Diagnostics represent the greatest opportunity to improve healthcare, by tailoring healthcare decision making to the patient. Alva10 works with laboratories and manufacturers on all facets of commercial strategy, including clinical validity, clinical utility, economics and pricing strategy, coding, coverage, and payment. Alva10 partners with employers and payors to bring diagnostics to patients to address clinical needs, rising healthcare spend, and other inefficiencies the result from trial-and-error medicine.
All aspects of coding, strategy and execution.
Claims-based cost impact analysis, with budget impact model.
Pricing strategy and execution.
Complete publication strategy across all stakeholders (payors, physicians, patients).
Multi-year strategic planning to align evidence development, fundraising, and launch.
Clinical utility market confirmation.
Pre-market engagement with payors.
Real world evidence generation.
Engagement and channel with self-insured employers.
Complete diagnostic dossier execution.
Precommercial contracts for coverage.
Investor support.
The standard diagnostic development cycle, coined the ‘Vicious Cycle’ of diagnostics, is what makes investors shy away from investing in innovative technologies. Companies tend to develop their test with the input from key opinion leaders, large academic centers, and their own scientists, as well as internally determine what the minimally viable product is, and launch onto the market with the intention of asking payers for pilot studies and joint development agreements in order to generate more data.
This is almost never successful. Why?
The payers (customers) see a product that isn’t fully complete and doesn’t have enough supporting evidence. Frequently, the payer also doesn’t agree with either the clinical utility, value proposition/pricing, or both. The payer deems the test ‘experimental’ and does not cover it, waiting for more data. The diagnostic developer finds themselves in the less than ideal position of needing to go to their investors, or board, and ask for more resources to generate sufficient data. Frequently, that request is turned down, because there is no clear path to market success. This is the valley of death for diagnostics.
Let’s look at the above Vicious Cycle compared to the Virtuous Cycle. In the latter cycle you, being the diagnostic developer, engage with the customer ahead of the validation data development. What, you may ask, does that do?
This ensures that there is agreement on:
1. Clinical utility
2. Value proposition (payer economics)
3. Reimbursement (diagnostic company and investor economics)
By coming to agreement upfront, the same resources are used on the payer side, but now the diagnostic developer has a clear path to the market, and a clear return on investment for the investors. It's a WIN-WIN-WIN from the start.
Let’s look at the above Vicious Cycle compared to the Virtuous Cycle. In the latter cycle you, being the diagnostic developer, engage with the customer ahead of the validation data development. What, you may ask, does that do?
This ensures that there is agreement on:
1. Clinical utility
2. Value proposition (payer
economics)
3. Reimbursement
(diagnostic company and
investor economics)
The standard diagnostic development cycle, coined the ‘Vicious Cycle’ of diagnostics, is what makes investors shy away from investing in innovative technologies. Companies tend to develop their test with the input from key opinion leaders, large academic centers, and their own scientists, as well as internally determine what the minimally viable product is,
and launch onto the market with the intention of asking payers for pilot studies and joint development agreements in order to generate more data.
This is almost never successful. Why?
The payers (customers) see a product that isn’t fully complete and doesn’t have enough supporting evidence. Frequently, the payer also doesn’t agree with either the clinical utility, value proposition/pricing, or both. The payer deems the test ‘experimental’ and does not cover it, waiting for more data. The diagnostic developer finds themselves in the less than ideal position of needing to go to their investors, or board, and ask for more resources to generate sufficient data. Frequently, that request is turned down, because there is no clear path to market success. This is the valley of death for diagnostics.
By coming to agreement upfront, the same resources are used on the payer side, but now the diagnostic developer has a clear path to the market, and a clear return on investment for the investors. It's a WIN-WIN-WIN from the start.