HighPoint Blog

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.

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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...

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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...

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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...

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Special thanks to co-writer Neelabh Saxena, Associate Director Pricing, Contracting, and Market Access. 

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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...

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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...

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Co-authored by Aubrey Elmore, Senior Consultant PCMA

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...

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