During the Early Pre-Launch Phase (see Blog entry 5 for a breakdown of phases), while the overall pharma launch strategy is being developed, one of the key items is whether or not a Reimbursement Hub is appropriate or necessary for your orphan drug or specialty pharmaceutical product. As described in an earlier post, using our trademarked BCSDS – the BioSolutia Commercialization Strategy Development System, will help determine the answer to this question – is a Reimbursement Service Hub needed for my product? The answer is based on a critical review of the needs of the 5 key stakeholders and the 15 key characteristics of your orphan drug or specialty pharmaceutical product.
BioSolutia Reimbursement Hub Services Call Center
In a situation where a Reimbursement Hub is indicated or even required due to various product characteristics, this is also the time where data needs in addition to reimbursement hub services design should also be determined. We’ll talk about data needs in a future post (see blog entry 7).
Reimbursement Hub Services Needs and Design
Reimbursement Hub Services needs and design should be a function of:
Products Characteristics: For example:
- Dose age form – oral solid, liquid, self-injectable (SC or IM), infused, etc
- Temperature – room temperature, refrigeration necessary, extremely labile, etc
- Inventory control – long manufacturer lead time, plasma-based, complex or simple manufacturing process. In-house or contract manufacturer. A Reimbursement Services Hub can help track or monitor inventory needs.
- Product’s Reimbursement Characteristics: For example:
- Coverage type: PBM, Major Medical or combination
- Prior Authorizations – What is the expected PA rate? Low, Medium or High? Who is doing the PA review (PBM or Major Medical)? What is the expected level of complexity of the review? What is the expected denial rate and how will appeals be handled? By a Reimbursement Services Hub or simply left up to the prescriber’s office staff? What is the level of Reimbursement Services Hub support is expected by prescribers or required to get the desired PA approval outcomes?
- Payer interaction – What specific level of interaction with payers do you want the Reimbursement Hub to have? How will the individual Reimbursement Hub interactions with payers be coordinated with your overall Managed Market/Payer Strategy?
- Patient Financial Support Services: For Example:
- Copay Assistance – copay cards, third-party foundation, level of Reimbursement Hub involvement? What are the financial parameters?
- Patient Assistance (PAP) – third-party foundation, level of Reimbursement Hub involvement? What are the financial parameters?
- Other items as identified through the trademarked BCSDS – the BioSolutia Commercialization Strategy Development System process.
So overall, you can easily see there are many potential areas where a Reimbursement Services Hub can impact the success of your orphan or specialty pharmaceuticals drug launch.
A new era in specialty pharmacy – Higher priced meds will require high-touch care, a role that the Reimbursement Hub plays.