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CalRx progress on naloxone; insulin timeline remains uncertain amid vendor scrutiny
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Summary
HCAI reported progress on a state‑backed naloxone supply contract and ongoing product development with Civica for an affordable insulin glargine product; lawmakers pressed agencies on timelines, confidentiality and a recent opioid‑related settlement involving the selected naloxone manufacturer.
The Department of Health Care Access and Information updated the Assembly subcommittee on CalRx programs to expand access to lower‑cost naloxone and a state‑supported biosimilar insulin glargine product.
Vishal Pagani of HCAI summarized the program history and recent steps. HCAI announced a $50 million CalRx/Civica arrangement in March 2023 to support development of an affordable biosimilar insulin glargine. Pagani said Civica has progressed through initial facility inspections, has manufactured vials and pens at a U.S. facility for upcoming clinical work, and is coordinating supply‑chain plans for distribution after FDA approval. HCAI said it expects Civica to begin clinical trials soon but did not provide a definitive public timeline for insulin availability.
On naloxone, HCAI described a separate, more advanced track. The Legislature provided $25 million in opioid settlement funds for a CalRx naloxone access initiative. HCAI awarded a contract to Amneal Pharmaceuticals following a public request for information; HCAI said it prioritized price, manufacturing readiness and speed to market. HCAI has arranged CalRx‑branded over‑the‑counter naloxone at $24 per twin pack and began supplying a state naloxone distribution project in May 2024; HCAI said it will launch a direct‑to‑consumer mail option at the same price point in the coming spring.
Legislative Analyst’s Office staff and lawmakers urged continued oversight. Jason Constanturos (LAO) noted initial implementation successes on naloxone and recommended ongoing monitoring of product availability, price effects in the market and whether competing generics provide comparable savings. He also noted the January budget included one‑time resources for a state manufacturing facility and urged the Legislature to reassess that plan as more implementation details emerge.
Assemblymember Patterson questioned HCAI about procurement oversight after disclosing that Amneal had recently reached a multistate settlement related to opioid litigation; the contract uses emergency procurement authority enacted during the COVID era to speed selection. HCAI acknowledged awareness of pending litigation and said the procurement evaluation considered litigation status among many factors. HCAI defended transparency by posting a public version of its Civica contract while redacting the insulin milestone payment schedule on commercial‑sensitivity grounds. HCAI said the milestoned payment schedule is withheld because disclosure could blunt the state’s competitive leverage when trying to disrupt concentrated drug markets.
Public commenters representing patient and advocacy groups urged parallel actions to reduce out‑of‑pocket costs immediately (for example, state co‑pay caps), arguing CalRx insulin will take time to reach the market and should not be the only policy tool.
Why this matters: insulin affordability remains a life‑critical, immediate problem for Californians who rely on insulin daily. Naloxone is an urgent overdose‑prevention medicine whose cost and distribution affect first responders and community programs. CalRx aims to create state‑backed supply options to lower prices, but timelines and procurement choices shape near‑term impacts.
What comes next: HCAI will continue tracking Civica’s product development and will expand naloxone direct‑to‑consumer distribution. LAO and committee staff said the Legislature should continue oversight of procurement, price effects, market competition and any plan to build manufacturing capacity.
Ending note: HCAI emphasized naloxone progress and said the insulin product remains in clinical development; the agency pledged to provide updates when Civica’s development milestones are public.
