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Reimbursement Assessment for Product Launch
An international pharmaceutical company needs an initial reimbursement assessment of both the inpatient and outpatient environments for their target product. Boston Healthcare is engaged to provide the full range of reimbursement services necessary to support product launch. Boston Healthcare conducts an internal reimbursement infrastructure needs analysis. Boston Healthcare develops a white paper to educate payers and increase awareness about a specific disease area, conducts field force reimbursement training, and develops a data capture system to profile major U.S. payers for peri-launch activities. Detailing the critical path and timeline for the relevant coding process, Boston Healthcare develops coding stakeholder relationships and enlists coding advocates in anticipation of submitting for a novel code. Conducting a reimbursement hotline needs analysis for the target and two additional products, Boston Healthcare develops key criteria for evaluating hotline vendors and interviewing and evaluating hotline vendors. Boston Healthcare was able to execute many of the tactical elements of the reimbursement plan and develop the subsequent U.S. reimbursement strategy for the target product.

Assessment and Strategy for Coding and Coverage of a New In Vitro Diagnostic
A diagnostics company is preparing to launch a new in vitro diagnostic test. Realizing that gaining reimbursement will be critical, particularly with Medicare, the manufacturer engages Boston Healthcare to assess the situation and develop a strategy for coding and coverage. We carefully document the current situation including competitive product strategies, and suggest a proactive educational effort with key Medicare contracting carriers. Based on this analysis, we partner on behalf of the client with the appropriate medical specialty society to submit a request to the American Medical Association (AMA) to revise the current CPT coding to ensure that our client’s technology will be included in the code description. The change to the coding is secured.

Reimbursement Assessment and Strategy for a Biotech Company’s Development-Stage Cancer Vaccine
A biotechnology company is developing a personalized cancer vaccine and is preparing to enter Phase III trials. Since the procedure to manufacture the vaccine requires a cell harvesting procedure in addition to the vaccine administration, attaining coverage, coding and payment for the product must incorporate the process to acquire the cells as well as to the final product. In addition, the patient population is primarily covered by Medicare, and issues pertaining to Medicare reform and payment reform for drugs and biologics covered by Medicare will impact distribution of the product and Medicare coverage and reimbursement. These issues will also influence private payers.

Situation Analysis and Implementation of Reimbursement Plan for Greater Utilization of FDA-Approved Product for Small Pharma Company
A small pharmaceutical firm with an FDA-approved product has been unsuccessful in achieving strong sales and reimbursement, despite early targeting of private managed care organizations (MCOs) and the VA, the two groups identified as key payers for the product. Boston Healthcare is engaged to conduct a situation analysis to define the causes of the low levels of utilization and reimbursement. We develop a strategy and plan for increasing awareness and maximizing reimbursement. Functioning as the national accounts component of our client’s sales force, we confirm or achieve coverage for the product in 152 MCOs and PBMs accounting for over 21 million lives. Additionally, we organize and spearhead a successful regional effort that results in our client’s product being added to the new VA National Formulary. Reimbursement status at key payer organizations is communicated to field sales representatives to facilitate greater utilization by providers and patients.

Business Development Assessment & Valuation Modeling
Boston Healthcare has worked with both established and emerging companies to assess the market opportunity for novel specialty drugs. These engagements typically examine everything from market potential, to likely reimbursement milestones, adoption curve modeling, and product forecasts. Detailed primary research is often conducted with a mix of opinion leaders and community practice physicians depending upon stage of development. Boston Healthcare also offers real options and discounted cash flow valuation modeling, often to support business development transactions.

Developing a Branded Business Strategy for a Generic Pharmaceuticals Company
Boston Healthcare worked with this established generic pharmaceuticals company to create a business development strategy for a newly-created branded pharmaceuticals division. Work included prioritized strategic initiatives that combined in-licensing marketed products with development of R&D capabilities capitalizing on core strengths.

