2022
Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure
Faridi K, Dayoub E, Ross J, Dhruva S, Ahmad T, Desai N. Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure. Journal Of The American College Of Cardiology 2022, 79: 2516-2525. PMID: 35738713, DOI: 10.1016/j.jacc.2022.04.031.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsAngiotensin receptor neprilysin inhibitorQuadruple therapyOOP costsMedicare coveragePocket costsAngiotensin-converting enzyme inhibitorPrior authorizationAngiotensin receptor blockersQuadruple drug therapyCotransporter 2 inhibitorsMineralocorticoid receptor antagonistsReduced ejection fractionDrug plansReceptor blockersEjection fractionHeart failureDrug therapyReceptor antagonistPrescription drug plansMedicare patientsEnzyme inhibitorsTherapyRegimensMedication pricesApprovals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
Gupta R, Morten CJ, Zhu AY, Ramachandran R, Shah ND, Ross JS. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021. JAMA Health Forum 2022, 3: e221096. PMID: 35977259, PMCID: PMC9123500, DOI: 10.1001/jamahealthforum.2022.1096.Peer-Reviewed Original ResearchConceptsCross-sectional studyNovel drugsTherapeutic valueUS FoodDrug AdministrationWorld Health Organization Model ListGeneric approvalCapsule formMultivariable analysisAccelerated approvalClinical usefulnessMAIN OUTCOMEPrescription drugsBrand-name drugsModel ListEssential medicinesDrugsApproval statusMedicine inclusionFDANovel tabletBlockbuster statusApprovalAdministrationDrug salesAssociation Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Internal Medicine 2022, 182: 418-425. PMID: 35226058, PMCID: PMC8886450, DOI: 10.1001/jamainternmed.2022.0045.Peer-Reviewed Original ResearchConceptsComparative effectiveness research studyIndex dateProportion of patientsTSH levelsNormal TSH levelsMIU/LThyrotropin levelsLevothyroxine productsGeneric levothyroxineNational administrative claims databasePropensity-matched patient pairsBaseline TSH levelsMean TSH levelsThyroid replacement therapyAdministrative claims databaseCurrent guideline recommendationsSerum thyrotropin levelsOptumLabs Data WarehouseStandardized mean differenceLevothyroxine doseLevothyroxine prescriptionsPropensity matchingGuideline recommendationsClaims databaseReplacement therapyRates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults. Endocrine 2022, 76: 349-358. PMID: 35107758, PMCID: PMC9210352, DOI: 10.1007/s12020-022-02987-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedDrugs, GenericFemaleHumansMaleMedicareMiddle AgedRetrospective StudiesThyroid HormonesThyroxineUnited StatesConceptsL-thyroxineLarge administrative claims databaseMultivariate logistic regression analysisAdministrative claims databaseThyroid hormone valuesLogistic regression analysisNumber of pharmaciesSettingRetrospective studyPrescription fillsTreatment initiationGuideline recommendationsThyroid surgeryClaims databaseFill dateMean ageHormone valuesLevothyroxine preparationsMore pharmaciesPractice guidelinesAdditional studiesGeneric preparationsNational dataAmerican adultsPatientsRegression analysis
2021
Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use
Brito JP, Ross JS, Deng Y, Sangaralingham L, Graham DJ, Qiang Y, Wang Z, Yao X, Zhao L, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine 2021, 74: 592-602. PMID: 34089480, PMCID: PMC9210353, DOI: 10.1007/s12020-021-02779-x.Peer-Reviewed Original ResearchMeSH KeywordsAgedDrugs, GenericFemaleHumansLongitudinal StudiesRetrospective StudiesThyroid HormonesThyroxineConceptsCongestive heart failureRate of fracturesCardiovascular outcomesL-thyroxineRate of fallHeart failureHip fractureAtrial fibrillationMyocardial infarctionNational administrative claims databasePropensity-matched patientsAdministrative claims databaseRate of hospitalizationMIU/L.Main outcome measuresSignificant differencesDose subgroupsHospitalization ratesClaims databaseThyroid cancerInpatient settingBaseline thyroidHormone levelsOutcome measuresPatientsEvaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors
Long AS, Zhang AD, Meyer CE, Egilman AC, Ross JS, Wallach JD. Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors. JAMA Network Open 2021, 4: e215731. PMID: 33956134, PMCID: PMC8103227, DOI: 10.1001/jamanetworkopen.2021.5731.Peer-Reviewed Original ResearchConceptsRandomized clinical trialsSafety end pointEnd pointClinical trialsDrug pairsPrimary end point resultsEnd point resultsImproved efficacyEfficacy end pointCochrane Central RegistrySeparate end pointsSingle-enantiomer drugsSingle enantiomer formulationPrimary efficacySecondary efficacyControlled TrialsOvid EmbaseOvid MEDLINESuperior efficacyDrug AdministrationCentral RegistrySystematic reviewMore efficacyTrialsRacemic drugsTrends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020
Liu P, Dhruva SS, Shah ND, Ross JS. Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020. JAMA Network Open 2021, 4: e2035064. PMID: 33481031, PMCID: PMC7823226, DOI: 10.1001/jamanetworkopen.2020.35064.Peer-Reviewed Original Research
2020
Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels
Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Network Open 2020, 3: e2017645. PMID: 32997127, PMCID: PMC7527873, DOI: 10.1001/jamanetworkopen.2020.17645.Peer-Reviewed Original ResearchConceptsNormal thyrotropin levelsPropensity score-matched patientsThyrotropin levelsLevothyroxine prescriptionsThyrotropin valuesProportion of patientsAdministrative claims databaseMonths of initiationMIU/LMild thyroid dysfunctionLongitudinal cohort studyMedicare Advantage enrolleesNormal thyrotropin valuesEligible patientsInitial therapyLevothyroxine formulationsCohort studyThyroid dysfunctionClaims databaseGeneric levothyroxineLevothyroxineMAIN OUTCOMENormal rangePatientsNormal vsProstaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017
Bartlett VL, Liu P, Dhruva SS, Shah ND, Bollinger KE, Ross JS. Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017. Journal Of Managed Care & Specialty Pharmacy 2020, 26: 10.18553/jmcp.2020.26.4.562. PMID: 32223594, PMCID: PMC10391193, DOI: 10.18553/jmcp.2020.26.4.562.Peer-Reviewed Original ResearchMedicare beneficiaries' out-of-pocket costs for commonly used generic drugs, 2009-2017.
