Assessment of US Reimbursement Environment for Specialty Pharmaceuticals
A large oncology care provider needed to assess the evolving market for specialty pharmaceuticals. Boston Healthcare examined the payer approach for managing specialty pharmaceuticals, and organized these payers into a series of strategic “buckets” denoting their timelines and approach to aggressive management. Boston Healthcare determined 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 delivered a dollar volume projection of management strategies in a five year pro-forma.
Evidence Development Strategy to Support Adoption and Reimbursement
A medical device company was facing a change in coverage of an established knee repair device due to negative clinical benefit assessment by the German SHI system, even though the procedure had been performed for 10 years in the German market with high success rates and fewer complications than alternatives. The company engaged Boston Healthcare for an evidence development strategy for discussions with payers. Boston Healthcare was challenged by the statement of insufficient evidence from the SHI review body and a complex mix of stakeholders (SHI review board, different SHI funds, and orthopedic surgeons). The Boston Healthcare team outlined an evidence based response towards the SHI review board report and conducted a scientific systematic literature review for benefit assessment in alignment with stakeholders. We also developed a value and communication strategy with key bodies, leveraging support of KOLs and other relevant decision makers. While the lack of RCTs was an issue, the common agreement between stakeholders of the approach managed to move positions. Boston Healthcare’s approach to evidence assessment in nonrandomized studies added relevant piece for the manufacturer in the discussions for further reimbursement.
Due Diligence Support for Medical Device Innovator
Boston Healthcare was engaged by a global medical device manufacturer to support due diligence activities by assessing the US and European reimbursement landscape for the lead device product. The device was still going through the central decision making process in key European markets. Our in-market team performed primary and secondary research and accessed key central decision makers to meet project objectives. We learned that the manufacturer had an overly optimistic timeline for obtaining reimbursement in two key European markets. This finding alone had a significant impact on the valuation of the company and the final acquisition price.
Global HE&R Infrastructure Planning and Implementation for Medical Device Company
A large, global medical device company asked Boston Healthcare to develop a global health economics and reimbursement (HE&R) infrastructure. This need was triggered by an evolving portfolio strategy into disruptive devices that demanded evidence-based value analysis and planning. Historically, the HE&R staff had little input into clinical evidence planning and there was no process or communication channel to feedback O-US country customization requirements. Boston Healthcare analyzed the portfolio of businesses by key HE&R drivers, and performed an internal situation analysis and external benchmarking analysis. We discussed multiple options with the company’s executive team before recommending a structure that positioned the global HE&R function to be part of a core product development team to assess, communicate, and capture global evidence needs. The implementation included development and rollout of market access and HE tools and training.
Reimbursement Strategy for Novel Breast Cancer Test
A diagnostic company needed a reimbursement strategy and assessment for a novel breast cancer test. Boston Healthcare was engaged to implement a strategy to achieve appropriate coding, coverage, and payment. Boston Healthcare performed primary research with key stakeholders including physicians, payers, and laboratory directors. Boston Healthcare also performed research with key coding decision-makers to understand the appropriate coding and how the codes would possibly change over time. A strategy was developed which aligned the clinical message with the best coverage and payment opportunity.
IVD Business Development Strategy
An IVD company with a novel cardiac risk marker needed to identify the critical path to achieve maximum value based on optimal business partnering and reimbursement pathways. Boston Healthcare was engaged to identify benchmarks that were critical for maximum success and to identify risks and rewards for different partnering models. Boston Healthcare used primary and secondary research with blinded technology profile and discussion guides to assist in testing various business models with key stakeholders. Boston Healthcare constructed laboratory payer mix model which estimated the average reimbursement and profit expectations for various laboratory markets. Boston Healthcare analyzed the difference in implementation support needs based on various partnering options and found 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 works 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 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.
Reimbursement Assessment for Product Launch
An international pharmaceutical company needed an initial reimbursement assessment of both the inpatient and outpatient environments for their target product. Boston Healthcare was engaged to provide the full range of reimbursement services necessary to support product launch. Boston Healthcare conducted an internal reimbursement infrastructure needs analysis. Boston Healthcare developed a white paper to educate payers and increase awareness about a specific disease area, conducted field force reimbursement training, and developed 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 developed coding stakeholder relationships and enlisted 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 developed 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 was preparing to launch a new in vitro diagnostic test. Realizing that gaining reimbursement would be critical, particularly with Medicare, the manufacturer engaged Boston Healthcare to assess the situation and develop a strategy for coding and coverage. We carefully documented the current situation including competitive product strategies, and suggested a proactive educational effort with key Medicare contracting carriers. Based on this analysis, we partnered 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 would be included in the code description. The change to the coding was secured.
Reimbursement Assessment and Strategy for a Biotech Company’s Development-Stage Cancer Vaccine
A biotechnology company was developing a personalized cancer vaccine and was preparing to enter Phase III trials. Since the procedure to manufacture the vaccine required a cell harvesting procedure in addition to the vaccine administration, attaining coverage, coding and payment for the product needed to incorporate the process to acquire the cells as well as the final product. In addition, the patient population was primarily covered by Medicare, and issues pertaining to Medicare reform and payment reform for drugs and biologics covered by Medicare were potentially impacting distribution of the product and Medicare coverage and reimbursement. These issues would also influence private payers. Boston Healthcare developed 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 addressed questions that were likely to arise in the technology assessment process by physicians and payers. Boston Healthcare recommended timing for initiation of other reimbursement activities and tactics to be completed prior to launch. The company incorporated findings from Boston Healthcare’s recommended strategy into the ongoing Phase III trial and engaged 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 had 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 was engaged to conduct a situation analysis to define the causes of the low levels of utilization and reimbursement. We developed a strategy and plan for increasing awareness and maximizing reimbursement. Functioning as the national accounts component of our client’s sales force, we confirmed or achieved coverage for the product in 152 MCOs and PBMs accounting for over 21 million lives. Additionally, we organized and spearheaded a successful regional effort that resulted in our client’s product being added to the new VA National Formulary. Reimbursement status at key payer organizations was communicated to field sales representatives to facilitate greater utilization by providers and patients.
Licensing Strategy & Implementation
A small biotechnology company with promising oncology product candidates in Phase III and Phase I of clinical trials needed immediate funding for on-going clinical development efforts and was also seeking to establish strategic relationships that would better position them for a near-to-mid-term IPO. Boston Healthcare identified a target list of potential partners, initiated discussions with these potential partners, established and negotiated the financial terms, and was 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 was 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, was seeking funding to continue the development of their technology and to better position themselves for an IPO. Boston Healthcare was retained to identify those indications best suited for out-licensing. Utilizing a unique screening and assessment approach, Boston Healthcare identified the optimal out-licensing opportunities. At the same time, Boston Healthcare initiated discussions with a large, multi-national pharmaceutical manufacturer and assisted our client in closing a $25 million deal. This enabled the company to continue R&D efforts and to enter the public market with greater credibility.
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.
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 of a pharmaceutical company 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.
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.
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.