Maryann Dowd, RPh

SPECIALTY MEDICATIONS CONTINUE be at the top of the pack in driving drug costs, accounting for more than one-third of the pharmacy industry’s total prescription dispensing revenue in 2018.

The definition of a traditional specialty product is well defined across the channel. Common attributes include products that treat serious conditions, are high cost (≥$6K annually), and require comprehensive patient care, drug administration, and reimbursement support. Support services around these products are well established and widely provided.

Manufacturers are faced with optimizing the patient and provider experience regardless of product characteristics by identifying opportunities to improve interventions, mitigate barriers to access, expand open access models, and leverage emerging technology solutions.

What, then, is the solution for the tweener products? These are products for which the price point hovers between $500 to $1000 per month. Although drugs in this category may not need the full complement of high-touch services, they may be candidates for modified programs to support ease of access.

What does often look different is the distribution approach. These products typically fall within a managed model—an open model in which manufacturers contract with select specialty pharmacies to enhance the service offering. Unlike a traditional limited distribution model for which there is a higher level of control, the wider availability of these products results in less control of the end-to-end experience. A major concern that is more pronounced in an open model is the age-old problem of prescription abandonment. Often, the patient suffers from sticker shock when presented with their financial obligation at the point of care and chooses to walk away from therapy.

The rate of prescription abandonment increases steadily as costs exceed $50, with prescription abandonment increasing by 0.6% with every out-ofpocket dollar.

Therefore, the focus of any channel strategy is to optimize speed-to-therapy and mitigate prescription abandonment, either due to reimbursement hurdles or the patient’s out-of-pocket obligation.

What should the distribution model look like? There are approximately 69,000 pharmacy providers in the US marketplace, from traditional retail to traditional specialty and everything in between.

The candidates in the mix may be emerging national or regional specialty pharmacies and community specialty pharmacies. These pharmacies can provide a strategic advantage given their network of locations and strong relationships with local health care providers.

Not to be forgotten is the retail class of trade, which is formidable and plays a large role to ensure ease of access to these products. Many organizations have specialty products at retail solutions that can be leveraged. Should a claim for any of these products require prior authorization (PA), that claim can be identified, and the reimbursement work shifted to the specialty division for processing. This facilitates access to therapy while not impeding the path of a willing prescription that will flow through the system unobstructed.

Also percolating in the market are the disruptor models that are finding their way into the pharmacy channel. It is worth keeping an eye on these models as they emerge.

Regardless of the composition of a distribution network, it is imperative that selected partners meet data-reporting requirements, execute patient support programs, and have the technology to deliver the desired patient and provider experience. There is wide variation in the sophistication level of potential channel partners that must be considered when building the optimal channel strategy.

Although traditional specialty products often require full hub services, a modified approach is more appropriate for specialty light products. Balancing the necessary support programs with the financial realities of tweener products is a fine line for manufacturers. A hub-light model providing some services, such as PA and co-pay programs without full high-touch services, is better suited for these products.

Currently, there are many options for a hub-light model in which support services are triggered when there is a need for intervention. Specialty at retail is widely available where PAs are flagged and the heavy lifting of reimbursement is shifted to the specialty arm. The patient can then choose to have the prescription shipped to their location of choice or pick up at the local pharmacy. The key for the success of these programs is to let the prescription flow naturally in the marketplace and intervene only when necessary.

When contemplating the hub model, it is critical to define who is doing what to avoid duplicative efforts, improve efficiencies, and mitigate stakeholder confusion or fatigue. The best patient and provider experience will result in a coordination of efforts across the channel continuum.

The advancement of innovations in technology such as electronic PAs (ePAs), electronic benefit verifications, electronic health records (EHRs), and prescriber portals provide a valuable ecosystem to expedite speed to therapy. 

The ability to conduct real-time benefit checks along with initiating eP As can shave off valuable time. An ePA solution helps improve the efficiency of the process by removing the phone and paper-based manual efforts.

Feedback from providers regarding the administrative burden of complete PAs is real. In many instances, the providers prescribing the tweener products are not accustomed to processing PAs, making the administrative challenges even more pronounced.

