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Case Studies
The Problem
A young child was diagnosed with a rare disease. After a series of tests and surgery, practitioners determined that the only effective treatment was an expensive medication, which cost $24,000 per dose. The family's insurer, however, denied payment. The patient required one injection a day, with each vial of medication lasting one week. Therapy was to continue over a six-week period.
The Solution
The child's physician contacted HealthBridge, which immediately began to investigate options. The HealthBridge Internal Verification group determined that the patient was denied service coverage because of plan restrictions and formulary limitations. HealthBridge, however, worked with the insurance plan administrator to override the plan limitations and cap benefit amounts, leaving the family with only a $25 co-pay per fill and refill.
The Problem
A sample operations manager at a pharmaceutical manufacturer with a field sales force of 500 determined that the company's representative carry-sampling program could be more effective. The traditional sampling program demanded unique operational requirements for each brand and required representatives to spend significant time reconciling, waiting and organizing samples. The representative carry-sampling program also increased the need for internal staff to handle sample reconciliation and manage operational processes. The client wanted a solution that would reduce expenditures needed to meet regulatory requirements while minimizing risk. In doing so, the client was looking for ways to increase the efficiency of the sales force.
The Solution
The client decided to implement a direct-to-practitioner sampling program to simplify their sales and supply chain processes. HealthBridge designed a customized approach to meet the unique business requirements of each brand. HealthBridge provided detailed client operating specifications to implement the programs while meeting regulatory requirements and eliminating the administrative burden of managing samples from the representatives. Upon implementation, the client simplified its sampling programs and achieved its goals:
- Saved more than over 65% in total costs compared to representative carry sampling program
- Increased sales force effectiveness and efficiency
- Obtained the same representative access to practitioners
- Minimized regulatory risks
The Problem
A pharmaceutical manufacturer has steadily been acquiring companies over the past few years. This resulted in 6 different vendors managing their PAP and reimbursement programs. Each vendor had unique operational requirements, reporting styles, billing routines, and other specific requirements. None of the vendors were meeting the required service metrics, patient and physician complaints were increasing, and operational redundancies and inefficiencies were elevating program management costs.
The Solution
With the launch of new drugs pending, the client decided that it was time to look for a single vendor to manage all of their programs. HealthBridge strategically designed and implemented a patient centric, streamlined single-source solution for the new and existing programs. In combination with CuraScript Specialty Pharmacy, we were able to create a cohesive end-to-end solution for all program services, including: Reimbursement, REMS requirements, PAP enrollment and distribution, home nursing service coordination, and specialty pharmacy distribution. In addition, a sophisticated web portal was launched to support patients, physicians, and the client in day-to-day care and management.
We flexibly responded to the client's needs and timelines and were able to seamlessly transition programs from the other vendors ahead of schedule and without disruption to service.
Single-Source Sample Management
The Problem
A pharmaceutical client anticipated significant challenges as it prepared to launch a controlled substance particularly since its 500-member sales force would be using the sample-carry method. This approach greatly elevated the company's compliance risk due to the nature of product. With only six weeks until product introduction, the client sought a way to proactively manage its samples, as well as to monitor representative activities.
The Solution
HealthBridge provided a single-source solution for sample management, shipping samples directly to representatives and initiating sample accountability measures. The client was able to monitor all activities through the HealthBridge sample operations portal, an online tool for ordering, tracking and managing sample inventory. In addition, HealthBridge streamlined and managed all vendors whose services supported the launch, including printers and paper suppliers.
As a result, the client was able to launch the sampling program three weeks ahead of schedule. The timely and efficient implementation strategy saved the client more than 40% in development costs. In addition, the client was able to identify non-compliant representatives by analyzing program data found in the sample operations portal.
Fast, Efficient Sample Fulfillment
The Problem
A pharmaceutical manufacturer developed a new product which had the potential for "blockbuster" success in the highly competitive market. To capitalize on this window of opportunity, the manufacturer needed to get samples of the therapy into the offices of more than 70,000 primary care physicians quickly. Along with the samples, the manufacturer wanted to deliver a targeted clinical message to practitioners and their patients.
The Solution
HealthBridge designed a multi-dimensional sampling approach to help increase market share for the manufacturer. The program featured both "sample-carry" and "sample-send" methodology. HealthBridge likewise helped to generate prescriptions by enabling the physicians to re-order samples through easy online order forms. The program targeted high prescribers for representative-carry sampling, and provided education materials to ensure patient retention and adherence.
