Formulary Management
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Drug Use Management |
AMCP recognizes the value of drug use review (DUR) as a means to understand, interpret, evaluate, and improve the prescribing, administration, and use of medications to improve patient outcomes and total cost of care. Using DUR information, managed care pharmacists can identify prescribing trends and initiate corrective action in collaboration with appropriate stakeholders to improve drug therapy for groups of patients, as well as individuals.
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Formularies 02/08/2017 Revised 04/23/2018 Revised 03/25/2019 Revised |
AMCP supports the use of appropriately designed formularies as quality-enhancing, cost-effective pharmaceutical care tool that meets the needs of the patient population and assist members of the health care team in effectively managing a patient's total medical care regimen. Formulary coverage decisions are based primarily on sound clinical evidence. Cost should be considered only after safety, efficacy, therapeutic need and patient outcomes have been assessed. The value of a formulary is maximized when it is part of an integrated patient care process and integrates with other health care management tools, such as drug utilization review and medical treatment guidelines. The overall formulary system encourages physicians, pharmacists, and other care givers to work together to ensure positive outcomes and cost-effective results.
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Generic Drug Products |
AMCP encourages pharmacists and managed health care systems to promote the use and benefits of FDA-approved and therapeutically equivalent generic drug products as safe, effective, and cost-effective alternatives to brand-name equivalents. AMCP supports legislative and regulatory changes that would promote the development and use of safe, efficacious and equivalent generic drugs and eliminate barriers that can unnecessarily delay the entry of the generic drugs into the marketplace. AMCP believes that Congress must ensure that the FDA has access to adequate resources in order to review and process applications for generic drugs and eliminate unnecessary delays of their approval. AMCP opposes state and federal legislative and regulatory provisions that would restrict the right of pharmacists, in collaboration with prescribers and patients, to exercise their professional judgment in choosing the most appropriate generic or brand-name equivalent products for patients.
(See AMCP Where We Stand Position Statement – Generic Drugs)
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Interchange of Narrow Therapeutic Index (NTI) Drugs |
AMCP supports the Food and Drug Administration's (FDA) position that when an FDA-approved and therapeutically equivalent generic drug is selected, patients, physicians, and pharmacists can be assured that they will see the same clinical results and safety profile as with the equivalent brand name product. Therefore, NTI drugs should not be considered as a separate category for purposes of generic substitution. AMCP believes that pharmacists, in consultation with prescribers, should have the right to use their professional judgment and knowledge of the available scientific information in determining when to substitute a generic product.
(See AMCP Where We Stand Position Statement – Interchange of Narrow Therapeutic Index (NTI) Drugs)
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Off-Label Use of Pharmaceuticals 02/21/2021 Revised |
AMCP supports off-label use of FDA-approved products when medically appropriate and necessary, but opposes government-mandated coverage of specific pharmaceuticals and related products, whether for FDA-approved or off-label uses. AMCP supports having managed care organizations and third-party payers consider the following criteria before deciding whether to provide coverage of FDA-approved products for certain off-label uses: • The product has been proven effective and accepted for the treatment of the specific medical condition for which it has been prescribed according to the current edition of nationally recognized compendia, including American Hospital Formulary Service - Drug Information® (AHFS-DI®), Thomson Micromedex DRUGDEX®, Clinical Pharmacology, or the National Comprehensive Cancer Network (NCCN) Drug and Biologics Compendium™. • The product is recommended specifically for the condition, and has been proven to be safe and effective for that condition according to reproducible formal clinical studies, the results of which have been published in peer-reviewed evidence-based medical literature. Randomized controlled trials are preferred over observational research or case studies.
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Pharmacist's Role in Formulary Management
11/01/1999 Introduced 03/01/2004 Revised 12/01/2008 Revised 10/01/2010 Reapproved 04/12/2021 Revised |
AMCP supports the use of an appropriately designed formulary as a quality-enhancing, cost-effective pharmaceutical care tool that meets the needs of the patient population and assist members of the health care team in effectively managing a patient's total medical care regimen. AMCP further recognizes that pharmacists are key to the success of formulary management. Pharmacists determine the P&T Committee agenda; analyze and disseminate scientific, clinical, and health economic information for P&T Committee member review; follow-up with research when necessary; and communicate P&T Committee decisions to health plan prescribers, other health care professionals, and patients.
