Branded Prescription Research Articles

An Elective Course for Student Pharmacists on Pharmaceutical Industry Practice

Objective. To design and implement an elective course on pharmaceutical industry practice and assess its impact on student pharmacists' knowledge and perceptions. Methods. This was a two-credit hour, elective course offered to second- and third-year student pharmacists during the 2015 and 2016 spring semesters. The goal of this course was to provide instruction regarding skills and competencies for pharmaceutical industry practice. Curricular content included didactic instruction, assigned readings, weekly quizzes, classroom discussion of industry-based functions and responsibilities, and three application projects. A 65-item survey instrument was developed to assess changes in student pharmacists' perceptions and understanding of pharmaceutical industry practice. Results. Forty-four students enrolled in the elective course over the two offerings. The average rating on the course evaluation was 4.7 out of 5. Average scores on graded quizzes were 90%, and grades on the application projects ranged from 92% to 99%. There was an increase in the number of students who perceived that they understood various functions and roles in the pharmaceutical industry, and who rated themselves confident in completing unique tasks associated with pharmaceutical industry practice. Furthermore, there was an increase in the number of students who reported improved perceptions regarding the trustworthiness of the pharmaceutical industry, costs of prescription medications, and promotional advertising for branded prescription medication. Conclusion. Student pharmacists' perceptions of the course were positive, and overall perceptions and understanding of the pharmaceutical industry improved. Active collaboration between colleges and pharmaceutical companies can lead to positive educational opportunities for students interested in pharmaceutical industry careers.

Is Bioequivalence a Sufficient Measure of Equivalence?

This article reviews the U.S. Food and Drug Administration (FDA) regulation of generic medications—specifically, the use of bioequivalence to compare generic and brand prescriptions. New or “brand” drugs are subjected to extensive review by the FDA before they can be marketed to the public. Generics, which are posited to be identical to brands, are subject to a less extensive review process and must prove only that the generic is the “bioequivalent” (BE) of the brand drug. Generic medications are important because they comprise almost 80% of prescriptions filled in the United States and cost 80% to 85% less than brand drugs, playing a crucial role in patients’ access to cost-effective treatments. However, there is dissension about whether they can be interchanged with brand drugs without any consequences for the patient, especially for Narrow Therapeutic Index (NTI) drugs, which have precise dosage requirements. The regulatory designation of bioequivalence also has implications for doctor–patient relationships, patient outcomes, and patient legal rights. This article aims to establish that there is insufficient evidence to conclude whether using bioequivalence is adequate to determine whether two drugs can be considered equivalent given the medical and legal implications that flow from deeming two drugs equivalent.

Abstract 3336: Changes in prescriptions for breast cancer medications after Medicaid expansion

Abstract Introduction: As of summer 2018, 34 states have expanded Medicaid eligibility under the Affordable Care Act. While the Medicaid expansions decreased rates of being uninsured among women with breast cancer and increased early breast cancer detection, it is unknown whether expansions increased receipt of medications used to prevent and treat breast cancer. This study examines differences over time in receipt of two types of breast cancer hormonal therapies (tamoxifen and aromatase inhibitors) and associated payments for these medications in states that did vs. did not expand Medicaid during the period 2011-2017. Methods: The study’s data source is the Medicaid State Drug Utilization Database (SDUD). This data set, compiled by the Centers for Medicaid and Medicare (CMS), is administrative data submitted by state Medicaid programs. The data comprise outpatient prescription medications that are covered under the Medicaid Drug Rebate Program for which Medicaid serves as a third-party payer; this includes aggregate numbers of prescriptions and associated payments for individuals enrolled in both fee for service and managed care Medicaid programs. Both branded and generic prescriptions for three aromatase inhibitors (anastrozole, exemestane, and letrozole) were included in the study’s analyses. Analyses used differences-in-differences and event study models (controlling for state characteristics) to compare changes in Medicaid expansion states to changes in non-expansion states before vs. after expansion. Results: Initial regression analyses indicate that prescriptions for all hormonal therapy medications increased by 27% (p<0.05) and prescriptions for aromatase inhibitors (branded and generics combined) increased by 29% (p<0.05) in expansion states relative to non-expansion states. Prescriptions for tamoxifen and for generic aromatase inhibitors only also increased significantly. Post-expansion, both total payments and Medicaid payments for all hormonal therapies increased by 13% (p<0.01) in expansion states relative to non-expansion states. The similar increases for total and Medicaid payments suggest that state Medicaid programs, not patients, financed the increased hormonal therapy prescription payments. Conclusions: Our findings indicate that states that expanded Medicaid with the ACA experienced increased prescriptions for breast cancer hormonal therapies relative to states that did not expand Medicaid; this effect of Medicaid expansion increased over time. The increased prescriptions were financed by Medicaid, not by patients. Citation Format: Johanna Catherine Maclean, Michael T. Halpern, Steven C. Hill, Michael F. Pesko. Changes in prescriptions for breast cancer medications after Medicaid expansion [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3336.

