Two critical factors that can affect the optimal product launch are Access (reimbursement) and Availability (distribution):
Access: The Payer’s willingness to reimburse for a product and the Patient’s inclination to pay their out of pocket portion.
Access is a crucial factor in optimal product launch planning. Formulary adoption, patient out of pocket costs, and restrictive barriers such as Prior Authorization and Step Therapy are all too common access issues at launch. Impressions gained by the provider through patients or pharmacies indicating the drug is either too expensive or incorrectly chosen in the treatment algorithm leaves a resounding negative effect on prescribing. Proper access launch strategies including use of 3rd Party Service Providers are central to ensure optimal commercial access of a product.
Availability: The readily obtainable or accessibility of a product at the point of service, whether in a Pharmacy (Retail & Specialty) or in a Physician’s Office.
Availability is vital to commercialization success. Failure to having a drug available when a patient presents a prescription can result in the loss of that prescription plus any future prescriptions if patients or physicians are left with an impression the drug is not available. Often it is not a case of manufacturer’s drug supply but rather the drug is not supplied through the appropriate supply chain channel. Stakeholder strategy and planning with 3rd Party Logistics Providers, Wholesalers, and Pharmacies is paramount to ensuring your product is available at the time of prescribing and dispensing.
Planning for Access and Availability should begin as early as possible, often during late Phase II or Phase III of product development.
Contact us at Prescription Alliance to speak about specific stakeholder strategies that will optimize your product availability and access outcomes.
Optimal success requires early commercial consideration of payer and supply chain channels. Manufacturers engage Prescription Alliance during late Phase II development through product launch.
A survey including 157 biotech CEOs indicates that securing insurance coverage and reimbursement is now perceived as the biggest threat to a successful drug launch.¹
“We’re seeing a shift in concern from the FDA to insurance coverage. From a company’s very early days, corporate partners and venture capitalists now want to know that if a product gets to the market, will it be reimbursed?” – Gail Maderis, CEO of BayBio1
“What we’re certainly seeing in the U.S. is a more dynamic marketplace – one where price is more of an issue, more competitive changes in contracting strategy, and switches across a whole range of therapy areas.” – Simon Dingemans, CFO Glaxo SmithKline, plc2
1.“Biotech CEOs See Insurers as the New Boogeymen, Not FDA”, FDAnews.com Drug Daily Bulletin, Vol. 10 No. 5
2.“Glaxo CFO Expects ‘Many More’ Shifts in Coverage by U.S. Payers”, Bloomberg.com, February 5, 2014
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