Biosimilars can generate competition and provide cost savings over reference biologics for the Medicare program and beneficiaries. The extent to which these benefits can be realized in the Medicare Part D program depends on how biosimilars and biologics are placed in the formulary. We conducted a study to examine Medicare formulary placement of the first biologic to have 2 biosimilars on the market-infliximab and its biosimilars infliximab-dyyb and infliximab-abda.
All standalone and Medicare Advantage (MA) prescription drug plans (PDPs) offered in Medicare Part D were examined between September 2016 (ie, at the end of the last quarter before the launch of the first infliximab biosimilar) and September 2018, at which time a second biosimilar had been on the market for about 14 months. When PDPs covered both the reference biologic and a biosimilar, we compared the cost-sharing tier and the frequency of prior authorization and step therapy requirements for each drug.
Nearly all PDPs covered infliximab throughout the study period. By September 2018, 31.7% of MA plans and 14.9% of standalone PDPs were covering a biosimilar on the market. Nearly all plans that covered a biosimilar also covered the reference product. Most plans (98% of standalone PDPs and 89% of MA plans) had placed prior authorization restrictions on both the biologic and the biosimilar. All plans covering both products placed them in the same cost-sharing tier. No plan required step therapy for either product.
Formulary placement of infliximab biologic and biosimilars in Medicare Part D is not optimized to generate cost savings for the Medicare program and beneficiaries, whose cost sharing is often based on the drug\'s list price. The Medicare program should provide incentives for PDPs to expand biosimilar coverage.

To optimize medication use in older adults, the Centers for Medicare & Medicaid Services (CMS) launched Medication Therapy Management (MTM) services as part of Medicare Part D policy; however, strategies for achieving high quality MTM outcomes are not well understood.
The objective of this study was to generate hypotheses for strategies contributing to community pharmacies\' high performance on policy-relevant MTM quality measures.
This mixed-methods comparative case study was guided by the Positive Deviance approach and Chronic Care Model. The study population consisted of pharmacy staff employed by a Midwestern division of a national supermarket-community pharmacy chain. Data consisted of demographics and qualitative data from semi-structured interviews. Qualitative and quantitative data were analyzed deductively and inductively or using descriptive statistics, respectively. MTM quality measures used to evaluate participant pharmacies\' MTM performance mirrored select 2017 Medicare Part D Plans\' Star Rating measures.
Thirteen of 18 selected case pharmacies (72.2%) participated in this study, of which 5 were categorized as high performers, 4 moderate performers, and 4 low performers. Eleven pharmacists, 11 technicians, and 3 student interns participated in interviews. Eight strategies were hypothesized as contributing to MTM performance: Strong pharmacy staff-provider relationships and trust, Inability to address patients\' social determinants of health (negatively contributing), Technician involvement in MTM, Providing comprehensive medication reviews in person vs. phone alone, Placing high priority on MTM, Using available clinical information systems to identify eligible patients, Technicians using clinical information systems to collect/document information for pharmacists, Faxing prescribers adherence medication therapy problems (MTPs) and calling on indication MTPs.
Eight strategies were hypothesized as contributing to community pharmacies\' performance on MTM quality measures. Findings from this work can inform MTM practice and Medicare Part D MTM policy changes to positively influence patient outcomes. Future research should test hypotheses in a larger representative sample of pharmacies.

Medicare Part D plans make coverage decisions according to FDA-labeled indications and off-label uses endorsed by two CMS-recognized compendia. Patients who rely on Medicare Part D for immunosuppressive drug coverage are at risk for denied coverage when these medications are prescribed off-label. The purpose of this multicenter collaboration was to assemble a case series documenting situations where immunosuppressive therapies prescribed for transplant patients were denied by Medicare Part D prescription drug plans. This case series documents 66 instances in 39 patients where immunosuppressive drug claims were denied coverage due to off-label use not endorsed by the compendia. Patients were recipients of lung (n = 28, 72%), heart (n = 7, 18%), or liver (n = 4, 10%) transplants. Denied claims were for mycophenolate mofetil (n = 22, 33%), azathioprine (n = 18, 27%), sirolimus (n = 15, 23%), mycophenolate sodium (n = 5, 8%), everolimus (n = 5, 8%), and belatacept (n = 1, 1%). Most denials were upheld across all the levels of attempted appeal, including those escalated to a Medicare Administrative Law Judge. This case series demonstrates a critical flaw in the construct of the Medicare Prescription Drug Benefit. The currently referenced compendia are not up to date and do not reflect best practices in organ transplantation.

