India’s NPPA Announces New Price Caps for Similar Drugs Sold by Same Drugmaker
India’s National Pharmaceutical Pricing Authority (NPPA) has rolled out a new policy capping prices on similar drugs sold by the same pharma company to the price of the least expensive version. The agency made the move based on the Drug Price Control Order, which it used previously to make medical devices like stents and knee implants more affordable to patients.
Drugmakers Are Putting Family-Funded Rare Disease Therapeutic Research on Hold
Families of patients have often led funding for rare disease therapeutic development through donation campaigns. However, many drugmakers have put these programs on hold, with 26 rare disease projects shelved in the past 16 months. This has caused an outcry from patient advocates. Pharma analysts argue financial reasons are to blame.
How Drugmakers Are Using Real-World Data to Accelerate Market Access
Market access for therapeutics requires extensive data to plan for regulatory compliance, reimbursement, and successful rollout. Drug manufacturers are increasingly relying on real-world data (RWD) like claims data, electronic health records (EHR), and clinical lab data, for this process, gleaning insights about patient journeys, barriers to access, and prescriber preferences.
Flatiron Health Adds End-to-End Services to RWE Offerings
Flatiron Health has announced the addition of new end-to-end services for oncology real-world evidence (RWE) generation and analysis to its real-world data (RWD) offerings. The new services are available through Flatiron’s OncoEMR® platform and are intended to help accelerate oncology research with human expertise and machine learning techniques.
Federal Appeals Court Keeps ACA Preventative Care Rules in Place
A US Federal appeals court has issued a stay on a lower court’s ruling that would gut the preventative care requirements in the Affordable Care Act. If not paused, the lower court’s ruling would end the requirements for payers to cover preventative care services like physicals, Pap tests, cancer screenings, and pre-exposure prophylaxis (PrEP) for HIV.
Monica Bertagnolli Nominated for Director of NIH
The Biden administration has nominated Monica Bertagnolli for the next director of the US National Institutes of Health (NIH). Bertagnolli formerly worked as the chief of surgical oncology at the Dana-Farber Brigham Cancer Center and is currently the director of the National Cancer Institute (NCI). Her appointment is expected to make it through the narrowly Democratic-leaning senate some time later this year.
NICE Recommends Gilead’s Bulevertide for Hepatitis Delta Virus
The UK’s National Institute for Health and Care Excellence (NICE) has announced its approval of Gilead Sciences’ bulevirtide for the treatment of hepatitis delta virus (HDV) in adults with compensated liver disease. This recommendation comes after the US Food and Drug Administration (FDA) shot down Gilead’s application for issues with manufacturing and delivery.
Supreme Court Refuses to Hear Teva & GSK’s Skinny Label Case
The US Supreme Court has rejected Teva’s bid to take up its case with GSK over skinny labels, which approve a generic for some, but not all, of the indications of the reference drug. Teva was sued by GSK in 2014 after it added an indication for congestive heart failure for its generic version of GSK’s heart drug Coreg.
Physicians Pushing Back Against Private Equity Firm Buyouts
Private equity firms are increasingly taking over small medical groups and nabbing hospital contracts in the process. To fight back against this growing trend, a group of providers formed the Association for Independent Medicine (AIM). AIM argues that practices like rolling smaller groups into larger companies or the sale-leaseback model are hurting providers and patients.
Real-World Evidence Study Supports Efficacy of Monoclonal Antibody for Infant RSV
Real-world evidence (RWE) presented at this year’s European Society for Paediatric Infectious Diseases meeting show that administration of nirsevimab, a monoclonal antibody (mAb), prevented hospitalizations in infants infected with respiratory syncytial virus (RSV). Data from over 8,000 babies was taken from the 2022-2023 RSV season.
ICER Announces Upcoming Value-Assessment for Pulmonary Arterial Hypertension Treatment
The Institute for Clinical and Economic Review (ICER) has announced it will perform a value-assessment for Merck’s sotatercept for the treatment of pulmonary arterial hypertension. The organization has been in talks with patient groups, clinical specialists, manufacturers, and patient advocates and will present its report at the Midwest CEPAC meeting this coming December.
ARS Pharmaceuticals Notches Win with FDA Adcomm Vote Recommending EpiPen Alternative
ARS Pharmaceuticals scored a win yesterday, May 11th, with a 16-6 Food and Drug Administration (FDA) advisory committee vote recommending the approval of its epinephrine nasal spray. Not only would this be the first nasal spray of the drug, but it would also represent a major challenger to Epipen’s dominance in the market.
ImmunityBio’s Marketing Application for Bladder Cancer Medication Shot Down by FDA
ImmunityBio took a loss today after receiving news its marketing application for its bladder cancer drug Anktiva was rejected by the US Food and Drug Administration (FDA). The decision came primarily because of issues with manufacturing facilities. The agency also wants more safety data and information on the duration of treatment response.
