Formularies

Formulary Clinical Benefits

Begin with FDA approved indications & synopsis of efficacy & safety information Summarize proposed therapy in terms of 1. Efficacy & effectiveness 2. Safety & tolerability 3. Shortcomings of currently available tx & unmet need that proposed therapy will meet

What are the two types of formulary design

1. Closed - Non-formulary drugs are not covered under the plan 2. Open - Non-formulary drugs are covered under the plan but are reimbursed at a higher copayment tier

FLIP project- six questions

1. Evidence of need: Is there compelling evidence of a need to add this drug to our formulary? 2. Efficacy: What is the strength and quality of evidence to support claims for this drug? 3. Safety: What safety issues need to be considered? 4. Misuse impact potential: If placed on the formulary, what is the potential for misuse or overuse? 5. Cost Issues: Can we justify the cost of this drug? 6. Decision-making information, calculations, timing and process: What is the quality and completeness of evidence, and deliberations of committee?

What are the setting that a formulary is used

1. Hospitals 2. Managed Care Organizations (MCO) 3. Pharmacy Benefit Managers (PBM) 4. Government agencies (Medicaid, VA system)

Formularies are used by

1. Managed Care Organizations -Insurance plans -National Health plans 2. Health systems -Individual hospitals -Groups of hospitals

Pharmacy & Therapeutics Committee (P&T) is usually comprised of

1. Physicians 2. Specialists 3. Pharmacists May also include: 1. Administrators 2. Nurses 3. Safety officers 4. IT analysts

Publishes "A format for submission of Clinical & Economic Evidence of Pharmaceuticals in Support of Formulary Consideration"

Academy of Managed Care Pharmacy (AMCP)

Within a health system

Additional issues such as workload might be considered: Whose work will change? How do they feel about it? Is it safe? Does it shift work from one department to another? Can they handle it?

Cost Implications

Can we justify the cost of this drug?

What evidence should be considered?

Clinical benefits Economic benefits Product description Place in therapy Health System procedures

"The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care" -IOM

Comparative Effectiveness Research

Formulary Economic Benefits

Cost per unit Context of proposed cost including potential quality of life benefits & savings or cost offsets Shortcomings of other therapies ICER or PMPM

Formulary Economic Impact

Cost-effectiveness models Budget impact models Financial models Sensitivity analysis

Why is a formulary beneficial

Discounts (i.e. rebates) offered by manufacturers for formulary positioning of their products allow for savings

Does Accountable Care give pharmacists new opportunities?

Example: Oncology Compare drugs, radiation, devices, surgical interventions Campaign to remove silos & compare all treatments based on 1. Value analysis 2. Financial & Clinical 3. Outcomes

A list of drugs approved for use in a given setting

Formulary

Formulary Leveraged Improved Prescribing Project (FLIP)

Formulary committee members & chairs from two public teaching hospitals & a university-based school of pharmacy US Attorney General Consumer and Prescriber Education Grant Program and US Agency for Healthcare Research and Quality Initial funding from Neurontin settlement

Formulary Product description

Generic, brand name & therapeutic class Basic package insert type information Place of the product in therapy, including: 1. Disease description 2. Approaches to treatment 3. Any treatment guidelines or consensus statements from national or international bodies 4. Pharmacogenomic tests & evidence

Open formularies 4-tier

Generics are on the lower copayment tier Preferred brands are on the 2nd copayment tier Non-preferred brands on the 3rd copayment tier High cost or specialty products are available at the 4th tier at a co-insurance i.e. $5 copayment for generics, $20 copayment for preferred formulary brands, $50 copayment for non-preferred brands, and 25% co-insurance for high cost specialty products

Open formularies 2-tier

Generics are on the lower copayment tier, brands are on the higher copayment tier i.e. $5 copayment for generics, $20 copayment for brands

Open formularies 3-tier

Generics are on the lowest copayment tier Formulary brands are on the middle copayment tier Non-formulary brands are on the highest copayment tier i.e. $5 copayment for generics, $20 copayment for formulary brands, $50 copayment for non-formulary brands

Who does these analyses?

Health Systems The government (CMS) DOD - Department of Defense Managed Care Organizations Nursing homes

Misuse impact potential

If placed on the formulary, what is the potential for misuse or overuse?

Evidence of Need

Is there a compelling need to add the drug to our formulary?

Department of Defense formulary

Military Treatment Facilities (MTFs) MUST have on formulary All BCF medications All ECF medications if the therapeutic class is on the MTF formulary Medications that are on the Uniform Formulary, but not on the BCF or ECF MAY have on formulary Medications in classes not yet reviewed by the DoD P&T Committee for the Uniform Formulary, unless not allowed by a national pharmaceutical contract MTFs MUST NOT have on formulary Medications designated as non-formulary under the Uniform Formulary Medications that are not allowed on MTF formularies due to a national pharmaceutical contract. Contracts currently exist for: statins, LHRH agonists, fluoroquinolones, and triptans

Evolution

Originally used in the early 20th century as a method to manage and control inventory -Fewer drugs on the shelves for the same indication Later it was used as a negotiating tool with drug manufacturers -Drugs not on the formulary would either not be available or would be available at a higher copayment, thus encouraging higher market share for the formulary drugs

_________ may be incorporated into the review process to determine overall cost-effectiveness

Pharmacoeconomic models

Meets regularly to review newly available drug therapies and treatment options

Pharmacy & Therapeutics Committee (P&T)

Summary

Recommendation Include or not? Restrict use? Tiered approach?

Medication safety coordinator

Reports on errors/trends Checks database for previous issues Checks national database for issues with new product Adverse drug events

Department of Defense Formulary Information - Basic/Extended Core Formulary (BCF & ECF)

The Basic Core Formulary (BCF) is a list of medications required to be on formulary at all full-service Military Treatment Facilities (MTFs). BCF medications are intended to meet the majority of the primary care needs of DoD beneficiaries The Extended Core Formulary (ECF) includes medications in therapeutic classes that are used to support more specialized scopes of practice than those on the BCF MTFs may choose whether or not to include an ECF therapeutic class on formulary, based on the clinical needs of its patients However, if an MTF chooses to have an ECF therapeutic class on formulary, it must have all ECF medications in that class on formulary

Future?

The use of: 1. Pharmacoeconomic evaluation 2. Pharmacogenomic evaluation 3. Outcomes analysis

What is the The P&T committee also involved with

Therapeutic Substitution Programs Pharmacy Education Programs Drug Utilization Reviews Pharmacy Quality Assurance Shortages & allocations

Summary of Key Clinical Studies

Trials Endpoints Published & unpublished studies supporting labeled indications Data supporting off-label indications CDER safety information

Efficacy

What is the evidence to support the claims for this drug?

Decision-making information, calculations, timing, and process

What is the strength and quality of evidence and information available to the Committee?

Safety

What safety issues need to be considered?

IT issues

What type of warnings will be seen? Who sees? Who can override? Restricted drugs?

A formulary is evaluated at a therapy class level and must be

clinically complete and up-to-date

The P&T committee is responsible for

developing, managing, updating and administrating the formulary

Drug selection is first based on

efficacy and safety

Formularies continue to be a method to control

escalating drug costs

The ________ dictates which prescription drugs/classes will be covered and/or the level of coverage (i.e. patient copayment)

formulary

As __________ expanded, formularies became more complex and more prevalent

managed care

Formularies are distinguished by

product availability

With all things being equal, selection will consider

the cost of the drug and the rebate offer from the manufacturer

Influenced by current

therapy guidelines

Open formularies use copayment _______ to drive product selection

tiers