Hot Topics From Around the World
New Year, New Price Hikes on Hundreds of Prescription Drug
In the beginning of 2021, 70 companies raised the price of hundreds of prescription drugs by an average of 3.3%. According to an analysis by 3 Axis Advisors cited by Reuters, the average price increase is lower than 1 year ago, when the cost of drugs was raised by an average of 5.8%, and 5.2% in 2019. Pfizer, Sanofi, and GlaxoSmithKline are among those leading the way in price increases.
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
On January 4, the US Food and Drug Administration (FDA) released a statement from Patrizia Cavazzoni, MD, the Center for Drug Evaluation and Research’s Acting Director and Deputy Director, Operations, outlining the agency’s draft guidance on investigational new drug submissions for individualized antisense oligonucleotide products. Because many of the investigators developing these products may be academics rather than biopharmaceutical or pharmaceutical companies, officials believe that they may be less familiar with the FDA’s regulations, policies, and practices, and less experienced in interacting with the FDA.
Trump Administration Will Let Nearly All Doctors Prescribe Addiction Medicine Buprenorphine
In its final days, the Trump administration announced a change in addiction medicine policy that will allow almost all physicians to prescribe buprenorphine, regardless of whether they have obtained a government waiver. Previously, doctors had to undergo an 8-hour training and receive the license, known as the “X-waiver,” before they could prescribe buprenorphine. For years, addiction treatment advocates have argued that tight buprenorphine regulations prevent thousands of doctors from providing high-quality addiction care.
2021—UK Market Access Prospects
Researcher and writer Leela Barham looks back at the year 2020 for market access initiatives in the United Kingdom, and makes some predictions for 2021. In October 2020, the United Kingdom joined 2 market access initiatives, Project Orbis (coordinated by the FDA and focused on cancer medicines) and the Access Consortium (focused on securing patient access to high-quality, safe, and effective medicines). Barham also examines the new licensing and access pathway (ILAP) at the Medicines and Healthcare Regulatory products Agency (MHRA), which brings together expertise from the MHRA, The National Institute for Health and Care Excellence, the Scottish Medicines Consortium, National Health Service England and National Health Service Improvement, and patients. According to Barham, “2021 will reveal just how the ILAP will be operationalized and whichever product will be the first to go through the Innovation Passport stage—a new designation as part of ILAP—will help everyone understand how the criteria for the passport will apply in practice."
Price Transparency and Variation in US Health Services
(Peterson-KFF Health System Tracker)
New rules about establishing price transparency requirements for healthcare services have been released by the US Department of Health and Human Services. As of January 1, 2021, hospitals are required to make payer-negotiated rates for common services available to consumers through an online tool and for all services to be contained in a machine-readable file. A second rule requires insurers in the individual and group markets and self-funded employer plans to make rates and individualized cost-sharing estimates for certain common services available to enrollees by January 1, 2023, and for all services by the following year. However, ongoing litigation challenging the constitutionality of the Affordable Care Act and the price transparency rule aimed at hospitals could affect the implementation and impact of these new rules.
CMS Issues Final Rule for Medicare Coverage of Breakthrough Technologies: 5 Things to Know
(Becker’s Health IT)
The Centers for Medicare & Medicaid Services (CMS) issued a final rule on January 12, 2021 that is expected to speed up the FDA approval process for Medicare coverage of new and innovative medical devices and technologies. Among the things the final rule will do is let Medicare provide national coverage simultaneously with FDA approval up to a 4-year period.
Paper Finds Gaps in Health Data Are a Barrier to Health Equity
Thirty-five years after the US Department of Health and Human Services released the Report of the Secretary’s Task Force on Black and Minority Health (Heckler Report), racial disparities in healthcare continue to exist, laid bare by the COVID-19 pandemic. PhRMA plans a series of its own reports in 2021 addressing this topic by identifying the challenges in data collection, solutions that have been identified, and actionable steps that can be taken.
Tennessee to Become the First State to Run a Closed Medicaid Drug Formulary
Tennessee, in an effort to overhaul spending by the state program, has been granted permission by the Trump administration to maintain a closed formulary, while at the same time being able to retain Medicaid drug rebates even as state officials negotiate with drug companies for other supplemental rebates.
Pandemic Propels Health Systems to Mull Insurer Acquisitions, Partnerships
At the JP Morgan Conference, which was held virtually in January 2021, the main subject of discussion was the impact of COVID-19. Several health system executives stated that they are on the hunt for health insurer acquisitions and partnerships or advocating for such arrangements as a result of the challenges of the pandemic in-person clinical revenue. Overall, executives acknowledged that health plans helped keep them profitable.
Cerner Wants to Build a $1B Data Business as it Expands Reach Into Pharma Market
Health IT giant Cerner wants to expand its data business to
$1 billion, building on its $375-million planned acquisition of Kantar Health announced in December 2020. The company is looking to create a leading data insights and clinical research platform and wants to harness data to improve the safety, efficiency, and efficacy of clinical research across life sciences, pharmaceuticals, and healthcare at large.