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Spending on specialty pharmaceuticals has been skyrocketing in the United States, and shows no signs of slowing down. While long a source of concern in the healthcare insurance industry, the issue drew wider attention earlier this year after sofosbuvir (SOVALDI) was approved for use in the U.S. In mid-September, Gilead Sciences announced plans to sell Sovaldi in India for about $10 per pill.
The growing costs of specialty pharmaceuticals is driven largely by their increasing availability, which in turn is the result of advances in pharmaceutical science and the economics of the industry. In recent months several new major drugs for treating diabetes have come on the market, such as dapagliflozin (Farxiga), canagliflozin (Invokana), and empagliflozin (Jardiance).
Confronted with the escalating costs of specialty drugs, payers and PBMs have been employing a variety of strategies in an attempt to limit their financial exposure and improve patient outcomes, as shown in responses to Managed Healthcare Executive’s State of the Industry survey. Payers use prior authorizations for two reasons, says Howard Flushman, MBA, research director for specialty focused payer services for HealthStrategies Group. The second is product selection control--making sure the product is being used according to label, under the correct protocols, and so on. Because of the burden prior authorizations impose, plans are experimenting with ways of minimizing them, says Flushman.
Requiring the use of specialty pharmacies is another tool payers use to limit their exposure to the cost of specialty drugs. Like most specialty pharmacies, BriovaRx employs nurses who provide regular clinical counseling to patients using specialty pharmaceuticals. Much of the counseling BriovaRx provides takes place remotely using video technology available on most computers and mobile devices. In addition to mandating the use of specialty pharmacies, some payers have begun narrowing their networks of them, says Susan Weber, director of brand access analysis for HealthStrategiesGroup, and requiring split fills of specialty prescriptions.
Along the same lines, Weber adds, some payers are negotiating contracts with biopharmaceutical companies, especially producers of oncology drugs, under which the payer will require first-line use of the specialty drug on its formulary in return for receiving a discount from the manufacturer.
Another way payers are attempting to reduce costs is by covering specialty pharmaceuticals under a plan’s pharmacy benefit rather than its medical benefit.
The ultimate goal for payers, Flushman adds, should be to collect enough data to measure costs and outcomes for an entire episode of care, rather than just the medication. All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated.
Yesterday I was privileged to speak at the Pharmaceutical Product Lifecycle Management Conference in London.
LCM and the Pharmaceutical Industry The evolving nature of the pharmaceutical industry, not to mention a more competitive business climate, has fuelled interest in the discipline of LCM as a way of sustaining growth and profitability in the pharmaceutical industry.
The pharmaceutical industry is going through a period of transformation where defining the value of a product is becoming more and more important. The only way pharmaceutical companies can create and communicate value is by taking an early and a proactive approach towards deciphering the journey of the product from its initial stages in the laboratory to the end of patent life and beyond. The pharmaceutical industry generates huge amounts of information but utilises only a small portion effectively, mainly due to poor information management and lack of integration. The Speed of Change The rapid pace of change in the industry is something that pharmaceutical companies have often been slow to adapt to.
Praful Mehta is a senior life sciences analyst for IHS and is responsible for the development of new tools, platforms and capabilities. About the IHS Life Sciences BlogIndustry insights from the IHS Life Sciences team covering market access, pricing and reimbursement, emerging markets, generics strategies, therapeutic development pathways, forecasting and market sizing, and general competitive intelligence. Develop your Health Economics and Outcomes Research team to support product success, manage costs and workflow, and communicate ROI.
Set a global strategy to meet the demands of the Medical Affairs' expanding set of sub-functions, diverse stakeholders, and widely varying regional needs.
Chart a comprehensive clinical trial patient recruitment and retention strategy with specific tools, processes and resource benchmarks. Overall, key account management groups would like increased influence over account strategies within their organizations.
