Projected 30-day out-of-pocket and total spending on pancreatic enzyme replacement therapy under Medicare Part D.

401 Background: Pancreatic enzyme replacement therapy (PERT) can reduce symptoms of indigestion and improve nutrition in patients with exocrine pancreatic insufficiency. PERT is under-prescribed, and this may be related to actual costs and prescriber sensitivity to these costs. Thus, we aimed to assess PERT costs. Methods: We used Medicare Part D formulary and pricing files for the first quarter of 2020 to conduct a patient-level modeling study to describe point-of-sale and out-of-pocket costs for each PERT formulation among Part D stand-alone and Medicare Advantage prescription drug plans. We calculated costs across nationwide plans under three scenarios: (1) standard benefit design ($435 deductible and 25% coinsurance after the deductible is met); (2) 25% coinsurance (for fills after the deductible and in the coverage gap until the patient spends $6,350 out-of-pocket); and (3) 5% coinsurance (once catastrophic coverage is reached). PERT doses are identified by the lipase content per capsule (in United States Pharmacopeia, USP, units). We calculated the number of units for each PERT formulation/ dose form that would provide optimally dosed PERT for the average US adult (250,000 USP units of lipase per day), based on guidelines and consensus. We first calculated costs for a single unit of PERT. Next, we calculated the number of units needed daily for each formulation/ dose form to provide optimally dosed PERT, and multiplied it by 30 to generate 30-day requirements and costs. Results: Across 3,974 plans nationwide, five PERT formulations in seventeen different doses were covered by Medicare plans in 2020. The range of lipase content in a single unit ranged from 3,000 to 40,000 USP units, and the per-unit list price ranged from $1.44 to $13.89. The point-of-sale price for a 30-day supply of optimally dosed PERT ranged from $2,109 to $4,840. For patients, the expected out-of-pocket costs for a 30-day supply of optimally dosed PERT averaged $999 across formulations (range, $853 to $1536) for those paying a deductible and coinsurance, $673 (range, $527 to $1210) for fills made after meeting the deductible until reaching catastrophic coverage, and $135 (range, $105 to $242) after reaching catastrophic coverage. Conclusions: In this analysis of 2020 Medicare Part D plans, the estimated out-of-pocket cost for just a 30-day supply of optimally dosed PERT was high— at least $100 in the catastrophic phase and approximately $1,000 in the initial phase. In the setting of pancreas cancer, already associated with heavy symptom burden and distress, the financial burden from a supportive care intervention (such as PERT) has been underappreciated. These costs may serve as a barrier to Medicare beneficiary drug access and contribute to financial toxicity.

The impact of enterprise unit policy change on the quantity demanded for crop insurance

PurposeThe article examines the impact of policy change on enterprise unit subsidies that took place in 2009 on the quantity demanded for crop insurance.Design/methodology/approachThe analysis covers corn, soybeans, and wheat that are grown in six economic regions and uses various measures of purchasing such as acres insured, unit structure, coverage levels, as well as crop hail use as proxies for the quantity demanded.The analysis first employs time series econometric tools to analyze whether the time path of the share of enterprise units within buyup acres is influenced by the policy change in enterprise unit subsidies. It then comparatively examines the insurance experience between 2008 (right before the change) and 2015 (well after the change).FindingsFor corn, soybean, and wheat, the analysis establishes that the time path of the share of enterprise units within buyup coverage acres is statistically and economically influenced by the intervention. The analysis further quantifies the intervention's immediate and long-term impacts and finds that farmers' unit choices are highly responsive (elastic) to subsidy rates in those units.Between 2008 and 2015, the insurance experience generally indicates that the share of enterprise units within buyup coverage surged, the share of acres under catastrophic coverage declined, and the share acres in high coverage levels increased. Meanwhile, growers have increasingly utilized crop-hail policies.Originality/valueThis appears to be the first study (1) quantifying the sensitivity of farmers' unit choices with respect to subsidy rates in those units and finding that such choices are actually highly responsive (elastic), and (2) pointing out the interaction between MPCI and crop-hail products and offering insights as to their combined use. The findings should be of considerable value to policymakers, academics, bankers, and producers in regards to the design and use of risk management tools.

Understanding the Battle for Universal Pharmacare in Canada Comment on "Universal Pharmacare in Canada"

Drug coverage in Canada is a patchwork; an inequitable inefficient and unsustainable patchwork with no coherence or purpose. Some people think that we can solve the problem by adding more patches, but the core of the problem is that it is a patchwork. For the working population, access to medicines is still organized as privileges offered by employers to their employees. Universal pharmacare would not only provide better access to needed prescription drugs, but also eliminate waste, ensure value-for-money and help improve drug safety and appropriate prescribing. Opponents fear that a universal pharmacare plan would ration drugs, and impede drug access for some patients. However, these claims misunderstand the reality of drug coverage, pricing and access. Opponents propose, instead, to "fill the gap" of current drug coverage by implementing catastrophic coverage, which would serve commercial interests without maximizing health outcomes for the Canadian population. In spite of overwhelming evidence and consensus in the academic community in favour of universal pharmacare, the battle is far from over.

