I am confident that Acadia is well across the issue of access and reimbursement.
- Already eighteen months ago, Acadia was seeking a Senior director of New Product Planning in Rare Disease. One of the candidate’s responsibilities was to work with Access & Reimbursement, Medical Affairs and Health Economics and Outcomes Research to develop differentiation and strategies designed to secure appropriate market access for trofinetide.
- Acadia currently has twelve positions advertised for Geographic Territory Senior Family Access Managers. The key function of these managers is to provide expert field-based access and reimbursement support within their geographic territory. Act as a dedicated point of contact between healthcare providers, hub/specialty pharmacy, payers, and Rett families for their on-label Trofinetide access-related questions. A description of key responsibilities can be found here.
- In Acadia's last Earnings Call, Steve Davis said that the company has been presenting clinical data at medical and market access congresses, highlighting the potential clinical value of proposition of trofinetide with KOLs and payers. He has previously said that discussions with both prescribers and payers had been supportive.
- Reimbursement was one of the issues mentioned here earlier this year with respect to another FDA-approved orphan drug - Sarepta’s Exondys 51. I’ve reproduced the relevant section below.
Prescription, Pricing and Reimbursement
At the time of Exondys’ approval, a survey of 101 specialist DMD physicians found that 70% were fairly convinced that the drug was sufficiently effective to justify its use.
Dosage is based upon weight. Sarepta had said that pricing would be roughly US$300,000 per year. However, annual treatment cost, based on a patient weight of 40kg, is just shy of US$900,000 per year.
The paperwork for reimbursement is described as complicated and Sarepta provides assistance with this process (I believe Acadia will be doing the same). Reported wait time for reimbursement approval was up to 3 months. Some DMD families had initial applications for reimbursement rejected by their insurance companies and subsequently launched appeals. It appears that the majority of insurance companies ultimately agreed to provide cover for the drug.
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