Reimbursement Hub

BioSolutia Selected by Kastle Therapeutics to Manage Kynamro Cornerstone Program

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Kastle Therapeutics, LLC today announced that Kastle has acquired global rights to develop and commercialize KYNAMRO (mipomersen sodium) injection. KYNAMRO is approved in the United States for use in patients with homozygous familial hypercholesterolemia (HoFH) to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC) and non-high density lipoprotein-cholesterol (non-HDL-C) as an adjunct to lipid lowering medications and diet. See the following link for the full press release:

Ionis Pharmaceuticals and Kastle Therapeutics Announce Acquisition of KYNAMRO®

Additionally, BioSolutia, Inc. with corporate offices in Lake Mary FL announced that its Pharmaceutical Services Division has been chosen by Kastle to manage the Kynamro Cornerstone Program which provides a variety of reimbursement and support services for patients taking KYNAMRO. “We are proud to have been chosen to provide strategic consulting and support services for Kastle’s first product acquisition and look forward to a successful collaboration” said Jim Long, Principal  & Co-Founder of BioSolutia. “Since 2004 our team has helped patients and their families taking specialty pharmaceuticals and orphan drugs, and we look forward to utilizing that expertise to support patients taking KYNAMRO” added Dan Desmarais, Principal  & Co-Founder of BioSolutia.

Categories:  Orphan Drug Launch StrategyPharma Launch StrategyPharma Product CommercializationReimbursement HubSpecialty Drug ConsultingSpecialty Pharmacy ConsultingSpecialty Pharmacy Distribution

Reimbursement Hub Services

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.

Reimbursement Hub Services Call Center

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:

  1. 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.
  2. 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?
  3. 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?
  4. 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.

Additional Resources:

A new era in specialty pharmacy – Higher priced meds will require high-touch care, a role that the Reimbursement Hub plays.

Tags: | Categories:  Clinical Support ProgramsOrphan Drug Launch StrategyPatient Assistance ProgramsPharma Launch StrategyPharma Product CommercializationReimbursement HubSpecialty Drug ConsultingSpecialty Pharmacy ConsultingSpecialty Pharmacy Distribution

Pharma Launch Strategy for Drug Commercialization

Numerous clients come to BioSolutia’s pharma consulting practice looking to duplicate what another product has done in terms of their pharma launch strategy eg. reimbursement support services (hub), specialty pharmacy distribution, patient assistance programs, clinical support services, etc. The issue is every pharma launch or product commercialization situation is different and requires a uniquely customized strategy. That’s where BioSolutia’s specialty pharmaceutical consulting services are different. Our expertise lies in having done over 50 pharma launches and re-launches of some of the most unique and successful products in the marketplace. You wouldn’t ask a surgeon to “just do the same thing you did on your last patient” so why would you take a “copycat” approach to your pharma launch strategy. When selecting a firm to provide pharma consulting or specialty pharmaceutical consulting, experience and the ability to develop a strategy specific for your product’s needs in your specific market situation is the key to success. That’s the BioSolutia difference.

Tags: | Categories:  Clinical Support ProgramsPatient Assistance ProgramsPharma Launch StrategyPharma Product CommercializationReimbursement HubSpecialty Pharmacy ConsultingSpecialty Pharmacy Distribution