Relying on this aggressive approach, HealthBridge responded with speed and efficiency, shipping more than 350,000 units over a three-day period. As a result, product samples were in the hands of the most important physicians first, helping to capture critical market share quickly.
Strategic Reimbursement Services
The Problem
A manufacturer of an orphan pharmaceutical injected product that had been on the market for 50 years with more than 50 indications (most off-label) decided to change distribution from retail to specialty pharmacy. Since patients would no longer be able to get the product at a local pharmacy, the manufacturer needed a program to protect their market share while the patients transitioned to the specialty pharmacy process.
Along with the change in distribution, the manufacturer significantly increased the price of the product. The manufacturer anticipated delays in getting patients on therapy and the product reimbursed while payers loaded the new pricing information and began requiring prior authorization for the product.
The client's objective was to re-launch program services, recognizing that outreach was needed to ensure patients, practitioners and payers were aware of the new program model. At the same time, the client wanted to maintain continuity of care, anticipating hospital discharge delays because of payer concerns about the price increase. The company was also concerned about the impact of positioning the product under the pharmacy benefit instead of major medical within such a short window of time.
The Solution
HealthBridge identified a five-pronged strategy to assist the manufacturer:
- Build a HUB model that would ensure cases were turned around in a timely manner and that relationships were built with key opinion leaders in the marketplace. Install a multi-tier and regional team approach to the HUB so that payer, practitioner and pharmacy work happened concurrently, which allowed the cases to be moved along expeditiously.
- Give high-prescriber offices access to dedicated HUB personnel at admission providing more time to process payer and pharmacy reimbursement-based tasks.
- Work strategically with payers to educate them on the price increase and shift to pharmacy benefits; confirm that payers have the manufacturer's product on their urgent drug list in order to turn approvals around in a timely manner.
- Coordinate conference calls with stakeholders to explain the HUB model and customize casework based on their discharge process.
- Recruit expert reimbursement specialists and deploy them into teams and regions. These individuals are selected because they display the ability to troubleshoot on the spot and move cases ahead while requiring limited oversight.
The innovative HealthBridge approach reduced benefit investigation and prior authorization turn-around times by 50%. The client was also able to sustain market share within a disease state they forecasted would not be profitable for them, based on the service offerings of the HUB. In addition, the manufacturer was able to maintain referral levels despite the price increase and significant changes to the distribution program.
The Problem
During a standard quarterly business review, HealthBridge identified a progressive increase in discontinuation rates for a client's product. Through the data our client captured and the data HealthBridge had available, the patient discontinuation rates by shipment intervals and reasons were identified including unmet expectations, adverse reactions/side effects, worsening of symptoms, variable expectations regarding length of therapy, etc.
The Solution
HealthBridge analyzed this baseline information and then collaborated with the client to design a customized program to address these intervals, actual percentage of discontinuation at each interval and the reasons. The program was designed and implemented including specific scripting for proactive nurse interventions, education, surveys and data analytics.
As a result of this custom compliance and persistency program the discontinuation rates improved by 32% overall.
Risk Evaluation and Mitigation Strategies (REMS) are FDA mandated safety requirements for managing known and potentially serious risks associated with oral solids or biologics. REMS are designed to ensure that product benefits outweigh the risks. The advent of REMS programs has dramatically impacted the pharmaceutical landscape by adding a new level of complexity to the drug commercialization process. HealthBridge has the proven capabilities to help navigate the hurdles of REMS program design, implementation, and management.
The Challenge
In 2008, one pharmaceutical manufacturer was presented with a FDA mandate to design and implement REMS programs for some of their new and existing products including a schedule III narcotic. This particular product was met with some of the most extensive REMS requirements to date. In addition to the REMS mandate, this product required complicated storage, packaging, and distribution.
Faced with these challenges, the manufacturer turned to HealthBridge to design and implement a REMS program that could be wrapped around a complex reimbursement, patient assistance, and distribution program. They needed an end-to-end provider to integrate all of these services and meet FDA requirements for:
- Patient and physician registries
- Extensive data capture
- Controlled distribution
- Traditional specialty pharmacy services
The Solution
HealthBridge worked collaboratively with the manufacturer and the FDA to design and gain approval for the REMS program. Once approved, HealthBridge developed detailed operating procedures that integrated REMS program requirements into the complex reimbursement, patient assistance and distribution activities. A dedicated call center was established and a single operational system was implemented to manage all data collection, management, and reporting components required by the FDA as well as the traditional reporting associated with reimbursement, PAP, and distribution of specialty pharmaceuticals.
