Expensive Anticancer Drugs Research Articles

A Systematic Evaluation of Cost-Saving Dosing Regimens for Therapeutic Antibodies and Antibody-Drug Conjugates for the Treatment of Lung Cancer

Expensive novel anticancer drugs put a serious strain on healthcare budgets, and the associated drug expenses limit access to life-saving treatments worldwide. We aimed to develop alternative dosing regimens to reduce drug expenses. We developed alternative dosing regimens for the following monoclonal antibodies used for the treatment of lung cancer: amivantamab, atezolizumab, bevacizumab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and ramucirumab; and for the antibody-drug conjugate trastuzumab deruxtecan. The alternative dosing regimens were developed by means of modeling and simulation based on the population pharmacokinetic models developed by the license holders. They were based on weight bands and the administration of complete vials to limit drug wastage. The resulting dosing regimens were developed to comply with criteria used by regulatory authorities for in silico dose development. We found that alternative dosing regimens could result in cost savings that range from 11 to 28%, and lead to equivalent pharmacokinetic exposure with no relevant increases in variability in exposure. Dosing regimens based on weight bands and the use of complete vials to reduce drug wastage result in less expenses while maintaining equivalent exposure. The level of evidence of our proposal is the same as accepted by regulatory authorities for the approval of alternative dosing regimens of other monoclonal antibodies in oncology. The proposed alternative dosing regimens can, therefore, be directly implemented in clinical practice.

564O_PR Oncologists' preferences for recommending expensive anticancer drugs

564O_PR Oncologists' preferences for recommending expensive anticancer drugs

Estimating the effect of optimizing anticancer drug vials on medical costs in Japan based on the data from a cancer hospital

BackgroundThe substantial increase in the use of expensive anticancer drugs has been accompanied by an increase in the amount of disposing residual liquid from drug preparations. Many Western countries, including the United States, have implemented drug vial optimization (DVO) to prevent the waste of anticancer drugs and have reported the reductions in the total drug costs. This study was designed to estimate the expected reduction in spending on anticancer drugs by Japanese cancer hospitals when DVO was implemented instead of individual preparations and to test the effectiveness of this approach.MethodsWe investigated the doses of drugs used and quantity specifications for individually prepared vials for patients who received anticancer drug treatment in December 2017 at the Outpatient Treatment Center of the National Cancer Center Hospital East. Based on these findings, we calculated the total quantity of each drug used on a given day, and the minimum cost for preparation of the number of specified combinations corresponding to the total cost (DVO preparation). Based on the differences in these two costs, we estimated the economic impact of implementing DVO.ResultsWhile the cost for anticancer drugs for the 1-month study period was US$3,305,595 (US$1 = \\110) for individual preparations, the estimated cost for DVO preparations was US$3,092,955, equivalent to a reduction of US$212,640.ConclusionsBased on these study results, implementation of DVO-based preparation of injectable anticancer drugs in Japan in 2017 would have resulted in saving approximately US$460 million. This calculation revealed the need for the Japanese government to modify the methods employed to calculate drug costs in the insurance system and develop policies for the proper and optimal use of medical resources.

Drug cost savings resulting from the outpatient pharmacy services collaborating with oncologists at outpatient clinics

Abstract Objectives: Impact of outpatient collaborative pharmacy services performed by pharmacists on drug costs has not yet been reported. Therefore, this study evaluated direct interventions made by pharmacists in the form of prescription proposals that resulted in drug cost savings from outpatient collaborative pharmacy services performed by pharmacists to support outpatient cancer chemotherapy. Methods: This was a retrospective cohort study wherein the drug cost savings resulting from the outpatient collaborative pharmacy services performed by 6 pharmacists and physicians from 6 medical departments were calculated and investigated from June 2016 to November 2016. Drug costs as of August 31, 2016 were used to calculate the drug cost savings. Results: During the 6-month study period, 6 pharmacists performed outpatient collaborative pharmacy services on weekdays within a span of 120 days for a total of 2177 hours each. The total drug cost savings were ¥6984,637, including ¥5842,061 for anticancer drugs, ¥1086,484 for oral drugs other than anticancer, ¥39,388 for premedications, and ¥16,704 for drugs for abuse. The total cost of the added drugs was ¥3224,227, allocated as follows: nonanticancer medicines, ¥1441,317; supportive medicines for adverse drug reactions in chemotherapy, ¥359,127; premedications for chemotherapy, ¥307,961; and anticancer medicines, ¥1115,822. Conclusion: The results of the present study are limited to “pharmacists assisting in reducing drugs by adjusting expensive anticancer drugs through a collaborative effort with physicians via outpatient consultations”; however, it indicated a significant overall health economic effect.

