Need For Substance Abuse Treatment

Appendix C: Need For Substance Abuse Treatment

Table: Need for Cocaine Treatment

Source	Estimate
ABT ASSOCIATES (Rhodes et al., 1995)
Hardcore (1993)	2,127,000
ABT ASSOCIATES (Rhodes et al., 1993)
Total (1990)	2,036,000
At risk (not incarcerated) (1990)	1,561,000
Heavy users in prison and jail(1990)	214,000
Heavy users in high school (1990)	ALIGN="RIGHT"> 24,000
High school age but incarcerated (1990)	10,000
Heavy users who are high school dropouts (1990)	7,000
Heavy users in college (1990)	15,000
Additional heavy users in household (1990)	205,000
RAND
Heavy users (1992)	1,720,000
HOMER (1993)
Past Month Total	1,872,000
Compulsive Prefer Crack (1990)	1,296,000
Compulsive Prefer Powder (1990)	576,000
SAMHSA (Office of Applied Studies, unpublished data, 1997)
Past Year Cocaine Users in Need of Treatment (1995)	2,703,000
Level 1 (1995)	567,000
Level 2 (1995)	2,136,000
Committee on the Judiciary US Senate (1990)
Total Unduplicated Hard-Core Cocaine Addicts	2,200,000
Arrested (1988)	1,530,000
Treated (1988)	200,000
Homeless (1988)	55,000
Household (1988)	862,000

Table: Need for Heroin Treatment

Source	Estimate
ABT ASSOCIATES (Rhodes et al., 1995)
Hard core (1993)	496,000

ABT ASSOCIATES (Rhodes et al., 1993)
Total(1990)	665,000
At risk (not incarcerated) (1990)	510,000
Heavy users in prison and jail(1990)	142,000
Heavy users in high school(1990)	6,000
High school age but incarcerated(1990)	2,000
Heavy users who are high school dropouts(1990)	2,000
Heavy users in college(1990)	4,000
Additional heavy users in household(1990)	0

SAMHSA (OAS, 1996)
Used at least once in lifetime (NHSDA, 1995)	2,400,000
Used at least once in lifetime (NHSDA, 1995) with Adjustments for Under-reporting and Under-coverage	2,900,000
Used at least once in past year (NHSDA, 1995)	428,000
Used at least once in past year (NHSDA, 1995) with Adjustments for Under-reporting and Under-coverage	541,000

Hamill and Cooley (1990)
Number of heroin addicts(1987)	640,000 -1,065,000

Source: Providers, The National Specialty Substance Abuse Treatment System

Appendix D: Literature Search Strategies For Case Study Reports Of LAAM, Naltrexone, Clozapine, And Nicorette

Literature Search Methods for LAAM Case Study

Database Type	Database Name	Years	MeSH
NLM	MEDLINE	1966-Present	LAAM and EXP opiate addiction LAAM, Methadone, and clinical trial (pt)
	HSTAR75	1975 - 1984	LAAM
	HSTAR	1984-Present	LAAM
Dialog	FDA Pink Sheet	1987 - Present	LAAM and opiate addiction
	FDA Tan Sheet	1990 - Present	LAAM and opiate addiction
	Health and Wellness Database	1976-1997	LAAM and opiate addiction

Literature Search Methods for Naltrexone Case Study

Database Type	Database Name	Years	MeSH
NLM	MEDLINE	1980-Present	Naltrexone and EXP alcoholism ALIGN="JUSTIFY"> Naltrexone and EXP Drug Industry
		1966-1984	trexan and review (pt) trexan and clinical trial (pt)
	HSTAR75	1975 - 1984	Naltrexone
	HSTAR	1984-Present	Naltrexone
	HSRProj	????-Present	Naltrexone (5)
Dialog	FDA Pink Sheet	1987 - Present	Naltrexone
	Scrips	1980 - Present	Naltrexone and Alcohol
	Health and Wellness Database	1976-1997	Naltrexone and Alcohol
	IAC Trade and Industry Database	1976-1977	Naltrexone and Alcohol
	ABI/INFORM ®	1971-1997	Naltrexone and Alcohol

