Pharmacy & Therapeutics Society: GENERAL SESSIONS

In: Health

20 May 2010

The Impact of P&T Committee Decision Strategies: Prescription to Over-the-Counter Switches

Speaker: Celynda Tadlock, PharmD, MBA, Director of Corporate Clinical Business Operations, Wellpoint Pharmacy Management, West Hills, California.

Over-the-counter (OTC) drugs are an undervalued resource for several reasons:

  • They are easily accessible to consumers.
  • They are at least as effective as many prescribed drugs.
  • The FDA’s standards for approving OTC drugs are the same as those for prescription drugs.
  • Prescription strengths are relatively rare, so they are generally safe.
  • Consumers like to use them, because doing so enables them to actively participate in their own care.

Consumers in the U.S. spend $32 billion on OTC medications per year; 58% of health problems are treated with one or more OTC products. Older adults buy 33% of all OTC drugs, which are less costly than prescribed drugs. For instance, the average cost of an OTC item is $7.00; the average cost of a brand-name drug is $74.90.

The requirements for OTC approval are as follows:

  • acceptable safety margins
  • a low potential for misuse or abuse
  • the ability of an average consumer to self-diagnose and self-treat the condition
  • adequate labeling that consumers can understand.

P&T committees should consider the following strategies when reviewing OTC drugs: (1) encourage the use of OTC drugs as first-line treatment, (2) exclude prescription drugs at OTC launches, (3) offer member coupons and prepare member announcements, and (4) provide point-of-service messaging.

The pros of switching to OTC products are as follows:

  • increased accessibility of medications to health plan members
  • encouragement of patient self-care when appropriate
  • preservation of health care dollars to be allocated for more severe disease
  • empowerment of plan members to participate in appropriate prescription treatment decisions.

The disadvantages of OTC products include:

  • the need for significant communication with brokers, group administrators, members, and providers about changing benefits and options
  • the requirement of additional resources for customer service personnel and the need for prior authorization
  • member dissatisfaction resulting from an attitude of entitlement (e.g., to prescription drugs).

When the prescription agent Claritin (Schering) was transferred to OTC status, P&T committees in managed care organizations (MCOs) (1) removed from their formularies but still covered other nonsedating antihistamines, (2) removed all nonsedating antihistamines from their formularies, and (3) covered OTC generic products.

Many health plans discontinued coverage of the prescription version of Claritin canadian, stopped covering the entire category, charged higher copayments for the prescribed version, and covered prescribed OTC products. There was a reduced ingredient cost of 32.6% per member per month and a decreased usage of 48.8% per member per year, and Claritin’s market share dropped dramatically in 2003. There was a shift to other prescription drugs, which increased the leukotriene market from 8% to 18%.

When (omeprazole canadian, AstraZeneca) was switched to OTC status, the MCOs responded in several ways:

  • they stopped covering prescribed drugs (provided coupons, did not cover OTC items, covered OTC drugs with prescriptions, or provided coupons).
  • they moved prescription drugs to the highest tier (provided coupons or covered the cost of OTC drugs with a prescription).
  • they continued to cover prescription drugs (some provided coupons, some did not; they did not cover OTC drugs).

Making the P&T Process Work in a Challenging Economic Environment: Past, Present, and Future

Speaker: Michael T. Brodeur, RPh, Head of the Formulary Development and Pharmacy Clinical Policies Unit, Aetna Pharmacy Management.

The traditional approach taken by MCOs and pharmacy benefit managers (PBMs) to drug coverage policy and formulary management is being challenged by dynamic changes within the pharmaceutical and benefit marketplace. Increasing pressure to provide affordable and consumer-directed benefits, coupled with issues surrounding patent expiration litigation, OTC switches, and drug safety, continues to affect the P&T process.

Aetna’s P&T committee formulary decision-making process includes therapeutic class reviews and takes into account prescription and OTC status and indications, current utilization, clinical reviews of the literature, appropriateness of treatment (precertification and “step therapy”), and cost.

