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PIPC Recommendations for Patient-Focused Listening Sessions on Drug Negotiation

9/15/2023

The June 30, 2023 guidance from the Centers for Medicare and Medicaid Services (CMS) stated that CMS will be holding “patient-focused listening sessions in Fall 2023 after the October 2, 2023 deadline for patients and other interested parties to share patient-focused input on therapeutic alternatives and other section 1194(e)(2) data regarding selected drugs.” In its guidance, CMS referenced these listening sessions as a resource for understanding unmet medical need, acquiring new information from patients, identifying relevant outcomes from patients and caregivers and related to therapeutic alternatives. Recently, more information was provided by CMS regarding the patient-focused listening sessions for the selected drug list.

PIPC Joins Over Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities

9/12/2023

On September 8, 2023, PIPC joined more than 1400 researchers, organizations and individuals in expressing opposition to the NIMHD Advisory Committee's decision to reject a recommendation to add people with disabilities as a health disparity population.

PIPC Offers Comments on Transitional Coverage for Emerging Technologies

8/28/2023

In a comment letter to the Centers for Medicare and Medicaid Services (CMS), PIPC offered feedback on the agency's Transitional Coverage for Emerging Technologies (TCET) notice.

PIPC Submits Comments on ICER Assessment of MLD Treatments

8/24/2023

In a letter to the Institute for Clinical and Economic Review (ICER), PIPC submitted comments on ICER's assessment of treatments for Metachromatic Leukodystrophy (MLD).

PIPC Submits Comments on CMS Proposed Guidance for Coverage with Evidence Development

8/21/2023

In a comment letter to the Centers for Medicare and Medicaid Services (CMS), the Partnership to Improve Patient Care (PIPC) offered feedback on CMS's Proposed Guidance Document for Coverage with Evidence Development (CED).

White Paper: The Use of Patient-Centered Outcomes in ICER Assessments

7/25/2023

Image of the Avalere/PIPC white paper cover page for the Use of Patient Centered Outcomes in ICER Assessments

US healthcare stakeholders are increasingly expected to define the value of technology and services provided. This is especially applicable to health technology manufacturers who are responsible for demonstrating the value of their treatments to payers, providers, patients, policymakers, and other stakeholders.

Over 75 Leading Patient Groups Join PIPC Comment Letter on ICER 2024 Value Assessment Framework

6/30/2023

More than 75 leading organizations representing patients, people with disabilities, and older Americans joined PIPC in submitting comments on the Institute for Clinical and Economic Review’s (ICER) proposed value assessment framework for 2024.

PIPC Submits Comments on FDA Guidance on Patient-Focused Drug Development

6/30/2023

In a letter to the Food and Drug Administration (FDA), PIPC offered comments on the FDA’s guidance on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints for Regulatory Decision-Making.”

Survey of Patient Perspectives Related to “Unmet Need”

6/21/2023

Defining Unmet Medical Need in the Inflation Reduction Act for the Maximum Fair Price: Reflecting Patient Input

The Partnership to Fight Chronic Disease led a survey of patients related to “unmet need” and joined with other organizations including PIPC to provide insights and recommendations related to the implementation of the Inflation Reduction Act provisions and Medicare Drug Price Negotiation.

PIPC Submits Comments to FDA on Patient Preference Information in Regulatory Submissions

6/7/2023

PIPC recently submitted a comment letter to the Food and Drug Administration (FDA) offering comments on FDA's proposed revision of guidance on the voluntary use of patient preference information (PPI) in regulatory submissions. The letter encourages FDA to review and incorporate best practices from several leading organizations as it revises its PPI guidance, including the Patient Centered Outcomes Research Institute (PCORI), Innovation and Value Initiative (IVI), and Everylife Foundation for Rare Diseases.

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