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INTRODUCTION

In a 2019 survey, 85 U.S. health plan officers identified atopic dermatitis (AD) among the top four conditions with the greatest financial impact to their plans.¹ Most plans support their formulary decisions with comparative effectiveness research (CER), but little CER is available for AD. For that reason, health systems must use alternate information when they plan how to provide care to patients with AD. One approach is to look at the value compass associated with this chronic skin disease. Similar to a directional compass, a value compass has four essential points. First, it looks at the patient’s functional status, risk status, and well-being. It also looks at costs, and then considers patient satisfaction with health care and perceived benefit. Finally, the fourth point on the value compass is clinical outcomes.¹ This continuing education activity will explore AD and look at the various ways that healthcare systems and pharmacies can measure its impact, document improvements associated with optimal treatment, and make educated formulary decisions.

ATOPIC DERMATITIS: AN OVERVIEW

Atopy is a genetic tendency to develop the classic allergic diseases, and AD is associated with a constellation called atopic triad (asthma, allergic rhinitis, and atopic dermatitis). For some patients, an allergist may need to be involved. Atopic conditions involve IgE production in response to common environmental proteins like house dust mites, grass pollen, and food allergens. The origins of these diseases are poorly understood, but immunologic dysregulation and increased Th2 immune response are often present.^2,3

To understand AD’s impact at the patient and the system level, a brief overview of this inflammatory skin disorder is necessary. Atopic dermatitis is a very common problem. Typically, it is called eczema, although eczema is an umbrella term describing several skin conditions. More common in wealthier, developed nations than in poorer, developing countries, this relapsing/remitting disease has approximately tripled in incidence over the last three decades.^2,3 Conservative estimates indicate that AD’s cost in the United States (U. S.) is approximately $5.3 billion in 2015 currency.⁴ AD affects between 10% and 20% of children.^2,3 It usually resolves in many children as they age, but not all. Traditionally we believed that adults were less likely to have AD, but statisticians have documented that around 10% of adults, and probably more, have some form of AD. Although AD is typically nonfatal, its episodic flares and remission are so serious that it has the highest disability-adjusted life-years among skin disorders. Thus, medical directors’ concerns reflect both the high prevalence and considerable patient burden.^2,3

AD is widespread, costly, and intrusive. Approximately 30 million Americans have AD, and it requires a myriad of prescription medications to treat it adequately.^5-8 One area in which pharmacists underestimate financial impact is the out of pocket (OOP) costs associated with treatment. In addition to prescription products, patients use numerous OTC products. The most important product is a good moisturizer that is typically costly. Some of AD’s cost is associated with time-consuming treatment regimens (discussed below). Its intrusiveness is associated with its itching, which is AD’s hallmark symptom.^5,7-9 Many people with other kinds of dermatitis say, “I have a rash that itches.” AD flips that response. AD is often called, “the itch that rashes” because itching is prominent and bothersome.^10,11 In general patients who have mild AD may have some redness, rash, and itching. As it worsens, the rash may spread in an age-typical fashion (See Figure 1). Severe AD is often red, scaly, and oozing. As patients scratch, skin thickens and they develop fairly typical excoriation and lichenification (hard leathery skin).^12,13

People who have AD often fall into a vicious cycle in which the time required to apply topicals and itching associated with the condition leads to cascading issues. Sleep disruption for themselves and other people in their homes, mental health issues, missed work and school, or social isolation are common.^4,5,14,15,16 This in turn increases the risk of psychological disorders, motor vehicle accidents, and workplace injury for the patient and the patient’s significant others.¹⁶ Subsequently, rates of depression and anxiety increase. Self-esteem falls and patients social functioning is impaired.^4,5,14,15,16

Adherence

Good-quality surveys indicate that patients spend 2 to 3 hours daily on treatments and treatment regimens interfere with life’s pleasures (e.g., hobbies, entertainment, and vacations). Providing ample care to self or others often strains relationships and the OOP expense can be stymieing. Adherence at or above 90% is a treatment goal. In AD, adherence to topical treatment exceeds 90% at the start of treatment but decreases to approximately 30% at 8 weeks.^17,18 This can lead to poor treatment response and unnecessary treatment escalation and related costs. A successful treatment plan must address hydration, skin barrier restoration, and prevention of skin infection.^17,18

