from fragments to focus:

Transcription

1 an educational ebook FroM ims health from fragments to focus: Finding Clarity Within the Specialty Brand Market

2 2 Finding Clarity Within the Specialty Brand Market Specialty markets: a challenging opportunity The pharmaceutical market is a constantly changing landscape of opportunities and challenges. Specialty product sales are growing at twice the rate of traditional products. By 2014, some estimates anticipate that 40 50% of drug spend will be with specialty pharmaceutical products 1. Unfortunately, disparate sources of information make this market confusing. This unclear picture is creating a crucial need for a comprehensive understanding of all drivers and channels, as well as a better way to measure success. How will you adapt? While many manufacturers are choosing to reinvent themselves as specialty pharma companies, this shift requires an even bigger change in how to view the market. It necessitates more comprehensive and reliable views of product performance across both traditional and non-traditional channels. Manufacturers operating in the specialty pharmaceutical market need a broad base of information on prescribing practices, sales transactions, treatment pathways and patient outcomes. Data requirements needed to make effective commercial decisions in the specialty market: Comprehensive sales volume and share in each relevant channel Representative drug use by indication Accurate dosing, compliance and persistence metrics Anonymized, patient-level data tracked over time to reveal patterns by patient characteristics, treatment pathways, utilization history and outcomes Source of business metrics to uncover market dynamics sooner A non-specialized product manufacturer might use a similar list when marketing a mass-market product, but the challenge is even greater in the specialty arena. Here data sources are extremely fragmented, requiring more time, effort and resources to measure and understand the market. 1 Express Scripts Drug Trend Report,

3 3 Finding Clarity Within the Specialty Brand Market Piecing together the fragments The figures on this page show the recent growth in the number of specialized distribution firms, where the majority of their sales are attributable to specialty products. Along with explosive growth, market fragmentation makes data collection increasingly difficult. Another challenge is that the specialty data cannot be validated against syndicated data sources, raising questions from key stakeholders about the timeliness and accuracy of the data received. While some syndicated data providers have invested heavily in recent years to bring more visibility to specialty distribution, the channel is still quite disjointed a situation that makes it difficult to create a comprehensive and uniform source of highquality sales and prescription data. The lack of data completeness and consistency causes analytics to be less reliable than with mass-market products. BILLIONS BILLIONS $6 $5 $4 $3 $6 $2 $5 $1 $4 $0 $3 $2 $1 $ % 145.0% 135.0% 125.0% 155.0% 115.0% 145.0% 105.0% 135.0% 95.0% 125.0% 115.0% % SP INDEXED $ GROWTH 95.0% SP LOCATION COUNTS (2NDARY AXIS) 2009 SP LOCATION COUNTS (2NDARY AXIS) SPs TOTAL BOOK OF BUSINESS 500 SPs TOTAL BOOK OF BUSINESS Specialty Market Growth ALL OUTLETS INDEXED $ GROWTH SP INDEXED $ GROWTH ALL OUTLETS INDEXED $ GROWTH

4 4 Finding Clarity Within the Specialty Brand Market Specialty data integration: key technical issues Issues inherent in data transfer Information management Handling disparate data sources creates overhead Timeliness of data submissions Ensuring data quality, standardization, cleansing and integration with existing sources of information The information Merging heterogeneous Setting up an operation Furnishing data is not a There is no existing management sophistication sources is complicated, and dedicated to data collection top priority of SPs, so it industry standard for the of most specialty pharmacy as a result it is not done involves a great deal of can be a time-consuming electronic data interchange providers is extremely very often. Consequently, supplier management, job to ensure that sources (EDI) within SPs. No two low. Most SPs are small commercial analysts are causing headcount and deliver data completely and sources report information and use Excel to share left to triangulate across capital to be diverted from on time. Valuable staff time in the same manner. information with the drug unintegrated sources core business and strategic is wasted on phone calls The result? Considerable manufacturer. They often to arrive at meaningful imperatives. Multiple following up on SP data record duplication, since use delivery, which is conclusions. Analytical failures and lost investment submissions and formulating anonymized patient histories not always secure. Security precision is low, and paying should be expected before what-if scenarios from one source cannot be is essential when protected for analytical resources to achieving stability. associated with missing matched with history from health information (PHI) is piecemeal the data together information information another source. Longitudinal involved. is not a viable or sustainable that could impact the tracking of a patient is solution. incentive compensation limited to patients who use process. only a single SP.

