Achieve

Licensing Strategy & Implementation
A small biotechnology company with promising oncology product candidates in Phase III and Phase I of clinical trials needs immediate funding for on-going clinical development efforts and also seeks to establish strategic relationships that will better position them for a near-to-mid-term IPO. Boston Healthcare identifies a target list of potential partners, initiates discussions with these potential partners, establishes and negotiates the financial terms, and is instrumental in closing a $97 million deal with a large, multi-national pharmaceutical company for both products for our client. With the partner relationship helping to validate the client’s core intellectual property, the client is able to raise an additional $16 million with a successful IPO.

Creating Commercialization Strategies for Novel Clinical Diagnostics
Boston Healthcare has worked with both test developers and service providers in the clinical diagnostics arena to assess the market opportunity and to then develop strategies for market entry of new tests or services. These engagements typically examine everything from test or service market potential, to likely reimbursement milestones, adoption curve modeling, and product/service forecasts and financial plans.

Concept and Promotional Material Testing
Boston Healthcare tested the promotional message and several visual concepts for a new sales aid for a hospital-based anti-infective. The research involved in-depth, in-person interviews at a focus group facility with several physician specialties that make treatment choices and are actively involved in the care of the patient. The research was completed within a very short time period thus allowing the company to work with its advertising agency to finalize the sales aid and launch it with the sales force, coupled with recommendations on the key elements to include in the sales message.

Patient Satisfaction Research
Boston Healthcare has worked with several companies to determine the degree of patient satisfaction with a newly launched therapeutic. These engagements can be completed using several different methodologies, including telephone-based interviews and web-based surveys.

Reimbursement Assessment and Managed Markets Strategy for Specialty Drug
Boston Healthcare assisted a client that was preparing to launch a new physician administered drug for chronic pain patients. As part of the assignment, Boston Healthcare conducted a situation analysis of the coding, coverage and payment environment for the drug within the physician office, inpatient, ambulatory surgical setting, and hospital outpatient department. The payer mix for the drug was also validated. Using primary market research with payers from public and private commercial plans, Boston Healthcare identified the key strategic issues that would accelerate routine reimbursement of the drug. Boston Healthcare worked with the client to develop a reimbursement strategic plan for the launch. Using this plan, the client and Boston Healthcare worked to develop tactical support materials to be used with the payer decision makers and decision making bodies such as technology assessment committees and pharmacy and therapeutics committees.

Several quarters before the launch of the drug, Boston Healthcare began a strategic profiling of the key payer organizations within all payer segments. The goal of this work was to examine any existing coverage policies for the drug, the expected decision making process for the technology, the expected time line for review and the decision makers to be involved. During the profiling, the top 40 commercial managed care plans were identified and profiled, all Medicaid states were contacted and profiled and the Medicare contracting carriers were also profiled. In addition, the team identified the Carrier Medical Committee members who work with the Medicare Contracting Carriers since it is important that these physicians are familiar with and support the technology in order to drive positive explicit Medicare policies.

Upon launch, Boston Healthcare conducted training on the reimbursement environment for the sales representatives as well as an advanced training program for the National Account Managers who call on the payers. Boston Healthcare also prepared and submitted two coding applications to CMS which subsequently have been successfully granted. The client’s team has been driving positive coverage policies from managed care and Medicare contracting carriers at an above industry standard rate.

Reimbursement Strategy for Novel Specialty Drugs
Boston Healthcare leverages its core competencies to develop reimbursement strategies for novel specialty therapeutics for a range of clients. Focus areas have included chemotherapeutics, oncology vaccines, pain management, Crohn’s disease, and psoriasis. Analysis includes all payer segments including Medicare, Medicaid and private payer markets.

Implementation Strategy to Influence Technology Adoption and Increase Reimbursement in Multiple Sites of Care
A medical device company wants to launch a new device for conducting an existing surgical procedure. The device offers numerous clinical and operational benefits, including the ability to visualize the surgical field more effectively and complete the procedure in approximately half the time it takes to operate using traditional technologies. However, since the technology is utilized in both inpatient and outpatient hospital settings and freestanding ambulatory surgical centers, it is impacted by multiple coverage and reimbursement systems and is subject to geographic and payer-related variations in payment rates. This highly complex reimbursement environment is negatively influencing technology adoption. Boston Healthcare is engaged to assess the situation and develop a strategy for securing appropriate and consistent coding, coverage and payment throughout the United States. Boston Healthcare works to develop an interactive cost effectiveness model to demonstrate the financial and operational impact of adopting the new technology. After introducing the reimbursement tools developed by Boston Healthcare, the client company realizes a greater than 30% increase in sales of its product in the United States.

Submissions Strategy for a Small Medical Device Company
A small company ready to enter the medical device arena has no current experience gaining clearance with the FDA. Boston Healthcare explains the regulatory process, advises on the documents needed, and provides the framework for the 510(k) submission. We provide templates and help author many of the 510(k) sections, as well as provide training in areas foreign to them such as Risk Management, Software Validation, Clinical testing, and Substantial Equivalence. After gaining a full understanding of the 510(k) process, the company successfully submits and receives clearance for their 510(k).