Developing Prioritization Criteria to Identify Target Drugs for CalRx, the California Generic Drugs Initiative.

OBJECTIVES: This study aimed to establish criteria to identify priority drugs for CalRx, a California-sponsored initiative to support the manufacture and distribution of affordable generic drugs. METHODS: A web-based ranking exercise was implemented with key stakeholders in August 2020, using pricing, spending, and public health criteria identified through a review of academic literature and public health agency reports. A total of 39 of 40 invited stakeholders in 4 different categories-patient advocates, healthcare providers, health insurers, and health policy and economic experts-participated in this study (98% response rate). RESULTS: Drugs that treat large populations, drugs that represent high cost to payors, and drugs that represent high cost to consumers were ranked a priority, receiving > 10% of ranking weights. Drugs that treat conditions with high morbidity or mortality, drugs without therapeutic alternatives, and drugs treating vulnerable populations represented criteria of further interest (9%-10% of weights). Shortage risk and curative effect (8%-9% of the weights), high price increases, communicable disease treatments, and high unit prices (< 8% of the weights) represented the bottom of the priority distribution. CONCLUSIONS: This study suggests that drugs that treat large populations, drugs that represent large costs to payors, and drugs that represent large costs to consumers should be the priority for California's CalRx generic drug initiative. A prioritizing algorithm will assist California in determining top drugs to target from a public health and spending perspective as it plans the rollout of the CalRx initiative and negotiates with drug manufacturers.

Factors Associated With Manufacturer Drug Coupon Use at US Pharmacies.

Importance: Drug companies offer coupons to lower the out-of-pocket costs for prescription drugs, yet little is known about why they do so for some drugs but not for others. Objective: To examine whether the following factors are associated with manufacturer drug coupon use: (1) patient-cost characteristics (mean per-patient cost per drug, mean patient copay); (2) drug characteristics (generics availability or "later-in-class-entrant" drugs); (3) drug-class characteristics (in-class coupon use among competitors; in-class generic competition; in-class mean cost and copay). Design Setting and Participants: This was a retrospective cohort analysis of anonymized transactional pharmacy claims sourced from retail US pharmacies from October 2017 to September 2019, supplemented with information derived from Medi-Span, Red Book, and FDA.gov. Data were analyzed from September 2020 to February 2021. Main Outcomes and Measures: The primary outcome was availability of a manufacturer's coupon. The secondary outcome was the mean proportion of transactions in which a coupon was used for each product. Results: The sample of 2501 unique brand-name prescription drugs accounted for a total of 8 995 141 claims. Manufacturers offered a coupon for 1267 (50.7%) of these drugs. When the manufacturer offered a coupon, it was used in a mean (SD) 16.3% (20.3%) of the transactions. Within a drug class, higher mean total cost per patient was positively associated with the likelihood of coupon use (odds ratio [OR], 1.03 per 10% increase; 95% CI, 1.01-1.04), but higher mean patient copay was inversely associated (OR, 0.98; 95% CI, 0.97-0.99). For drug characteristics, single-source later-in-class-entrant products were associated with a greater likelihood of coupon use compared with first entrants and multisource brands (OR, 1.44; 95% CI, 1.09-1.89). The intensity of coupon use was associated with later-in-class-entrant products and the class mean per-patient cost (4.16-percentage-point increase; 95% CI, 1.20-7.13; 0.27 per 10% increase; 95% CI, 0.09-0.44). Drugs with a new in-class brand-name competitor had greater mean coupon use compared with drugs without a new competitor (10.2% of claims with a coupon vs 5.9%). Conclusions and Relevance: In this cohort study of transactional pharmacy claims, higher mean per-patient total cost within a class was significantly associated with the likelihood of coupon use, but not patient out-of-pocket cost. Manufacturers' coupons were more likely to be used for expensive later-in-class-entrant products facing within-class competition where coupon use was prevalent.

Association of Placental Pathology With Childhood Blood Pressure Among Children Born Preterm.

BACKGROUND: The in utero pathologies underlying the link between preterm birth and offspring high blood pressure (BP) are still unknown. We investigated the prospective associations of placental histopathological findings with childhood BP among children born preterm. METHODS: Our study sample included 546 mother-child pairs with preterm birth (before 37 weeks gestation) enrolled from 1999 to 2013 at the Boston Medical Center. Early preterm birth was defined as gestational age between 23 and 34 weeks. We histologically classified maternal placental pathology using the latest recommended categories: no placental complications, histologic chorioamnionitis, maternal vascular malperfusion, and other placental complications. We calculated age-, sex-, and height-specific systolic BP (SBP) percentiles for children using the 2017 American Academy of Pediatrics Clinical Practice Guideline. We used linear regression models with generalized estimating equations to examine the associations. RESULTS: The mean (standard deviation (SD)) postnatal follow-up of the study children was 9.29 (4.1) years. After adjusting for potential confounders, histologic chorioamnionitis was associated with a 5.42 percentile higher childhood SBP (95% confidence interval: 0.32, 10.52) compared with no placental pathologic findings. This association was stronger among early preterm children. Maternal vascular malperfusion was associated with a 8.44 percentile higher childhood SBP among early preterm children (95% confidence interval: 1.54, 15.34) but the association was attenuated (6.25, 95% confidence interval: -0.76, 13.26) after additional adjustment for child standardized birthweight, a potential mediator of the association. CONCLUSIONS: These findings suggest that among children born preterm, especially those born early preterm, both placental histologic chorioamnionitis and vascular malperfusion may help to differentiate a child's risk of high BP.