Providers report spending an average of 2 business days per week (14.9 hours) completing PA requests.3 There has been widespread adoption of ePAs across the health care network. Nearly 100% of pharmacies, payers, and EHRs have adopted an ePA solution.

The importance of ePAs has not gone unnoticed by the Centers for Medicare & Medicaid Services (CMS). There is currently a proposal for a new rule that will leverage the National Council for Prescription Drug Programs’ SCRIPT standard for the use of ePA transactions for Medicare Part D claims. Prescribers will be able to determine whether the beneficiary’s plan requires a PA and then submit an eP A in real time, facilitating speed to therapy.

Despite the advancement of technology, a large volume of PAs are still submitted through phone and fax. The use of ePA is an important cog in the reimbursement wheel. There is clearly more work to be done on this front.

The evolution of high-deductible plans and coinsurance financial responsibilities for patients reinforces the need for a thoughtful approach to the development of co-pay programs. These programs are an important tool in a drug manufacturer’s arsenal to mitigate financial barriers to access.

Overall out-of-pocket costs have risen from $56 billion in 2014 to $61 billion in 2018. As out-of-pocket costs have risen, $13 billion has been of fset by coupons for commercially insured patients.

Abandonment Rates for Branded Medicines in Commercial Plans

The execution of co-pay programs is particularly significant for products with a lower price point given that they often find their way into the retail class of trade. When developing these programs, the product sponsor must identify which savings offer the best support to brand objectives.

The identification of unambiguous business rules and safeguards to ensure compliance with federal and state guidelines is a top priority. Other considerations include channel participant technology capabilities, metrics capture, and return on investment measurement. Co-pay accumulator programs are part of a growing trend and have the potential to affect the patient’s out-ofpocket exposure. According to Zitter Health Insights, close to 60% of commercial lives are covered by payers that have implemented a co-pay accumulator program.

There are a host of solution providers in the marketplace that offer a variety of co-pay programs. The key to success is to ensure that the end result delivers a seamless execution of the patient co-pay program regardless of the point of sale.

In conclusion, a brand strategy for the tweener products requires thoughtful planning to address channel dynamics. The optimal plan must deliver a costeffective model that addresses barriers to access while clearing the path for a willing prescription, optimizing rapid access to therapy and clinical outcomes. 

The views expressed in this article are the opinions of the author and not of Optinose Inc.

, is director of market access operations at Optinose US Inc. Dowd has more than 30 years of experience in the health care sector spanning retail and specialty pharmacy, biotechnology, and management consulting.

The 2019 Economic Report On US Pharmacies And Pharmacy Benefit Managers

. Drugchannelsinstitute.com. Available at drugchannelsinstitute.com/files/2019-PharmacyPBM-DCI-Overview.pdf. Published March 2019. Accessed April 7, 2020.

Cover My Meds. Available at covermymeds.com/main/medication-access-report/prescription-decision-support. Accessed April 12, 2020.

2018 AMA Prior Authorization (PA) Physician Survey

. American Medical Association. Available at ama-assn.org/system/files/2019-02/prior-auth-2018.pdf. Accessed April 13, 2020.

Cover My Meds. Available at covermymeds.com/main/medication-access-report/electronic-prior-authorization/. Accessed April 12, 2020.

Medicare Program; Secure Electronic Prior Authorization For Medicare Part D

. Available at federalregister.gov/documents/2019/06/19/2019-13028/medicare-program-secure-electronic-prior-authorization-for-medicare-part-d. Accessed April 14, 2020.

. Available at iqvia.com/en/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023. Accessed April 10, 2020.

. Conference.medimpact.com. Available at conference.medimpact.com/documents/398252/398821/DougLong_KeynotePresentation_MedImpactAnnualConference2018.pdf/7df9d8b3-8eb5-4bcd-81e7-c1de79a0378e. Accessed April, 13 2020.

