TLDR: Prior authorizations (PA) often delay necessary treatments, causing adverse outcomes and frustration from the patient and HCP communities. Pharma companies try to help, e.g., by providing checklists on how to apply for PAs. However, according to studies, the problem remains unsolved.
Prior authorizations (PAs) are a process where a health care provider must obtain approval from a patient’s insurer before prescribing a specific medication. Originally designed as a tool for insurers to prevent suboptimal prescription practices, PAs have faced increased criticism as studies and anecdotal stories have shown:
- Treatment delays, leading to serious adverse events and in some cases death (Source)
- High administrative burden, with extensive forms to be filled out manually and required to be submitted via phone or fax (Source)
- Unpredictability of PA decisions and rejections for unclear reasons (Source)
- Horrible patient experience of waiting, uncertainty, frustration and stakeholder management (Source)
- Policy: Following pleas from professional associations (esp. AMA) and patient groups the Biden administration has made several advances promising to increase speed and transparency for prior authorizations - but only for federal insurers and only for medical devices and services (leaving out drugs). Observers speculate that clamping down on prior authorizations more holistically could take a back seat to other policy initiatives such as the inflation reduction act (Source).
- Digital solutions: Several startups are offering solutions that help providers compile PA applications, submit them electronically and follow up. Examples include referralMD, Akasa and SamaCare. Most of these solutions seem focused on preventing process lapses (e.g., wrong coding of the disease) and less on supporting the provider to tailor a convincing PA application for a specific combination of therapy and patient.
- Physician support programs, checklists and guides: Most pharma companies include various guides for providers to navigate the PA process. The best versions are product-specific and include a wealth of ready-to-use arguments for a specific therapy, going beyond generic process support. Novartis' materials stand out here (see Leqvio example below). However, if a physician wants to use their "sample letter of medical necessity", they would have to visit the Novartis physician portal, find the PDF, copy and paste the letter in WORD, completely reformat it and then fill in the brackets, etc. Novartis, like others, offers physician support programs and representatives eager to help, but whether providers are able to integrate externals into their daily processes may vary across practices.
- It should ideally be accessible for all providers, including the long tail of smaller practices not able to afford high-end digital solutions
- It should reduce the process burden of creating, tracking, and following up on prior authorization submissions
- It should prevent clerical errors, including wrong or missing basic information (ICD-10 code, patient age, ...), submission to incorrect recipients, forgetting to follow up, etc.
- It should provide content guidance, predicting likely rejections, selecting strong messages based on the specific situation, and supporting to author easy-to-read, yet convincing prose where needed
- It should have a low user barrier of entry, integrating seamlessly into established workflows and being easy to use across staff roles
The question remains, who has the strongest incentive and the best position to fund and/or develop and/or roll out this solution - will pharmaceutical companies take lead or leave the field to entrepreneurs and tech companies?