Case Studies

Legal support for Creatives, Artists, and Innovators.


Case Studies

 

Xcelsum works with start ups, medium sized and Fortune 500 companies on a variety of projects - from product opportunity assessment to large scale commercial team deployment.

Examples of our work:


Companion Diagnostic Testing messaginG

To drive utilization of a novel oncology therapy, a client needed to communicate the requirement for a companion diagnostic test to a varied audience of payers, providers and patients. Payer messaging was built on educating them on how by covering the diagnostic they would target the appropriate patients for the therapy, saving money by getting them into treatment sooner while not wasting the healthcare dollar on other drugs that would not be efficacious. Physician messaging was built on the need for the companion diagnostic and coverage for the therapy that included payers not just covering the test, but not approving the therapy without the test. Given patients would be incurring additional costs in the form of copays on the diagnostic plus wait time for results, patient education materials were developed to explain why these diagnostic tests were a critical part of their treatment plan.


Medical device reimbursement strategy and training

The client received positive CMS and private insurance coverage for its continuous glucose monitoring device. However there were nuances in coverage among the various plans which required educating the patient of potential coverage gaps. We provided reimbursement training to the sales team and streamlined redundancies in the transaction process. One key learning identified which benefits were most likely to result in faster approval to ensure that patient’s quality of life was improved. The company incorporated this change in strategy and has enjoyed significantly increased sales.


Colorectal Diagnostic Test messaging

A new, non-invasive diagnostic test needed to revise messaging to consumer and physician audiences. The physician messaging did not fully consider the economic impact to a physician’s practice if the test was used inappropriately. This hurt the adoption rate of the new technology. Physician messaging was revised to ensure physicians viewed the tests more positively; Patient messaging was too complex as determined by key payers. We developed a more consumer friendly content that was more consistent with the managed care plans’ audience. Both content revisions tested well with their respective audience.


KOL impact on treatment guidelines

During a meeting with a disease advocacy organization, we were informed of a meeting to revise treatment guidelines for an acute condition. We noticed that the guidelines committee did not include an emergency medicine physician. The organization asked for recommendations and they identified an appropriate physician for inclusion in the committee. Subsequently, treatment guideline revisions resulted in improved patient safety.


Product Portfolio Positioning and Payer Strategy

A pharma company with a portfolio of products in the metabolic disease market wanted to reassess its strategy with smaller, regional payers. We led a war games scenario to provide insight on how to properly position the portfolio vs competitors. We concluded that overall product positioning was on target, but due to differences in regional payers’ decision-making process, evidence presented needed to represent the regions’ population and culture. Account executives were provided with materials that incorporated relevant local information.


Increasing pull through at a managed care plan

Several months after signing an agreement with one of the largest MCOs in the country, the company noticed that prescriptions for a specialty drug was virtually nil. We brought key stakeholders together among the market access team, field force and sales management to develop a pull through strategy tailored for this scenario. Access to the physician specialty was restricted by several gatekeepers within the organization. The strategy session uncovered potential clinical influencers using KOL relationship mapping and identified access points outside of the MCO institution where field reps were permitted to discuss the value proposition of the product. Initial prescriptions were generated as a result.


Commercialization of a novel analgesic

A start up company was seeking to divest an analgesic asset with a unique delivery system. We created a complete go to market commercial plan including budgets, sales forecast, commercial team staffing , clinical support, HEOR studies and product life cycle planning. The asset was shortly acquired by an established pharmaceutical company.


Prepare a Fortune 500 Company for regulatory audit of their pharmacies 

The client needed to perform an internal audit in preparation for an FDA audit. Utilizing our team’s knowledge and experience, we reviewed the company’s procedures, created SOPs, provided guidance to the regulatory group and conducted an internal audit of their facilities. The company passed FDA audit with no form 483 issued.