Content by Keyword: Drugs, Medical Devices, and Pharmacy Services

Three of the four case study drugs were for patient populations perceived to be difficult to study for a variety of reasons (e.g., patient recruitment, compliance, and co-morbidities). For example, patient compliance has been seen as a barrier to the success of naltrexone in both the heroin addiction and alcoholism markets, because the drug is not

Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.

Another critical market barrier is the uncertainty surrounding the reimbursement of cocaine abuse and addiction treatment. The pharmaceutical company respondents, as well as one from a VC firm, voiced their concern over the heavy reliance of the substance abuse market on federal and state government reimbursement. The perception among the drug com

There was consensus among the pharmaceutical company representatives that the current substance abuse treatment system constitutes a great market barrier that severely limits opportunities for market penetration.

The small size and uncertainty of the market for cocaine pharmacotherapies constitutes a critical barrier to development of a cocaine abuse pharmacotherapy. Although all of our interviewees agreed that the total number of cocaine users is large, they recognized that the market for a cocaine abuse treatment is likely to be much smaller than the abs

Some of the market barriers identified in the 1995 IOM report were confirmed through the interviews with private firms and case studies conducted for this effort. Figure 36 summarizes the market barriers that were confirmed (in full or in part) and not confirmed during this study. (As noted above, the number of interviews and case studies was limi

Venture capital firms (VCs) reported market potential (e.g., projected revenues) and probability of financial success as the main factors guiding investment decisions on new products. VC interviewees suggested that the evaluation of pharmacotherapies is no different from that of any other product or business plan. These companies are most interest

As discussed above, a pharmaceutical company's decision to develop and market a drug is predicated on a number of factors related to the probability of economic success of a given product. Each of the several companies that were interviewed for this study indicated that the evaluation of a candidate drug project hinged on an overall assessment of

In order to provide context for the market environment and background for understanding the market barriers from industry's perspective, this section summarizes pharmaceutical and venture capital firms' approaches to the evaluation of new drug investments.

The purpose of this section is to characterize private industry's views on market barriers to anti-addiction pharmacotherapy development. The 1995 IOM report, Development of Medications for the Treatment of Opiate and Cocaine Addictions , identified numerous market obstacles that appear to hamper private sector investment in anti-addiction medica

Introduction Drug Overview

Introduction Drug Overview

Introduction Drug Overview

Introduction Drug Overview

The federal government exercised a coverage mandate in the case of clozapine. Once Sandoz separated its expensive Clozaril Patient Monitoring System (CPMS) from sales of clozapine, the Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS)) required all state Medicaid agencies to

A) Fast-track approval

The government was involved in aspects of development and marketing for each of the four case study drugs. These phases, adapted from the 1995 IOM report, include discovery, clinical studies, NDA phase, and marketing. Figure 23: Overview of Past Government Strategies to Lower Market Barriers   Strategy

The four case studies have several elements in common, particularly with regard to the target patient population. For example, three of the four drugs involve treatment for substance abuse including LAAM and naltrexone for heroin addiction, naltrexone for alcoholism, and Nicorette for smoking.

The purpose of the case studies is to gain insight into the experiences of companies that are relevant to developing and marketing medications for drug abuse and addiction. Presented below are two in-depth case studies of LAAM (Roxanne), for heroin addiction, and naltrexone (DuPont Merck), for heroin (as Trexan) and alcohol (as ReVia) addiction. I