- Email: [email protected]
One-year biologic cost per patient with psoriatic diseases in a managed care population
2518
3159
Network metaanalysis of new biologic agents targeting IL-23/Th17 pathway for moderate to severe plaque psoriasis Francisco G omez-Garcıa, MD, Department of Dermatology, IMIBIC/Reina Sofıa University Hospital/University of C ordoba, C ordoba, Spain; David Epstein, PhD, Department of Applied Economics, School of Economics, University of Granada, Granada, Spain; Juan Ruano, MD, PhD, Department of Dermatology, IMIBIC/Reina Sofıa University Hospital/University of C ordoba, C ordoba, Spain Introduction: Targeting proinflammatory cytokines such as tumor necrosis factor-a (TNF-a) has been an effective therapeutic approach for patients with moderate to severe plaque psoriasis. A new generation of biologics targeting IL-23/Th17 pathway has been developed. This study aimed to assess the clinical effectiveness of these new therapeutic agents using network metaanalysis. Methods: Randomized trials were identified by a systematic literature review. Study quality was assessed by Jadad score. Network metaanalysis was used to make direct and indirect comparisons among the therapeutic options. Results: 39 clinical trials (n ¼ 22,457) met the inclusion criteria. Guselkumab and tildrakizumab were excluded due to small numbers of patients and/or Jadad scores below 4. There were 26 direct comparisons in the network. Ixekizumab 80 mg Q2W is ranked the most effective, followed by brodalumab 210 mg Q2W and infliximab 5 mg/kg- 1 Q6/8W. The probability of either an anti-IL17A or an anti-IL17RA agent was the most efficient treatment for a particular case reached almost 80%. A high degree of consistency between the direct and the indirect evidence was observed. Conclusions: New agents targeting the IL-23/Th17 pathway seem to be more effective than most of the classical anti-TNF-a drugs. Future treatment recommendations also must consider adverse effects and cost.
Occlusivity and moisturization potential of a new lotion formulation of halobetasol propionate, 0.05% Gary Grove, PhD, cyberDERM Inc, Broomall, PA, United States; Charles Zerweck, PhD, cyberDERM, Inc, Broomall, PA, United States; Tim Houser, MS, cyberDERM, Inc, Broomall, PA, United States; Anthony Andrasfay, Therapeutics Inc, San Diego, CA, United States; Robert Gauthier, MS, Therapeutics Inc, San Diego, CA, United States; Charles Holland, PhD, Therapeutics Inc, San Diego, CA, United States; Daniel Piacquadio, MD, Therapeutics Inc, San Diego, CA, United States When a topical treatment for psoriasis and other corticosteroid-responsive dermatoses is indicated, patients often prefer a lotion to a cream. However, lotions are perceived to be less occlusive, and consequently less hydrating, than creams. Therefore, since ultrapotent topical corticosteroids are a cornerstone of such topical treatments, a novel lotion formulation of halobetasol propionate, 0.05% (HBP lotion) that provides the beneficial occlusion and moisturization of a cream was developed. The objective of this study was to determine and compare the occlusivity and moisturization potential of HBP lotion and ultravate (HBP) cream when applied to skin whose barrier integrity has been challenged by dry shaving. A single center, evaluator-blinded, randomized within subject study was conducted in 16 healthy volunteers (aged 18-55 years). On Day 1, the stratum corneum barrier was challenged by dry shaving the skin surface of both volar forearms with a disposable razor and six test sites (3/arm; area ¼ 25cm2) were identified: 2 sites each for HBP lotion, ultravate cream, and dry-shaved controls. On Day 2, transepidermal water loss (TEWL) and conductance measurements were performed. Then, a single application of ;100 mg of each test article was applied to the designated test sites of the volar forearms in duplicate, and was maintained in situ for 6 hours by protecting the arms with a raised perforated guard secured with nonocclusive tape. TEWL and conductance measurements were performed 2, 4, and 6 hours postapplication of the test articles. TEWL values did not vary between HBP lotion and ultravate cream (2h: P ¼ .12; 4h: P ¼ .80; 6h: 0.37), which suggests that the two HBP formulations provide similar occlusivity and can participate equally in the management of dry and inflammatory skin conditions. Additionally, HBP Lotion treated sites had significantly greater conductance compared to: (1) dry-shaved controls at all time points (each, P \.001) and (2) ultravate cream at 2h and 4h (each, P \.001). Both HBP lotion and ultravate cream improved skin moisturization at 6h. However, at 2h and 4h following single applications of HBP lotion and ultravate cream conductance results indicated greater skin moisturization with HBP lotion than ultravate cream, suggesting that HBP lotion more rapidly penetrates the outer skin layers to ensure optimal hydration during treatment.
