NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
Sales, marketing, And R&D Trends affecting the healthcare industry
Verified Physicians Ensure Quality Data
As online physician panels gain popularity among pharmaceutical and medical device companies that conduct Web-based surveys, research shows there is little interest in verifying that the respondents in these surveys are indeed genuine physicians. This can severely impact the quality of the data and compromise the integrity of the study. Although some panel vendors make efforts to verify the identity of their physicians, it is the pharmaceutical marketing and brand managers who must advance the issue of data-quality standards. Frost & Sullivan’s white paper, Unmasking the Respondent: How to Ensure Genuine Physician Participation in an Online Panel, investigates the process of panel member verification. Frost & Sullivan analysts found some online panel vendors to be conscientious about verifying their panelists’ information against credible sources, while other vendors depended far more on self-reporting by physicians and were perhaps not as rigorous in imposing crucial checks on respondents wishing to participate in online surveys. “The pharmaceutical industry makes crucial business decisions on the basis of data obtained through online surveys of doctors,” says Analyst Fernanda Lopez Araujo. “So it was surprising for us to find how little consideration went into the verification of physicians used to generate this data by many of the companies funding the surveys.” For more information, visit frost.com. Diabetes Drugs Face Heightened Scrutiny Cardiovascular risks are at the heart of a new FDA mandate requiring additional clinical testing on Type 2 diabetes drugs. The FDA has come under intense scrutiny for the approvals of GlaxoSmithKline’s Avandia and Takeda Pharmaceuticals’ Actos, both of which now carry strong “black box” warnings for increased risk of heart failure. As a result, in December 2008, the FDA issued guidelines requiring that pharmaceutical companies submit long-term cardiovascular studies for new Type 2 antidiabetic therapies, effective immediately. The first victim of these new guidelines is likely to be Takeda and its highly anticipated follow-up to Actos, the DPP-IV inhibitor alogliptin. According to a Cutting Edge Information report, Diabetes Market Forecast to 2013, analysts had been expecting alogliptin to generate sales of $110 million upon its anticipated market entry in 2009. But the drug has yet to be approved, and the FDA has extended its review deadline to June 26, 2009. Alogliptin may have the distinction of becoming the first diabetes drug to trip on the new cardiovascular hurdles. “These new FDA guidelines threaten to freeze smaller companies out of the development process because it will become too costly to design their own Phase III trials,” says Jeremy Spivey, lead research analyst for the Cutting Edge report. For more information, visit cuttingedgeinfo.com. Physicians Support Commercially Funded CME Despite ongoing concerns about the potential bias of commercially funded continuing medical education programs (CME), only a minority of physicians surveyed for a recent Manhattan Research study were against the practice. The study found 9% of U.S. physicians oppose commercial support for CME funding, and that only 8% of physicians who participated in CME believe that it is biased. In fact, if commercial support is halted, nearly half of the physicians surveyed said they would decrease their use of CME. According to the study, almost all physicians use CME programs to maintain and expand their medical knowledge and to keep up to date on the latest advances in their specialty, with the ultimate goal of improving patient care. Pharmaceutical companies are a funding source for CME programs, which has prompted some critics to question their influence over CME course content. “While there’s been debate around the value of industry-supported CME, as our study reveals, it’s important to listen to the voice of the majority of physicians,” says Manhattan Research President Mark Bard. For more information, visit manhattanresearch.com. best practices for physician verification n Recruitment of physicians based on clinical services n Use of extensive databases maintained by government agencies or bodies such as the AMA and DEA, updated frequently, to verify panel participants n Use of multiple fields within each physician record to confirm a match, not just overreliance on a few data points such as last name and license number n Greater reliance on automated verification to exclude subjectivity in verification process n Use of reliable, third-party services to independently verify physicians using extensive databases n Frequent revalidation of panelists to identify physicians with lapsed credentials, not just relying on self-reporting by physicians n Secure methods of honoraria disbursement, limiting its use to the verified panelist Source: Frost & Sullivan, Unmasking the Respondent: How to Ensure Genuine Physician Participation in an Online Panel. For more information, visit frost.com. number of u.s. physicians in different online physician panels * Medscape/WebMD automatically enrolls all physicians into the Market Research panel, allowing them to explicitly opt out at later times. This may slightly inflate the number of physicians on Medscape/WebMD’s panel compared with other panels in the paper. Source: Frost & Sullivan, Unmasking the Respondent: How to Ensure Genuine Physician Participation in an Online Panel. For more information, visit frost.com. Jeremy Spivey Concerns over side effects have put a damper on sales of Type 2 antidiabetics. Resources, Guidelines Key to Effective Competitive Intelligence Function In today’s fast-changing, high-pressure pharma marketplace, the competitive intelligence (CI) function helps companies anticipate external threats