The P&T review includes clinical quality evaluation of the literature, by physicians and pharmacists, in terms of the drug’s safety, effectiveness, and efficacy. Clinical policy bulletins and criteria developed to support precertification and step therapy programs, as well as nonformulary drugs, are also reviewed. cialis canadian pharmacy

The national P&T committee clinical process categories I to III are also considered. These categories are used to rank the drug in question according to safety, efficacy, “breakthrough” potential, and efficacy in its class; its specific advantages; or its role as a niche product. The process consists of P&T reviews; category designation; and manufacturer contract area, which determines whether the drug adds quality for its members, whether it is cost-effective, the market share, and the drug’s additional value.

Patient safety is a key area of concern. Aetna partners with the Leapfrog Group, the Coalition for Affordable Quality Healthcare, Hospital Quality Review, and pharmacy initiatives. Aetna publishes alerts, disseminated to pharmacies, that are related to drug-drug interactions; drug-disease relationships; drug-age cautions; electronic prescribing alerts; and reports on controlled substances, drug recall programs, and polyphar-macy. Pharmacy contraindications associated with patient safety are reported to physicians.

The future of quality-driven health care will necessitate greater consumer management and responsibility for health care through increased financial contributions from consumers along with improved information and decision support tools, which should increase literacy among patients. There will also be more “cash account” models, such as health reimbursement accounts and health savings accounts. kamagra tablets

Evaluating Outcomes Evidence: Pharmaco-economics and Outcomes Study Interpretation

Speaker: Michael B. Nichol, PhD, University of Southern California, Los Angeles.

The focus of this talk was to help health plan staff and P&T committee members understand the key concepts in evaluating drugs for formulary consideration and disease-management interventions sponsored by MCOs.

Observational studies, in contrast to randomized, controlled studies, are important in outcomes comparisons. They allow comparisons among multiple treatments; however, blinding is not possible. In addition, longitudinal data are lacking, and definitions differ over time.

The problems of MCOs that affect data systems include capitation, shifting enrollment (e.g., Medicare + Choice), shifting participation by physician groups, changes in reporting, and data system alterations. There are also special problems associated with evaluating disease-management programs:

  • Not all disease-management programs are created equal.
  • Most personnel in managed care programs do not consider the literature in determining their intervention of choice.
  • The nature of the intervention might be changed part way through the program because the MCOs don’t really know what they want to achieve.

To evaluate disease-management programs, one needs to know (1) the inclusion and exclusion criteria of patients and physicians, (2) the motivation for the program, (3) when to initiate interventions, and (4) the mechanism used to accomplish the program’s goals, such as mailings, referrals to management staff, or phone contacts.
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Medication Safety Programs: Network Physicians and Integrated Health Systems

Speaker: Linda R. Young, PharmD, Drug Information Clinical Pharmacist, Lovelace Sandia Health Systems, Albuquerque, New Mexico.

The components of an integrated Lovelace Sandia health care delivery system were identified as part of Ardent Health Services. The Lovelace health plan covers four medical-surgical hospitals, a rehabilitation hospital, S.E.D. Medical Laboratories, and 15 outpatient clinics. The health care system follows the JCAHO standard MM.2.10 regulation, which states that medications available for dispensing or administration are selected, listed, and procured on the basis of several criteria:

  • the indications for their use
  • their effectiveness
  • the risks, such as their propensity for medication errors, abuse potential, and sentinel events
  • cost

This health care delivery system has several advantages: a good organizational structure; available resources; efficient communications via e-mail, voice mail, print articles, newsletters; and the ability to monitor and analyze effectiveness and compliance. The disadvantages include:
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  • the size and layers of bureaucracy.
  • the system’s inability to accommodate individual practices.
  • a greater number of people to notify.
  • the absence of a guarantee that everyone will use all of the communications systems.
  • the fact that variations might not be recognized as quickly in this type of system, compared with an independent practice.
  • a prolonged improvement cycle because of the number of people involved.

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