In the film business, opening weekend is the critical barometer: a movie’s receipts from the first couple of days typically predict how popular it will be at the box office. The EU is a major player in global Health, both through its research base and through its role in supporting development. Improving global health is a multi-faceted challenge due to the many barriers preventing access to quality care. The diversity of initiatives needed to tackle all diseases (both communicable and non-communicable) requires the commitment of all healthcare actors. In addition, pharmaceutical companies have created partnerships in many low- and middle-income countries that focus on R&D discovery, funding for awareness and prevention campaigns, investing in capacity building and training of healthcare workers, as well as donations. Through donation programmes, and flexible pricing strategies among other tools, companies can improve access to the latest medicines.
EFPIA believes that trade, health and development are policy areas that can reinforce one another, and that collaboration between industry, governments and other stakeholders can advance shared objectives. Today is rare disease day.  These are diseases we do not often talk about and they do not get the attention that other diseases do.
Brussels, 23 January 2013: Yesterday, the MEP Christofer Fjellner (Sweden, EPP) and EFPIA hosted a panel discussion to discuss healthcare technology transfer to third countries.
On 22 January, MEP Christofer Fjellner hosted a lunch debate in the European Parliament on the transfer of technology from developed to developing countries. PDCI develops effective P&R strategies and market access road maps to help manufacturers successfully navigate the challenging Canadian environment.

The company also said it had licensed Indian pharmaceutical companies to produce the drug for sale in India and other developing countries for far less than the cost in the U.S.
Zeglinski notes, however, that these drugs had been in development for the past five to 10 years.
Primarily these efforts  consist of negotiating with a hospital system or physician group to use only agreed-upon medications and protocols for treating certain conditions in exchange for not requiring prior authorizations. Unlike retail pharmacy chains, specialty pharmacies have the resources to monitor patient adherence and reaction to drugs. That’s because claims submitted under the pharmacy benefit, unlike those submitted under the medical benefit, include a national drug code number. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium.
Managed Healthcare Executive, in partnership with Access Market Intelligence and the National Institute of Collaborative Healthcare, is seeking your opinion on the current state of pharmacy, and where it’s headed in the future.
After meeting with the industry’s core stakeholders, I grew ever more convinced that the concept of Life Cycle Management (LCM) in the pharmaceutical industry needs more attention, as it may well become a critical part of the overall business strategy.
Life Cycle Management (LCM), as the term might imply, is the implementation of optimization strategies as the product goes through the traditional development and marketing pathway, in order to harness the total value of the product during its market journey.
But while the industry has realised its importance as an area of investment in the last couple of years, adoption has been lacklustre, with poor senior management commitment and a lack of clarity on the basic rationale for implementation. One of the first steps towards creating greater value for a product is by integrating information sources to generate meaningful insights and realistic conclusions about the business environment. Payers and regulators hold a very different perspective to pharmaceutical companies about the value of a product in a particular therapeutic area. Praful has been a long-time advisor to senior teams within the pharma industry on issues of market competitiveness, business integration, and commercialization strategies.
Ideally, KAM groups would be more involved with account strategies across the organization. The pharmaceutical industry cannot resolve the access issue alone and nor can any other actor. These partnerships often involve Ministries of Health and local health professionals, global and local NGOs, and institutes of research focussing on a wide range of treatments, from malaria to diabetes. A principle for competitiveness is to develop sustainable solutions which improve access to medicines while also supporting investment in R&D on new medicines. Subscribers stay informed on the current activities at the PMPRB, the Common Drug Review Directorate, Health Canada and emerging issues in Canada. That’s especially important in the case of oral oncology drugs, Flushman notes, because of the adverse reactions they produce in many patients. This saves them a lot of money, because some of these drugs can cost thousands of dollars per month,” Weber says. That provides payers with large quantities of data on prescription drug use among a plan’s beneficiaries, says Flushman, which better enables them to forecast their future expense levels. This is part of a multi-year benchmarking effort focusing on broad issues such as managing specialty drugs to specifics like fighting opioid abuse.
It is a highly evolved approach, especially in competitive industries such as FMCGs and electronics, and has been instrumental in sustaining many big brands. An integrated information source will provide timely and meaningful insights about markets, competitors, payers and regulatory bodies, and can help design the most appropriate strategy for sustaining competitive advantage.
