Author's posts
Mental Health Awareness Isn’t Enough: More Funding Is Needed
Raising awareness of issues regarding mental health problems should be the start of a process of addressing them. Yet, society isn’t doing enough to fund mental health research, alleviate shortages in inpatient beds, pay healthcare providers, build inf…
Lost In Translation In RCT Colonoscopy Study: Some Kind Of Colorectal Cancer Screening Is Essential To Lower Mortality Rates
The study may have people wondering whether they should have a colonoscopy. Much more problematically, the snippets people read or hear about the study in the news, in social media, and elsewhere, may have them questioning whether they should get scree…
Turning Very Old Drugs Like Makena Into Profits: Regulatory Reform Needed
There is nothing inherently wrong with profiting from old drugs. It depends on the drug in question, its efficacy and safety, and the context within which it was approved and priced in the market. Problems can arise if the newly branded drug has limite…
Europe’s Emerging Covid-19 Wave Reminds Us That The Pandemic Isn’t Over Till It’s Over
During an interview on the television program 60 Minutes, President Biden asserted that “the pandemic is over.” For all intents and purposes, pre-pandemic life has resumed across the U.S. and many other parts of the world. But just because things appea…
Inflation Reduction Act Provision Aims To Further Spur Biosimilar Uptake With Temporary Add-On Payment In Medicare Part B
A temporary increase in payments from Medicare for physician-administered biosimilars is designed to further boost their uptake. The increase went into effect on October 3rd. It’s one of the lesser-known drug pricing provisions contained in the Inflati…
HHS Implements Inflationary Rebates For List Prices Of Medicare Part D (Outpatient) Drugs
The inflationary cap on list price growth will impact drug makers, which have already seen their net prices stagnate in recent years and even enter negative territory. It will also lower Medicare beneficiaries’ out-of-pocket spend and affect price nego…
Newly Approved ALS Drug Relyvrio To Face Its Next Challenge: Pricing And Reimbursement
There’s a swirl of controversy around FDA’s approval of Relyvrio, a new drug indicated for ALS (amyotrophic lateral sclerosis), often called Lou Gehrig’s Disease. But there are also pricing and reimbursement issues the drug will face as its sponsor, A…
Auvelity, Newly Approved Drug For Major Depressive Disorder, To Face Payer Pricing And Reimbursement Challenges
Overcoming market access hurdles will be a challenge for a newly approved drug for major depressive disorder, Auvelity. But, a favorable efficacy and adverse event profile will likely help to facilitate patient access.
Alzheimer’s Drug Lecanemab’s Positive Phase 3 Data Could Lead To Loosening Of Medicare Coverage Restrictions
If deemed to meet the reasonable and necessary criteria, Medicare may – for lecanemab – remove the conditional access barrier it imposed on all beta amyloid-directed monoclonal antibodies in the National Coverage Determination (NCD) issued in April of …
British Obstetrician Recounts 2014 West African Ebola Outbreak – Lessons For How To Cope With Current Crisis In Uganda
Perhaps lessons can be learned on how to cope with the current Ugandan crisis from a British obstetrician’s account of what it was like to be a doctor on the front lines of an unfolding Ebola epidemic in Sierra Leone in 2014 while struggling to save th…