The Managed Care Biologics & Injectables Index And Oncology Index: Copay Accumulator Programs

. Available at drugchannelsinstitute.com/files/Zitter_Copay%20Accumulator%20and%20Maximizer_09.17.2018.pdf. Accessed April, 11 2020.

Articles

The best patient and provider experience will result in a coordination of efforts across the channel continuum.

Challenges in Brand Strategies for Tweener Products

ADHERENCE TO MEDICATION REGIMENS BY PATIENTS

 has always been, and continues to be, an area of great concern to the health care community.

Nonadherence to drug therapy can result in an alteration of the risk/benefit ratio, and can literally be a matter of life and death. The impact of noncompliance is staggering in terms of both health care outcomes and cost. It is estimated that the cost of nonadherence in the United States totaled $337 billion in 2013

Up to 30% of prescriptions are never filled,

and poor compliance has been linked to increased mortality and hospitalization across various disease states.

		nonadherence causes ~30% to 50% of treatment failures and 125,000 deaths annually

		medication is not continued as prescribed in approximately 50% of cases

		medication rates of compliance drop off after 6 months

		only 51% of Americans treated for hypertension are compliant with their therapy

		25% to 50% of patients discontinue statins within one year

Even for those prescriptions that are filled, the patients are often noncompliant with prescriber directions by missing doses, taking the incorrect dose, not following instructions, such as taking the medication with or without food, and failing to complete the prescribed days of therapy.

There are a host of dynamics that influence a patient’s lack of commitment to adherence, including simply forgetting to take the medication, disease states that have no symptoms, such as hypertension, cost, and side effects, to name a few. Those patients treated for multiple conditions, for which they are often prescribed concomitant medications with varying intervals throughout the day, can face additional complications in adhering to instructions.

There is often confusion between the terms that float about regarding adherence. It is important to understand exactly what “Medication Adherence” is.

		Medication adherence: The patient’s conformance with provider recommendation with respect to timing, dosage and frequency of medication taken during the prescribed duration.

		Compliance: Patient’s passive following of provider’s orders.

		Persistence: Duration of the time patient takes medication, from initiation to discontinuation of therapy. 

Additional buzzwords around this topic include abandonment, which applies when the patient fails to fill a prescription, or prematurely discontinues therapy. Another term used by manufacturers is “time to fill,” which refers to the period from the time the provider prescribes the medication to the start of therapy.

Time to fill is comprised of several segments that need to be fully defined and understood in order to accurately depict the prescription journey.

The standard for measuring adherence includes Medication Possession Ratio (MPR) and Portion of Days Covered (PDC).

		Medication Possession Ratio is defined as the sum of the days’ supply for a given period of time dispensed to a patient, divided by the number of days in the time period.

		Portion of Days Covered is defined as the number of days covered in a given period of time, divided by the number of days in the time period. 

PCD is a bit more accurate in measuring adherence, in that it removes the potential for dispensing overlap. Utilization Review Accreditation Commission (URAC), the gold standard for specialty pharmacy accreditation, uses PCD for their credentialing measure of adherence.

This is a complex, multifaceted issue and there is no single definitive reason. There are a myriad of factors that can impact the level of adherence to drug therapy. As noted earlier, this may include patients forgetting to take their medications, skipping doses, taking an incorrect dose, not following directions on how to take the medications, side effects, and cost and coordination with concomitant therapies. One or more of this host of dynamics, none easily solved, can cause non adherence.

According to the 2015 Express Scripts International drug trend report, 37.7% of drug spending was represented by specialty medications, with that number expected to increase to 50% by 2018.

Specialty drug spend is expected to reach $1.7 trillion by 2030.

The critical importance of medication adherence is especially true for certain disease states and conditions where noncompliance can lead to resistance, tissue rejection, and even morbidity. These include HIV, post transplant, and oncology patients. Adherence via taking medications every day prevents HIV from multiplying, which reduces the risk that the disease will mutate and produce drug-resistant HIV. Missing doses of transplant medications can cause tissue rejection.

According to a study of 418 oncology patients, 10% stopped taking their medications, 7% never filled their prescription, and 9% did not regularly fill their prescription.

