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  1. Article ; Online: Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss.

    Kelly, Elizabeth M / Tungol, Alexandra A / Wesolowicz, Laurie A

    Journal of managed care pharmacy : JMCP

    2013  Volume 19, Issue 8, Page(s) 642–654

    Abstract: Background: Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are ... ...

    Abstract Background: Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities.
    Objective: To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result.
    Methods: A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website.
    Results: 5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate.
    Conclusions: Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.
    MeSH term(s) Adult ; Anti-Obesity Agents/adverse effects ; Anti-Obesity Agents/therapeutic use ; Appetite Depressants/adverse effects ; Appetite Depressants/therapeutic use ; Benzazepines/adverse effects ; Benzazepines/therapeutic use ; Body Weight/drug effects ; Clinical Trials, Phase III as Topic ; Female ; Fructose/adverse effects ; Fructose/analogs & derivatives ; Fructose/therapeutic use ; Humans ; Male ; Obesity/drug therapy ; Phentermine/adverse effects ; Phentermine/therapeutic use ; Randomized Controlled Trials as Topic ; Topiramate ; Weight Loss/drug effects
    Chemical Substances Anti-Obesity Agents ; Appetite Depressants ; Benzazepines ; Topiramate (0H73WJJ391) ; Fructose (30237-26-4) ; lorcaserin (637E494O0Z) ; Phentermine (C045TQL4WP)
    Language English
    Publishing date 2013-05-17
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2022394-8
    ISSN 1944-706X ; 1083-4087
    ISSN (online) 1944-706X
    ISSN 1083-4087
    DOI 10.18553/jmcp.2013.19.8.642
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Formulary management of the protease inhibitors boceprevir and telaprevir for chronic hepatitis C virus.

    Tungol, Alexandra / Rademacher, Kellie / Schafer, Jeremy A

    Journal of managed care pharmacy : JMCP

    2009  Volume 17, Issue 9, Page(s) 685–694

    Abstract: Background: Hepatitis C virus (HCV) is the most common chronic bloodborne illness in the United States. The incidence of acute hepatitis C in the United States peaked near 50,000 cases in the late 1980s but has stabilized since 2003 to less than 5,000 ... ...

    Abstract Background: Hepatitis C virus (HCV) is the most common chronic bloodborne illness in the United States. The incidence of acute hepatitis C in the United States peaked near 50,000 cases in the late 1980s but has stabilized since 2003 to less than 5,000 cases annually. The combination of pegylated interferon (peginterferon) and ribavirin has been the standard recommended treatment for HCV. Protease inhibitors telaprevir and boceprevir were approved by the FDA in May 2011 for the treatment of hepatitis C genotype 1 in combination with peginterferon and ribavirin.
    Objective: To review the phase 3 trials for telaprevir and boceprevir and provide managed care considerations.
    Methods: A MEDLINE review was performed for articles published and available through September 15, 2011, using keywords "boceprevir" or "telaprevir" with an emphasis on phase 3 trials. The literature search was limited to articles in English, clinical trials, randomized controlled trials, and research conducted in humans. Additional information was obtained from the FDA website.
    Results: Three phase 3 trials are available for telaprevir, which provided data that were the basis for FDA approval. Boceprevir demonstrated efficacy and safety in 2 pivotal phase 3 trials. Both agents demonstrated statistically significantly higher rates of virologic response compared with the standard of care involving peginterferons and ribavirin. Telaprevir and boceprevir also demonstrated efficacy in the treatment of patients who had previously failed dual therapy for hepatitis C. Safety concerns for both agents include anemia, drug interactions, skin rashes, and gastrointestinal adverse events.
    Conclusions: Decision makers have many factors to consider in developing a strategy around hepatitis C. Increased drug costs, patient management, adherence, comparative safety and efficacy, and appropriate utilization management controls are important issues. Payers may consider developing clinical programs to encourage adherence and appropriate use and leverage an appropriate channel to ensure cost-effective therapy.
    MeSH term(s) Adolescent ; Adult ; Aged ; Algorithms ; Clinical Trials, Phase III as Topic ; Drug Costs ; Female ; Hepatitis C, Chronic/blood ; Hepatitis C, Chronic/drug therapy ; Humans ; Male ; Managed Care Programs ; Middle Aged ; Oligopeptides/adverse effects ; Oligopeptides/pharmacokinetics ; Oligopeptides/therapeutic use ; Patient Compliance ; Proline/adverse effects ; Proline/analogs & derivatives ; Proline/pharmacokinetics ; Proline/therapeutic use ; Protease Inhibitors/adverse effects ; Protease Inhibitors/pharmacokinetics ; Protease Inhibitors/therapeutic use ; RNA, Viral/blood ; Randomized Controlled Trials as Topic ; Viral Load ; Young Adult
    Chemical Substances Oligopeptides ; Protease Inhibitors ; RNA, Viral ; telaprevir (655M5O3W0U) ; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide (89BT58KELH) ; Proline (9DLQ4CIU6V)
    Language English
    Publishing date 2009-04-15
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Review
    ZDB-ID 2022394-8
    ISSN 1944-706X ; 1083-4087
    ISSN (online) 1944-706X
    ISSN 1083-4087
    DOI 10.18553/jmcp.2011.17.9.685
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

