A major global pharmaceutical company has a compound in Phase III development for chemotherapy-induced neuropathic pain and is seeking a better understanding of other types of neuropathic pain and the opportunities for this compound in those market segments. The company is seeking a comprehensive background document that will potentially be used by the following:
- Company management, for awareness and understanding of the market basics, history, trends, and pipeline.
- Clinical development, for background information on the market for use in protocols.
- Market research and marketing vendors who have been assigned to specific tasks in support of the current compound/indication.
- New products personnel, who are evaluating other opportunities in the class as well as other indications for the current product.
Cello Health Advantage developed a precise outline for the project, and a detailed list of secondary data needs was provided to the client at the briefing conference call. While secondary sources vary by project, in this case, they included audit data (IMS/SDI Verispan, CD Promo, Adis R & D Insight, and others), syndicated reports (Decision Resources, Datamonitor, and others), textbooks, Web sites, RedBook (for pricing), and previously conducted primary research in the category (only 1 study had been conducted by the European global headquarters of the client and included a limited number of respondents in the United States).
In addition, Cello Health Advantage conducted ten 60-minute, in-depth telephone interviews with neuropathic pain thought leaders in the United States. Advantage Healthcare developed the thought leader list based on a highly methodical approach of matching each thought leader to at least 3 of 7 determining criteria.
Moreover, Cello Health Advantage developed the recruiting script and research tool, conducted the interviews, developed a detailed report from the research, and extracted key learnings from that research to incorporate in the final deliverable for the Neuropathic Pain Market Assessment.
The first week of the project involved defining the conditions that would be included in the analysis; 31 separate International Classification of Diseases, 9th edition (ICD-9) codes were identified, confirmed by secondary sources, discussed with Cello Health Advantage’s neurology advisor at Mt. Sinai Hospital in New York, and submitted the definition to the client for approval. The ICD-9 codes were then used as a basis of all audited data pulled and assessed for the project.
Three major areas of neuropathic pain were identified and were the focus of the report (for those sections where secondary data broke out these subsets):
- Painful diabetic neuropathy.
- Postherpetic neuralgia.
- Neuropathic pain related to HIV.
For this document, it was determined by the client that fibromyalgia would not be included in the definition, although other companies and some in the medical community (varying by specialty) do include that disease state as a bona fide subset of neuropathic pain.
The etiology of the disease, and data on the burden of disease, where known, were researched and provided.
Diagnosis of Neuropathic Pain
The diagnostic tools and criteria, pain scales frequently used, and how the disease progression is tracked were presented. Risk factors for each major type of neuropathic pain were identified. The patient flow, or patient pathway, was presented to better understand where opportunities (based on potential market size) may exist.
Incidence and prevalence of the major subtypes of neuropathic pain were quantified.
Neuropathic Pain Treatment Overview
Treatment goals, treatment options, key products, and general prescribing factors were included in this section. Treatment guidelines published by professional associations were also included. A timeline was created for the approval and patent expirations of drugs that have formal Food and Drug Administration (FDA) approval for neuropathic pain:
Treatment patterns and algorithms from secondary sources and the thought leader interviews were described.
Products in development for neuropathic pain were listed based on their estimated time from launch in the United States. Development and marketing companies, phase of development, mechanism of action, and clinical data were provided for each compound in Phase I development through preregistration in the United States.
Current sales and prescription patterns were included in concise charts and graphs. Promotional expenditures, including numbers of sales representatives, detailing expenditures, print advertising spends, and direct-to-consumer advertising investments, were documented for the current year and the prior 5 years, by product, and for the total market.
The final report, which was owned by the client, included the following elements:
- A 280-slide repository on the client’s current slide template.
- A glossary, which included definitions and sources for 51 key terms.
- A bibliography, which included full citations for the 265 individual sources used in preparation of the report.
- Sixty-one additional back-up slides of auxiliary data.
- A detailed list of neuropathic pain thought leaders in the United States, along with their contact information, credentials, and lists of their current consulting contracts, where available.
- A list of upcoming professional congresses over the next 2 years.
- A list of professional organizations and patient advocacy groups.
- A list of professional journals of interest.
- A more detailed and separate report (in slide format) of the findings from the thought leader research.
- A comprehensive narrative report on reimbursement dynamics in the United States, covering both public and private payers, current trends, and details on product reimbursement for neuropathic pain.
- Samples of current promotional literature (professional and direct-to-consumer) for products being promoted for neuropathic pain.
- Current package inserts for all products indicated for neuropathic pain.
- Copies of the thought leader interviews on CDs (blinded).