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HEOR Feature

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.

ISPOR 2023 – Last Chance to Submit Abstracts – January 12th

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

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

January 4th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

January 2nd, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

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

December 30th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

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.

ICER Report Suggests Lower Price for Lecanemab Than Aduhelm

December 22nd, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

The Institute for Clinical and Economic Review (ICER) has issued a report evaluating the value and cost-effectiveness of two amyloid-targeted therapeutics for Alzheimer's disease. Biogen and Eisai’s lecanemab was deemed by the agency to be cost effective if priced between $9,000 and $21,000, whereas Eli Lilly’s donanemab was valued between $14,500 and $46,900, although evidence was limited regarding the latter.

ICER Releases Evidence Report Reviewing Multiple Sclerosis Therapeutics

December 21st, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

The Institute for Clinical and Economic Review (ICER) has released a newly revised evidence report covering several therapies for multiple sclerosis, comparing their clinical efficacy and relative value. The treatments include five monoclonal antibody therapies and eight oral drugs. Although the analysis was unable to differentiate the value of individual monoclonal antibody treatments, they were collectively deemed cost-effective at annual prices ranging from $16,500 to $34,900.

Coalition for Health AI Lays Out Blueprints for Ethical Healthcare AI Usage

December 19th, 2022|Categories: HEOR Feature, Industry News|Tags: , |

The recently launched Coalition for Health AI (CHAI) has released its framework for the ethical use of AI in healthcare and healthcare research. The framework, entitled the Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare, makes the case that the propensity for bias and perpetuation of existing systemic health inequities currently holds back the implementation of AI in healthcare settings.

Pharma and Payers Gear Up for 2023

December 16th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

Coming off the heels of an upset in the US mid-term elections, drugmakers and payers are preparing for what is set to be a tumultuous upcoming year. A major upcoming event on the minds of stakeholders is the beginning of Medicare negotiations with pharma to lower drug prices, a key provision of the Inflation Reduction Act. This only applies to a few drugs and with Medicare, but some fear it may portend future, more comprehensive legislation.

EMA and ECDC Collaborate on Vaccine Real-World Evidence Generation Efforts

December 13th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

Officials from the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency met earlier this month to begin a new collaboration intended to boost real-world evidence (RWE) generation for vaccine safety and efficacy trials. The collaboration, the Vaccine Monitoring Platform (VMP), will work to develop an RWE infrastructure for vaccines in the EU without outside industry funding.  

EMA Emergency Task Force Recommends Bivalent COVID-19 Vaccines for Initial Inoculations

December 7th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

An Emergency Task Force (ETF) of the European Medicines Agency (EMA) has announced that it supports the use of bivalent mRNA COVID-19 vaccines for primary inoculations. The vaccines, which contain mRNA from the original SARS-CoV-2 and the Omicron BA.4/BA.5 strains, were previously only used as boosters for those who have already been vaccinated with one of the original versions of the shots.

ICER Releases List of Top Drugs with Unsubstantiated Price Hikes in 2021

December 6th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

A new report published by the Institute for Clinical and Economic Review (ICER) lays out a list of the top 10 therapeutics that had unsupported price hikes last year. Among the top ten were several high-price drugs that contributed significantly to US drug spending. Seven of the top 10 list were hiked without any new evidence.

DARWIN EU Real-World Evidence Studies Begin

December 2nd, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , |

The first real-world evidence (RWE) studies have begun in the DARWIN EU initiative of the European Medicines Agency (EMA). The project is a collaboration between the European Commission and the health technology assessment bodies of 27 member countries. Through the project, members hope to support and optimize the use of RWE in regulatory decision-making.

Pharma Skeptical of US FDA Plan for OTC Indications of Prescription Drugs

December 1st, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

A group of pharma industry organizations have banded together and leveled their complaints and concerns at the US Food and Drug Administration’s recent plans to make a pathway for prescription drugs to receive over-the-counter (OTC) status for certain indications. A key sticking point was that insurers are likely to end coverage of prescriptions of these medications, complicating patient access and drugmakers’ earnings.

