James Q. Del Rosso, DO, is research director at JDR Dermatology Research, Las Vegas, NV; a clinical dermatologist at Thomas Dermatology, Las Vegas, NV; and an adjunct clinical professor (Dermatology) at Touro University Nevada, Henderson, NV. We asked Dr Del Rosso to share his insights on current treatment options for acne vulgaris (AV) and to discuss some of the challenges with treating acne successfully in real-world practice, including barriers to patient access of certain medications.
Q: How would you describe the current treatment landscape for acne vulgaris (AV)? Would you say that most patients can be managed with currently available therapies, or do unmet needs remain?
A: Current management of acne incorporates several topical therapy options; a few selected oral antibiotics (primarily tetracyclines) and anti-androgen therapies (spironolactone, combination oral contraceptives); oral isotretinoin (branded generics, Lidose oral formulation); and a variety of physical modalities (photodynamic therapy, laser and light-based therapies, and others). In most cases—presenting as comedones and papulopustular lesions on the face and also on the trunk in 50-60% of cases—a combination approach is usually optimal.
Selection of which agents to utilize depends on several factors specific to each patient (such as age, gender, medical history, prior therapies used); the assessment of current severity of acne; the patient’s access to specific therapies; and the motivation of the patient to comply with the recommended treatment regimen and suggested follow up visits. As acne is a chronic and dynamic inflammatory skin disorder, successful management mandates reasonable compliance with therapies prescribed and follow-up to appropriately adjust the regimen based on response to treatment and/or any adverse effects. In refractory cases, especially when multiple inflammatory lesions, nodules, and/or scarring are present, an appropriate course of oral isotretinoin is a very effective and rational option, with the majority of patients achieving excellent control of acne, often with sustained remission. Ultimately, if the patient truly becomes a “partner” with their dermatologist, understands that a satisfactory response to treatment may take several weeks, and follows through with and complies with treatment, most will achieve very good to complete control of their acne. Also, the clinical pattern and severity of acne can change over time, which requires adjustments in the therapies used.
It is important to recognize that new therapies are always welcome, especially those which impart higher lesion reductions, faster onsets of action, greater ease of use, better efficacy results as monotherapy and/or in combination with other agents, and very favorable tolerability and safety profiles. Continued basic science and clinical research serves to improve our understanding of acne pathophysiology and will hopefully bring to our treatment rooms new and effective medical therapies and physical modalities that overall will provide better therapeutic outcomes.
Q: What is the discrepancy seen between results in clinical trials with products for the treatment of AV compared with results seen in real-world practice? In your experience and research, what are some of the reasons for this discrepancy?
A: In fact, discrepancies in perceived efficacy for acne between results achieved in clinical trials compared with those observed in real-world practice are to be expected. The “parameters” used to evaluate responses to treatment in clinical studies are different in many ways from how we, as dermatologists, determine efficacy responses in real-world practice. The patients enrolled in clinical studies (referred to in that setting as “subjects”) are selected based on both inclusion and exclusion criteria that are strictly mandated in the approved study protocol. Inclusion criteria characteristically include protocol-defined global assessment definitions used to rate acne severity, age specifications, allowed ranges of individual acne lesion types, skin care recommendations, study medication that is usually used as monotherapy, frequency of application, and follow up times. Exclusion criteria define washout periods from previously used acne therapies, disallow patients with acne with certain lesion types and/or lesion counts, stipulate certain co-existing disease states that cannot be included, and do not allow concomitant use of any therapies that can affect study outcomes. Importantly, clinical studies also strictly define the major endpoints used to classify responses as “treatment success” or “treatment failure” at defined time points based on the mandated study protocol; response definitions are based on investigators following described definitions of how to score responses, with the perceptions of the subject not included in the major study assessments to evaluate “success” versus “failure”. Ultimately, the study protocol is the “bible” to which the investigators must adhere.
In contrast, in real-world clinical practice, dermatologists are faced with the challenge of assessing and treating “all comers”. This challenge is inclusive of all types of acne lesions and their counts and a variety of concomitant disease states and/or medications that the patient is using for acne or other medical indications. In addition, in the real-world, patients have to cover the cost of their office visits and the medications/treatments used, which can have impact on compliance with therapy and follow-up visits. Lastly, a combination therapy approach is often used in real-world management of acne, which is very different than the controlled monotherapy studies that are often used in acne clinical studies, especially pivotal phase 2 and phase 3 trials.
Q: What are some of the barriers that patients commonly encounter in accessing medications for AV?
A: Despite the best intentions of the dermatologist, their staff, and the motivated patient, there are several frequently encountered barriers that interfere with the patient gaining access to the prescription therapies that are recommended by their dermatologist. It is difficult for the dermatologist and their staff to identify the true source of these barriers in any individual circumstance, nor is it fully their responsibility to do so beyond a certain level of effort. Barriers may be put in place at the pharmacy level; at the level of a pharmacy benefit manager (PBM, whose value to the care of the patient or to a reduction in costs has never been successfully explained to me yet); at the level of the insurance company; or any combination of the above. Very often, the dermatologist receives a perfunctory fax that explains that some faceless committee at one of the above levels has determined that a recommended therapy is not allowed, with a variety of poorly substantiated reasons given that conveniently justify why they are not covering a specific therapy. These faxes are “faceless” in the sense that there is almost never an individual named at the end of the letter who accepts accountability for interfering with the therapeutic recommendation of the dermatologist.
From here, trying to get the desired medication for the patient progresses into a spiral of paperwork, the expenditure of a significant amount of time on the part of the dermatologist and their staff, and sometimes phone calls that also consume large amounts of time. These barriers often serve the needs of the payers by effectively interfering with access to recommended treatments. The pharmaceutical companies do need to assume some responsibility by developing systems to optimize access to therapies, which many appear to do; however, the “access frontier” is still a very complicated and unresolved area in the real-world practice of dermatology, and medicine in general.
Q: What are some things that dermatologists can do to help patients overcome these barriers? What are some things that need to be done on a larger scale?
A: Dermatologists can assist in overcoming barriers to medication access by being open-minded about methods that are available to enhance access. This predominantly includes education of office staff that can direct and assist patients with the access process. Admittedly, this is not a small task; different companies utilize a variety of systems to optimize access to their medications, and these systems often change over time. What is most valuable is when dermatologists selectively engage in peer-to-peer discussions with professionals designated by third parties to handle appeals when a therapy is initially denied. However, these live conversations are time-consuming and are best done selectively for therapies that are definitively needed for patients suffering from refractory or severe disease states. There is not enough time in the day for the dermatologist to address all of the access challenges that arise, and the third-party payers know this.
All of that being said, it is not reasonable to hold the dermatologist and their staff fully accountable for doing all of the work to fight for access to medications and treatment. It is important that the patient get involved in being their own advocate if they trust their dermatologist’s recommendation for a specific medication that has been prescribed. Too many patients expect that all of the work should be done for them by the dermatology office which is not a reasonable expectation. Dermatologists have limited resources and availability of staff, whose primary obligation is to evaluate patients and provide and oversee their treatment. In addition, pharmaceutical companies cannot expect that the dermatology office can or will provide the manpower and associated costs designated primarily for medication access. All parties need to contribute to the process—both functionally and financially—and need to be active in challenging the barriers to medication access so that patients can receive the best therapy suggested by their dermatologist.