5 5 Finding Clarity Within the Specialty Brand Market Business and legal issues: the challenges continue While the technical challenges of specialty data integration are considerable, there are also some important business and legal issues that must be addressed. Compliance issues related to HIPAA and Prescriber Data Restriction Manufacturers take on risk when working with an SP that does not fully understand federal and state regulations. For instance, several states have a variation of HIPAA rules for certain therapeutic areas like HIV, which does not allow PHI data to be shared by the covered entity. For smaller organizations, particularly those with limited bandwidth, keeping up with legislation can be difficult, time consuming and expensive. The penalties for non-adherence range from fines to prison time. Determination of fair market value Typically, there is a distribution agreement in place between the manufacturer and the SPP. Since 2009, separate data agreements have evolved as a result of the law contained in 42 CFR 447. The determination of fair market value regarding the data exchange currently does not have a standard methodology, so manufacturers and SPs each have their own protocols for determining value. These calculations sometimes can be so far apart that the data component of the manufacturer-to-sp relationship has ended causing a data disruption with downstream implications in product forecasting and compensation.

6 6 Finding Clarity Within the Specialty Brand Market Closing the analytics gap In situations where state laws limit the ability to identify prescribers, the data is collected with the prescriber identification already masked. Getting prescriber data cleansed and matched even when the identity is known is challenging, but with masked data, the challenge is unprecedented and raises many questions. How can companies cleanly integrate this information when the detail is not there, particularly when reverse engineering is prohibited? In situations where longitudinality of patients across retail pharmacy and SPs is missing, how can companies analyze prescriber behavior? Companies need to think about how these challenges affect their operations and look for ways to close these information gaps. Only by combining a truly representative view of the entire market will companies be able to accurately understand brand performance. Syndicated Rx data (60%) SP supplier A Rx data (20%) SP supplier B Rx data (20%) Enabling a Complete View True Value of the Prescriber (100%)

7 7 Finding Clarity Within the Specialty Brand Market Operational hurdles Prescriber targeting in the specialty world remains elusive. The most basic challenge: the prescriber cannot be matched to a consistent prescriber ID. When integrating this prescriber data across several sources, analysts end up with more data points because they re working with a series of unidentifiable or unmatched prescriber records whose volume is dispersed. Even when there is a solid master data management system in place, working with prescriber identifiable data is not easy. Examples exist where customer data has been allocated to up to six different prescriber IDs for the same prescriber. Understanding the affect of dirty data on sales applications There could be a forced shift from target-based compensation plans to territory-level quotas Compensation with target-based plans may no longer be an option due to duplication of data or missing data. Similar to the foundational problem with targeting, if the prescriber is missing in the database because he/she is masked, results data (i.e., sales) will not be present to indicate whether or not the sales person is being effective with the prescriber. In the case of duplicate data, consider the incentive compensation process and subsequent performance tracking. The creation of the quota is done as a one time or intermittent activity, which may follow a specific process; performance tracking is a recurring activity following another process. In this case, a single prescriber quota might be twice as high as it should be, but the associated performance data shows something less than half. In order to keep field sales focused on selling instead of inspecting the data that drives their compensation, a territory-level quota can cure the dirty data issue since a target-based model is no longer optimal. Optimizing the sales force will be more challenging Sales force sizing is potentially inaccurate with seemingly more prescribers having less volume in the universe. The data being listed in a resource optimization methodology, as well as the territory alignment process, presents two difficulties: plans will either overestimate or underestimate resource demand because of the seemingly larger prescriber universe. Consider the case where a high-value prescriber cannot be reconciled across different data sources. He/she will be broken down into smaller, unrelated prescribers that spread associated prescription volume across multiple prescribers, resulting in lower desirability. The lower desirability causes the prescriber to be dropped from the call list because he/she is no longer target-worthy.