Achieving Better Health Outcomes with AI-Based Data Analytics – Interview with Richard Gliklich of OM1

November 29th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: |

Robert Gliklich, CEO and founder of OM1, recently sat down with Forbes to discuss how launched his company, which uses real-world data (RWD), big data analytics, and artificial intelligence (AI). Gliklich developed his interest in RWD and AI after his first major acquisition as a venture capitalist, noting that there was a wealth of data held by specialists that could be used to advance care for those with chronic conditions.

Canada and Australia to be Added to South Korea’s Drug Pricing Reference Countries

November 24th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

In a new announcement by the South Korean government, Canada and Australia will be added to the nation’s list of countries it uses as references for drug pricing purposes. Previously, the group of countries used for price-setting includes seven nations. The addition puts Canada and Australia into the cluster, which includes the UK, Germany, Japan, France, Italy, the US, and Switzerland

The Latest Shifts in the FDA Accelerated Approval Pathway

November 23rd, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

The US Food and Drug Administration (FDA) is actively retooling its accelerated approval pathway, with or without actions by Congress. GSK announced yesterday, November 22nd, that the agency asked it to pull a multiple myeloma drug based on negative post-confirmatory trial data. Unlike previous situations of the sort, the agency moved in just over two weeks.

WHO Draft Pandemic Rules Could Make Pharma Disclose Prices

November 21st, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

New draft rules by the World Health Organization (WHO) may force pharma companies to reveal the prices of any drugs under public procurement contracts. This comes after criticism of the industry over a lack of pricing transparency regarding therapeutics like vaccines during the COVID-19 pandemic.

Real-World Evidence Studies Show Efficacy of COVID-19 Therapeutics

November 17th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

Two new real-world evidence studies exploring the efficacy of two treatments for COVID-19 have been published in the British Medical Journal (BMJ). The first study investigated real-world data (RWD) from fully vaccinated high-risk adult patients in England. Those taking sotrovimab had better COVID-19 outcomes than people taking molnupiravir, most notably a 46% reduction in severe COVID-19.

Study Highlights Barriers to Care for Disabled People in US Healthcare System

November 14th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

A newly published study in Health Affairs further characterizes significant physical and structural barriers to care. The survey found that many physicians felt uncomfortable taking on disabled patients, often denying care. Furthermore, many care delivery locations are not ADA compliant and inaccessible to some disabled people.

Study Finds Racial Health Disparities Negatively Impacted by Medicaid and Medicare DSH Payment Model

November 11th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

A recently published article in JAMA Network Open found that structural problems in Medicaid and Medicare DSH payment programs hurt the marginalized, low-income populations they are meant to benefit. Data was gathered from DSH programs in largely majority Black counties in all US states except Massachusetts. The results showed that payment models based on healthcare utilization underpay majority Black counties due to barriers of access to care.

New Data Reveals Burden of Oral Disease on Managed Care Plans

November 10th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

New research in Managed Care shows the burden of oral disease on managed care plans. The researchers looked at data from the IBM Watson Medicaid Marketscan data base, the IBM Dental Database, and the Medical Expenditure Panel Survey to ascertain the burden on Medicaid and commercial plans separately.

FDA Officials Point Out Interchangeability Essential to Biosimilar Competition

November 8th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: |

Despite a range of biosimilars entering the market, their ability to lower drug spending for patients is dependent on payer reimbursement, which is inconsistent and based on approved uses. According to FDA officials, one avenue to ease these issues is with interchangeables, drugs that can be substituted without a doctor’s permission. However, only a few of these drugs have been approved for interchangeable use. The market landscape is shaky, even for approved interchangeables like Semglee by Viatris, an insulin biosimilar.

Drug Pricing Reform on the Back Burner in Ramp-Up to US Mid-Term Elections

November 7th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

Although healthcare is front and center on tomorrow’s ballot in terms of abortion and Medicare, drug pricing reform has not been a key talking point in the lead-up to the US mid-term elections. This is in spite of the Democrats’ recent legislative win with the Inflation Reduction Act, which included major drug pricing reform. However, some Republicans hope to completely or partially repeal the act, including popular portions like price capping prescription costs for older adults.

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