What is a new drug worth? An innovative model for performance-based pricing.

This article focuses on a novel method to derive prices for new pharmaceuticals by making price a function of drug performance. We briefly review current models for determining price for a new product and discuss alternatives that have historically been favoured by various funding bodies. The progressive approach to drug pricing, proposed herein, may better address the views and concerns of multiple stakeholders in a developed healthcare system by acknowledging and incorporating input from disparate parties via comprehensive and successive negotiation stages. In proposing a valid construct for performance-based pricing, the following model seeks to achieve several crucial objectives: earlier and wider access to new treatments; improved transparency in drug pricing; multi-stakeholder involvement through phased pricing negotiations; recognition of innovative product performance and latent changes in value; an earlier and more predictable return for developers without sacrificing total return on investment (ROI); more involved and informed risk sharing by the end-user.

Clinical trial design in biosimilar drug development.

In contrast to most drugs which are chemically synthesized and have a known structure, biological drugs are derived from living organisms or their products. Biologicals are structurally more complex and unique from chemically synthesized small drug molecules because of their larger size and intricate manufacturing process. Secondary to their protein structure, they are also more prone to acute and chronic immune responses. Biosimilars are intended to offer comparable safety and efficacy relative to reference brand biologicals, yet they are not generic alternatives to the original compounds and so are currently not considered interchangeable. Given their structural complexity, multifaceted manufacturing processes and risk for immunogenicity, biosimilars require class-specific regulatory approval pathways. Here we seek to provide a general overview of clinical trial design in the era of biosimilar drug development. This will include a review of the regulatory requirements for clinical trials in Europe and the United States, followed by a review of two biosimilars that have recently reported results of randomized trials against branded biologicals.

Cervical dilation before first-trimester elective abortion: a controlled comparison of meteneprost, laminaria, and hypan.

Preoperative cervical dilation makes first-trimester abortion safer, but increases costs and inconvenience to patients if extra visits are required. Eighty-four pregnant primigravid volunteers who requested first-trimester abortion were assigned randomly to one of four study groups: placebo, 16 dimethyl prostaglandin E2 (PGE2) vaginal suppository, 4-mm hypan plastic dilator, or small Laminaria japonica tent. This grouping was done to determine which of three modalities is most effective for cervical dilation within three hours before abortion. After three to four hours of treatment, hypan achieved greater cervical dilation among primigravid women and only modestly increased side effects, as compared with 16 dimethyl PGE2 suppositories or laminaria tents.