Pre-Launch Market Analytics for a Specialty Pharmaceutical
Boston Healthcare was engaged over a period of three years to act as the market analytics arm and generate and assimilate the market data needed for a targeted market launch of a specialty pharmaceutical in the gastroenterology market space. Over the course of the engagement, Boston Healthcare conducted a product/market opportunity assessment, a reimbursement assessment and strategy, a KOL evaluation of the product, qualitative and quantitative positioning and messaging research, market sizing, including the creation of a forecast model, and evaluation of sales material and collateral. In addition, Boston Healthcare worked with the company to test and obtain market input on several iterations of a risk management program. The research methodologies used ranged from telephone interview to in-person research at facility and web-based designs (including internet surveys and tools such as Webex in combination with a telephone discussion). A range of stakeholders were included in the numerous research projects, including physicians, patients, payers, infusion nurses, and hospital pharmacists.

Pricing Analysis
Boston Healthcare examined the impact of several pricing scenarios on the adoption and utilization of a new therapeutic for an autoimmune condition. Boston Healthcare assessed the likelihood to prescribe the drug relative to potential treatment outcomes (clinical and economic), coverage scenarios (insurance status and co-pay structure), and price. Combinations of these attributes were tested qualitatively and quantitatively with physicians, payers and patients. The recommendations from the research allowed the company to develop targeted strategies for each stakeholder group in order to maximize its price opportunity.

Assessment of US Reimbursement Environment for Specialty Pharmaceuticals
A large oncology care provider needs to assess the evolving market for specialty pharmaceuticals. Boston Healthcare examines the approach payers take to manage specialty pharmaceuticals, and organizes these payers into a series of strategic “buckets” denoting their timelines and approaches to aggressive management. Boston Healthcare determines a key distinction between oncology agents, supportive care agents, and other specialty drugs with regard to levels and timing of management through specialty pharmacy or other options to physicians “buy and bill.” Boston Healthcare delivers a dollar volume projection of management strategies in a five year pro-forma.

Specialty Distribution and Specialty Pharmacy: Trend Analysis
Boston Healthcare has worked with several pharmaceutical companies and service providers examining the evolving specialty pharmacy arena. Work has included specialty pharmacy player profiling and positioning, and forecasting industry evolution. Boston Healthcare has also worked with biopharmaceutical companies to develop specialty distribution strategies.

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).

Reimbursement Strategy for Novel Breast Cancer Test
A diagnostic company needs a reimbursement strategy and assessment for a novel breast cancer test. Boston Healthcare is engaged to implement a strategy to achieve appropriate coding, coverage, and payment. Boston Healthcare performs primary research with key stakeholders including physicians, payers, and laboratory directors. Boston Healthcare also performs research with key coding decision-makers to understand the appropriate coding and how the codes may change over time. A strategy is developed which aligns the clinical message with the best coverage and payment opportunity.

Reimbursement Assessment & Implementation for Women’s Health IVD
Boston Healthcare has worked with a company focused on novel diagnostics in the women’s health. Boston Healthcare has assisted the company in many areas to support reimbursement and commercialization, including development of a reimbursement strategy, preparation and submission of CPT coding applications, development of payer strategies and profiling, and health economic modeling and white paper development. Boston Healthcare has also worked closely with the client’s laboratory partners to support their effort in maximizing reimbursement and developing payer pull-through programs.

Reimbursement Strategy, Pricing, & Sales Forecasting for Cardiovascular Risk Technology
Boston Healthcare has worked extensively with this novel in vitro cardiovascular risk assessment technology to develop a reimbursement and coding strategy, as well as pricing and forecast models. Work has continued on implementation of these strategies, with Boston Healthcare providing support on alignment of reimbursement and market strategies, engaging laboratory partners to drive adoption, and preparation of a novel CPT coding application.

Reimbursement Strategy for Novel Molecular Diagnostics Platform
Boston Healthcare examined the reimbursement and coding environment for a novel amplification and hybridization technology. Issues addressed included the complex and changing environment for reimbursement and coding for genetic testing, likely reimbursement and payment outcomes for the technology, and strategies for engaging in and influencing the ongoing debate regarding coding and payment for molecular diagnostic technologies.