Cisplatin & IV Etoposide combination in the treatment of advanced breast cancer pretreated with anthracyclines

Background: Aims of this study was to determine the benefit of cisplatin and i.v etoposide combination in treatment of advanced breast cancer (ABC) patients who were pretreated with anthracyclines, as an alternative to the newer, more expensive, and unavailable anticancer drugs like Taxanes, carboplatin, and gemcitabine.Patients and methods: The study was performed in the period from March 2010 to June 2016, 235 patients were given cisplatin 50mg/m2 and etoposide 100mg /m2 for 6 cycles. The patients were divided into 4 groups according to the site of metastasis (vertebral metastases, liver metastases, loco-regional metastases, and pleuro-pulmonary metastases).Results: Evaluation of treatment was considered on two levels: Whole 235 patient level, and patient-group level. On whole patient level: Response to Treatment was 65.1%, which is higher than similar responses in many other studies. While on patient-group level: response to treatment was highest in patients with vertebral secondaries 75.3%. There was drug toxicity in all groups of patients. Some patients did not continue the treatment protocol because of bad performance status, toxicity and death. Conclusion: In comparison with other regimes of chemotherapy cisplatin and i.v etoposide are still useful anticancer drugs in the management of advanced breast cancer.

Paradigm shift in cancer treatment: Cancer treatment as a metabolic disease – fusion of Eastern and Western medicine

Current standard therapies for cancer, including surgery, anti-cancer drugs, and radiotherapy, are thought to contribute to the improvement in the survival rates of cancer patients. However, such standard therapies have 3 major problems: in advanced cancers, it is unlikely that standard cancer treatments will cure the disease; adverse side effects that accompany standard cancer treatments put many patients in distress; and a large amount of medical expenditure is required for new and expensive anti-cancer drugs. These problems may be viewed as a result of establishing treatments without any consideration regarding the root cause of the cancer. Otto Warburg suggested that particular changes in the energy metabolism of cells, which are associated with a shortage of oxygen, are the root cause of cancer. Cancer cells have unique metabolic characteristics, and thus we believe that it is important to treat cancer as a metabolic disease. More specifically, not only is it important to suppress cancer cell metabolism, but it is also important to improve the chronic inflammation that is associated with the development and progression of cancer, and to support the functions of immune cells. This type of view of cancer treatment coincides with the principles of Chinese medicine, which has a history of 4000 years, such as “fuzheng quxie” and “zhibing qiuben”, which can assist in the establishment of cancer treatments for patients. In this article, we discuss cancer treatments from the view of cancer as a metabolic disease and their association with Chinese medicine, and introduce some clinical cases along with a review of the literature.

Discussing and prescribing expensive unfunded anticancer drugs in Australia

ObjectiveAustralia has a publicly funded universal healthcare system which heavily subsidises the cost of most registered anticancer drugs. The use of anticancer drugs that are unfunded, that is, not subsidised by the government, entails substantial out-of-pocket costs for patients. We sought to determine how frequently Australian medical oncologists discuss and prescribe unfunded anticancer drugs, and their attitudes and beliefs about their use.MethodsMembers of the Medical Oncology Group of Australia (MOGA) completed an online survey about their clinical practices over a recent 3-month period. A negative binomial regression model was used to examine the influence of respondent characteristics on the rate of discussions about, and prescription of, unfunded anticancer drugs.ResultsOf the 154 respondents (27% of 575 MOGA members), 92% had discussed and 68% had prescribed at least one unfunded anticancer drug in the last 3 months. Respondents reported discussing unfunded anticancer drugs with an average of 2.5 patients per month (95% CI 2.1 to 2.9), and prescribed them to an average of 0.9 patients per month (95% CI 0.7 to 1.2). The rate of discussing unfunded anticancer drugs was associated with being fully qualified (p=0.01), and being in a metropolitan practice (p=0.009), the rate of prescription was associated only with being in metropolitan practice (p=0.006). The concerns about discussing and prescribing unfunded anticancer drugs rated most important were as follows: ‘potential to cause financial hardship’ and ‘difficulty for patients to evaluate the benefits versus the costs’.ConclusionsAustralian medical oncologists frequently discuss and prescribe unfunded anticancer drugs, and are concerned about their patients having to face difficult decisions and financial hardship. Further research is needed to better understand the factors that affect how oncologists and patients value expensive, unfunded anticancer drugs.

