Reimbursement Planning and Implementation

Boston Healthcare has worked with established and emerging companies to create innovative market and reimbursement strategies. Below are summaries of typical project case studies:

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.

Boston Healthcare develops an implementable strategy for preparing to secure appropriate and consistent coverage, coding, and payment through research with physician stakeholders, Medicare Carrier Medical Directors, and cell collection providers to assure that data captured in the course of the Phase III trial addresses questions likely to arise in the technology assessment process by physicians and payers. Boston Healthcare recommends timing for initiation of other reimbursement activities and tactics to be completed prior to launch.

The company incorporates findings from Boston Healthcare’s recommended strategy into the ongoing Phase III trial and engages Boston Healthcare to conduct follow up research to incorporate updated distribution models and to account for the impact of recent Medicare legislation in commercialization plans.

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 Strategy and Implementation

Boston Healthcare has worked with established and emerging companies to create innovative business development strategies. Below are summaries of typical project case studies:

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.

Partnering, Deal Structuring & Negotiation
A small biotechnology company, with an innovative technology platform having applications across a variety of clinical areas, seeks funding to continue the development of their technology and to better position themselves for an IPO. Boston Healthcare is retained to identify those indications best suited for out-licensing. Utilizing a unique screening and assessment approach, Boston Healthcare identifies the optimal out-licensing opportunities. At the same time, Boston Healthcare initiates discussions with a large, multi-national pharmaceutical manufacturer and assists our client in closing a $25 million deal. This enables the company to continue R&D efforts and to enter the public market with greater credibility.

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.

Assessing the Business Development Potential for a Bioinformatics Tool Company
Boston Healthcare worked with this life sciences knowledge management software company to outline a business development strategy. Our team examined market trends, competitor profiles, and opportunities in the drug discovery, clinical trials, and patient level informatics arenas. We then went on to develop and compare potential service/business models and probable deal structures and values for the business development group.

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.

Market Analytics

Boston Healthcare has worked with established and emerging pharmaceutical companies in a variety of capacities, ranging from formulating full marketing plans to developing components of a launch plan, such as positioning and pricing assessments. Boston Healthcare sets high standards for its market research capability and prides itself in the ability to conduct quality research and offer actionable recommendations to its clients. Below are summaries of typical project case studies:

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.

Strategic Mapping (Positioning) Research
Boston Healthcare worked with a biopharmaceutical company preparing for the launch of a pain management therapeutic. Boston Healthcare conducted qualitative research with potential prescribers to assess the impact of two potential strategic directions and to understand the opportunities and barriers associated with each potential scenario. Recommendations from this research led to in-depth, in-person research to test positioning “stories” and determine the key elements to be incorporated into the initial launch message.

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.

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.

Developing a Market Strategy for a Drug Discovery and Clinical Diagnostics Platform
Boston Healthcare worked with this emerging analytical platform company to assess the market opportunity in the US in the preclinical and clinical diagnostics markets. Issues examined included market segment trends, market potential by segment, service/business models, competitor profiles, pricing, and the complex and changing environment for reimbursement and coding for genetic testing.

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.

Biopharmaceuticals

Boston Healthcare has worked with established and emerging biopharmaceutical companies to create innovative market and reimbursement strategies. We have particular expertise in analyzing the market and reimbursement environment for office-administered specialty drugs. Below are summaries of typical project case studies:

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.

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.

Market Opportunity Assessment and 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.

Medical Devices

Boston Healthcare has worked with established and emerging medical device companies to create innovative market and reimbursement strategies. Below are summaries of typical project case studies:

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.

Portfolio Growth Strategy for Wound Care Technologies
Boston Healthcare worked with a global wound care company to examine its entire product and technology portfolio and the market in which its products compete. The assignment involved identifying market drivers and a detailed analysis of the competitive landscape and pipeline, pricing pressures, reimbursement, contracting, and competitor marketing and sales structures. Issues addressed included a gap analysis of the client’s portfolio and its licensing strategy to identify and acquire new technologies.

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).

Diagnostics

Boston Healthcare has worked with established and emerging IVD companies to create innovative market and reimbursement strategies. Below are summaries of typical project case studies:

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.

IVD Business Development Strategy
An IVD company with a novel cardiac risk marker needs to identify the critical path to achieve maximum value based on optimal business partnering and reimbursement pathways. Boston Healthcare is engaged to identify benchmarks that are critical for maximum success and to identify risks and rewards for different partnering models. Boston Healthcare uses primary and secondary research with blinded technology profile and discussion guides to assist in testing various business models with key stakeholders. Boston Healthcare constructs laboratory payer mix model which estimates the average reimbursement and profit expectations for various laboratory markets. Boston Healthcare analyzes the difference in implementation support needs based on various partnering options and finds coding application, cost impact modeling, lab partner support, and payer engagement to drive necessary coverage.

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.

Commercialization Strategies for Novel Clinical Diagnostics
Boston Healthcare has worked with many companies, both test developers and service providers in clinical diagnostics, to assess the market opportunity and 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.