Spotlight on Market Access

The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.

As precision medicine continues to evolve, companion diagnostics (CDxs) are increasingly being used to guide sometimes life-or-death treatment decisions. Their aim is to improve clinical outcomes by using predictive biomarkers to target patients, especially those with cancer, who could respond well to particular therapeutics. But industry experts cite a disconnect at times between FDA approval and payer reimbursement, slowing the potential impact of a burgeoning array of CDxs and prompting pharma companies to take proactive steps to market them.

MMIT’s FormTrak solution allows pharma companies to keep providers updated with real-time, accurate data about coverage for their brands — a critical step in ensuring a therapy gets to patients who need it. Now it’s even easier to communicate new coverage wins to healthcare providers, with FormTrak’s native integration with Veeva CRM.

The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a treatment regimen. But in a therapeutic class with limited therapeutic options, the approvals are a welcome addition, particularly in the second-line setting.

The FDA recently approved a third agent to treat paroxysmal nocturnal hemoglobinuria (PNH). With some conditions, that number of treatments may prompt payer preferencing, but that is unlikely to happen with this ultra-rare, potentially fatal disease, observe industry experts.