According to 2014 data from the CDC, diabetes affects 12.6 percent of the US adult population (CDC 2016), and of those individuals, fewer than half have been believed to be in their treatment goal (ODPHP 2016). The two provider-related and patient-related factors contribute to results. Patient-related factors include high out-of-pocket treatment costs that lead to reduced adherence to drug regimens and outpatient monitoring of diabetes, especially in the setting of high-deductible health plans (Fronstin 2013). As individuals in the lowest socioeconomic class have the highest prevalence of diabetes, costs borne by patients are a major factor in adherence to diabetes medications and monitoring. Cognitive or behavioral factors, including health literacy and medical care consumer participation, are a concern for this particular subpopulation and might influence treatment adherence in other subgroups as well.
From the point of view of a healthcare delivery system factors likely influence effectiveness of education regarding diabetes self-care, diabetes treatment outcomes, including timeliness of intensification, and attention to social determinants of health. High out-of-pocket costs for patients can reduce the frequency of physician visits for diabetes care that is routine, thus limiting diabetes monitoring and management capacities. The resulting suboptimal disease control is associated with a heightened risk of complications and their related costs. Notably, these problems may be most prevalent among low-wage employees, where disease prevalence is best and control may be poor (Sherman 2016).
Patient-focused (demand-side) initiatives have yielded limited advantage. Some value-based advantage designs that reduce enrollees’ out-of-pocket costs for treatments that enhance clinical outcomes, lower price, or both, have resulted in only single-digit improvements in drug adherence (Appearance 2015). Many companies have implemented coverage of preventive drug lists for individuals in health plans. However, these plans normally include only generics, so their significance of diabetes is restricted because branded products account for 47 percent of market volume (Express Scripts 2016). Condition-management programs, in addition to incentives for compliance using evidence-based treatment, also have been utilized in an attempt to improve diabetes control (Misra-Hebert 2016). Digital self-care programs have yielded positive treatment outcomes (Lorig 2016). Nevertheless, these approaches haven’t been widely employed. Employers, managed care entities, and neighborhood teams have set up them in specific conditions or on a trial basis.
Health care system–based (supply-side) quality enhancement programs have also been used to enhance diabetes care management. These attempts have included projects and policies aimed at closing HEDIS gaps in care and enhancing patient involvement, in addition to value-based contracting for diabetes medicines (Barlas 2016). However, despite both patient- and medical care system–focused initiatives, national survey data indicate that less than half of individuals with diabetes have the disorder under control (ODPHP 2016), with recent deterioration in the percentage of those with controlled diabetes despite greater drug use (Lipska 2016). There’s a need for other approaches to diabetes management.
New insulin-delivery apparatus
Ongoing product-development attempts have addressed a range of factors to enhance diabetes management, including improved insulin efficiency and innovative drug-delivery technologies and monitoring apparatus (Bancroft 2016). 1 focus for improved diabetes management involves novel medication-delivery apparatus that enhance medication adherence for insulin and noninsulin drugs.
Insulin-delivery apparatus have been a focal point of industry investment, with the aim of enhancing the simplicity and efficacy of insulin delivery. Substantial research-and-development action has resulted in a number of products receiving FDA approval, including a disposable device named V-Go, produced by Valeritas, and MiniMed 670G was named by an insulin pump.
24-hour subcutaneous insulin device V-Go
As a self-administered, disposable, 24-hour subcutaneous insulin device using preprandial bolus dosing capacities, V-Go has been shown to improve diabetes treatment outcomes, as measured by hemoglobin A1c (HbA1c), in several clinical and real-world trials. As an instance, at a 27-week retrospective analysis of 204 poorly controlled, predominantly type 2 diabetes patients that were transitioned from multiple daily insulin injections (MDI), use of V-Go for insulin infusion resulted in a statistically significant HbA1c decrease of 1.8 percentage points (P<.001) from a baseline value of 9.6 percent (Lajara 2015).
Improvement in HbA1c outcomes with V-Go could be credited in part to greater patient adherence, given that the once-daily use of this device and simplicity of preprandial bolus management lessens the burden and risk of suboptimal compliance with MDI during the daytime. The pharmacokinetics of insulin infusion may contribute to improved outcomes that are HbA1c.
