Justification of Cost: Therapeutic Outcomes in Specialty Pharmacy

As the cost of specialty medications continues to rise at a rapid rate and more medications enter the specialty pharmacy space, stakeholders across the health care continuum are looking for ways to accurately quantify value. Patients, who have the most to gain, want to ensure the therapies they are receiving are the best options for their given disease state. 
Likewise, prescribers and pharmacists are seeking data to reinforce their clinical product selection, patient counseling, and monitoring parameters. Manufacturers are also extremely engaged in analyzing data and clinical response to therapies that they have developed. 
Not only do they want to continue the post marketing surveillance of their products, but they are also looking for ways to improve on existing therapies currently in use. Lastly, third party payers want prescribers, pharmacists, and manufacturers to demonstrate that patients are receiving similar clinical benefits that have previously been documented in the FDA trials which led to the product’s approval. 
Perhaps the best way to quantify value of these therapies is through patient outcomes. Several questions arise when discussing outcomes measures.
  1.  What types of outcomes should be measured?  
  2.  How will outcomes be measured?  
  3.  How much customization is required for a given therapy?  
  4.  How strictly should outcome measures be tied to reimbursement models?  
  5.  Who is responsible for collecting and reporting on outcomes?  
  6.  What constitutes a positive response to therapy?
Most importantly, patient experiences are the fundamental driving force behind reporting outcomes. By demonstrating positive responses through proper medication utilization and therapy management, both pharmacists and manufacturers can demonstrate the value of treatment to payers. 
It provides an opportunity to highlight components of care that improve the patient journey. Through the proof of outcomes, pharmacies are able to maintain a line of business with existing and potential business partners, along with meeting contractual obligations. 
Clinical responses are often times difficult to quantify. A key measure to show clinical improvement is a proper baseline measurement. 
Ideally, this baseline measure will have a quantifiable value. For example, medications that treat congestive heart failure may use a 6-minute walk test.
Therapies that treat HIV would measure viral load, and hepatitis C therapies would examine the sustained virologic response 12 weeks following completion of therapy. Additionally, patient reported outcomes, such as quality of life and improvement in activities of daily living for select treatments may be appropriate to use. 

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