The announced Centers for Medicare & Medicaid Services price negotiations for Medicare Part D drugs introduces a fundamental change for the process of drug pricing related to Medicare. The implications for the new initiative go far beyond the 10 drugs that CMS will select as their first program participants. The action is expected to significantly impact same-class drugs’ pricing and profitability as well.

• Brief: CMS Part D Price Negotiations: Is your drug on the list?
• Blog: Identifying the drugs likely to be on the CMS list in advance
• Blog: Highlights from the revised Medicare Drug Price Negotiation Program guidance
• Webinar: Medicare Part D Price Negotiation panel discussion
• CMS.gov Medicare Drug Price Negotiation initial guidance release
• CMS.gov Medicare Drug Price Negotiation revised guidance

In this whitepaper we explain the concepts behind the various advanced statistical methods of evidence synthesis used to address non-standard data such as informative priors, subgroup analyses, meta-regression, and matching-adjusted indirect comparisons.

Randomized controlled trials are the gold standard for determining the efficacy of a new therapy or evaluating its comparative effectiveness against the standard of care. Yet there are situations, such as in rare or orphan diseases, with breakthrough therapies, or in areas of high unmet medical need, when RCTs are either unfeasible or unethical.

Until now US payers have absorbed and managed the cost of ultra-expensive therapies, but how long can they continue to do so? Read our whitepaper to understand the payer perspective on advanced therapy medicinal products.

Discover the key regulatory and development concerns for sponsors, including the factors that affect biosimilar uptake in the United States and Europe and recommendations to address these issues.

The precision medicine strategies discussed in this paper present a range of opportunities for new drugs and devices targeted to specific patient populations. These technologies work synergistically together, creating greater value during development and in the clinic. The future will continue to bring rapid convergence of the pharmaceutical and device industries, driven together by the patient, payer, and regulatory forces that are currently shaping the precision medicine market. As we look forward, the future patient may even create a new relationship with device manufacturers as a partner in personalising his or her own healthcare and clinical trial experiences.

The following briefing is drawn from our webinar ‘Using Early Economic Models in Developing Your Evidence Strategy,’ and explains the nature and value of these models and presents guidelines for their development.