Effect of Evergreened Reformulations on Medicaid Expenditures and Patient Access from 2008 to 2016.

Annual spending on retail and nonretail prescription drugs exceeds $450 billion and is projected to outpace growth in all other national health expenditure categories over the next decade. Evergreened reformulations of drugs, defined here as extended-release or other reformulations that came to market more than 2 years after initial approval of the immediate-release product, increase drug spending and delay patient access to extended-release formulations. Reforming drug approval incentives may encourage earlier introduction of extended-release formulations, hastening generic adoption and patient access. To (a) systematically identify evergreened reformulations, defined as reformulations that extend drug exclusivity (i.e., extended-release or other reformulations that came to market more than 2 years after initial approval of the immediate-release product), and (b) estimate the effect on Medicaid spending and the delay in patient access to extended-release formulations. Evergreened reformulations were identified using FDA Orange Book drug approval data (1982-2018); these data were used to characterize mean time from initial brand approval to evergreen reformulation approval and subsequent generic approval. Medicaid expenditure data from 2008-2016 were used to estimate increased expenditures from delayed introduction of generic extended-release formulations. Outcome measurements include time from FDA approval of immediate-release brand drug to evergreened reformulation extended-release brand drug approval, annual generic share of immediate-release and extended-release prescriptions in Medicaid, and annual price difference between brand and generic prescriptions in Medicaid. 73 drug active ingredients were subject to evergreened reformulations; these evergreened reformulations increased Medicaid expenditures by $9.35 billion from 2008-2016. Among reformulations that increased expenditures by over $100 million each, the mean time between the initial brand approval and evergreen reformulation approval was 8.1 years (SD = 3.9; median = 8.8; interquartile range [IQR] = 3.7-11.7); across all evergreened reformulations where the initial drug was approved after January 1, 1982, the mean was 7.9 years (SD = 4.3; median = 6.8; IQR = 4.0-11.0). Evergreened reformulations increase Medicaid drug expenditures and delay patient access to extended-release formulations. Reforming drug approval laws could alter market incentives for evergreened reformulations, decreasing spending and hastening patient access to extended-release products. No outside funding supported this research. The author has no competing interests to disclose.

The clinician impact and financial cost to the NHS of litigation over pregabalin: a cohort study in English primary care

ObjectivesFollowing litigation over pregabalin’s second-use medical patent for neuropathic pain, National Health Service (NHS) England was required by the court to instruct general practitioners (GPs) to prescribe the branded form...

Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis

ABSTRACTDirect-to-consumer (DTC) television ads for prescription drugs are required to disclose the product’s major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the “major statement”). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks’ severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia.

ImportanceGifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.ObjectiveTo analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.DesignGifts data from the District of Columbia’s (DC) AccessRx program and the federal Center for Medicare and Medicaid Services (CMS) Open Payments program were analyzed with claims data from the CMS 2013 Medicare Provider Utilization and Payment Data.SettingWashington DC, 2013ParticipantsPhysicians, nurse practitioners, physician assistants, podiatrists, and other licensed Medicare Part D prescribers who participated in Medicare Part D (a Federal prescription drug program that covers patients over age 65 or who are disabled).Exposure(s)Gifts to healthcare prescribers (including cash, meals, and ownership interests) from pharmaceutical companies.Main outcomes and measuresAverage number of Medicare Part D claims per prescriber, number of claims per patient, cost per claim, and proportion of branded claims.ResultsIn 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with more branded claims. Gift acceptance was associated with increased average cost per claim for PAs and NPs. Gift acceptance was also associated with higher proportion of branded claims for PAs but not NPs. Physicians who received small gifts (less than $500 annually) had more expensive claims ($114 vs. $85) and more branded claims (30.3% vs. 25.7%) than physicians who received no gifts. Those receiving large gifts (greater than $500 annually) had the highest average costs per claim ($189) and branded claims (39.9%) than other groups. All differences were statistically significant (p<0.05).Conclusions and relevanceGifts from pharmaceutical companies are associated with more prescriptions per patient, more costly prescriptions, and a higher proportion of branded prescriptions with variation across specialties. Gifts of any size had an effect and larger gifts elicited a larger impact on prescribing behaviors. Our study confirms and expands on previous work showing that industry gifts are associated with more expensive prescriptions and more branded prescriptions. Industry gifts influence prescribing behavior, may have adverse public health implications, and should be banned.

Reducing Branded Prescription Drug Prices: A Review of Policy Options.

The high prices of specialty pharmaceuticals are causing some public programs to ration care and many private insurers, including Medicare drug plans, to place specialty drugs on high cost-sharing tiers. As a result, access to these drugs is often restricted, and only a small portion of the population with a disease may receive treatment. This concern has generated a wide range of proposed solutions. We conducted a literature review and identified 52 solutions in the peer-reviewed literature that we classified into five broad categories: revising the patent system, encouraging research to increase development of new drugs, altering pharmaceutical regulation, decreasing market demand, and developing innovative pricing strategies. We discuss the rationale for these five approaches and summarize the proposed solutions. We also discuss four empirical issues that are particularly important in any discussion of policy options.

Branded prescription drug spending: a framework to evaluate policy options

BackgroundHigh drug spending is a concern for policy makers due to limits on access for patients. Numerous policies have been proposed to address high drug spending. The existence of multifarious proposals makes it difficult for policy makers to consider all the alternatives. We developed an approach to select the most viable options to present to policy makers.MethodsWe identified 41 different proposals in the peer-reviewed literature to reduce the level of spending or change the incentives for branded prescription drugs; ten of which we identified as promising proposals. Based on criterion used to assess various legislative proposals regarding branded pharmaceuticals we developed a framework to evaluate the ten promising proposals. We then used a modified Delphi technique to iteratively evaluate these ten proposals starting with the initial criterion. During each iteration, five researchers independently evaluated the ten policies based on available criterion and assessed how to modify the criterion to achieve consensus on what attributes the criterion were intended to measure. We highlight areas of disagreement to show where modifications to existing criterion are needed.ResultsWe found general agreement for most policy-criterion combinations after three iterations. Areas with the greatest remaining disagreement include possible unintended consequences, the concept of value implied by many of the policies, and secondary effects by the pharmaceutical industry, insurers, and the FDA.ConclusionsOur analysis provides an approach that can be applied to evaluate policy proposals. It also suggests factors that policy analysts and researchers should consider when they propose policy options and where additional research is needed to assess policy impacts. Developing an objective approach to compare alternatives may facilitate the adoption of policies for branded prescription drugs in the U.S. by allowing policy makers to focus on the most viable options.