Given the impact of nonadherence for cancer patients, the outcome can be dire.

There is no doubt that specialty pharmacies have, and will continue, to play a major role with regards to facilitating a continuum of care for patients dealing with complex disease states and accompanying challenging therapies. Specialty pharmacies and the highly educated health care professionals at these pharmacies sit at the epicenter of patient care coordination.

Health plans are increasingly requiring the use of specialty pharmacies to ensure their patients are receiving care from specialty-trained clinicians to optimize clinical outcomes. United Health Group research demonstrated that specialty pharmacies and coordinated medical services resulted in a total cost savings of about 13% for cancer and transplant services, as well as an increase in compliance for patients with cancer, multiple sclerosis, and rheumatoid arthritis.

There are countless studies documenting that specialty pharmacies consistently outperform retail pharmacies with respect to adherence metrics. The results for one such study for hepatitis C treatment determined:

		Study patients who exclusively used a specialty pharmacy had a 60% higher likelihood of achieving optimum adherence compared with retail pharmacy users.

		Average regimen adherence was 8.6% higher for specialty pharmacy patients than for retail pharmacy patients.

		Specialty pharmacy services (eg, disease-specific and drug-specific patient counseling, patient training on proper drug self-administration, identifying and treating side effects, assistance with administrative issues) may overcome barriers to adherence in hepatitis C patients.

One large-scale study was conducted to compare compliance and persistence results between all products in a specialty class across the retail and specialty channels. Insights confirmed that specialty pharmacies consistently outperform not only retail pharmacies, but also traditional mail order in medication possession ratio.

Drilling down to specific specialty therapies, a major specialty pharmacy reports the following adherence rates.

Specialty Pharmacy Accreditation and Compliance 

While there is no current industrywide accepted definition for a specialty pharmacy, specialty pharmacy accreditation has become a must-have versus a nice-to-have. Any pharmacy that puts forth the rigorous effort to gain accreditation can distinguish itself as a provider of specialty services. Accreditation bodies, such as URAC, have specific standards of focus, including customer service, communications and disclosure, specialty drug management, pharmacy operations, and patient management.

Patient management criteria are built around the patient and based on the best available science and clinical practice. Comprehensive standards for accreditation include a focus on individualized patient services and interventions to optimize therapeutic outcomes through appropriate medication use.

Effective communication protocols, monitoring and promotion of medication adherence, development of care, service plans, and education related to medication are all elements of accreditation. The health care professionals at these accredited specialty pharmacies are highly qualified and best positioned to support adherence to specialty products.

Given the multitude of dynamics that influence adherence, it is no surprise the solution to optimizing compliance requires a multifaceted approach. Effective communication is the cornerstone of building a results-driven adherence plan. Regardless of the site of service, the need to educate, remind, and coach patients and caregivers is of critical importance. Traditional strategies, such as refill reminders, medication counseling, simplifying dosing regimens, and customized packaging, do improve outcomes.

The use of digital tools, such as e-mail, text messages, and video training are playing an expanded role in supporting the larger compliance plan. Customized patient services programs, coupled with actionable intelligence from data reporting, are crucial to support adherence goals. In some specialty therapies, there may be an opportunity to introduce a targeted clinical intervention, based on the product profile, to anticipate a patient falling off therapy.

For example, if the product has a side effect that could be exacerbated by a dosing titration schedule, this could be an opportunity to head off any compliance issues with a proactive clinical intervention above and beyond the pharmacy’s standard of care. There are a number of medication adherence tools, including the Morisky Medication Adherence Scale (MMAS), used as a predictor of noncompliance. Any adherence program should be customized, by patient, as a one-size fits all approach may not provide meaningful results.

There is no single solution leading to adherence nirvana. Medication adherence is a complex issue that demands a herculean effort. The one constant in this challenge is the specialty pharmacy. Study after study confirm that adherence results are consistently higher when using a specialty pharmacy. Highly skilled health care professionals practicing at specialty pharmacies are most often the best equipped to provide comprehensive therapy management to maximize clinical outcomes.

