- Email: [email protected]
Biosimilar substitution: European prescriber perspectives
abstracts to ensure that the size of effect is systematically approached in appraisals, and to complement a multiple criteria based system. Legal entity responsible for the study: CatSalut. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1630O
Reimbursement reality for off-label use in cancer care: A systematic empirical investigation
Background: In situations of limited treatment options, off-label use (OLU) may be the most promising therapy for cancer patients. However, OLU is regulated by reimbursement restrictions. Little is known about the prevalence of OLU and factors that drive reimbursement decisions. We investigate the reimbursement reality of OLU in patients with solid or hematological malignancies in the Swiss healthcare system, which is characterized by a high diversity of jurisdictions and statutory health insurers. Methods: We conduct an ongoing cross-sectional study using routinely collected health data. All patients with cancer who received drug treatment at three major hospitals in Switzerland between 01/2015 and 07/2018 are screened for OLU. For patients with at least one reimbursement request, we extract demographics, disease and treatment characteristics, and correspondence with the health insurer. We define OLU as intentional drug use outside of the Swissmedic (Swiss Agency for Therapeutic Products) approval label at the time of request. We use descriptive statistics to describe the frequency and characteristics of OLU requests and multivariable logistic regression to assess the association of pre-specified patient characteristics and the reimbursement decisions. Results: So far, we screened medical records of 1561 eligible patients. For 276/1561 patients (18%), at least one reimbursement request for OLU was issued (319 requests in total, 1 - 3 per patient). The most frequent indications were adjuvant zoledronic acid in breast cancer (27; 8%), adjuvant nivolumab in melanoma (11; 3%) and atezolizumab in advanced urothelial cancer (10; 3%). Health insurers rejected the request in 93/319 cases (29%). Preliminary analyses showed no association of patient characteristics and reimbursement decisions (e.g. odds for disapproval for solid vs hematological malignancies, OR 1.43, 95% CI 0.70 to 2.91, p ¼ 0.32). Conclusions: Preliminary results indicate that access to cancer care with OLU in Switzerland is characterized by substantial inequity and lack of transparency of the underlying decision-making process. Further results and details on the relationship of reimbursement decisions and the underlying clinical evidence for OLU will be presented at the meeting. Legal entity responsible for the study: The authors. Funding: Swiss Cancer League. Disclosure: All authors have declared no conflicts of interest.
1632PD
were funded and 100% of drugs with a negative recommendation were not funded. Tumour type was predictive of TTF (p < 0.001): CRC drugs slowest at a median of 2541 days (IQR 702-4379), and NET drugs quickest at a median of 0 days (IQR 0-502). Cancer type predicted decision to fund in at least 1 province (p ¼ 0.005), with funding for 100% of NET drugs at the high end and 29% of CRC drugs at the low end. Drug class was predictive of TTF (p ¼ 0.01): 465 days (IQR 245-702) for targeted agents, 443 days (IQR 298-587) for chemotherapy, and 339 days (IQR 164-446) for immunotherapy. Conclusions: Determinants of drug funding include cancer type, drug class, and pCODR recommendation, but not list price. Factors other than cost are more heavily weighted in the funding decisions of cancer drugs in Canadian provinces. Legal entity responsible for the study: Paul Wheatley-Price and Joanna Gotfrit. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1633PD
Biosimilar substitution: European prescriber perspectives
M.S. Reilly Health Policy, Alliance for Safe Biologic Medicines, Alexandria, VA, USA Background: As countries seek to control health costs and expand access to biologic therapies, biosimilars are a valuable tool. With the automatic subsitution of biosimilars banned in much of Europe, building physician confidence in biosimilars is critical to promoting their uptake and reaping their cost savings benefits. This study is a refresh of a study done in 2013, and documents the perspectives of European prescribers regarding biosimilar substitution and related issues, to serve as a guide to policymakers. Methods: 579 prescribers were recruited from France, Germany, Italy, Spain, Switzerland, UK. Drawn from Dermatology, Endocrinology, Gastrointestinal, Hematology oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, Rheumatology. 15 minute web-based survey, offered in multiple languages. The data was collected in March 2019. Results: Respondents consider it very important or critical that there are multiple suppliers for government tenders. They also consider it important/critical that tenders include factors besides price. Sole prescription authority is considered very important/ critical, as is authority to prevent a substitution. Physicians are more comfortable switching bio-naı¨ve patient to biosimilar, but less comfortable switching a stable patient. Physicians are more comfortable switching a patient for non-medical reasons, but less so when switching is done by a third-party. Conclusions: In countries with a government tender, physicians consider it important to have several therapeutic options available, and consider factors beyond price to be important. As physicians’ familiarity has increased since the 2013 survey, so has the percentage of physicians characterizing sole prescription authority as "very important or critical". The percentage of prescribers characterizing the ability to prevent/deny a substitution very important or critical has also risen. While comfortable making biosimilar substitutions- including for cost reasons- with new/bio-naive patients, physicians remain cautious about doing so with stable patients. Physicians remain uncomfortable with third-party switching of patients for non-medical (e.g. cost) reasons. Legal entity responsible for the study: Alliance for Safe Biologic Medicines. Funding: Alliance for Safe Biologics which receives some funding from manufacturers of originators and biosimilars. Disclosure: The author has declared no conflicts of interest.