and opportunities in a timely manner so they can respond strategically, take advantage of opportunities, and manage risk. The recent Best Practices report — Competitive Intelligence Policies, Ethics, and Data Collection: Navigating the Gray Zone — analyzes how U.S. pharmaceutical and biotechnology organizations can optimize their CI operations while working within defined guidelines. The findings illustrate that world-class companies maximize CI success by providing sufficient human and information resources, encouraging innovation and creativity in data collection processes, and, perhaps most importantly, adopting a clear set of operating guidelines and policies. Guidelines that establish ethical and legal boundaries, spell out standard operating procedures and detail codes of conduct for CI practitioners increasingly are necessary to protect companies from financial and corporate risk. CI guidelines also help practitioners to manage end-user expectations regarding what kind of information can be collected. But rigorous guidelines and policies intended to mitigate risk sometimes can be too restrictive, preventing or hindering practitioners from doing their jobs. The report recommends that CI functions work to build credibility with colleagues to ensure buy-in when difficult decisions must be made based on ethical and legal input. One factor in gaining the ability to push back against requests that fall into gray, or sometimes even blatantly inappropriate, areas is having established credibility within the field. Though reputation is built over time, the best way to ensure that expectations are managed in an appropriate way is by sticking to the ethical and legal standards that are intended to govern CI. Once credibility, based on sound decision-making and proven ethical standards, has been established with internal clients, the clients learn to trust the advice. This leads to the client better understanding the ethical and legal constraints that must be factored in when deciding what information they should choose to pursue, and developing a mutual respect for CI to protect corporate integrity. For more information, visit best-in-class.com. Novartis Regains Top Spot with Managed Care Pharmacy Executives After falling second to Merck last spring, Novartis reclaimed the top overall ranking from pharmacy executives, according to SDI’s Fall 2008 Managed Care Pharmacy Executive Promotional Audit. Merck remained No. 1 among medical directors in the fall 2008 edition of SDI’s Managed Care Medical Director Promotional Audit. Novartis’ rebound to No. 1 with pharmacy executives can be attributed to a big win in the area of value-added services, where the company took the top spot away from Pfizer following what one pharmacy executive called a strong response to a previous deficiency in the area. Pharmacy executives considered Novartis a leader in value-added services due in large part to its successful patient education materials and staff support. In addition to recapturing the top overall ranking, Novartis maintained its top position in the corporate approach category, which won praise from pharmacy executives. One executive observed, “Novartis corporate has made some very effective changes to its personnel on the ground for managed care; they have also been very much supportive on non-drug programs such as speakers for patient experience.” Novartis also rebounded in the contract category, where it rose to second compared with fourth in spring 2008. SDI’s Fall 2008 Managed Care Formulary Drug Audit also shows clear evidence of the success Novartis is having with its contracting strategies; according to that audit, more than 80% of HMO members had access to Novartis’ hypertension drug Diovan, an angiotensin II receptor blocker (ARB), at a preferred formulary position, the highest percentage of access for all ARBs. For more information, visit sdihealth.com. Economic Downturn Could Hamper Success of Specialty Drugs Now that the blockbuster model appears to be a thing of the past, many companies are looking to niche pharmaceuticals to salvage their portfolios. Mounting economic pressures combined with specialty drugs’ high per-patient cost, however, could push payers to restrict standard benefits for these treatments — or exclude them from their schemes altogether. According to the most recent edition of Thomson Reuters’ Pharma Matters report, The Ones to Watch, the pharma industry is already seeing how the recession is making payers reluctant to supply brand drugs to their members when a cheaper generic is available. This is effectively forcing patients beyond their old worries about the safety and efficacy of generic drugs; when faced with having to pick up a greater share of the cost of their trusted brand, they may have to make the hard choice of abandoning their regime before treatment is complete or attempting to use less than the prescribed dose of their brand, or taking the full course of a generic. Those lost sales won’t suddenly shift back to the brands when the economy recovers, the report predicts. But even in today’s sobering economic climate, pharmaceutical innovators remain committed to their pipelines of both large-scale and specialty drugs. Promising late-stage and approval-phase products reviewed in the October-December 2008 edition of The Ones to Watch include potential large-population treatments for cancer, HIV infection, asthma, and osteoporosis, as well as a number of promising niche pharmaceuticals for small patient populations. For example, MGI Pharma’s Lusedra, approved in December 2008, is a water-soluble form of the widely used general anesthetic propofol that is better-tolerated by patients than the traditional lipid-based formulation. Thomson Pharma has forecast sales of $90 million for Lusedra in 2011. In the cancer sector, Genzyme gained clearance in December 2008 for Mozobil, one of a series of CXCR4 inhibitors for use