Roadmap to reimbursement and access

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Roadmap to reimbursement and access

  1. 1. Original Article Roadmap to reimbursement and access Received (in revised form): 23rd December 2009 Rhonda Greenapple is President of Reimbursement Intelligence. She spent her career focused on gaining access and reimbursement for her clients. Her clients’ products have ranged from unique chemical entities to highly competitive therapeutic categories. Reimbursement Intelligence was founded to serve her desire to focus strictly on biologics and emerging technology and the payer factors that can influence commercial success. Over the past 15 years, she has been involved in the reimbursement launch planning for over 40 products. She has spoken at professional meets both domestically and internationally on a range of topics including Reimbursement Due Diligence for investors and emerging biotech companies, and Medicare Part D drug benefit trends. She is a columnist in Fierce Pharma Industry Voices on reimbursement trends and has published in Managed Care Magazine, American Health and Drug Benefits and Oncology News International. Greenapple received her BS from Cornell University and received her Master’s of Science in Public Health from the University of North Carolina. Julie Schachter is Vice President of Strategic Planning. She is responsible for developing managed market strategies and business planning and is the head of Research and Analytics at Reimbursement Intelligence. As the head of the research team, Schachter is responsible for proprietary syndicated surveys as well as all client-driven research conducted in both the United States and European payer markets. She has more than 10 years of experience in the pharmaceutical industry and has successfully launched pharmaceutical drugs and medical devices in various categories. Before working at Reimbursement Intelligence, Schachter worked at Bayer Healthcare and Novartis Pharmaceuticals in both Product and Marketing Management positions and was key to the launch of several unique products in the United States. She also worked as a private consultant with several biotechnology and life science companies on product and disease management initiatives. Schachter received her bachelor degree from University of Delaware and is an MBA candidate at Seton Hall University. Maxim Miller is Manager of Market Research and Analytics. He leads the Reimbursement Intelligence research and analytics team to deliver strategic recommendations for pharmaceutical, biotech and device manufactures. With over 10 years of reimbursement and access consulting. Miller is sought by emerging biotech as well as top 10 pharmaceutical companies. He has conducted diabetes landscape research in multiple therapeutic categories. Previously, Miller worked as an analyst at both Campbell Alliance and PriceSpective LLC. He received his BS in Marketing/International Business from Drexel University and is an MBA candidate at the Temple University – Fox School of Business. ABSTRACT The article evaluates the recent challenges faced by the pharmaceutical industry and the impact of those challenges on the product development process. Upon identification of key hurdles faced by the pharmaceutical companies during the development process, the article proposes solutions that may help to optimize the commercial opportunity of select pharmaceutical products. Although the clinical perspective is addressed, the focus of the article is on the economic perspective; specifically, strategies that pharmaceutical manufacturers can employ to maximize access and commercial viability of their pipeline products. Journal of Medical Marketing (2010) 10, 15–23. doi:10.1057/jmm.2010.1 Keywords: pharmaceutical product value assessment; pharmaceutical product drug development process; life cycle management Correspondence: Rhonda Greenapple Reimbursement Intelligence, BACKGROUND cost to bring a drug to market continues 2 Shunpike Rd., 3rd Floor, In 2008, the Federal Drug Administration to rise along with an increase in the Madison, NJ 07940, US E-mail: rgreenapple@ (FDA) approved 25 novel treatments, an failure rate as products progress through reimbursementintelligence .com increase from 19 the previous year.1 The the development process. Currently, there © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23 www.palgrave-journals.com/jmm/
  2. 2. Greenapple et al are approximately 2000 drugs in various significant resources into development of stages of clinical development. novel drugs, they must be cognizant of Approximately one quarter of the drugs the importance of incorporating the are in Phase II/III or Phase III clinical economic value proposition of their trials. Although the rate of approval pipeline products into the overall value improved moderately from 2007 to 2008, proposition. Currently, the pharmaceutical the overwhelming majority of pipeline industry faces significant uncertainty as products are never brought to market as legislators attempt to address the rising costs evidenced by the numbers of agents in the of health care. Consequently, the economic pipeline versus those that received FDA value proposition may become as important approval.2 Furthermore, the cost of as the clinical