What is an Early Access Program (EAP)?
Early access programs (EAPs) provide an alternative regulatory pathway for existing therapies and new medicines to more efficiently meet patient needs. Prior to market approval, promising new drugs can be made available outside of the clinical trial space to individuals with life threatening or chronic, debilitating diseases. Likewise, an existing...Read More
Why is Gross to Net information important for companies in the Life Sciences Industry? That is a question I kept asking myself when I started working on my first GTN project as a consultant.Read More
Projected trends in population growth and size published by the U.S. Census Bureau indicate the U.S population is projected to increase by 98.1 million between 2014 and 2060. Over that same time span, the population aged 65 and over is expected to grow from 15 percent to 24 percent of the total population — an increase of 9 percent. One can surmise from the statistics alone that a huge...Read More
A recurring issue observed when we conduct assessments of manufacturer “Gross to Net” operations is the apparent disconnect among multiple stakeholders on the role and responsibilities of the forecasting group. Similar to organizational and project charters, most disconnects can be resolved through the exercise of creating a forecasting charter.Read More
Commercial contracting within the pharmaceutical industry has undergone a dramatic transformation over the last decade. Payers have become more sophisticated and are applying additional pressure on manufacturers to “put their money where their mouth is.” But there is still a lot of confusion and misunderstanding about the different contract types, objectives, and associated risks. In this...Read More
The 340B Drug Discount Program (otherwise known as PHS program) was created in 1992 as a federally-funded program to provide reduced drug pricing to “safety net providers” that serve uninsured or vulnerable patients. The concept was simple: Manufacturer drug pricing for covered outpatient drugs offered at extremely reduced prices—sometimes even at a penny—to eligible, qualified entities. The...Read More
With the recent pricing wars among pharmaceutical and biotech drug manufacturers, the U.S. government, and even the patient population, one thing is certain — it’s not stopping anytime soon. Manufacturers are being “asked” (read: strongly urged) to justify all product pricing to all parties impacted. That said, while some price adjustments are justified based on the costs of bringing a product...Read More
Risk-sharing agreements have emerged as a popular mechanism to balance increased payer focus on managing costs and the manufacturer’s need to gain market access for new products. In Europe, variations of these agreements are common and in the U.S., they are gaining more prominence. However, a lot of confusion exists among payers and manufacturers on terminology. This article aims to clarify...Read More
Special thanks to co-author Joe Cabe, Manager, Pricing, Contracting & Market Access.
It’s common to lump the medical device and pharmaceutical industries together. Both are essential to the healthcare industry and have similar business models. However, when we examine each, we uncover vast differences between the two markets.Read More
Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14?
Background for ICH E6 (R2)
The ICH GCP E6 regulation was introduced in 1996 when clinical trials were largely run on paper. Since then, the following trends have significantly increased:• the scale, complexity, and cost of clinical trials • the degree of outsourcing for... Read More
Market Access is becoming more and more challenging. This is irrespective of drug classes and new technologies. Payers are applying the same scrutiny on orphan drugs as on drugs for primary care. This is driven by increased budget constraints in healthcare systems and the heterogeneity of reimbursement systems worldwide.Read More
Special thanks to co-writer Heenal Patel, Manager Pricing & Contracting.
In United States' managed care contract administration, price protection is a strategy frequently used on executed contracts.
In simple terms, price protection calculates a ceiling price, safeguarding a price point as price increases occur. As drug prices rise, a rebate is issued for anything above the maximum price...Read More
Are “traditional” product launch strategies falling short of delivering desired results as it relates to your specialty drugs? Are product launch strategies including the full spectrum of “market conditions” that could impact the successful positioning of products at global and local levels? What are those “market conditions” impacting product launch? Should they be analyzed and incorporated...Read More
Innovation and competition are constantly influencing commercial drug decisions worldwide in the life sciences industry. This is evident by years of record drug approvals by the FDA and EMA, followed by a sharp decline in new therapies in 2016. Additional factors affecting commercial decisions include the advent of Biosimilars, the passage of the U.S. Affordable Care Act and recent proposed...Read More
Special thanks to co-writer Neelabh Saxena, Associate Director Pricing, Contracting, and Market Access.Read More
The goal of a public company and the fiduciary responsibility of company executives is to maximize shareholder value. In simple terms, maximize profit, which drives long-term shareholder value. Pharmaceutical companies are no exceptions.
However, when commercial strategy is scrutinized, an interesting trend emerges. Let us assume that an executive goal is to maximize profit over the life of...Read More
One of the major work streams of a contract management repository initial implementation involves the processing of your existing contracts. These existing contracts will often be referred to as your backfile, or legacy contracts. How you decide to handle them will have a considerable bearing on both the duration and cost of your implementation.
Why is backfile important? Many experts feel...Read More
By the year 2025, the government-sponsored share of health spending is projected to increase and account for 47% of national health care expenditures, indicating a majority of Americans will receive pharmaceutical benefits through a publically funded program, such as Medicaid, Medicare, The Veterans Health Administration (VA) or Public...Read More