Subject(s)
Humans , Male , Female , Pharmacy , Legislation, Pharmacy , Biosimilar Pharmaceuticals/supply & distribution , Legislation, Drug , SpainABSTRACT
Rising costs have made access to affordable insulin far more difficult for people with diabetes, especially low-income individuals, those on high deductible health plans, beneficiaries using Medicare Part B to cover insulin delivered via pump, Medicare beneficiaries in the Part D donut hole, and those who turn 26 and must transition from their parents' insurance, to manage their diabetes and avoid unnecessary complications and hospitalizations. For many patients with diabetes, insulin is a life-saving medication. Policymakers should immediately address drivers of rising insulin prices and implement solutions that would reduce high out-of-pocket expenditures for patients. The Endocrine Society recommends policy options to expand access to lower cost insulin in this paper.
Subject(s)
Health Services Accessibility , Health Services Needs and Demand/economics , Insulin/economics , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Biosimilar Pharmaceuticals/therapeutic use , Cost Sharing/standards , Cost Sharing/trends , Costs and Cost Analysis , Diabetes Mellitus/drug therapy , Diabetes Mellitus/economics , Diabetes Mellitus/epidemiology , Drug Costs/trends , Endocrinology/organization & administration , Endocrinology/standards , Health Expenditures , Health Services Accessibility/organization & administration , Health Services Accessibility/standards , Health Services Accessibility/trends , Health Services Needs and Demand/trends , History, 21st Century , Humans , Insulin/supply & distribution , Insulin/therapeutic use , Medicare Part D/economics , Societies, Medical/organization & administration , Societies, Medical/standards , United States/epidemiologyABSTRACT
Healthcare systems worldwide are struggling to find ways to fund the cost of innovative treatments such as gene therapies, regenerative medicine, and monoclonal antibodies (mAbs). As the world's best known mAbs are close to facing patent expirations, the biosimilars market is poised to grow with the hope of bringing prices down for cancer treatment and autoimmune disorders, however, this has yet to be realized. The development costs of biosimilars are significantly higher than their generic equivalents due to therapeutic equivalence trials and higher manufacturing costs. It is imperative that academics and relevant companies understand the costs and stages associated with biologics processing. This article brings these costs to the forefront with a focus on biosimilars being developed for Rheumatoid Arthritis (RA). mAbs have remarkably changed the treatment landscape, establishing their superior efficacy over traditional small chemicals. Five blockbuster TNFα mAbs, considered as first line biologics against RA, are either at the end of their patent life or have already expired and manufacturers are seeking to capture a significant portion of that market. Although in principle, market-share should be available, withstanding that the challenges regarding the compliance and regulations are being resolved, particularly with regards to variation in the glycosylation patterns and challenges associated with manufacturing. Glycan variants can significantly affect the quality attributes requiring characterization throughout production. Successful penetration of biologics can drive down prices and this will be a welcome change for patients and the healthcare providers. Herein we review the biologic TNFα inhibitors, which are on the market, in development, and the challenges being faced by biosimilar manufacturers.
Subject(s)
Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Drug Industry , Antibodies, Monoclonal/therapeutic use , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Biosimilar Pharmaceuticals/therapeutic use , Drug Approval , Drug Industry/economics , Drug Industry/legislation & jurisprudence , Drug Industry/trends , Humans , Patents as TopicABSTRACT
Biosimilars are the biological drugs that are granted after the expiry of the patent of an affirmed innovator. Asia Pacific countries are characterized by significant demand as they account for majority of the world population and poor affordability due to low per capita income in most regions. Some of these countries offer potential to emerge as global suppliers of affordable, safe and efficacious biosimilars. This article highlights the prospects of biosimilars in the Asia Pacific market. Regulatory framework in the various countries is also discussed.
