Expensive Cancer Drugs Research Articles

Can Patients Afford to Be Adherent to Expensive Oral Cancer Drugs?: Unintended Consequences of Pharmaceutical Development.

Can Patients Afford to Be Adherent to Expensive Oral Cancer Drugs?: Unintended Consequences of Pharmaceutical Development.

Coalition Priorité Cancer and the Pharmaceutical Industry in Québec: Conflicts of Interest in the Reimbursement of Expensive Cancer Drugs?

In the context of scarce public resources, patient interest groups have increasingly turned to private organizations for financing, including the pharmaceutical industry. This practice puts advocacy groups in a situation of potential conflicts between the interests of patients and those of the drug companies. The interests of patients and industry can converge on issues related to the approval and reimbursement of medications. But even on this issue, interests do not always align perfectly. Using the Quebec example of Coalition Priorité Cancer (CPC) as a case study, we examine the ethical issues raised by such financial relationships in the context of drug reimbursement decision-making. We collected, compiled and analyzed publicly available information on the CPC's organization and activities; this approach allowed us to raise and discuss important questions regarding the possible influence exerted on patient groups by donors. We conclude with some recommendations.

International comparison on the factors influencing reimbursement of expensive cancer drugs.

6614 Background: Reimbursement policy for expensive cancer drugs is heterogeneous and inconsistent among countries. We compared the pattern of publically funded drug programs of ten countries. Methods: We investigated reimbursement policies of 19 indications with expensive cancer drugs (nilotinib, dasatinib, imatinib, pemetrexed, bevacizumab, sunitinib, temsirolimus, lapatinib, crizotinib, erlotinib, cetuximab, sorafenib and lenalidomide) in ten countries (Australia, Canada, England, France, Germany, Japan, Korea, Sweden, Taiwan, and the United States). Microarray analysis methodology is adopted to cluster the countries according to the pattern of reimbursement, based on incremental cost effectiveness ratio (ICER) and other variables of 19 indications. The earlier a country starts reimbursement for the indication, the higher reimbursement score (RS) is assigned to the country. Fairness index (FI) was determined for each country, depending on whether reimbursement decision follows ICER sequence. Results: Except for US, Japan and France were more likely to reimburse the indications (16/19), whereas Sweden and UK were less likely to reimburse them (5/19 and 6/19, respectively). From array analysis, we observed three separate groups: 1) France and Germany, 2) Korea and Japan, 3) UK, Sweden, Canada, Taiwan and Austrailia. The details of analysis will be presented. Regarding FI, Sweden (0.75), France (0.73) and UK (0.71) were the countries with high FI, in which health system was financed by general taxation and health technology assessment (HTA) was performed by government agency. Korea (0.34), Taiwan (0.40) and Germany (0.46) were the countries with low FI, in which social health insurance was financed by payroll tax or premium rather than general taxation. HTA was performed by non-government agency (Germany) or recently established government agency (2007 in Taiwan and 2009 in Korea) in these countries. Conclusions: Reimbursement policies for expensive cancer drugs are variable among the nations. Countries where health system is funded by general taxation and HTA is performed by government agency showed consistency of reimbursement policy based on ICER.

Pharmacogenomics and personalized medicine: wicked problems, ragged edges and ethical precipices

In the age of genomic medicine we can often now do the genetic testing that will permit more accurate personal tailoring of medications to obtain the best therapeutic results. This is certainly a medically and morally desirable result. However, in other areas of medicine pharmacogenomics is generating consequences that are much less ethically benign and much less amenable to a satisfactory ethical resolution. More specifically, we will often find ourselves left with 'wicked problems,' 'ragged edges,' and well-disguised ethical precipices. This will be especially true with regard to these extraordinarily expensive cancer drugs that generally yield only extra weeks or extra months of life. Our key ethical question is this: Does every individual faced with cancer have a just claim to receive treatment with one of more of these targeted cancer therapies at social expense? If any of these drugs literally made the difference between an unlimited life expectancy (a cure) and a premature death, that would be a powerful moral consideration in favor of saying that such individuals had a strong just claim to that drug. However, what we are beginning to discover is that different individuals with different genotypes respond more or less positively to these targeted drugs with some in a cohort gaining a couple extra years of life while others gain only extra weeks or months. Should only the strongest responders have a just claim to these drugs at social expense when there is no bright line that separates strong responders from modest responders from marginal responders? This is the key ethical issue we address. We argue that no ethical theory yields a satisfactory answer to this question, that we need instead fair and respectful processes of rational democratic deliberation.