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Therapeutic Interchange 03/25/2019 Revised |
AMCP supports the use of evidence-based therapeutic interchange programs as a part of a comprehensive approach to quality, cost-effective patient care. AMCP believes that therapeutic interchange may improve the patient's access to more affordable health care and represents an efficient use of pharmaceutical resources that helps keep medical costs down. The therapeutic interchange programs are designed to work in conjunction with other tools that health care professionals use to promote quality medical outcomes, and increase affordability to patients and payers. Therapeutic interchange is not always about simply lowering the medication costs; however, therapeutic interchange frequently occurs when overall health care savings can be achieved. There are instances where replacing one drug with a more costly drug may result in fewer treatment failures, better patient adherence to the treatment plan, fewer side effects, and improved clinical outcomes, which could result in lower overall health care spending. |
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Best Practice Principles
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AMCP supports identifying, recognizing and exchanging best practices in managed care pharmacy in all practice sites. Furthermore AMCP supports the inclusion of best practice principles in mentoring and preceptor programs. |
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Development of Quality Performance Measures
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AMCP recommends the continued development of standardized and reproducible evidence-based quality performance measures that are fair, attainable, meaningful, reproducible, and relevant. AMCP partners with complementary organizations to ensure alignment of all health care stakeholders in the pursuit of measures to improve the quality of patient care. |
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Prescription to Over the Counter "Rx-to-OTC" Switches Policy 0108 03/01/2001 Introduced |
AMCP supports the Food and Drug Administration’s regulatory process that allows the marketing of over-the-counter (OTC) drug products which were previously available by prescription only. In the process of determining whether a drug product should be classified as prescription only or available as OTC, AMCP encourages that: (1) a range of stakeholders such as health care providers and managed care organizations be included in the evaluation process; (2) procedures to initiate petitions to switch drugs from one status to another be available to stakeholders; and (3) stakeholders take an active role in the FDA's scientific and clinical evaluation of drugs potentially eligible for OTC status. |
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Patient Adherence and Persistence 04/07/2015 Revised
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AMCP supports programs that encourage patients to adhere to prescribed treatment regimens and continue those regimens (persistence) for maximum therapeutic benefit. Programs should be developed with knowledge of the patient's history, value for the prescribed treatment, and expected positive therapeutic outcome. AMCP believes that the pharmacist, as the medication management professional, has an important role in this process. Such programs should use comprehensive communications and evidence-based approaches to support patient adherence and persistence. |
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Utilization Management |
AMCP supports the role of utilization management in the provision of quality, cost-effective prescription drug benefits. The fundamental goal of utilization management is to promote the appropriate and cost-effective use of medications and optimize patient outcomes. Pharmacists in all practice settings must work collaboratively to develop specific policies and procedures to ensure that the utilization management process is administered in the most efficient manner possible, is fully compliant with statutory and regulatory requirements and provides members, pharmacists and prescribers with an evidence-based, rational process to promote appropriate drug use. Examples of utilization management strategies used within a prescription drug benefit include, but not limited to, prior authorization, step therapy, quantity management, drug utilization review (DUR), channel management strategies, and the application of a formulary management system (See AMCP Concepts in Managed Care Pharmacy – Prior Authorization). |
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Comparative Effectiveness of Prescription Drugs |
The purpose of comparative effectiveness research is to assist consumers, clinicians, purchasers and policymakers to make informed decisions that will improve health care at both the individual and population levels. The Academy supports research and the development of practical tools to provide guidance on the comparative effectiveness and value of prescription drugs to improve patient outcomes. Recent legislation, including the Affordable Care Act, has directed new funding toward this research. The Academy believes that the federal government must continue to assume principal responsibility for sponsoring this type of research. Such research is a fundamentally necessary component of any rational approach to determining the value and usefulness of prescription drugs. Currently, only limited authoritative research exists that distinguishes the effectiveness and safety profile offered by any particular drug as compared to other drugs in the same or a similar treatment class. The Academy believes that patient treatment decisions must take into account the clinical effectiveness and safety of prescription drugs and that a decision to utilize prescription drugs must be based upon the strength of credible scientific evidence and best practices.
