CLL Society Introduces the Protecting Innovation in Rare Cancers Coalition

CLL Society Introduces the Protecting Innovation in Rare Cancers Coalition

SAN DIEGO, July 25, 2023 /PRNewswire/ — CLL Society, the world’s leading authority for chronic lymphocytic leukemia and small lymphocytic lymphoma patients, is proud to announce the formation of the Protecting Innovation in Rare Cancers (PIRC) Coalition. PIRC is a collaborative, multi-stakeholder, patient advocacy group that aims to implement the ‘wins’ achieved by CLL Society and others in the cancer community to reduce out-of-pocket costs while addressing growing concerns surrounding the implementation of the Inflation Reduction Act (IRA) by the Centers for Medicare & Medicaid Services (CMS).

Recognizing the need for a collective voice to represent the broader rare cancer community, PIRC will work tirelessly to educate policymakers about our concerns for maintaining continued innovation in rare cancers as policymakers seek to bring down health care costs in the Medicare program. PIRC’s mission is to safeguard access to existing treatments while protecting future innovations in rare cancers for our patients and families.

Unique challenges in rare cancers require particular policy solutions and advocacy. Scientists face numerous clinical challenges in advancing research in rare cancers, including whether and how to account for treatment-naive patients and sicker patient populations, whether to begin research development programs in more aggressive cancers, lesser-understood cancers, and at what stages of their cancer. Sadly, these factors often tip the scales away from research in rare cancers; therefore, the cancer community is increasingly concerned that requiring researchers to layer in reimbursement considerations under the IRA will only further deteriorate an already delicate balance of research and development of newer and better treatments in rare cancers.

Cancer patients face a lifelong challenge to afford their treatments, and rare cancer patients typically face even higher costs. The rare cancer community applauds the enactment of an out-of-pocket cap and smoothing provisions to help patients spread their financial obligations throughout the calendar year. However, other IRA provisions could compromise innovation in rare cancers.

While CMS’ reliance on a single designation may be helpful to rare diseases generally because there are often related subtypes for an umbrella rare disease, rare cancer treatments are more difficult to bring together under one designation. Treatments for CLL, for example, are often studied first in mantle cell, a more aggressive cancer where a delta can be proven sooner); however, a designation combining mantle cell and CLL is not practical. This problem is widespread in rare cancers, where disparate indications are studied in succession for the same drug. In addition, the decision to treat all drug and biologic applications as a single product for negotiation purposes, especially when combined with the narrow orphan drug exemption, will curb interest in research toward adding new rare cancer indications to existing approved treatments. The ever-evolving treatment landscape for rare cancers can shorten the life cycle in unpredictable ways.

The reimbursement landscape has long influenced where research dollars go. Oncology had seen this before when, before the advent of the Part D benefit, we saw significant investment in physician-administered drugs, even when technological advances had made patient-friendly oral or self-administered options feasible. The impact of IRA-related investment decisions being made now is likely far more negative and will be felt for generations.

“Artificially imposing a reimbursement framework on an already fragile ecosystem of rare cancer research and development is a dangerous experiment on our patients and families,” warns Brian Koffman, MD, a founder of the Protecting Innovation in Rare Cancers (PIRC) Coalition. “It is imperative that we establish a collective voice to advocate for the protection of innovations in and accessibility to rare cancer treatments. We hope PIRC will fill this crucial role, bringing together diverse stakeholders to educate policymakers on the vital importance of supporting the rare cancer community.”

PIRC seeks to unite patients, caregivers, the breadth of oncology providers, researchers, industry representatives, and other relevant stakeholders to foster collaboration and promote thoughtful policy changes. By convening the collective expertise of those affected by rare cancers, the coalition will educate stakeholders, advocate for policy change, and shape regulations that prioritize the needs of the rare cancer community.

PIRC aims to enhance policymakers’ understanding of the intricate challenges faced by rare cancer patients and the urgent need for continued innovation in treatment options. The coalition firmly believes that policymakers must prioritize protecting patient access to cutting-edge therapies and advancing research breakthroughs in rare cancers.

About CLL Society
CLL Society is a leading authority for chronic lymphocytic leukemia patients, families, caregivers and medical professionals. Founded in 2013 by Dr. Brian Koffman, a physician, CLL patient and advocate, and Patricia Koffman, a caregiver and advocate, the nonprofit organization addresses the unmet needs of the chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) community through patient education, advocacy, support and research. CLL Society is a registered 501(c)(3) tax-exempt organization. To learn more, visit

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