They have a holistic view of the patient’s entire medical and therapeutic status, including concomitant therapies, medical history, allergies, comorbid conditions, and are best positioned to assess, recognize, and intervene if they see compliance trouble brewing. The consistent patient-management protocols, disease-specific care plans, and specialized clinical teams at specialty pharmacies combine to create a formidable force to mitigate barriers to adherence, while positively impacting clinical outcomes and maximizing the benefits of specialty therapies.

The views expressed in this article are the opinions of the author and not of Mallinckrodt Pharmaceuticals. 

1. The Express Scripts 2015 Drug Trend Report. http://lab.express-scripts.com/lab/drug-trend-report. Accessed May June 2, 2016

2. CMS. Medication Adherence. https://www.cdc.gov/primarycare/materials/medication/docs/medication-adherence-01ccd.pdf. Accessed June 2, 2016

3. Martin Sipkoff. Improved Adherence Highlights Specialty Pharmacy Potential. 

: October 2009. http://www.managedcaremag.com/archives/2009/10/improved-adherence-highlights-specialty-pharmacy%E2%80%99s-potential. Accessed June 2, 2016

4. Kelly Matthews. Improving Medication Adherence for Oncology Patients Through High-Tech Interventions. 

: June 2015. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/june-2015/improving-medication-adherence-for-oncology-patients-through-high-tech-interventions. Accessed June 2, 2016

5. The Growth of Specialty Pharmacy. UnitedHealth Center for Health Reform & Modernization. Issue Brief April 2014. http://www.unitedhealthgroup.com/~/media/uhg/pdf/2014/unh-the-growth-of-specialty-pharmacy.ashx. Accessed June 2, 2016

6. Jay Visaria, and Sharon Glave Frazee. Role of Pharmacy Channel in Adherence to Hepatitis C Regimens. February 2013. http://www.ajpb.com/journals/ajpb/2013/AJPB_JanFeb2013/Role-of-Pharmacy-Channel-in-Adherence-to-Hepatitis-C-Regimens. Accessed June 5, 2016

7. Understanding and Improving Adherence for Specialty Products. IMS Intelligence Applied. http://adhereforhealth.org/wp-content/uploads/pdf/Understanding_Improving_Adherence_Specialty_Products_IMS_Health.pdf. Accessed June 3, 2016

, has over 30 years of experience in the health care sector spanning retail/specialty pharmacy, biotechnology, and management consulting. Maryann specializes in channel optimization, providing strategic and tactical insight into the specialty pharmacy service model. She has held various leadership roles at Biogen Idec, Pricewaterhouse Coopers, and EMD Serono. She has provided thought leadership in the management of multi-sponsored risk evaluation and mitigation strategies programs and led an innovative limited distribution track and trace program designed to mitigate diversion and counterfeiting of high-target biologics. Maryann practiced pharmacy at CVS Health in Massachusetts after graduating from Massachusetts College of Pharmacy. She is a member of the editorial board of Specialty Pharmacy Times.

Medication adherence is a complex issue that demands a herculean effort by the specialty pharmacy. 

The Role of Specialty Pharmacy in Medication Adherence

The development and management of a successful data strategy require a team effort.

Use of specialty medications to treat complex conditions such as rheumatoid arthritis, multiple sclerosis, and cancer is on an upward trajectory. One only needs to look at the current number of specialty products in various pharmaceutical manufacturers’ pipelines as an indicator that current trends are not likely to diminish in the near future.

, a small percent of patients (3.6%) account for 25% of health care costs, and it is estimated that specialty spend will quadruple by 2020 (Figure 1).

Manufacturers of specialty products are focused on optimizing channel strategies to deliver maximum value for their respective organizations while delivering a positive patient and provider experience. That said, the breadth and depth of specialty pharmacy (SP) data could be a bonanza for manufacturers. The robust transaction-level data that manufacturers are able to procure through their SP partners can provide market intelligence that would otherwise not be unavailable. This valuable data can be mined to support achievement of critical business objectives.

