Faculty Bibliography

OBJECTIVE:This study aimed to understand the factors limiting access to medications for the preventive treatment of migraine and to improve access to evidence-based preventive care. BACKGROUND:For decades, the effective use of medication for the preventive treatment of migraine was limited by slow onset, slow and complex dose titration schedules, modest benefits, drug interactions, frequent side effects, and very low long-term adherence. The calcitonin gene-related peptide (CGRP) targeted preventive medications mitigate some of these limitations and demonstrated substantial therapeutic benefits in a significant proportion of adults with migraine. The American Headache Society considers these medications among the first-line options for migraine prevention, although access to them remains limited. The American Migraine Foundation hosted a single-day, multidisciplinary expert panel discussion to identify barriers to optimal preventive care and developed recommendations to address them. METHODS:Participants identified and prioritized barriers and used a modified nominal group technique to achieve consensus on them. A series of moderated discussions in plenary and breakout sessions was used to create possible solutions. Modified nominal group technique was also employed to achieve consensus on the priorities among these barriers and to achieve whole-group consensus on the recommendations. Ethical issues that inform access were discussed. RESULTS:Participants included eight neurologists and board-certified headache specialists, six representatives of reimbursement decision-makers, six employees of life sciences companies, four patient advocates with lived experience with migraine, and a medical ethicist. Among those who have consulted healthcare professionals and received a diagnosis of migraine, we identified four main barriers to accessing preventive treatment: restrictive prior authorization requirements, the perceived lack of real-world evidence and treatment guidelines, the need for clinician education, and the need for patient education. Consensus recommendations for eliminating barriers centered on using new evidence to evaluate policies that restrict the selection of first-line therapies, initiating/improving collaboration among stakeholders, sharing of data and best practices, and increased training. Participants agreed to explore novel definitions of the value of preventive treatment and to establish the Migraine Prevention Network to facilitate ongoing cooperation and collective action. However, due to financial limitations, staffing changes, and time constraints, post-meeting discussions led to a shift from establishing a broad Migraine Prevention Network to forming smaller task forces focused on the top-priority barriers (real-world evidence and The Patient Playbook) identified through collaborative voting among American Headache Society, American Migraine Foundation, and industry stakeholders. CONCLUSIONS:Adults with migraine face multiple barriers in accessing novel migraine-specific, CGRP-targeted preventive treatment. Stakeholders in the delivery of care, including clinicians, reimbursement decision-makers, life sciences companies, and patient and clinician advocates, may be able to overcome many of these barriers and improve access by working with and on behalf of patients.

Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.

Several unexpected fatalities in patients who received adeno-associated virus (AAV)-based gene therapies have recently occurred. These tragic events have cast a pall over the entire sector with some stakeholders suggesting that AAV is patently unsafe as a gene delivery platform and ought not to be pursued. This conclusion is not warranted.

An epidemiologist advocates for vaccine equity.