Barriers in accessing medical cannabis for children with drug-resistant epilepsy in Canada: A qualitative study.

INTRODUCTION: The use of medical cannabis to treat drug-resistant epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children. METHODS: In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with drug-resistant epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness. RESULTS: Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs. CONCLUSIONS: Parents pursue medical cannabis as a treatment for their children's drug-resistant epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in epilepsy care, antiepileptic drugs, and medical cannabis.

Principles of Financing the Medical Home for Children.

A well-implemented and adequately funded medical home not only is the best approach to optimize the health of the individual patient but also can function as an effective instrument for improving population health. Key financing elements to providing quality, effective, comprehensive care in the pediatric medical home include the following: (1) first dollar coverage without deductibles, copays, or other cost-sharing for necessary preventive care services as recommended by Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents; (2) adoption of a uniform definition of medical necessity across payers that embraces services that promote optimal growth and development and prevent, diagnose, and treat the full range of pediatric physical, mental, behavioral, and developmental conditions, in accord with evidence-based science or evidence-informed expert opinion; (3) payment models that promote appropriate use of pediatric primary care and pediatric specialty services and discourage inappropriate, inefficient, or excessive use of medical services; and (4) payment models that strengthen the patient- and family-physician relationship and do not impose additional administrative burdens that will only erode the effectiveness of the medical home. These goals can be met by designing payment models that provide adequate funding of the cost of medical encounters, care coordination, population health services, and quality improvement activities; provide incentives for quality and effectiveness of care; and ease administrative burdens.

Hyperbaric medicine today: an historically noble discipline challenged by loss of critical access and overutilization - invited commentary.

As the title implies, much appears amiss with hyperbaric medicine. Long recognized for its life-saving, CNS-sparing,infection-fighting and tissue-salving attributes, its current application has been rightly called into question by a broad cross-section of health care delivery system stakeholders [1, 2, 3, 4, 5]. This paper will examine what lies behind the stunning loss of availability for a majority of the Federal Drug Administration-approved uses, arguably those for which patients have the most to gain. It will address overutilization in the context of an erosion of practice standards and widespread manipulation of the reimbursement process. It will make suggestions aimed at restoring its broader availability across the full extent of FDA-approved uses. Finally, it offers guidance to ensure that HBO2 therapy is employed only when medically necessary by adoption of the drug administration "rights" principle, namely the right indication for the right patient at the right time and only for the right amount of time.

[Medication: 15 years 'EU-directive orphan drugs']. / WEESGENEESMIDDELEN: 15 Jaren "EU-directive orphan drugs".

The article describes the compounding, dispensing and reimbursement of orphan drugs in Belgium 15 years after the implementation of the EU Directive on orphan drugs. Despite the fact that they are life-threatening and free of charge, patient compliance to oral orphan medication seems to be a major problem that needs to be handled by the dispensing pharmacist. Parenteral orphan medication needs to be compounded in the hospital pharmacy following strict guidelines concerning handling and storage. For ultra-rare disorders the medication needs to be compounded using sometimes chemical grade ingredients without any pharmaceutical monograph. Cost-effectiveness will always remain a subject for debate.

Critical assessment of belgian reimbursement dossiers of orphan drugs.

BACKGROUND: Orphan medicinal products are designed to diagnose or treat rare diseases that are serious, life threatening or chronically debilitating and that affect 50 or fewer people in every 100 000 in the EU. In Belgium, the Drug Reimbursement Committee (DRC) evaluates reimbursement requests for orphan drugs based on multiple criteria: the therapeutic value, price and proposed reimbursement tariff; the importance of the drug in clinical practice; and the budget impact of the drug. OBJECTIVES: This study aimed to assess reimbursement dossiers of orphan drugs in Belgium and to compare them with the clinical evidence submitted to the European Medicines Agency (EMA). METHODS: A qualitative analysis examined all reimbursement dossiers of orphan drugs that were submitted in Belgium between January 2002 and June 2008. The following information was extracted from each dossier: description of the orphan drug; indication; reimbursement status; therapeutic value and needs; budget impact; and number of registered indications. For selected orphan drugs, an in-depth analysis extracted and compared information about the clinical trials, their primary endpoints and results from EMA documents (i.e. the marketing authorization application file, European public assessment report and summary of product characteristics) and the Belgian reimbursement dossiers. RESULTS: Reimbursement was awarded to the majority of orphan drugs. In addition to the official criteria, other negotiable factors, such as price adjustments, employment incentives, patient population restrictions and funding of diagnostic tests by the company, seemed to play a role in the reimbursement decision. Despite the low number of patients, randomized controlled trials were conducted for many orphan drugs. Budget-impact analyses were simplistic and did not consider the impact across multiple indications. Some differences were also observed between the clinical evidence submitted to the EMA and that submitted to the Belgian DRC. CONCLUSIONS: In addition to the official criteria, other negotiable factors, such as price adjustments and employment incentives, may play a role in Belgian reimbursement decisions of orphan drugs. Some differences have also been noted between the clinical evidence reported in EMA documents and the evidence included in Belgian reimbursement dossiers of orphan drugs. There appears to be a need for further standardization of Belgian reimbursement applications and for European cooperation in sharing clinical evidence of orphan drugs.

