Expansion of the Low-Risk Substances in the Framework of the European Pesticide Regulation (EC) No 1107/2009

Signed in 2009, the plant protection Commission Regulation EC No 1107/2009 created a new category of active substances, the low-risk substances, with specific status defined in Article 22. The initial and specific criteria, not suitable for microorganisms and natural substances, were modified in 2018, and the first low-risk substance, allocating Part D of Regulation EC No 540/2011, was granted in the same year. Since then, thirty-three low-risk substances have been granted with this specific status through approvals and renewals, while a larger list of potential low-risk substances from already-approved active substances was published. This list is only exploited during renewals, and this process would take another five years to complete. After four years of the implementation of this status, the number of such substances is still low, but is intended to increase slowly. Two more low-risk substances are already pending in 2021, which will bring the number of low-risk substances to thirty-five, while the initial list of potential low-risk substances (only renewals) included fifty-seven substances.

Utilization of Generic Cardiovascular Drugs in Medicare’s Part D Program

Background: Generic medications cost less than brand-name medications and are similarly effective, but brand-name medications are still prescribed. We evaluated patterns in generic cardiovascular medication fills and estimated the potential cost savings with increased substitution of generic for brand-name medications. Methods: This was a cross-sectional study of cardiovascular therapies using the Medicare Part D database of prescription medications in 2017. We evaluated drug fill patterns for therapies with available brand-name and generic options. We determined the generic substitution ratio and estimated the potential savings with increased generic substitution at the national, state, and clinician level. We compared states with laws related to mandatory pharmacist generic substitution and patient consent for substitution. Results: Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings. Conclusions: There are substantial potential cost savings from substituting brand-name medications with generic medications. These savings would be primarily driven by lower use of brand-name therapies by the minority of clinicians who prescribe them at increased rates.

Impact of Medicare prescription drug (Part D) coverage expansion on utilisation and financial burden of benzodiazepines among older adults: an interrupted time series analysis

ObjectiveBenzodiazepines were excluded from Medicare Part D coverage since its introduction in 2006. Part D expanded coverage for benzodiazepines in 2013. The objective was to examine the impact of Medicare Part D coverage expansion on the utilisation and financial burden of benzodiazepines in older adults.DesignInterrupted time series with a control group.SettingNationally representative sample.Participants53 150 468 users of benzodiazepines and 21 749 749 users of non-benzodiazepines (an alternative therapy) from the Medicare Current Beneficiary Survey between the pre-expansion (2006–2012) and post-expansion (2013–2017) periods.InterventionMedicare Part D coverage expansion on benzodiazepines.Primary and secondary outcome measuresAnnual rate of benzodiazepines and non-benzodiazepines, average number of benzodiazepines and non-benzodiazepines and average cost of benzodiazepines and non-benzodiazepines.ResultsAfter Medicare Part D coverage expansion, the level of the annual rate of benzodiazepines increased by 8.20% (95% CI: 6.07% to 10.32%) and the trend decreased by 1.03% each year (95% CI: −1.77% to −0.29%). The trend of the annual rate of non-benzodiazepines decreased by 0.72% each year (95% CI: −1.11% to −0.33%). For the average number of benzodiazepines, the level increased by 0.67 (95% CI: 0.52 to 0.82) and the trend decreased by 0.10 each year (95% CI: −0.15 to –0.05). For the average number of non-benzodiazepines, the level decreased by 0.11 (95% CI: −0.21 to –0.01) and the trend decreased by 0.04 each year (95% CI: −0.08 to –0.01). No significant level and trend changes were identified for the average cost of benzodiazepines and non-benzodiazepines.ConclusionsAfter Medicare Part D coverage expansion, there was a sudden increase in the utilisation of benzodiazepines and a decreasing trend in the long-term. The increase in the utilisation of benzodiazepines did not add a financial burden to older adults. As an alternative therapy, the utilisation of non-benzodiazepines decreased following the coverage expansion.

Does Closing the Donut Hole Reduce Financial Burdens Among Medicare Part D Beneficiaries?

The Medicare Part D donut hole has been gradually closed since 2010. But it is still unclear how it has impacted the beneficiaries’ relative financial burdens, especially in the later stage of the closing plan. The measurement of catastrophic health expenditure induced by prescription drugs (CHE-Rx) reflects the relative financial burdens to beneficiaries’ household income, which bears more information than the measure of dollar-value expenses or the absolute poverty line used in prior studies. Using the Medical Expenditure Panel Survey 2008-2017 longitudinal national representative data and the method of difference-in-differences, this study found that the donut hole closing policy was associated with more usage of prescription drugs (b=2.84, p=0.023) and a higher likelihood of experiencing CHE-Rx (b=2.4%, p=0.011) among those who fell in the donut holes. Besides, the results show that the donut hole closing policy did not generate any immediate effects on prescription drug usage, CHE, and CHE-Rx. For the first time, this paper examined both the aggregated and marginal impact of the policy implementation, which had closed by an additional 35% between 2013 and 2017, on the relative financial burden among the beneficiaries.

Bone-Active Medication Utilization from 2013-2017 Amid Beneficiaries Aged 65+ with Medicare Part D by Provider Type

As the United States’ population increasingly consists of older adults aged 65+, an increase is expected in the prevalence of osteoporosis and the number of osteoporotic fractures. Bone-active medications (BAM) delay osteoporosis progression and prevent fragility fractures, but historically low treatment persistence rates and drug utilization for BAM exist among at-risk older adults. This research assessed for differences in the BAM utilization rates over five-years in Medicare Part D by provider type: geriatric specialists (GERO), generalists, specialists, nurse practitioners (NP), and physicians’ assistants (PA). This longitudinal retrospective analysis included providers with at least one BAM prescription among beneficiaries aged 65+. An analysis of response profiles was used to model the mean BAM utilization rates overall and by provider group. Of the 50,249 providers included in this analysis, 88.15% were generalists, 5.76% specialists, 1.48% GERO, 2.73% NP, and 1.87% PA. From 2013-2017, the prevalence of BAM utilization was 6%. Over the five years, BAM utilization rates did not change significantly, but provider-specific rates were significantly different (F=12.53, p<.001). Provider-specific utilization rates were inconsistent with the highest utilization rates and most considerable variation observed among specialists (14.95%). PAs and NPs’ BAM utilization rates were stable at around 9.02% and 9.20%, but GERO and generalists exhibited the lowest utilization rates, 4.86% and 5.79%, respectively. While specialists had the higher-than-expected utilization rates, the overall and provider-specific BAM utilization rates were low and did not increase over time. Further research is needed to identify how provider-related factors, like geographic region and clinical training, influence underutilization.