Japan: achieving UHC by regulating payment

The triple goals of Universal Health Coverage (UHC) are to cover the whole population, to reduce patients’ costs, and to expand coverage to all effective services, equitably available to all. This paper analyses the experience of Japan in achieving these goals, focusing on the central role played by the payment system. The payment system, or fee schedule, sets the price of services and pharmaceuticals, as well as the conditions that providers must comply with in order to receive payment. The fee schedule was first introduced following the enactment of social health insurance (SHI) in 1922. Initially, the SHI program covered only manual workers, who comprised a mere 3% of the population. However, the fee schedule of the largest SHI plan was subsequently adopted by all other SHI plans. From 1958, there has been only one fee schedule. Population coverage was achieved in 1961 by mandating all residing in Japan to enroll in SHI, thereby making everyone entitled to all the services and pharmaceuticals listed in the fee schedule. Next, co-insurance was capped to an affordable level by the introduction of catastrophic coverage in 1973. Lastly, extra billing and balance billing were explicitly restricted in 1984. The key to achieving and sustaining UHC goals in Japan lies in being able to contain costs and reallocate resources by revising the fee schedule.

States With Medically Needy Pathways: Differences in Long-Term and Temporary Medicaid Entry for Low-Income Medicare Beneficiaries

Medically needy pathways may provide temporary catastrophic coverage for low-income Medicare beneficiaries who do not otherwise qualify for full Medicaid benefits. Between January 2009 and June 2010, states with medically needy pathways had a higher percentage of low-income beneficiaries join Medicaid than states without such programs (7.5% vs. 4.1%, p < .01). However, among new full Medicaid participants, living in a state with a medically needy pathway was associated with a 3.8 percentage point (adjusted 95% confidence interval [1.8, 5.8]) increase in the probability of switching to partial Medicaid and a 4.5 percentage point (adjusted 95% confidence interval [2.9, 6.2]) increase in the probability of exiting Medicaid within 12 months. The predicted risk of leaving Medicaid was greatest when new Medicaid participants used only hospital services, rather than nursing home services, in their first month of Medicaid benefits. Alternative strategies for protecting low-income Medicare beneficiaries’ access to care could provide more stable coverage.

Closure of Medicare Part D coverage gap by the Affordable Care Act (ACA) and use of oral anti-myeloma agents.

6522 Background: Medicare Part D pays for oral anti-myeloma immunomodulatory drugs (IMiDs, lenalidomide and thalidomide), but has a coverage gap resulting in an out-of-pocket (OOP) expense of > $ 3000 for the 1st prescription (Rx). Patients (pts) eligible for Low Income Subsidies (LIS) are exempt from cost sharing, and LIS is associated with IMiD receipt ( Olszewski, ASH 2016). In 2011, the ACA partly closed the coverage gap with a 50% manufacturer discount on the price of brand-name drugs within the gap. We examined effects of this policy on IMiD use. Methods: From the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we selected Part D enrollees who started anti-myeloma chemotherapy in 2008-2012. We identified IMiD use in periods pre-ACA (2008-10) and post-ACA (2011-12), among pts with or without LIS. After confirming parallel trends in IMiD use before the ACA, we examined the effect of ACA discount on IMiD use in a difference-in-differences (DiD) model, using LIS recipients as controls whose OOP costs were not influenced by the ACA. Results: Among 3,313 Part D enrollees (of whom 31% received LIS), 41% received IMiDs as part of their anti-myeloma regimen. Compared with the pre-ACA period, in the post-ACA period the median gross IMiD cost of the 1st Rx increased for all pts (Table). OOP costs for the 1st Rx, and for the 1st year of IMiD therapy, decreased for LIS non-recipients. Proportion of pts entering catastrophic coverage with their 1st IMiD Rx decreased from 71% to 49%. However, there was no statistically significant effect of the ACA discount on the proportion of pts treated with IMiDs (DiD estimator, 3% [95%CI, -4 to 10]; P=.40), or on the time from diagnosis to 1st Rx (median 1.5 mo. in all groups). Conclusions: The ACA-mandated partial closure of coverage gap lowered the OOP costs for Part D enrollees treated with IMiDs. As the median OOP cost remains > $2400 for the 1st Rx, and > $4900 for the 1st year of therapy, the policy may be insufficient to overcome the financial barrier for beneficiaries who do not receive the LIS. [Table: see text]