Family physician attitudes about prescribing using a drug formulary.

BACKGROUND: Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers. METHODS: Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis. RESULTS: Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions. CONCLUSION: Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms.

[Suggestions for implementation of DRG in the fields of Orthopaedics and Trauma Surgery for 2004]. / DRG-Anpassungsvorschläge der Fachgebiete Orthopädie und Unfallchirurgie für 2004.

OBJECTIVE: The Implementation of a DRG-Variant in Germany - voluntarily since January 1 st, 2003 and obligatory from January 1 st, 2004 - has been leading to uncertainty, particularly in the hospitals, due to fears that currently practised German diagnostic and therapeutic measures will not be financed properly by a DRG-Variant. The G-DRG-Version 1.0 that was drawn up in connection with an executive order law is to a large degree identical to the Australian AR-DRG-Version 4.1. Adjustments to German requirements were made only marginally. Therefore it is necessary for every medical field to investigate by stock-taking to what extent currently practised German diagnostic and therapeutic measures are considered in the G-DRG-Version 1.0 and whether and where modifications and adaptations need to be made. In order to make qualified statements scientific evaluations of possible problems have to be made based German data. Therefore an evaluation was made of the mapping of the medical fields of orthopaedics and trauma surgery. The German Society of Trauma Surgery (DGU), the German Society of Orthopaedy and Orthopaedic Surgery (DGOOC) in cooperation with the DRG-Research-Group of the University Hospital Muenster, the German Hospital Federation (DKG) and the German Medical Association carried out a DRG evaluation project in order to investigate the medical and economical homogeneity of the case groups. METHOD: 12,645 orthopaedic and trauma surgery cases from 23 hospitals - 11 university hospitals and 12 non-university hospitals - were collected within an period of three months and were scientifically evaluated with regard to their performance homogeneity and length of stay homogeneity. RESULTS: The data formed the basis for the proof of suspected deficiencies of mapping of orthopaedic and trauma surgery cases within the G-DRG-Variant. Based on the data and additionally on conclusions of medical experts when the number of cases were small, 14 suggestions for adaptation were proposed and submitted by the deadline of March 31 st, 2003 to the InEK. CONCLUSION: The results of the DRG-Evaluation Project demonstrate the problems of mapping the very heterogenous and complex medical performances of orthopaedy and trauma surgery to a flat rate financing system that is not adapted properly to German conditions. The G-DRG-Variant Version 1.0 does not offer the sufficient possibilities of differentiation that are needed to map the various orthopaedical and trauma surgical measures in Germany.

Commentary on Sommer et al. 'A randomized experiment of the effects of including alternative medicine in the mandatory benefit package of health insurance.

The study by Sommer et al. recently reported in Complementary Therapies in Medicine has been heavily criticised in Switzerland since its original publication. Its major problems are an inadequate reflection of real practice, an inadequate study design relative to the central research objective, questionable value of the applied instrument and procedure for health assessment, methodological and statistical problems, and failure to consider literature relevant to the topic. For these reasons, this experimental study does not allow an answer to its central questions as to costs and effectiveness of complementary medicine made available within Switzerland's mandatory basic health insurance provisions. We propose more practice-related, non-experimental prospective study designs to realistically answer these questions.

A randomized experiment of the effects of including alternative medicine in the mandatory benefit package of health insurance funds in Switzerland.

OBJECTIVES: The present investigation focuses on the following questions: 1. Are complementary medical services paid for by a health insurer used in addition to orthodox medical services, or as substitute for them?; 2. If health insurers include complementary medical services in the basic cover, what will be the effect on costs?; 3. If complementary medical services as included in the basic cover, what will be the effect on the policyholders' subjective state of health? STUDY DESIGN: A randomized experiment was set up in which 7500 members of Switzerland's biggest health insurance fund, Helvetia, were offered free supplementary insurance for alternative medicine for 3 years. This simulated a situation in which the experimental group had access to the full range of complementary medical treatments under their health insurance policies. The remaining members in the scheme (670,000) people) formed the control group. To evaluate the effect on costs, we analysed the health insurer's cost and benefits data. In addition, a survey was carried out among random samples of subjects from the experimental group and from the control group using the 36-Item Short-Form Health Survey (SF-36) to examine the effects of including complementary medicine on subjective state of health. RESULTS: The analysis of the cost data shown that subjects used alternative in addition to orthodox medical services. It is also clear that alternative medical treatments are given in combination with orthodox medicine; less than 1% of the experimental group used exclusively alternative medical services. However, as only a very small percentage of experimental subjects (6.6%) took advantage of complementary medicine, no significant impact on overall health costs can be inferred. On the other hand, multiple regressions show that use of complementary medicine has a greater effect on treatment costs than sex, age or language region. Neither at the beginning nor the end of the experiment were any significant differences noted in the scales of the SF-36 between the experimental and the control group. Nor did multiple regressions reveal any effects on subjects' state of health due to the inclusion of complementary medicine in the basic insurance cover.