Publications

In an effort to demonstrate measurable value of pharmaceuticals in the United States, many payers and drug manufacturers have entered into value-based purchasing contracts that link payment for prescription medications to patient outcomes, creating shared risk between the 2 entities. These agreements have emerged as part of a larger movement within the health care landscape to transition away from volume-based payment models and towards value-based designs that promote high-quality and affordable care. Key to the success of pharmaceutical value-based contracting is agreement on meaningful and measurable outcomes that reflect drug performance. Traditional value-based contracts are developed by pharmaceutical companies and payers and may not reflect values of other important stakeholders, such as patients, providers, and employers (when applicable). One approach to more effectively align the interests of all key stakeholders and to maximize the effect and transparency of value-based pharmaceutical contracts is to use the validated Delphi surveying technique, which can gather information and build stakeholder consensus on key elements before contract development. In this Viewpoints article, we describe our experience conducting Delphi studies in 5 disease contexts to inform pharmaceutical value-based contract development, including insights learned and practical considerations for real-world application. In addition, we outline advantages to using this validated consensus-building tool to solicit vital and underrepresented stakeholder input, foster transparency in the contract development process, and promote shared learning for future value-based initiatives. DISCLOSURES: No outside funding supported this project. All authors are or were employed by UPMC Health Plan at the time of this study and have no other disclosures to declare.

OBJECTIVE: To identify meaningful migraine outcome measures among key stakeholders to inform value-based contracts for migraine medications.

BACKGROUND: Value-based contracts linking medication payments to predefined performance metrics aim to promote value through aligned incentives and shared risk between manufacturers and payers. The emergence of new and expensive pharmaceuticals for migraine presents an opportunity for value-based contract development. However, uncertainty remains around which outcomes are most meaningful to all migraine stakeholders.

METHODS: This study utilized a Delphi survey to incorporate views from 82 stakeholders, including patients (n = 21), providers (n = 23), payers (n = 10), employers (n = 18), and pharmaceutical company representatives (n = 10). A list of 15 migraine-related outcomes was created from a literature review and subject matter expert consultation. Stakeholders reported on the value of these outcomes through a 5-point Likert scale and selection of their top 3 most meaningful outcomes. All participants except patients and employers also used a 5-point Likert scale to rate the feasibility of collecting each outcome measure. Consensus was defined as ≥75% agreement on the importance and feasibility of an outcome (Likert scores ≥4/5 or selection of an outcome as most meaningful).

RESULTS: After 2 rounds, consensus was achieved for importance of 9 outcomes on the Likert scale. "Decrease in migraine frequency" reached 100% agreement (82/82), followed by "increased ability to resume normal activities" (96%, 79/82). When asked to choose the 3 most meaningful outcomes, stakeholders selected "decrease in migraine frequency" (88%, 72/82) followed by "decrease in migraine severity" (80%, 66/82). The 2 measures rated as most feasibly collected were "decrease in emergency department/urgent care visits" (95%, 40/42) and "decrease in migraine frequency" (90%, 38/42). There were statistically significant differences between non-patient and patient stakeholders in selection of "decrease in emergency department/urgent care visits" [20% (12/61) vs 0% (0/21), P = .031]; and employer and patient stakeholders in selection of "decrease in work days missed" [44% (8/18) vs 5% (1/21), P = .006] and "decrease in emergency department/urgent care visits" [22% (4/18) vs 0% (0/21), P = .037] as most meaningful outcomes.

CONCLUSIONS: The measures "decrease in migraine frequency" followed by "decrease in migraine severity" were identified as top priority migraine outcome measures.

IMPORTANCE: The shift toward value-based care has placed emphasis on preventive care and chronic disease management services delivered by multidisciplinary health care teams. Community pharmacists are particularly well positioned to deliver these services due to their accessibility.

OBJECTIVE: To compare the number of patient visits to community pharmacies and the number of encounters with primary care physicians among Medicare beneficiaries who actively access health care services.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed a 5% random sample of 2016 Medicare beneficiaries from January 1, 2016, to December 31, 2016 (N = 2 794 078). Data were analyzed from October 23, 2019, to December 20, 2019. Medicare Part D beneficiaries who were continuously enrolled and had at least 1 pharmacy claim and 1 encounter with a primary care physician were included in the final analysis (n = 681 456). Those excluded from the study were patients who were not continuously enrolled in Part D until death, those with Part B skilled nursing claims, and those with Part D mail-order pharmacy claims.

EXPOSURES: We conducted analyses for the overall sample and for subgroups defined by demographics, region of residence, and clinical characteristics.

MAIN OUTCOMES AND MEASURES: Outcomes included the number of visits to community pharmacies and encounters with primary care physicians. Unique visits to the community pharmacy were defined using a 13-day window between individual prescription drug claims. Kruskal-Wallis tests were used to compare the medians for the 2 outcomes.

