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
One of the major organizational challenges presented by health economics groups is the fact that they need data from the clinical and scientific side of the organization in order to make an effective case for payers that may be used to speaking with the commercial side of the company. This issue is part of why many health economics groups report into medical affairs so that they can preserve their scientific expertise and credibility while bridging the gap to payers as needed. Continue reading
Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies. Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance. In other instances, one investigator can simply prove more difficult than others.
To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives. Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. 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
According to a Cutting Edge Information study, attaining favorable Medicaid pricing remains a key factor in life science companies’ market access preparations. Broadly, government payer acceptance often sets the precedent for whether private payers will reimburse company products or not. Unsurprisingly, private payers are less likely to support products that fail to meet government approval. As one market access advisor explained, “Failure to receive Medicaid coverage is like a kiss of death for company products.” Subsequently, market access teams work diligently to ensure that drugs attain Medicare and Medicaid reimbursement. 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
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
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