Brief Treatment Overview

A brief treatment overview can help pharmacists understand why AD is such a concern in terms of cost and adherence. Moisturization is a lifelong requirement for people who have AD, and as stated earlier, it’s time-consuming.^8,19-21 For many patients with mild AD, moisturization alone can manage the condition.^8,20 These patients will need to moisturize at least once daily and preferably more if their skin feels tight and dry. The type of topical product they use depends heavily on patient preference. If the patient finds a topical too greasy or heavy, he or she probably will not use it as often as necessary.^8,19,20

Bathing is also a concern and goes hand-in-hand with moisturization.^19,21 Patients who have AD should bathe no more than once daily with tepid water and avoid strong soaps. Bathing helps remove dead skin and freshens the skin. Patients should moisturize immediately after bathing. ^19,21

Patients need mild, soap-free, fragrance-free products which tend to be costly.^19,21 As AD worsens, patient need more occlusive products. Pharmacists should recall that topicals progress from gels to lotions to creams to ointments in becoming more occlusive. Gels can be drying, and most patients will prefer lotions and creams to ointments.⁸ But as AD progresses, patients will need to use more occlusive products that form a physical barrier or seal over the skin’s surface to prevent trans-epidermal water loss and lock moisture in.^19,21 Some formulations can cause skin sensitivity which is usually due to product additives and switching to a different formulation often helps.⁸

Follow the Steps

The following is a brief review of AD treatment. Guidelines recommend treating AD in a stepwise fashion. AD waxes and wanes in most patients, and once patients start to develop a flare, they need to address it as soon as possible. In addition to moisturization, patients often need topical corticosteroids (TCS) as a first step to address flares.²² One contributor to poor adherence is steroid phobia. Approximately 21% to 83.7% of people including healthcare providers report steroid phobia, which is the unfounded fear of using these products.^23,22 When used appropriately TCSs have few adverse effects and little systemic absorption.²³ To avoid alarming patients when they have TCS prescriptions, explain how to use TCSs properly and reassure them. Don’t say, “Use sparingly.” Instead provide more clarity and say, “Use this exactly as I’ve explained (or demonstrated) starting as soon as a flare begins.”

As a next step, patients who have used TCSs for a long time with little response or who have some contraindication to TCSs might try the topical calcineurin inhibitors (TCNIs), pimecrolimus or tacrolimus.²² TCNIs are second line agents, and are often good for flares and sensitive areas (e.g., the face or the skin folds).²² Another option is the topical phosphodiesterase inhibitor crisaborole.²² Crisaborole down regulates nuclear factor-kB and activates T-cell signaling pathways to suppress cytokine release.²² Since March 2020, crisaborole has been approved by the Food and Drug Administration (FDA) for infants aged 3 months or older. It has few adverse effects but patients may experience some stinging or burning.²²

The next step has traditionally been phototherapy or systemic immunomodulating drugs, alone or together.²² Again, patients may need to use topical therapy with these modalities and must continue to moisturize. The traditional systemic immunomodulating drugs include the oral agents cyclosporine, azathioprine, mycophenolate mofetil, and methotrexate. These products have some fairly serious adverse reactions and require close monitoring. Cyclosporine and azathioprine often cause photosensitivity and mycophenolate mofetil is teratogenic. Methotrexate requires coadministration of folic acid, and it can cause bone marrow suppression, aplastic anemia, and gastrointestinal toxicity.²²

The FDA has approved one subcutaneous biologic: dupilumab. This monoclonal antibody targets pathways that are key mediators in AD. It inhibits the IL-4 and the IL-13 cytokine-induced inflammatory cascades. Results from 4 phase 3 clinical trials have demonstrated that dupilumab is safe and effective. All study participants used concomitant TCSs with or without topical TCNIs and patients could self-manage with topical products as the disease waxed and waned.^24,25 Most adverse events were injection site reactions. Dupilumab has also been associated with conjunctivitis. It’s curious to many people that dupilumab is associated with an eye problem. Patients who have AD have a higher prevalence of ocular comorbidities than other people. And barrier function in the skin – including the eye which is a kind of skin – is impaired. For these reasons, people who have AD may be predisposed to coular problems.²⁶

Cost of treatment is a concern for payers, health systems, and patients. TCS prices have been volatile. Medicare Part D annual OOP costs for TCSs increased from $41.4 million to $101.8 million between 2011 and 2015.²⁷ The cost of dupilumab is estimated at up to 37,000/year but meets the threshold for cost effectiveness.²⁸ Pharmacists and managed care administrators must remember that the cost of medication does not represent the entire cost of the disease.

