“In the pharmaceutical drug reimbursement system, access to a new product is determined by two separate, yet equally important groups. The manufacturers who develop the product and the government payers who reimburse it. These are their stories.” Continue reading
In our most recent study examining health economics teams, 64% of responding global health economics and outcomes research teams revealed that they begin working with developing products during Phase 2 — though most desired an even earlier start. HEOR directors and managers want early involvement to help them understand payers’ hot-button issues as early as possible. Continue reading
As the pharmaceutical industry transitions to more patient-centric marketing, companies are looking to patient-reported outcomes to inform product labels. Often, clinical or PRO teams will implement PRO instruments during Phase 2 or Phase 3 trials to collect end-user feedback. This feedback is particularly useful as companies look to prove a product’s comparative effectiveness and product label claim approval. While PRO endpoints are becoming increasingly popular, companies still find gaining approval for these findings is a complex process. Continue reading
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. 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
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