Subject(s)
Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Drug Approval/economics , Drug Approval/legislation & jurisprudence , Drug Industry/economics , Drug Industry/legislation & jurisprudence , Asia, Southeastern , Asia, Western , Asia, Eastern , Humans , Marketing/economics , Marketing/legislation & jurisprudenceABSTRACT
OBJECTIVES: To estimate the effect of filgrastim-sndz market entry on patient out-of-pocket costs and claim payments for filgrastim products. METHODS: This study used a single interrupted time series design with longitudinal, nationally representative, individual-level claims data from IBM MarketScan. Analyses included all outpatient and prescription claims for branded filgrastim (filgrastim and tbo-filgrastim) and biosimilar filgrastim (filgrastim-sndz) from January 1, 2014, to December 31, 2017. Outcomes of interest included changes in monthly claim payments and monthly patient out-of-pocket costs for filgrastim products. RESULTS: In the baseline period (January 2014 to February 2016), insurers paid an average of $472.21 (95% confidence interval [CI]: 465.38-479.03) for 480 mcg of branded filgrastim, whereas patients paid an average of $49.26 (CI: 34.25-64.27). Filgrastim-sndz market entry was associated with a statistically significant and immediate 1-month decrease in insurer payment of $30.77 (95% CI: -40.59 to -20.94) and a significant decrease in monthly insurer payment trend of $3.10 per month (95% CI: -3.90 to -2.31) relative to baseline. Long-term changes in patient out-of-pocket costs were modest and restricted to beneficiaries enrolled in high cost sharing plans. CONCLUSIONS: Biosimilar filgrastim availability led to significant immediate and long-term decreases in claims payments for filgrastim products, supporting efforts to facilitate biosimilar adoption in the United States. Nevertheless, there were only slight changes in patient out-of-pocket costs, restricted to beneficiaries enrolled in high cost sharing plans, suggesting the importance of further work assessing the relationship between biosimilar availability and patient out-of-pocket costs.
Subject(s)
Biosimilar Pharmaceuticals/economics , Filgrastim/economics , Health Expenditures/statistics & numerical data , Biosimilar Pharmaceuticals/supply & distribution , Biosimilar Pharmaceuticals/therapeutic use , Cost Savings/statistics & numerical data , Drug Costs/statistics & numerical data , Female , Filgrastim/therapeutic use , Humans , Insurance Claim Review , Insurance, Health/economics , Insurance, Health/statistics & numerical data , Interrupted Time Series Analysis , Longitudinal Studies , Male , Middle Aged , United StatesSubject(s)
Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/therapeutic use , Gastroenterology/organization & administration , Inflammatory Bowel Diseases/therapy , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Canada/epidemiology , Cost-Benefit Analysis , Drug Substitution/economics , Gastrointestinal Agents/therapeutic use , Humans , Inflammatory Bowel Diseases/epidemiology , Infliximab/therapeutic use , Therapeutic EquivalencyABSTRACT
Tumor necrosis factor (TNF) inhibitors account for a large proportion of drugs used to treat psoriasis and are indicated first-line options in certain settings. Several biosimilar drugs based on the anti-TNF agents adalimumab, infliximab, and etanercept are now available for use in patients with psoriasis. The favorable cost differential of biosimilars is expected to improve access to biologic therapy for biologic-naive psoriasis patients, who are often undertreated. Also, substantial cost savings can be made if patients are switched to biosimilars. To date, most clinical testing of anti-TNF biosimilars approved for use in psoriasis has been performed in patients with rheumatoid arthritis, and the results extrapolated to psoriasis. Although this may initially raise concerns for clinicians looking to start their psoriasis patients on biologic treatment with a biosimilar or switch from an original biologic to a biosimilar, the process of extrapolation is tightly regulated and scientifically justified. Furthermore, available real-world evidence of the safety and efficacy of anti-TNF agents in patients with psoriasis complements clinical trial data in patients with rheumatoid arthritis. When equipped with the appropriate knowledge, clinicians should have confidence to use biosimilars for the treatment of psoriasis.