as an injectable stem-cell mobilizer for use in stem-cell transplantation. The drug is approved for use in combination with granulocyte colony stimulating factor (G-CSF) in stem-cell transplantation in non-Hodgkin’s lymphoma and multiple myeloma patients. Genzyme has projected that peak sales of Mozobil in the transplant setting could reach $400 million annually. European Union approval is expected in the second half of 2009, with approval in Australia and Brazil to follow. More than 1,000 patients have already received Mozobil through a compassionate use program in the United States and through similar programs in Europe. Meanwhile, the drug is also in Phase II development for the potential treatment of acute myelogenous leukemia. Another notable drug moving through worldwide approvals is Zypadhera, a long-acting injection formulation of Eli Lilly’s oral atypical antipsychotic Zyprexa intended for maintenance treatment in adults with schizophrenia who have sufficiently stabilized during acute treatment with the standard formulation of the drug. Long-acting injection formulations have a number of benefits in treating long-term schizophrenia, where poor or partial treatment compliance is a major problem. Zyprexa was the sixth top-selling prescription pharmaceutical worldwide in 2007, with sales totaling $4.76 billion, and Thomson Pharma projects Zypadhera sales of more than $240 million in 2011. In November 2008, GlaxoSmithKline gained accelerated FDA approval of Promacta, the first oral tablet formulation of a non-peptide, hematopoietic receptor agonist that mimics hematopoietic growth factors, including thrombopoietin, for the potential treatment of idiopathic thrombocytopenia purpura (ITP), as well as thrombocytopenia related to hepatitis C infection or chemotherapy. Thomson Pharma forecasts sales of more than $300 million for Promacta in 2011. TriLipix, developed by Abbott in collaboration with Solvay, is a next-generation fenofibrate PPAR alpha agonist formulated as delayed-release capsules for the potential treatment of mixed dyslipidemia. It received approval from the FDA in December 2008 for use in combination with a statin, the first fibrate to be approved for use in this way. Filings in other territories are likely to follow, the report says. Meanwhile, a combined formulation of TriLipix and Crestor is in Phase III trials for lipid disorders, including hyperlipidemia, and Solvay has initiated Phase II trials for diabetic macular edema. For more information, visit thomsonreuters.com. U.S. Substance Abuse Treatment/Diagnostic Market to Reach $3.1 Billion in 2013 The U.S market for addictions and substance abuse treatment and diagnostics generated $2.7 billion in 2008, according to a new technical market research report from BCC Research. This is expected to increase to $3.1 billion in 2013, for a compound annual growth rate (CAGR) of 2.7%. The report, U.S. Markets for Addictions and Substance Abuse Treatments and Diagnostics, says that pharmaceutical treatments have the largest market share, generating $2.5 billion in 2008. This should increase to almost $2.8 billion in 2013, for a CAGR of 2.3%. The relapse rate for addiction is significant, and it is clear that pursuing products that address not only the acute conditions of addiction but also continued treatment, perhaps for a lifetime, are needed. Since addiction seems to be a multidisciplinary problem, the focus of treatment needs to be broadened, as is evident in the types of new products in development for drug addiction. Companies that are operating in this arena will need to continue to advance products that tackle all facets of the addiction process to be successful. The diagnostic testing segment, which accounts for about 8% of the market, was valued at $230 million in 2008, and is expected to increase at a CAGR of 5.9% to reach $307 million in 2013. The testing market should continue to show moderate growth due to advancements in technology, making testing more accessible and easier to accomplish. Growth also will be fueled by advancements in quality and design, helping to make the tests more accurate and cost-effective, and by a growing trend within the general public to take greater responsibility for healthcare. The need for instant results at an affordable price will also help the substance-abuse diagnostic testing industry to grow. For more information, visit bccresearch.com. Companies Jockey for Position in Neurodegenerative Disease Market Neurodegenerative diseases, caused by the loss or dysfunction of neurons in the brain or spinal cord, are especially devastating because the affected cells typically cannot regenerate following damage or death. These diseases are drawing immense interest from the pharmaceutical industry and have inspired heavy competition in the race to introduce the next generation of improved drugs. A recent study from Insight Pharma Reports, Neurodegenerative Diseases: Next-Generation Drugs for Four Major Disorders, focused on four of the most comprehensively studied such conditions: Alzheimer’s disease (AD), Parkinson’s disease (PD), Huntington’s disease (HD), and amyotrophic lateral sclerosis (ALS). To the pharmaceutical industry, perhaps the most important defining characteristic of these debilitating diseases is the inadequacy of the standard of care, with existing treatments tending to address symptoms rather than modify disease course. AD and PD present huge potential markets, with 5 million and 1 million U.S. patients, respectively. HD and ALS are uncommon in comparison, with only about 30,000 U.S. patients apiece. All four diseases disproportionately affect the elderly, who comprise a steadily increasing share of the population in the developed world. Without an outright cure, most therapies would likely require long-term administration. These factors suggest that a company that can deliver an improved compound for one of these