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HHS to Pick Drugs Subject to Medicare Price Negotiations by September

January 12th, 2023|Categories: Featured, Industry News|Tags: , , , , |

In an announcement this week, the US Department of Health and Human Services has revealed its schedule for the leadup to Medicare drug price negotiations, as granted by the Inflation Reduction Act. While negotiations don’t commence until 2026, the list of 10 drugs to be negotiated will be released in early September, with a public comment phase this spring.

Drug Pricing in 2023 – Five Key Issues to Look Out For

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

As the pharma industry leaves a tumultuous 2022 in terms of drug pricing, 2023 does not seem any less turbulent. Congress and the US Federal Trade Commission (FTC) are zeroing in on pharmacy benefit managers (PBM) while pharma prepares their legal rebuttals to the drug pricing reform included in the Inflation Reduction Act. In a new article by White and Case, learn about the 5 drug pricing trends you need to watch in this new year.

Indian Pharma Industry Growth May Hit Drug Pricing and Regulatory Overhang Roadblocks

January 9th, 2023|Categories: Featured, Industry News|Tags: , , , , |

A report covered in Express Pharma predicts that growth in the Indian pharma market may be capped just shy of last year’s numbers. In its prediction, the report notes this may occur in response to pricing negotiations, ongoing supply chain disruptions, inflation, and regulatory pressure. However, the report is overall neutral-to-positive for the industry

FDA Approves Alzheimer’s Treatment by Biogen and Eisai

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

The US Food and Drug Administration (FDA) has approved Biogen and Eisai’s new Alzheimer’s drug, lecanemab. The drug is the first of its kind because it slowed cognitive decline in patients, a sticking point with the ill-fated Aduhelm that was pulled from the market last year. However, it is unclear whether payers will cover the therapy, which looks to be expensive.

Pharma Braces for Challenges from Inflation, Drug Pricing Reform, and Reimbursement Changes

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

Although the pharma industry was bolstered by the successful rapid development and deployment of COVID-19 vaccines, it was still beset by challenges that are following it into the new year. High inflation rates and an employee-friendly labor market are driving up operational costs, all while supply chain issues are impeding production and distribution efforts.

Pfizer Wins US Patent Case with Astellas and Gilead Over Generic Lexiscan

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

Pfizer was granted a win by the US Court of Appeals for the Federal Circuit in its legal battle with Astellas and Gilead. The case centered around the active ingredient in Hospira, which is also the active ingredient in Astellas and Gilead’s myocardial perfusion imaging drug Lexiscan. The court decided that Hospira didn’t pose any direct infringement on Gilead and Astellas’ patents.

2022 FDA New Drug Approvals Lowest in Six Years

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

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) gave the nod to 37 new drugs for clinical use last year, a low after the past five years. However, this number was buffered by a slate of approvals by the Center for Biologics Evaluation and Research (CBER), reflecting a growing push for biologics.

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.

OIG Calls for CMS to Improve Medicare Part B Payment Accuracy

January 3rd, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Office of the Inspector General (OIG) released a recommendation for the Centers for Medicare & Medicaid Services (CMS) to work on better internal processes to improve the accuracy of Medicare Part B drug payment data. The OIG found notable gaps in the agency’s processes for drug payment tracking data and concluded that CMS was unable to calculate prices for 8 percent of drugs at least once over the observed period, 2016-2020.

Pharma Looks to Raise US Prices on Over 350 Drugs for 2023

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

In the coming weeks, pharma companies from across the industry will raise the price of 350 drugs in the US. The industry contends that the cost increases will come from higher manufacturing costs caused by supply chain disruptions and high inflation rates. Many speculate that the price hikes are in preparation for the coming drug pricing reform under the Inflation Reduction Act.

Top 5 Managed Care Executive Tuning in to the C-Suite Podcast Episodes of 2022

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

Managed Healthcare Executive (MHE) has published its top 5 most-listened episodes of its Tuning in to the C-Suite podcast. The episodes feature host Jim Graham’s interviewed with executives in pharma and healthcare, as well as a member of the MHE advisory board, Ateev Mehrotra. At number 5 is an interview with Tim Ashe of Wellsky

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.

