Pharmacotherapies for Cocaine Addiction: Overcoming Market Barriers

Two types of market barriers for development of cocaine pharmacotherapeutics were identified in Response to Institute of Medicine Report, Development of Medications for the Treatment of Opiate and Cocaine Addiction¹:

·        critical barriers—those that must be surmounted for financial feasibility, and

·        noncritical barriers—those that, if lowered or eliminated, might enhance financial feasibility, but would be unlikely to transform an unattractive market into an attractive one.

Some solutions for overcoming these barriers were presented in the report cited above, and others have emerged in recent years.

Critical Market Barriers—Potential Solutions

Small and uncertain market—Market building to tap full potential

Although the total number of cocaine users is large, the market for a cocaine abuse medication is likely to be much smaller. Some experts estimate the market to equal about half of the generally accepted two million heavy users. Factors affecting market penetration include, among others, limited access to patients, the lack of acceptance of a medical model of addiction by the (nonmedical) treatment community, and potential patient compliance problems.

Market building: Although the total Western World market for addiction pharmacotherapies is only about $250 million, some observers believe that market potential is very great. As Elizabeth M. Greetham, CEO of DrugAbuse Sciences, points out, the market for antidepressants before the introduction of Prozac was only about $250 million, and, as more effective addiction therapies are introduced and accepted and physician education efforts continue, the market will grow. Some observers, noting the $7 billion spent on treatment of addicts in the US and the much higher total cost of addiction, believe that the market opportunity is great for new effective compounds, particularly those that reduce costs of inpatient care in hospitals or drug rehabilitation facilities, but also for compounds that shorten the duration of relapses, reduce craving, improve productivity, etc. In the cited study, the potential solution of a guaranteed market (i.e., guaranteed by governmental purchase orders for minimum volumes of a medication) does not appear to be realistic. Estimates of the need for substance abuse treatment (in the US) from many different sources are provided in the Institute of Medicine (IOM) report.

Limited market access—Education of physicians and the public, increased spending on substance abuse treatment

Multiple, interrelated aspects of the current substance abuse treatment system limit market access. Executives cited the low sales of LAAM and naltrexone, which have been restricted by the limited number and capacity of heroin and alcohol treatment programs. Distribution of LAAM is restricted to maintenance programs, where approximately 25% of opiate addicts receive treatment. Prescription of naltrexone is recommended to be linked to enrollment in comprehensive treatment centers, but only about 5% of alcohol-dependent people are treated in such centers. Nicorette, on the other hand, is an over-the-counter formulation that does not require a visit to treatment center or a provider, vastly expanding penetration of this drug’s potential market.

The lack of acceptance of medical models of addiction by substance abuse treatment centers is viewed as a critical market barrier. Many publicly funded treatment centers are managed by nonphysicians who tend to (sometimes strenuously) oppose the use of medications to treat addictions, which they regard as behavioral conditions. Substance abuse treatment often involves little or no physician care. Case studies of LAAM and naltrexone show that treatment decisions and funding for heroin addiction are often mediated by state-level substance abuse program administrators who do not have clinical backgrounds.

Education of physicians and the public about the medical model of addiction and increasing funding by government and insurance providers in rehabilitation argue for increased access for effective therapeutics. The number of people with addiction disorders who are treated by physicians is increasing; and physician education efforts have increased markedly. People with alcohol dependence may be more accessible because they are more likely than opiate or stimulant addicts to be treated as outpatients.

Limited and uncertain payment for pharmacotherapy—Increased spending on substance abuse treatment

The substance abuse market is heavily reliant on federal, state, and local government reimbursement. According to 1995 data, more than 68% of enrolled cocaine abusers had no health insurance, and an additional 17% had Medicaid coverage. Industry executives have been concerned that even cocaine addicts with private insurance often do not use their benefits for drug abuse treatment.

Price sensitivity of a cocaine medication is another aspect of payment that may limit payment and market size. Although no medication for cocaine abuse has been tested on the market, indirect evidence from LAAM and naltrexone and the current financing of cocaine addiction treatment suggest a very high price sensitivity. (Average daily treatment cost at the time of the IOM report was $9.00 per outpatient and $23.00 per inpatient.)

Companies are now generally confident that reimbursement can be obtained, but are less certain about obtaining access to this patient population.

Noncritical Market Barriers

Regulatory issues

Industry has been concerned about the ability to obtain US Food and Drug Administration (FDA) approval (i.e., the general regulatory climate). They cite ambiguous clinical trial endpoints in a field that lacks the rigor of other medical fields, including the harder psychiatric diagnoses. In fact, the current regulatory environment is very friendly to drug developers as the FDA strives to find approvable medications.

Clinical trials issues/difficult, costly clinical trials

In addition to ambiguous clinical trials end points, executives express concern about the high cost of clinical trials, patient recruitment, compliance, the high rate of comorbidities, the high drop-out rates and other factors related to the difficulties of studying addicted and alcoholic patient populations. Currently, federal (National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism) and state assistance is available in many different forms, including scientific and lab support, access to compounds for development and implementation of the National Drug Abuse Treatment Clinical Trials Network. Clinical trials with high drop-out rates that demonstrate effectiveness have been well-received by the FDA.

DEA regulation

Distribution channels are restricted when rescheduling (in every state) is required. DEA restriction is unlikely for most addiction medications in development.

Social stigma

Executives expressed concern about the public associating their companies with the poor public image of alcoholics and drug addicts. Advances in scientific understanding, development of medical models, educational efforts, and media presentations of addiction as disease have done much to change public attitudes during the last decade, but educational efforts must continue.

Sufficiency of science base

Industry perceptions of the sufficiency of the scientific basis for R&D of medications for treatment of addictions were widely disparate. Advances in basic science have led to many potential drug targets related to cueing, craving, cognitive problems, genetic factors, etc.

References

1.      Development of Medications for the Treatment of Opiate and Cocaine Addiction; pharmaceutical industry views on market barriers, Institute of Medicine (1995, last updated Jan 2001).

This article was written by D&MD Newsletter’s founder, Timothy Tankosic, MD.

©Drug and Market Development 2002

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