THE CONCEPT OF EXCEPTIONALITY: A LEGAL FARCE?

How do we decide which treatments should be offered by the National Health Service (NHS) when we cannot afford to fund them all? In the absence of a positive appraisal by the National Institute for Health and Clinical Excellence (NICE), which mandates the provision of a treatment by the NHS, Primary Care Trusts (PCTs) are free to decide whether to provide a particular drug to some, or all, of their population. However, as public bodies, it is a well-established principle of Administrative Law that PCTs are not at liberty to fetter the exercise of their own discretion. They must recognise the possibility that some patients will have exceptional circumstances, and as a consequence, any general policy prohibiting the funding of a drug cannot be absolute. In the absence of statutory guidance on what might constitute exceptional, clinicians are left guessing as to whether their patients might be eligible for funding on the grounds of exceptionality. Using the context of expensive cancer drugs, I will examine the concept of exceptionality from clinical, moral, and legal perspectives, focussing particularly on the role of social factors in determining exceptionality. I will review the cases where PCTs' decisions not to fund cancer drugs were subject to legal action and argue that the courts have provided little guidance on interpreting the term exceptional, and that the concept has a limited role to play in the allocation of scarce health resources at a local level.

Less than ideal: how oncologists practice with limited drug access.

To evaluate Canadian medical oncologists' perspectives on how barriers to accessing new expensive cancer drugs have affected their practice and their opinions on the drug approval and funding processes. Canadian medical oncologists treating colorectal cancer (CRC) were surveyed by means of a self-administered, cross-sectional survey. Of the 164 eligible oncologists, there were 68 respondents (41.4% response rate). Only 29.4% of physicians felt they had been using the ideal first-line chemotherapy regimen for patients with metastatic CRC. Although all considered bevacizumab to be a component of the ideal first-line regimen, only 18% could use bevacizumab routinely, and less than half (44.8%) always discussed its role with their patients. In terms of accessing unfunded drugs, most physicians agreed that private payment should be allowed for drugs to be delivered at their own centers (76.1%) or private infusion clinics (52.2%). Ninety-seven percent of physicians reported major concerns about the drug approval and funding processes, and 85% of physicians supported the establishment of a national drug formulary. Canadian medical oncologists are struggling to provide optimal cancer care for their patients with metastatic CRC as a result of nonuniform access to preferred therapeutic drugs. In face of these challenges, physicians have had to use clinical trials and private infusion clinics and, at times, may avoid discussing drugs with limited access. Many oncologists are dissatisfied with the existing funding mechanism and approval processes and support private payment for unfunded drugs.

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.

Top‐up Payments for Expensive Cancer Drugs: Rationing, Fairness and the NHS

This article examines the implications for patient care, and for the future of rationing within the NHS, of the recent decision to permit NHS patients to supplement their care by paying for medicines — mainly expensive new cancer drugs — which are not available within the NHS. The starting point is the recommendations of the Richards' Report and their implementation through new guidance issued by the Department of Health and the National Institute for Health and Clinical Excellence. Practical challenges arise from the insistence upon the ‘separate’ delivery of self‐funded medicines, and more flexible cost‐effectiveness thresholds for end of life medicines may have repercussions for other patients. While undoubtedly part of the trend towards explicit rationing, top‐up fees might also represent a significant step towards regarding the NHS as a core, basic service. Finally, the issue of top‐up fees is located within the broader context of current cancer research priorities and persisting health inequalities.

