Evaluation of real-world cost savings and utilization of biosimilar drugs in a community-based oncology practice.

73 Background: Biosimilar drugs, defined as biologic products with no clinically significant differences in quality, efficacy and safety compared to approved reference products have gained increasing adoption based on studies projecting significant cost savings[1]. Real world evaluation of biosimilar related cost savings and adoption is however still limited. We prospectively evaluate cost savings generated by transitioning to biosimilar monoclonal antibodies in a community based oncology practice. Methods: In July 2020, a process for transitioning patients to biosimilar equivalents of Rituximab, Trastuzumab and Bevacizumab was implemented in a community based oncology practice. Provider adoption was facilitated by monthly oncology pharmacy governance meetings that allowed provider participation and feedback followed by defaulting the preferred biosimilar product in oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI). The treatment templates allowed for care personalization by listing reference products that could be chosen if desired. Cost savings achieved by switching to biosimilars was calculated by subtracting the actual spending on the biosimilar product from projected acquisition cost of the branded reference product (Table). Biosimilar adoption, defined as amount of biosimilar drug used over total amount of the drug ordered was also calculated. Results: Between July 2020 and April 2021, transitioning to biosimilar products for Rituximab, Bevacizumab and Trastuzumab resulted in net savings of $268,194.64, $285,251.89 and $274,359.51 respectively. Actual spending on Rituximab biosimilar product was $726,476.10 against a projected spending of $994,670.74 on the branded reference product. Actual spending on Bevacizumab biosimilar product was $1,254,977.30 against a projected spending of $1,540,229.19 on the branded reference product. Actual spending on Trastuzumab biosimilar product was $1,218,641.60 against a projected spending of $1,493,001.11 on the branded product. Average biosimilar utilization between October 2020 and April 2020 has been 92%, 100% and 98% for Rituximab, Bevacizumab and Trastuzumab respectively. Conclusions: Significant cost-savings can result from widespread utilization of biosimilar drugs in community oncology practices. References: Mulcahy, A.W., J.P. Hlavka, and S.R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Rand Health Q, 2018. 7(4): p. 3.[Table: see text]

Challenge of polymers for biosimilar products packaging

Presently Packaging plays a significant role for Biosimilar product. The process of selecting materials and the type of packaging also offers an opportunity for the Packaging scientist to look for new biological delivery choices. Most injectable protein products were supplied in some sort of glass vial, prefilled syringe, and cartridge. Those product having high Ph content there is a chance of “delamination “from inner surface of glass vial. With protein-based drugs, the biggest issue is the effect of packaging derivatives on the protein’s three-dimensional and surface structure. These are any effects that relate to denaturation or aggregation of the protein due to oxidation or interactions from contaminants or impurities in the preparation. The potential for these effects needs to be carefully considered in choosing the container and the container closure system to avoid putting patients in jeopardy.

Current status of biosimilars in Turkey: A survey among medical oncologists

Introduction To evaluate biosimilar understanding and preference trends of medical oncologists in Turkey. Methods A survey consisting of 24 multiple-choice questions with checkbox answers was conducted among medical oncologists. The questionnaire was divided into five parts to some intentions: demographic characteristics, general knowledge about biosimilars, knowledge about local approval and reimbursement issues, individual preference trends, and ranking the knowledge of their own. All answers were analyzed as whole cohort, specialists and fellows. Results Fellows (n = 47) consisted 42%, and academic clinicians (n = 37) consisted 35% of the participants. In the whole cohort, the overall rate of correct answers was 55.1% in the general knowledge about the biosimilars part, and 26.7% in the local approval and reimbursement issues part. At all, 57.7% of the participants declared that they object to switch from a reference product to a biosimilar product. The rate of those who defined themselves as extremely knowledgeable decreased from 8.1% to 2.7% in the whole cohort at the end of the survey. Conclusion The need for more accurate and clarified local regulations and education emerging in the biotechnology era must be met.