Real-Word Burden

Few data document AD’s burden in adults relative to the general population and other chronic skin disorders. The 2013 National Health and Wellness Survey evaluated the real-world burden in adults with AD relative to both adults without AD and adults with psoriasis.²⁹ The researchers inquired about comorbidities, healthcare resource utilization (HCRU), and costs and evaluated the impact of AD severity on these outcomes. The researchers distributed this Internet-based survey to roughly 1.2 million people; 9.3% responded (N = 109,592); 68.4% of responders met the inclusion criteria. Predictably, patients with AD had a significantly greater risk for atopic comorbidities (e.g., asthma and nasal allergy or hay fever). HCRU and total direct costs were more than double among responders with AD compared with non-AD controls. However, there was no statistically significant difference in HCRU among patients with moderate/severe AD as compared to mild AD patients. Although AD’s burden was similar to that of psoriasis, patients with AD tended to use the emergency room more than patients with psoriasis. Patients with AD also have an elevated risk for all types of arthritis.²⁹AD’s substantial disease burden suggests an unmet need for more effective treatment options.

Clinicians often struggle to find appropriate treatment combinations for patients with AD. In collaboration with the patient, there is a need to conduct risk-benefit analyses that consider toxicity and cost to ensure better use of existing, widely used topical and systemic treatments.^30,31 A team of experts recently wrote, “Providers must be aware of safety and cost issues for available agents and be prepared to inform families about the range of treatment choices available as well as the evidence available to date regarding the safety of these various agents.”³¹ These experts suggest that using newer agents such as systemic biologic agents initially, with subsequent "pulsed" topical corticosteroid dosing in tandem or in concert with topical PDE inhibitors, could be a safe, viable, and cost-effective therapeutic plan.^30,31

It’s clear from other disease states that are plagued with adherence issues that successful care management programs have 4 key components.³² The first is a sound therapy selection process. Patients need initial therapy with an optimal option. Clinicians must review patients’ medical status, family history of atopic diseases, and comorbidities and then comply with treatment guidelines and managed care policies. Pharmacists can also provide on-going support by checking drug-drug, drug-disease, and drug-patient interactions while ensuring treatment guidelines are followed at therapy initiation and throughout the course of therapy.³² Next, the team must formulate a monitoring plan.³² Therapy tolerance increases the likelihood of adherence with prescribed therapy and helps achieve therapy goals. Proactive attention to potential side effects, identified adherence barriers, and patient support systems also keep patients on track.

Third, pharmacy needs to measure therapy effectiveness in collaboration with a multidisciplinary team within the health system. Drug therapy outcome metrics should be defined early in the development phase of any care management program, so this step can be challenging. The focus is to measure patient-reported outcomes (PROs), quality of life (QoL), or both depending on the pharmacy’s capabilities. Starting with simple, executable measures builds pharmacy staff’s capabilities and confidence. Programs can increase their measures’ sophistication, adding measures that are more targeted or comprehensive, as the program matures

Fourth and finally, frequent, redundant education is critical in AD. Healthcare providers need to remind patients constantly that AD waxes and wanes. Once patients control flares, maintaining control requires excellent adherence.^33,34

Guidelines and Care Plans

Several times, we have referred to guidelines and the step therapy described above summarizes the approach used in current American Academy of Dermatology guidelines.²² Other organizations have created or modified AD guidelines, but they all have very similar approaches.³⁵ Following guidelines ensures that patients begin treatment with effective, appropriate medications and clinicians escalate treatment aggressively. It also prompts clinicians to recommend appropriate moisturizer, communicate instructions to patients effectively, increase community health literacy, and connect patients living with AD to patient-support organizations.³⁵

