Next Generation Therapies: Access, Pricing, and Challenges

Publications
Category:
Published on:
March 17, 2022
Written by:
Andrea Mantovani, Vice President Global Market Access & Pricing

2018 was a watershed year for medicine, showing us the transformative and curative future for biopharmaceuticals:

  • The first patient was treated with an approved gene therapy
  • The first therapy based on gene suppression (RNA interference) was approved
  • Hospitals in Europe and the U.S. administered newly approved chimeric antigen receptor T-cell (CAR-T) therapies for the first time

Next Generation Therapies (NGTs) currently in development will deliver treatments that address the underlying cause of diseases, disrupt the biopharmaceutical environment, and offer a life-long solution to patients.

What Qualifies as an NGT?

NGTs is a term for a range of new, leading-edge therapies that:

  • Expand science
    NGTs employ an expanding number of scientific approaches to diagnose and treat disease, including gene therapy, cell therapy, RNA therapy, immunotherapy, and hybrids of these therapeutic models
  • Meet the significant unmet need
    NGTs have secured approval by the EMA and/or FDA to meet significant unmet medical needs or promise significant improvement in patient health over current standards of care
  • Gain expedited market access
    NGTs are often approved through the FDA’s Breakthrough Therapy, EMA Prime Review, Rare Disease, and other priority review pathways—often after expedited reviews and clinical trials based on surrogate endpoints

Next Generation Therapies: Access, Pricing, and Challenges

Overview of Next Generation Therapies (NGTs)

Challenges Related to NGTs

This surge of new therapies creates unprecedented opportunities for patients and will be measurable in lives saved, disabilities reduced, and overall quality of life improvements.  And, along with these benefits come unprecedented challenges for insurance coverage, reimbursement, and payment.

These new therapies are expected to create major challenges for healthcare, including:

  • Timely patient access to treatment
  • Overall treatment costs, including patient initiation and adherence support
  • Spending that supports sustainable health coverage for all patients
  • Continued biopharmaceuticals innovation

Governments, health insurers, and other healthcare payers have historically relied on volume-based discounts, hidden discounts/rebates, and price/volume agreements as their primary tools for managing or containing pharmaceutical costs. But these approaches have real limitations when applied to the new wave of highly innovative pharmaceuticals.

What’s Next for NGTs?

What can the industry do right now to embrace the arrival of therapies that can benefit patients in such an unprecedented manner?

First, biopharmaceutical organizations, providers, payers, and patient communities must share information about NGTs in development.

Early information sharing reduces the chance that payers and providers are caught unaware of new therapies that could impact yearly health care budgets and insurance rates. Information sharing will also help payers and providers:

  • Gauge the impact of NGTs on patient utilization and costs as access and availability grows over time
  • Increase the likelihood for more competitive therapeutic options
  • Ensure availability of new diagnostics or advanced analytics in “the right therapy for the right patient, at the right time” way

Information sharing may also encourage the development of alternative policies on coverage and payment.

Second, stakeholder collaboration around shared principles for affordable patient access at a manageable cost to the healthcare system—while sustaining continued innovation—is essential. These fundamental principles should include:

  1. Linking payment for next generation therapies to a demonstration of durable health outcomes in real-world medical practice
  2. Expanding available reimbursement options for physician administered drugs, including:
    1. Innovative access, payment, and pricing models
    2. A commensurate commitment to models of fair provider reimbursement for the administration of new and complex therapies
  3. Collaboration across sectors to standardize and harmonize novel contract models to cut the complexity, time, and contract execution expenses
  4. Measuring the “all in” costs and benefits of NGTs, including—if possible—payment and finance models. The highest and best use of NGTs may not be achieved within standard, one-year budgets supporting one-year insurance enrollments. These therapies may create medical spending offsets realized over a period of years, and they may also trigger new and ongoing medical costs. And they may create social benefits, such as reducing the patient’s need for social services. This raises the question of whether health insurance programs should bear the total responsibility for covering treatment or whether government or other, non-insurance sources should share the cost.
  5. New engagement on innovations in reinsurance and risk adjustment so payers have a level competitive playing field that accommodates affordable coverage of NGTs.

Learn more about NGTs, from concept through commercialization, and how our GMA experts can help.

Related news

Events January 27, 2023
Alira Health and Biocat Startup Support Program Presentation
Biocat and Alira Health partnered to foster Market Access for startups. Alira Health, a global healthcare advisory and technology company, and Biocat, a strategic stakeholder building(...)
Market Access Startups
Publications January 20, 2023
Insights on Market Access
To get her perspective on market access and what to expect in 2023, we spoke with Nerea Blanqué, Senior Vice President of Market Access and Pricing at Alira Health.
Market Access Medical Devices Pharma
Publications December 21, 2022
2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Clinical Digital Health Market Access MedTech Pharma Regulatory
News November 15, 2022
Alira Health Partners with Policy Matters to Foster Market Access in the UK
Alira Health, a global advisory and clinical research firm whose mission is to humanize healthcare and life sciences, announces its partnership with leading UK market access specialist(...)
Digital Health Healthcare Consulting Market Access
News November 10, 2022
Alira Health and GDMH together to boost Life Sciences innovation
The companies join forces for collaborative research and co-development of projects in the fields of Digital Health, Real-World Evidence and Market Access.
Clinical Trials Digital Health DTx Market Access Real-World Evidence RWE
Events October 7, 2022
Debate Sobre los IPT en Oncología
We are pleased to announce our next event, “Debate Sobre los IPT en Oncología,” focusing on price and reimbursement (P&R) of vital oncology and oncohematology therapies.
Market Access Product Development Regulatory
Publications October 5, 2022
Relative Weight of the Variables Evaluated Through the Therapeutic Positioning Reports in the Pricing and Reimbursement of Oncological and Oncohematology Medicines in Spain
Discover how companies’ target prices are impacted by the different variables leveraged during the P&R process for oncology and oncohematology’s first indication.
Market Access Oncology Spain
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.