Pfizer’s RSV Vaccine Gets FDA Approval
The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market that’s estimated at $17 billion.
Over 500,000 Disenrolled from Medicaid After COVID-19 PHE Ends
Shortly following the end of the COVID-19 public health emergency, pandemic-era restrictions on Medicaid redetermination ended. In that time, over 500,000 people have been disenrolled, interrupting their coverage and impacting their access to healthcare. Some states have kicked off more beneficiaries than others, with Florida taking the lead.
US Congressional Research Service Asks When Pharma Can Challenge Drug Pricing Reform
The Congressional Research Service (CRS), a nonpartisan public policy research institute, released a report asking for more clarity on when lawsuits over upcoming Medicare drug pricing reform can commence. The report comes as industry groups also seek more transparency on time windows as they prepare their legal challenges in advance.
Incorporating Value-Based Care into Nursing Homes with the Payvider Model
As nursing homes increasingly look for ways to incorporate value-based care into their practices, some are moving towards payvider models, wherein they partner with a Medicare Advantage insurer and play the roles of payer and provider together. A panel of experts spoke about this strategy in a recently broadcast webinar by NetSmart Technologies.
Eli Lilly Reaches $13.5 Million Settlement in Insulin Pricing Case
Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which claims no wrongdoing occurred, will apply this cap to three insulin products, Humalog, Humulin, and Basaglar.
Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform
Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma industry’s concerns and led to the reform being postponed.
Real World Data Study Finds Comprehensive Genomic Profiling Improves Cancer Outcomees
Real-world data (RWD) to be presented at this year’s upcoming American Society of Clinical Oncology’s Annual Meeting shows that comprehensive genomic profiling (CGP) improves cancer patients’ outcomes. The study, which covered 1,423 advanced cancer patients who received CGP from 2019 to 2021, showed that CGP was associated with improved survival.
Patients Turning to Illegal Pharmacies for Essential Medications
US patients are increasingly turning to illegal pharmacies due to high prescription drug prices and shortages of essential medications. The issue has grown in recent years, catching the eyes of officials at the US Food and Drug Administration. It is especially concerning for the attention deficit hyperactivity disorder drug Adderall, which is currently difficult to impossible to find at many legal pharmacies.
Real-World Data Backs Dolutegravir Combo Therapies for HIV
A real-world data study published in AIDS found that three two-drug dolutegravir combination therapies were as effective in managing HIV as commonly used three-drug treatment regimens. The study covered over 3,000 patients from 2015 and 2021 taking dolutegravir in combination with lamivudine, rilpivirine, and emtricitabine.
Speaking with the Person Behind the Inflation Reduction Act Drug Price Negotiations
The US drug pricing reform in the Inflation Reduction Act was concocted by John Barkett of the Berkely Research Group. In a new interview, Politico’s Ben Leonard spoke to Barkett to talk about the process and the next steps for the Centers for Medicare and Medicaid Services (CMS). Barkett first spoke about pharma’s criticism of the move and the agency.
Expiration of Temporary Provisions Set to Change Up Insurance Coverage for People Under 65
COVID-era policies expanded access to Medicaid and Marketplace plans for millions of people in the US, resulting in the lowest rates of uninsured status ever. However, these policies are set to expire soon, resulting in many people under 65 losing their coverage. In a new Health Affairs article, learn more about the state of insurance coverage of people under 65 years of age and how it’s set to change in the coming decade.
Part D Out-of-Pocket Prescription Drug Price Cap Will Help New Part D Recipients
A newly published study in JAMA Health Forum found that new Medicare Part D price caps on out-of-pocket prescription drug costs will help new beneficiaries switching from commercial plans. The study found that the $2000 price cap in the provision, included in the Inflation Reduction Act, would save people switching from commercial plans to Part D.
Accelerating and Improving Clinical Trials with Real-World Data
The ubiquitous adoption of electronic health records (EHR) has supported the explosion of real-world data (RWD) applications in clinical trials. RWD has the potential to accelerate and optimize clinical trials while expanding their reach. In a new Life Science Leader article, learn more about the many ways that RWD can improve clinical trials and accelerate clinical development and market access.
Looking at Real-World Data Supporting Durvalumab in NSCLC
In a new Targeted Oncology Case-Based Roundtable, clinicians discussed new real-world data (RWD) supporting the use of durvalumab in unresectable stage III non-small cell lung cancer (NSCLC). The clinicians discussed their use of the immunotherapy, noting that most of them continued the treatment for 12 months, the length of treatment used in the observational study.
US FDA Fast Tracks Antithrombotic from BMS and J&J
Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary syndrome. Fast track designation is often granted for drugs that address medical conditions with limited treatment options.
US FDA Approves Paxlovid for High-Risk Adults
The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if given Paxlovid early in the disease. However, some experts have expressed concern over whether these results will translate to people who are up-to-date on their vaccinations.
India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half
The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines (NLEM). Many pharma companies have lambasted the plan, saying it will negatively impact their profits.
US CMS Announces New Strategy to Lower Medicaid Drug Prices
The US Centers for Medicare and Medicaid Services (CMS) has announced a new proposal to help lower prescription drug prices for Medicaid. The rule would establish a survey for drugmakers about drug manufacturing costs and would ensure that Medicaid payments for therapeutics, especially high-price cell and gene therapies, are reasonable via the Medicaid Drug Rebate Program (MDRP).
Yuhan Corp. Releases Real-World Data Supporting Leclaza in Lung Cancer
Researchers at Korea’s National Cancer Center have released new real-world data (RWD) supporting the use of Yuhan Corp’s Leclaza (lazertinib) in the treatment of a subset of non-small cell lung cancer (NSCLC). The study, basefd on data from 103 patients who used Leclaza as a second-line treatment, showed that the drug improved median progression-free survival (mPFS) out to 13.9 months, an improvement on the 11.1 months mPFS demonstrated in a randomized clinical trial.
CMS Using Real-World Evidence in Medicare Drug Pricing Negotiations
The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world
US House Members Call on FDA to Address Chemotherapy Shortages
A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and point out they were either caused or exacerbated by a manufacturing hold last year on Intas Pharmaceuticals over quality issues.
US FDA Still Mulling Over Sarepta’s Duchenne’s Gene Therapy
The US Food and Drug Administration (FDA) has yet to make a call on Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, although it appears to be leaning towards a limited “yes”. As a result, the agency has pushed back its decision from May 29th to June 22nd. Deliberations will continue in the meantime, and some expect approval for a limited age range.
FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach
The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be covered in a new guidance that will be up for public comment.
Value in Health Regional Affairs: Developing Generic Drugs for Rare Diseases
Orphan drug development in the US and EU languished for years due to high development costs and low sales until it was bolstered by legislative action. While this has brought powerful therapeutics to patients, these drugs are still prohibitively expensive. In a new Value in Health: Regional Issues article, learn about the challenges of developing generic orphan drugs and the value they could bring to patients and drugmakers.
US FDA Approves Gene Therapy for “Butterfly Children”
The US Food and Drug Administration (FDA) has approved Krystal Biotech’s Vyjuvek, the first gene therapy for dystrophic epidermolyis bullosa (DEB), a rare disease that leaves affected patients, dubbed “butterfly children” with skin that damages extremely easily and heals poorly. The treatment, which would cost $24,250 per dose, is applied to wounded skin, delivering a collogen gene that is missing in patients.