Each patient’s care plan must be based on whether an acute or maintenance treatment course is needed and the current disease severity. Because the treatment paradigm is evolving, a team of clinicians from across the U.S. developed the Atopic Dermatitis Yardstick.³⁶ It translates guidelines into steps that accelerate therapy for patients with poorly controlled AD. The treatment goal is clear to almost clear skin and the authors provide two concise flowcharts to help guide treatment selection. A key take-away is that patients need frequent evaluations (every 4 to 8 weeks) even if they respond to treatment lest they slide into recurrence. Clinicians need to reassess patients who experience frequent exacerbations and poor long-term disease control, first to ensure that the lack of response is unrelated to nonadherence or comorbidities and then to step up treatment.³⁶ Patients also need an AD Action Plan, which is similar to an asthma action plan. AD action plans help patients know what to do as their AD waxes and wanes, so they can step up care, or step down as the hallmark pruritis lessens.^33,34,36 Many organizations have created AD (or Eczema) Action Plan templates, and they are easily located on the Internet.

Multidisciplinary approaches to AD care have been developed to address the complex interplay among biologic, psychological, behavioral, and dietary factors that affect disease control. Patients and families require a wide range of knowledge, skills, and support to manage AD effectively and cope with this condition.^22,37

Measure to Manage

As noted, pharmacies need simple, executable patient-reported outcome measures (PROMs) to ensure they measure patients’ progress. Developing measures is a science unto itself and begins with a multiyear review of primary and secondary research and guidelines. Once guidelines are formalized, quality improvement specialists generally spend 4 to 12 months developing draft measures. Then, the measures are field tested over 9 to 24 months and endorsed if appropriate.^38,39 For this reason, most organizations usually use tested measures developed by reliable organizations. Measures address specific issues, and in AD, healthcare systems are interested in PROMs at several levels. The first are measures that reflect general health. Table 1 lists 4 instruments used in this capacity in general populations (i.e., not AD-specific) and highlights items clinicians should consider when selecting an instrument. Respondent burden is a prime consideration.⁴⁰

Moving from general health to more targeted measures, roughly 10 dermatology-specific PROMs are available, with 3 used often (see Table 2). These PROMs are not specific to AD, but provide some information about quality of life and symptoms.

More specific to dermatologic symptomatology, PROMs that are specific to pruritis are available, too. Since itching is AD’s hallmark symptom, these are valuable when measuring AD outcomes. Table 3 lists several of these highlighting factors that are important to consider.

Finally, several AD-specific PROMs are available, and Table 4 lists several. The most commonly used disease severity scales are the SCORAD index, the Eczema Area and Severity Index (EASI), the Investigator's Global Assessment (IGA), and the Six Area, Six Sign Atopic Dermatitis (SASSAD) severity score. The SCORAD index, the EASI score, and the Patient-Oriented Eczema Measure (POEM) severity scale have been adequately tested and validated; therefore, clinicians can consider using them when practical. POEM was specifically designed to measure severity from the patient perspective and uses 7 questions regarding symptoms and their frequency. The best practice is to assess AD’s impact on daily life by asking general questions about itch, pain, sleep, impact of daily activities, and psychosocial activities. For example, using the questions developed in the 5-D Itch tool will provide insight into AD’s impact on sleep, school/work, social life or emotions.³⁹

Care Management Plans

Patients often have barriers that prevent them from achieving therapy goals.³⁶ Approximately 50% of patients on long-term therapy fail to take or apply medications as directed, at least part of the time. Contributing factors include drug cost, belief in therapy, medication side effects or the simple reason that the patient just forgets to take their medications as scheduled. Medications themselves may have characteristics that are barriers. Complicated drug regimens and drug administration processes are examples. The major barrier is that clinicians fail to identify poor adherence early.³⁶ Care management plans help patients navigate complicated, costly, difficult treatment regimens, and adherence barriers.

