The new law authorizes $5.5 billion in new bond funding to the California Institute for Regenerative Medicine (CIRM) for stem cell research. CIRM was established in 2004 via voter approval of Prop. 71 which, at the time, provided $3 billion in bond proceeds for stem cell research in California. CIRM has allocated over $550 million to fund 56 clinical trials, mostly over the past four years. The passage of Prop. 14 will give CIRM the critical funding to continue its research and clinical trials, while requiring CIRM to prioritize increasing access to and affordability of clinical trials for patients.
The new law makes federal conforming changes to California law with respect to health insurance coverage of clinical trials, ensuring California law matches the Affordable Care Act (ACA), which provides more comprehensive coverage of clinical trials. Clinical trials allow patients to voluntarily take part in new drugs or procedures that have the potential to treat their cancer or other disease. Many of the most effective cancer and disease therapies are based on the results of clinical trials – trials that literally save lives. The ACA recognized this fact by mandating more comprehensive insurance coverage of clinical trials than what is required in California. By conforming California statute to federal law with respect to clinical trial coverage, SB 583 will protect patient access to life-saving experimental drugs and procedures while preserving cancer and disease research for future generations.
To evaluate the quality and significance of the projects’ scientific achievements and clinical contributions, the California Office of Planning and Research facilitated assessments of funded projects by expert scientists recruited from outside the state. This report serves as a summary of their assessments. According to the report, in its first three years the California Initiative to Advance Precision Medicine has awarded over $11 million, funding 11 projects across the state of which eight have been completed. Recently, Governor Gavin Newsom sought nominations for members of the new Precision Medicine Advisory Council to provide additional guidance to the Governor’s Office of Planning and Research on CIAPM related issues.
The legislation AB 1860 (Limon) aims to protect access to affordable, oral chemotherapy treatment. AB 1860 specifically extends for another six years the law that caps co-pays for oral chemotherapy at $250 per filled prescriptions. Because this cap expires in 2024, the Legislature will likely revisit this issue in 2023.
SB 1034 (Mitchell) extended for six years the requirement that health facilities that perform mammograms provide a notice to patients that have dense breasts, which affects the ability of mammography to detect breast cancer. Thirty other states have dense breast tissue notification laws, which arm women with more information to allow them to be informed participants in their health care decisions.
By signing SB 440 (Hertzberg) into law, Governor Brown ensured that Californians could continue to make voluntary donations to the California Breast Cancer Research Voluntary Tax Contribution Fund and the California Cancer Research Voluntary Tax Contribution Fund until 2025. The revenue in these funds pays for cancer research at the University of California.
California Cancer Facts & Figures 2017, a combined product of the American Cancer Society and the California Cancer Registry (CCR) showed a 30% decline since 1988 in cancer mortality and a 15% decline in the cancer rates over the same period. The five-year survival rate for all cancers combined over the last three decades increased by 20% among whites and 24% among blacks – reflecting improved treatment and earlier diagnoses. The California Department of Public Health operates the CCR, which collects and maintains data on cancer diagnoses in California. Statewide cancer reporting was implemented over 30 years ago, and the CCR is now viewed as one of the leading cancer registries worldwide.
AB 1795 (Atkins) increased access to cancer screenings for low-income women in California. Specifically, the legislation made changes to the Every Women Counts program and the Breast and Cervical Cancer Treatment Program to expand eligibility for cancer screenings, require coverage for the entire duration of breast and cervical cancer treatment, and expand coverage for treatment of reoccurring cancers.
AB 2325 required pathologists who diagnose cancer to report those diagnoses electronically to the Ken Maddy California Cancer Registry. This data provides critical information to researchers that helps them determine risk factors and conduct early detection of cancer clusters. By requiring electronic reporting, AB 2325 reduces delays in relaying this vital information and also allows cancer researchers to request the cancer diagnosis data to identify matches to clinical trials they are performing.
The California Initiative to Advance Precision Medicine (CIAPM) was launched with $3 million, since growing into a $53 million statewide initiative. CIAPM is a collaboration between the state, the University of California, and a number of other public and private entities with the goal of advancing innovation in health care and promoting emerging science and technology while considering costs and focusing on patients and health improvement.