8 8 Finding Clarity Within the Specialty Brand Market Marketing and contracting: An uncertain view Inflation of prescriber counts after the merge of syndicated and SP data makes it hard to measure promotional effectiveness. The impact on marketing applications Decile prescribers could be marginalized to less desirable deciles, causing an omission from a call plan or for budgeted samples. Patient persistency and compliance are not optimally calculated due to the inability to bridge anonymized patient data across the syndicated and SP sources. Negative outcomes include potential miscalculations in patient-driven forecasts where a persistence/compliance variable is used. The downstream impacts of inaccurate forecasts could affect a specialty firm s go-to-market budget as well as manufacturing schedules. Contract challenges Writing the most favorable contract won t be easy. Patient persistency and compliance likely assume that an SP is more capable of driving these measures compared to a retail pharmacy. If part of the planned contract rebate incentive includes assumptions about increased revenue due to higher persistence or compliance, it may be difficult to determine the appropriate KPI, especially if a portion of the patient s care requires a view outside the contracted SP. In order to obtain accuracy in calculating persistence and compliance, companies need visibility to all possible prescription sources, as well as a consistent identification of the underlying patient records.

9 9 Finding Clarity Within the Specialty Brand Market A best practice approach for specialty analytics For capturing information, manufacturers should establish a centralized point of integration that enables conduits to SPs, hubs and distributors. This enables the receipt of inbound information at the most granular level with full visibility, so that master data management and data integration techniques can be applied to achieve the most accurate results. A deeper view is not always possible. Manufacturers seeking to understand patient dynamics by utilizing transaction or patient level data will not be able to accept the data directly because the SP partner uses PHI to conduct treatment, payment and operations (TPO). Information has to be anonymized before the manufacturer can access it. That access brings manufacturers into a gray area if it already possesses identifiable patient information collected with a patient opt-in, perhaps from registration on the brand s web site. The ability to access both identifiable and anonymized data leaves the potential for reverse engineering and the identification of patients in the anonymized pool. Due to patient privacy concerns, even if the manufacturer was not connecting this information, the circumstantial nature may make it difficult for the manufacturer to defend itself in the court of public opinion. Beyond the patient anonymization above, a manufacturer s access to these levels of deep visibility are further encumbered if a conflict-of-interest interpretation is made by the manufacturer s legal team, precluding a manufacturer from receiving competitive information of any kind. For proper analysis, the competitive data should be grouped to allow a market share calculation assuming there are enough competitors to enable this.

10 10 Finding Clarity Within the Specialty Brand Market Completing the picture A solution for manufacturers is to continue to contract as they do, but have data streams sent directly to a service provider. The service provider would then de-identify and standardize the data so a single view of the account, prescriber and patient is achieved. Though the identities of patients and some prescribers may be masked, the masking can be done post-integration by the service provider for a clean representation of a prescriber or patient history. For specialty brands that have a portion of sales occurring outside of the SP-contracted distribution network (e.g., retail pharmacy or direct ship model), there is an additional layer of complexity if the manufacturer is using syndicated data sets. Trying to link prescribers and patients across the SP component is necessary in order to value the prescriber correctly and to follow a patient longitudinally. Working with a specialist on the integration will help achieve increased cleanliness, speed and longitudinality. Working with an organization that lacks expertise may cause failure to achieve the integration necessary for a clean view of prescribers and anonymized patient histories in common across the two sets of data (the SP-pooled set and the syndicated set). PRIMARY THERAPUTIC It takes more than one prescription source to truly map a specialty care patient longitudinally First Visit, Retail Rx close to work Follow up, Retail Rx close to home SP Rx Snowbird or Vacation Emergency Retail Rx Employer Standard Mail order pharmacy Diagnosed Refill/ Administration PRIMARY SPECIALTY THERAPEUTIC TIME Refill/ Admin2 Refill/ Admin3 Refill/ Admin4 Refill/ Admin5 SUPPORTIVE CARE