Comparative cost-effectiveness analysis of use versus MDI insulin has yielded outcomes. In a 27-week study of 116 patients with type 2 diabetes suboptimally controlled on insulin and oral agents and that obtained intensification therapy with either MDI or V-Go, use of V-Go resulted in levels along with reduced insulin dosing. Direct pharmacy-related costs were 55 less for V-Go consumers (Lajara 2016).
The MiniMed 670G device pairs an insulin pump as a system using a constant glucose monitoring sensor. Basal insulin management based on readings from the constant glucose monitor every five minutes is adjusted by this system. If sugar levels fall below a threshold, insulin management is suspended to permit sugar levels to grow prior to resumption of pumping. Similarly, increases will be prompted by the results of glucose monitoring if blood sugar measurements are above a threshold. Individuals still must self-administer meal-related boluses of insulin.
Outcomes data were generated from a three-month study of device use by individuals using an insulin pump, when the pump was functional employing the interval of 14 days but not in manner as the comparator. Results showed improvement in HbA1c by 7.4 percent to 6.9 percent, 44% decrease in time spent with sugar <70 mg/dL, and 11 percent less period with blood sugar >180 mg/dL, though there were six episodes of hyperglycemia with blood sugar >300 mg/dL (Bergenstal 2016). These findings were sufficient for the FDA to approve the apparatus.
Despite their perceived clinical value, cost-effectiveness of them and other closed-loop systems has been contested (Riemsma 2016), especially given the deadline for projected cost savings. Further research is essential to quantify the worth of these integrated devices with the potency of the components.
Innovations in noninsulin diabetes apparatus have also received attention. ITCA 650 out of Intarcia Therapeutics, a device that uses an osmotic pump mechanism to deliver exenatide in steady-state concentrations, is just one such offering. Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is commercially available as twice-daily and once-weekly (extended release formula) self-injection therapy for type 2 diabetes. When the ITCA 650 device has been implanted under the patient skin a six- or 12-month source of exenatide could be supplied, depending on the amount of medication. Adherence rates are 100%, given technique and the device placement. Research results haven’t yet been released, although the pivotal phase 3 clinical trial for ITCA 650 was finished in 2016. The impact of ITCA 650 on diabetes-related complications neurologic, renal, and cardiovascular disease, has not yet been evaluated. Similarly, data aren’t yet available regarding cost-effectiveness since the product is not commercially available, although there was for ITCA 650 a new drug program submitted at November 2016.
These products have had limited evaluation in real world configurations, since they haven’t been on the market long. For the insulin-delivery apparatus, patient training and compliance with appropriate device use is especially important. Furthermore outcomes depend upon compliance with bolus dosing prior to foods.
Price may be a barrier to their use. The initial price of the closed-loop insulin management apparatus and continuous glucose monitoring sensor may appear prohibitive for payers, who tend to have a shorter-term advantages–price time horizon. Health programs will benefit from a better knowledge of the health advantage implications and a projected deadline that could cancel acquisition costs of those devices. The individuals are likely those who have enough knowledge to operate. The possible savings within this subpopulation may be for individuals that poorly adhere to treatment and whose diabetes is controlled.
In comparison, constraints for ITCA 650 appear to be straightforward, since exenatide is a medication with a proven safety profile. Reported and the effect of exenatide management via ITCA 650, along with implantation-related complications, have to be assessed outside of this context of clinical trials.
Given patient-adherence concerns, in addition to the cost and clinical implications of diabetes, health plans will have to weigh coverage of these goods. Numerous questions will develop. Should these products be included in the medical or pharmacy benefit? How will the magnitude of the value proposal be impacted by selective product placement in one but not the other advantage offering? What entity is equipped to manage appropriateness determinations? How should value-based advantage design be applied, and that must do it–the health care carrier or pharmacy benefit manager (PBM)?
