Cell & Gene Therapy Financing Solutions 2023 Review

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983.

Patients with a rare disease have seen a growing number of new orphan drug approvals and spending recently with many Cell & Gene Therapies (C&GT) in progress.

The projected increase in the number of gene therapies on the market, with projected high prices, have increased the challenge for stakeholders in developing methods to afford the drugs. Even though many organizations may not currently have  gene therapy patients, there is the concern that the number may increase going forward.

The industry is seeking answers to the challenge of financing or payment for cell and gene therapies, with no exact answer to this point in time.

A number of financing solutions have been used or considered to date that include outcomes-based contracting, risk-pooling, stop-loss and reinsurance programs, warranty payment programs, subscription-based financing, specific patient assistance programs, among others.

AMI’s report, Cell & Gene Therapy Financing Solutions 2023 Review, provides background on gene therapy, including FDA approved products, financing challenges and solutions, outcome-based contracting and FDA approved products pricing, revenue patient population, and market access.

The report also identifies and provides profiles on the companies offering financing solutions in the market. Each company profile includes background, key decision-makers, solutions, and recent activities.

The report is available for $249 for a single-user license. Department and Corporate Licenses are available, please click here.

Table of Contents

Gene Therapy – pgs. 5-24

• Background
• FDA Approved Products
• Anticipated Regulatory Decisions in 2023
• Ongoing Cell & Gene Therapy (CGT) Clinical Trials
• CGT Industry Financing Challenges/Solutions
• Value (Outcome) Based Contracting
  • United States VBCs by Therapeutic Area, 2009-2022
  • U.S. Pharmas with three or more VBCs since 2009 with Number of Contracts
• Drug Revenue and Market Access
  • FDA Approved Drugs – Pricing and Patient Population

 

Cell & Gene Therapy Financing Solution Company Profiles

• Amwins – pgs. 26-28
• Audaire Health Inc. – pgs. 29-30
• August – pgs. 31-32
• Blue Cross Blue Shield Association – pgs. 33-35
• CareMetx, LLC – pgs. 36-38
• CVS Health/Aetna – pgs. 39-41
• Emerging Therapy Solutions – pgs. 42-45
• Evernorth Express Scripts/Cigna – pgs. 46-49
• Independence Health Group – pgs. 50-51
• MaxorPlus – pgs. 52-53
• MedImpact Healthcare Systems, Inc. – pgs. 54-55
• Octaviant Financial, Inc. – pgs. 56-58
• OptumRx/UnitedHealth Group – pgs. 59-61
• PayRx Inc. – pgs. 62-63
• Prime Therapeutics/Magellan Rx – pgs. 64-67
• ProAct – PBM – pgs. 68-70
• Real Endpoints – pgs. 71-73
• RxParadigm – pgs. 74-76
• Synergie Medication Collective – pgs. 77-78

 

Report Figures & Charts

• New Orphan Drug Approvals
• FDA Approved Products
• Anticipated Regulatory Decisions in 2023
• Ongoing Clinical Trials
• United States VBCs by Therapeutic Area, 2009-2022
• U.S. Pharmaceutical MFGs with 3+ more VBCs since 2009 – with Number of Contracts
• FDA Approved Drugs – Pricing and Patient Population