Determining and implementing a data strategy that will ultimately deliver desired business outcomes requires a village. The scope and effort for this task must be underestimated, as both manufacturers and SPs are faced with many moving parts that will influence the quality and completeness of the data.

There are a host of environmental factors that will have a direct influence on any data approach. Data strategies are heavily impacted by privacy regulations such as the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act, as well as state regulations on the sharing of protected health information. Patient consent is a key driver of the level of information that manufacturers can expect to receive given the increasingly more onerous scrutiny by regulators. In today’s environment, a successful data strategy requires close collaboration with both internal and external functional stakeholders. In addition, one can expect variations across the universe of SPs as a result of each pharmacy’s interpretations of the regulations governing data sharing.

The first step toward a successful data strategy is to develop a data governance approach to ensure alignment across internal functions including, but not limited to, brand teams, sales, trade/channel, legal, compliance, patient services, and information management. Once a team is formed, the next step is to conduct a cross-functional needs assessment to determine the scope of the data needs from the ultimate users, including the necessary data elements and the data reporting protocols (Figure 2).

When determining the level and frequency of the data that a manufacturer desires, there are a few key questions that will inform the final data strategy:

		What are the critical data elements needed to effectively manage the business?

		What is the frequency of the data reporting that supports actionable strategies/tactics?

		Does my organization have the expertise and bandwidth to aggregate, cleanse, validate, and interpret the data?

Manufacturers must determine what level of data is necessary to effectively manage their business to ensure optimal outcomes, both clinically and financially. The data specification will be a function of the product characteristics and the complexity of the disease state. For example, an oral tablet with minimal side effects may require less stringent reporting than a product or disease state with a more complex profile, (eg, a product that requires multiple clinical interventions or is under an FDA-mandated risk evaluation and mitigation strategy). SP data can be classified into 3 general categories:

		Base data: data that are readily available and require minimal effort for the SP to provide

		Enhanced data: data that are available and may require additional effort for the SP to provide

		Customized data: data that are not readily available and would require significant effort for the SP to provide 

An example of base data would be dispensed data, including elements such as product name, National Drug Code, date dispensed, quantity, prescriber information, and refill information. An example of enhanced data may be referral data, which indicates the status of the referral and includes status codes with categories such as pending, active, denied, or discontinued. To go a level deeper, sub-status codes may be captured. Sub-status code examples include benefit investigation, prior approval, appeal, and no insurance coverage. Customized data may include information captured regarding a targeted clinical intervention outcome. With respect to the data approach, manufactures should be careful not to seek to overachieve and should be realistic when choosing the scope of the data approach to meet their business needs

The next decision point is the frequency of the data reporting from the SP. This will likely be a function of not only the product profile and disease state but also any additional services the pharmacy may be performing on behalf of the manufacturer. For example, if hub services are involved, there may be a need for a daily report of referral status to inform the hub of any reimbursement interventions required. If there is an adherence program for the product, including a targeted intervention, what information from that outreach may be of value to capture? It is important to note that the dynamics at the pharmacy level regarding status, shipments, and other data points are not static. The fluid nature of a daily pharmacy data feed in and of itself can contribute to an overreaction by manufacturers. For example, a referral status can change several times within a short timeframe. A weekly or monthly data frequency may provide more reliable and actionable intelligence thereby, allowing the real word dynamics to flush themselves out.

Once the data strategy is identified, the real work begins. Given the many moving parts involved in the data implementation, a defined implementation plan is critical to meet timelines and business objectives.

Typical data implementation timelines range from 30 to 120 days from start to completion, depending on the complexity of the data strategy. The expertise needed to receive, scrub, quality check, and translate the data into a usable reporting vehicle may or may not be found internally. Manufacturers must look inward to determine if they have the expertise and capacity to manage the data effectively or if external support such as a data aggregator and/or an external data reporting tool is necessary.

Once the data is received, it must be properly interpreted so that the outcome accurately represents the market dynamics and actual product performance. SPs can provide a rich source of transaction-level data that can give greate insight into brand effectiveness and support business strategies if properly understood.

