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US Senators Weighing Approaches to Lowering Insulin Prices for All

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

As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.

States Increasingly Coordinating Care for Dual Eligibles with Managed Care, FAIs, and PACE

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

Dual eligible special needs plans often run up against significant difficulties coordinating care for beneficiaries. A recent analysis by the Kaiser Family Foundation (KFF) examined how states accomplish this complex task, finding that many use managed care, a Financial Alignment Initiative (FAI), or rely upon the Program of All-Inclusive Care for the Elderly (PACE).

Immunotherapy Utilization Lower at Small and Rural Clinics

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

A recently published article in JAMA Oncology finds that cancer clinics that are smaller or in rural areas are less likely to use immunotherapy for their patients compared to larger clinics and those in urban and suburban areas. The study, based on Medicare claims data taken from 1700 cancer clinics, also showed that the majority of practices implemented new immunotherapies within 2 years of their approval by the US Food and Drug Administration (FDA).

Potential Partnerships Between Retailers and Real-World Data Firms Could Advance Clinical Trials

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

Major retail chains like CVS, Walgreens, and Kroger are increasingly entering the clinical trials space, effectively creating a swath of new recruitment sites for clinical research partners. According to COTA CEO and president Miruna Sasu, PhD, there is fertile ground for partnerships between retailers and real-world data (RWD) companies which, if capitalized upon, could accelerate clinical research.

Pharma Already Bristling at Parts of EU Drug Overhaul

May 1st, 2023|Categories: Featured, Industry News|Tags: , , , |

As the EU preps for a massive pharma regulation overhaul, industry groups have already begun levelling complaints. The reforms include simplifying the approval process, cutting approval timelines, and reducing exclusivity periods from 10 years to 8 years for new drugs, the key sticking point for pharma companies.

Real-World Data Study Supports Decipher Prostate Genomic Classifier

May 1st, 2023|Categories: Featured, Industry News|Tags: |

Research analyzing real-world data from over 100,000 patients shows that Veracyte’s Decipher Prostate Genomic Classifier can provide accurate metastatic risk stratification in prostate cancer. Results from the first of two studies to be presented at this year’s American Urological Association meeting compared test results to adverse pathology (AP) found when radical prostatectomy (RP) is performed, which is associated with poorer outcomes.

FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza

May 1st, 2023|Categories: Featured, Industry News|Tags: , , , , |

AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and J&J’s Zytiga only for a small subset of mCRPC patients.

Paying for Legal Psychedelic Therapeutics in Australia

May 1st, 2023|Categories: Featured, Industry News|Tags: , , , |

This summer, providers in Australia can legally prescribe psychedelics, MDMA and psilocybin, to patients suffering from post-traumatic stress disorder (PTSD) and depression that has not responded to other treatments. How these drugs will be paid for, however, is still up in the air. Due to a lack of cost-effectiveness analysis, it is unclear whether the therapeutics will be publicly subsidized.

UN Negotiating Price of Takeda’s New Dengue Vaccine

April 28th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The World Health Organization’s (WHO’s) Pan American Health Organization (PAHO) is working with Takeda to negotiate pricing for the manufacturer’s new dengue vaccine Qdenga, the only one for the widespread illness. A key strategy being proposed is that large nations can pool their resources to purchase the vaccines in bulk at a lower price.

Study Investigates Reasons Commercial Plans Don’t Cover Some Biosimilars

April 28th, 2023|Categories: Featured, Industry News|Tags: , |

Despite significant potential savings, many commercial plans do not cover biosimilars for many high-price drugs. In a recently published paper in BioDrugs, researchers found several factors underlying why payers have a low coverage preference for biosimilars over name-brand therapeutics. These include plan size, relationships with pharmacy benefit managers (PBMs), and the average yearly savings per patient.

CMS Announces New Rules to Improve Medicaid and CHIP Programs

April 28th, 2023|Categories: Featured, Industry News|Tags: , , |

In two back-to-back announcements, the US Centers for Medicare and Medicaid Services (CMS) has revealed policies targeting healthcare access and quality for patients on Medicaid and the Children's Health Insurance Program (CHIP) The rules changes would standardize fee-for-service (FFS) reimbursement rates and improve access for both programs.

Study Finds Safety-Net Hospitals with High Uncompensated Care Rates in Disadvantaged Areas Have Lower Margins

April 28th, 2023|Categories: Featured, Industry News|Tags: , , , |

A recently published study in Health Affairs finds that safety-net hospitals’ margins are lower in disadvantaged areas or when they have high rates of uncompensated care. The Disproportionate Share Hospital (DSH) program was designed to compensate hospitals who treat underserved communities, but state-level policies can cause disparities in payments to different health centers.

Using Real-World Evidence to Advance Geometric Atrophy Care

April 28th, 2023|Categories: Featured, Industry News|Tags: , , |

Despite advances in treating geometric atrophy (GA), a progressive eye disorder, patient responses to treatment are variable. In a new interview with AJMC, Ashard Khanani, MD, talks about how real-world evidence (RWE) can help advance GA care by revealing the real-world impact of treatments on patient health outcomes.