BACKGROUND: Medication-related problems (MRPs) are a major healthcare burden. The rate of MRPs in those ≥65 years old is ∼50 events per 1000 person-years, and contributes to a four-fold higher hospitalization rate when compared to younger patients. Medication therapy management (MTM) can identify MRPs in high-risk patients. However, in 2015, only 12.9% of Medicare patients qualified for MTM services through their Part D plan.
OBJECTIVE: To examine the type and frequency of MRPs in community-dwelling Medicare beneficiaries and which patient factors are associated with having ≥1 MRP.
METHODS: Fourteen health clinics targeting Medicare beneficiaries were held in 10 Northern/Central California cities during Fall 2017. Trained student pharmacists, supervised by licensed pharmacists, conducted comprehensive medication reviews. Sociodemographic, chronic condition, medication, and MRP data were collected via standardized surveys.
RESULTS: MTM services were provided to 910 patients, of which 633 (69.6%) had at least 1 MRP. The most common MRPs were severe drug-drug interaction [n = 297(33.4%)] and untreated condition [n = 134 (14.7%). Individuals with MRPs took significantly more prescription and over-the-counter medications. Additionally, those with MRPs were more likely to be subsidy recipients and in a Medicare Advantage Prescription Drug Plan. A total of 120 (13%) individuals were found to have had an MRP severe enough to warrant prescriber follow-up.
CONCLUSIONS: Although only a fraction of Medicare beneficiaries qualify for MTM services through their Part D plan, many can benefit from such services. Understanding the type, frequency, and factors contributing to MRPs is imperative to identify and avoid negative sequelae. Reduction of MRPs can potentially improve patient clinical outcomes, increase quality-of-life, and decrease overall cost of care.

BACKGROUND: Medicare Part D was implemented as a prescription drug benefit in 2006. Since then, high-cost new therapies have emerged, resulting in large increases in prices for pharmaceutical products, share of government spending from pharmaceutical products, and patient out of pocket costs.
OBJECTIVE: The objectives of this study were to: 1) evaluate the role of pharmacy benefit managers who are intermediaries in the processing and payment of prescription drug plans, and 2) to analyze the formulary selections of Medicare Part D plans in the context of differing wholesale acquisition costs, list prices and potential rebates, while building on prior work on the out of pocket costs associated with rebates.
METHODS: Hepatitis C was used as a case study to compare the list prices, clinical merits, and preferred drug coverage frequency of select pan-genotypic direct acting agent Hepatitis C treatments. The treatments were then put through a hypothetical 2018 Medicare Part D standard cost structure to illustrate differences in out-of-pocket costs to consumers at various list prices among treatments.
RESULTS: Hepatitis C treatments with lower list prices were offered as covered benefit less frequently than high list price treatments, despite being clinically superior and lower out-of-pocket cost.
CONCLUSIONS: Consumers, regulators and policy advocates need to work to limit the impact of financial conflicts of interest and perverse incentives of pharmaceutical rebates in drug selection. This is especially true for high-cost treatments with substantial out-of-pocket cost implications for consumers, which also prevent widespread access, hindering public health goals.

Plan sponsors of Medicare Part D must provide beneficiaries who receive a comprehensive medication review (CMR) with a written summary using the Medicare Part D Medication Therapy Management Standardized Format (SF). The SF is a means to advance consistency in the CMR program by providing a template of expected content. However, barriers remain with beneficiary use and integration into existing electronic health records. The current study assessed Medicare beneficiary, caregiver, and case manager perceptions of the SF through five focus group interviews with a total of 23 participants. Qualitative analysis found that beneficiaries and case managers preferred a consolidated SF document to share and update their entire health care team. Beneficiaries suggested adding information to the SF on dosage, timing, drug interactions, cost, and less expensive alternatives. Identifying elements of the SF that are perceived as useful to beneficiaries will allow for a more streamlined SF that may enhance interoperability among the health care team. [Journal of Gerontological Nursing, 45(4), 7-13.].