profile. Historically, development is an integral component in manufacturers focused on the clinical the selection process of which molecules profile of pipeline products and the will be chosen to progress through the economic value proposition was often a development process.3 The conservative secondary concern. However, as cost- estimated cost of developing a single New effectiveness gains traction as one of key Chemical Entity exceeds US $800 million components of a drug’s value proposition, with clinical costs comprising over $400 the manufacturers will have to learn to million of the overall cost. A substantial identify as well as effectively communicate portion of the development costs is their product’s economic value story. Most derived from late-stage clinical trials. importantly, given the cost of development, Given that over 60 per cent of trials are the expectations for identification and terminated during late-stage development, understanding of a product’s economic this is an area of concern for the health value story may be required earlier in the care industry as a whole due to the development process. This article will resources that are wasted by the failed identify key considerations along the trials. Phase III trials are typically the development pathway, as well as offer costliest due to the number of patients actionable strategies that will serve to assist involved in the trial, typically in the the manufacturers in optimizing their thousands, and can cost tens or even product offering’s economic value story.5 hundreds of millions of dollars to conduct. Consequently, high costs associated with late-stage clinical trials emphasize OBJECTIVES the importance of minimizing commercialization risks while maximizing • Understand the key questions to shareholder value. Furthermore, the ask regarding access and reimbursement emphasis to minimize costs extends to at key product lifecycle milestones. molecules that fail during late-stage • Identify opportunities and challenges clinical trials, as well as those that are in private and government health brought to market. Those products that plans that can impact commercial reach the market are burdened to recoup success. the resources invested in the molecule • Integrate reimbursement and health during clinical development.4 outcomes activities throughout the This article will examine potential commercial planning process. strategies and methodologies that • Ensure continuous monitoring of manufacturers can employ in order to the entire managed markets maximize the commercial success of their landscape that can impact access and product portfolio. As manufacturers invest reimbursement. 16 © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23
  3. 3. Roadmap to reimbursement and access METHODOLOGY PHASE I: PROOF OF This article will review four critical steps CONCEPT in product development: Proof of The high cost of product development Concept, Opportunity Identification, coupled with poor economic conditions Pre-launch Planning and Post-launch makes it vital for manufacturers to be able and Life cycle Management. In addition, to efficiently and effectively identify reimbursement, health outcomes and products with the greatest potential for pricing activities, as well as key questions commercial success. Conducting a market for consideration at each stage will be landscape analysis during early phases of identified. product development can help to identify early clinical and economic scenario models that incorporate: the unmet INTRODUCTION medical needs in the category; the pricing In the current health-care landscape, and reimbursement of currently available there is greater scrutiny paid to products and how they are managed; expensive biotech products in an clinical and economic profiles; which environment where biologics represent Health Economics Outcomes Research 30 per cent of the cost of cancer (HEOR) and clinical endpoints will be treatment 3 and are evolving into a key required; and ultimately gauge the component of many therapeutic product’s commercial viability. treatment algorithms. Health plans, both In oncology, for example, there are government and private, are attempting more than 850 agents in development.3 to ensure appropriate access and For a new oncolytic agent in the proof utilization of costly biologics via of concept stage, the first step will be to implementation of management tools determine whether the product can meet such as: prior authorization, step edits, an unmet need versus current or future quantity limits, genetic testing, lockouts, competitors. In a recent survey regarding exclusions, and formulary management. key tumor types (Figure 2), Additionally, a number of health plans, Reimbursement Intelligence asked 60 public and private, have also altered Medical and Pharmacy Directors from their benefit design to include a private and commercial health plans, specialty tier that often requires the which tumor types they perceived to have patient to pay a co-insurance for use of the greatest unmet need for new cancer injectable and biologic products, with therapies. The report also assessed the the member paying anywhere from impact of select clinical and HEOR 10–40 per cent of the cost of the drug endpoints that novel