Subject(s)
Biosimilar Pharmaceuticals/therapeutic use , Psoriasis/drug therapy , Tumor Necrosis Factor Inhibitors/therapeutic use , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Cost Savings , Drug Costs , Health Services Accessibility/economics , Humans , Kaplan-Meier Estimate , Tumor Necrosis Factor Inhibitors/economics , Tumor Necrosis Factor Inhibitors/supply & distributionSubject(s)
Antibodies, Monoclonal/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Psoriatic/drug therapy , Biosimilar Pharmaceuticals/supply & distribution , Infliximab/therapeutic use , Psoriasis/drug therapy , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Treatment OutcomeSubject(s)
Biosimilar Pharmaceuticals/therapeutic use , Health Care Reform , Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Drug Approval , Drug Costs , Health Care Reform/economics , Health Care Reform/legislation & jurisprudence , Health Services Accessibility , Humans , United StatesABSTRACT
Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access. However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to patients, overall utilization has been limited. This article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.
Subject(s)
Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Drug Industry/legislation & jurisprudence , Jurisprudence , Patents as Topic/legislation & jurisprudence , Prescription Drugs/economics , United States , United States Food and Drug AdministrationSubject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Arthritis, Psoriatic/drug therapy , Antirheumatic Agents/therapeutic use , Biosimilar Pharmaceuticals/supply & distribution , Infliximab/therapeutic use , Antibodies, Monoclonal/therapeutic use , Psoriasis/drug therapy , Follow-Up Studies , Treatment OutcomeABSTRACT
No disponible
Subject(s)
Humans , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Access to Essential Medicines and Health Technologies , Health Knowledge, Attitudes, Practice , EuropeSubject(s)
Biosimilar Pharmaceuticals , Attitude , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Biosimilar Pharmaceuticals/therapeutic use , Cost Control , Drug Approval , Drug Costs/trends , Drug Utilization , European Union , Health Care Costs/trends , Humans , Marketing of Health Services , Patient Acceptance of Health Care , Retrospective StudiesABSTRACT
The joint 24th Medicines for Europe and 21st International Generic and Biosimilars Association (IGBA) Annual Conference brought together key industry leaders and more than 200 participants in Budapest, Hungary, to discuss both challenges and opportunities for the global generic, biosimilar and value added medicines industries. Challenges relating to sustainability were debated with key experts, who shared perspectives on topics such as medicines shortages, use of data, Brexit, international regulatory cooperation, the E.U. Falsified Medicines Directive (FMD) and the potential impact of antimicrobial resistance. European industry leaders outlined the period of intense preparations needed to ensure compliance by the early 2019 milestones for the FMD and Brexit. The conference also anticipated exciting opportunities for the industry and broadly welcomed the European Commission's legislative proposal for a (long-awaited and much discussed) E.U. Supplementary Protection Certificate manufacturing waiver. Medicines for Europe and IGBA are committed to supporting and strengthening such policy initiatives aimed at boosting European competitiveness, increasing investments in R+D for biosimilar medicines, and most importantly, delivering faster access to medicines for patients. The importance of not forgetting that the ultimate aim of the industry was to facilitate patient access to necessary medicines was stressed throughout the conference. As the conference took place in Hungary, László György (State Secretary for Economic Strategy and Regulation at the Ministry of Innovation and Technology) spoke about the role of technology innovation and access to medicines in the country and the role of his ministry. He indicated that the primary goal of the newly established ministry was to maintain and improve decent living conditions in the light of aging populations and enhance the competitiveness of the pharmaceutical industry, "which plays a decisive role in the Hungarian economy."