Positive Phase 3 Trial Results Set Up Lilly’s Mounjaro for Potential Approval This Year

April 27th, 2023|Categories: Featured, Industry News|Tags: , , |

Eli Lilly just wrapped up its SURMOUNT-2 phase 3 trial for Mounjaro (tirzepatide), with results showing that the drug successfully helped patients with Type 2 diabetes lose weight. Patients taking a 15 mg maintenance dose lost 15.7% of their body weight while those taking a lower dose lost 13.4%, significantly higher than the 3.2% lost by those given placebo.

European Commission Reveals Plans for Single Market

April 27th, 2023|Categories: Featured, Industry News|Tags: , , , |

Despite having region-level drug approval agencies like the European Medicines Agency (EMA), member states have their own approval agencies. This fragmented framework slows the rollout of new pharmaceuticals. To address this issue, the European Commission has released their plans to unify the approval process across all member states.

Study Finds Medicaid Supplement Payments Need Restructuring

April 27th, 2023|Categories: Featured, Industry News|Tags: , , , |

Research released by the Robert Woods Johnson Foundation finds that Medicaid supplement payments are inefficiently distributed, requiring a significant overhaul to fix. For example, disproportionate share hospital payments are based on figures from 1992 and leave some states receiving less than $100 for uninsured patients, much less than the $1,500 that others receive per uninsured patient.

Medicaid Redetermination Process to Take Coverage from Millions of Children

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

With the COVID-19 public health emergency on its way out, states are set to start up the redetermination for Medicaid beneficiaries. Among the millions who will lose healthcare coverage in this process are children, who make up the majority of Medicaid recipients. The number of children to be dropped is still uncertain, but it is estimated to be around 1/3 of kids on the program.

Study Shows Real-World Evidence Studies Produce Similar Results to RCTs

April 26th, 2023|Categories: Featured, Industry News|Tags: , |

A newly published study in JAMA finds that real-world evidence (RWE) studies produce similar results to randomized clinical trials (RCTs). The researchers analyzed 32 RCTs and created protocols for RWE studies that mirror them using the Aetion Evidence Platform (AEP). Analysis of the mirror studies showed that RWE study outcomes reached the same conclusion half of the time.

Low Value, High Prices: Which Therapeutics Are Worth It?

April 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Two recent value-assessment analyses found that many of the highest priced drugs in the US do not deliver enough beneficial effects to justify their list price. The first analysis came from the Institute for Clinical and Economic Review (ICER), which showed that the newly approved Alzheimer’s drug lecanemab was almost 20% higher than the maximum justified cost based on potential therapeutic benefits. The second analysis was published recently in JAMA examined Medicare spending on the top-selling prescription name brand drugs.

US House Committee to Hold PBM Hearing

April 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Today, April 26th, a representative for the pharmacy benefit manager (PBM) industry will speak before the US House Energy and Commerce Health Committee in a hearing focusing on improving transparency and countering anti-competitive practices. The industry, to be represented by Kristen Bass of the Pharmaceutical Care Management Association (PCMA), has faced significant public and congressional scrutiny in recent years over allegations that their processes are opaque and push smaller pharmacies out of the market.

US Democrats Introduce Bill to Expand Medicare Prescription Drug Price Negotiations

April 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

A group of 21 US Democrats introduced a new bill that seeks to strengthen the upcoming Medicare pricing negotiations with the Centers for Medicare and Medicaid Services (CMS) instantiated by the Inflation Reduction Act. The bill, if passed, would shorten the timeframe for drug pricing negotiations to begin to 5 years, a significant departure from the 9 years currently established for small molecule drugs and the 13 years set for biologics.

Value-Based Care Front and Center at NAMCP Spring Forum

April 25th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Value-based care will be a major theme of discussion at this week’s National Association of Managed Care Physicians (NAMCP) Spring Managed Care Forum. In addition, speakers will cover managed care decision-making in a variety of disease contexts, covering how to improve patient outcomes and reduce costs. The final focus is oncology.

FDA Approves Medtronic’s Automatic Insulin Pump

April 25th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Meditronic has scored a win with the long-anticipated approval of its MiniMed 780G insulin pump by the US Food and Drug Administration (FDA). The pump, which works in concert with the company’s Guardian 4 continuous glucose monitor to allow for automated insulin management, even bolus injections which weren’t automated by the previous version.

The Fight Between Pharma and CMS Over Drug Pricing Reform Has Only Just Begun

April 25th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Despite efforts by the pharma industry to stop it, Medicare prescription drug pricing negotiations from the US Inflation Reduction act still loom on the horizon. As a result, the industry is shifting its approach, now focusing on changing the law to its favor. Although pharma is putting energy into lobbying, litigation is soon to come.

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