FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY

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1 WHITE PAPER FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY By Nicole May, Research Analyst at Cutting Edge Information OVERVIEW National and private payers, especially in the US and EU, are becoming more restrictive in drug reimbursement approval in an effort to tighten budgets and improve health outcomes. Demonstrating product value is now one of drug manufacturers top priorities if they hope to gain optimal formulary positions. An effective payer discussion results from aligning the market access strategy to focus on building a strong value proposition for each drug this means incorporating many players early in drug development to foresee and plan for all possible access obstacles. Concentrating on budget analyses and comparative data is essential to demonstrating product value. Some pharmaceutical companies have even collaborated directly with payers, taking the guesswork out of payer expectations and preferences. In all, the focus must be on drug value, clinically and economically, if manufacturers hope to achieve successful market access in this strict and budget-conscious reimbursement environment. Pressure from payers is impacting drug manufacturers in the US and worldwide. Seemingly everywhere, but especially in the US and austerity-stricken Europe, the current focus is on containing healthcare costs for patients and payers. Emphasis on containing payer budgets, both public and private, is forcing drug companies to focus on market access strategies. Payer approval is elbowing regulatory approval out of its spotlight, as payers now hold nearly as much power over a drug s success as do national regulatory bodies. The US is notoriously the biggest, and perhaps least efficient, healthcare spender. The US spends significantly more on healthcare as a percentage of GDP than any other country, although costs are increasing across the board (Figure 1). 1

2 FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY 2 Figure 1: Total National Healthcare Expenditure, Individual and Collective as a Percentage of GDP A major target in the effort to reduce healthcare costs is drug prices. Although prescription drug spending made up only 10% of the US s $2.7 trillion health expenditures in 2011, 2 this sector of spending receives much of the heat for unnecessary cost. Out-of-pocket costs for prescription drugs have remained relatively stable in the US, even decreasing slightly in recent years. However, health insurance prescription drug spending has risen on average $8.5 billion each year between 2007 and 2011 (Figure 2). 3 Since payers are forced to pick up the extra drug bills, they are especially concerned with containing drug costs. These budget pressures are being shifted to drug manufacturers, forcing them to prove the overall value of the drug to earn its formulary spot. Proof of superior health outcomes, real-world effectiveness and overall lower long-term costs are all on payers checklists. Companies are allocating more resources to health economics and outcomes research (HEOR) and even building or boosting the liaison teams responsible for delivering data to payer organizations. BUILDING A STRONG VALUE PROPOSITION Overcoming the payer approval hurdle depends on the drug manufacturer s ability to present a strong value story to the payer. These value stories are built on strong data, both clinical and economic, which in turn depend on a comprehensive market access strategy. These data points and value propositions cannot be left to the end of product development: a strong value story is created by incorporating market access initiatives throughout drug development. A strong payer strategy includes creating a product portfolio that goes beyond simple efficacy data and may even involve collaboration with payer organizations themselves.

3 FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY 3 Figure 2: Total US Prescription Drug Expenditures, Out-of-Pocket and Health Insurance START ADDING REIMBURSEMENT ENDPOINTS EARLY IN PRODUCT DEVELOPMENT A robust payer presentation is a result of a longplanned market access strategy. Whereas the development of a product portfolio was once the last step of commercialization, now companies must tie future reimbursement decisions to clinical decisions even as early as Phase 2 of drug development. Multi-function involvement also ensures all elements of the payer strategy are covered. By aligning clinical, regulatory and access goals early, liaison teams will have more compelling cases come launch time. The HEOR function is a key part of early reimbursement planning. Shifting this research earlier, in Phase 3 or even the late stages of Phase 2, allows the team to develop strong studies. Larger companies are especially keen to involve HEOR teams early on, with 35% of teams at Top 10 companies beginning Phase 3 or earlier. 4 Pricing teams can also play a large part before product launch, preparing payers for future pricing decisions and investigating the drug s competitive landscape. Regulatory and government affairs groups play particularly important roles in developing payer strategy, and companies benefit from involving these players early on. Regulatory input as early as Phase 2 ensures that important reimbursementrelated endpoints are incorporated into clinical trials. Government policies and payer requirements specific to a certain region can be planned and accounted for from the beginning of drug development. Waiting until registration and launch to plan for often significant obstacles to market access risks a drug s overall market success. Involving these teams and adding an emphasis on proof of economic and clinical value to all stages of drug development minimize risk of payer reluctance come reimbursement time. These economic and health outcomes endpoints are just as crucial as the trial protocol s clinical endpoints. A drug with a perfectly proven primary endpoint will be a dead duck without a demonstrated value story.