Subsidies for Oral Chemotherapy and Use of Immunomodulatory Drugs Among Medicare Beneficiaries With Myeloma.

Purpose The low-income subsidy (LIS) substantially lowers out-of-pocket costs for qualifying Medicare Part D beneficiaries who receive orally administered chemotherapy. We examined the association of LIS with the use of novel oral immunomodulatory drugs (IMiDs; lenalidomide and thalidomide) among beneficiaries with myeloma, who can receive either orally administered or parenteral (bortezomib-based) therapy. Methods Using SEER-Medicare data, we identified Part D beneficiaries diagnosed with myeloma in 2007 to 2011. In multivariable models adjusted for sociodemographic and clinical characteristics, we analyzed associations between the LIS and use of IMiD-based therapy, delays between IMiD refills, and select health outcomes during the first year of therapy. Results Among 3,038 beneficiaries, 41% received first-line IMiDs. Median out-of-pocket cost for the first IMiD prescription was $3,178 for LIS nonrecipients and $3 for LIS recipients, whereas the respective median costs for the first year of therapy were $5,623 and $6, respectively. Receipt of the LIS was associated with a 32% higher (95% CI, 16% to 47%) probability of receiving IMiDs among beneficiaries age 75 to 84 years and a significantly lower risk of delays between refills in all age groups (adjusted relative risk, 0.54; 95% CI, 0.32 to 0.92). Duration of therapy did not significantly differ between LIS recipients and nonrecipients (median, 7.6 months). Patients treated with IMiDs had significantly fewer emergency department visits and hospitalizations compared with patients receiving bortezomib (without IMiDs), but 1-year overall survival and cumulative Medicare costs were similar. Conclusion Medicare beneficiaries with myeloma who do not receive LISs face a substantial financial barrier to accessing orally administered anticancer therapy, warranting urgent attention from policymakers. Limiting out-of-pocket costs for expensive anticancer drugs like the IMiDs may improve access to oral therapy for patients with myeloma.

Is it all about price? Why requests for government subsidy of anticancer drugs were rejected in Australia.

Australians access anticancer drugs predominantly through the Pharmaceutical Benefits Scheme (PBS). To determine why the Pharmaceutical Benefits Advisory Committee (PBAC) rejects submissions to list anticancer drugs on the PBS. We reviewed publicly available information about submissions made to the PBAC for PBS listing of anticancer drugs from 2005 to 2014. Submission characteristics, including clinical and economic evidence, PBAC recommendations, and the reasons offered for rejection were recorded. Two reviewers independently categorised the reason for rejection offered by the PBAC. Logistic regression was used to determine submission characteristics associated with rejection. We identified 213 submissions for 110 unique indications of 60 anticancer drugs. The overall rejection rate was 56% (119/213). Of the 110 indications assessed, 69% (76/110) were rejected at least once. The annual rejection rate ranged from 50 to 73% with little evidence of a trend over time (P = 0.2). Submission characteristics strongly associated with rejection in multivariable analysis included: PBAC judged the clinical evidence to be problematic or uncertain (P < 0.001); PBAC judged the economic evidence to be problematic or uncertain (P < 0.001); and, inactive comparator used (P < 0.001). The most frequent reasons for rejection offered by the PBAC was 'inadequate cost-effectiveness or drug price too high' (75/109, 69%). Inadequate cost-effectiveness and PBAC uncertainty about the clinical and economic evidence were the most frequent reasons for rejection. Clarity of information about PBAC deliberations and their reasons for rejection are important for patients and doctors grappling with decisions about the use of expensive unfunded anticancer drugs.

564O_PR Oncologists’ preferences for recommending expensive anticancer drugs

564O_PR Oncologists’ preferences for recommending expensive anticancer drugs

Guideline Adherence Regarding the Use of Expensive Drugs in Daily Practice: The Examples of Trastuzumab in Breast Cancer and Bortezomib in Multiple Myeloma