SP data are the golden nugget for manufacturers and can provide invaluable and actionable insight for specialty products. The effort to identify, build, and manage a comprehensive data strategy is substantial, but the rewards of a well thought out and executed data strategy cannot be underestimated. 

The views expressed in this article are the opinions of the author and not of Mallinckrodt Pharmaceuticals.

, has over 25 years of experience in the health care sector, spanning retail/specialty pharmacy, biotechnology, and management consulting. Maryann specializes in channel optimization providing strategic and tactical insight into the specialty distribution/pharmacy service model. She has held various leadership roles at Biogen Idec, PriceWaterhouseCoopers, and EMD Serono. She has provided thought leadership in the management of multisponsored risk evaluation and mitigation strategies programs, and led an innovative limited distribution track-and-trace program designed to mitigate diversion and counterfeiting of high target biologics. Maryann practiced pharmacy at CVS Health in Massachusetts after graduating from Massachusetts College of Pharmacy. She is a member of the editorial board of 

Specialty Pharmacy Data: The Golden Nugget for Manufacturers 

Specialty product manufacturers collaborate with specialty pharmacies because of the services and support pharmacies provide in their shared mission to achieve optimal clinical outcomes. 

Use of specialty medications to treat complex, chronic conditions such as rheumatoid arthritis, multiple sclerosis, and cancer is projected to reach $235 billion by 2018. The current trend is likely to continue, given the number of biologics in the pipeline to meet the medical needs of these most complex of disease states. There were 19 specialty products approved in 2013, with 150 additional specialty products currently in phase 3.

In 2013, specialty medications represented less than 1% of all US prescriptions and at the same time accounted for more than 25% of the country’s total pharmacy spend, according to Express Scripts’ Drug Trend Report.

Given that the specialty product growth trajectory is likely to continue, manufacturers of specialty products are focused on developing distribution strategies for their products that optimize the patient journey and medical community experience. Mitigating barriers to therapy and maximizing positive clinical outcomes are key drivers of manufacturer specialty pharmacy service model strategies.

An effective strategy to support complex disease states requires focused and targeted services for patients, prescribers, and payers. The growth of specialty product markets has been matched by the increased sophistication of the specialty pharmacy business model. Manufacturers of specialty products will continue to collaborate with specialty pharmacy providers (SPPs) to assist in the management of these complex products by providing customized care management services and innovative drug delivery systems. Many payers prefer the specialty pharmacy channel for their members to ensure appropriate utilization management and services for complex and high-cost therapies.

The manufacturers of these complex and costly products will continue to collaborate with their specialty pharmacy trading partners to take advantage of the myriad of services that the specialty pharmacies offer in support of the manufacturer and patients. The good news is that both manufacturers and SPPs have the same ultimate goal. The common focus is to deliver excellence in drug therapies that will optimize clinical outcomes and result in the best possible patient and provider experience.

As manufacturers develop their plans for SPP collaboration, there is a need to identify reliable barometers for identifying specialty pharmacies that distinguish themselves as leaders in a particular therapeutic category. While there are industry accreditations such as URAC that demonstrate an SPP’s commitment to the specialty pharmacy model, there does not exist a vehicle that targets expertise in a key disease state area. Therefore, manufacturers will conduct their own due diligence to validate that an SPP has the requisite disease state expertise.

Manufacturers must first define their organizational needs, determine the strategy to meet those needs, and execute on the tactics to meet business objectives.

The million-dollar question for a manufacturer is, “What SPP services would add the most value to deliver the best outcomes and facilitate a superior patient and prescriber experience?” Before a manufacturer can answer this question, there needs to be a careful consideration of several factors to determine the appropriate service model.

