesitation is driven by fear

Providers: The physician-centric recommendations were developed using the KOL conversations and were focused on answering the previously mentioned core questions. Based on these conversations we recommend that Diasome should:

1. Focus on direct education of providers in Centers of Excellence and spreading the word on the safety and efficacy of HDV technology

2. Consider emphasizing the benefits of HDV technology for patients (on top of the increased clinical outcomes), including lifestyle flexibility and improvements in quality of life

3. Market the product simplicity as well as provide real-time guidance, perhaps in the digital health management space, to get providers to drive patients to the product

Payers: The payer-centric recommendations were developed based on an analysis of in-depth telephone interviews with 15 pharmacy directors from national and regional plans (including traditional health insurers, PBM’s and IDN’s) covering Commercial, Medicare, and Medicaid lives provided by the client. Based on this analysis we recommend that Diasome:

1. Develop compelling educational materials for payers—specifically around prevalence of Type 1 diabetics not meeting glycemic targets—to maximize favorable coverage and formulary inclusion

2. Focus their positioning of HDV therapy around preventing hypoglycemic events that cause direct healthcare costs (e.g., emergency room visits, hospitalizations)

3. Start their positioning with a stand-alone add-on mix, and then when the opportunity presents to partner with a "Big Three" player, they could leverage the respective player’s well-established insulin into a pre-mix

4. Consider designing a pragmatic “real world” study with an open label to demonstrate to both potential partners and payers increased compliance, which is a large focus of both of these stakeholders

Given HDV is perceived by payers as a unique additive product, not a direct competitor to existing insulins, we believe this favors Diasome positioning HDV for bolt-on acquisition by a "Big Three" player to allow for ease of inclusion within the existing competitive contracting space.

Conclusion

Innovation in the diabetes market is necessary and possible, but to stand out, a product needs to show promise amongst all the stakeholders. According to the analyses done by our group, we concluded that Diasome’s HDV product has the potential to create an impact in the diabetes space if the stakeholders’ concerns and needs are managed well. Physician endorsement of the product as well as positioning the product as one that lowers hypoglycemic emergency events would aid the company in creating a path of acceptance and adoption. Implementing these recommendations will ultimately allow Diasome to reduce healthcare costs for the system and aid patients in controlling their insulin levels without disrupting daily activities or making extreme lifestyle changes.

Final Thoughts

Overall, it was an extremely enriching and fulfilling learning opportunity for our group to collaborate with the Diasome team. We value the strategy-centric project that we worked on throughout the semester and hope our work was impactful in the process. Thank you to Professors Carri Chan, Peter Tollman, and Taylor Sewell for the constant guidance and support as well.

Contributors: Amna Abbasi, Nicholas Cosentino, Joe Crosson, Harrison Shapiro, Jaques Williams