Pharmaceutical R&D lies at the crux of various shaping influences. First, the R&D is difficult to complete with many failures for each success. Second, the regulatory agency imposes minimum requirements in both safety and efficacy that must be met, while passing through a path of tests (of which there are multiple paths available). Third, each approved drug must compete in an imperfect market to meet certain therapeutic needs. Although a given drug may have a period of exclusivity related to its chemical formulation, it may be that it always faces competition from chemically dissimilar compounds. Fifth, entry of competing products is not guaranteed. Finally, the way that pharmaceutical compounds are paid for – involving a mixture of private, insurance, and government funds – makes tracking profit incentives quite difficult.
Pharmaceutical R&D lies at the crux of various shaping influences. First, the R&D is difficult to complete with many failures for each success. Second, the regulatory agency imposes minimum requirements in both safety and efficacy that must be met, while passing through a path of tests (of which there are multiple paths available). Third, each approved drug must compete in an imperfect market to meet certain therapeutic needs. Although a given drug may have a period of exclusivity related to its chemical formulation, it may be that it always faces competition from chemically dissimilar compounds. Fifth, entry of competing products is not guaranteed. Finally, the way that pharmaceutical compounds are paid for – involving a mixture of private, insurance, and government funds – makes tracking profit incentives quite difficult.
Because the Federal Government pays for a significant share of prescriptions for those over the age of 65 through the medicare program, identifying the effects of proposed laws on expenditures is a concern of the Congressional Budget Office. Examples of general concerns include:
Because the Federal Government pays for a significant share of prescriptions for those over the age of 65 through the medicare program, identifying the effects of proposed laws on expenditures is a concern of the Congressional Budget Office. Examples of general concerns include:
@ -41,11 +41,11 @@ Some areas of interest.
3. Denormalizing this path may work as a proxy for changes in regulatory strictness?
3. Denormalizing this path may work as a proxy for changes in regulatory strictness?
1. Probably not, because choice of path is probably dependent on already known information on safety.
1. Probably not, because choice of path is probably dependent on already known information on safety.
2. Estimate probability of success for approval based on trial data? How do biologics differ from standard small-molecule drugs?
2. Estimate probability of success for approval based on trial data? How do biologics differ from standard small-molecule drugs?
1. Haven’t put much thought in to this, not sure what the value proposition would be.
1. Haven’t put much thought in to this, not sure what the value proposition would be.
3. Estimate entry rates/Probability Of Success of Biologics/biosimilars
3. Estimate entry rates/Probability Of Success of Biologics/biosimilars
1. There appear to be lots of competing biosimilars in insulin.
1. There appear to be lots of competing biosimilars in insulin.
4. Develop “diagnostic tests” that will allow effects of policy to be forecast partway through implementation.
4. Develop “diagnostic tests” that will allow effects of policy to be forecast partway through implementation.
1. Something such as measures of phase 1 trials and phase 2 trials to predict phase 3 & approval rates.
1. Something such as measures of phase 1 trials and phase 2 trials to predict phase 3 & approval rates.
Will King
4 years ago