Liu P, Dhruva SS, Shah ND, Ross JS. Medicare beneficiaries' out-of-pocket costs for commonly used generic drugs, 2009-2017. The American Journal Of Managed Care 2020, 26: 112-117. PMID: 32181626, DOI: 10.37765/ajmc.2020.42635.Peer-Reviewed Original ResearchConceptsPrescription drug plansPocket costsMedicare prescription drug plansGeneric drugsDrug price transparencyCash pricesPrice transparencyPocket expenditureDiscount programDrug plansDrug discount programsMedicare beneficiariesGeneric drug discount programsBeneficiariesCostGeneric drug prescriptionPricesDrug listGeneric medications
2019
Medicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics
Vijay A, Gupta R, Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Formulary Coverage of Brand-Name Drugs and Therapeutically Interchangeable Generics. Journal Of General Internal Medicine 2019, 35: 1928-1930. PMID: 31625043, PMCID: PMC7280368, DOI: 10.1007/s11606-019-05432-6.Peer-Reviewed Original ResearchCharacteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
Jiao K, Gupta R, Fox E, Kesselheim A, Ross JS. Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration. JAMA Network Open 2019, 2: e1913029. PMID: 31603482, PMCID: PMC6804024, DOI: 10.1001/jamanetworkopen.2019.13029.Peer-Reviewed Original ResearchGeneric and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016
Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. The Journal Of Clinical Endocrinology & Metabolism 2019, 104: 2305-2314. PMID: 30690529, DOI: 10.1210/jc.2018-02197.Peer-Reviewed Original ResearchConceptsBrand-name useDrug useMedicare AdvantageThyroid hormone replacement therapyLarge administrative claims databaseBeneficiary populationAdministrative claims databaseHormone replacement therapyCertain patient characteristicsMedicare Part DPrescriber specialtyPatient characteristicsPrescriber characteristicsClaims databaseReplacement therapyGeneric levothyroxineWhite raceHealth plansOlder adultsHormone drugsInsurance coverageProduct useLevothyroxineNational dataPart DGeneric Drugs in the United States: Policies to Address Pricing and Competition
Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clinical Pharmacology & Therapeutics 2019, 105: 329-337. PMID: 30471089, PMCID: PMC6355356, DOI: 10.1002/cpt.1314.Commentaries, Editorials and LettersConceptsPrice increasesDrug pricesPatent drugsGeneric drugsBrand-name manufacturersGeneric drug applicationsGeneric competitionGeneric versionsPricesPolicy solutionsUnited StatesCompetitionPolicySource of concernPrescription drugsCostPricingMarketAgency policiesPolicymakersCompetitorsPast decadeFDA's roleShortageManufacturers
2018
Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs.
Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs. Annals Of Internal Medicine 2018, 169: 817-819. PMID: 30039170, DOI: 10.7326/m18-0965.Peer-Reviewed Original ResearchThe Impact of Off-Patent Drug Acquisitions on Prices
Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. Journal Of General Internal Medicine 2018, 33: 1007-1009. PMID: 29687433, PMCID: PMC6025665, DOI: 10.1007/s11606-018-4372-3.Peer-Reviewed Original ResearchMedicare Spending and Potential Savings on Brand-Name Drugs With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015
Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drugs With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015. JAMA Internal Medicine 2018, 178: 567-569. PMID: 29340562, PMCID: PMC5876838, DOI: 10.1001/jamainternmed.2017.8016.Peer-Reviewed Original ResearchAffordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment areaPediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS
Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA 2018, 319: 21-22. PMID: 29117365, DOI: 10.1001/jama.2017.16477.Commentaries, Editorials and Letters
2017
High Costs of FDA Approval for Formerly Unapproved Marketed Drugs
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA 2017, 318: 2181-2182. PMID: 29131905, DOI: 10.1001/jama.2017.16481.Commentaries, Editorials and Letters