Commercial support: None identified.
Supported 100% by Ferndale Laboratories.
2589 Numbers needed to treat and costs per responder for novel treatments of moderate to severe psoriasis April Armstrong, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States; Keith Betts, Analysis Group, Inc, Boston, MA, United States; Junlong Li, Analysis Group, Inc, Boston, MA, United States; Murali Sundaram, AbbVie Inc, North Chicago, IL, United States; Eric Wu, Analysis Group, Inc, Boston, MA, United States; James Signorovitch, Analysis Group, Inc, Boston, MA, United States Objective: The clinical benefits of novel treatments for moderate to severe psoriasis (biologics and apremilast) have been well-established, including variations in patient response across different therapies. We estimated the number needed to treat (NNT) to achieve a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) with biologic agents and evaluated the incremental drug cost per PASI-75 responder for biologic treatments relative to apremilast. Methods: A systematic literature review was conducted to identify randomized controlled trials of novel treatments in patients with moderate to severe psoriasis. Relative probabilities of achieving PASI-75 response with each treatment during the clinical trial period (10 weeks for infliximab; 12 weeks for etanercept, ustekinumab, and secukinumab; and 16 weeks for adalimumab and apremilast) were estimated using a Bayesian network metaanalysis. The NNT was estimated as the reciprocal of the difference in estimated PASI-75 response rates between each biologic treatment and apremilast (apremilast was chosen as the reference based on its lower price and lower efficacy). Costs were assessed in 2015 US dollars including drug acquisition and administration. The incremental cost per PASI-75 response for each biologic was estimated for the clinical trial period and annually. Results: A total of 20 trials meeting all inclusion criteria were identified. Compared with apremilast, the NNT to achieve 1 additional PASI-75 response during the clinical trial period was 1.96 (95% credible interval: 1.69e2.31) for secukinumab 300 mg, 2.09 (1.77e2.52) for infliximab, 2.58 (2.07e3.28) for secukinumab 150 mg, 2.72 (2.18e3.59) for adalimumab, 2.75 (2.21e3.58) for ustekinumab, and 5.71 (3.70e9.86) for etanercept. The 1-year incremental cost per PASI-75 responder relative to apremilast was $20,419 ($17,375e$24,735) for infliximab; $48,405 ($39,331e$64,926) for adalimumab; $61,941 ($53,770e$73,308) for secukinumab 300 mg; $71,187 ($57,936e$93,983) for ustekinumab; $80,788 ($65,827e$104,187) for secukinumab 150 mg; and $136,223 ($93,500e$250,072) for etanercept 50 mg. A similar ranking of these biologic treatments was observed for cost per PASI-75 responder during the clinical trial period. Conclusions: Infliximab and adalimumab had the lowest incremental cost per PASI75 responder among the biologic treatments compared with apremilast. Design, study conduct, and financial support for the study were provided by AbbVie; AbbVie participated in the interpretation of data, review, and approval of the abstract; all authors contributed to the development of the publication.