First Amendment Protection of Evidence-Based Promotion of Prescription Drugs: A Study of Published Clinical Evidence Supporting Off-Label Promotion in the USA

A heated debate surrounds pharmaceutical companies’ proactive dissemination of information about uses of their drugs beyond those approved by the US Food and Drug Administration (FDA), a practice commonly referred to as “off-label promotion”. At the core of this debate is an underlying assumption that pharmaceutical company speech about off-label uses is inherently false and misleading and not in the best interests of patients. If, however, the companies’ off-label speech is truthful and not misleading, the speech may be protected by the First Amendment, making the FDA’s prohibition of off-label promotion unconstitutional. This study is the first to link alleged pharmaceutical company speech with published clinical evidence bringing data to inform the debate. To evaluate whether pharmaceutical company speech alleged in False Claim Act (FCA) complaints is supported by published clinical evidence. Reviewed were 66 FCA complaints alleging off-label promotion of branded prescription drugs. Indications in these complaints were matched to published clinical evidence using a nationally recognized compendium, Micromedex® 2.0. Of the uses alleged in FCA complaints, 51.6% (at least 22.1% of which were off-label) were supported by at least some published clinical evidence and, therefore, not inherently false or misleading. Given this evidence, the current government policy of prohibiting proactive dissemination of off-label information by manufacturers may not be consistent with the First Amendment. Some of the off-label uses alleged in FCA complaints investigated and settled by the federal government were supported by published clinical evidence; however, many of the alleged uses were unsupported by any clinical evidence and, thus, false and misleading. These results suggest that government regulation of pharmaceutical company speech remains warranted because company speech is not consistently evidence-based. Even so, evidence-based pharmaceutical company speech is protected by the First Amendment. As a result, the federal government’s historic practice of prohibiting all off-label promotion may be unconstitutional.

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011

ObjectivesPrior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. DesignLongitudinal analysis of the household component of the Medical Expenditure Panel Survey. SettingInterview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Patients or participantsNationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. InterventionDrugs and dose/formulations with versus without an authorized generic drug marketed. Main outcome measuresMultiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. ResultsDuring 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (−$3.03) and brand (−$60.64) prescriptions, and over time this price change slowly diminished. ConclusionAvailability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences.

Zyrtec: Responding to Allegra

In April 2010, the ZYRTEC brand manager at Johnson & Johnson's McNeil Consumer Healthcare, learned that Sanofi's Allegra, the leading brand in the prescription antihistamine category, was anticipated to secure over-the-counter (OTC) approval by spring 2011. With the recent successful launch of ZYRTEC Liqui-Gels, ZYRTEC was poised to overtake Merck's Claritin, the leader in the OTC antihistamine category. The case asks students to recommend how a strong brand might respond to a new market entrant that threatens to disrupt the category. The case is used in Darden's Consumer Brands elective course and would fit in courses covering consumer marketing, brand marketing, or brand strategy as well as a first-year marketing management course. Although written for an MBA audience, the content and decision points are easily accessible to advanced undergraduate marketing students and an Executive Education audience. Excerpt UVA-M-0847 Rev. Dec. 2, 2014 ZYRTEC: Responding to Allegra In April 2010, Leigh Carron, the director of McNeil Consumer Healthcare's allergy franchise, stepped out of the weekly health-of-the-business review when late-breaking competitive news was announced—Sanofi's market-leading Allegra brand prescription (Rx) antihistamine was anticipated to secure over-the-counter (OTC) approval from the U.S. Food and Drug Administration (FDA) by spring 2011. The news caught Carron's attention. McNeil Consumer Healthcare (MCH) had anticipated Allegra's eventual switch, but now it was front and center. MCH had launched ZYRTEC Liquid Gels in the OTC allergy market earlier in the year and experienced great success. In fact, ZYRTEC was poised to overtake Claritin, the market leader. Would Allegra's imminent move into the OTC space dampen ZYRTEC's positive momentum? How would this new competitive entrant change the market dynamics? What kind of competitive strategy was in order? And what communications strategy would be needed to support the brand strategy? McNeil Consumer Healthcare Acquired by Johnson & Johnson in 1959, MCH was founded as McNeil Laboratories, marking the addition of OTC pharmaceuticals to the company's business. McNeil comprised a range of brands, many of which held leadership positions within three key OTC categories: Upper Respiratory, Pain, and Digestive Health (Table 1). Original MCH products included Tylenol acetaminophen products, the leading pain reliever brand in the adult and pediatric categories, and Imodium A-D antidiarrheal products. With the acquisition of Pfizer Consumer Healthcare in 2007, MCH's brand portfolio expanded to include such equities as Benadryl allergy medicines, Sudafed nasal decongestants, and Rolaids antacid products, as well as ZYRTEC allergy medicines, which would imminently switch from a prescription to an OTC drug. . . .