At the top of the list for this exercise is understanding the product profile, including:

		Product tolerability/side effect profile

The next step is to understand the needs and goals of internal and external stakeholders, including:

Other considerations in the development of value-added services include:

		Cost of product versus competitor’s price

		Competitor service models for like products

		Risk evaluation and mitigation strategy (REMS) requirements

The first rule of understanding the specialty pharmacy model is to accept the reality that all specialty pharmacies are not created equal. There may be a significant variation in service-level models from SPP to SPP, given the variation in business models and SPP management interpretations. Some services are consistent across the channel, such as dispensing of prescriptions, patient counseling, and refill management. In other instances, a particular service at one pharmacy may be considered a core service while at another pharmacy the same service may be considered a customized service. When building a service model, manufacturers should clearly understand the distinction between 

services are those that are part and parcel to the pharmacy standard practice of care. For many SPPs, these could include such services as:

		Standard patient education/clinical counseling

services are those that are offered in addition to the pharmacy’s standard of care model and therefore may require separate fair market value payment from the manufacturer.

These could potentially include such services as:

		Targeted patient outreach that is additive to the pharmacy’s standard compliance and persistency protocols

		In-home nursing services such as injection training

		Shipment of product starter/welcome kits directed by the manufacturer

The unavoidable variations across the specialty pharmacy market with respect to core versus customized services pose a challenge for manufacturers whose goal it is to provide a consistent patient and provider experience. Manufacturers strive to build a consistent service model for patients and the medical community and will work with their trading partners in an effort to minimize the variations across the specialty pharmacy channel.

While the need for some services is consistent across the spectrum of products, each product that falls into the specialty pharmacy category demands its own set of unique services. A self-injectable agent that is mature may not require the intense level of services as an agent that must be infused or is associated with a comprehensive REMS program. An oral product may not require the same level of nursing support as a product that is administered intravenously or intramuscularly.

Nursing services span the range from telephonic to in-home injection training, depending on the product profile and specific patient needs.

A product that has a side effect profile with tolerability issues may require a more comprehensive compliance and persistency program than a product that is generally well tolerated. The design of the compliance and persistency program must consider the product characteristics, including tolerability, mode of administration, and dosing frequency. Specialty pharmacies hold a unique position as they are the final stop in the delivery of critical specialty products to patients who are dealing with complex conditions. The SPP clinicians have the advantage of a holistic view of the patient’s medical and therapy profile and therefore are best positioned to positively impact adherence goals.

Benefit investigation and prior approval facilitation efforts tend to be fairly standard across the channel. Specialty pharmacies typically provide financial assistance such as administration of manufacturers’ co-pay programs, referral to manufacturers’ patient-assistance programs, and working with foundations to identify funds to support patient therapies. There can, however, be wide variations in the pharmacy operational process to achieve the end result of mitigating administrative and financial barriers to specialty therapies. In some instances there are enhanced or additional services beyond the standard, such as facilitation of medical exception/appeals or co-pay support services that could move the service into the customized bucket.

The comprehensive data services that specialty pharmacies provide are the golden nugget for manufacturers. SPPs are able to provide robust transaction-level data and offer market intelligence that would not otherwise be available to manufacturers. When determining the level and frequency of the data that a manufacturer desires, there are a few key questions that will inform the final data strategy, including:

		How will the data be interpreted to ensure that they are reflective of the actual market dynamics?

		Does my organization have the expertise and bandwidth to receive and process the data into meaningful data metrics?

Determining and implementing a data strategy that will ultimately deliver the desired business outcomes takes a village. The scope and effort for this task cannot be underestimated as both manufacturers and SPPs are faced with many moving parts that will influence the quality and completeness of the data.

The data effort is impacted by privacy regulations such as those established in the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act as well as some state regulations on the sharing of protected health information. Patient consent is a key driver of the level of information that manufacturers can expect to receive given the increasingly more onerous scrutiny of regulators. In today’s environment, a successful data strategy requires close collaboration with cross-functional stake holders.

Once the manufacturer has completed its due diligence regarding optimal support programs for its specific product, the next step is to determine the SPP services that will most closely align with brand objectives. It is crucial to implement programs that meet the needs of external stakeholders including patients/caregivers, prescribers, and payers. In addition, internal cross-functional teams have a vested interest in leveraging the SPP services that will deliver the most value that, absent the SPP services, would not be available.