SummaryRecently released guidance and a second draft Negotiation Data Elements ICR introduce several opportunities for patients and caregivers to shape negotiation.
The Inflation Reduction Act (IRA) is bringing landmark policy changes to the healthcare industry, raising important questions about drug pricing, plan economics, and patient impacts. In this series, the IRA Question of the Week, Avalere answers the pressing questions shaping healthcare stakeholders’ strategic decision-making as the IRA is implemented.
In this installment, Avalere experts discuss how patients, caregivers, and their advocates can participate in the Medicare drug price negotiation process.
The Centers for Medicare & Medicaid Services (CMS) issued revised Drug Price Negotiation Program guidance and a second draft Negotiation Data Elements Information Collection Request (ICR) on June 30. Both the guidance and ICR indicated that CMS will seek significant patient and caregiver feedback about the value of products selected for negotiation. The focus on patient and caregiver involvement reflects feedback from many commenters who said that the process for patient and caregiver involvement outlined in the March initial guidance was complicated, burdensome, and insufficient. The revised guidance is not subject to stakeholder comment, although stakeholders may comment on the draft ICR through July 31.
Patient and Caregiver Listening Sessions
Under initial guidance, patient and caregiver involvement was limited to written data submissions. The revised guidance, however, allows patients and caregivers to directly engage with CMS through patient-focused listening sessions. CMS says that these sessions will be a forum for patients, other Medicare beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input on therapeutic alternatives, comparative effectiveness, and unmet medical needs. While CMS did not set a specific date for these listening sessions, the agency said they would occur after manufacturer data submission in fall 2023. Given this timeline, it is likely that the listening sessions would occur in October or November.
Patient and Caregiver ICR Submission
The initial guidance permitted patients and caregivers to submit information to CMS using the data elements ICR. The revised guidance maintains this, and the second draft ICR includes provisions to facilitate it. The ICR includes a question (#31) for patients and caregivers that includes the following prompts:
- What is your experience taking the selected drug and/or its therapeutic alternative(s)? How long have you been taking the selected drug and/or its therapeutic alternative(s)?
- How did treatment with the selected drug and/or its therapeutic alternative(s) impact your health, including your symptoms?
- Please describe any side effects that you have experienced, and the impact of [sic] these side effects have had on you.
- How did treatment with the selected drug and/or its therapeutic alternative(s) impact your quality of life and wellbeing?
- Have you had challenges accessing or taking the drug? For example, challenges affording the drug, gaining coverage through your health insurance, or taking the drug as prescribed.
Answers are limited to 2,000 words.
Other Considerations for Patients and Caregivers
Additional pieces of the data elements ICR and negotiation guidance may affect patient and caregiver data submissions. In the ICR, for example, CMS added the ability for patients, caregivers, and other stakeholders to submit information via charts, tables, and graphs. These visual representations may help submitters include more information in an easily digestible manner for CMS.
The revised guidance confirmed that CMS will not use data reliant on quality-adjusted life years (QALYs) or similar measures when assessing the impact of a selected drug or therapeutic alternative, but it will consider background information from studies with results reported in QALYs. To better separate permissible and non-permissible evidence, CMS added a prompt on evidence-related questions. For each evidence-related question, submitters will indicate whether their answer uses cost-effectiveness measures that do or do not rely on QALYs or similar measures.
Patients and caregivers should consider how best to demonstrate the value of a selected drug or its therapeutic alternatives before CMS releases the list of drugs selected for negotiation on September 1. Patient-advocacy organizations will likely play a key role in organizing patient responses. Additionally, manufacturers seeking to demonstrate the value of their drugs should consider engaging with patients, caregivers, and advocacy organizations to determine the best strategy for ICR responses and the listening sessions.
Avalere experts in drug pricing, Medicare, evidence strategy and generation, and plan design can help you understand what IRA provisions mean for your organization and weigh in on key implementation decisions. To better prepare for and shape the changing healthcare landscape in 2023 and beyond, connect with us.
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