MAY 2016
3564 One-year biologic cost per patient with psoriatic diseases in a managed care population Tao Gu, HealthCore, Wilmington, CA, United States; Gaurav Deshpande, HealthCore, Wilmington, DE, United States; Derek Tang, Amgen, Inc, Thousand Oaks, CA, United States; Neel Shah, Amgen, Inc, Thousand Oaks, CA, United States; David Harrison, Amgen, Inc, Thousand Oaks, CA, United States; Debra Eisenberg, HealthCore, Wilmington, DE, United States; Bradley Stolshek, Amgen, Inc, Thousand Oaks, CA, United States Background: The rising health care cost in specialty pharmacy has led providers to place economic factors into treatment decisions. Current evidence on biologic costs in psoriatic diseases is lacking. Objective: To determine the annual drug and administration cost of US-approved biologics per patient with psoriasis (PsO) and/or psoriatic arthritis (PsA) in a managed care population comprising beneficiaries predominantly enrolled in a large managed care health plan. Methods: This is a retrospective cohort study using administrative data for individuals in the HealthCore Integrated Research Database (HIRDSM). The cohort included patients initiating a tumor necrosis factor inhibitor [TNFi] (adalimumab [ADA], etanercept [ETN], golimumab [GOL], infliximab [INF]) or a non-TNFi (ustekinumab [UST]) between Jul 1, 2009 and Jan 31, 2013. Patient entry criteria were age $18, continuous enrollment during the 180 days prior to and 360 days postindex, and PsO and/or PsA diagnosis in the 6 months preindex. The index event and date was defined as the first biologic use following 6 months of enrollment. Unit biologic and administration costs as of Jan 1, 2015 were applied to the real-world dosing and administration data to calculate annual per patient cost. Costs were stratified by drug mechanism, disease indication, and new versus established users. Results: A total of 8981 patients with PsO and/or PsA met the eligibility criteria (ADA: n ¼ 3,161; ETN: n ¼ 4,721; GOL: 94; INF: n ¼ 547; UST: 458; mean age 45.1, 42.9% female). Among new users (n ¼ 4093), non-TNFi users (UST) had numerically greater cost per patient ($36,745) compared with TNFi users ([ADA]: $27,949; [ETN] $30,090; [GOL]: $24,474; [INF]: $26,646). Among established users (n ¼ 4888), the cost per patient for non-TNFi users ($28,771) was within the cost range of TNFi users ([ETN]: $28,125; [INF]: $31,813). ADA had numerically greater cost than other agents in both new ($27,397) and established users ($30,590) with only PsA. UST and INF had numerically greater cost than other agents in new ($36,574$38,395) and established users ($31,832-$33,793) with PsO 6 PsA, respectively. Conclusion: Although similar annual biologic cost per patient may be expected among established users of TNFi and non-TNFi, new non-TNFi users were found to incur at least 22% greater annual cost than new TNFi users. Average cost varied considerably across psoriatic indications and individual agents. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc.
J AM ACAD DERMATOL
AB261
3159
Network metaanalysis of new biologic agents targeting IL-23/Th17 pathway for moderate to severe plaque psoriasis Francisco G omez-Garcıa, MD, Department of Dermatology, IMIBIC/Reina Sofıa University Hospital/University of C ordoba, C ordoba, Spain; David Epstein, PhD, Department of Applied Economics, School of Economics, University of Granada, Granada, Spain; Juan Ruano, MD, PhD, Department of Dermatology, IMIBIC/Reina Sofıa University Hospital/University of C ordoba, C ordoba, Spain Introduction: Targeting proinflammatory cytokines such as tumor necrosis factor-a (TNF-a) has been an effective therapeutic approach for patients with moderate to severe plaque psoriasis. A new generation of biologics targeting IL-23/Th17 pathway has been developed. This study aimed to assess the clinical effectiveness of these new therapeutic agents using network metaanalysis. Methods: Randomized trials were identified by a systematic literature review. Study quality was assessed by Jadad score. Network metaanalysis was used to make direct and indirect comparisons among the therapeutic options. Results: 39 clinical trials (n ¼ 22,457) met the inclusion criteria. Guselkumab and tildrakizumab were excluded due to small numbers of patients and/or Jadad scores below 4. There were 26 direct comparisons in the network. Ixekizumab 80 mg Q2W is ranked the most effective, followed by brodalumab 210 mg Q2W and infliximab 5 mg/kg- 1 Q6/8W. The probability of either an anti-IL17A or an anti-IL17RA agent was the most efficient treatment for a particular case reached almost 80%. A high degree of consistency between the direct and the indirect evidence was observed. Conclusions: New agents targeting the IL-23/Th17 pathway seem to be more effective than most of the classical anti-TNF-a drugs. Future treatment recommendations also must consider adverse effects and cost.
