Attaining US government payer reimbursement is not always easy for life sciences organizations. Facing evolving regulatory expectations, companies can get bogged down with the details when mapping out their plan of attack. Cutting Edge Information found, however, three precursors to a successful US government payer reimbursement campaign are:
Cutting Edge Information analysts often emphasize the importance of getting started on an initiative as soon as possible — no matter the time within a product’s lifecycle or the teams involved. Government reimbursement is no different. The sooner teams initiate discussions with payers, the better. Instigating early conversations with payers means that companies can design future clinical studies with payer expectations in mind. By catering their reimbursement campaigns to top payer concerns the first time, companies reduce the likelihood of needing a second time to make their case.
When seeking reimbursement from government payers, there is no right or wrong number of staff. Most often, team size — and the scope of team members’ responsibilities — depends largely on how companies prioritize US government payer reimbursement. Teams that rely heavily on government payer approval may be large and highly specialized. For example, companies may assign one point person to manage best price (BP) and another to focus on average manufacturer price (AMP). Teams that are less reliant on government payer approval may be leaner, with members that each possess broad expertise.
Finally, having standardized SOPs provides companies with assurance that procedures will remain seamless — even if the staff responsible turns over. Likewise, tracking all activities that teams undertake to achieve government reimbursement goes a long way toward effective regulatory compliance. Companies that do not track their reimbursement processes risk scrambling to piece together an incomplete timeline should regulatory agencies ask for these details.
When health economics groups are working on developing HEOR data, they need to keep in mind the different gaps that the research may be needed to fill. Depending on the market, whether right at launch or years afterwards, payers may see product’s position significantly strengthened by the appropriate HEOR data. Developing the right information can require customization based on geography or based on the competitive landscape. Continue reading
Making sure that a new product has a successful US launch is a top priority for many groups. A botched or uncoordinated launch in such a large market can have a ripple effect on strategic planning throughout the organization. There are too many individual factors that combine to influence the success of a US product launch. However, the ability of a product to obtain favorable formulary position within US government drug reimbursement systems provides a useful barometer for the product. Continue reading
Managed markets groups, like most commercial functions, see their activities peak around product launch as they try to make sure products reach as many consumers as possible. The managed markets account manager role generally continues well after launch as competitors change and new data emerge.
In a study conducted recently here at Cutting Edge Information, we found that for a significant number of companies the product support role for account managers never ends. While most companies will begin to stop talking to payers about products around or before patent expiry, some companies with specialized products see value in continuing these discussions even after the product has lost market exclusivity. Continue reading
The key to managing payer relationships lies in Thomas Jeffersons old adage: “I am a great believer in luck, and I find the harder I work, the more I have of it.” Like Jefferson, managed markets account managers must make their own luck when they meet with payers by preparing beforehand. Continue reading
After being untouchable for decades, US biologics companies are finally facing biosimilar competition. Well, sort of. Cutting Edge Information’s report on counter-generics strategies found that the high cost of biosimilar production will not allow companies to price biosimilars substantially below that of the original product – meaning they may not have the same market impact that a typical generic would. Instead, biobetters may be the next biggest thing to rock the biologics world. Continue reading
The uses for Big Data in pharma are limitless. Commercial, clinical and market access teams can all benefit from Big Data insights. With so many options, its no wonder some companies get decision paralysis and don’t know where to begin. The first step is to define the corporate objectives of the Big Data initiative. Continue reading
In this era of increasing healthcare spending scrutiny, the onus is on managed markets account managers to deliver a persuasive payer value proposition. In meetings about formularies, payers will want to see not only product efficacy but also health economics data and comparative effectiveness research (CER). These value propositions require a great deal of scientific expertise, and this is where medical science liaisons (MSLs), health outcomes liaisons (HOLs) and managed care liaisons (MCLs) come in handy. Continue reading
Health economics and outcomes research (HEOR) groups have carved out their place in life sciences organizations throughout the industry. Though pharmaceutical and biotech companies have long-since accepted the utility of this function, many medical device HEOR efforts have leveraged other groups to perform HEOR tasks — often ad hoc. Now, HEORs’ prominence is more widespread, and device companies are structuring health economics staff to take on a number of reimbursement-related responsibilities. One of these teams’ most prominent activities is aiding interactions with government and private medical device payers. Continue reading
Working with payers and hospitals in order to maintain profitability is a key role for managed markets groups and the account managers responsible for these contacts. Payers are becoming increasingly interested in data that demonstrate the efficacy and value of products to their patients. And in this case, a company’s pharmaceutical reimbursement strategy can be informed by something as simple as the favorite snack of a little bear from the Hundred Acre Wood. Continue reading