RESULTS: A total of 681 456 patients (mean [SD] age, 72.0 [12.5] years; 418 685 [61.4%] women and 262 771 [38.6%] men) were included in the analysis; 82.2% were white, 9.6% were black, 2.4% were Hispanic, and 5.7% were other races/ethnicities. Visits to the community pharmacy outnumbered encounters with primary care physicians (median [interquartile range (IQR)], 13 [9-17] vs 7 [4-14]; P < .001). The number of pharmacy visits was significantly larger than the number of primary care physician encounters for all subgroups evaluated except for those with acute myocardial infarction (median [IQR], 15 [12-19] vs 14 [7-26]; P = .60 using a 13-day window). The difference in the number of pharmacy and primary care physician encounters was larger in rural areas (median [IQR], 14 [10-17] vs 5 [2-11]; P < .001) than in metropolitan areas (median [IQR], 13 [8-17] vs 8 [4-14]; P < .001). In all 50 states and in all but 9 counties, the number of community pharmacy visits was larger than the number of encounters with primary care physicians.

CONCLUSIONS AND RELEVANCE: This cross-sectional study suggests that community pharmacists are accessible health care professionals with frequent opportunities to interact with community-dwelling patients. Primary care physicians should work collaboratively with community pharmacists, who can assist in the delivery of preventive care and chronic disease management.

BACKGROUND: Millions of American adults do not receive the recommended vaccinations each year. Community pharmacies are well positioned to help fill this gap through easy access and innovative patient-centered interventions. The primary goal of this demonstration project was to implement new notification and motivational interviewing processes at a regional supermarket chain pharmacy to increase the number of influenza, pertussis, pneumococcal, and herpes zoster vaccines provided to adults.

METHODS: This prospective, observational project utilized a pre-post design. Algorithms were developed with pharmacy dispensing data to identify vaccine-eligible patients. Pharmacy staff then received automated notifications through one of the following: (1) a vaccine message printed on the prescription receipt or on paper attached to the prescription bag when patients came to the pharmacy; or (2) a patient list generated through commercially-available software listing patient contact information and which vaccine they were eligible to receive. Irrespective of the notification process, pharmacy staff employed motivational interviewing techniques either face-to-face or telephonic to engage patients in conversation about getting vaccinated. Finally, an interface to the statewide vaccination registry was developed and tested to transmit vaccination information from all pharmacy locations.

RESULTS: Ninety-nine pharmacies participated in the demonstration project across western Pennsylvania. A 33% increase in vaccinations was recorded over the prior year. Increases in vaccines were demonstrated in three of the four vaccine types: 45% for influenza, 31% for pertussis, and 7% for pneumococcal vaccinations. A decrease of 5% was observed for herpes zoster vaccinations. A successful connection to the statewide vaccine registry was established and 100% of all vaccines administered were transmitted to the registry.

CONCLUSION: A combination of face-to-face and telephonic interventions with motivational interviewing were successful at increasing adult vaccinations in a regional supermarket chain pharmacy. Equal and sustained prioritization for all vaccines is necessary to achieve increases across all vaccine types.

OBJECTIVE: To identify implementation strategies used by community pharmacists when initiating the National Diabetes Prevention Program (NDPP).

DESIGN: This study was a qualitative, mid-implementation study using a semi-structured interview guide.

SETTING AND PARTICIPANTS: Community pharmacies in Pennsylvania that received grant funding from the Pennsylvania Pharmacists Association to begin the NDPP.

OUTCOME MEASURES: A final list of implementation strategies from the Expert Recommendations for Implementing Change and corresponding action items for pharmacists to begin the NDPP in their community pharmacies.

RESULTS: Twenty strategies were used by community pharmacists when implementing the NDPP. These strategies were grouped into 3 implementation phases: (1) designing the program; (2) enrolling patients; and (3) keeping patients engaged. Strategies were further organized into 8 clusters based on strategy characteristics. Pharmacists commonly noted that making classes dynamic, keeping patients engaged through interactive activities, and encouraging patients to join classes with a companion were important when implementing the NDPP.

CONCLUSION: Pharmacists used an array of strategies to implement the NDPP. This comprehensive list of strategies and accompanying action items can be used by community pharmacists nationwide to facilitate the implementation of the NDPP.

