2025
Generics, Biosimilars and Follow‐On Non‐Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists
Berger T, Zeitlinger M, Popescu V, Magyari M, Airas L, Alkhawajah M, Pugliatti M, Zakaria M, Pozzilli C, Drulovic J, Van Wijmeersch B, Vermersch P, Oreja‐Guevara C. Generics, Biosimilars and Follow‐On Non‐Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists. European Journal Of Neurology 2025, 32: e70140. PMID: 40231751, PMCID: PMC11998027, DOI: 10.1111/ene.70140.Peer-Reviewed Original ResearchConceptsDisease-modifying treatmentsNon-biological complex drugsImprove patient accessLiterature searchMultiple sclerosisMS careHealthcare systemPatient accessComplex drugsPubMed literature searchSocioeconomic burdenNarrative reviewTolerability profileGlatiramer acetateClinical efficacyClinical studiesEarly onsetEuropean neurologistsClinical implicationsProgressive natureDrugSclerosisOriginal drugPeopleCare
2023
Impact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction
Zhu C, Dreyer R, Li F, Spatz E, Caraballo‐Cordovez C, Mahajan S, Raparelli V, Leifheit E, Lu Y, Krumholz H, Spertus J, D'Onofrio G, Pilote L, Lichtman J. Impact of Marital Stress on 1‐Year Health Outcomes Among Young Adults With Acute Myocardial Infarction. Journal Of The American Heart Association 2023, 12: e030031. PMID: 37589125, PMCID: PMC10547344, DOI: 10.1161/jaha.123.030031.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionCardiac-specific qualityGeneric health statusMyocardial infarctionBaseline healthMarital stressHealth outcomesHealth statusWorse patient-reported outcomesMental healthYoung adultsObservational cohort studyPatient-reported outcomesSocioeconomic factorsWorse mental healthReadmission 1Cause readmissionCohort studyYounger patientsRoutine screeningDepressive symptomsGreater oddsAnginaMale participantsOutcomes
2022
Perceptions of generic medicines and medication adherence after percutaneous coronary intervention: a prospective multicentre cohort study
Pettersen TR, Schjøtt J, Allore HG, Bendz B, Borregaard B, Fridlund B, Larsen AI, Nordrehaug JE, Rotevatn S, Wentzel-Larsen T, Norekvål TM. Perceptions of generic medicines and medication adherence after percutaneous coronary intervention: a prospective multicentre cohort study. BMJ Open 2022, 12: e061689. PMID: 36127123, PMCID: PMC9490600, DOI: 10.1136/bmjopen-2022-061689.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionProspective multicentre cohort studyMulticentre cohort studyMedication adherenceCohort studyCoronary interventionFemale sexGeneric medicinesSelf-reported medication adherenceOlder ageSelf-reported health statusLow socioeconomic statusPoor mental healthLow education levelSecondary outcomesPCI centerBrand-name medicinesClinical variablesMean agePatients' perceptionsMAIN OUTCOMEHealth statusMental healthSocioeconomic statusTime pointsMedicare 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, PMCID: PMC12293934, 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 analysisCost-Effectiveness of Long-Acting Injectable HIV Preexposure Prophylaxis in the United States : A Cost-Effectiveness Analysis.
