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
Pharmaceutical lifecycle management strategies have changed in the past decades. In the old days of industry lore, companies could roadblock generic market intrusion by conducting clandestine laboratory tests and sending letters to FDA pointing out flaws in the generic’s bioequivalence – just to list one colorful example. But those days are past. Today, pharma companies will have better success countering generics with strategic pricing techniques.
Generics often toll the death knell for branded drugs because of their low price. Since companies can’t beat generic prices, they might as well join them by lowering the price or offering rebates of their branded drugs at the entrance of generics. A recent study by Cutting Edge Information found that 40% of surveyed companies with strategic pricing utilized these strategies to slow market share decline after exclusivity loss (Figure 1). Continue reading
When a drug first hits the market, lifecycle management (LCM) teams have a host of weapons in their arsenal to increase market share. As that same drug approaches patent expiry, the choices become more limited. But all hope is not lost! Here are three late-stage pharma lifecycle management tactics highlighted in our new report with a track-record of success:
- Pediatric exclusivity
- Strategic pricing
- Medical publications
In today’s global market, life science companies worldwide face challenges such as increased austerity measures, unfamiliar emerging markets payers and governments, greater emphasis on health economics and regulatory reforms.
To address these challenges, many companies are turning to integrated teams that include health economics, comparative effectiveness research and market access alongside pricing functions. The added focus to develop a presence in emerging markets creates new pricing challenges, especially when facing an unfamiliar market with unique regulatory and access issues. Continue reading
Fresh news out of India this week is likely to add to pharmaceutical companies’ concerns about pricing and sales in emerging markets. Despite indications in February that compulsory licensing may be coming to an end, on March 18, BDR Pharmaceuticals applied for a compulsory license on dasatinib, an oncology product sold by Bristol-Myers Squibb. If granted, the compulsory license would severely undermine BMS’s sales in India by allowing BDR to sell a generic product for much lower prices. Continue reading
Over the past few years, political, social and economic upheavals worldwide have thrust change on the life sciences landscape — and forced pricing teams to work overtime. Today, these teams must deal with a series of events and trends that each have some effect on business operations, like increased focus on comparative effectiveness and the implementation of the US health reform. Continue reading
Growing up, siblings have an unspoken rule that if one received something or was allowed to do something that another wasn’t, instantly, life became “unfair” for the other party. The smaller the age differential between the siblings, the more unfair the perceived slight. Ultimately, any attempt toward corrective actions was conceived in “the name of fairness.” The same rules apply to pharma, especially with respect to global market access considerations. The difference is that companies are looking beyond markets of similar size and structure. Continue reading
As the year comes to a close, Cutting Edge Information is taking a look at the best and worst brand launches in the US over the past year. The line between a massively successful launch and a potentially disastrous one is razor thin. With that a mind, we’ve put together a few recommendations for brand managers to stay on the right side of that line. Continue reading
In this harsh reimbursement environment, payers are looking beyond a drug’s efficacy and to its cost-effectiveness when approving drugs for their formularies. To adapt to new payer demands, pharma companies are incorporating health economics and outcomes research (HEOR) early in clinical development, gathering valuable data they use when submitting their products for reimbursement. Right now, payers are in the driver’s seat when it comes to reimbursement discussions. Pharma companies must consider both the medical and economic value of drugs as early as possible during development to present a convincing case—which is where HEOR teams come in. Understanding HEOR value all the way through – from lab to launch – is critical. Continue reading
Before US managed markets teams approach payers, they need to understand the different payer groups. All groups — Medicare and Medicaid, insurance companies, specialty pharmacies, hospitals, etc. — share the same fundamental function: to sift through the many treatment options for their clients and decide which ones to approve. However, each payer group must factor in different considerations. Continue reading