In many health care settings, naltrexone may not be on the formulary. This appendix provides substance abuse counselors and treatment providers who are interested in making naltrexone available for their patients with a greater understanding of the formulary system.
After a drug has been approved by the Food and Drug Administration (FDA) for treatment of a particular condition or disease, any licensed physician may prescribe it for that purpose, and any licensed pharmacist may dispense that prescription, on a patient-by-patient basis. Naltrexone hydrochloride, which was approved by the FDA in 1994 for use in the treatment of alcohol dependence, is thus theoretically available to any patient who demonstrates a need for it.
Within an integrated health care system, health maintenance organization (HMO), managed care organization (MCO), State substance abuse authority, or public health care system, however, the drug use process is more complicated. The number of FDA-approved medications is growing rapidly. The drugs themselves, as well as the ways in which they are administered, are often quite complex. Health care providers are concerned about the possibility of adverse reactions, side effects, and drug interactions. In addition, many new drugs are quite expensive, creating a need for pharmacoeconomic analyses. For these reasons, health care providers take measures to ensure that only those drugs with proven safety, efficacy, and cost-effectiveness are used within their organizations.
The formulary and the formulary system are tools that health care organizations use to improve the quality and control the cost of drug therapy (American Society of Hospital Pharmacists, 1991). A health care organization's pharmacy and therapeutics (P & T) committee has a key role in maintaining the formulary system.
The formulary is a continually revised compilation of drug products that have been approved for use within a health care organization or system (American Society of Hospital Pharmacists, 1983). The formulary, for example, of a university-based health care system may include more than 3,000 products. Much more than an alphabetical product list, the formulary provides a wealth of information about each approved product, including generic and brand names, dosage form, strength, packaging, and size stocked by a pharmacy, as well as a list of active ingredients. The formulary entry for a particular product may also include indications for use, situations in which it should not be used (contraindications), drug interactions, and adverse drug reactions. The formulary also provides information regarding organizational policies and procedures concerning drug use and other special information.
Pharmacies do not stock products that are not on their formulary. If a physician prescribes such a drug, a pharmacist is responsible for discussing the request with the prescriber and determining whether an alternative formulary product can be used. At institutions such as the University of Maryland Medical System, where pharmacists work closely with physicians on a day-to-day basis, more than 92 percent of such requests are resolved without recourse to a nonformulary product.
A formulary system is the process by which the medical staff of a health care organization, working through the P&T committee, evaluates drug products and selects those it believes will be most beneficial in the care of patients for whom it is responsible (American Society of Hospital Pharmacists, 1983).
The P&T committee is the "organizational keystone" to the formulary system (American Society of Hospital Pharmacists, 1992). Its members include physicians, pharmacists, and other health care professionals. The committee operates under the overall direction of the medical staff, and a pharmacist generally serves as its secretary. It formulates policies relating to drug evaluation, selection, procurement, storage, distribution, and use. The second major function of the P&T committee is to develop or assist in developing training programs to educate staff members on issues related to drug use (American Society of Hospital Pharmacists, 1992).
The functioning of the formulary system, as well as the formulary itself, varies from setting to setting and from State to State. The process by which a drug is added to the formulary can best be characterized by examining three typical health care settings: a university-based health care system, an HMO or MCO system, and a State health care system. The following cases are meant to serve only as examples.
The process begins when a physician submits a written request form. The generic name of the drug is used in this request. (If the product is approved, the pharmacy will decide what brand to purchase.)
The written request asks for information about indications for use of the requested drug, products used for treating the condition of interest before the new product was available, and references from the peer-reviewed primary literature and combined analyses. The request also asks for anecdotal reports concerning the requestor's use of the product and for names of colleagues who may support the request. The form requests information about the principal diagnosis for which the medication will be used and the number of inpatients and outpatients expected to receive the drug each month. The pharmacy department uses this information to prepare budget forecasts.
Submission of a request triggers a review by the pharmacy's drug information service. The result of that review is a drug formulary monograph. This monograph, often prepared by a pharmacy doctoral candidate or a pharmacy resident, consolidates input from the requesting physician, the primary literature, and data that the pharmacy has requested from the drug's manufacturer. It often contains sections regarding indications, pharmacology (the drug's source, chemistry, and action), pharmacokinetics (how the drug moves through the body), efficacy, adverse effects, drug interactions, contraindications, administration route, dosage, monitoring, and cost. The monograph concludes with a recommendation for approval or rejection of the formulary request.
In the next step in the process, a pharmaco-economic analysis of the drug product is conducted. This analysis includes both therapeutic and fiscal factors. Figure B-1 presents a model of the formulary process at a major medical center. The model is especially valuable because it offers a structure through which concerns of clinical, fiscal, administrative, and quality improvement staff may be addressed and accommodated in the formulary system.
The two key therapeutic considerations for any new product are safety and efficacy. Ideally, these are documented by controlled, randomized, clinical trials in the peer-reviewed literature. In many cases, supporting data may be scarce or unpublished, in which case anecdotal data or abstracts assume greater importance. Specific considerations that enter into these discussions are mechanism of action, adverse effects, contraindications, and drug interactions.