4 FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY 4 PROVE THE FULL VALUE STORY Once companies have multi-player input, preparing for payer conversations involves generating a strong product value proposition. Each team can ensure that the data necessary to overcome all future reimbursement obstacles are included in dossier development. Payer dossiers are no longer complete without strong economic data and budget analyses. Budget impact models evaluate the cost to payers of adding a new drug to the formulary and are easily customizable depending on the target population. Cost-effectiveness assessments and other pharmacoeconomic data also highlight the bang for their buck payer organizations would gain with a new drug. Real-world data, when available, may also help clinch a drug s formulary spot. Mark Wilkinson of the UK s National Health Service explained in an EyeforPharma webinar 5 that a key challenge in creating a strong value dossier is including data about the real-world benefit of a drug. Real-world use data show that the benefits that might be claimed by clinical trial results are not the same as those experienced by patients post-approval. Although real-world and claims data are often only available years after product launch, these data tell a compelling value story to both UK and US payers. Head-to-head and comparative effectiveness data show payers why a drug is a better choice than competitors why should a payer reimburse a new drug when existing drugs are just as effective? In a marketplace with ever-increasing competition, generic or otherwise, drug manufacturers must demonstrate explicitly how their product is superior and why it deserves reimbursement. Figure 3 highlights the important data sets according to surveyed health outcomes liaison (HOL) and managed care liaison (MCL) teams working with small-molecule drugs in the US. 6 Comparative effectiveness data and budget impact models are the most preferred by liaison teams. Survey respondents find these data sets to be most effective during payer discussions because these data highlight the true value of the drug. The key is proving the full value story: strong clinical results are essential, but success in the sterile clinical setting is not the entire story. Payers want to know how the drug will affect their budgets and how it can reduce long-term costs. Costsavings stem from cost-effective improved health outcomes -- some drugs deliver clinically stronger results with smaller price-tags, others may have a simpler dosing schedule that results in fewer doctor visits, and another drug may encourage patient adherence and lead to less frequent relapses. All of these elements add to the drug s overall value, both clinically and economically, and are crucial to outline in a value dossier. FOCUS MARKET ACCESS STRATEGIES TO MEET PAYER NEEDS Where once the physician and the regulator ruled as the stakeholders to be wooed, payers are now requiring similar attention. Payer liaison teams of HOLs and MCLs are growing in size analogous to the growth of sales forces years ago. These teams must deal with payers, both public and private, that are getting more selective when building their drug formularies.

5 FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY 5 Figure 3: Average Effectiveness Ratings of Tools Used in Payer Conversations (US): Small-Molecule Drugs Beyond adapting the value story to creating a more convincing proposition, drug manufacturers can work directly with payers to plan for future reimbursement discussions. Although pharma may still be mistrusted by other arms of the healthcare industry, in the end both pharma and payers have a shared interest in getting effective drugs to market. Mark Wilkinson explains that the key for pharma to regaining trust is to steer away from the direct sales model and to find people who are willing to build collaborative relationships at a local level. Communication between the two stakeholders will facilitate the reimbursement process and help streamline drug manufacturers market access strategies. CONCLUSION Demonstrating overall value must be a priority. Companies will attain a strong value story, successful reimbursement and overall drug success by bolstering market access strategies and pinpointing the data that truly matter to payers. Updating and refocusing their market access plans will help pharmaceutical companies navigate this more complex reimbursement environment. The trend of increasingly restrictive payers will only intensify as budgets are further tightened. If national and private healthcare costs are to be reduced or at least stemmed, market access strategies can no longer take a backseat to regulatory requirements.

6 FOCUS REIMBURSEMENT STRATEGY TO DEMONSTRATE FULL VALUE STORY 6 References: 1. National Health Expenditures, stats.oecd.org 2. The Nation s Healthcare Dollar, Research-Statistics-Data-and-Systems/Statistics-Trendsand-Reports/NationalHealthExpendData/Downloads/ PieChartSourcesExpenditures2011.pdf 3. National Health Expenditure Accounts, Centers for Medicare & Medicaid Services 4. Market Access and Reimbursement: Demonstrating Product Value to Meet Payer Demands. Cutting Edge Information. (2013) 5. Mark Wilkinson via Eyeforpharma webinar, Create the Perfect Value Proposition, July 25, Advanced Health Outcomes Liaison and Managed Care Liaison Teams: Delivering Health Economics and Clinical Data to Payers. Cutting Edge Information. (2013) ABOUT CUTTING EDGE INFORMATION We are a boutique consulting firm with offices in Research Triangle Park, North Carolina, and Boston, Massachusetts, providing primary and secondary research to Life Science organizations. Cutting Edge Information was founded in 2002 by consultants with extensive experience conducting research studies for high-level clients. We put this experience to work to eliminate traditional consulting s hurdles and to focus on producing high-quality information drawn from top executives at real-world companies for you and your organization. SHARE THIS WHITE PAPER

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