Ultimately, any care management plan needs to:

• Create a written eczema action plans for all enrollees
• Provide education to patient/caregivers
• Establish treatment goals
• Enroll patients in care and adherence management programs
• Proactively manage side effects
• Derive care plans with specific follow ups and a monitoring plan
• Connect patients to support groups and educational events

Thus, care management is complex. Both pharmacy staff and patients face limitations and challenges.¹⁷ Patients are often encumbered by their knowledge deficits, stigma associated with AD’s manifestations and associated medical condition that cause physical limitations and adherence barriers. Financial hardship limits some patients’ ability to achieve therapy goals.¹⁷

In the pharmacy, having the capabilities to capture, track, and analyze data is often the most daunting challenge.⁴¹ Currently, health systems often view patient or clinical care management programs as an added-value services.^42,43 Obtaining approvals to dedicate personnel and resources to clinical care management is often a limitation.⁴³ Once these programs start, patient collaboration is a hurdle because most patients don’t realize the benefits of having clinical coaching that pharmacists and the care management services provide.⁴²

Tailoring programs to patient needs is critical. To attract and engage patients in care management programs, many organizations categorize care services in 3 logical levels and implement the most feasible for the organization and patient population⁴⁴:

• A Standard Service Level offers simple services using basic touch points and uncomplicated therapy goals. This might include providing refill reminders and tracking and measuring the easiest of interventions and outcomes (e.g., tracking refills to reflect adherence, noting counseling sessions).
• A High Touch Service Level provides care management throughout the course of drug therapy. It includes proactive patient care interactions (e.g., anticipating and addressing events in advance rather than waiting to respond to it after they happened). In this approach, clinicians begin comprehensive assessment, education, and monitoring at the first patient contact, then follow up as frequently as necessary based on the patient’s AD severity. An example of a proactive approach would be to remind patients that AD waxes and wanes and ensure they know how to manage flares. Clinicians also manage side effects proactively and identify adherence barriers early.
• A Customized Service Level goes above and beyond standard care, catering to high-risk patients and focusing on targeted outcomes. For example, patients on specialty drugs may have an increased risk of malignancy, and the health care team would screen for a family history of cancer and monitor closely.

For effective training and education of patients, motivational interviewing works efficiently as it focuses on the patient’s ability to incorporate medication administration steps into normal daily activities and coaches patients without lecturing.⁴⁵ In addition to the care components discussed earlier (e.g., proactive flare management, consistent skin care, trigger avoidance, education and adherence support, comorbidity and adverse effect management), care programs need to address health maintenance like diet, nutrition, exercise, smoking status, psychosocial issues and QoL. As mobile devices become the norm to a majority of patients, technology has been a facilitator for all these components. New technology offers the ability to send assessment questions to patients’ mobile devices and increases efficiency. This approach helps to minimize patient abrasion and motivate more patients to respond at their convenience.

Real-World Evidence and Value-Based Contracting

Managed care plans are interested in integrating real-word evidence (RWE) into value-based contracting (VBC) processes.⁴⁶ A value-based contract ties payment terms for medications or other healthcare technologies to agreed-upon clinical circumstances, patient outcomes, or measures. To accomplish this, plans need to work within the quality improvement process. They need access to data to manage formulary, benefits, prior authorization, and switching decisions. Ideally, plans would use patient reported outcomes (PROs) to tailor treatment for patients who have AD.

VBC’s long-term goals are to have multiple outcomes contracts for competing therapies so results could be applied to formulary decisions and informed changes could be made.^46,50 VBC also assesses the treatments’ true benefit and determines value associated with dollars spent on pharmaceuticals. Additionally, it can reduce waste and slow disease progression if prescribers use an informed medication prescribing process.^46,50

Finding Data, Applying it to Formulary Decisions

The data extracted from the health system generally comes from 2 tracks. The pharmacy benefit includes products provided to patients from retail, mail order, and specialty pharmacy facilities. Pharmacies submit claims online to the pharmacy benefit manager (PBM) or use a direct-to-plan claim submission process. Prices are based on average wholesale price (AWP) or wholesale acquisition cost (WAC) with associated discounts. NDC codes are the principle identifying piece of data and are very specific. Patients have OOP copayments, coinsurance, or deductibles. Reporting capabilities are excellent with the typical pharmacy claims approach.⁴⁷ In the medical benefit, a healthcare practitioner (e.g., physician office, infusion clinic, home infusion clinic, or hospital inpatient or outpatient service) provides the product. Clinicians use the CMS 1500 electronic claims form and enter J codes or CPT codes for procedures, which are less specific than NDC codes. The prescriber buys the drug and bills the payer based on the average sales price (ASP). Manufacturers provide ASP to the Centers for Medicare and Medicaid Services quarterly. Here, patients also have OOP copayment, coinsurance, or deductible responsibilities for drugs provided on the medical benefit. In this system, it may take 60 days to accumulate enough analyzable data.⁴⁷