oncology therapies (Figure 1(a) and 1(b)).6 will be expected to achieve in order to Health outcomes data becomes even demonstrate incremental value over more important for costly biologics, as the current standard of care. This type of Centers for Medicare and Medicaid analysis is the crucial first step in ensuring (CMS) and private health plans are that resources are allocated appropriately considering comparative effectiveness in R&D efforts. analysis and lowest cost alternative when Another trend in the current health- creating their product formularies. In care environment is the increase in 505 order to maintain access and utilization, (2)(b) products introduced into the manufacturers must be able to demonstrate market. The 505 (2)(b) process allows for cost effectiveness and the product’s impact a faster development time without the on the total cost of care. need for extensive clinical trials. Generally, © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23 17
  4. 4. Greenapple et al 505 (2)(b) products are generic products generic with many iterations introduced that have new delivery systems, a under the 505 (2)(b) path, that utilizes formulation change or a novel dosing novel delivery mechanisms. Table 1 shows regimen that allow them to have an three migraine medications that used the abbreviated New Drug Application. 505 (2)(b) pathway to launch products The FDA allows the manufacturers to derived from the same ingredient use safety and efficacy data already in the (sumaptriptan).7 public domain thereby eliminating the In these examples, the primary market need to conduct trials that would landscape analysis should focus on the demonstrate safety and efficacy.7 current and future (2 years out) markets, The 505 (2)(b) path allows companies including an analysis to determine if to shorten the development times and payers perceive the new delivery significantly lower R&D costs. For mechanism to offer any tangible example, the migraine product Imitrex improvements in health outcomes. (sumatriptan) provides an example of a Without concrete improvements in health 2006 2007 2008 2009 96% 98% 93% 92% 87% 88% 82% 69% Stand-alone Prescription Drug Plans Medicare Advantage Drug Plans 50% 48% 55% 57% Coinsurance rates: 33% 5% 10% 26%-30% 4% 6% 25% <25% 45% 39% 39% 37% 3% 2% 2008 2009 2008 2009 PDP's MA-PD plans Figure 1: (a) Share of enrollment in Medicare Part D plans with tiered cost sharing using specialty tiers, 2006–2009; and (b) Share of enrollment in Medicare Part D plans with specialty tiers, by specialty tier co-insurance rate, 2008–2009. Source: Georgetown/NORC analysis of data from CMS for PedPAC and the Kaiser Family Foundation and Henry J. Kaiser Family Foundation. Notes: (a) Estimates weighted by enrollment in each year; and (b) Estimates weighted by enrollment in each year. Analysis excludes small share of plans with copayments for specialty tiers (0.1% of PDPs and 2% of MA-PD plans). Analysis of MA-PD plans excludes Special Needs Plans. 18 © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23
  5. 5. Roadmap to reimbursement and access 10 9.6 10 9.2 8.9 9 8 6.9 6.6 7 6.2 6.1 5.8 5.7 5.5 6 5.4 5.4 5 4 3 2 1 0 10 = Ranked Greatest Unmet Need, 1= Ranked Lowest Figure 2: Payers perception of unmet need for new treatment options. Table 1: Migraine medications that used the 505 Table 2: Key questions for consideration – ‘Proof of (2)(b) pathway to launch products derived from the Concept’ same ingredient (sumatriptan) Does this product meet an unmet need versus current Brand Delivery Manufacturer or future market entrants? Who are the key stakeholders, and what is their Sumavel™ Needle-free Zogenix involvement in managing the disease and treatment DosePro™ delivery pathways? (sumatriptan system How are payers managing the disease and injection) therapeutic category? Zelrix™ Transdermal NuPathe What is the commercial viability? (sumatriptan patch What HEOR/Patient Reported Outcomes (PRO) transdermal have been used in this indication? patch) Which HEOR/PRO endpoints will need to be Levadex™ Oral inhaled MAP developed and tested during Phase II of clinical (sumatriptan Pharmaceuticals development to optimize market access? oral inhaled) What product attributes will be important in this category? outcomes, the overall value proposition of PHASE II: OPPORTUNITY the product may not be enhanced, and in IDENTIFICATION some instances it may be diminished. Phase II clinical trials play an integral role With no perceived ‘value’ the 505 (2)(b) in determining the ultimate success or product will likely be disadvantaged in demise of a product. After Phase I trials health plans that have implemented establish the ‘proof of concept’, Phase II generic first formularies designed to trials build upon the outcomes of Phase I transition patients from branded to generic trials and further test the molecular drugs. Conducting comprehensive due entity’s safety and efficacy. Furthermore, diligence at this early stage can help to well-designed and executed Phase II trials ensure that the value proposition resonates should enable the manufacturer to make with the appropriate stakeholders. Table 2 the go or no-go decision regarding shows the questions that must be progression to Phase III trials. Phase III considered before commencement of trials often require several years to proof of concept trials. complete, and can cost tens or even © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23 19