Background: The present study was designed to obtain insights into guideline adherence regarding the use of expensive drugs in The Netherlands in daily practice and into the patients' perspective on the decision-making process. Material and Methods: A retrospective review of medical charts regarding the use of trastuzumab in early and metastatic breast cancer (EBC/MBC) and bortezomib in multiple myeloma (MM) was conducted. Prescription according to clinical practice guidelines was assessed. The review was supplemented with patient interviews. Results: Of 702 adjuvant-treated EBC patients, 97% had a documented human epidermal growth factor receptor 2 (HER2) testing (23% HER2 positive). 92% (147/160) of the HER2-positive EBC patients were treated with trastuzumab. Of 594 MBC patients, 81% had a documented HER2 testing (19% HER2 positive). 82% (75/91) of the HER2-positive MBC patients were treated with trastuzumab. Of 68 MM patients, 50% were treated with bortezomib. Reasons not to treat were consistent with the guidelines. Patients were generally satisfied with the decision-making process; improvements in patient education were suggested (e.g., repeating the information given, adding information on side effects). Conclusions: Guidelines were generally well followed with respect to trastuzumab and bortezomib, indicating that funding did not influence the treatment decisions of physicians. In view of the growing numbers of both cancer patients and expensive new anticancer drugs, and increasing budget constraints, it is unclear whether the present-day policies will guarantee a similar level of guideline adherence. Patient involvement in decision-making could be increased by improving the patient education on treatment.

1202 Discussing and prescribing expensive unfunded anticancer drugs in Australia

1202 Discussing and prescribing expensive unfunded anticancer drugs in Australia

Contemporary diagnostic methods for breast cancer

Breast cancer is the most common malignant neoplasm diagnosed in Polish women. The results of treatment for breast cancer in Poland are worse than those received in highly developed European countries. The factor that is decisive in reducing mortality due to breast cancer is an early diagnosis. Conversely, the diagnosis, which is established too late contributes to poor prognosis and prevents obtaining satisfactory results in treatment even with expensive anti-cancer drugs. An early diagnosis of breast cancer is more and more difficult to reach; it requires experienced specialists and high quality equipment. This article presents contemporary diagnostic methods for breast cancer and analysis of diagnostic standards for every single procedure.

Access to innovation: Is there a difference in the use of expensive anticancer drugs between French hospitals?

In DRG-based hospital payment systems, expensive drugs are often funded separately. In France, specific expensive drugs (including a large proportion of anticancer drugs) are fully reimbursed up to national reimbursement tariffs to ensure equity of access. Our objective was to analyse the use of expensive anticancer drugs in public and private hospitals, and between regions. We had access to sales per anticancer drug and per hospital in the year 2008. We used a multilevel model to study the variation in the mean expenditure of expensive anticancer drugs per course of chemotherapy and per hospital. The mean expenditure per course of chemotherapy was €922 [95% CI: 890–954]. At the hospital level, specialisation in chemotherapies for breast cancers was associated with a higher expenditure of anticancer drugs per course for those hospitals with the highest proportion of cancers at this site. There were no differences in the use of expensive drugs between the private and the public hospital sector after controlling for case mix. There were no differences between the mean expenditures per region. The absence of disparities in the use of expensive anticancer drugs between hospitals and regions may indicate that exempting chemotherapies from DRG-based payments and providing additional reimbursement for these drugs has been successful at ensuring equal access to care.

Cost-effectiveness Considerations of Individualized Cancer Chemotherapy

The running cost for clinical cancer treatment has risen dramatically. It is a huge burden to government fiscal budgets and cancer patients’ medical expenditure. Previously, we often create new drug and methodology of high cost and waste human resources for development of many less effects and expensive anticancer drugs or other sophisticated methodologies. These efforts will greatly increase therapeutic costs. Now some countries, such as USA or Japan, are overburden with high expense of medical resources in human

The views of patients and the general public about expensive anti-cancer drugs in the NHS: a questionnaire-based study

ObjectivesTo determine the views of patients and members of the public about who should pay for expensive new cancer drugs not recommended by the National Institute for Health and Clinical Excellence (NICE).DesignA study-specific questionnaire was used to elicit the views of patients and the general public between April and June 2010. It examined whether participants thought patients should be told about all possible cancer treatments, if the NHS should always fund non-NICE recommended drugs and attitudes towards self-funding/co-payments. The influence of sociodemographic factors on responses was also examined.SettingOncology clinics in Sussex and various locations including old persons' lunch clubs, parks, sports venues and support groups.ParticipantsTwo hundred and 10 patients with common solid tumours, and 416 members of the general publicMain outcome measuresFrequencies of responses to items regarding payments for expensive anti-cancer drugs stratified by sociodemographic factors and comparison of responses between patients and members of the public.ResultsMost respondents (70% [147/210] of patients and 64% [266/416] of the general public) had heard of NICE. Both groups believed that doctors should tell patients about all available cancer treatments even if the NHS cannot pay (94%, 196/208; 93%, 388/415). However, only 49% (101/207) of patients and 36% (146/409) of the public believed that the NHS should always fund all new cancer drugs that have failed health technology assessments. Strong predictors of willingness to purchase expensive new cancer drugs included younger age (<45 years), sex (female) and higher educational level.ConclusionThe general population appear realistic about the difficulties of providing funding for expensive new drugs. A communication skills training course has been developed to help clinicians with these difficult consultations.