The formulary review process is universal and it applies across all disease areas.⁴⁸ Review committees look at clinical efficacy, safety, tolerability, therapeutic need, adherence to clinical guidelines and standards of medical practice.⁴⁸ They also consider RWE, other treatment options, pharmacoeconomics, PROs, and the net cost to the plan.⁴⁹ Historically, once a drug achieved formulary status, further review was unlikely. Today, plans are actively evaluating patient response and outcomes in the real world.

To obtain RWE, plans or manufacturers can purchase data from management companies like IBM Watson or Iqvia, which maintain large claims databases from broad populations.⁵⁰ Small regional plans may have insufficient data and may rely on manufacturers to purchase and supply data to facilitate analyses. Manufacturers purchase large amounts of data to stimulate informative discussions and develop value-based contract designs. RWE can also be extracted from specialty meeting presentations at dermatology conferences, poster presentations, and peer reviewed publications. Manufacturers conduct post marketing surveillance that informs RWE. General health plan claims can be a rich source of data. Health economics outcomes research (HEOR) data from academic settings, providers, or manufacturers is also helpful.

The AMCP Partnership Forum: Building the Foundation for Patient-Reported Outcomes – Infrastructure and Methodologies document indicates that PROs must emanate from consensus-based discussion and undergo validation.⁵¹ PRO stakeholders include patients and caregivers, healthcare providers, managed care organizations, science companies, and researchers. People in the drug development process are stakeholders, as is the FDA Patient Engagement Collaborative (a group of patient organizations and individual representatives that promotes more meaningful patient engagement in medical product development and other regulatory discussions at FDA).⁵² Developing these tools is time-consuming, which is why organizations use proven measures.^38,39 RWE is not available until after FDA approves the medication and the general population uses it. Plans need to monitor and interpret data carefully. They must also discuss implementation and use to clarify who owns the data, the security issues, and the opt-in and opt-out strategies for patients or plans depending on where the data is housed.⁵¹

Specialty pharmacies involved in the distribution of products and services can apply quality improvement processes and generate excellent data. Some use DMAIC (define, measure, analyze, improve, control) from Six Sigma. Here, the quality team takes time to define common problems or concerns, and then uses measures to collect data. Periodically, they analyze the data to they understand causes that impede improvement. In the control stage, they focus on sustaining the improvements.⁵³ Health plans can use this data to evaluate outcomes in patients and validate formulary and utilization management decisions. The Institute for Healthcare Improvement Triple Aim is another program that offers resources to galvanize new or growing quality improvement initiatives. It aims to improve the experience of care, improve population health, and reduce the per capita cost of healthcare.⁵⁴ Plans must balance the needs of the population by managing efficiently with available resources.

Preferred products are key formulary drivers, and traditional formulary approaches start with tiered co-pays or coinsurance. Closed formularies have become more common in recent years because they slow new product uptake and give plans an opportunity to develop prior authorization (PA) criteria which may also include step edits and quantity limits. Plans also use switch programs although some states have legislative restrictions prohibiting these programs. In states that allow switch programs, plans try to move patients from less preferred products to preferred products or newer agents with better efficacy or safety and cost savings. Formularies also incorporate current standard of care (SoC) options. For AD, SoC includes topicals, phototherapy, and immunosuppressants. Patients may have to work through these in a stepwise manner before they can access biologics.