neurodegenerative disorders will earn a rich return on its investment, the report notes. Developing effective drugs for these diseases, however, continues to be challenging. Insight Pharma notes that several relatively new drugs are available for AD, but they have only modest impact, and AD research has been stung by the recent setbacks of several novel compounds in Phase III trials. PD is an active field, both in terms of available therapies and pipeline products, but existing treatments are plagued by the issues of side effects and diminishing returns, and the greatest development progress has been made with next-generation versions of drugs that are already available. The landscape is even bleaker for HD and ALS, with only a single, moderately effective drug for each of these conditions, and late-stage clinical candidates that are most often non-specific drugs originally developed for other indications. As a general trend, the novel, disease-targeted compounds tend to be further back in the pipeline than the “copycats” and “generalists.” This may mean that true breakthrough drugs are still several years away, at a minimum. Four of the five drugs approved by the FDA to treat AD are cholinesterase inhibitors, which work by blocking acetylcholinesterase, an enzyme that breaks down the neurotransmitter acetylcholine, thereby helping to restore cholinergic neurotransmission. According to the report, pharmaceutical companies are exploring other approaches to modulating the activity of cholinergic neurons, including the use of acetylcholine receptor agonists targeted to both muscarinic and nicotinic receptor subtypes to increase cholinergic transmission. Unfortunately, the early promise of muscarinic receptor candidates, which showed great efficacy in preclinical models, failed to live up to expectations in human trials, either because of lack of efficacy or unacceptable cholinergic side effects. Serotonergic compounds may provide cognitive benefits in Alzheimer’s patients; antagonists of the serotonin 5HT1A receptor, for example, have been found to enhance the release of glutamate and acetylcholine in the hippocampus. Other notable classes under investigation are 5HT4 receptor agonists and 5HT6 receptor antagonists. For more information, visit insightpharmareports.com. findings and best practices for competitive intelligence operations Multiple sources are vital to effective CI n Triangulate from multiple data sources to develop the most accurate projections. n Critical types of secondary sources range from trade publications to investor feeds. n Integrate primary data with these existing sources. n People, processes, and use of third-party vendors are keys to optimizing data collection. n Hire the right people, use advanced Internet search techniques, and collect and review data over time to distill relevant, actionable information. n Talk with employees across company functions to discover information gaps. n Involve the legal function to mitigate risk if internal employees gather external CI information. n All large — and most small — pharma companies use vendors to minimize risk, to avoid the perception of wrongdoing, to improve the process, and to get better finished intelligence. n Develop clear processes, practices, and guidelines for all critical activities, such as collecting CI at trade shows. Hold vendors to strict standards n Gain experience with and knowledge of third-party research vendors. n Most companies using third-party research vendors indicate that vendors proactively identify self, company, and purpose when conducting primary CI research. n Ensure third-party research vendors know and understand your company’s code of ethics. n Discontinue work with vendors who cross into gray areas when collecting information. CI guidelines enable success n Work collaboratively with the legal function to protect the company and to obtain legal’s buy-in and support. n Involve upper management to prove the value of conducting CI. n SCIP guidelines, the company’s code of ethics, and relevant laws provide the foundation for CI guidelines. n All large and many small pharma companies have formalized guidelines in place to govern CI operations; many explicitly define policies for primary data collection. n Ensure employees understand the legal and ethical guidelines that govern CI collection. Manage internal expectations up front n CI must help educate the employees who make inappropriate or unobtainable requests for information. n Management must stand behind CI to protect the company and ensure the long-term success of the CI function. CI executives advise emerging CI functions to evolve n Link CI to the financial perspective to gain clout in the company. n Establish an information strategy first, then an intelligence strategy. n Concentrate on building a network of information sources rather than just answering requests to fetch data. Source: Best Practices, Competitive Intelligence Policies, Ethics, and Data Collection: Navigating the Gray Zone. For more information, visit best-in-class.com. the five most promising drugs launched or receiving approval, oct-dec 2008 the five most promising drugs entering phase iii clinical trials, oct-dec 2008 Drug Disease Developer Lusedra Anesthesia care sedation MGI Pharma Mozobil Cancer Genzyme Zypadhera Schizophrenia Eli Lilly Promacta Idiopathic thrombocytopenia purpura GlaxoSmithKline TriLipix Mixed dyslipidemia Abbott/Solvay Drug Disease Developer GS-101 Corneal graft rejection Gene Signal Edoxaban Atrial fibrillation Daiichi Sankyo Belinostat Peripheral T-cell lymphoma TopoTarget VP-003 Acromegaly Indevus Justiva Scarring Renovo Source: Thomson Reuters, The Ones To Watch – A Pharma Matters Report, October-December 2008. For more information, visit thomsonreuters.com. Source: Thomson Reuters, The Ones To Watch – A Pharma Matters Report, October-December 2008. For more information, visit thomsonreuters.com.