Occlusivity and moisturization potential of a new lotion formulation of halobetasol propionate, 0.05% Gary Grove, PhD, cyberDERM Inc, Broomall, PA, United States; Charles Zerweck, PhD, cyberDERM, Inc, Broomall, PA, United States; Tim Houser, MS, cyberDERM, Inc, Broomall, PA, United States; Anthony Andrasfay, Therapeutics Inc, San Diego, CA, United States; Robert Gauthier, MS, Therapeutics Inc, San Diego, CA, United States; Charles Holland, PhD, Therapeutics Inc, San Diego, CA, United States; Daniel Piacquadio, MD, Therapeutics Inc, San Diego, CA, United States When a topical treatment for psoriasis and other corticosteroid-responsive dermatoses is indicated, patients often prefer a lotion to a cream. However, lotions are perceived to be less occlusive, and consequently less hydrating, than creams. Therefore, since ultrapotent topical corticosteroids are a cornerstone of such topical treatments, a novel lotion formulation of halobetasol propionate, 0.05% (HBP lotion) that provides the beneficial occlusion and moisturization of a cream was developed. The objective of this study was to determine and compare the occlusivity and moisturization potential of HBP lotion and ultravate (HBP) cream when applied to skin whose barrier integrity has been challenged by dry shaving. A single center, evaluator-blinded, randomized within subject study was conducted in 16 healthy volunteers (aged 18-55 years). On Day 1, the stratum corneum barrier was challenged by dry shaving the skin surface of both volar forearms with a disposable razor and six test sites (3/arm; area ¼ 25cm2) were identified: 2 sites each for HBP lotion, ultravate cream, and dry-shaved controls. On Day 2, transepidermal water loss (TEWL) and conductance measurements were performed. Then, a single application of ;100 mg of each test article was applied to the designated test sites of the volar forearms in duplicate, and was maintained in situ for 6 hours by protecting the arms with a raised perforated guard secured with nonocclusive tape. TEWL and conductance measurements were performed 2, 4, and 6 hours postapplication of the test articles. TEWL values did not vary between HBP lotion and ultravate cream (2h: P ¼ .12; 4h: P ¼ .80; 6h: 0.37), which suggests that the two HBP formulations provide similar occlusivity and can participate equally in the management of dry and inflammatory skin conditions. Additionally, HBP Lotion treated sites had significantly greater conductance compared to: (1) dry-shaved controls at all time points (each, P \.001) and (2) ultravate cream at 2h and 4h (each, P \.001). Both HBP lotion and ultravate cream improved skin moisturization at 6h. However, at 2h and 4h following single applications of HBP lotion and ultravate cream conductance results indicated greater skin moisturization with HBP lotion than ultravate cream, suggesting that HBP lotion more rapidly penetrates the outer skin layers to ensure optimal hydration during treatment.
Commercial support: None identified.
Supported 100% by Ferndale Laboratories.
2589 Numbers needed to treat and costs per responder for novel treatments of moderate to severe psoriasis April Armstrong, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States; Keith Betts, Analysis Group, Inc, Boston, MA, United States; Junlong Li, Analysis Group, Inc, Boston, MA, United States; Murali Sundaram, AbbVie Inc, North Chicago, IL, United States; Eric Wu, Analysis Group, Inc, Boston, MA, United States; James Signorovitch, Analysis Group, Inc, Boston, MA, United States Objective: The clinical benefits of novel treatments for moderate to severe psoriasis (biologics and apremilast) have been well-established, including variations in patient response across different therapies. We estimated the number needed to treat (NNT) to achieve a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) with biologic agents and evaluated the incremental drug cost per PASI-75 responder for biologic treatments relative to apremilast. Methods: A systematic literature review was conducted to identify randomized controlled trials of novel treatments in patients with moderate to severe psoriasis. Relative probabilities of achieving PASI-75 response with each treatment during the clinical trial period (10 weeks for infliximab; 12 weeks for etanercept, ustekinumab, and secukinumab; and 16 weeks for adalimumab and apremilast) were estimated using a Bayesian network metaanalysis. The NNT was estimated as the reciprocal of the difference in estimated PASI-75 response rates between each biologic treatment and apremilast (apremilast was chosen as the reference based on its lower price and lower efficacy). Costs were assessed in 2015 US dollars including drug acquisition and administration. The incremental cost per PASI-75 response for each biologic was estimated for the clinical trial period and annually. Results: A total of 20 trials meeting all inclusion criteria were identified. Compared with apremilast, the NNT to achieve 1 additional PASI-75 response during the clinical trial period was 1.96 (95% credible interval: 1.69e2.31) for secukinumab 300 mg, 2.09 (1.77e2.52) for infliximab, 2.58 (2.07e3.28) for secukinumab 150 mg, 2.72 (2.18e3.59) for adalimumab, 2.75 (2.21e3.58) for ustekinumab, and 5.71 (3.70e9.86) for etanercept. The 1-year incremental cost per PASI-75 responder relative to apremilast was $20,419 ($17,375e$24,735) for infliximab; $48,405 ($39,331e$64,926) for adalimumab; $61,941 ($53,770e$73,308) for secukinumab 300 mg; $71,187 ($57,936e$93,983) for ustekinumab; $80,788 ($65,827e$104,187) for secukinumab 150 mg; and $136,223 ($93,500e$250,072) for etanercept 50 mg. A similar ranking of these biologic treatments was observed for cost per PASI-75 responder during the clinical trial period. Conclusions: Infliximab and adalimumab had the lowest incremental cost per PASI75 responder among the biologic treatments compared with apremilast. Design, study conduct, and financial support for the study were provided by AbbVie; AbbVie participated in the interpretation of data, review, and approval of the abstract; all authors contributed to the development of the publication.