Table 5 list PA’s objectives. The 2017 Magellan RX Management Medical Pharmacy Trend Report analyzed PA and found that the drug or biologic’s indication is always identified as a criteria.⁵⁵ Many plans use FDA-approved labeling to construct a PA. Prescribers can complete PA forms and plans generally approve well-documented PAs at very high rates. Many PAs also stipulate a treatment duration (90%), frequency and dose (~ 60%), and the presence or absence of concomitant therapies (68%). PAs may also require mandatory specialty pharmacy distribution. In many disease categories, multiple options create a situation in which cost and cost-effectiveness are key drivers.⁵⁵

Specialty pharmacy services can be pivotal to this process. They provide high-quality distribution, clinical services and disease management. They can implement utilization management to operationalize PAs on behalf of the plan and promote prescriber compliance and patient adherence. (The plan or a PBM can also manage PAs directly.) Most data show that specialty pharmacies high-touch routines improve prescriber compliance and patient adherence.⁴⁴ Specialty pharmacies also generally offer competitive reimbursement rates. When FDA approves a new product, specialty pharmacies may have been monitoring the pipeline and can share information with the plan and help with utilization management of new high cost specialty items. Limited specialty pharmacy networks also drive the marketplace and influence the patient journey. Larger networks negotiate less costly contracts with payers while limited specialty pharmacy networks consolidate usage in support of VBCs. They may also capture PROs that the plan can use to support contracting. Specialty pharmacies are very valuable in this realm of patient care.

Value-based contracting can be applied to chronic or acute medical conditions and cover topical, oral, injectable, or infusible products, so it is possible to use VBC in AD.^46,51 VBC collaborators—the plan and the manufacturer—need to identify measurable outcomes or proxy measures that are population-or individual-based.^46,51 For example, a gene therapy VBC would be individually-based while in AD, the contract would likely focus on a population-based design. Adherence requirements are ubiquitous because adherence drives good outcomes. Manufacturer will not want to assume risk for nonadherent patients.

Management challenges include the ability to access pharmacy and medical data which are core metrics in typical plans.^46,51 All measures need timelines, as plans can measure some things in 3-6 months and others may require a year or more to measure effectively and spread the risk. Plans need to identify data collection methods and validation options or analytics.^38,39 Manufacturers sometimes hire a third party to process and analyze the data for the contract. All involved must respect the Health Insurance Portability and Accountability Act (HIPAA) to prevent data breaches.

Potential Outcome Measures in AD

Some PROMs, including SCORAD, EASI, and POEM were discussed as potential outcomes measures, however,³⁹ clinicians generally do not use them in clinical practice. Specialty pharmacies could use a very simple measurement during the monthly medication renewal visit or monitoring phone calls to capture information. In addition, plans can examine flares, remission, IgE levels, adherence, steroid reduction or elimination, additional treatments, and switching. Some specific situations will still allow for use of validated instruments.

Information technology (IT) strategies can be complex and require access to data including medical claims and pharmacy claims. Diseases with specific, measurable outcomes are easily assessed using claims. AD’s outcomes are more patient-specific and a claim will not capture the magnitude of improvement or decline. The electronic health record (EHR) has the capability to provide more information, although most plans do not use the EHR as a data source at this time.⁴¹ Plans must have standard approaches, schedule data runs, and employ a number of end-user tools to capture information.

Success depends on anticipating obstacles to VBC execution.⁵⁶ Transaction and administrative costs can be high and information technology teams may have some limitations. All parties must select outcome measures and agree on them; if any party is unhappy with the results after monitoring occurs, it’s not usual to go back and use different outcome measures, rather changes can be made upon a subsequent contract renewal. Physician resistance and the need to change behavior can be a barrier, especially when operating switching programs. Developing the contract collaboratively circumvents potential trust issues. VBCs also need to include reasonable risk for all parties. Legislative issues including antitrust, best price, and off-label promotion are germane at the federal and the state level.⁵⁶ Savings can be substantial if the VBC results in event avoidance; decreased ER visits (recall that people with AD are prone to accident and injury), hospitalizations, ancillary resource use, or specialist office visits; fewer additional medications; and lower long-term medical/pharmacy expenses. VBCs must tie specific products to outcomes and patient response.⁵⁷

CONCLUSION

Critical drivers to improve access to AD treatments will include benefit design, formulary structure, the need for RWE, a potential specialty pharmacy role in distribution, outcomes-based contract opportunities, and the new concept of including PROs in the evaluation. Plans need to develop strategies to collect relevant data.

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