India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension
Johnson & Johnson notched a loss today as India’s patent office refused to extend the patent on bedaquiline, a drug for treatment-resistant tuberculosis. The company was looking to extend the patent to 2027, but the patent office’s refusal means J&J will lose the patent by July, ending the company’s monopoly of the drug and opening the door for cheaper generics.
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, Sanofi set an out-of-pocket cap of $35 a month for patients.
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put out a call for feedback. Responses are due by April 14th.
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only 22 drugs getting simultaneous review in the past five years.
Biden Administration Looks into Expanding Reach of Medicare Drug Pricing Negotiations
During a statement about his administrations budgetary plans, US president Joe Biden argued that more drugs should undergo Medicare pricing negotiations. In addition, he called on the process to go more quickly, considering that only a small number of drugs will be negotiated starting in 2026 under the Inflation Reduction Act.
HealthCore Changes Name to Carelon Research
The healthcare data company HealthCore announced today, March 1st, that it has undergone a name change. The company, now dubbed Carelon Research, will continue its dedication to providing its healthcare data and evidence generation services to its clients across industry, academia, and other life science stakeholders. The change marks the company’s entrance into the broader Carelon family.
Do Commercial Payers Rely on ICER Assessments During Specialty Drug Coverage Deliberations?
The Institute for Clinical and Economic Review (ICER) releases value assessment reports that determine cost-effectiveness ratios (CERs) for new and existing therapeutics. A newly published study in the Journal of Managed Care + Specialty Pharmacy, examines whether and how commercial insurance plans in the US incorporate these reports into their reimbursement decision-making process.
CDC Launches Initiative to Accelerate Health Data Modernization Efforts
The US Centers for Disease Control and Prevention (CDC) has announced a new initiative to modernize its public health data infrastructure. The Initiative, announced today, February 27th, will be a cooperative public-private effort led by the agency, the National Coordinator for Health Information Technology (ONC), and the CDC Foundation, an independent non-profit started by Congress.
Clinical Trials Must Include Diversity Plan in FDA Applications
Many patients from rural areas and marginalized backgrounds are severely underrepresented in many clinical trials. To address this problem, the US Food and Drug Administration (FDA) has announced that in the near future, all clinical trials registered through the agency must contain a plan to ensure diversity in the participant population. The plan will take time, however, as the agency must issue a final guidance and wait for public input.
FDA Lays Out Three Ways to Fight US Opioid Crisis in New Report
The US Food and Drug Administration (FDA) has outlined three steps in a newly released report that it can take to help combat the ongoing opioid crisis. The report, entitled the External Review of FDA Regulation of Opioid Analgesics Final Report, examines how the agency acted upon the 2017 findings of the National Academies for Sciences, Engineering, and Medicine (NASEM). The first is to evaluate study designs that consider public health for regulatory decision-making. In addition,
Moderna CEO Will Testify Before Senate Committee Headed by Sanders Over COVID Vaccine Price Hike
Stéphane Bancel, CEO of Moderna, will speak before a US Senate committee headed by Sen. Bernie Sanders (I-VT) over planned price hikes for the company’s COVID-19 vaccine. The shot, which the US federal government paid around $30 per dose for during the pandemic, will jump in price to $130 as it enters the market.
US GSA Launches AI Healthcare Challenge
The US General Services Administration (GSA) has announced the launch of a new competition to develop artificial intelligence (AI) solutions to improve health outcomes. The challenge, launched by the Centers of Excellence (CoE) and Challenge.gov, will focus on accessibility, oncology, logistics and safety, mental healthcare, and substance use disorders.
Operation Warp Speed for Rare Diseases is on the Way
Director Peter Marks of the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research has announced the next stage of Operation Warp Speed, a program intended to find cures and treatments for rare diseases. The program will support drugmakers developing drugs for rare diseases and will establish close lines of communication between companies and the agency to expedite the process.