Effect on Patients’ Outcomes of a Change to Biosimilar Filgrastim Product in Autologous Stem Cell Mobilization

Background: Following addition of a biosimilar filgrastim product to the formulary, sites in the authors’ provincial health authority transitioned from using the originator filgrastim to the biosimilar for autologous stem cell mobilization. Objective: To assess the effect on patient outcomes of a universal change to use of the biosimilar filgrastim in stem cell mobilization. Methods: This retrospective pre–post study included patients undergoing autologous stem cell mobilization at 2 cancer hospitals in Alberta, Canada, between July 1, 2018, and November 30, 2019. Clinical outcomes were investigated for patients treated with a granulocyte colony-stimulating factor (biosimilar or originator product) for mobilization before stem cell transplant, approximately 6 months before and after the defined date of product change. Results: In total, 102 patients were treated with the originator product and 101 patients with the biosimilar. Effectiveness was similar between the originator and biosimilar products, with 98% successful harvest of stem cells in all patients treated. Independent t tests showed no statistically significant differences between patients receiving the originator and those receiving the biosimilar in terms of time from mobilization to collection (difference of means –0.9 days, 95% confidence interval [CI] –2.12 to 0.32), time for neutrophil engraftment (difference of means 0 days, 95% CI –0.36 to 0.36), time for platelet engraftment (difference of means 1 day, 95% CI –0.55 to 2.55), average length of stay (difference of means –0.7 day, 95% CI –2.71 to 1.31), and CD34+ value (difference of means –1 × 106/kg body weight, 95% CI –2.11 to 0.11). A 98% rate of conversion to use of the biosimilar filgrastim was achieved, with an estimated annual drug-cost saving of $67 500. Conclusions: In this pre–post study, changing to the biosimilar product from the originator maintained clinical effectiveness outcomes while decreasing overall drug expenditures. A well-planned change to the biosimilar product, executed in conjunction with clinician consultation and monitoring of effectiveness outcomes, can ensure appropriate patient therapy while significantly improving the uptake of biosimilars and decreasing expenditures for biologic drugs. RÉSUMÉ Contexte : À la suite de l’ajout d’un produit filgrastim biosimilaire à la liste des médicaments, les sites relevant de l’autorité sanitaire provinciale des auteurs sont passés de l’utilisation du filgrastim princeps à la version générique pour la mobilisation des cellules souches autologues. Objectif : Évaluer l’effet sur les résultats des patients d’un changement généralisé visant à utiliser le filgrastim générique pour la mobilisation des cellules souches. Méthodes : Cette étude rétrospective pré-post comprenait des patients soumis à une mobilisation des cellules souches autologues dans deux hôpitaux de cancérologie en Alberta (Canada) entre le 1er juillet 2018 et le 30 novembre 2019. L’examen des résultats cliniques des patients traités à l’aide d’un facteur stimulant les colonies de granulocytes (G-CSF) (générique ou princeps) pour une mobilisation avant la greffe de cellules souches a eu lieu environ six mois avant et après la date du changement de produit. Résultats : Au total, 102 patients ont été traités à l’aide du produit princeps et 101 patients à l’aide du générique. Les deux produits présentaient une efficacité similaire, et 98 % de réussite dans la récolte de cellules souches chez tous les patients traités. Des tests t indépendants n’ont montré aucune différence statistique significative entre les patients recevant le princeps et ceux recevant le biosimilaire en termes de temps allant de la mobilisation à la collecte (différence des moyennes –0,9 jour, intervalle de confiance [IC] 95 % –2,12 à 0,32); temps de la prise de la greffe neutrophile (différence des moyennes 0 jour, IC 95 % –0,36 à 0,36); temps de la prise de la greffe des plaquettes (différence des moyennes 1 jour, IC 95 % –0,55 à 2,55); durée moyenne du séjour (différence des moyennes –0,7 jour, IC 95 % –2,71 à 1,31) et valeur CD34+ (différence des moyennes –1 × 106/kg masse corporelle, IC 95 % –2,11 à 0,11). Un taux de conversion de 98 % visant à utiliser le filgrastim générique a été atteint, avec une estimation des économies annuelles sur le coût des médicaments de 67 500 $. Conclusions : Dans cette étude pré-post, le passage du produit princeps au générique a préservé l’efficacité des résultats cliniques, tout en diminuant les dépenses générales liées au médicament. Un changement bien programmé pour passer au produit générique, mené conjointement avec la consultation d’un clinicien et un contrôle des résultats d’efficacité, peut assurer une thérapie du patient appropriée tout en améliorant grandement la prise de produits génériques et en diminuant les dépenses associées aux médicaments biologiques.

