The pharmaceutical reimbursement formulary system is intended to promote rational, clinically appropriate, safe and cost effective drug options for plan members. The key managers of this system are pharmacy benefit managers (PBMs) and managed care plans. The drug formulary system provides a mechanism for patients to access drugs under a "tiered" coverage system. In order for a plan to provide coverage for a new drug, or device marketed as a drug, the product must be listed or "available" under the formulary system, or an exception for coverage be made based upon a clinical review or prior authorization.
New drugs must be introduced to payers including governmental and non-governmental plans. Medicare develops a national drug formulary that is the primary resource for Medicare Part D plan coverage. The Medicare national formulary lists drugs that are required to be provided by Medicare Part D contractors, however, these contractors have the flexibility to add additional drugs not listed on the national formulary. Many devices cleared by the FDA are distributed as drugs through the pharmacy network, but not listed on national formularies, including Medicare.
Medicaid plans are managed by a national rebate agreement for state managed fee for service patients, and state managed care plans manage the pharmaceutical benefit through a managed care program. To add coverage for Medicaid beneficiaries the complex environment of fee for service with a managed care mix makes this coverage even more complex to navigate.
Pinnacle works directly with pharmacy benefit managers (PBMs), managed care plans, FSS, Medicaid state programs and Medicare Part D contractors, on behalf of manufacturers, to add new drugs and devices to the plan formularies so patients may have access to these new products under the pharmacy benefit. Understanding that the formulary system principles are applied to new drugs and pharmacy distributed devices and working within the payers plans to add these products to a covered benefit list for patients is key to achieving sales and marketing objectives for these products.
The Pinnacle Health Group has successfully:
- Developed strategic plans for coverage of new drugs and pharmacy distributed devices;
- Worked directly with managed care plans and PBMs to add drugs and devices to standard formularies;
- Presented formulary products to plan and PBM pharmacy and therapeutic (P&T) Committees for coverage and tier assignment consideration;
- Provided support for the development of Academy of Managed Care Pharmacy (AMCP) formatted documentation for formulary approval support;
- Sales and Marketing reimbursement education programs
- Negotiated discount and rebate agreements on behalf of manufacturers; and
- Provide pharmaceutical coverage education for sales and marketing to provide a clear understanding of the formulary coverage and payment system.
Appropriate coverage and payment support the formulary systems that ensure that patients have access to clinically appropriate, safe and cost effective therapy within a sustainable drug benefit program. The Pinnacle Heath Group works directly with all key stakeholders within this system to expedite the listing of these new drugs and pharmacy distributed devices to provide coverage and appropriate payment.