Subject(s)
Biosimilar Pharmaceuticals/therapeutic use , Commerce , Drug Industry , Drugs, Generic/therapeutic use , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/supply & distribution , Commerce/economics , Commerce/legislation & jurisprudence , Commerce/trends , Drug Costs , Drug Industry/economics , Drug Industry/legislation & jurisprudence , Drug Industry/trends , Drug and Narcotic Control , Drugs, Generic/economics , Drugs, Generic/supply & distribution , HumansABSTRACT
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2+ metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2+ MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease. In 2006, both agencies approved trastuzumab as adjuvant therapy for patients with HER2+ early breast cancer (EBC). Observational studies on real-world treatment patterns for HER2+ EBC between 2005 and 2015 suggest that 19.1% to 59.5% of patients across regions of North America, Europe, Australia, New Zealand, and China did not receive (neo)adjuvant trastuzumab. Data suggest that some patient subgroups, including older patients, those with HER2+/hormone receptor-positive disease, and women with small and/or node-negative HER2+ tumors, were less likely to receive anti-HER2 therapy. Barriers to accessing trastuzumab are multifactorial and include issues related to drug funding and high treatment costs for patients that have been reported worldwide. Herein, we review available literature on the use of, and barriers to, treatment with trastuzumab in patients with HER2+ breast cancer. We also discuss how the availability of safe and effective biosimilars might increase access to trastuzumab and allow greater use of anti-HER2 therapy, potentially improving patient outcomes.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biosimilar Pharmaceuticals/supply & distribution , Breast Neoplasms/therapy , Health Services Needs and Demand , Trastuzumab/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/economics , Antineoplastic Combined Chemotherapy Protocols/pharmacology , Antineoplastic Combined Chemotherapy Protocols/supply & distribution , Australia , Biosimilar Pharmaceuticals/economics , Biosimilar Pharmaceuticals/pharmacology , Biosimilar Pharmaceuticals/therapeutic use , Breast Neoplasms/economics , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Chemotherapy, Adjuvant/economics , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/statistics & numerical data , China , Disease-Free Survival , Drug Costs/statistics & numerical data , Europe , Fees, Pharmaceutical/statistics & numerical data , Female , Global Health/statistics & numerical data , Humans , Mastectomy , Neoadjuvant Therapy/economics , Neoadjuvant Therapy/methods , Neoadjuvant Therapy/statistics & numerical data , New Zealand , Patient Selection , Receptor, ErbB-2/antagonists & inhibitors , Receptor, ErbB-2/metabolism , Trastuzumab/economics , Trastuzumab/pharmacology , United StatesABSTRACT
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
Subject(s)
Adalimumab/economics , Antirheumatic Agents/economics , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/economics , Dissent and Disputes/economics , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adalimumab/therapeutic use , Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Antirheumatic Agents/supply & distribution , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/economics , Arthritis, Rheumatoid/genetics , Arthritis, Rheumatoid/immunology , Biosimilar Pharmaceuticals/supply & distribution , Biosimilar Pharmaceuticals/therapeutic use , Certolizumab Pegol/economics , Certolizumab Pegol/therapeutic use , Dissent and Disputes/legislation & jurisprudence , Drug Administration Schedule , Drug Dosage Calculations , Etanercept/economics , Etanercept/therapeutic use , Gene Expression Regulation , Humans , Infliximab/economics , Infliximab/therapeutic use , Patents as Topic , Tumor Necrosis Factor-alpha/genetics , Tumor Necrosis Factor-alpha/immunologyABSTRACT