MAY 2016
3564 One-year biologic cost per patient with psoriatic diseases in a managed care population Tao Gu, HealthCore, Wilmington, CA, United States; Gaurav Deshpande, HealthCore, Wilmington, DE, United States; Derek Tang, Amgen, Inc, Thousand Oaks, CA, United States; Neel Shah, Amgen, Inc, Thousand Oaks, CA, United States; David Harrison, Amgen, Inc, Thousand Oaks, CA, United States; Debra Eisenberg, HealthCore, Wilmington, DE, United States; Bradley Stolshek, Amgen, Inc, Thousand Oaks, CA, United States Background: The rising health care cost in specialty pharmacy has led providers to place economic factors into treatment decisions. Current evidence on biologic costs in psoriatic diseases is lacking. Objective: To determine the annual drug and administration cost of US-approved biologics per patient with psoriasis (PsO) and/or psoriatic arthritis (PsA) in a managed care population comprising beneficiaries predominantly enrolled in a large managed care health plan. Methods: This is a retrospective cohort study using administrative data for individuals in the HealthCore Integrated Research Database (HIRDSM). The cohort included patients initiating a tumor necrosis factor inhibitor [TNFi] (adalimumab [ADA], etanercept [ETN], golimumab [GOL], infliximab [INF]) or a non-TNFi (ustekinumab [UST]) between Jul 1, 2009 and Jan 31, 2013. Patient entry criteria were age $18, continuous enrollment during the 180 days prior to and 360 days postindex, and PsO and/or PsA diagnosis in the 6 months preindex. The index event and date was defined as the first biologic use following 6 months of enrollment. Unit biologic and administration costs as of Jan 1, 2015 were applied to the real-world dosing and administration data to calculate annual per patient cost. Costs were stratified by drug mechanism, disease indication, and new versus established users. Results: A total of 8981 patients with PsO and/or PsA met the eligibility criteria (ADA: n ¼ 3,161; ETN: n ¼ 4,721; GOL: 94; INF: n ¼ 547; UST: 458; mean age 45.1, 42.9% female). Among new users (n ¼ 4093), non-TNFi users (UST) had numerically greater cost per patient ($36,745) compared with TNFi users ([ADA]: $27,949; [ETN] $30,090; [GOL]: $24,474; [INF]: $26,646). Among established users (n ¼ 4888), the cost per patient for non-TNFi users ($28,771) was within the cost range of TNFi users ([ETN]: $28,125; [INF]: $31,813). ADA had numerically greater cost than other agents in both new ($27,397) and established users ($30,590) with only PsA. UST and INF had numerically greater cost than other agents in new ($36,574$38,395) and established users ($31,832-$33,793) with PsO 6 PsA, respectively. Conclusion: Although similar annual biologic cost per patient may be expected among established users of TNFi and non-TNFi, new non-TNFi users were found to incur at least 22% greater annual cost than new TNFi users. Average cost varied considerably across psoriatic indications and individual agents. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc.
J AM ACAD DERMATOL
AB261