Together, HealthBridge and the manufacturer designed and implemented an integrated solution that both satisfied FDA requirements around patient safety and ensured successful product commercialization. As a result of this effective program and ongoing relationship with HealthBridge, the manufacturer is positioned well today to expand the program to a broader patient population by offering new drug indications.
By integrating their REMS, reimbursement, patient assistance, and distribution programs through a customized business solution, the client:
- Simplified the patient and practitioner experience through a dedicated single point of contact
- Provided best-in-class program effectiveness and turn-around time
- Satisfied all FDA requirements and maximized commercialization
- Established a single point of contact for all data requirements for this therapy
- Provided their patients maximum therapeutic outcomes
- Increased overall patient and physician satisfaction
- Accelerated time to therapy
- Realized revenue enhancements
Pharmaceutical leader deploys innovative virtual sales force solution
Challenge
A widespread regional layoff of pharmaceutical sales representatives prompted an immediate action at a top ranked pharmaceutical manufacturer company. The abrupt layoffs affected over 12,000 "called-on" healthcare prescribers (HCPs). Based upon initial feedback, the HCPs were used to visits from the sales representative for the most up-to-date clinical information and product samples. Despite efforts by analysts, sales alignments were unable to remediate the promotional gap. Increased competition from other therapy brands compounded the problem. In addition, one product was a scheduled controlled substance, which provided an additional challenge with respect to sampling the product.
Concerns
In reviewing the challenges, customer's initial concern was that a program needed to be put in place to mitigate any damage to the HCP relationship and market share. Implementation time needed to be days, not weeks or months. Next, the promotional channel was a major concern. What channel should we use to reach these HCPs? Should we utilize a digital marketing approach, or use mail, or the telephone? Which will have the best response rate and be the quickest to implement? In addition, in order to prevent revenue cannibalization, the allowable number of samples had to be systematically managed as tightly as possible.
HealthBridge consulted with the marketing director, providing key sampling knowledge to create an innovative, and cost-effective promotional channel. HealthBridge designed a solution to reach HCPs to inform them of the recent change in sales force and offer the HCP offices the ability to request product samples. The "virtual sales force" solution consisted of proactive telephone calls with key messages to the prescribers with the specific goal of soliciting product samples and disseminating clinical information. A configurable HealthBridge business rules engine allowed the customer to provide sample allocations down to the HCP level.
Solution Components
So why was tele-sales the best promotional channel? Direct mail was a low-tech option that ultimately could not obtain the type of response required to efficiently communicate with HCPs. And while digital marketing promotion (including e-detailing, e-sampling and messaging) has been a key promotional tactic for certain situations, the immediacy of the situation and cost factors could not afford such luxury. HealthBridge advocated using a direct contact approach (tele-sales) as the conduit for its virtual sales force solution.
In configuring the solution, HealthBridge was able to integrate important detail messaging in the promotional call guide, as well as assist the manufacturer with the medical/regulatory approval of the guide. With all tracks running in parallel, HealthBridge was able to configure and deploy the complete virtual sales force solution within 2 weeks, allowing minor disruption to the manufacturer's customers.
In order to prevent revenue cannibalization due to over sampling, HealthBridge was able to provide a configurable business rules engine. The business rules engine allowed the marketing director to configure sample allocations down to the HCP level, and make future dynamic changes to these allocations.
A crucial element of the virtual sales force solution included HealthBridge receiving, warehousing, and fulfilling samples directly to the HCPs who returned the sample request forms. In doing so, HealthBridge was able to perform quality service and adhere to regulations associated with the handling of pharmaceutical and controlled substance products.
Immediate results
Positive feedback from practitioners indicated the HealthBridge virtual sales force was well-received. As a result, the brand was able to maintain and grow market share for the product over the course of the ongoing program. The program had the following results:
- 60% physician acceptance and penetration rate using tele-sales channel
- A calculated 1:6 return on investment based upon a personal sales representative call
- Stabilization of NRx over program duration
Supported by Express Scripts Specialty Distribution Services, HealthBridge Reimbursement Services, Inc. and Phoenix Marketing Group, LLC.