More than half of enrollees in the U.S. Department of Veterans Affairs (VA) are also covered by Medicare and can choose to receive their prescriptions from VA or from Medicare-participating providers. Such dual-system care may lead to unsafe opioid use if providers in these 2 systems do not coordinate care or if prescription use is not tracked between systems.
To evaluate the association between dual-system opioid prescribing and death from prescription opioid overdose.
Nested case-control study.
VA and Medicare Part D.
Case and control patients were identified from all veterans enrolled in both VA and Part D who filled at least 1 opioid prescription from either system. The 215 case patients who died of a prescription opioid overdose in 2012 or 2013 were matched (up to 1:4) with 833 living control patients on the basis of date of death (that is, index date), using age, sex, race/ethnicity, disability, enrollment in Medicaid or low-income subsidies, managed care enrollment, region and rurality of residence, and a medication-based measure of comorbid conditions.
The exposure was the source of opioid prescriptions within 6 months of the index date, categorized as VA only, Part D only, or VA and Part D (that is, dual use). The outcome was unintentional or undetermined-intent death from prescription opioid overdose, identified from the National Death Index. The association between this outcome and source of opioid prescriptions was estimated using conditional logistic regression with adjustment for age, marital status, prescription drug monitoring programs, and use of other medications.
Among case patients, the mean age was 57.3 years (SD, 9.1), 194 (90%) were male, and 181 (84%) were non-Hispanic white. Overall, 60 case patients (28%) and 117 control patients (14%) received dual opioid prescriptions. Dual users had significantly higher odds of death from prescription opioid overdose than those who received opioids from VA only (odds ratio [OR], 3.53 [95% CI, 2.17 to 5.75]; P < 0.001) or Part D only (OR, 1.83 [CI, 1.20 to 2.77]; P = 0.005).
Data are from 2012 to 2013 and cannot capture prescriptions obtained outside the VA or Medicare Part D systems.
Among veterans enrolled in VA and Part D, dual use of opioid prescriptions was independently associated with death from prescription opioid overdose. This risk factor for fatal overdose among veterans underscores the importance of care coordination across health care systems to improve opioid prescribing safety.
U.S. Department of Veterans Affairs.

We extend an interrupted time series study design to identify heterogenous treatment effects using group-based trajectory models (GBTMs) to identify groups before a new policy and then examine if the effects of the policy has consistent impacts across groups using propensity score weighting to balance individuals within trajectory groups who are and are not exposed to the policy change. We explore this by examining how adherence to endocrine therapy (ET) for women with breast cancer was impacted by reducing copayments for medications by the introduction of generic ETs among women who do not receive a subsidy (the \"treatment\" group) to those that do receive a subsidy and are not exposed to any changes in copayments (the \"control\" group).
We examined monthly adherence to ET using the proportion of days covered for women diagnosed with breast cancer between 2008 and 2009 using SEER-Medicare data. To account for baseline trends, we characterize adherence for 1 year before generic approval of ET using GBTMs, within each groups we generate inverse probability treatment weights of not receiving a subsidy. We compared adherence after generic entry within each GBTM using a modified Poisson model.
GBTMs for adherence in the 1-year pregeneric identified 6 groups. When comparing patients who did and did not receive a subsidy we found no overall effect of generic introduction. However, 1 of the 6 identified adherence groups postgeneric adherence increased [the \"consistently low\" (risk ratio=1.91; 95% confidence interval=1.34-2.72)].
This study describes a new approach to identify heterogenous effects when using an interrupted time series research design.

暂无摘要。

OBJECTIVE: \"Me-too\" drugs are new pharmaceuticals with the mechanism of action of an existing drug and are considered less innovative than breakthrough drugs. The objective of this study was to evaluate whether the adoption patterns of the breakthrough drug sitagliptin and the \"me-too\" drug saxagliptin differed; and to assess whether the patterns differed between Medicare stand-alone (PDP) and Medicare-Advantage Part D (MA-PD) plans.
METHODS: Pharmacy claims from a 5% random sample of Medicare Part D beneficiaries were used to identify all prescriptions filled for sitagliptin (breakthrough drug) and saxagliptin (\"me-too\" drug) between October 1, 2006 and December 31, 2011. The number of new sitagliptin and saxagliptin users by month and type of plan were plotted, and Bass diffusion models were constructed to estimate the rate of diffusion.
RESULTS: Sitagliptin had a longer adoption life than saxagliptin, and its adoption was quicker among MA-PD than PDP beneficiaries: it peaked at 51 and 66.7 months after its approval, respectively. However, the adoption of saxagliptin did not differ by type of plan: it peaked at 20.5 months in PDP and 22.9 months in MA-PD. At the end of our study, the market share of the innovative drug sitagliptin measured as the cumulative number of users since market entry was almost nine times higher than the \"me-too\" drug, saxagliptin.
CONCLUSIONS: The breakthrough drug sitagliptin had a much longer adoption life compared to the \"me-too\" drug saxagliptin, and the breakthrough drug sitagliptin was adopted quicker among managed care plans compared to PDP plans.