The Impact of Drug Shortages on Patient Care
Additionally, oncologists may be forced to substitute the missing medication with an alternative that may not be as effective, may not have a favorable toxicity profile, or well-suited to the patient's specific type of tumor. This not only leads to less optimal outcomes but may also cause more severe side effects, further complicating the patient's health. As important, the psychological impact on the patient and the patient’s family with delays can be daunting. They may also silently ask themselves “Is this delay affecting my chances of survival?” Additionally, the financial burden on healthcare systems and patients increases as substitutes for drugs in shortage are often more expensive and also susceptible to low supply as utilization shifts This situation can result in higher out-of-pocket expenses for patients, especially if the substitute drug is not fully covered by their insurance. According to a report by the RAND Corporation,
A separate but related issue arises with the dosages and administration methods of alternative drugs, which can differ from the original medication, adding complexity to treatment regimens. This change necessitates additional training for healthcare providers and increases the risk of errors, complicating the care process for patients. In cancers where long-term treatment strategies are vital, such as certain chronic leukemias, shortages can necessitate changes in planned therapies, potentially compromising long-term disease management and patient survival. Understanding Authorization Challenges for Cancer TreatmentAuthorization for drug use in oncology is a MAJOR bureaucratic hurdle that often delays treatment. The process can be cumbersome, involving multiple layers of verification and approval from insurance providers, which can be critical time lost in the treatment of cancer patients. As Dr. García describes, "Securing drug authorizations is labor-intensive, involving extensive manpower dedicated to navigating complex insurance requirements." As if this was not enough, many of the authorizations given today are for standard-of-care and routine cancer treatments from well-established national protocols. For example, when initiating therapy with the compendia-supported, standard of care in the first-line setting; what is the value of a lengthy authorization process? The insurance authorization methodology for receiving cancer-treating drugs can significantly hinder patient care due to a variety of factors that contribute to delays and complications. One major issue is the complexity of cancer treatment regimens, which often involve high-cost medications requiring thorough scrutiny by insurance companies. These treatments have specific indications, dosages, and administration protocols that must be meticulously reviewed against the patient's insurance policy coverage. Another challenge is the variability in insurance policies. Different insurance companies (and even different plans within the same company) can have varying levels of coverage and pre-authorization requirements. Insurance providers also frequently demand extensive documentation to establish the medical necessity of a specific drug. This documentation may include detailed medical records, diagnostic results, and rationales for choosing a particular treatment over others. This variability forces healthcare providers to tailor their authorization requests to the specific details and stipulations of each patient’s insurance plan, a process that is both time-consuming and complex. Some care paths require failures at certain levels that may ultimately lead to a drug the provider felt was the best option from the start but was not initially covered – talk about a tedious process just to arrive at your original suggestion! And yes, medical literature consistently shows that the vast majority of initial authorization requests, even after an initial denial, are ultimately successfully overwritten upon authorization appeals. Additionally, regulatory and policy constraints imposed by insurance companies can complicate the authorization process. Each policy might have its own set of rules regarding cancer treatment, varying widely depending on the regulatory environment of the state or country. Advocacy for Policy ChangeDrastic policy changes are necessary to address the underlying causes of drug shortages and convoluted authorization processes. Dr. García advocates for value-based care models, which have begun to influence how treatments are authorized and reimbursed based on patient outcomes rather than mere usage. "Pharmaceutical value-based contracting with payers is making progress, aligning payment with patient outcomes to reduce the authorization burden," he explains. Internationally, some countries are experimenting with outcome-based reimbursement models to ensure that payment is tied to the efficacy of the treatments provided, which could serve as a model for U.S. healthcare reform. To address these issues, a coordinated effort is required among pharmaceutical manufacturers, healthcare providers, regulatory bodies, and policymakers. Ensuring timely and effective treatments for cancer patients involves managing the underlying causes of shortages and authorization delays, enhancing supply chain transparency, and developing robust contingency plans. Future Outlook and Preparing for ChangesIn response to these challenges, innovative solutions such as the "gold carding" approach in authorization processes show great promise. Originally implemented in radiation therapy, gold carding involves streamlined, pre-approved authorization for agreed-upon first-line treatments. Adopting this method for oncology pharmaceuticals could substantially reduce delays by ensuring that standard treatments are quickly and efficiently authorized. This approach would significantly ease the administrative burden on healthcare providers, allowing them to dedicate more resources to direct patient care rather than navigating bureaucratic hurdles. The dialogue on drug shortages and authorization issues in oncology underscores a critical need for systemic change. Insights from experts like Dr. García highlight the urgency of adopting innovative solutions, advocating for meaningful policy reforms, and preparing for future trends that will impact drug availability and treatment efficacy. As the medical community continues to navigate these challenges, proactive measures and continued advocacy are essential to improve patient care and outcomes in oncology. While the obstacles posed by drug shortages and complex authorization processes are formidable, they are not insurmountable. With strategic implementation of systems like gold carding and improvements in drug supply chain management, the oncology field can better serve patients by ensuring timely access to necessary treatments. Continuing innovation and systemic changes are vital to shift the focus back to what matters most—providing optimal care to every patient. Clinicians and coders alike are encouraged to participate in the advocacy process. Giving tours of your facilities to local government representatives as well as national congressional and senate representatives from your state is vital to get knowledge into the hands of those who can create practical laws that can help us care for our patients in an efficient, effective and cost-conscious manner. Have you taken the time to identify your representatives by location? You may be surprised to find out the positive interest they have in helping their constituents and simultaneously educate yourself in how to make a tangible difference for our country and our patients. Find your local representative: https://www.congress.gov/members/find-your-member Sources
Impact of Drug Shortages on Consumer Costs | RAND Getting Medical Pre-approval or Prior Authorization | American Cancer Society Value-Based Payment Models in Oncology: Will They Help or Hinder Patient Access to New Treatments? (ajmc.com) “Gold card” approach to prior authorization introduced in Congress | American Medical Association (ama-assn.org) The Cost Of New Cancer Drugs Is Increasing | Managed Healthcare Executive Find Members | Congress.gov Comments are closed.
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