News from Wednesday, September 13, 2023
Articles
Osimertinib Plus Chemotherapy Demonstrated Greater PFS Benefit in Patients With EGFRm Advanced NSCLC Than Osimertinib Alone
(9/12, Justina Petrullo, The American Journal of Managed Care) reports “Osimertinib with the addition of chemotherapy showed a statistically significant and clinically meaningful progression-free survival (PFS) benefit compared with only osimertinib in patients with epidermal growth factor receptor–mutated (EGFRm) advanced non–small cell lung cancer (NSCLC) in the FLAURA2 study, according to results presented at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer.” Full
A Framework For Prioritizing Pharmaceutical Supply Chain Interventions
(9/13, Marta E. Wosinska, et al., Health Affairs Forefront) comments “...To assess criticality is to address the following question: Without which pharmaceuticals will individual patients suffer great harm? The answer to this question will necessarily consider the severity of the condition the medicine treats and the comparative effectiveness of the drug relative to alternatives. In the criticality assessment, it is important to consider heterogeneity of treatment effect and the drug’s importance to specific vulnerable subgroups that face challenges in accessing needed medical care.” Full
Pharma Cries Procedural Foul in Next Front of Drug Price War
(9/13, Ian Lopez, Bloomberg Law) reports “...AstraZeneca's complaint in particular has gotten the attention of legal experts. The company argues that the HHS overrides the statutory definition of Qualifying Single Source Drug, for which there's no biosimilar or generic competition, and essentially lumps together separately approved products and justifies making them eligible for negotiations...‘They're claiming an excess of statutory authority,’ and ‘they have a point,’ said Robert Charrow, who served as HHS general counsel in the Trump administration.” Subscription Required
America’s New Drug-Pricing Rules Have Perverse Consequences
(8/30, The Economist) comments "…According to research published in 2021, once their spending on research and development is treated as an investment rather than an expense, pharma firms are not making outsize returns compared with the average firm in the S&P 500. If they doubt that they will make a sufficient profit on their investments, they will spend less on finding new drugs. Sure enough, studies suggest that falling revenues hit research and development spending hard. This is typical of the unintended and undesirable effects from price regulation. Lower prices are popular with patients today and mean less of a drain on the public purse in the near term. But if they discourage investment in new medicines, that will be to the detriment of patients and society tomorrow.” Subscription Required
Pharma Industry Urges HTA Bodies To Look Beyond Survival Data For Cancer Drugs
(9/13, Eliza Slawther, Pink Sheet) reports “...A new report by industry association EFPIA says that health technology assessment bodies often rely too heavily on overall survival data when assessing the value of novel cancer drugs, and should take into account other clinical and patient-reported outcome measures where appropriate.” Subscription Required
Press Releases
Mental, Maternal and Heart Health Headline PCORI’s 2023 Annual Meeting October 4-5
(9/13, PCORI Press Release) “...Two full days of dynamic sessions will tackle some of the most newsworthy health issues and greatest concerns among health care stakeholders, such as: Improving perinatal mental health. Using social determinants of health data to advance health equity. Improving mental health for people with intellectual and developmental disabilities. Creating pathways to optimal heart health for women. Addressing racism and discrimination in care delivery. Leveraging telehealth in the post-pandemic environment.” Full
Improving the Understanding, Acceptance and Use of Oncology–Relevant Endpoints in HTA Body / Payer Decision-Making
(9/12, EFPIA Press Release) “In clinical trials, overall survival (OS), defined as the time from randomisation (assignment of clinical trial participants to treatment groups) until death from any cause, remains a robust measure of the clinical benefit of cancer medicines. Its objectivity, suitability for comparing treatment regimens and relevance to patients have made it the preferred measure of clinical efficacy in regulatory and HTA body / payer decision-making. However, reliance on OS data in regulatory and HTA body / payer decisions has its limitations.” Full
Journals
A Clinical Pathway to Well-Being: Putting Patient Priorities at the Center of Care
Neil Wagle, MD, MBA, Claire Campbell, MD
September 2023, The American Journal of Accountable Care
Reports
Improving the Understanding, Acceptance and Use of Oncology–Relevant Endpoints in HTA Body / Payer Decision-Making
September 2023
European Federation of Pharmaceutical Industries and Associations