    Tungol, Alexandra / Starner, Catherine I / Gunderson, Brent W / Schafer, Jeremy A / Qiu, Yang / Gleason, Patrick P

    Journal of managed care pharmacy : JMCP

    2012  Volume 18, Issue 9, Page(s) 690–700

    Abstract: Unlabelled:  : Background: In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug ... ...

    Abstract Unlabelled:  
    Background: In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown.
    Objective: To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs.
    Methods: This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing supply on July 1, 2006, was the index claim. Members with a Kmart pharmacy index claim were excluded, since the Kmart membership drug discount program began prior to July 1, 2006. Levothyroxine claims capture nonpersistency, defined as the occurrence of a claim supply end date prior to a 180-day gap, was the primary outcome variable and was assessed from July 1, 2006, through June 30, 2010 (follow-up period). The odds of levothyroxine claims capture nonpersistency by pharmacy group were assessed using a logistic regression analysis adjusted for the following covariates: age, gender, median income in the ZIP code of residence (binomial for ≤ $50,000 vs. greater than $50,000), switch to a brand levothyroxine product during the follow-up period, index levothyroxine claim supply of 90 days or more, and index levothyroxine claim member cost share per 30-day supply in tertiles (≤ $5.00, $5.01-$7.99, ≥ $8.00).
    Results: Of 2,632,855 eligible members aged 18 years or older, 13,427 met all study eligibility criteria. The baseline pharmacy groups were membership with 3,595 (26.8%), nonmembership with 1,919 (14.3%), and all other pharmacies with 7,913 (58.9%) members. The rates of levothyroxine claims capture persistency throughout the 4-year follow-up period were 85.4% for nonmembership (P = 0.593 vs. all other pharmacies), 77.7% for the membership group (P  less than  0.001 vs. all other pharmacies), and 85.9% for all other pharmacies. The Kaplan-Meier comparison of claims capture persistency found nearly identical claims capture loss for the nonmembership compared with all other pharmacies group, and when compared in a multivariate logistic regression model, there was no difference in the odds of levothyroxine claims capture over 4 years follow-up (OR = 1.01, 95% CI = 0.88-1.16, P = 0.900). The membership generic drug discount programs (Walgreens, CVS, Alberstons, and Savon pharmacies) had a statistically significant 61% higher odds (OR = 1.61, 95% CI = 1.45-1.79, P  less than  0.001) of levothyroxine claims capture nonpersistency. The onset of the difference between the membership group and the all other pharmacies group was temporally associated with the launch of the membership programs. In comparison to index levothyroxine member cost of ≤ $5.00 per 30-day supply, higher cost shares were associated with higher levothyroxine claims capture nonpersistency ($5.01 to $7.99 OR 1.34, 95% CI 1.19-1.52 and ≥ $8.00 OR 1.60, 95% CI 1.40-1.82).
    Conclusions: Among levothyroxine utilizers in 2006 (prior to the advent of drug discount programs), those with claims from a pharmacy that subsequently implemented a nonmembership generic drug discount program did not appear to have a different rate of levothyroxine claims capture than members from the reference group when followed through June 2010. Utilizers with claims from a pharmacy that subsequently implemented a membership program had a significantly lower levothyroxine claims capture rate. Increasing index levothyroxine member cost was associated with higher levothyroxine claims capture loss. Because the analysis could not directly measure claims capture loss associated with members who switched to a new pharmacy group without presenting their insurance information (e.g., membership discount programs), further research is needed to confirm these findings.
    MeSH term(s) Adolescent ; Adult ; Confidence Intervals ; Drugs, Generic/economics ; Female ; Humans ; Insurance Claim Review ; Insurance, Pharmaceutical Services ; Male ; Managed Care Programs ; Markov Chains ; Middle Aged ; Odds Ratio ; Retrospective Studies ; Thyroxine/economics ; Thyroxine/therapeutic use ; United States ; Young Adult
    Chemical Substances Drugs, Generic ; Thyroxine (Q51BO43MG4)
    Language English
    Publishing date 2012-03-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2022394-8
    ISSN 1944-706X ; 1083-4087
    ISSN (online) 1944-706X
    ISSN 1083-4087
    DOI 10.18553/jmcp.2012.18.9.690
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5450: Show issues Location:
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  4. Article ; Online: Prevalence and predictors of utilization of community pharmacy generic drug discount programs.