Discussing expensive anti-cancer drugs

Funding expensive new cancer therapies is increasingly problematic for healthcare systems worldwide. In this study wthe authors report UK clinicians' views and experiences when discussing expensive anti-cancer drugs with patients. A study-specific survey was emailed to members of relevant professional oncology organisations between April and August 2010: 368 clinicians responded. During the previous 12 months, 71% had made exceptional/individual funding requests; few were successful. Only 9% of clinicians discussed expensive drugs with all patients, 75% with ‘some’ and 16% with ‘none’. Among those who told ‘some’, 81% (224/276) did so only if convinced of clinical benefit, 72% only if patients initiated the subject, and 55%, if relatives did. Clinicians treating both privately funded and NHS patients (43%) were three times more likely to discuss expensive treatments (p&lt;0.001) than those working only within the NHS. Clinicians' reporting of patients' and relatives' reactions to such discussions was ‘understanding’ (63%, 45%), ‘distress’ (40%, 41%) and ‘indignation’ (24%, 38%). A majority of clinicians (98%) had received no guidance on conducting such discussions and 76% wanted training. This survey clearly demonstrated that few clinicians discuss expensive anti-cancer treatments with their patients and welcome access to a training programme to assist them.

Nutzen-Risiko-Bewertung neuer Wirkstoffe als Grundlage für Priorisierungsentscheidungen in der Hämatologie/Onkologie: Methodische Herausforderungen und Lösungsansätze

Medikamentöse Therapieinnovationen in der Onkologie werfen medizinische und ethische Fragestellungen auf. Die zunehmende Inzidenz und Prävalenz von Krebserkrankungen sowie die Zulassung neuer, in aller Regel kostspieliger Wirkstoffe sind mit steigenden Gesamtkosten für die Behandlung von Krebserkrankungen verbunden. Deshalb ist die Entwicklung von wissenschaftlich begründeten Strategien zur Nutzenbewertung neuer medikamentöser Therapieverfahren unentbehrlich. Im Mittelpunkt dieses Beitrags steht die Nutzen- beziehungsweise Nutzen-Risiko-Bewertung als Grundlage für Entscheidungen über die Priorisierung bei hämatologischen Neoplasien und soliden Tumoren. Zunächst werden regulatorische Anforderungen an die Zulassung und Defizite in klinischen Zulassungsstudien als Grund für die zum Zeitpunkt des Markteintritts häufig nicht mögliche Nutzenbewertung neuer Wirkstoffe in der Onkologie dargestellt. Anschließend werden mögliche Lösungsansätze zur Optimierung einer Nutzen- bzw. Kosten-Nutzen-Bewertung und Vorschläge zur Verbesserung der wissenschaftlichen Datenlage diskutiert.

Dose standardisation of anticancer drugs

Body size based dosing is often used for prescribing anticancer drugs. However the scientific and the clinical rationales of this historical method have recently been criticized. As a result, alternative dosing strategies have been suggested, as flat-fixed dosing regimens, but not implemented in routine practice. Dose standardisation is a first step in order to rationalise chemotherapy dose calculation. A new method, derived from dose-banding, was developed, taking into account prescription and economic criteria. Feasibility and interest of this concept were studied in two French cancer centres Institut Curie and Hôpital Saint-Louis. The aim of our study was to assess dose standardisation of expensive anticancer drugs in objectives of quality and economy. Nine candidate drugs were selected and standardized rounded doses (SRD) were proposed. To determine the specific standard doses of these two centres, two theoretical and practical methods were applied, and then, their results were compared. For each anticancer drug the objective was to fix SRD in order to cover all the doses most frequently prescribed. It has been possible to propose SRD for six of the nine drugs. These SRD have been implemented with the agreement of the medical staff. These doses are, whenever possible, rounded to the nearest vial size, or correspond to a combination of the different strength of the commercial drug. Our study shows that dose standardisation is a help to optimise the productivity and improve the organisation of the preparation unit.

PC-FACS

PC-FACS