Determinants of the cancer drug funding process in Canada
1
J. Gotfrit , J.J.W. Shin2, R. Mallick3, P. Wheatley-Price1 Medical Oncology, The Ottawa Hospital Regional Cancer Centre, Ottawa, ON, Canada, 2Undergraduate Medical Education, University of Ottawa, Ottawa, ON Canada, 3Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada
1
Background: Canada has a publicly-funded healthcare system with a complex drug funding process. After Health Canada approval to market a drug, the pan-Canadian Oncology Drug Review (pCODR) makes a non-binding funding recommendation to the Canadian provinces (except Quebec), which each then decide whether the drug will be publicly funded. We identified the determinants of funding in this process. Methods: We analyzed drugs for advanced lung (n ¼ 15), breast (n ¼ 8), colorectal (CRC) (n ¼ 7), melanoma (n ¼ 10), and neuroendocrine (NET) (n ¼ 3) cancer undergoing the funding decision process from 2011-2019. Determinants of funding assessed in the model included list price, cancer type, drug class, and pCODR recommendation. The primary outcome was the correlation between list price and time-to-funding (TTF: Health Canada approval to first provincial funding). Secondary outcomes included an exploratory analysis of predictors of drug funding. Results: We analyzed 43 drugs: targeted agents 72%, immunotherapy 20%, chemotherapy 7%. 72% were funded in at least 1 province. Median TTF was 379 days (IQR 203601). Median list price (28-day course) was $8213 (IQR 5391-9445). Higher list price was not correlated with TTF (correlation coefficient -0.20, p ¼ 0.28). There was no association between list price and pCODR recommendation, or the decision to fund in at least 1 province. A positive pCODR recommendation correlated with the provinces’ funding decisions (p < 0.001), where 89% of drugs with a positive recommendation
v672 | Public Policy
1634PD
Cost avoided in drugs derived from participation in clinical trials in colorectal cancer
L. Sanchez- Rubio Ferrandez, N. Rodrıguez Salas, E. Villama~ nan Bueno, G. Casado Abad, A. Sierra Mu~ noz, S. Feli u Torres, A. Herrero Ambrosio Farmacia, Hospital Universitario La Paz, Madrid, Spain Background: Colon cancer presents at high incidence and its treatment generates an important economic impact in hospitals. In Spain, it is mandatiory for the sponsors of clinical trials to supply the investigational drugs without charge to the national health system. Avoided cost is defined as the cost that would have had to be paid if the patient did not participate in a clinical trial with the free contribution of the drugs. The objective of the main study was to calculate the cost avoided in drugs derived from the participation of patients in clinical trials of colon cancer in a university hospital. Methods: This was a retrospective observational study. A data cut was made in April 2018 and the active clinical trials in colon cancer were selected. All patients who had participated in them were included, regardless of the date of inclusion. Sources of data R electronic Citostatic precollection: Pharmacy Service database, Farmis OncofarmV scription program, and Clinical Records. The cost of the cycles received in the investigation was estimated for each patient and the cost of the standard treatment during the same period was calculated. For this, the following variables were collected: name of the trial, drug in research, number of cycles, duration, cost of treatment in the experimental arm and in the comparator or standard therapy. The costs of the medication associated with chemotherapy were not taken into account.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz263.005/5576699 by guest on 27 October 2019
A.K. Herbrand1, A.M. Schmitt1, A. Hoogkamer1, M. Joerger2, S. Diem2, U. Novak3, L.G. Hemkens4, B. Kasenda1 1 Department of Medical Oncology, University Hospital Basel, Basel, Switzerland, 2 Department of Medical Oncology & Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland, 3Department of Medical Oncology, University Hospital Bern, Bern, Switzerland, 4Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland
Annals of Oncology
1630O
Reimbursement reality for off-label use in cancer care: A systematic empirical investigation
Background: In situations of limited treatment options, off-label use (OLU) may be the most promising therapy for cancer patients. However, OLU is regulated by reimbursement restrictions. Little is known about the prevalence of OLU and factors that drive reimbursement decisions. We investigate the reimbursement reality of OLU in patients with solid or hematological malignancies in the Swiss healthcare system, which is characterized by a high diversity of jurisdictions and statutory health insurers. Methods: We conduct an ongoing cross-sectional study using routinely collected health data. All patients with cancer who received drug treatment at three major hospitals in Switzerland between 01/2015 and 07/2018 are screened for OLU. For patients with at least one reimbursement request, we extract demographics, disease and treatment characteristics, and