Literature Search Methods for Clozapine Case Study

Database Type	Database Name	Years	MeSH
NLM	MEDLINE	1980-Present	Clozapine and Drug Costs or Drug Industry Clozapine and Review (pt) Clozapine and Clinical Trial (pt)
		1966-1984	Clozapine and Review (pt) Clozapine and Clinical Trial (pt)
	HSTAR75	1975 - 1984	Clozapine
	HSTAR	1984-Present	Clozapine
	HSRProj	????-Present	Clozapine
Dialog	FDA Pink Sheet	1987 - Present	Clozapine and Schizophrenia
	Scrips	1980 - Present	Clozapine and Schizophrenia
	Health and Wellness Database	1976-1997	Clozapine and Schizophrenia
	IAC Trade and Industry Database	1976-1977	Clozapine and Schizophrenia
	ABI/INFORM ®	1971-1997	Clozapine and Schizophrenia

Literature Search Methods for Nicorette Case Study

Database Type	Database Name	Years	MeSH
NLM	MEDLINE	1966-Present	Nicorette and nicotine addiction Nicorette and smoking cessation therapy Nicotine polacrilex
	HSTAR75	1975 - 1984	Nicorette and nicotine addiction Nicorette and smoking cessation therapy
	HSTAR	1984-Present	Nicorette and nicotine addiction Nicorette and smoking cessation therapy
Dialog	FDA Pink Sheet	1987 - Present	Nicorette and smoking cessation therapy
	FDA Tan Sheet	1990 - Present	Nicorette and smoking cessation therapy
	Health and Wellness Database	1976-1997	Nicorette and smoking cessation therapy

Appendix E: Selection Criteria And Discussion Guide For Interviews With Private Firms

Interviews With Private Firms

Pursuant to Task 6.0 of our contract, the present document contains the three components of the interviews with private firms: a) selection criteria for firms to be interviewed, b) list of selected firms to be interviewed, and c) discussion guide for interviews. The purpose of meeting with private firms is to explore and characterize private industry's views on market barriers to the development of these pharmacotherapies and on the readiness of the science base for developing such medications. We will meet with leaders (e.g., senior executives, marketing and research directors) of pharmaceutical and venture capital firms (a total of five firms), one firm at a time.

We will seek industry views on market barriers with the objective of determining their relative impacts on private investment in these pharmacotherapies. In addition, we will determine the facts and reasoning underlying industry's judgment on these issues, and the extent to which additional information, such as that obtained in our market analysis, might alter industry's view (or the view of one or more firms) on a particular market barrier. Finally, we will determine the industry's perceptions about the readiness of the science base for the development of such pharmacotherapies.

Selection Criteria for Firms and Candidate List

As discussed with ASPE informally and during our meeting of May 1, we will select firms that are actively working, or appear to be fully capable of initiating efforts, in the field of substance abuse. We will select firms that may be involved in such efforts and, to the extent possible, choose firms that can provide a diverse set of experiences and perspectives on drug development. In addition, because of potential scheduling difficulties, we will select firms that are most likely to cooperate in the study. Below, we list the types of companies we propose to target.

A large pharmaceutical company that is fully capable of developing or licensing a product in the treatment of addiction. We would seek a company that is likely to share insights into its strategies and plans.
A mid-size to large pharmaceutical company with a strong CNS identity and/or mission.
A small pharmaceutical company that is developing at least one product relevant to the present study.
Two venture capital / investment banking firms with real or potential interest in drug development.

Of course, there is no assurance that a given company would be willing to participate in the study. In addition, scheduling may be difficult, given that our interviews must be with senior individuals. We would therefore propose to initiate calls to first-choice companies as soon as possible to discuss participation and to obtain commitments.

Discussion Guide

The discussion guide is designed to ensure that questions addressing private sector views on market barriers to the development of cocaine pharmacotherapies and the readiness of the science base in developing such medications are appropriately covered.

Our interviews will be designed to assess the primary concepts of concern to ASPE. For example, we will determine whether any stigma associated with management of drug addiction plays a role in the decision to develop a compound, as do more conventional factors such as market size and anticipated return on investment (ROI). We will also probe on the extent to which a pharmaceutical company's decision to proceed with a compound is based on potential market size in absolute terms, or on market size relative to other factors (e.g., potential for orphan drug status). We will also seek insights regarding interactions between research and marketing departments within a pharmaceutical company concerning assessment of a compound's market potential. Some of the questions posed to venture capital executives will differ from those posed to pharmaceutical company officials.

Wherever possible, we will ask interviewees to respond in the context of particular case examples, including products that are now or had been considered for development, products in R&D pipelines, and products on the market. We recognize that responses to various questions about factors influencing decisions to pursue pharmacotherapies may be product- and application-specific, i.e., with respect to readiness of the science base and various types of market barriers.

