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.
Just like virtually every other function within pharmaceutical organizations, medical information teams must make strong cases to increase — and often simply justify — budget and personnel resources. For many medical information leaders, one avenue to justifying their resources is an expansion of their teams’ duties beyond the primary duty of answering inquiries placed by internal and external clients. Continue reading
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
Pharmaceutical companies have no shortage of options when looking for line extension strategies. Many turn to new formulations, new indications or combination drugs to boost their brand’s lifespan. However, for those companies that have to capital to invest in pharma LCM solutions, next generation drugs may be their best bet. This particular strategy yields the highest returns, but also takes the largest investment. Continue reading
There are many key elements to running a successful investigator sponsored trails (ISTs) program, such as:
- Evaluating IST proposals efficiently
- Only approving ISTs that have high scientific merit and align with corporate research objectives
- Maintaining compliance with fair market value (FMV) and milestone payments
The investigator sponsored trials evaluation committee is at the heart of many of these processes. A company’s IST team runs the program, but the IST committee is responsible for evaluating the submissions. 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
As risk-based monitoring techniques gain footing in the clinical space, life sciences companies are looking for the best way to implement these processes. Often, RBM responsibilities fall to clinical operations groups. These groups already have a thorough understanding of a company’s scientific procedures and expectations. However, dedicated risk-based monitoring teams may be more able to ensure that RBM strategies are applied and leveraged throughout clinical trials. Continue reading
By comparing pharmaceutical companies’ reported 2012 and 2014 medical science liaison salaries, Cutting Edge Information found that large and mid-sized pharma teams have replaced small company teams in offering the most competitive average MSL salaries. Back in 2012, Cutting Edge Information found that small companies offered MSLs the highest average annual salaries (Figures 1 and 2). However, soon-to-be-published research shows that MSL operations have evolved in the past two years. Continue reading
So far, over 600 drug manufacturers report participating in the Medicaid Drug Rebate program. Each of these life sciences companies have individually contracted with the Secretary of the Department of Health and Human Services (HHS) via national rebate agreements. Such agreements stipulate that state Medicaid agencies cover most of enrolled companies’ drugs in exchange for routine product and pricing data updates. Specifically, life sciences companies must use the Drug Data Reporting for Medicaid system (DDR) to submit information regarding any new covered outpatient drugs they market. These companies must also notify states of each new drug’s coverage. After states agree to cover companies’ products, contracted companies are responsible for paying Medicaid rebates, on a quarterly basis. Once paid, state and Federal governments share these payments, to help offset the overall expenditures of prescription drugs under the Medicaid Program. Continue reading
Investigator-initiated trial (IIT) teams constantly strive to prove value to their companies. In today’s pharmaceutical environment, it is not enough to merely approve trials suited to company research objectives. Rather, teams must approve these trials and negotiate clinical trial agreements (CTAs) efficiently. Continue reading