Biosimilar usage in practices within the ASCO PracticeNET learning network.

77 Background: In recent years, several antineoplastic biosimilar products have been approved and marketed for use. We analyzed data from the ASCO PracticeNET learning network to gain insights on the adoption of biosimilar products for bevacizumab, rituximab, and trastuzumab. Methods: Our analysis included the following products: bevacizumab, bevacizumab-awwb, bevacizumab-bvzr, rituximab (excluding rituximab and hyaluronidase), rituximab-abbs, trastuzumab, trastuzumab-anns, and trastuzumab-dkst, administered from July 2019 to March 2020. 19 practices submitted their billing data; practices ranged in size from 2 to 29 hematologists/oncologists. Products were identified through use of healthcare common procedure coding system codes. The proportion of biosimilar product doses administered, as a percent of total doses for all related products, was calculated per participating practice. Results: Use of biosimilar products for bevacizumab (first biosimilar approval in September 2017) was first detected in August 2019, averaging 1.4% of administered doses (confidence intervals included in Table) with a range from 0% to 27% among participating practices; by March 2020, average use increased to 31% with a range from 0% to 100%. Use of biosimilar products for rituximab (first biosimilar approval in November 2018), was first detected in January 2020, averaging 2.6% of administered doses, with range of 0% to 30%; by March 2020, average use increased to 18%, with a range of 0% to 61%. Use of biosimilar products for trastuzumab (first biosimilar approval in December 2017) was first detected in September 2019, averaging 0.9% of administered doses with a range of 0% to 17%; by March 2020, average use increased to 35%, with a range of 0% to 98%. Conclusions: The release of biosimilar products has been identified as a potential opportunity to lower the cost of drug therapy for cancer patients. Our analysis identified an approximate 2-year lag from product approval to initial utilization followed by a steady increase in the use of biosimilar products, along with a wide range of use among practices. [Table: see text]

Efficacy of a conversion from filgrastim to filgrastim-sndz in stem cell transplant patients undergoing mobilization

During autologous stem cell transplant, granulocyte colony-stimulating factors (G-CSF) serve the integral role of mobilizing hematopoietic cells into the peripheral blood for subsequent collection by leukapheresis. Filgrastim (Neupogen®) is a G-CSF and affects hematopoietic cells by stimulating growth and differentiation of neutrophils. Filgrastim-sndz (Zarxio®), a biosimilar of filgrastim, received landmark approval as the first biosimilar product approved by the FDA in the United States. As a result of the recent FDA approval, our medical center made the conversion in August 2016 from using filgrastim to filgrastim-sndz to provide patients the same benefits of the filgrastim injection at a reduced cost. This retrospective, observational cohort study evaluated the comparative efficacy of the filgrastim-sndz biosimilar in 147 patients who underwent mobilization prior to stem cell transplant with filgrastim between 1 August 2015 and 31 July 2016 or filgrastim-sndz between 1 September 2016 and 30 November 2017. The mean number of CD34 cells collected during apheresis was 7.38 × 106 in the filgrastim group and 8.86 × 106 in the filgrastim-sndz group. Filgrastim-sndz was significantly non-inferior, as the difference between filgrastim and filgrastim-sndz was −1.48 × 106 with an upper 95% confidence bound equal to −0.24 × 106 that did not include the non-inferiority margin of 1 × 106 ( p = 0.0006). The median number of days of apheresis was 2 in both groups ( p= 0.3273). In conclusion, the biosimilar product was non-inferior for mobilization and the conversion from filgrastim to filgrastim-sndz afforded patients similar efficacy for mobilization in stem cell transplant at a reduced cost.