The only way to bridge this value perception gap would be to start early and engage effectively at every level of the life cycle of the product whilst indentifying core strength and weaknesses to fully capitalise on the market opportunity. A product’s performance during its launch often indicates how successful it will be during its life cycle.  Effectively launching a new biopharma product, however, has never been more challenging.
To encourage collaboration on global health issues with European stakeholders (NGOs, policy makers, etc.) EFPIA started a dialogue to address major issues related to healthcare delivery in developing and emerging countries. Without political commitment, the funding for infrastructure and capacity building will not be available. The GHI working group aims to encourage collaboration among European political actors to create unique solutions for shared problems in global health.
As a thank-you to survey-takers, when the survey closes June 17, we will hold a drawing to give away not one, but two $200 Visa gift cards. The Global Health Initiative (GHI) series of public debates, sponsored by members of the European Parliament, seeks to improve understanding and identify new opportunities for collaboration in this complex area. Product Development Partnerships (PDPs, also known as public-private partnerships) joining the pharmaceutical industry with other healthcare stakeholders with complementary expertise have become one of the established approaches to tackle diseases in the developing world. To this end, it was decided that public debates bringing together all relevant stakeholders in the European Parliament would be a productive means of delivering tangible conclusions. The pharmaceutical industry plays a broad role in this, extending from inventing and developing new medicines to the development of new business models adapted to the circumstances of emerging economies. More often, market access is coming with heightened reimbursement restrictions.In this uncertain environment, companies are increasingly focusing on their launch strategy. Typically, launch managers use their estimates of peak sales to determine investment levels, resource allocations, and manufacturing plans. We followed the sales development of a group of products that were launched from 1994 through 1997 and found that company estimates of peak sales at launch were not predictive of peak sales reached during the products’ life cycles.In fact, the correlation between estimated and realized peak sales was close to zero.
In addition, we analyzed data from EvaluatePharma and discovered that the peak sales for new treatments introduced from 2001 through 2005 averaged $950 million per year; however, this number dropped to $570 million in the second half of the decade. Specifically for drugs launched in 2008, only 33 percent were expected to achieve peak annual sales of more than $1 billion.
And looking ahead to 2013, no forthcoming drugs are projected to post peak sales in excess of $750 million.Pipelines are thinner, and blockbusters are fewerStill, company valuations are highly dependent on the potential of the product pipeline.

Not only is the environment more complex but also the traditional guidelines no longer apply. With fewer therapies under development, realizing the full potential of every product is critical to a company’s health and, in some cases, its survival. Therefore, it is more important than ever for companies to pursue a more sophisticated launch strategy.Traditionally, companies have built launches almost solely around promoting a product’s efficacy and safety to physicians.
Rather, companies must take a comprehensive approach—one that includes more precisely differentiating the product from the competition, devising an effective strategy for winning market access, performing timely market research, and mobilizing the company around the effort. Because all these tasks are interconnected, and the marketing environment is complex and shifting, planning is often what distinguishes the successes from the failures. Much of the groundwork for a successful launch must be laid 24 months or more before the therapy receives approval. So to assist companies in their planning, we have identified six levers that launch managers should pull to create a winning rollout.Create a Winning PlaybookMuch like an athlete or a coach, launch managers need to think strategically if they are going to lead their team to victory. This is a critical departure from the more static approach, which takes into account market conditions, how much companies have spent to support a competing product, and how they have positioned their product – at a particular point in time.
Considering only competitors’ past actions leaves managers ill-prepared to react to changes in rivals’ tactics.
For example, The Boston Consulting Group used war-gaming to help a company with an injectable biologic product prepare for the launch of competing products. We created four possible scenarios on the basis of these unknowns and had teams play out how they would respond in each situation. This exercise identified important vulnerabilities and led to a plan for addressing them, which is expected to protect about $100 million in annual revenue from sales of the biologic product.Put Market Access Front and CenterFor many in the industry, winning in the marketplace has been achieved by having sales representatives continually communicating information about a product’s efficacy and safety directly to physicians. In today’s world, biopharma companies need to effectively make the case for their product to a host of payers and health technology assessment (HTA) agencies, which are now operating in most markets.