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Pharmacy & Therapeutics (P&T) Committees-Advisory Role
Policy 0602 |
AMCP recognizes that the clinical staff of a prescription benefit management (PBM) company or health plan is professionally responsible for the formulary and clinical decisions of the plan. Therefore, AMCP believes each organization that uses a pharmacy and therapeutics (P&T) committee should designate whether the committee’s decisions are advisory or binding.
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Decision-making in the Absence of Evidence-based Data
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AMCP recommends that managed care organizations exhibit due diligence in information gathering and document the rationale for decisions related to coverage in the absence of evidence-based data. |
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Maximum Allowable Cost (MAC) Pricing |
AMCP believes that government regulation of prescription drug pricing, regardless of its structure, would have an overall negative impact on consumer cost, quality, and access to health care benefits. Legislation that allows the government to dictate reimbursement terms of a private contract between a payer and a pharmacy or that mandates that the payer disclose proprietary pricing methodology is not an appropriate focus of government regulation. Further, AMCP believes that competitive negotiations between parties are more likely to provide fair and equitable reimbursement on drugs dispensed. AMCP does not support the intervention of government into private contracts to require payers to advise pharmacies on where to purchase their drugs; that is an unnecessary and inappropriate intrusion into the private arrangements of a pharmacy with its supplier. This type of government mandate takes away the incentive for a pharmacy to make wise purchasing decisions. The payers and consumers will not benefit from a system of government mandated payments to a private entity; rather it will decrease competition and further drive up the cost of the prescription drug benefit.
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Co-payment Offset Programs
02/01/2013 Introduced |
AMCP is supportive of programs that help patients afford their prescription drugs. However, some programs can needlessly encourage the use of more expensive brand-name products over their generic counterparts. They can also undermine the formulary development process by encouraging the use of products that have lower cost therapeutic alternatives. Patient safety can also be threatened when prescriptions are frequently transferred between retail pharmacies. Therefore, AMCP is opposed to manufacturer coupon programs that are promotional in nature and are not means-tested.
(See AMCP Where We Stand Position Statement – Co-Payment Offset Program) |
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Regulation of the Prescription Drug Benefit
Policy 1402
10/07/2014 Introduced 04/12/2021 Revised |
AMCP recognizes that government should encourage an environment in which managed care pharmacists continue to develop innovative and integrated strategies to manage prescription drug benefits for a given patient population. AMCP supports statutory and regulatory efforts that will continue to enable the ability of managed care pharmacists to consider the range of clinical, legal, quality-of-life, safety, and pharmacoeconomic factors which form the basis for the design and implementation of effective drug benefit strategies and programs. However, the Academy opposes statutory and regulatory proposals that unduly restrict the ability of managed care pharmacists from using proven tools and practices, such as drug utilization review, formulary management, utilization and network management, that are essential for the management of a prescription drug benefit. These types of proposals are objectionable if they go beyond procedural protections and enter an arena traditionally within the purview, expertise and experience of health care professionals. Unnecessary or overly burdensome regulatory restrictions could place patients at risk and increase the cost of health care. The result could compromise the availability and affordability of the prescription drug benefit.
(See AMCP Where We Stand Position Statement – Regulation of the Prescription Drug Benefit) |
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Value Based Contracts
Policy 1801
04/23/2018 Introduced |
AMCP supports the development of value-based contracts (VBCs) as an innovative means of shifting health care payment models from focusing on volume to focusing on value. The shift in payment models is expanding beyond the delivery of health care services to encompass models of compensation between payers and biopharmaceutical manufacturers. VBCs have emerged as a mechanism that payers may use to better align their contracting structures with broader changes in the overall health care system. A value-based contract is a written contractual agreement in which the payment terms for medication(s) or other health care technologies are tied to agreed-upon clinical circumstances, patient outcomes, or measures. AMCP is committed to advocating for legislative and regulatory changes when necessary to address barriers to the optimal execution of VBCs. |
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Pharmaceutical Information Exchange
Policy 1804
02/21/2018 Introduced 12/11/2020 Revised |
AMCP supports ongoing bi-directional exchange of information between health care decision-makers and pharmaceutical manufacturers in advance of FDA approval of products to ensure effective planning, budgeting, and forecasting for benefit development. |
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