  6. 6. Greenapple et al hundreds of millions of dollars. Table 3: Key questions for consideration – ‘Opportunity Identification’ Consequently, manufacturers rely upon the outcomes of Phase II trials to inform What PRO endpoints should be included in our clinical trials? and offer guidance for the largest Does the clinical program enhance the value investment they have to make during the proposition? Are the endpoints correct comparators, and is the development process.8 subpopulation in the Phase II studies relevant for Beyond the financial pressures associated market release? with Phase II trials, Phase II trials Is there a need to undertake burden of illness studies to support value proposition and market building generally unveil the product’s clinical and positioning activities? profile, and consequently initiate the What is the optimal pricing band, based on expected levels of effectiveness, physician and payer development of the compound’s value perception and pricing research? proposition. These early data provide enough information to begin gauging success factors for the product, assuming manufacturer should also seek to the trials result in clinical significance. understand if the proposed Target Product Other market factors, including pricing Profile has clinical and economic scenario planning and price sensitivity relevance for payers across all target analysis, economic modeling, value markets. Although it may seem too early proposition validation and payer evidence at this phase of development to analyze requirements, are especially important for these market factors, it could ultimately manufacturers considering exit strategies save a manufacturer millions of dollars and for their compound in development. The thousands of man hours. Consequently, it more information that is available to is imperative for manufacturers to support a good market outcome, the proactively plan and integrate the more attractive partnerships and necessary value measurement into the acquisitions will be. latter stages of clinical development in Clinical endpoints that are used in order to optimize market access and Phase II trials are often mirrored and commercial viability of the product. expanded in Phase III trials. In order to Table 3 shows the questions that must be optimize the value proposition of a considered prior initiation of Phase II compound, the manufacturer must (Opportunity Identification) trials: develop a thorough understanding of the expectations of key stakeholders, including PHASE III: LAUNCH those related to managed markets. PLANNING AND GLOBAL Although a particular endpoint may be PRICING AND MARKET clinically significant, if it does not resonate ACCESS (P&MA) with managed market key stakeholders, Phase III trials determine how the the product could ultimately have market compound measures up to the current access issues that make it a less desirable treatment armamentarium. Often called compound for development.9 For pivotal or comparative trials, Phase III example, a manufacturer developing a trials involve a large number of patients novel therapy for rheumatoid arthritis, and consequently make up the largest which has a costly and crowded existing portion of drug development costs. It is market, will not only need to understand estimated that 40 per cent of Phase III how key stakeholders measure efficacy, clinical trials fail.10 Of those failed trials, but also need to determine what their 30 per cent fail due to an inability to expectations are for most appropriate demonstrate efficacy, while another 30 per comparators. Furthermore, the cent fail due to toxicity issues, further 20 © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23
  7. 7. Roadmap to reimbursement and access underscoring the value and importance of Table 4: Key questions for consideration – ‘Launch Planning & Global P&MA’ Phase II trial design.11 Although Phase III trials mostly serve in a confirmatory What is the ‘value’ proposition to payers? What is optimal pricing and reimbursement strategy? capacity to validate and expand upon the How wide is the price variance across markets? outcomes of earlier phase trials, they What is the launch sequence across major markets? ultimately determine the success or failure What are the primary drivers that influence the pricing corridor? of a compound. How have we maximized synergy for United States The outcomes of Phase III trials will be and ex-US markets? What are the key resources, timelines and budgets for used to construct the compound’s clinical development of key Pricing and Reimbursement, and economic value propositions. The HEOR and market access milestones? manufacturer must focus on development of the value proposition, which will in the trial design in order to optimize ultimately influence the pricing, the value proposition of the compound. reimbursement and marketing strategies To design an effective pricing strategy, for the compound. An incorrect or a manufacturer must consider all of the inappropriate selection of comparator(s) or nuances and differences in expectation in clinical endpoints may lead to