MODDERN Cures Act Reintroduced
Ask your Representative to support today!
Rep. Leonard Lance (R-NJ) has reintroduced the MODDERN Cures Act in the House of Representatives. MODDERN Cures (H.R. 3091) is a game-changer when it comes to the search for a treatment. The legislation provides new incentives to pursue ALS drug development and will significantly increase opportunities to find a treatment for the disease. We urge you to contact your Representatives and ask them to co-sponsor the MODDERN Cures Act TODAY!
The MODDERN Cures Act would accelerate the search for a treatment for ALS and other diseases by removing the barriers that limit medical innovation and by providing incentives to develop new treatments and diagnostic tools that can improve, prolong and, ultimately, save lives. Specifically the bill will: encourage research on treatments, which have been set aside in the lab, but hold promise for treating diseases like ALS that have unmet medical needs; remove barriers and provide incentives to develop new diagnostics; and ensure timely and appropriate reimbursement for new tests and treatments so that patients have access to the latest medical technology as soon as possible. A summary of the bill is available here:
The MODDERN Cures Act would accelerate the search for a treatment for ALS and other diseases by removing the barriers that limit medical innovation and by providing incentives to develop new treatments and diagnostic tools that can improve, prolong and, ultimately, save lives. Specifically the bill will: encourage research on treatments, which have been set aside in the lab, but hold promise for treating diseases like ALS that have unmet medical needs; remove barriers and provide incentives to develop new diagnostics; and ensure timely and appropriate reimbursement for new tests and treatments so that patients have access to the latest medical technology as soon as possible. A summary of the bill is available here:
MODDERN CURES ACT
The ALS Association urges Congress to enact the MODDERN Cures Act (H.R. 3091) to accelerate the
development of new diagnostic tools and a treatment for Lou Gehrig’s Disease.
ALS is Always Fatal
No treatment: There currently is no effective treatment for ALS that stops, significantly slows or
reverses the steady progression of the disease. There is no known cause, cure or means of
prevention. The average life expectancy for a person with ALS is just two to five years from
diagnosis and approximately half of all people with ALS will die within 14 months.
Everyone at risk: ALS does not discriminate and can strike anyone at any time. However, military
veterans are approximately twice as likely to die from ALS as the general public.
No biomarkers: Biomarkers that predict or diagnose the disease or determine the efficacy of a
treatment or proposed treatment do not currently exist for ALS. In fact, ALS is a diagnosis of
exclusion, meaning that physicians reach an ALS diagnosis after first exhausting all other
possibilities. These facts not only delay access to needed support services that can help improve care
for people with ALS, but they also delay the development of treatments for the disease. Diagnostic
tools like biomarkers can speed treatment development by predicting earlier in the development
process whether and in whom a possible therapy may work.
Barriers to Treatments, Barriers to Diagnostics
There are a number of significant barriers that have limited and discouraged the development of a
treatment for ALS. These include:
Risk: It can take more than 15 years and cost over $1 billion to develop a new drug for ALS and the
chances of successfully developing a new drug are small. About 99% of all compounds screened fail
during development and never reach patients. This presents an enormous risk, and can discourage
drug development especially in a rare neurological disease, like ALS, with a limited population.
Patents: Patent protection and the ability to make a treatment available without generic competition
for a period of time helps to drive drug development and reduce risk. Indeed, patents enable
manufacturers to recover part of the R&D costs that are necessary to pursue new treatments,
including those that ultimately do not make it to clinical development. The Orphan Drug Act is an
example of how patent protection can spur innovation. However, there are hundreds of thousands of
potential treatments that either have lost patent protection, or have weak patents. These potential
treatments that could save lives are sitting on the lab shelf and never will be developed simply
because they lack patent protection. Moreover, the patent system can create disincentives to pursue
treatments for diseases like ALS where the time it takes to develop a therapy can exceed 15 or more
years. That’s because the patent clock starts at the beginning of the development process, leaving
only a limited amount time after approval for a company to recoup its costs before the patent expires.
Regulatory challenges: There is no clear regulatory pathway for the approval of new diagnostics,
making it difficult to predict risk and success and discouraging diagnostic development and
personalized medicine.
Delays in coding and reimbursement: It can take a year or longer for a diagnostic to receive a
reimbursement code. These delays not only discourage development of diagnostics, but also further
delay patient access to vital diagnostics tools.
The Solution: the MODDERN Cures Act introduced in the House of Representatives by Congressman Leonard Lance (R-NJ),
Addresses Unmet Medical Needs: Facilitates the Development of Treatments
MODDERN Cures would create a new category of drugs called “dormant therapies,” which are those
that are deemed to have insufficient patent protection and also show promise for treating diseases like
ALS for which there are limited or no treatments. The bill would encourage development of dormant
therapies by providing a 15 year period of data exclusivity, which offers incentives for therapy
development similar to those afforded by patent protection. However, unlike patents, the period of
data exclusivity would begin at the time of FDA approval so that manufacturers are not penalized for
pursuing treatments for diseases like ALS that can take 15 or more years to develop.
For a rare disease like ALS, MODDERN Cures builds upon the Orphan Drug Act and opens new
opportunities to find a treatment.
Removes Barriers for Developing New Diagnostics and Personalized Medicine
MODDERN Cures would ensure prompt coding and reimbursement for new diagnostic tests by
defining improvements to the process for determining payment rates and developing a system for
assigning temporary HCPCS codes to new tests until a permanent code is established. HCPCS codes
are necessary to ensure reimbursement, coverage and patient access to new diagnostics.
The bill would encourage the development of companion diagnostics that accurately predict for
whom a medicine will work by prolonging the period before which generics may enter the market by
an additional 6 to 12 months.
MODDERN Cures would establish a council to develop educational tools and programs to promote a
common understanding of the terminology and definitions related to the development and use of
diagnostics. In these ways, the MODDERN Cures Act will speed the development of new treatments and diagnostic tools that can improve and extend the lives of people living with Lou Gehrig’s Disease. MODDERN CURES ACT
The ALS Association urges Congress to enact the MODDERN Cures Act (H.R. 3091) to accelerate the
development of new diagnostic tools and a treatment for Lou Gehrig’s Disease.
