Maximizing Market Access: THE 5 MOST CRITICAL QUESTIONS TO ASK WHEN LAUNCHING A SPECIALTY DRUGS

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1 Maximizing Market Access: THE 5 MOST CRITICAL QUESTIONS TO ASK WHEN LAUNCHING A SPECIALTY DRUGS by Jan Nielsen, division president, Access & Patient Support

2 Are You Asking the Right Questions? We ve all heard the statistics. A recent report by the Pharmaceutical Research and Manufacturers of America (PhRMA) stated that in the United States alone, 452 new medicines are being developed to treat rare diseases. In fact, according to the Federal Drug Administration (FDA), in the last five years, one third of all new drug approvals were for rare diseases. The market debut of these specialty drugs means hope for many patients who have run out of treatment options. It can also mean success for biopharma companies that have invested many years and millions of dollars into research and development of specific molecules. As specialty drugs continue to gain approval in both phase 2 and phase 3 clinical trials, pharmaceutical executives who are responsible for brand management and patient access need to start early in identifying the answers to the following critical questions in order to ensure that their drug will optimize its market potential both in its impact on the patient population for which the drug is targeted and in return on investment for the manufacturer. 1 DO YOU HAVE A COMPLETE PICTURE OF THE MARKET LANDSCAPE IN WHICH YOUR DRUG WILL BE LAUNCHED? With the acceleration of the development and approval of specialty drugs, it s critical to understand the potential competition. Before a brand manufacturer of a specialty drug is ready to go to market, the company must first have a clear picture of the class of drugs they are entering. This analysis needs to include price, co-pay and assistance strategies and all indications that the competing drugs serve. This will help you make the decisions on resource spend. Understand the minimum level at which your drug needs to be delivered in order to capture market share. Then identify the gaps that are left with those drugs that are already in the market. This will better enable you to position your product for more market share as soon as it comes onto the market.

3 MAXIMIZING MARKET ACCESS BY JAN NIELSEN 2 3 ONCE YOU ACHIEVE FDA APPROVAL, HOW DO YOU PLAN TO GET THE INFORMATION ABOUT YOUR PRODUCT TO THE MARKET QUICKLY? In a highly competitive market, timing is of the essence, not only for you but also for the patients that need access to the treatment. In addition to the patient who has potentially failed other treatment options, there are many other parties in the supply chain who are anxious about the arrival of your drug. At a minimum, do you have a medical hotline set up to take inbound calls? Medical hotlines can field calls from a variety of sources. Other specialty pharmacies outside of the manufacturers network call to inquire about joining the network. Providers IN A HIGHLY COMPETITIVE MARKET, TIMING IS OF THE ESSENCE, NOT ONLY FOR YOU BUT ALSO FOR THE PATIENTS THAT NEED ACCESS TO THE TREATMENT. who participate in buy and bill programs inquire about the cost of the drug and how to reach a distributor. Patients who may have mutations or who have just been diagnosed will call to find doctors who are prescribing the drug. They also have questions about side effects and tolerability. It s important to have a strong communications campaign on day one of launch in order to get resources to the marketplace and communicate toll-free numbers and websites that can provide this important information. HOW ARE YOU GOING TO GET THE SPECIALTY DRUG TO THE PATIENT AS QUICKLY AS POSSIBLE? The challenge at the point of launch is delivering 4 access to medications as quickly as possible and at the most cost- effective sites of care. The cost to payers for complex specialty drugs is soaring, even though the disease populations are small. It s important to know when payers will be adding the new drug to the formulary, and if the payer will require a prior authorization. You should also identify other delays and barriers to access patients might face. If your drug is being launched in the first half of the year, patients may require co-pay assistance programs if they haven t yet met their out-of-pocket expenditures. If your drug is being launched in the fourth quarter, co-pay strategies might not be necessary. However, a free drug, quick-start program could be very useful to a patient so there is no delay fill time due to prior authorization, pre-determination, appeals and payer formulary issues In addition, physicians that participate in buy and bill models need to know how to bill your product. Billing teams need to be educated on the right coding process so the physician is reimbursed appropriately. Determine the actual length of time that a paid claim will go through and set expectations with physicians. WHAT ARE THE CULTURAL EXPECTATIONS OF YOUR ORGANIZATION AND HOW WILL THIS AFFECT THE PROGRAMS AND SERVICES YOU PROVIDE AT THE POINT OF LAUNCH? Human tendencies dictate the cultural nature of an organization. It s already assumed that large Big Pharma companies operate in a more conservative environment than a smaller, biotech companies that are more nimble. The culture of your organization will influence the structure of your program; and if you are not careful to operate efficiently within your environment, if can result in costly delays to market.