In discussions with BCG, industry experts revealed that payers and HTA agencies have the most influence over a product’s performance in the market, sometimes being responsible for as much as 70 percent of a product’s success. And yet, companies generally spend only 2 to 10 percent of their total marketing budget on these stakeholders.Certainly many companies have a market access team, but it rarely includes individuals from across the organization. To have a constructive conversation with payers, companies must create a cross-functional market-access team comprised of individuals from R&D, sales and marketing, and medical affairs.
This team should begin a dialogue with payers and HTA agencies early and then keep them apprised of the decisions made throughout the R&D process. The team should especially communicate the type of patient populations that are being targeted and the expected benefits. Such a dialogue will also give payers and HTA agencies the opportunity to provide guidance on the kind of efficacy and safety data they would be looking for, which would help companies define more targeted clinical studies.Change the Game with Innovative PricingPrice increases have been a major driver of growth for pharmaceutical companies, accounting for 65 percent of industry growth worldwide and even more in the US But although the industry has relied heavily on price increases, it has not used pricing as a tool for gaining competitive advantage.
They are more likely to approve reimbursement if a therapy can guarantee certain treatment successes or outcomes.
Evidence-based pricing agreements, which may offer a payer rebate or a patient refund, are still low in volume but growing. In 2010, they accounted for 8 percent of total pharmaceutical sales in the UK, but they are growing at an annual rate of 15 percent worldwide. BCG has successfully deployed social-network analysis to visualize stakeholder networks and define the most effective ways to engage with the key players.
Social-network analysis helps companies answer questions such as, which institutions or individuals – for example, key opinion leaders, payers, HTA agencies, guideline committees, or physician and patient groups – are the most influential across stakeholder groups? And what are the most effective ways of conveying messages to the stakeholder network given the patterns of influence and communication?When the most influential or connected stakeholders are identified, a cross-functional stakeholder-engagement plan is developed that defines the deployment of resources, outlines the roles of the various customer-facing functions, sets forth a concrete program of actions for approaching the stakeholders in a coordinated way, and details a way to measure the impact of key messages.Measure, Measure, MeasureCollecting the right information and harnessing it is critical at every step of a product’s launch.
Sophisticated analysis is required to help teams figure out what is working and what is not. Currently, most companies collect launch data in an uncoordinated fashion, analyze KPIs that track past events and actions, and then take several months to compile the data. Instead, launch teams need to create a comprehensive system that tracks KPIs in real time, enabling companies to understand what is happening in the marketplace and to make necessary adjustments quickly and effectively.Biopharma companies could learn a thing or two from consumer products companies. These organizations have measured with great accuracy the impact that various marketing tools – such as promotions, coupons, and advertisements – have on their business. But if it is done well, it can help companies create the optimal mix of tools and reduce spending overall – a savings that can be reinvested in activities that more effectively drive future success.Prepare to Pursue Alternate RoutesIn the past, investment levels for a new launch were more predictable. The rule was to spend aggressively for the launch and for a few years after and then to let spending decline as a product aged.
In an environment where it is difficult for companies to predict whether they will gain market access and be approved for reimbursement, and where competitors are responding to new market entrants much more quickly, sticking to one strategy is a sure-fire way for getting out-maneuvered. Rather, investment strategies need to be dynamic and adapt to the realities of the marketplace. When it is apparent plan A is not working, companies need to shift gears and quickly pursue previously mapped out alternate routes.Sticking to one strategy is a sure-fire way for getting outmaneuveredThe new reality of the pharmaceutical marketplace is one of increasing complexity, mounting uncertainty, and intense competition.
These challenges stem from a host of pressures, including declining R&D productivity, increasingly crowded markets, and high market-access and reimbursement hurdles. As a result, a new product’s success or failure hinges on the effectiveness of the launch and is judged by the market more quickly than ever before. But like their Hollywood counterparts, pharmaceutical launch managers must rewrite their go-to-market rules one launch at a time.

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