General Company Background (for Rx companies only)*

What is the size of the company (e.g., employees, annual revenues)?

How geographically diverse is your market?

Please describe your company's portfolio in health care and, in particular, in the area of CNS-related products.

Do you have any products, in the pipeline or on the market, in the area of substance abuse addiction, or do you have relationships with companies that do have such products?

*Some of this information may be available in company reports.

Approach to evaluation of new investments (for Rx companies only)

What current priorities do you have in health care, and, in particular, in the area of CNS-related products?

What criteria do you use to establish these priorities?

Who is responsible for the evaluation of new investments in health care?

What are the most important factors in deciding whether or not to pursue the development of a drug (e.g., ROI, focus in particular disease area, corporate mission, other competitive factors)?

Are there particular financial thresholds that serve as criteria for pursuing a drug, e.g., a particular ROI or net present value (NPV)?

Do you have internal staff capacity devoted to conducting market analyses? If so, how many FTE employees, and how is this organized?

Do you have internal staff capacity for regulatory affairs?

What are the relative roles (and authorities) of the research department and the marketing department in the decision to pursue the development of a drug?

Have you conducted any market analyses in the area of cocaine abuse and addiction?

Do you consider market analyses of other drugs (internal or external) when considering markets for treatments for cocaine abuse and addiction?

Approach to evaluation of new investments (for venture capital firms only)

What current priorities do you have in health care, and, in particular, in the area of CNS-related products?

What criteria do you use to establish these priorities?

What are the most important factors in deciding whether to invest in a drug and, if so, when to invest (e.g., potential market size, market penetration, total capital required, break-even point, ROI or NPV threshold, regulatory status, product cycle)?

What due diligence do you perform on drugs that you are evaluating for potential investment? Can you briefly describe this process?

Have you invested in or evaluated investment opportunities in the area of pharmacotherapies for cocaine abuse and addiction? If yes, for which drug, and why?

Perceived Market Barriers (for both Rx and venture capital firms)

What do you perceive to be the most important market barriers to developing pharmacotherapies for addiction?

In addition to the ones you have cited, which of the following factors do you consider to be important market barriers? (This is a sample list meant to complement those barriers identified above and to help elicit further insights; it may not be necessary to review all of these with each interviewee.)

size of the market

cost of developing and marketing a drug

pharmacological feasibility

potential for clinical value

public sector role in development and/or evaluation

FDA requirements affecting research, development, and approval

DEA requirements affecting research, development, and approval (esp. implications of treatments with addictive vs. non-addictive properties)

other requirements for development and approval (e.g., state requirements)

clinical trials management (i.e., enrollment and retention issues, clarity of definable clinical endpoints)

time frame for development and approval

patent life / protection

orphan drug requirements

price potential for the drug

coverage / reimbursement requirements

dispensing requirements (e.g., prescription restrictions, clinical settings)

social attitudes about treatments for substance abuse (including, e.g., stigma that may prevent firm from exploring substance abuse indications for drugs marketed for other conditions)

physician attitudes about treatments for substance abuse

commercial / competitive value

probability of achieving marketing success

legal considerations

Among these real or potential barriers, which are of the greatest and least consequence from industry's perspective?

Would the lowering or elimination of one or more of these barriers significantly increase the magnitude of industry activity in pharmacological treatment for cocaine abuse and addiction?

Does the venture capital world hold a different view?

Readiness of Science Base (for Rx companies only)

Is the readiness of the science base currently a barrier to the development of cocaine pharmacotherapies? If so, why, and specifically in which areas (e.g., craving control, relapse prevention)? What is the basis for your assessment of the science base (e.g., internal strategic assessments)?

Is the infrastructure (including in the public and private sectors) for clinical research adequate for strengthening the science base? What forms the basis for your answer?

Would a seminal discovery be required to stimulate private sector interest? What forms the basis for your answer?

How would you compare the state of the science base in this field to other fields of pharmaceutical R&D? What forms the basis for your answer?

What is the maturity or readiness of the science base in this field compared to other fields, e.g., HIV/AIDS research in the late 1980s, Alzheimer's disease research today?

Does the science base for anti-addiction drugs have applications for other products in other areas? What forms the basis for your answer?

Does the current science base for CNS drugs offer potential for development of effective new cocaine pharmacotherapies? Can you give some examples?

What drugs for treating cocaine abuse and addiction are in the pipeline now (to the extent this information can be made available)?