Pharmacy Benefit Managers as Bargaining Agents

The largest expansion of entitlement programs in the United States in decades – Medicare Part D – is set to commence on January 1st of 2006. On that day, retirees will be eligible for subsidized insurance covering outpatient drug prescriptions. The plan will be managed by private sector entities called pharmacy benefit managers (PBMs)This paper attempts to reverse misconceptions about PBMs that can be traced to price theory. Proposed is an alternative view based on bargaining theory. There are several fundamental insights gained by looking at PBMs through bargaining theory. First, rebates are not received in consideration for “moving markets” but for refraining from discretionary switching of one brand prescription for another. Second, rebates are not linear price reductions designed to increase demand, but the fixed component of a two-part tariff designed to shift rent to the buy side in a bilateral oligopoly.

Statin Adherence Rates in Patients Utilizing a Patient-Centered Medical Home-Based Pharmacy

Background: Medication nonadherence contributes to approximately US$290 billion per year in avoidable health-care spending. Statins are of particular interest because of their importance to patient outcomes, costs of treatment failure, and categorization as a Medicare star measure linked to financial reimbursement. Objective: To evaluate statin adherence as defined by the proportion of days covered (PDC) among patients who use an embedded dispensing pharmacy in a patient-centered medical home (PCMH). Methods: This study is a retrospective chart review of Lifetime Health Medical Group’s electronic health record and third-party prescription claims data of statin therapy. Statin adherence is reported using PDC, with 0.8 or greater considered adherent for statin therapy. Statistics used include 2-sample unpaired t test to compare PDC between gender and age, and analysis of variance was used to determine differences in PDC among different insurance types. Results: One hundred ninety-three patients were included, and 917 statin prescriptions were filled. PDC for statin medications in the population was 0.92 ± 0.20. Eighty-six percent of patients were considered adherent, with a PDC ≥80%. The average insurance and patient costs for brand prescriptions (n = 106) were US$233 ± US$143 and US$31 ± US$27, respectively, and costs for generic prescriptions (n = 811) were US$8 ± US$13 and US$7 ± US$6, respectively. Conclusion: Statin adherence rates for patients utilizing a dispensing pharmacy embedded in a large PCMH exceed the national average of 40% to 50% adherence.

A mixed-methods approach to assessing actual risk readership on branded drug websites

Despite FDA requirements that drug benefits and risks be presented in a ‘fair balance’ manner, little is known about the extent to which individuals actually seek and process risk information. Self-report measures of drug risk reading show mixed results. This exploratory study investigates this topic within the context of a branded prescription drug website for a fictional seasonal allergy drug. We use a mixed-methods approach involving eye-tracking, survey and qualitative data. While approximately 80% of participants (N = 29) claimed to have read half or more of the risk information, eye-tracking measures revealed limited to no risk reading when given the opportunity to freely view the site without explicit directions to read risk information. Survey results showed minimal unaided recall and modest aided recall of risks. To gain insight into why participants failed to seek drug risk information, we analyzed retro-active think aloud post-task interviews for potential explanations and looked for expressions of social desirability, information avoidance, optimism bias and familiarity. Perceived familiarity with the health condition, its risks and companion drug options surfaced as the primary explanation for failure to seek, and subsequently process, the risk information. This perceived familiarity prompted participants to ignore the risk information and discount the commercial information source. We offer practical recommendations to encourage risk reading in light of our findings.

