Navigating the world of specialty biologic drugs

Navigating the world of specialty biologic drugs. A top challenge for specialty drugs category has been the complexity of treatment plans for patients, especially in context of managing chronic health conditions with a specialty biologic drug. The problem emanates from opaque and complex care delivery mechanisms to administer the drug and manage frequent approvals and coverage considerations.


A patient is highly likely to be in the care a chronic health condition specialist and a family physician at the time of receiving a prescription for a specialty biologic drug. The pathway to speciality drugs usually involves a series of random treatment alternatives with unpredictable and inconsistent outcomes from patient to patient. Some new prescription drugs may require prior authorization from a provincial health program or their insurer while others may not. Moreover, the drugs are likely to have been ingested instead of requiring special handling or temperature controls.


A key strategy of specialty biologic companies has been to offer patient assistance programs (PAPs) for patients whose treatment plans may include the use of specialty drugs. These PAPs may include a financial assistance component for patients and may include patient education and support. Patient assistance programs often start with an education session with new patients about the specialty drug and process of purchase and use since most are delivered by intravenous at one of three locations: infusion clinic, at a hospital, or by injection at home. The complexity of adjusting to these variables can be daunting for patients and thus, the process of PAP education to provide patients with the right information regarding private drug coverage will accelerate the authorization process.


Patient assistance programs have another benefit after provincial health and private drug plan coverage begins – it helps to increase compliance levels of drug use and also regular check-ins on therapy monitoring and side effect tracking. The programs also increase communication between the prescribing specialist for dosing and medical test scheduling which are essential treatment monitoring mechanics. An example may be a commination of antibiotics for bronchitis during an infusion. In such a situation, the program clinician would connect with the patients physician to ensure the biologic drug infusion is scheduled at the appropriate time to reduce wastage.


An important trend is self-delivery of specialty drugs. In such cases, the patient is trained to self-administer the drug by the PAP nurse. This process includes a robust education component and ongoing monitoring of the patient. The focus of the process is to improve patient health outcomes with education, monitoring and follow up. Another consideration is a requirement for lower cost therapies unrelated to the drug brand.  This allows PAPs to decide on the appropriate drugs from a range of available options.


The goal of insurance programs should be to focus their communication on the PAP to ensure qualified care givers screen, monitor and deliver information to patient to manage medication risk and better health outcomes.  to integrate with PAPs without duplicating services or creating more work for the plan member. Another emerging step is to coordinate pharmacy set­up with the insurers requirements where a provider network or pricing preference is in place. This may allow for greater flexibility in terms of financial support options for patients and augment information flow regarding treatment options and care mechanisms. An important consideration for Plan managers is to ask about authorization processes and financial support mechanisms to ensure the patient experience is not compromised.


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