Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September

Posted 06 September 2017 By Gloria Hall

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Feature articles over the past several weeks highlighted various global reimbursement strategies including integrated scientific advice, the regulatory significance of wearable technologies, prescription drug reimbursement issues in Canada and the harmonization of marketing, regulatory and reimbursement strategies for US medical devices. Other articles covered regulations and guidance for conducting bioavailability and bioequivalence studies for generic drugs, risk management challenges for medical devices, and the future of phage therapy including the need for more scientific investigation and clinical trials and the regulatory issues impacting bacteriophage development.

Reimbursement Profile

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. In the article, "The Value of Health Technology Assessment Scientific Advice," Bending and Udechuku discuss how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

Wearable technologies and mobile health devices continue to help patients report meaningful outcomes and manage their conditions while enhancing their quality of life. In the article, "Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes," Davies and Tyson discuss how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.

Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has become a more prominent hurdle to market adoption. Domyahn discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy in the article, "Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices."

Regulatory processes in Canada are managed by Health Canada, which is responsible for determining efficacy, safety and quality. Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval. Wyatt's article, "Drug Reimbursement in Canada," provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.

Policy and Guidance

Generic drugs offer a significant cost saving and are typically less expensive than their reference drugs.

In the article, "Bioequivalence Studies of Solid Oral Dosage Forms Overview," Aroradiscusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Quality and Compliance

Although medical devices have significantly improved the quality of countless lives, those improvements cannot be achieved without risk and the occasional adverse event. Oppenheimer and Ramachandran discuss the importance of organizational culture and memory in the medical device industry's risk management practices in "Organizational Culture and Memory in Managing Risk in the Medical Device Industry." The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."

Science and Research

Sherman reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article, "Is increasing antibiotic resistance driving bacteriophage therapy closer to being a reality?" also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.

Feature Articles Coming Throughout September

Feature articles throughout the month of September will cover two main themes advertising, labeling and marketing and an in-depth look at global reimbursement strategies. Continuing the topic from August, Regulatory Focus takes a deeper dive into reimbursement with six individual country profiles, including the United Kingdom, Spain, Italy, Germany, France and Canada. A candid interview with two leaders from the Alliance for Regenerative Medicine (ARM) provides insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies. Other articles will cover new guidance for prescription drug promotion, policies and best practices for developing advertising and marketing materials for prescription drug labeling, recent FDA enforcement trends and practical guidance related to broadcast advertisements, and the benefits of developing and maintaining a promotional claims compendium. Look for these feature articles and other topics throughout September.

If you have a suggestion for a feature article, contact me at ghall@raps.org.

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Categories: Biologics and biotechnology, Generic drugs, Medical Devices, Reimbursement, Regulatory strategy, Features, FDA, Health Canada

Tags: Regulatory Focus, Feature Articles, Editorial

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