11 11 Finding Clarity Within the Specialty Brand Market Making the complex simple A service partner can also help companies build the most appropriate data strategy for new products. For instance, if a company has a specialty product in Phase 3, it should be working on its data strategy in conjunction with its product distribution strategy. Some of the choices that are important to consider: The graphic shows how a third-party partner partner can provide the centralization, standardization and compliance mitigation that a manufacturer needs improving the quality of the information and the speed of insights for better decision-making. For which SP is data needed, and which are covered with syndicated data? What level of data is needed to manage and measure my BIOPHARMA WAREHOUSE product prescriber, patient and/or account? Is a Fair Market Value (FMV) analysis required? Should our organization use only syndicated data? SUPPLIER 1 SUPPLIER 2 SP SUPPLIERS THIRD-PARTY SERVICE PROVIDER Market Research Staging Is SP data alone enough? Should SP data be integrated with syndicated information? SUPPLIER 3 Reporting SUPPLIER N 3RD PARTY HUBS Comp Client-contracted Full set of SPs supplied data

12 12 Finding Clarity Within the Specialty Brand Market Finding clarity HIPAA limits. State legislation restrictions. Conflicts of interest. There should be no doubt that these challenges necessitate the need for manufacturers to partner with a service provider that has experience in this area. Finding a partner to take on data integration and management functions allows companies to vary capacity and cost for specific support of objectives and the requirements for execution. This will help companies consider all information and performance measures, enabling them to drive efficiencies across the organization and consequently drive better decisions.

13 13 Finding Clarity Within the Specialty Brand Market A precise future With pharma becoming more specialized, the industry needs to have even better analytics than those available for mass-market products. With patient populations in new, targeted therapy areas significantly smaller than previous ones, precise analytics are key not just for improving performance but also to justify entry into micro-therapeutic areas where patient populations are small. Who will get ahead? Organizations that plan ahead for a specialty launch and contemplate a data acquisition strategy as they prepare their distribution network will get ahead. They will have the data needed to manage rebates, direct field activity, and triage patient reimbursement issues in hand for launch. Organizations that leverage efficient specialty data integration to gain precise analytics will also get ahead, by enhancing their commercial potential. The combination of advanced analytics, flexible data integration, streamlined information management, and well-defined performance management processes will allow these organizations to achieve levels of operating efficiency and commercial effectiveness that are unmatched by their competitors. All of these elements will work together to yield better decision support, reduced complexity and business risk, lower operational costs and ultimately, better success.

14 IMS Health 200 Campus Drive Collegeville, PA USA Tel: IMS helps make specialty companies more effective in their operations with a tailored set of capabilities for manufacturers distributing through specialty networks: Specialty data strategy and current state assessments Outsourced data stewardship of SPs, hubs or distributors SP contract rebating Data cleansing, calibration and integration with IMS DDD, Xponent or LifeLink Hosted reporting solutions built on account, prescriber or patient databases Integrated SP plus IMS LifeLink patient studies Options for non-ims data clients Drawing from our extensive industry experience with methodologies honed over hundreds of client engagements, we recommend approaches, guide analytics, design processes and deploy systems even manage these activities on an ongoing basis to lower operating costs, provide staffing flexibility and improve overall performance. Clients tap into our extensive global industry experience, deep domain expertise and knowledge of precisely how their commercial organizations operate. The result? Faster speed to insight and better business performance IMS Health Incorporated or its affiliates. All rights reserved 12028