The Novel Drugs of 2015 – An Extraordinary Growth of Innovative Pharmaceuticals

The FDA has approved 45 new drugs in 2015, a record approval in two decades, indicating another year of excellent innovation and productivity. There are many regulatory pathways at the FDA for the approval of novel drugs. Sixteen drugs (36%) were First-in-Class with a new or unique mechanism of action for treating a disease. About 29% of the new drugs are biologics. Moreover, 21 of 45 (47%) are orphan drugs for the treatment of rare diseases. The FDA approved many new drugs to treat various forms of cancer, urinary tract infections, chronic hepatitis C, cystic fibrosis, irritable bowel syndrome, heart failure, and high cholesterol, as well as the first approved reversal agent for a commonly-used blood thinner. For the second consecutive year, the FDA approved more “orphan” drugs for rare diseases than any previous year in recent history. From 2006 through 2014, the FDA averaged about 28 novel drug approvals per year. Such products represent innovation and provide important new therapies for patients worldwide. Despite such record new drug approvals, there is a continued productivity crisis in R&amp;D due to a progressive rise in cost for drug discovery and development. The U.S. pharmaceutical market is forecasted to reach $548 billion by 2020. The prices appear to be increasing faster for generic and branded prescription drugs. Overall, faster development and regulatory review contributed to a spike in record approval of innovative pharmaceutical products in 2015

Physician Payments from Industry Are Associated with Greater Medicare Part D Prescribing Costs

BackgroundThe U.S. Physician Payments Sunshine Act mandates the reporting of payments or items of value received by physicians from drug, medical device, and biological agent manufacturers. The impact of these payments on physician prescribing has not been examined at large scale.MethodsWe linked public Medicare Part D prescribing data and Sunshine Act data for 2013. Physician payments were examined descriptively within specialties, and then for association with prescribing costs and patterns using regression models. Models were adjusted for potential physician-level confounding features, including sex, geographic region, and practice size.ResultsAmong 725,169 individuals with Medicare prescribing data, 341,644 had documented payments in the OPP data (47.1%). Among all physicians receiving funds, mean payment was $1750 (SD $28336); median was $138 (IQR $48-$394). Across the 12 specialties examined, a dose-response relationship was observed in which greater payments were associated with greater prescribing costs per patient. In adjusted regression models, being in the top quintile of payment receipt was associated with incremental prescribing cost per patient ranging from $27 (general surgery) to $2931 (neurology). Similar associations were observed with proportion of branded prescriptions written.ConclusionsWhile distribution and amount of payments differed widely across medical specialties, for each of the 12 specialties examined the receipt of payments was associated with greater prescribing costs per patient, and greater proportion of branded medication prescribing. We cannot infer a causal relationship, but interventions aimed at those physicians receiving the most payments may present an opportunity to address prescribing costs in the US.

Medicaid prescription limits: policy trends and comparative impact on utilization.