4 MAXIMIZING MARKET ACCESS BY JAN NIELSEN For example, as you begin to concept your program, decide how this program fits into your product portfolio. If you have other specialty drugs being developed in that disease state oncology, for example then you might consider a market strategy in which all the drugs fit under an umbrella brand. This would affect all aspects of your product positioning, from the naming convention of your programs to the way you establish your toll-free lines and Interactive Voice Response services. If your product is the only product you will be launching for that therapeutic area, then you can consider more out-of-the box solutions and outreach. ON AVERAGE, MANUFACTURERS SHOULD BEGIN PLANNING THEIR LAUNCH PROGRAM AT LEAST 18 MONTHS OUT FROM ESTIMATED FDA APPROVAL. Organizational culture can also affect the way you design the technology and data warehouse solutions for your program. What does the C-suite expect to see as part of the program? What metrics and key performance indicators need to be reported? What is your plan for feeding the data back into the organization during the first 90 to 120 days of your program launch? Identify the important metrics needed to provide this transparency and give yourself time to design the program accordingly. It s also important to understand the legal culture of your organization and its impact on your program. Again, some legal departments are extremely conservative, and you don t want to experience any costly launch delays due to hold-ups with legal reviews. Finally, partnership is key to your corporate culture. Specialty pharmacies in your network need to work 5 together in order for patients to achieve fast access to the drug and adherence support. A key element of this specialty pharmacy partnership is successful technology integration. Allow enough time in your launch plan for specialty pharmacies to build their data feeds. This can sometimes take six to 12 weeks to get established, so plan accordingly. HOW EARLY SHOULD A MANUFACTURER START PLANNING FOR LAUNCH? On average, manufacturers should begin planning their launch program at least 18 months out from estimated FDA approval. There are some key signs that indicate when you should begin to focus on your market launch strategy. Follow the response rates from the research team and uptake of the drug revealed by trial data. When the decision is made to focus on specific indications for the largest potential or on smaller rare disease state, it s time to start your launch planning and program design. This is the point at which many manufacturers will engage a consultant to help evaluate different Hub models and distribution options. Manufacturers tend to operate with limited staff prior to launch date to keep operating costs down and focus dollars on research and development. In fact, many wait until launch date to build their marketing team. This often delays planning and adds more costs as the transition takes place and changes are made to the program. Plan to put your marketing leadership in place early in the process rather than transitioning right before launch date; the additional cost up front could save critical time and dollars in the end. By taking a strategic approach to market launch planning and asking the critical questions at the right time, you can ensure a successful and efficient launch that gets patients on therapy faster and strengthens the market potential of your product.

5 ABOUT THE AUTHOR Jan Nielsen provides the vision and direction for Sonexus Health s Access & Patient Support division. Beginning her career as a registered nurse, Nielsen has more than 20 years of experience in the healthcare arena providing innovation and leadership. She has developed and launched best-in-class patient adherence solutions both in the pharmaceutical and payer environments. Her inventive programs and technical solutions have demonstrated and delivered improved outcomes and measurable returns on investment. ABOUT THE SONEXUS HEALTH Delivering an exclusive model that fully integrates direct drug distribution to site-of-care with non-commercial pharmacy services, patient access support, and financial programs, Sonexus Health helps specialty pharmaceutical manufacturers have a greater connection to the customer experience and better control of product success. Personalized service and creative solutions executed through a flexible technology platform means providers are more confident in prescribing drugs, patients can more quickly obtain and complete therapy, and manufacturers can directly access more actionable insight than ever before. With all services centralized in our custom-designed facility outside of Dallas, Texas, Sonexus Health helps manufacturers rethink how far their products can go.

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