The FDA issued 25 new and nine updated draft guidance documents intended to support development of generic medications including HIV antiretrovirals, antibiotics, ophthalmic drugs, cancer drugs, azelaic acid and ivermectin. The documents offer product-specific recommendations on the design of bioequivalence studies.
The CMS issued new guidance calling on the Children's Health Insurance Program and Medicaid managed care plans to include spread pricing in calculation of medical loss ratios. According to the CMS, any price concessions or discounts obtained by a managed care plan or its pharmacy benefit manager must be included in the calculation of medical loss ratios.
A coalition that includes labor, advocacy and health groups has launched the Consumers First campaign to change financial incentives in health care and increase funding of primary care. The group's action areas include health care prices, provider payment system distortions, industry consolidation, tax policy for nonprofits, workforce policy, and access to data and transparency.
Pharmaceutical and biotech companies are lagging in digital health care, and only seven out of almost 30 valued at more than $10 billion have a chief digital or information officer on their executive committees, six of them appointed in the past two years. "The pharma industry is behind compared to other industries in terms of digital disruption," said Novartis CDO Bertrand Bodson. "But, gosh, the impact could be bigger than in most industries."
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 266 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.
Contact PCMA Charles Cote
Vice President, Strategic Communications