Objective. To cross reference the core entrustable professional activities (EPAs) to a complete set of educational guidance documents for the Doctor of Pharmacy (PharmD) curriculum to create a map for pharmacy educators.Methods. The Mapping EPAs Task Force consisted of nine members who first worked independently and then together in small working groups to map five assigned educational guidance documents (eg, Center for the Advancement of Pharmacy Education [CAPE] Outcomes, Accreditation Council for Pharmacy Education [ACPE] Standards 1-4, and the Essential Elements for Core Advanced Pharmacy Practice Experiences [APPEs]) to the Core Entrustable Professional Activities for New Pharmacy Graduates. Four working groups completed the mapping process during phases 1 and 2, which was followed by an independent quality assurance review and consensus in phase 3.Results. All 15 core EPA statements were mapped to one or more of the educational documents. One item from the CAPE Outcomes could not be mapped to a core EPA statement. The first five EPA statements mapped directly to the five elements of the Pharmacists' Patient Care Process: collect, assess, plan, implement, and follow-up: monitor and evaluate.Conclusion. This comprehensive EPA map is the first curriculum crosswalk that encompasses a complete set of educational guidance documents including the Essential Elements for Core APPEs for the Doctor of Pharmacy curriculum. If adopted by the Academy, this curriculum crosswalk will provide pharmacy schools with a common interpretation of important educational guidance documents; serve as the foundation for curricular development, revision, and assessment; and ensure student pharmacists are prepared to enter the pharmacy profession.

OBJECTIVE: To design a value-based payment model to incentivize pharmacists for increased administration of influenza, herpes zoster, pertussis-containing, and pneumococcal vaccines to adults at community pharmacies.

DESIGN: A modified delphi technique was used to create a concept for a value-based payment model through consensus of expert opinion.

SETTING: and participants: Experts were recruited from a regional supermarket pharmacy, a self-insured employer, a managed care organization, and an academic institution to participate in 4 electronic surveys and 1 in-person meeting.

OUTCOME MEASURES: Consensus on model design by means of a modified delphi technique.

RESULTS: A panel of 11 experts participated in a series of electronic surveys and 1 in-person meeting. The final value-based payment model addressed how and when pharmacists would receive an incentive for meeting specific vaccination goals. The final value-based payment model also addressed the following concepts: estimated cost avoidance, vaccine effectiveness, and community protection. A 3-tiered incentive model was agreed on by the participants to tie increased vaccination rates with increased payment. Vaccination goals for each tier were defined as the percent increase in vaccination rates from the year immediately preceding. Incentives were defined as a percentage of estimated direct medical costs avoided to be shared between the payer and pharmacy.

CONCLUSION: A conceptual value-based payment model to incentivize pharmacists for increased delivery of adult vaccinations at community pharmacies was designed and agreed on by experts representing a regional supermarket pharmacy, a self-insured employer, a managed care organization, and an academic institution. Consensus was achieved by aligning the interests of both payers and pharmacies. The final model included 3 tiers of bundled incentives to reward percent increases in adult vaccination from historical baselines. This model may be used as an example for community pharmacies and health care payers to design future value-based immunization programs.

This study characterizes government, academia, and private funding for gene therapy trials in the United States by technology type and therapeutic and disease area.

OBJECTIVE: To develop and validate a machine-learning algorithm to improve prediction of incident OUD diagnosis among Medicare beneficiaries with ≥1 opioid prescriptions.

METHODS: This prognostic study included 361,527 fee-for-service Medicare beneficiaries, without cancer, filling ≥1 opioid prescriptions from 2011-2016. We randomly divided beneficiaries into training, testing, and validation samples. We measured 269 potential predictors including socio-demographics, health status, patterns of opioid use, and provider-level and regional-level factors in 3-month periods, starting from three months before initiating opioids until development of OUD, loss of follow-up or end of 2016. The primary outcome was a recorded OUD diagnosis or initiating methadone or buprenorphine for OUD as proxy of incident OUD. We applied elastic net, random forests, gradient boosting machine, and deep neural network to predict OUD in the subsequent three months. We assessed prediction performance using C-statistics and other metrics (e.g., number needed to evaluate to identify an individual with OUD [NNE]). Beneficiaries were stratified into subgroups by risk-score decile.

RESULTS: The training (n = 120,474), testing (n = 120,556), and validation (n = 120,497) samples had similar characteristics (age ≥65 years = 81.1%; female = 61.3%; white = 83.5%; with disability eligibility = 25.5%; 1.5% had incident OUD). In the validation sample, the four approaches had similar prediction performances (C-statistic ranged from 0.874 to 0.882); elastic net required the fewest predictors (n = 48). Using the elastic net algorithm, individuals in the top decile of risk (15.8% [n = 19,047] of validation cohort) had a positive predictive value of 0.96%, negative predictive value of 99.7%, and NNE of 104. Nearly 70% of individuals with incident OUD were in the top two deciles (n = 37,078), having highest incident OUD (36 to 301 per 10,000 beneficiaries). Individuals in the bottom eight deciles (n = 83,419) had minimal incident OUD (3 to 28 per 10,000).

CONCLUSIONS: Machine-learning algorithms improve risk prediction and risk stratification of incident OUD in Medicare beneficiaries.