The healing of America

The healing of America

In This Issue

In This Issue

22 Talking with patients about expensive and unavailable new cancer drugs

22 Talking with patients about expensive and unavailable new cancer drugs

Evaluating Off-Label Uses of Anticancer Drugs: Time for a Change

The articles in this issue by Abernethy and colleagues, Gillick, and Tillman and associates shine a bright light on a weak point in our efforts to inform clinical practice by the best possible evid...

Expensive Cancer Drugs With Modest Benefit Ignite Debate Over Solutions

L ike many oncologists, Don Dizon, M.D., doesn’t like to candy-coat bad news. “I try to be realistic about what we can accomplish with treatment,” said Dizon, who specializes in treating gynecological cancers at Women and Infants Hospital of Rhode Island. But it’s in what he tells his patients afterward that Dizon may stray from the norm. Dizon also discusses with his patients the cost of drugs and the fact that their particular insurance may not cover them. Patients then meet with a hospital-appointed nurse manager, who not only explains chemotherapy to them but also helps them navigate the morass of health insurance coverage in the U.S. The nurse manager is responsible for fi guring out whether a prescribed course of therapy will be covered by a patient’s insurance. And if it isn’t, that patient is sent to a hospital-appointed fi nancial counselor who then explains that if insurance won’t pay, the patient is responsible for all costs. Welcome to the new world of cancer care. As pharmaceutical companies charge ever-higher prices for new drugs, American health care insurers have responded by tightening their belts. Many are denying payment for treatments that aren’t backed by clinical evidence. Others are asking patients to share a portion of the costs. Consequently, oncologists can no longer focus only on prescribing the best therapy; they must also consider the price tag. Moreover, hospitals and other facilities that treat cancer have had to hire additional staff to navigate the stony path of reimbursement. “Things have changed a lot,” said AnneMarie Bradley, a nurse manager at Women and Infants Hospital who has worked there for 22 years. Oncology isn’t the only medical discipline affected by high drug prices. But the fi eld has been especially hard hit by belttightening policies because most new cancer drugs have a modest, sometimes minimal, benefi t. “In oncology, we’re looking at a lot of drugs that extend life by a matter of months. We are in the gray zone in terms of benefi t,” said Jane Weeks, M.D., Ph.D., a professor in the department of health policy and management at Harvard School of Public Health. “High costs are harder to justify.” Even though experts agree that expensive drugs with modest benefi ts present a huge dilemma in healthcare, few see signs of positive change.

6-STEPPPs: A Modular Tool to Facilitate Clinician Participation in Fair Decisions for Funding New Cancer Drugs.

To design a tool to assist clinician participation with cancer drug funding decisions. Public policy-makers and insurers are struggling with funding decisions regarding increasingly expensive new cancer drugs. Increasingly, oncologists are contributing to the process of review that leads to such decisions. We were asked to design a system for ranking new cancer drugs for priority-based funding decisions. The "Accountability for Reasonableness" framework informed the design of a six-module multistakeholder decision process blending evidence-based traditional technology assessment methods with individual and cultural values elicitation. The tool was piloted in three settings: (1) videotaped simulated multistakeholder deliberation sessions; (2) clinical oncology leaders; and (3) a regional (Canadian provincial) pharmacy and therapeutics committee making formulary decisions. The modules involve: decision clarification, drug eligibility screening (filtering), clinical performance scoring index, cost modeling, data integration and values clarification, and process evaluation. The tool was feasible to use, acceptable to participants, and able to rank candidate drugs. The pharmacy and therapeutics committee with whom it was tested used the tool as a part of their deliberations, and the tumor group leaders requested its incorporation into organization-based decision making. The decision tool can facilitate priority-based cancer drug funding decisions that meet the conditions of fairness as perceived by participants, including oncologists.

Please give us objectives we can aim at

Please give us objectives we can aim at