BackgroundMedicaid programs face growing pressure to control spending. Despite evidence of clinical harms, states continue to impose policies limiting the number of reimbursable prescriptions (caps). We examined the recent use of prescription caps by Medicaid programs and the impact of policy implementation on prescription utilization.MethodsWe identified Medicaid cap policies from 2001–2010. We classified caps as applying to all prescriptions (overall caps) or only branded prescriptions (brand caps). Using state-level, aggregate prescription data, we developed interrupted time-series analyses to evaluate the impact of implementing overall caps and brand caps in a subset of states with data available before and after cap initiation. For overall caps, we examined the use of essential medications, which were classified as preventive or as providing symptomatic benefit. For brand caps, we examined the use of all branded drugs as well as branded and generic medications among classes with available generic replacements.ResultsThe number of states with caps increased from 12 in 2001 to 20 in 2010. Overall cap implementation (n = 3) led to a 0.52 % (p < 0.001) annual decrease in the proportion of essential prescriptions but no change in cost. For preventive essential medications, overall caps led to a 1.12 % (p = 0.001) annual decrease in prescriptions (246,000 prescriptions annually) and a 1.20 % (p < 0.001) decrease in spending (−$12.2 million annually), but no decrease in symptomatic essential medication use. Brand cap implementation (n = 6) led to an immediate 2.29 % (p = 0.16) decrease in branded prescriptions and 1.26 % (p = 0.025) decrease in spending. For medication classes with generic replacements, the decrease in branded prescriptions (0.74 %, p = 0.003) approximately equaled the increase in generics (0.79 %, p = 0.009), with estimated savings of $17.4 million.ConclusionsAn increasing number of states are using prescription caps, with mixed results. Overall caps decreased the use of preventive but not symptomatic essential medications, suggesting that patients assign higher priority to agents providing symptomatic benefit when faced with reimbursement limits. Among medications with generic replacements, brand caps shifted usage from branded drugs to generics, with considerable savings. Future research should analyze the patient-level impact of these policies to measure clinical outcomes associated with these changes.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1258-0) contains supplementary material, which is available to authorized users.

The Novel Drugs of 2014 –Record Approvals for Niche Markets

In 2014, 41 new drugs were approved by the FDA, the highest approval in two decades. This number was 52% higher than the 27 approvals in 2013, indicating another year of excellent innovation and productivity. Seventeen drugs (41%) were First-in-Class with a new or unique mechanism of action for treating a disease. Moreover, 17 of 41 (41%) of these novel drugs were for the treatment of rare diseases, a testament to continued focus or shift to niche diseases. The U.S. FDA is the leading authority for drug approvals worldwide. Many schemes and tracks at the FDA have led to accelerated approval of novel drugs. Such reviews as fasttrack or breakthrough designation are established for meeting demand more quickly. Despite such historic drug approvals, there is continued productivity crisis in R &amp; D due to steady cost escalation for drug discovery and development. The U.S. pharmaceutical market is forecasted to increase from an estimated value of $395 billion in 2014 to reach $548 billion by 2020. The prices appear to be increasing faster for branded prescription drugs. Overall, the current drug approvals and trends clearly reveal the pharma industry shift to niche diseases for pricing power and return on investment. &#x0D;

Provider and patient drivers of ototopical antibiotic prescription variability

ObjectiveTo determine if providers prescribe more affordable topical antibacterial therapy for patients who are economically disadvantaged or come from economically disadvantaged communities. Study designPrescription drug database review. SettingLarge academic hospital network. Subjects and methodsOtotopical prescription records of 2416 adults and children presenting with acute and chronic otologic infections from 2009 to 2013 were reviewed. Prescription, patient, provider, and institution variables including diagnosis, prescription type, demographics, health insurance status, healthcare provider type and setting were analyzed. ResultsOtitis externa and acute otitis media were the most common diagnoses. Non-OHNS (Otolaryngology-Head and Neck Surgery) providers served 82% of all patients. OHNS providers prescribed proportionally less fluoroquinolone, and more brand-name antibiotics compared to non-OHNS providers. Adults were more likely to receive a non-fluoroquinolone antibiotic and a generic prescription versus pediatric patients. Patients who self-identified as ‘white’ ethnicity received proportionally more fluoroquinolone prescriptions than patients who identified as ‘non-white,’ but there was no difference in provider type. The proportion of fluoroquinolone prescriptions was significantly higher in patients from low-poverty counties, however poverty level was not associated with patients seeing a particular provider type. The majority of our patients had commercial insurance, followed by Medicaid. Medicare patients had the lowest proportion of fluoroquinolone antibiotic prescriptions, and were less likely to receive fluoroquinolone prescriptions versus commercial insurance. Non-insured patients received proportionally more generic versus brand prescriptions than insured patients. ConclusionOur results indicate potential provider, patient demographic, and financial factors producing considerable variability in the prescribing patterns for topical antibiotics for common otologic infections.