irreparable their clinical trial design.12 damage to the product’s value proposition In considering these variables, it will be and consequently the product’s important to incorporate vital pre-launch commercial viability. However, the planning activities to uncover and selection of the appropriate comparator maximize the product’s commercial may be challenging due to geographic potential. Some critical activities include: differences in what the appropriate development of value messages and global comparator should be. This may be value dossier development; pricing studies particularly challenging in ex-US markets and modeling; contracting intelligence and where expectations for clinical endpoints, pricing and reimbursement negotiation pricing and clinical comparators may differ tools; global payer segmentation and payer significantly among the respective markets. advisory boards; and value drivers and Consequently, manufacturers must launch sequencing for each target market. consider the unique requirements and Table 4 shows the questions that must be expectations for the markets where the considered before initiation and execution product will be launched. of launch planning. Similarly, Phase III trials will have a fundamental impact on manufacturers that PHASE IV: POST LAUNCH intend to launch their product in more AND LIFE CYCLE than one market. Although expectations for MANAGEMENT outcomes of Phase III trials have a number Based on the complexities and the failure of similarities, specifically proof rate of gaining approval for a New of safety and efficacy, a number of Molecular Entity, most manufacturers differences exist even among neighboring have allocated significant resources toward markets. Secondary endpoints such as expanding the utilization of their quality of life and site of care can have an marketed compounds. There are several integral impact on reimbursement and means that manufacturers have at their market access for a product in one market, disposal to maximize and expand the while having minimal to no impact in revenues generated by their marketed other markets. Consequently, manufacturers products. Expanding an indication of a must be cognizant of the differences in marketed product is one of the most expectations, and factor in those differences frequently used approaches. In 2004, © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23 21
  8. 8. Greenapple et al over 80 per cent of the top-selling drugs a new formulation of an existing product. sought and attained approval for an Unlike the addition of a new indication, indication post-launch. The approval of which leverages the product’s intrinsic an additional indication enables the attributes, and consequently is not manufacturer to gain access to a new typically heavily scrutinized, introduction market without having to go through the of a novel formulation of an existing entire development process. While some product often faces significant scrutiny manufacturers carefully craft their patent from payers. Payers are hesitant to pay extension strategies, others must develop more for just a novel formulation unless them out of necessity.13 it offers some concrete benefits and are A number of manufacturers have looking specifically for improved launched products that fell short of outcomes.13 expectations, or failed to get approval Another patent life-extending option in the targeted indication. Consequently, is the development of a Fixed Dose manufacturers have had to develop a Combination (FDC) product. Similar to strategy to target another indication and novel formulations of existing products, reposition the product. This scenario FDCs using existing or available products emphasizes the importance and value can provide a tremendous opportunity and of planning and gaining a thorough expanded revenue stream, if the product’s understanding of the value proposition clinical and economic value drivers are during the early stages of product relevant to managed market stakeholders. development. For example, bupropion In order for an FDC to be effective, it hydrochloride (Wellbutrin) that was must add incremental value beyond the initially commercialized by Glaxo offering of the individual components. Smithkline (GSK) as an antidepressant, Payers will generally disfavor FDC subsequently became available under the products that do not offer any incremental brand name Zyban™ as a smoking value beyond convenience while charging cessation agent. GSK’s experience with a premium over the individual bupropion hydrochloride emphasize the components. For example, GSK’s importance of developing a thorough Advair™ is a FDC that has been far more understanding of the molecule’s successful than the individual components commercial potential in the early part that make up the combination. By of clinical development. However, offering both anti-inflammatory and manufacturers must be cognizant of some bronchodialatory activity, Advair was able of the complexities that may arise from to offer a distinct advantage that directly seeking an additional indication. Using translated into improved outcomes and the same molecule for a new indication consequently resulted in preferred access may require changes in formulation and utilization in most plans.13 and/or dosing, which may impact the Conversely, Pfizer’s Caduet™, which is a product’s P&MA. Consequently, all of the FDC of two products that will become aforementioned factors must be considered available in generic form in the near future, in early phases of development in order to has failed to meet expectations. The optimize the commercial opportunity of a individual products’ (Lipitor™ and novel pipeline entity. Norvasc™) combined sales exceeded $18 Another approach used by billion in 2006, while the FDC attained manufacturers to optimize the life and annual sales of $274 million in 2006. This revenue generating capacity of their can be attributed directly to a lack of marketed products is via introduction of perceived value from a payers perspective. 