Limiting the number of drugs in the formulary, which has distinct economic advantages, is sometimes accomplished through the use of generic equivalents. If a generic product becomes available for a brand name product (as will eventually be the case with ReVia®), the pharmacy must decide whether the new product is equivalent to the approved product. If so, it will recommend that the generic product be added to the formulary and will strongly encourage its use.
The use of therapeutic equivalents may also help control drug costs without sacrificing quality. If, for example, there were four drugs in a class, all of which were shown to be therapeutically equivalent, the P&T committee might recommend that the institution place all four products on the formulary but stock only the least expensive product. The goal would be to stock and dispense the drug that does the greatest good for the greatest number of patients but to retain the capacity to serve the occasional patient for whom that product is for some reason unsatisfactory.
The first step in a fiscal analysis is to determine the drug's impact on the pharmacy budget. If the P&T committee determines that the drug is safe and effective and that its effect on the pharmacy budget will be neutral or positive, it will generally recommend that the product be approved.
The costs of naltrexone include the costs of the medication itself (approximately $116 to the pharmacy for a bottle of 30 tablets) and the need for baseline and follow-up liver function tests ($30 total over the 3-month period). Thus, the costs associated with a 3-month treatment episode using 50 mg daily would be approximately $370 (although the price would be higher if naltrexone were purchased by a retail pharmacy). If patients do not routinely receive physical examinations or psychiatric examinations, these would represent additional costs. While these costs may not be a problem for private practitioners whose patients can be reimbursed by insurance, they may pose real fiscal challenges for public systems in which budgets are fixed. DuPont Pharma's exclusive right to market naltrexone for use in alcohol dependence expired in December 1997. If a generic version now becomes available, the costs of treatment can be expected to decrease.
Because naltrexone is a new class of drug and will not replace existing medications, it will raise pharmacy costs. Physicians who want to add naltrexone to the formulary of their health care organization may wish to consider the application of a systemwide fiscal analysis because it may offer a better way to evaluate the cost-effectiveness of the drug. For example, the use of naltrexone could potentially result in cost savings elsewhere in the health care system (e.g., hospital care, detoxification services, domestic violence reduction) if it helps a proportion of patients avoid relapse to heavy drinking. These potential cost savings may be greatest among high and chronic users of the physical health and mental health systems (e.g., patients with serious medical illnesses that are exacerbated by drinking, patients with dual disorders).
Unfortunately, at this time, potential cost savings associated with naltrexone can only be hypothesized because formal cost-effectiveness studies have not been completed.
The P&T committee meets to discuss the monograph and the results of the therapeutic and fiscal analyses. The individual who has requested that the drug be added to the formulary is often invited to participate in this meeting. The P&T committee may also invite other knowledgeable individuals to serve as consultants. If the committee recommends adding the drug to the formulary, further financial analyses may be requested. The motion is eventually forwarded to the appropriate committees of the medical staff and to the quality improvement staff for final action.
Once the drug has been approved for the formulary, the pharmacy staff meets with members of the appropriate medical or surgical department to develop guidelines for drug use.
Approximately 1 year after the drug has entered the formulary, the pharmacy performs a drug use review. Results of this review are important because they indicate the impact of the drug on the patient population of the particular health care system, rather than on the population at large. In some cases, results of the review may indicate the need for in-service educational efforts to ensure that physicians are prescribing the drug appropriately.
The process by which new drugs are added to the formulary in HMO and MCO systems are generally based on--and similar to--those used in university-based systems. However, depending on the size of the health care organization, the process may be somewhat less structured.
The experience at Kaiser-Permanente may be typical of many large HMOs. Within this health care organization, the request is usually generated by a participating physician. Kaiser's P&T committee is composed of staff members at various sites. In addition to evaluating individual clinician requests as they are received, the committee keeps an eye on new drugs in the FDA pipeline. It gathers information on these products in order to be prepared to review them once they are approved.
The drug review is done at a central level, as is drug purchasing. Kaiser's P&T committee reviews information collected and analyzed by the pharmacy's drug information service and makes its recommendation on the basis of that data.
Decisionmakers at HMOs are favorably impressed by published data in the peer-reviewed literature. If such information is not available, anecdotal data can be persuasive. In some cases, the product is put on the formulary as an interim measure, and use of the product is monitored carefully. The final decision on adding the product to the formulary is based on local experience, as well as reports published since the original review took place.
Some MCOs have expressed fears of legal reprisal for not making drugs available to their patients. This is based on the belief that if there is no alternative drug, a new drug must be available to the patient, regardless of its cost or its risk-benefit ratio. Advocacy groups for patients with AIDS and other terminal illnesses often present powerful cases for action and insist that a new product be put on formularies for publicly funded as well as private health care organizations.
This situation poses ethical, as well as clinical and fiscal questions. Issues of this nature should be referred for discussion to the facility's legal and administrative staff. Of key importance in such deliberations is the need to define the current standard of care for a particular condition or disease and to determine whether the product is necessary to meet that standard. If a drug is added to a formulary primarily to reduce the potential of legal liability, the drug use review process may eventually have a key role in producing new evidence that will help demonstrate whether it is indeed safe and effective.