Neilan AM, Landovitz RJ, Le MH, Grinsztejn B, Freedberg KA, McCauley M, Wattananimitgul N, Cohen MS, Ciaranello AL, Clement ME, Reddy KP, Hyle EP, Paltiel AD, Walensky RP. Cost-Effectiveness of Long-Acting Injectable HIV Preexposure Prophylaxis in the United States : A Cost-Effectiveness Analysis. Annals Of Internal Medicine 2022, 175: 479-489. PMID: 35099992, PMCID: PMC9087297, DOI: 10.7326/m21-1548.Peer-Reviewed Original ResearchConceptsCAB-LAHIV preexposure prophylaxisCost-effectiveness analysisPreexposure prophylaxisHigh riskNational InstituteIncremental cost-effectiveness ratioCost-effectiveness ratioBase-case analysisHealth care systemEunice KennedyInjectable cabotegravirPrEP retentionOral PrEPHIV PrEPHIV incidenceBlood InstituteDisoproxil fumarateNational HeartChild healthSide effectsTransgender womenInfectious diseasesPrEPQALY
2021
Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms
Gupta A, Nshuti L, Grewal US, Sedhom R, Check DK, Parsons HM, Blaes AH, Virnig BA, Lustberg MB, Subbiah IM, Nipp RD, Dy SM, Dusetzina SB. Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms. JCO Oncology Practice 2021, 18: 140-147. PMID: 34558297, PMCID: PMC9213200, DOI: 10.1200/op.21.00466.Peer-Reviewed Original ResearchConceptsCancer-associated symptomsChemotherapy-induced peripheral neuropathyCancer-associated fatigueSymptom control drugsPatient-clinician discussionsExocrine pancreatic insufficiencyCost of drugsBrand-name formulationProphylaxis regimenPeripheral neuropathyDrug prescribedPancreatic insufficiencyNew agentsControl drugSame drugFinancial toxicitySymptomsDrugsFinancial burdenRelevant guidelinesAnticancer drugsCardiovascular 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 drugsFive-Year Trends in Payments for Neurologist-Prescribed Drugs in Medicare Part D.
de Havenon A, Delic A, Dehoney S, Whetman P, Sheibani N, Callaghan B, Ney J, Esper GJ, Magliocco B, Nair KV. Five-Year Trends in Payments for Neurologist-Prescribed Drugs in Medicare Part D. Neurology 2021, 96: e2132-e2137. PMID: 33692164, PMCID: PMC8166447, DOI: 10.1212/wnl.0000000000011712.Peer-Reviewed Original ResearchTrends 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 vsDissecting drug pricing: Supply chain, market, and nonmarket trends impacting clinical dermatology
Nguyen HP, Go JA, Barbieri JS, Stough D, Stoff BK, Forman HP, Bolognia JL, Albrecht J, Dermatology F. Dissecting drug pricing: Supply chain, market, and nonmarket trends impacting clinical dermatology. Journal Of The American Academy Of Dermatology 2020, 83: 691-699. PMID: 32330637, DOI: 10.1016/j.jaad.2020.04.063.Peer-Reviewed Original ResearchProstaglandin 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 ResearchComparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis.
Walensky RP, Horn T, McCann NC, Freedberg KA, Paltiel AD. Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis. Annals Of Internal Medicine 2020, 172: 583-590. PMID: 32150602, PMCID: PMC7217721, DOI: 10.7326/m19-3478.Peer-Reviewed Original ResearchConceptsIncremental cost-effectiveness ratioCost-effectiveness analysisFair priceCost-effectiveness ratioBase-case analysisJustifiable priceSocietal willingnessComparative pricingHealth care sectorPricesTime horizonEnd-stage renal diseaseCases of ESRDQALYDemand PrEPCare sectorEconomic savingsHIV preexposure prophylaxisSensitivity analysisCostPreexposure prophylaxisLife effectsHorizonPricingDiscountMedicare 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
Population Impact of Generic Valsartan Recall
Jackevicius CA, Krumholz HM, Chong A, Koh M, Ozaki AF, Austin PC, Udell JA, Ko DT. Population Impact of Generic Valsartan Recall. Circulation 2019, 141: 411-413. PMID: 31707798, DOI: 10.1161/circulationaha.119.044494.Peer-Reviewed Original ResearchConceptsNational Ambulatory Care Reporting System databaseEmergency department visitsRegistered Persons DatabaseOntario Registered Persons DatabaseReporting System databaseHealth care systemDrug recallsSegmented regression analysisBaseline comorbiditiesOral medicationsDepartment visitsHospital admissionMedication useClinical outcomesDischarge diagnosisVital statusChronic conditionsHealthcare databasesHealth CanadaCare systemCanadian InstituteHealth informationPopulation impactPatientsRegression analysisMedicare 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 Research
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