FDA Opens Public Comments for Draft Guidance on External Controls in Clinical Trials
The US Food and Drug Administration (FDA) is seeking comments for its newly released draft guidance on using external controls in clinical trials, a move that comes as the agency is increasingly relying on real-world evidence (RWE) for regulatory decision-making. Comments must be submitted by May 2nd, 2023 to be considered during the development of the final guidance.
US Senate Finance Chair Wyden Asks CMS to Enact Inflation Rebates
Although the Inflation Reduction Act includes a provision that makes drugmakers provide rebates to US Centers for Medicare and Medicaid Services (CMS) if they hike prices at a rate exceeding inflation, no such penalties have yet been divvied out. This week, Sen. Ron Wyden (D-OR), Senate Finance Chair, penned a letter asking the head of CMS when the rebates would kick in, emphasizing the need for quick action as many drug prices jumped significantly higher than the current rate of inflation in the past month.
First Humira Biosimilar Finally Hits Pharmacies with Two Price Points
After a 20-year monopoly on the market, AbbVie’s Humira has lost exclusivity with the entrance of Amgen’s biosimilar, Amjevita. This marks the beginning of the end of the $114 billion rheumatoid arthritis drug’s dominance, propped up by widely critiqued patent thicketing. The biosimilar will follow a dual pricing system that, at best, will be half the cost of brand name Humira.
FDA Approves Two New Treatments for Breast Cancer and Lymphoma
Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost $21,000 per month of treatment.
J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the trials primary endpoint of progression-free survival.
APAC Therapeutic Access and Financing Trends to Watch in 2023
The market access and reimbursement landscape in APAC is set to shift in 2023, according to a new interview with Jeff Weisel, APAC managing director for PRMA Consulting. Weisel notes that global economic forces will play a significant role in payer decision-making in APAC, with inflation and the strengthening dollar being counterbalanced by the availability of biosimilars.
India’s NPPA Finalizes Price Caps on 128 Formulations
India’s National Pharmaceutical Pricing Authority has announced final price caps for 2023, affecting some 128 formulations. The list includes new ceiling prices for 97 formulations and revised prices for an additional 31. Included on the list are treatments for conditions like seizures, intestinal swelling, heart disease, HIV/AIDS, and more.
Connecting Payers to Patients with Rare Diseases
Patients with rare diseases often require complex, expensive medications that may or may not be on their payer’s formulary. In a recently published paper in Future Medicine, Siva Narayanan put forward a payer-patient engagement framework (PPEF) intended to connect rare disease patients with payers to make informed reimbursement decisions based on the individual's needs.
ISPOR 2023 – Last Chance to Submit Abstracts – January 12th
The deadline to submit abstracts for ISPOR 2023 is fast approaching! ISPOR 2023 takes place in Boston, MA, USA, from May 7th-10th, and is a leading conference for the field of health economics and outcomes research (HEOR), bringing together professionals from pharma, healthcare, payer organizations, academia, and more. Abstract submissions are due no later than January 12th.
US Drug Price Hikes Extensive but Don’t Match Inflation Rate
Hundreds of drugs have just had their wholesale prices raised at the beginning of the year, a well-treaded practice for the pharma industry. However, these hikes did not outstrip inflation, sitting around 5% on average. Companies raising prices include Pfizer, which drove up the prices of over 90 drugs, many of which are for cancer.
Modern Segregation in US Worsens Cancer Outcomes
In a newly published JAMA Oncology paper, researchers find that people living in US counties with higher levels of racial and socioeconomic segregation face a 20% increase in mortality rates. This effect was more pronounced in lung cancer, with mortality rates spiking by 50% in the most segregated counties.
STAT News: 8 Points to Note About Aduhelm Congressional Investigation
With the release of the US congressional report about the US Food and Drug Administration’s approval of Biogen’s ill-fated Alzheimer's drug Aduhelm, STAT News has published and article detailing 8 points to keep in mind going forward. The first is that the agency’s officials didn’t document communications with the manufacturer as required.
