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Removing Access Barriers for Long-Acting Injectables

By Brian Quirante

The past few years have seen an increase in the number of long-acting injectable (LAI) therapies for a variety of disorders and diseases, including schizophrenia, bipolar disorder, and HIV. These LAI antipsychotics and antiretroviral therapies include brand-name drugs such as Invega Sustenna (paliperidone palmitate by Jannsen), Abilify Maintena (aripirazole by Otsuka), and Cabenuva (cabotegravir/rilpirivine by ViiV).

Manufacturers with LAIs in the pipeline will need to be mindful about the persistent barriers to access faced by drugs with this formulation. Manufacturers with a comprehensive market access strategy will likely need to invest heavily in provider education and prioritize the collection of real-world data to make a strong case for payer adoption of their therapy.

Benefits of the LAI formulation

With a long administration interval ranging from two to twelve weeks, LAI therapies were specifically developed to improve medication adherence in patients accustomed to taking daily, short-acting oral medications. Many manufacturers and providers believe LAI therapies can potentially decrease overall healthcare costs by reducing hospitalizations and the worsening of disease. In a recent study comparing the treatment of more than 70,000 patients with schizophrenia over a 16-year time period, researchers found that patients treated with LAI antipsychotics were 37% less likely to be hospitalized than patients treated with oral antipsychotics.

The convenience of receiving monthly or bimonthly injections rather than remembering to take a daily pill can also improve patients’ overall quality of life. In a pivotal study for Cabenuva, the first FDA-approved LAI antiretroviral medication for the treatment of HIV/AIDS, 98% of patients with no previous Cabenuva use preferred injections every other month over daily oral medications.

As LAI psychiatric drugs have been around for much longer, they have garnered a favorable standing with payers. Many of these products have gained favorable formulary placement, with payers noting factors such as fewer side effects versus oral medications, improved cognition, and reduction in psychiatric episodes. However, cost remains a limiting factor for payers, as LAI products are much more expensive than comparable oral medications.

Current barriers for LAI therapies

Although there are many benefits to LAIs, several barriers continue to exist for both patients and payers in adopting LAIs as a preferred method of treatment.

Many patients are hesitant to switch to an injectable formulation due to societal stigmas around the route of administration, as well as a fear of pain related to injections. Cost also remains an issue, as branded injectable agents are typically more costly for the patient compared to oral medications, especially generics.

Another issue, which was magnified during the COVID-19 pandemic, is that LAI therapies require administration by a healthcare professional. At the height of the pandemic, patients were hesitant to leave their homes, and healthcare providers faced staffing issues. While patients might prefer to go to a local pharmacy to receive their injection, LAI therapies typically require administration by a specialist or primary care provider to ensure the medication is dosed properly and is working as intended.

For payers, despite the comparable efficacy and safety of LAIs, cost remains a barrier to access. According to MMIT’s PAR Analytics data, almost half of all health plans require prior authorization, and/or the trial and failure of other regimens, before a patient can begin treatment with Cabenuva. More than 50 million lives are represented by payers who do not cover the medication at all.

Increasing patient access to LAI drugs

Patient advocacy and education is imperative for the success of an LAI therapy. Providers must provide encouragement for patients to switch to a formulation that would be more beneficial in the long run. As research indicates that providers may misjudge their patients’ willingness to receive LAI therapies, manufacturers may have an opportunity to significantly increase prescribing behavior with a targeted provider education campaign. As patients will also need strong social support systems in place to help with issues like copay expenses and transportation to a healthcare provider, manufacturers should consider establishing patient support hubs to better connect patients with available resources.

Manufacturers that collect and show payers real-world data for their LAI products are more likely to have success achieving preferred treatment status. For LAI antipsychotics, for example, real-world data can indicate that patients are not only more compliant, but also less likely to be admitted to the hospital for psychiatric reasons.

MMIT research also shows that payers are receptive to pharmacoeconomic analyses, and often discuss the results of these analyses in P&T committee meetings. A thoughtful cost-benefit analysis, which compares the total cost of interventions with multiple outcomes, can prove the cost effectiveness of LAI products over the long term.

In addition, manufacturers can lean on ratings data to help open the door for payers to willingly adopt long-acting injectables for patients when appropriate. For example, Healthcare Effectiveness Data Information Set (HEDIS) measures, which outline various factors used to rate health plan performance, identify schizophrenia medication adherence and other mental health priorities as key elements of a health plan’s effectiveness.

Developing an LAI therapy? Learn more about tracking granular policy and restriction data with MMIT’s Analytics solution.

© 2024 MMIT
Brian Quirante

Brian Quirante

Brian Quirante, PharmD, is a Senior Consultant, Advisory Services at MMIT.

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