correspondence with the health insurer. We define OLU as intentional drug use outside of the Swissmedic (Swiss Agency for Therapeutic Products) approval label at the time of request. We use descriptive statistics to describe the frequency and characteristics of OLU requests and multivariable logistic regression to assess the association of pre-specified patient characteristics and the reimbursement decisions. Results: So far, we screened medical records of 1561 eligible patients. For 276/1561 patients (18%), at least one reimbursement request for OLU was issued (319 requests in total, 1 - 3 per patient). The most frequent indications were adjuvant zoledronic acid in breast cancer (27; 8%), adjuvant nivolumab in melanoma (11; 3%) and atezolizumab in advanced urothelial cancer (10; 3%). Health insurers rejected the request in 93/319 cases (29%). Preliminary analyses showed no association of patient characteristics and reimbursement decisions (e.g. odds for disapproval for solid vs hematological malignancies, OR 1.43, 95% CI 0.70 to 2.91, p ¼ 0.32). Conclusions: Preliminary results indicate that access to cancer care with OLU in Switzerland is characterized by substantial inequity and lack of transparency of the underlying decision-making process. Further results and details on the relationship of reimbursement decisions and the underlying clinical evidence for OLU will be presented at the meeting. Legal entity responsible for the study: The authors. Funding: Swiss Cancer League. Disclosure: All authors have declared no conflicts of interest.
1632PD
were funded and 100% of drugs with a negative recommendation were not funded. Tumour type was predictive of TTF (p < 0.001): CRC drugs slowest at a median of 2541 days (IQR 702-4379), and NET drugs quickest at a median of 0 days (IQR 0-502). Cancer type predicted decision to fund in at least 1 province (p ¼ 0.005), with funding for 100% of NET drugs at the high end and 29% of CRC drugs at the low end. Drug class was predictive of TTF (p ¼ 0.01): 465 days (IQR 245-702) for targeted agents, 443 days (IQR 298-587) for chemotherapy, and 339 days (IQR 164-446) for immunotherapy. Conclusions: Determinants of drug funding include cancer type, drug class, and pCODR recommendation, but not list price. Factors other than cost are more heavily weighted in the funding decisions of cancer drugs in Canadian provinces. Legal entity responsible for the study: Paul Wheatley-Price and Joanna Gotfrit. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1633PD
Biosimilar substitution: European prescriber perspectives
M.S. Reilly Health Policy, Alliance for Safe Biologic Medicines, Alexandria, VA, USA Background: As countries seek to control health costs and expand access to biologic therapies, biosimilars are a valuable tool. With the automatic subsitution of biosimilars banned in much of Europe, building physician confidence in biosimilars is critical to promoting their uptake and reaping their cost savings benefits. This study is a refresh of a study done in 2013, and documents the perspectives of European prescribers regarding biosimilar substitution and related issues, to serve as a guide to policymakers. Methods: 579 prescribers were recruited from France, Germany, Italy, Spain, Switzerland, UK. Drawn from Dermatology, Endocrinology, Gastrointestinal, Hematology oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, Rheumatology. 15 minute web-based survey, offered in multiple languages. The data was collected in March 2019. Results: Respondents consider it very important or critical that there are multiple suppliers for government tenders. They also consider it important/critical that tenders include factors besides price. Sole prescription authority is considered very important/ critical, as is authority to prevent a substitution. Physicians are more comfortable switching bio-naı¨ve patient to biosimilar, but less comfortable switching a stable patient. Physicians are more comfortable switching a patient for non-medical reasons, but less so when switching is done by a third-party. Conclusions: In countries with a government tender, physicians consider it important to have several therapeutic options available, and consider factors beyond price to be important. As physicians’ familiarity has increased since the 2013 survey, so has the percentage of physicians characterizing sole prescription authority as "very important or critical". The percentage of prescribers characterizing the ability to prevent/deny a substitution very important or critical has also risen. While comfortable making biosimilar substitutions- including for cost reasons- with new/bio-naive patients, physicians remain cautious about doing so with stable patients. Physicians remain uncomfortable with third-party switching of patients for non-medical (e.g. cost) reasons. Legal entity responsible for the study: Alliance for Safe Biologic Medicines. Funding: Alliance for Safe Biologics which receives some funding from manufacturers of originators and biosimilars. Disclosure: The author has declared no conflicts of interest.