On the outside, the answers to those questions aren’t clear, especially for drug-delivery apparatus that could reasonably fall under either benefit offering. As an instance, standard insulin pumps normally are covered as durable medical equipment in the health care benefit, which may continue to become authentic for closed-loop insulin management devices. Yet the disposable insulin apparatus may warrant coverage under the pharmacy benefit, especially for those PBMs already contracted to market the offering. Naturally, V-Go, since it’s disposable and not lasting, is a Medicare Part D benefit (as mandated by CMS), using a proven pharmacy advantage path for payers. Given that this designation, it may make sense to incorporate it under the health care benefit for non-Medicare patients. The ITCA 650 device could be categorized as either a medical device or a physician-administered medicine, potentially amenable to either “brown-bagging” (where patients bring from the drug) or “white-bagging” (where the drug is shipped straight to the physician). This blurring of this old-fashioned distinction between pharmacy, medical, and durable medical equipment domains could be expected to continue as other novel medication management devices are brought to market.
Lessons learned from specialty pharmacy management in the pharmacy and medical plans would imply that the PBM may well be the favored option. PBMs have abilities to ensure medication use, including step therapy, prior authorization, utilization management, formulary management, and site of care management, along with case management. PBMs also have experience with minimizing potential “buy-and-bill” physician behaviours, to eliminate possible improper medication use. Additionally, for plan sponsors who carve out pharmacy and medical benefits, consolidation of medication-related information into a single data collection will probably be important to enhance treatment outcomes. Lower prices that may further benefit the plan sponsor may be also yielded by PBM purchasing. Finally, PBM value-based contracting with product manufacturers can also help to align objectives that are mutual .
Benefit-design concerns may support product placement in the pharmacy benefit. Rather than dealing with outpatient copayments for a clinician visit medication dispensing, incurred, individuals incur copayment or no more than the medication-related co-insurance in agreement. It may not be suitable, although this is the case for V-Go. Benefits design factors might be administratively simpler to administer in the context of an present pharmacy benefit that is tiered. With the present flat-rate price pressures the PBM option may therefore represent the cheapest option.
Managed care factors
With drugs adherence representing a substantial–and ongoing–to attaining treatment goals, strategies that are newer to drug delivery barrier that boost adherence merit attention. For managed care, new diabetes treatment modalities while lowering treatment costs should justify thoughtful consideration for inclusion in health plans that enhance adherence and clinical outcomes. The reductions in risk of complications and costs may further expand the value proposition.
Handling these devices from the pharmacy benefit may well help to maximize stakeholder price savings by consolidating purchasing that is volume-based and capitalizing on PBM plans for enhancing adherence. Grouping medications and these products in the pharmacy benefit will empower direction and make immediate product comparisons potential. Drug coding is more special from the pharmacy benefit, so health plans are better able to analyze treatment outcomes. Increased assurance may be provided by inclusion in the pharmacy benefit for plan sponsors that drug cost containment and utilization management capacities can be suitably executed, such as prior authorization criteria.
Direction through the pharmacy benefit placement could have a few disadvantages. The capability to incorporate data and potentially reduce the efficacy of health plan — supplied diabetes care management may be limited by it. In that scenario, two-way information sharing between pharmacy and medical plans should minimize that issue.
New diabetes medication-delivery apparatus can help to enhance treatment outcomes while lowering medical care costs and near-term, disease-specific pharmacy costs. Plan sponsors will benefit as part of an expanded approach to effective diabetes management from consideration of these and other novel drug-delivery apparatus. Inclusion of those offerings as part of their pharmacy benefit may enhance adherence since PBMs center on drug adherence and might lower acquisition costs for both plan sponsors and patients. Positioning of those products in the pharmacy benefit may leverage benefit design capacities and existing PBM contracting to benefit patients, buyers, and producers. Approaches deserve attention due to their potential for attracting cost savings from better management of diabetes in the long term about drug-cost savings in the near term, or both.
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Bruce W. Sherman, MD
3175 Belvoir Blvd..
Shaker Heights, OH 44122
Disclosures: The writer reports receiving an unrestricted educational grant from Valeritas in 2016 for preparation of this manuscript and an honorarium from Intarcia in 2015 for participation in an employer advisory board. The companies are producers of two apparatus discussed in this article.