Exploring the Impact of PBMs on High Drug Prices
The US pays the highest amount per capita on prescription drugs than any other nation. Several factors interact to drive prices up in the nation. Since a major portion of pharmaceutical development occurs in the US, drugmakers argue high prices are necessary to offset research costs and promote exclusivity. In addition, pharmacy benefit managers (PBMs) play a large role in setting drug prices because they negotiate formularies and drug rebates.
Takeda Anticipates Revenue Losses as End of Vyvanse Exclusivity Looms Large
Takeda is preparing for a substantial drop in revenue as two of its major drugs approach patent cliffs this summer. The first is the company’s attention deficit hyperactivity disorder (ADHD) drug Vyvanse, which will lose US exclusivity this August. Takeda’s hypertension medication Azilva will lose exclusivity in Japan this June. The combined hit of the two losses is expected to reach $2.4 billion (330 billion yen).
Bipartisan US PBM Reform Bill Moves Forward
A bipartisan bill including reforms to the Food and Drug Administration (FDA) and the pharmacy benefit manager (PBM) industry has been advanced by the US Senate Health, Education, Labor, and Pensions committee. The bill, approved with an 18-3 vote, picked up several amendments in the mark-up session before it was advanced.
Promoting Health Equity and Community Health with Medicaid Reinvestment Requirements
Several states have adopted policies that make Medicaid managed care plans put money back into local communities to promote health equity and community health by targeting social determinants of health (SDoH) associated with poor health outcomes. In a new Health Affairs Forefront article, learn about the challenges blocking the full realization of these policies’ potential and best practices in developing them.
OM1 Expands Lupus Dataset to 56,000 Patients
The real-world data (RWD) company OM1 announced it has expanded its PremiOM ™ SLE lupus dataset. The expansion adds deep clinical data from patients with cutaneous lupus erythematosus (CLE) and lupus nephritis to the database. In combination with additional data from patients with systemic lupus erythematosus (SLE), this effectively doubles the RWD pool provided by the company, now covering 56,000 patients.
New Proposed CMS Medicaid and CHIP Managed Care Rule Targets Access, Quality, and Payment Rates
A newly released proposed rule by the US Centers for Medicare and Medicaid Services (CMS) targets transparency, quality, care access, and payment rates for Medicaid and Children’s Health Insurance Program (CHIP) managed care. States would need to provide an annual payment analysis of all managed cares payment rates for a variety of services. In addition, states will need to develop a quality rating system for Medicaid and CHIP plans.
Real-World Evidence Backs Venetoclax-Based Treatment in Chronic Lymphocytic Lymphoma
A real-world evidence (RWE) study presented at this year’s ISPOR meeting shows that venetoclax-based treatment regimens improve patient outcomes in chronic lymphocytic lymphoma (CLL). Patients on venetoclax (Venclexta) had reduced rates of treatment initiation and had a longer time before new treatments or death. The study was based off electronic health records (EHR) from CLL patients across the US.
PBMs and Pharma Leaders Point Fingers During US Senate HELP Committee
At yesterday’s US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, representatives from pharma and the pharmacy benefit manager (PBM) industry are blaming one another for high prescription drug prices. While PBMs argue that drugmakers could lower list prices on their own, pharma reps argue that PBMs’ practices drive drug prices up.
Real-World Data Study Finds Sickle Cell Decreases Life Expectancy by 32 Years in Brazil
A recently published real-world data (RWD) study in Blood Advances found that sickle cell disease (SCD) is associated with a 32 year decrease in life expectancy in Brazil. SCD has a significant impact on health outcomes worldwide, causing a 22-year drop in the US, for example. This study examined healthcare data collected between 2015 and 2019.
Medicare Advantage Programs Not Helping with US Healthcare Spending
Medicare Advantage is a program set up by the US federal government to allow private plans to provide government-funded healthcare services to older adults. Although the goal was to offset spending per Medicare beneficiary, it’s done the opposite, with Medicare Advantage plans often costing much more per member than Medicare Parts A and B.
Talking Immunology Biosimilars and Managed Care with Dr. Colby Evans
Biosimilars have taken an increasingly prominent role in healthcare in recent years, representing a significant point of savings for patients and managed care organizations (MCOs). However, there are still some significant challenges to increase their utilization. In a new AJMC interview, Dr. Colby Evans of Evans Dermatology Partners discusses these hurdles. The first is that patients and providers are often unwilling to make the change from more expensive reference drugs.
Pharma Prepares for Legal Battle Over US Drug Price Reform
As the upcoming Medicare drug pricing negotiations loom large over the industry, pharma companies are preparing to challenge the government in court. One sticking point for the companies is that they aren’t allowed to talk about negotiations, facing heavy fines for any infractions. Another issue is how drugs to be negotiated are chosen.
