The Wrong Prescription At Exactly The Wrong Time: Build Back Better Prescription Negotiation Strategies Will Limit Access To Needed Medications and Chill Innovation

Men’s Health Network (MHN) as do all Americans, want to insure access to affordable, effective and safe medications.  There have been many suggested approaches on how to achieve this goal, including those now being negotiated as part of the Biden Administration’s Build Back Better legislative package.  Analysis of the proposed approaches to achieve the goal of affordability that have been proposed as part of this package MHN believes would neither achieve meaningful long term out-of-pocket savings on medications but instead would create a system of establishing medication pricing that would effectively amount to a government fixed maximum price for important medications.  While the process that would be used to do this is sugar-coated as negotiation the design essentially would be one of price-setting rather than open-market, transparent and true negotiation.  Further, the consequences of this Federally mandated price control would have a very detrimental impact on long-term medication innovation and the overall ability of the essential pharmaceutical industry to innovate and to step-up, as it has in response to the COVID-19 pandemic with vaccines, monoclonal antibodies and soon oral medications to treat COVID-19.

 

MHN believes that those legislators on both sides of the aisle who have carefully read and analyzed the legislation and price-setting approach and understood the dangers it poses to access, long-term price management and innovation got it right by opposing the approaches proposed in the Build Back Better legislation.   MHN encourages these legislators to stand fast in their advocacy for access and true market-based approaches to manage prescription drug costs and not cave to pressures to change their positions.  MHN encourages other legislators on both sides of the aisle to carefully review the true nature of the approaches being put forward and similarly reject them.

 

Government price setting is not an effective way to lower drug pricing.  Instead, Men’s Health Network urges the Biden administration and Congress to pursue other types of free market policies to drive down costs and maintain quality care and access to medications.  For example, we supported the previous administration’s Executive Order that directed all negotiated savings from pharmaceutical purchasing contracting to be returned to consumers to lower out of pocket costs.

 

Furthermore, given the important impact this type of pricing policy will have on the efficacy of health care in the United States and the well-being of patients across the country, Men’s Health Network strongly urges policy makers and regulators as well as private sector decision makers to adhere to the following principles to ensure that proposed reforms are focused on ultimately benefiting patients through quality care.

 

MHN Recommendation For Five Key Principles to Sound Prescription Medication Pricing Reform:

 

Prioritize Straightforward and Effective Reforms

Create systems and procedures that are simple, transparent, understandable and effective. This is of paramount importance to restoring the faith of patients in a system that has become mysterious, veiled in secrecy and overly complex and convoluted.

 

Ensure Cost Reductions Are Passed to Patients

Any reforms must honor the tenant that was at the forefront of establishing the current system by returning the lion’s share of cost savings – whether they be from contract-rates, rebates, price concessions or whatever – to the patient.  Further, the goal of reform should be to reduce patient out-of-pocket expenditures for prescription medications from current levels, rather than just holding the line on costs which are already problematic for many.  Returning cost savings to insurance companies and PBMs (most of which are interlaced) or any other entity other than the patient is wrong.

 

Protect Access to Care

Pricing reforms must be such that they do not impede access to treatments.  A “Rob Peter To Pay Paul” strategy where short term caps are imposed at the expense of significantly higher premiums or more restrictive access has not worked.  If caps are instituted, they should be designed in a way to reduce out-of-pocket expenses without compromising other core elements of prescription care or access.

 

Preserve the Provider/Patient Relationship

Access to the full spectrum of medications and innovative therapies should not be restricted by limited formularies or an undue trial-and-error process.  The selection of therapeutic alternatives must honor the wishes and values of patients within a system that keeps the patient-healthcare provider relationship as the focal point of treatment decision making.

 

Allow Markets (Not Government) to Reduce Prices

Pricing models and mechanisms should be market based, not dictated by government or policies.  Establishing arbitrary price targets using reference standards that are not applicable to the needs, wishes and way of life of American patients undercuts fundamental principles of free markets.

 

These five principles have one commonality – keeping the long-term best interests of patients in focus.  In the end that will fulfill the ethical and social obligations of providers, government and health benefit managers and enhance the care of patients.

 

 

Dr. Salvatore Giorgianni

View posts by Dr. Salvatore Giorgianni
Dr. Giorgianni is an expert in men's health, is Senior Science Advisor to Men's Health Network, and is a registered pharmacist. He is a recognized expert in drug regulatory and US pharmaceutical policy as well as in organizational reputation management and strategic alliance development. He has authored, co-authored or presented some 200 works in health care, industry regulation and business. He is an advisor and board member to several health advocacy associations including: Men's Health Network; American Osteopathic Medical Foundation; Kappa Psi Scholarship Foundation; Nurse Practitioner Health Care Foundation and the National Association for Continence. He is a founding member of the Dialogue on Men's Health, a presenter at the White House conference on Men's Health, and a contributor to the SAGE publication, American Journal of Men's Health. Dr. Giorgianni had a 26 year career with Pfizer Inc, where he held positions in the medical, regulatory, training, public policy, business planning, sales and marketing groups. Most recently he served as Pfizer's Director, External Relations. He also directed several publications, including the Pfizer Careers In Health Care series and The Pfizer Journal: Perspectives in Health Care and Biomedical Research.

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