    Gatwood, Justin / Tungol, Alexandra / Truong, Christopher / Kucukarslan, Suzan N / Erickson, Steven R

    Journal of managed care pharmacy : JMCP

    2009  Volume 17, Issue 6, Page(s) 449–455

    Abstract: Background: Since 2006, select pharmacies in the United States have been offering programs where prescriptions for certain generic medications can be filled at very low cost (e.g., a 30-day supply for $4). However, limited knowledge exists on the ... ...

    Abstract Background: Since 2006, select pharmacies in the United States have been offering programs where prescriptions for certain generic medications can be filled at very low cost (e.g., a 30-day supply for $4). However, limited knowledge exists on the characteristics of patients who have used these services.
    Objective: To examine the prevalence of use of community pharmacy generic drug discount programs and the characteristics of patients using these programs.
    Methods: Two cross-sectional surveys of patients in a university-affiliated health system general medicine clinic were conducted over an approximately 4-week period in the summers of 2008 and 2010. The survey measured self-reported information in 3 parts: a listing of current medications, questions about program use, and patient demographics. The survey was administered to patients as they were waiting to see their physicians with a research assistant on-site for assistance and to collect the completed surveys. Medications listed by patients were classified as acute or chronic by pharmacists on the research team. Descriptive statistics (Pearson chi-square or Student's t-tests) were used to compare subjects across years and between groups of discount program users and nonusers. Logistic regression models were constructed to identify significant predictors of program use, testing demographic factors, prescription drug coverage, number of medications, monthly out-of-pocket payments, and year of the survey.
    Results: The convenience sample included 414 individuals overall, 203 in 2008 and 211 in 2010. After excluding respondents who did not answer all survey questions, the sample size was 311 (n = 148 in 2008 and 163 in 2010). The sample was mostly Caucasian; most patients had prescription coverage; and a large majority of medications filled were for chronic use. Patient characteristics were similar in the 2 groups except for a higher mean number of self-reported medications in 2010 than 2008 (4.2 vs. 3.4, respectively, P = 0.01). Use of a discount medication program was reported by 52 (31.9%) of those surveyed in 2010 compared with 7 (4.7%) in 2008 (P less than 0.001). When both groups were combined, factors associated with use of generic drug discount programs included filling prescriptions for a higher number of medications (odds ratio [OR] =1.13, 95% CI =1.01-1.27, P =0.036) and the year of the survey (OR for 2010 =9.02, 95% CI =3.8221.29). Differences in program use were also observed among categories of age and income.
    Conclusions: Over a 2-year period, there was an increase in the use of discount generic medication programs in this university clinic population. Patients who take more prescription medications are more likely to choose such plans, and differences in program use were observed between ranges of age and income. More extensive analysis is needed to better predict patient use of such services.
    MeSH term(s) Adult ; Aged ; Community Pharmacy Services/economics ; Cross-Sectional Studies ; Drug Costs ; Drugs, Generic/administration & dosage ; Drugs, Generic/economics ; Drugs, Generic/therapeutic use ; Female ; Health Care Surveys ; Humans ; Insurance Coverage/economics ; Insurance, Pharmaceutical Services/economics ; Logistic Models ; Male ; Middle Aged ; Prescription Drugs/administration & dosage ; Prescription Drugs/economics ; Prescription Drugs/therapeutic use ; Prevalence ; United States
    Chemical Substances Drugs, Generic ; Prescription Drugs
    Language English
    Publishing date 2009-04-15
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2022394-8
    ISSN 1944-706X ; 1083-4087
    ISSN (online) 1944-706X
    ISSN 1083-4087
    DOI 10.18553/jmcp.2011.17.6.449
    Database MEDical Literature Analysis and Retrieval System OnLINE

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