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HEOR Feature

28 US States Will See Medicaid Enrollment Drop to Near Pre-Pandemic Levels

April 5th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

Just as US states begin the Medicaid redetermination process, a new report by Moody’s Investors Services finds that 28 states will see enrollment drop to numbers equivalent to pre-pandemic levels. Some states, the report notes, will settle on enrollment levels higher than those seen before the pandemic-era Medicaid redetermination pause.

State Level Look at Who’s About to Lose Medicaid Coverage

March 31st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

With the imminent end to the COVID-19 public health emergency looming large, pandemic-era Medicaid expansions are set to kick millions off the program in the US. A newly published report from the Urban Institute and Robert Wood Johnson Foundation predicts that up to 18 million people are set to be dropped from Medicaid in the coming weeks and months. Examine this at the state-by-state level in a new Becker’s Payer Issues article.

Darwin EU Seeks New Partnerships After Successful First Year

March 29th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

The European Medicines Agency (EMA) has issued a call for applications for new partnerships with Darwin EU. The move comes after a successful first year that saw the implementation of four real-world data (RWD) projects that investigated rare blood cancers, the use of certain medications tied to pregnancy issues, antibiotic prescription patterns, and severe asthma.

US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval

March 27th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.

India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension

March 24th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

March 17th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

March 16th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

March 9th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

March 7th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

March 1st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , |

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?

February 28th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

February 27th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

February 23rd, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

February 20th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

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

February 17th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

February 15th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

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

February 14th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

February 8th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , |

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

February 3rd, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

February 1st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

January 31st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

January 27th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

January 11th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

January 10th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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

January 6th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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.

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