Before a patient receiving publicly funded health care can receive naltrexone or any other prescription drug, that product must be on the State prescription drug formulary. Responsibility for maintaining and revising such a formulary is usually delegated to a unit or board within the State public health care system. In some States, the State Board of Pharmacy also has a role in drug approval.
Policies regarding selection of and reimbursement for drugs provided to patients on medical assistance vary. Health care providers who become involved in this process must familiarize themselves with the particular policies of their own State. The following two examples, drawn from the experience of two Consensus Panel members, illustrate the variety of ways in which States approach this issue.
Washington
In the State of Washington, a board of the State Medical Assistance Administration (MAA) has responsibility for making decisions about adding drugs to the State formulary. On learning that naltrexone had received FDA approval for use as an adjunct to alcohol treatment, MAA board members consulted with the State Division of Alcohol and Substance Abuse (DASA). MAA and DASA agreed to conduct a pilot project to determine whether naltrexone would be effective for individuals receiving publicly funded alcoholism treatment. DASA then approached two substance abuse treatment programs in Seattle to explore their interest in conducting the pilot project. Although these providers were familiar with the positive reports in the peer-reviewed literature, MAA board members wanted to ensure that the results would be applicable to the treatment of indigent persons receiving publicly funded treatment (see Appendix C for a description of the pilot project).
The results of the pilot project were quite positive, indicating that 42 percent of patients completed 90 days of outpatient substance abuse treatment while on naltrexone; 72 percent reported a decrease in alcohol craving, and the reported side effects were generally minimal and short-lasting (i.e., less than 2 weeks' duration). Both the treatment counselors and the physician who participated in the pilot project reported positive experiences and recommended that naltrexone be used as an adjunct to the treatment of alcohol dependence (Division of Alcohol and Substance Abuse, Department of Social and Health Services, State of Washington, 1995).
On the basis of these results, MAA added naltrexone to the Washington State Prescription Drug Program for the treatment of alcohol dependence. Shortly thereafter, the director of DASA sent a memorandum to certified substance abuse treatment providers statewide informing them of the results of the pilot project and of MAA's decision to add naltrexone to the formulary. A summary of the published literature concerning naltrexone, a description of the Seattle pilot project, indications for use, and various authorization forms necessary to prescribe naltrexone were included in the mailing (Division of Alcohol and Substance Abuse, Department of Social and Health Services, State of Washington, 1995).
California
To reduce administrative costs, California has delegated responsibility to the counties for decisions concerning the care of patients receiving publicly funded medical assistance. Using funds allocated by the State, each county is expected to either provide such care internally or contract with an HMO to provide the care.
In this situation, the decision to place naltrexone on the formulary is made at the county or HMO level. Members of each county's medical association provide input into HMO standards of care, including issues related to the use of prescription medications.
In addition to treatment providers becoming familiar with therapeutic and cost issues related to the use of naltrexone, the Consensus Panel recommends that they employ strategies such as the following:
Keep informed of State and local policies. The health care environment is changing, and practices differ from State to State and from organization to organization. Substance abuse treatment providers must not only inform themselves of existing policies, but must also keep an eye on the horizon for possible changes and provide input when there are opportunities to do so.
Keep abreast of research. In addition to keeping up with literature in peer-reviewed journals, substance abuse treatment providers should explore other sources. This can be done through networking and informed use of data available on the Internet. (See Figure B-2 for a listing of Federal and private Web sites that may be useful.) Staff of programs affiliated with an academic health center may wish to explore information available through the University Hospital Consortium, a membership organization. It sponsors a Technology Assessment Group that provides objective evaluations of new drugs and equipment.
Make strategic allies. Treatment providers can forge alliances with three key groups: pharmacists, physicians, and fiscal analysts. Each brings special value to the drug-approval and drug-use processes:
Pharmacists are medication use experts. As part of the practice of pharmaceutical care, more and more pharmacists interact daily with physicians, other health professionals, and patients and their families in ambulatory, community, and inpatient settings. Substance abuse treatment providers in need of sound information can turn to pharmacists for advice about naltrexone. Other counselors and health care providers who are already well versed in the use of this drug may take a proactive role in sparking pharmacist interest in naltrexone. Pharmacists, in turn, can share their insights with prescribers.
Physician support is essential.
Fiscal analysts who have the ability to take a systemwide perspective on drug costs can be strategic partners in efforts to secure approval of naltrexone. Once informed of the clinical and financial implications of sobriety, they can help devise ways of documenting its cost-effectiveness on large scales.
Regardless of its importance, getting naltrexone on the formulary, one Panelist observed, is a "smaller piece of the problem." Ensuring that naltrexone is appropriately used in the treatment of alcohol dependence may be even more challenging. Achieving this goal requires educational efforts directed at policy makers, prescribers, pharmacists, health administrators, patients, and the public at large. Use of this TIP can facilitate that educational effort and improve patient access to naltrexone for the treatment of alcohol dependence.
>ReVia Pilot Project Results.> Olympia, WA: Division of Alcohol and Substance Abuse, Department of Social and Health Services, State of Washington, November 1995.
Site Map
Help
Account
Cart
Home