22 © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23
  9. 9. Roadmap to reimbursement and access Table 5: Key questions for consideration – ‘Post exceed $800 million to bring a new drug Launch & Life cycle Management’ to market, it is essential to make the Have we provided clinical, marketing and account commitment to allocate the necessary management with consistent Pricing and Market Access (P&MA) messaging and tools? resources in order to be able to develop a How are we continuing to differentiate in the market ‘roadmap’ that will identify the impact of place to maintain and enhance access? market access and pricing factors at each What materials exist to handle P&MA objections? What impact is the competition placing on pricing and phase of product development. This will reimbursement? increase the likelihood of success What are regional/local barriers to market access? What product changes could trigger new price/ throughout the product development reimbursement negotiation or submission? process and enable manufacturers to optimize their investment. Early analysis of the payer market REFERENCES AND NOTES expectations could have identified these 1 Blum, J. (2008) Specialty medicines led rebound in hurdles earlier in development and provided US drug approvals in 2008. Bloomberg [Online] Jan 2009, http://www.bloomberg.com, accessed insights as to how the compound could 5 October 2009. have achieved better payer acceptance. The 2 David, E., Tramontin, T. and Zemmel, R. (2009) key stakeholders did not perceive that Pharmaceutical R&D: The road to positive returns. Caduet offered any incremental value over Nature Reviews Drug Discovery 8: 609–610. 3 Medco. (2009) Medco Drug Trend Report [Online], the individual components to warrant a http://medco.mediaroom.com/, accessed 2 October premium price, consequently the product 2009. was disadvantage in most plans and has seen 4 Schachter, A. (2007) Economic evaluation of Bayesian model to predict late-phase success of new chemical limited uptake.13 entities. Value in Health 10: 377–385. In this phase, the manufacturer must 5 Nagle, T. (2007) Thoughtleader: Thomas Nagle. ensure successful and flawless Pharmaceutical Representative [Online]. May 2007, http://pharmexec.findpharma.com/, accessed implementation of the product launch or 5 October 2009. life cycle management strategies. These 6 Henry J. Kaiser family foundation. (2009) Medicare strategies must incorporate communication Part D Data 2009 Data Spotlight: Specialty Tiers. tactics including: global value slide kits [Online]. June 2009, http://www.kff.org/, accessed 2 October 2009. and proposition brochures; payer/HEOR 7 Code of Federal Regulations. (2009) Title 21, Vol. 5., publications, training tools, patient Revised as of 1 April 2009. advocacy materials and pull-through 8 Chin, J.Y. (2004) The clinical side: Clinical trials take drugs from the lab to the bedside. Pharmaceutical activities; as well as health outcomes Representative [Online]. 2004; [2 screens], http:// tactics including: global Pricing and license.icopyright.net/user/viewFreeUse.act?fuid=NT Reimbursement/HEOR value dossier; EzMjg3Ng%3D%3D, accessed 2 October 2009. 9 Ratain, M.J. and Sargent, D.J. (2009) Optimising the cost effectiveness and budget impact design of phase II oncology trials: The importance of models; global database and registry randomization. European Journal of Cancer 45: 275–280. studies; and global pricing research and 10 Collier, R. (2009) Drug development cost estimates real-world data analysis. Table 5 shows hard to swallow. Canadian Medical Association Journal 180(3): 279–280. the questions that must be considered 11 Yue, C., Colucci, P. and Ducharme, M. (2009) Stop before development of post-launch and costly phase III failures. Applied Clinical Trials [Serial life cycle management strategies. on the Internet] 18(6): 4–6, Available from: Academic Search Premier, accessed 2 October 2009. 12 Optimal launch sequence for pharmaceuticals within CONCLUSION the EU. M.C. Gouy Consulting GmbH 2000 May: There is a considerable amount of due 1–6. 13 Sandner, P. and Ziegelbauer, K. (2008) Product- diligence and analysis that goes into every related research: How research can contribute to phase of development for a ‘successfully’ successful life-cycle management. Drug Discovery Today marketed product. Given that costs can 13(9/10): 457–463. © 2010 Macmillan Publishers Ltd. 1745-7904 Journal of Medical Marketing Vol. 10, 1, 15–23 23

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