White House
Research confirm That most Americans recognize the value of prescription drugs. But the same research also shows that Americans are worried that they will not be able to offer the necessary medicines.
These conflicting emotions show the inherent tension when it comes to prescription drugs – how do we encourage innovation to help patients who do not have effective treatments, while promoting more financial access to drugs today?
Very often, proposals take this balance between innovation and accessibility.
Politics, such as Medicare prices negotiations, which were identified by the law on inflation (IRA) law and signed by former President Biden in August 2022, are essentially imposing price checks on targeted medicines. Unless abolished by Congress, prices in the first 10 medicines under Medicare Part D will take effect on 1 January 2026. Additional new medicines according to Parts D and B will be subject to checks in the coming years. Price checks improve financial access, but only by reducing the incentive for constant innovation. Consequently, these controls exacerbate the tension between patients who have access to safe and effective drugs and patients living with non -treatment or poorly processed conditions.
Different Price checks, there are many possible regulatory changes that will improve the financial accessibility of the drugs without reducing the hope of patients waiting for the development of effective treatment. A Executive order (EO) was signed on April 15th It is a steady first step towards achieving this goal.
While the EO contains some sad changes, the EO faces the main causes of today’s economic accessibility problems and improves the incentives for the development of new innovative therapies. As a result, EO’s beneficial changes would essentially address many of the Problems that plague the pharmaceutical industry.
For example, today’s manufacturers of an innovative drug earns only 50 cents of every dollar They are spent on medicines. The other half of the revenue goes to insurers, pharmacy benefits (PBMs) and hospitals through discounts and discounts. These discounts and discounts are opaque and often fail to reduce the costs out of the pocket of patients. In fact, the current opaque discount system is largely responsible for the problem of affordable drugs. The EO requires a regulatory review to improve market transparency and ensure patients to benefit directly from the large discounts already paid.
Then there are actions that are oriented towards dealing with fraud and abuse that plague the 340B program. The 340B is well-intentioned-it is assumed to help in low-income patients, especially in rural areas, increasing the ability of hospitals and health care facilities that serve these patients disproportionately. However, instead of increasing the financial accessibility of the drugs and boosting the finances of targeted institutions, the program has become a profitable source of revenue for large hospitals and pharmacy chains.
Worse still, the uncontrolled development of the program now has a negative impact. The huge size of the program creates a cost shift that increases the cost of drugs to other private payers and patients. It encourages the unjustified integration of health care that increases costs and refuses to choose patient care. And, as if these impacts were not bad enough Less charity from the average hospital.
Storage of the 340B program requires legislative action that returns the program to its original intention, which the EO intends to begin.
In addition to the issues of economic accessibility, the EO focuses on improving the innovative environment. Get the so -called “punishment“ Ira created. This disincentive exists because IRA authorizes HHS to impose price controls on medicines derived from biological processes (eg biologies usually injected into a clinical environment) 13 years after FDA approval. However, small molecule drugs (eg, usually patients with pills take home) who are usually more convenient and affordable for patients are eligible after 9 years.
This different patents of biologicals against small molecules creates a disincentive that is already reducing Lining on small molecules. Also noteworthy, small molecules drugs have advantages over biological for the treatment of certain diseases such as cancers. As a result, the “pills penalty” biased the innovation environment against these patients.
The EO will help here, by directing the organization’s officials to work with Congress with the aim of aligning the treatment of prescription small tissue drugs with biologists under the IRA.
There are some unfortunate provisions in the EO, especially its appeal to increase the introduction of prescription drugs. Since these are controlled drugs, the call for imports of prescription drugs is merely a suspension of drug price controls in the US, whether imposed by the US or by a foreign government, adopting drug price controls in the US, will have the same raising inferior rise in The result will be worse health results today and tomorrow.
In spite of some imperfections, the recommendations contained on April 15th EO significantly improves the economic access of the drugs and encourages continuing innovation in the pharmaceutical sector. It achieves the right balance missing from recent efforts to impose price controls and, if it is finally made, will improve the results for patients now and in the future.
