New Pancreatic Cancer Drug Approved by FDA Faces Cost and Accessibility Hurdles

The U.S. Food and Drug Administration (FDA) has approved Rasonque, a new drug for metastatic pancreatic cancer developed by Revolution Medicines. The approval has generated excitement, with the company's stock soaring 477% in the past year due to positive trial results. While not a cure, Rasonque offers a significant extension of life for pancreatic cancer patients, increasing average survival from approximately six to 13 months in clinical trials, and potentially improving quality of life.

The drug is not yet approved for marketing in Israel, but patients can import it personally under Section 29c of Israeli health regulations, which allows for the import of FDA-approved medications. However, this personal import comes at full cost. Rasonque is expected to cost $40,000 per month in the U.S., translating to about 1.4 million shekels annually. While some private insurance policies in Israel offer coverage for out-of-pocket medications up to 3 million shekels over two years, which might cover this drug, older or supplementary insurance plans may offer less coverage, and patients might require multiple such medications.

Several Israeli pharmaceutical companies have expressed interest in bringing Rasonque to Israel for official import, but Revolution Medicines currently prioritizes larger markets, leaving the timeline for Israeli market entry uncertain. Inclusion in Israel's national health basket is not expected before early 2028, if at all. Furthermore, U.S. regulations, such as the Most Favored Nation rule, could impact pricing negotiations, potentially making it difficult for Israel to secure a discounted price for inclusion in the health basket.

Professor Ido Wolff, head of oncology at Ichilov Hospital, estimates that 500-600 patients in Israel are immediately eligible for the drug based on its FDA approval. The immediate cost for these patients could reach hundreds of millions of shekels. Doctors are hopeful the drug could also be effective for other cancers with RAS mutations, which could escalate annual costs to over a billion shekels. This potential cost increase may force insurance companies to raise premiums, limit coverage for non-basket drugs, or tighten eligibility criteria.

Revolution Medicines was founded by Iranian-American professor Kourosh Shokat to develop drugs targeting the Ras protein, a common factor in many cancers. The company acquired Warp Drive Bio in 2018, which had developed a unique method for modifying protein activity. Analysts estimate the drug's peak market potential at $11.8 billion if its use is expanded to earlier stages of the disease. The company's market value is currently $44 billion, following a failed acquisition attempt by Merck earlier this year.