Determinants of the cancer drug funding process in Canada
1
J. Gotfrit , J.J.W. Shin2, R. Mallick3, P. Wheatley-Price1 Medical Oncology, The Ottawa Hospital Regional Cancer Centre, Ottawa, ON, Canada, 2Undergraduate Medical Education, University of Ottawa, Ottawa, ON Canada, 3Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada
1
Background: Canada has a publicly-funded healthcare system with a complex drug funding process. After Health Canada approval to market a drug, the pan-Canadian Oncology Drug Review (pCODR) makes a non-binding funding recommendation to the Canadian provinces (except Quebec), which each then decide whether the drug will be publicly funded. We identified the determinants of funding in this process. Methods: We analyzed drugs for advanced lung (n ¼ 15), breast (n ¼ 8), colorectal (CRC) (n ¼ 7), melanoma (n ¼ 10), and neuroendocrine (NET) (n ¼ 3) cancer undergoing the funding decision process from 2011-2019. Determinants of funding assessed in the model included list price, cancer type, drug class, and pCODR recommendation. The primary outcome was the correlation between list price and time-to-funding (TTF: Health Canada approval to first provincial funding). Secondary outcomes included an exploratory analysis of predictors of drug funding. Results: We analyzed 43 drugs: targeted agents 72%, immunotherapy 20%, chemotherapy 7%. 72% were funded in at least 1 province. Median TTF was 379 days (IQR 203601). Median list price (28-day course) was $8213 (IQR 5391-9445). Higher list price was not correlated with TTF (correlation coefficient -0.20, p ¼ 0.28). There was no association between list price and pCODR recommendation, or the decision to fund in at least 1 province. A positive pCODR recommendation correlated with the provinces’ funding decisions (p < 0.001), where 89% of drugs with a positive recommendation
v672 | Public Policy
1634PD
Cost avoided in drugs derived from participation in clinical trials in colorectal cancer
L. Sanchez- Rubio Ferrandez, N. Rodrıguez Salas, E. Villama~ nan Bueno, G. Casado Abad, A. Sierra Mu~ noz, S. Feli u Torres, A. Herrero Ambrosio Farmacia, Hospital Universitario La Paz, Madrid, Spain Background: Colon cancer presents at high incidence and its treatment generates an important economic impact in hospitals. In Spain, it is mandatiory for the sponsors of clinical trials to supply the investigational drugs without charge to the national health system. Avoided cost is defined as the cost that would have had to be paid if the patient did not participate in a clinical trial with the free contribution of the drugs. The objective of the main study was to calculate the cost avoided in drugs derived from the participation of patients in clinical trials of colon cancer in a university hospital. Methods: This was a retrospective observational study. A data cut was made in April 2018 and the active clinical trials in colon cancer were selected. All patients who had participated in them were included, regardless of the date of inclusion. Sources of data R electronic Citostatic precollection: Pharmacy Service database, Farmis OncofarmV scription program, and Clinical Records. The cost of the cycles received in the investigation was estimated for each patient and the cost of the standard treatment during the same period was calculated. For this, the following variables were collected: name of the trial, drug in research, number of cycles, duration, cost of treatment in the experimental arm and in the comparator or standard therapy. The costs of the medication associated with chemotherapy were not taken into account.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz263.005/5576699 by guest on 27 October 2019
A.K. Herbrand1, A.M. Schmitt1, A. Hoogkamer1, M. Joerger2, S. Diem2, U. Novak3, L.G. Hemkens4, B. Kasenda1 1 Department of Medical Oncology, University Hospital Basel, Basel, Switzerland, 2 Department of Medical Oncology & Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland, 3Department of Medical Oncology, University Hospital Bern, Bern, Switzerland, 4Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland
Annals of Oncology