A artrite reumatoide (AR) é uma doença inflamatória crônica, autoimune, que afeta as articulações, podendo produzir sintomas sistêmicos. O infliximabe é um medicamento biológico incorporado no Sistema Único de Saúde (SUS) para o tratamento da AR, que teve um biossimilar aprovado em 2015. Além do biossimilar, existe um produto derivado de uma Parceria de Desenvolvimento Produtivo (PDP). Este estudo estimou o impacto orçamentário da incorporação do infliximabe biossimilar no tratamento da AR no SUS. O impacto orçamentário da incorporação do produto da PDP foi contemplado como um dos objetivos secundários. As estimativas foram calculadas pelo método de demanda aferida para um horizonte temporal de cinco anos. Foram estimadas duas estratégias de uso: (A) apenas casos novos de AR recebendo o infliximabe inovador utilizarão o biossimilar (ou o produto da PDP) e (B) tanto os casos novos como 50% daqueles já em uso do infliximabe inovador utilizarão o biossimilar (idem). As projeções da população com AR foram realizadas a partir dos dados presentes no Datasus e da "quota de mercado"1 do infliximabe. Adicionalmente, foram realizadas análises de sensibilidade univariadas, considerando uma difusão progressiva dos dois produtos e de pior e melhor cenário. A incorporação do infliximabe biossimilar e do produto de PDP para casos novos (estratégia A) implicariam em economias de -R$ 284.430.468,79 e -R$ 366.194.377,69, respectivamente, em cinco anos. Esses valores representariam reduções de 19% e 24%, respectivamente, nos gastos em saúde de infliximabe para o tratamento de AR. Na estratégia B, onde também são considerados parte dos pacientes em terapia de manutenção as economias geradas seriam de -R$ 419.006.071,14 para o biossimilar e -R$ 539.455.804,86 para o produto da PDP. Na análise de sensibilidade por difusão progressiva, as economias reduzem se a -R$ 178.544.332,95 (estratégia A) e -R$ 263.639.280,49 (estratégia B) para o biossimilar e -R$ 229.869.645,03 (estratégia A) e -R$ 339.426.443 (estratégia B). Na análise de melhor cenário, os resultados apontaram para economias de -R$ 1.011.789.713,83 e -R$ 1.222.955.301,30 para o biossimilar e produto da PDP, respectivamente. Já no pior cenário, as estimativas mostram que a introdução das tecnologias analisadas produziria um ônus ao sistema de saúde de R$ 8.552.019,91 (para o biossimilar) e R$ 5.366.519,91 para o produto da PDP. A incorporação do produto biossimilar no tratamento da AR proporcionaria redução dos gastos, tornando possível uma alocação de recursos mais eficiente para o tratamento dessa doença.
Rheumatoid arthritis (AR) is a chronic, autoimmune, inflammatory disease that affects the joints, but also may produce systemic symptoms. Infliximab is a biologic drug incorporated into the Brazilian Public Health System (SUS) for the treatment of AR, which had a biosimilar approved in 2015. In Brazil, in addition to biosimilar, there is a product derived from a public-private partnership (PDP). This study aimed to estimate the budgetary impact of the incorporation of biosimilar infliximab in the treatment of AR in SUS. The budgetary impact of the incorporation of the PDP product was considered as one of the secondary objectives. Estimates were calculated using a measured demand approach over a five-year time horizon. Two strategies of utilization was estimated for the biosimilar product or PDP: (A) only new cases that would receive the innovative infliximab will use the biosimilar (or the PDP product) and (B) both new cases and 50% of those already in use of the innovative infliximab will use biosimilar (idem). The projections of the AR population were based on data from Datasus and the "market share" of infliximab. In addition, univariate sensitivity analyzes were performed, considering the progressive diffusion and analyses of "best-case scenario" and "worst-case scenario". The incorporation of biosimilar infliximab and PDP product for new cases (strategy A) would save -R$ 284,430,468.79 and -R$ 366,194,377.69, respectively, in five years. These values would represent reductions of 19% and 24%, respectively, in the health expenditures of infliximab for the treatment of AR. In strategy B, where part of the maintenance therapy patients were also considered, the savings would be -R$ 419,006,071.14 for biosimilar and -R$ 539,455,804.86 for the PDP product. For both drugs, the practiced price was the parameter with the greatest impact on the cost savings estimates, both in strategy A and B. In the sensitivity analysis by progressive diffusion the savings would decrease to -R$ 178,544,332.95 (strategy A) and -R $ 263,639,280.49 (strategy B) for biosimilar and -R $ 229,869,645.03 (strategy A) and -R$ 339,426,443 (Strategy B). In the analysis of best-case scenario, the results showed savings of -R$ 1,011,789,713.83 and -R$ 1,222,955,301.30 for biosimilar and PDP products, respectively. On the other hand, in the worst-case scenario the introduction of the analyzed technologies would result in a health system burden of R$ 8,552,019.91 for the biosimilar and R$ 5,366,519.91 for the PDP product. The incorporation of the biosimilar product in the treatment of AR would reduce the health care expenditures for this treatment, allowing the budget manger to allocate resources more efficiently for the treatment of AR.