South Korea’s HIRA Leaves Australia Off Drug Pricing Reference List

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

South Korea’s Health Insurance and Assessment Service (HIRA) has released its “detailed evaluation criteria for drugs subject to negotiation,” and Australia has been left off the list of countries used for reference pricing. The agency was considering it for inclusion into its’ A7 list, which includes Germany, Switzerland, Japan, Italy, France, the UK, and the US.

New Drug Prices Top Records

December 28th, 2022|Categories: Featured, Industry News|Tags: , , , , |

The latest round of newly approved therapeutics are peppered with high costs in the US that peak in the millions of dollars, a growing trend in the industry. Many of these therapeutics are gene therapies or antibody-based treatments. These therapies are opening up new, powerful options to patients, but the high costs are often prohibitive.

CNBC: The State of Pharma in 2022

December 27th, 2022|Categories: Featured, Industry News|Tags: , |

2022 has been a tumultuous year for pharma and biotech, with shifting market conditions, the Russian invasion of Ukraine, and US policy changes that spell an uncertain for the industry over the next few years. A newly published article by Ekta Batra reviews how the pharma industry performed in 2022, for better or worse.

2023 Biopharma Predictions

December 26th, 2022|Categories: Featured, Industry News|Tags: , |

Evaluate Vantage recently asked readers to anonymously provide their predictions for the upcoming year. The respondents, comprised of industry employees, investors, and bankers, speculated on everything from market conditions to M&A strategies. A key sticking point for many was the impending US drug pricing reforms implemented in the Inflation Reduction Act

India’s NPPA Updates Price Caps on 107 Scheduled Drug Formulations

December 26th, 2022|Categories: Featured, Industry News|Tags: , , , , |

India’s National Pharmaceutical Pricing Authority (NPPA) has announced it updated its ceiling price for 107 scheduled formulations, as per the drug (prices control) order, 2013 (NLEM 2022). This includes drugs like acetaminophen, risperidone, heparin, atorvastatin, levofloxacin, and more. The ceiling price update will cap the maximum price of drugs to retailers.

FDA Accelerated Approval Reforms Makes the Cut on US Congress Government Spending Bill

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

The US Food and Drug Administration (FDA) got a win in the just-passed $1.7 trillion government spending bill. The bill includes provisions that would allow the agency to ask applicants start confirmatory studies before they are granted accelerated approval. In addition, companies receiving accelerated approval would need to provide data from confirmatory studies every six months.

Spanish Agency for Medicines and Health Products Expedites Drug National Code Application Process

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

The Spanish Agency for Medicines and Health Products (AEMPS) has implemented changes to the application process for national code (NC) of centrally authorized medicinal products. Applicants may now send their NC application once they and the relevant regulatory agencies finalized texts. This and other changes are intended to speed up the application process.

2023: Upcoming Drug Pricing Developments to Look Out For

December 20th, 2022|Categories: Featured, Industry News|Tags: , , , , |

With the passage of the US Democrats’ Inflation Reduction Act and increased scrutiny over the practices of pharmacy benefit managers (PBMs), 2023 is set to be a year defined by drug pricing for pharma. In a new Law360 article, learn about 5 key upcoming issues related to drug prices to keep an eye on in the upcoming year. One key issue are Medicare price negotiations.

Market Analysts Eye Rare Disease Drug Development as the FDA Asks for Public Comments on Rare Disease Cures Program

December 19th, 2022|Categories: Featured, Industry News|Tags: , , , |

The US Food and Drug Administration (FDA) released a request for public comments last week on its Accelerating Rare Disease Cures Program, signaling growing market interest to Wall Street analysts. The announcement comes as therapeutics for rare diseases account for over half of novel drug approvals in the US.  Comments must be submitted to the agency before January 31st, 2023.

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